The Administrative Procedure Act governs the procedure for the adoption, amendment, or repeal of regulations by state agencies and for the review of those regulatory actions by the Office of Administrative Law.

Existing law establishes within state government the State Department of Public Health for purposes of administering certain duties and powers related to public health, as specified. Existing law authorizes the department to adopt and enforce regulations for the execution of its duties, as specified.

This bill would require the State Department of Public Health to report to the Legislature by January 1, 2020, on its efforts to update or modernize its regulations, as specified, including with regard to its use of program flex waivers. The bill would also require the department to focus on adopting amendments to regulations related to cardiovascular surgery and cardiac catheterization laboratory services. The bill would require a health facility that received program flexibility from the department to post a notice stating that it has been approved for program flexibility and where documents are available for inspection, as specified. The bill would prohibit a health facility from being required to post the documents requesting or granting program flexibility.

The Administrative Procedure Act governs the procedure for the adoption, amendment, or repeal of regulations by state agencies and for the review of those regulatory actions by the Office of Administrative Law.

Existing law establishes within state government the State Department of Public Health for purposes of administering certain duties and powers related to the public health, as specified. Existing law authorizes the department to adopt and enforce regulations for the execution of its duties, as specified.

This bill would require the State Department of Public Health to report to the Legislature annually by January 1, 2020, on its efforts to update or modernize its regulations, as specified, including with regard to its use of program flex waivers. The bill would also require the department to focus on adopting amendments to regulations that tend to receive the highest number of program flex waivers, as specified. related to cardiovascular surgery and cardiac catheterization laboratory services. The bill would require a health facility that received program flexibility from the department to post a notice stating that it has been approved for program flexibility and where documents are available for inspection, as specified. The bill would prohibit a health facility from being required to post the documents requesting or granting program flexibility.

The Administrative Procedure Act governs the procedure for the adoption, amendment, or repeal of regulations by state agencies and for the review of those regulatory actions by the Office of Administrative Law.

Existing law establishes within state government the State Department of Public Health for purposes of administering certain duties and powers related to the public health, as specified. Existing law authorizes the department to adopt and enforce regulations for the execution of its duties, as specified.

This bill would require the State Department of Public Health to report to the Legislature annually on its efforts to update or modernize its regulations, as specified, including with regard to its use of program flex waivers. The bill would also require the department to focus on adopting amendments to regulations that tend to receive the highest number of program flex waivers, as specified. The bill would require a health facility that received program flexibility from the department to post a notice stating that it has been approved for program flexibility and where documents are available for inspection, as specified. The bill would prohibit a health facility from being required to post the documents requesting or granting program flexibility.

The Administrative Procedure Act governs the procedure for the adoption, amendment, or repeal of regulations by state agencies and for the review of those regulatory actions by the Office of Administrative Law.

Existing law establishes within state government the State Department of Public Health for purposes of administering certain duties and powers related to the public health, as specified. Existing law authorizes the department to adopt and enforce regulations for the execution of its duties, as specified.

This bill would require the State Department of Public Health to report to the Legislature annually on its efforts to update or modernize its regulations, as specified, including with regard to its use of program flex waivers. The bill would also require the department to focus on adopting amendments to regulations that tend to receive the highest number of program flex waivers, as specified. The bill would require a health facility that received program flexibility from the department to post a notice stating that it has been approved for program flexibility and where documents are available for inspection, as specified. The bill would prohibit a health facility from being required to post the documents requesting or granting program flexibility.

The Administrative Procedure Act governs the procedure for the adoption, amendment, or repeal of regulations by state agencies and for the review of those regulatory actions by the Office of Administrative Law.

Existing law establishes within state government the State Department of Public Health for purposes of administering certain duties and powers related to the public health, as specified. Existing law authorizes the department to adopt and enforce regulations for the execution of its duties, as specified.

This bill would require the State Department of Public Health to report to the Legislature annually on its efforts to update or modernize its regulations, as specified, including with regard to its use of program flex waivers. The bill would also require the department to focus on adopting amendments to regulations that tend to receive the highest number of program flex waivers, as specified.

 THIRD READING  

Bill No: AB 1225

Author: Patterson (R)

Amended: 6/18/18 in Senate

Vote: 21

SENATE HEALTH COMMITTEE: 2-2, 7/5/17 (FAIL)

AYES: Nguyen, Nielsen

NOES: Hernandez, Leyva

NO VOTE RECORDED: Atkins, Mitchell, Monning, Newman, Roth

SENATE HEALTH COMMITTEE: 9-0, 6/27/18

AYES: Pan, Nguyen, Beall, Hernandez, Leyva, Mitchell, Monning, Nielsen, Roth

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

ASSEMBLY FLOOR: 77-0, 5/11/17 (Consent) - See last page for vote

SUBJECT: State Department of Public Health: regulations and program flexibility

SOURCE: Author

DIGEST:

This bill requires the Department of Public Health (DPH) to report to the Legislature by January 1, 2020, on its efforts to update regulations regarding health facilities, and also on its use of program flex waivers, and requires DPH to prioritize the adoption of specified regulations relating to cardiovascular surgery and cardiac catheterization laboratories.

ANALYSIS:

Existing law:

1. Licenses and regulates various types of health facilities by DPH, including hospitals, long-term care facilities, primary care clinics, and specialty clinics, among others.
2. Requires DPH to adopt reasonable rules and regulations as may be necessary to enable DPH to carry out the purposes of provisions of law governing the various types of facilities licensed by DPH.
3. Establishes, under the Administrative Procedures Act (APA), a process for adopting, amending, or repealing regulations through the Office of Administrative Law (OAL).
4. Permits DPH to approve the use of program flexibility to permit facilities to use alternate methods of compliance with regulations, with the prior written approval of DPH.

This bill:

1. Requires DPH to report to the Legislature by January 1, 2020, on its efforts to update or modernize its regulations under Division 5 of Title 22 of the California Code of Regulations to better reflect modern day best practices and technologies with regard to DPH’s administration of those codes and also its use of program flex waivers. Requires this report to be submitted in compliance with specified requirements in law governing legislative reports.
2. Requires DPH to focus on, an prioritize, adoption of amendments to the following regulations:
   1. Sections 70435 and 70437 of Title 22 of the California Code of Regulations, related to cardiovascular surgery staff, equipment, and supplies; and,
   2. Sections 70438, 70438.1, and 70438.2 of Title 22 of the California Code of Regulations, relating to staffing requirements and procedural limitations with cardiac catheterization laboratories.
3. Requires a licensed health facility, which has been granted program flexibility by DPH, to post a notice immediately adjacent to the public posting of the health facility’s license, stating that program flexibility has been approved and is available for inspection. Requires the notice to also state where the documents are available for inspection, and specifies that the facility is not required to post the documents requesting or granting program flexibility.

Comments

1. Author’s statement. According to the author, this bill is needed to bring healthcare regulations up to date with modern day practices. Title 22 – the regulatory body of codes and regulations that DPH adheres to regulate hospitals and other facilities – has not kept up in recent decades with the technological advancements made in the healthcare industry. Despite the codes and regulations being decades old, there is no formal process that the department must undertake to evaluate whether a regulation from the 1970s or ’80s still makes sense in 2017. Understanding that updating all of Title 22 is a large task, this bill first asks DPH for a one-time report on the status of reviewing and updating Title 22 regulations. It then directs DPH to focus first on amending and updating two specific sections which are most often granted program flexibility, which highlights their need to be reviewed and updated promptly.
2. DPH has begun seeking input on cardiovascular surgery and cardiac catheterization regulations. This bill requires DPH to prioritize updating regulations regarding cardiac surgery, as well as those pertaining to cardiac catheterization labs. With regard to cardiovascular surgery requirements, one of the problems is that the regulations require a minimum of three surgeons to constitute a surgical team, but the third physician requirement is frequently waived and replaced with a nurse. The regulations for cardiac catheterization laboratories still requires equipment such as videotape recording and playback equipment, as well as magnetic tape recording and playback equipment, among other things. Additionally, the procedures that can be performed in cardiac catheterization laboratories are limited by the regulations, and these limits do not encompass all the procedures that are now part of current practice.

On June 12, 2018, DPH sent a letter to all hospitals announcing that they were seeking assistance in amending the cardiovascular surgery service and cardiac catheterization laboratory service regulations, and were requesting input from interested stakeholders by June 29th. This is the first step in the process of revising regulations, and DPH estimates that these regulations will be completed in 2020.

1. Title 22 and program flex. Division 5 of Title 22 contains the regulations that govern the different types of health facilities, home health agencies and clinics. However, there a number of places in the Health and Safety Code which permit DPH to grant “program flexibility” to comply with the law in an alternate manner. For example, in the statutes governing primary and specialty clinics, the statutes permit applications for program flexibility for the use of “alternate concepts, methods, procedures, techniques, equipment, personnel qualifications, bulk purchasing of pharmaceuticals, or conducting of pilot projects as long as statutory requirements are met and the use has the prior written approval” of DPH. With regard to hospitals, there is similar explicit author to permit DPH to grant program flexibility with regard to hospital building code requirements, among other provisions of law. DPH has a form on its Web site for facilities to request program flexibility, which simply asks what section of Title 22 is being requested for program flexibility, and what is the proposed alternate method for meeting the intent of the regulations. According to DPH, since January 1, 2012, DPH as approved 962 program flexes, received from 13 types of facilities, for more than 140 types of regulations. DPH reports that most (66%) of the program flexes were requested by general acute care hospitals, followed by skilled nursing facilities (15%) and home health agencies (10%). DPH states that on average, 192 program flexes have been approved per year.
2. Regulatory process. According to OAL, the regulatory process is designed to provide the public with a meaningful opportunity to participate in the adoption of regulations or rules that have the force of law and to ensure the creation of an adequate record for the public, OAL, and judicial review. OAL is responsible for reviewing administrative regulations proposed by over 200 state agencies for compliance with the standards set forth in the APA. To initiate a rulemaking action, an agency first issues a public notice, and has one year within which to complete the rulemaking and submit to OAL. The APA requires a minimum of 45-days comment to the agency, in writing, on the proposed regulation. After the initial public comment period, changes to the initial proposal may be made. Agencies must make each substantial, sufficiently related change available for public comment for at least 15 days before adoption. Upon receipt of a proposed regulation, OAL has 30 working days to conduct its review and determine whether it demonstrates that the agency satisfied the procedural requirement of the APA, and review the proposed regulations for compliance with the six legal standards set forth in the APA. According to DPH, their experience is that a relatively simple regulation packet could move through the process in as few as 15-18 months, while regulations pertaining to more complicated subject matter can sometimes take several years, depending on the volume of public comments.
3. DPH and troubled history of adopting regulations. There has been a longstanding problem in DPH of ignoring mandates to adopt regulations. In 2008-09, the Legislative Analyst’s Office, in analyzing the health and social services budget, reported that “the Department of Public Health is slow to promulgate regulations and consequently, state laws are not being enforced or applied consistently across the state. We recommend the department report at budget hearings on the status of the development and promulgation of unissued regulations.” This problem has affected health care facilities, labs, pharmacies, and narcotic treatment facilities, among others. There have been a number of bills that have come through the Senate Health Committee to work around outdated regulations, without leaving facilities unregulated entirely. Those bills have been drafted to address specific instances in which an outdated regulation was limiting the ability of providers to practice in the most effective manner. For example, federal regulations were amended in 2001 to allow for Sunday or holiday closure of methadone clinics in certain cases while state regulations have not been updated for over 20 years and require methadone clinics to be open seven days a week. There are take-home doses of methadone available that are safe to use, ensuring that patients do not have a break in treatment if a facility were closed one day a week. Another bill heard by the Senate Health Committee permits pharmacy technicians, rather than pharmacists, to check expiration dates on the labels of drugs in a hospital pharmacy – something currently prohibited by a regulation not updated since its promulgation in 1986.

However, while it has taken a long time, new regulations are moving forward. According to DPH, its Center for Health Care Quality reorganized its Policy and Enforcement Branch in 2015 to create a regulations unit in the Policy Section. The unit is staffed by four full-time Associate Governmental Program Analysts and one Staff Services Manager I, all of whom work exclusively on regulations development. DPH reports that it is currently working on 21 regulatory packages that are at different stages in the development process, including regulations on hospice providers, certified hemodialysis technician training programs, intermediate care facility/developmentally disable-nursing facilities, pediatric day health facilities, skilled nursing facilities 3.5 direct care hours, and certified nursing assistant and home health aide training, among others. There are currently 12 regulatory packages which have not been started, including several updates to standards of care for specified general acute care hospital services, an update to requirements establishing minimum, specific, and numerical nurse-to-patient ratios for direct care givers in acute psychiatric hospitals, and regulations that are needed to establish standards that govern Congregate Living Health Facilities. DPH states that the last regulatory package in the work plan is scheduled to be filed at the Secretary of State Office in 2024, and as new laws are chaptered requiring clarification, Title 22 will continue to be updated.

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

SUPPORT: (Verified 8/7/18)

California Hospital Association

California Physical Therapy Association

Central Valley Pharmacist Association

Community Medical Centers of Fresno

Nursing Leadership Coalition of the Central San Joaquin Valley

Saint Agnes Medical Center

Sierra View Medical Center

Tenet Healthcare

Valley Children’s Healthcare

OPPOSITION: (Verified 8/9/18)

California Nurses Association

Department of Finance

Department of Public Health

ARGUMENTS IN SUPPORT: The Nursing Leadership Coalition of the Central San Joaquin Valley (NLC) states in support that this bill requires DPH to focus efforts on updating regulations, including those that reference roles and equipment in cardiac care flows that have not existed in years. NLC points out that three cardiac surgeons are no longer required for an open heart procedure, nor would it be a good use of this expert clinician time. This bill is supported by Tenet Healthcare who states that their hospitals each maintain a dozen or more flex plans, with a large number filed for the purpose of allowing the hospital to follow current law or medical best practices that are at odds with the outdated Title 22. Tenet states that regulatory flexibility should serve to address unique situations, yet the historical lack of timely updates to Title 22 has created an administrative burden for both hospitals and DPH. Tenet strongly supports the prioritization of Title 22 updates to focus on eliminating the needs for routine flex plans. Valley Children’s Healthcare states that despite many Title 22 codes and regulations being decades old, there is no formal process that DPH must undertake to evaluate whether a regulation from the 1970s or 80s still makes sense in 2017. Community Medical Centers of Fresno states in support that Title 22 needs updating in order to accommodate the ever-changing healthcare environment. The California Physical Therapy Association states in support that regulations are important for patient safety, and it is important that periodically there is a process in which DPH evaluates the regulations and best practices given the changing landscape of healthcare delivery.

ARGUMENTS IN OPPOSITION: DPH is opposed to this bill, stating that it has already instituted a multi-year plan to revise Title 22 regulations. According to DPH, it has recently implemented new strategies to increase its ability to complete and update regulations, which include reorganizing the Center for Health Care Quality’s Policy and Enforcement Branch in 2015 to create a regulations unit in the Policy Section. DPH states that the staff in this unit works exclusively on regulations development. DPH states that part of the regulation development for the modernization of Title 22 regulations includes examining those regulations that receive a high number of program flex requests, and revising these regulations as necessary. Because DPH frequently reports, upon request, to various committees the status of regulation packages pertaining to Title 22, DPH states a statutory reporting requirement is also unnecessary, and that existing law already requires health facilities to post program flexes next to their license so the public has the opportunity to review and inspect the facility’s approved program flexes.

The California Nurses Association (CNA) is opposed to this bill because it would reduce transparency of program flexibility waivers by no longer requiring hospitals to post the actual program flexibility waiver, making it more difficult for nurses, patients, and their family members to access this important information. Additionally, CNA opposes the provision of this bill requiring the prioritization of regulatory changes for cardiac procedures because it does not include protective guidelines to protect minimum safe staffing standards.

ASSEMBLY FLOOR: 77-0, 5/11/17

AYES: Acosta, Aguiar-Curry, Travis Allen, Arambula, Baker, Berman, Bigelow, Bloom, Bocanegra, Bonta, Brough, Burke, Caballero, Calderon, Cervantes, Chau, Chávez, Chen, Chiu, Choi, Chu, Cooley, Cooper, Cunningham, Dababneh, Daly, Eggman, Flora, Fong, Frazier, Friedman, Gallagher, Cristina Garcia, Eduardo Garcia, Gipson, Gloria, Gomez, Gonzalez Fletcher, Gray, Grayson, Harper, Holden, Irwin, Jones-Sawyer, Kalra, Kiley, Lackey, Levine, Limón, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Muratsuchi, Nazarian, Obernolte, Quirk, Quirk-Silva, Reyes, Ridley-Thomas, Rodriguez, Rubio, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Voepel, Waldron, Weber, Wood, Rendon

NO VOTE RECORDED: Dahle, O'Donnell, Patterson

Prepared by: Vincent D. Marchand / HEALTH / (916) 651-4111

8/9/18 13:38:58

**** END ****

SENATE COMMITTEE ON HEALTH

Senator Dr. Richard Pan, Chair

BILL NO: AB 1225

SUBJECT: State Department of Public Health: regulations and program flexibility

SUMMARY:

Requires the Department of Public Health (DPH) to report to the Legislature by January 1, 2020 on its efforts to update regulations regarding health facilities, and also on its use of program flex waivers, and requires DPH to prioritize the adoption of specified regulations relating to cardiovascular surgery and cardiac catheterization laboratories.

Existing law:

1. Licenses and regulates various types of health facilities by DPH, including hospitals, long-term care facilities, primary care clinics, and specialty clinics, among others.
2. Requires DPH to adopt reasonable rules and regulations as may be necessary to enable DPH to carry out the purposes of provisions of law governing the various types of facilities licensed by DPH.
3. Establishes, under the Administrative Procedures Act (APA), a process for adopting, amending, or repealing regulations through the Office of Administrative Law (OAL).
4. Permits DPH to approve the use of program flexibility to permit facilities to use alternate methods of compliance with regulations, with the prior written approval of DPH.

This bill:

1. Requires DPH to report to the Legislature by January 1, 2020, on its efforts to update or modernize its regulations under Division 5 of Title 22 of the California Code of Regulations to better reflect modern day best practices and technologies with regard to DPH’s administration of those codes and also its use of program flex waivers. Requires this report to be submitted in compliance with specified requirements in law governing legislative reports.
2. Requires DPH to focus on, an prioritize, adoption of amendments to the following regulations:
   1. Sections 70435 and 70437 of Title 22 of the California Code of Regulations, related to cardiovascular surgery staff, equipment, and supplies; and,
   2. Sections 70438, 70438.1, and 70438.2 of Title 22 of the California Code of Regulations, relating to staffing requirements and procedural limitations with cardiac catheterization laboratories.
3. Requires a licensed health facility, which has been granted program flexibility by DPH, to post a notice immediately adjacent to the public posting of the health facility’s license, stating that program flexibility has been approved and is available for inspection. Requires the notice to also state where the documents are available for inspection, and specifies that the facility is not required to post the documents requesting or granting program flexibility.

FISCAL EFFECT:

According to the Assembly Appropriations Committee, minor and absorbable costs to DPH to comply with this bill (Licensing and Certification Program Fund).

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, this bill is needed to bring healthcare regulations up to date with modern day practices. Title 22 – the regulatory body of codes and regulations that DPH adheres to regulate hospitals and other facilities – has not kept up in recent decades with the technological advancements made in the healthcare industry. Despite the codes and regulations being decades old, there is no formal process that the department must undertake to evaluate whether a regulation from the 1970s or 80s still makes sense in 2017. Understanding that updating all of Title 22 is a large task, this bill first asks DPH for a one-time report on the status of reviewing and updating Title 22 regulations. It then directs DPH to focus first on amending and updating two specific sections which are most often granted program flexibility, which highlights their need to be reviewed and updated promptly.
2. DPH has begun seeking input on cardiovascular surgery and cardiac catheterization regulations. This bill requires DPH to prioritize updating regulations regarding cardiac surgery, as well as those pertaining to cardiac catheterization labs. With regard to cardiovascular surgery requirements, one of the problems is that the regulations require a minimum of three surgeons to constitute a surgical team, but the third physician requirement is frequently waived and replaced with a nurse. The regulations for cardiac catheterization laboratories still requires equipment such as videotape recording and playback equipment, as well as magnetic tape recording and playback equipment, among other things. Additionally, the procedures that can be performed in cardiac catheterization laboratories are limited by the regulations, and these limits do not encompass all the procedures that are now part of current practice.
   
   On June 12, 2018, DPH sent a letter to all hospitals announcing that they were seeking assistance in amending the cardiovascular surgery service and cardiac catheterization laboratory service regulations, and were requesting input from interested stakeholders by June 29^th. This is the first step in the process of revising regulations, and DPH estimates that these regulations will be completed in 2020.
3. Title 22 and program flex. Division 5 of Title 22 contains the regulations that govern the different types of health facilities, home health agencies and clinics. However, there a number of places in the Health and Safety Code which permit DPH to grant “program flexibility” to comply with the law in an alternate manner. For example, in the statutes governing primary and specialty clinics, the statutes permit applications for program flexibility for the use of “alternate concepts, methods, procedures, techniques, equipment, personnel qualifications, bulk purchasing of pharmaceuticals, or conducting of pilot projects as long as statutory requirements are met and the use has the prior written approval” of DPH. With regard to hospitals, there is similar explicit author to permit DPH to grant program flexibility with regard to hospital building code requirements, among other provisions of law. DPH has a form on its website for facilities to request program flexibility, which simply asks what section of Title 22 is being requested for program flexibility, and what is the proposed alternate method for meeting the intent of the regulations. According to DPH, since January 1, 2012, DPH as approved 962 program flexes, received from 13 types of facilities, for more than 140 types of regulations. DPH reports that most (66%) of the program flexes were requested by general acute care hospitals, followed by skilled nursing facilities (15%) and home health agencies (10%). DPH states that on average, 192 program flexes have been approved per year.
4. Regulatory process. According to OAL, the regulatory process is designed to provide the public with a meaningful opportunity to participate in the adoption of regulations or rules that have the force of law and to ensure the creation of an adequate record for the public, OAL, and judicial review. OAL is responsible for reviewing administrative regulations proposed by over 200 state agencies for compliance with the standards set forth in the APA. To initiate a rulemaking action, an agency first issues a public notice, and has one year within which to complete the rulemaking and submit to OAL. The APA requires a minimum of 45-days comment to the agency, in writing, on the proposed regulation. After the initial public comment period, changes to the initial proposal may be made. Agencies must make each substantial, sufficiently related change available for public comment for at least 15 days before adoption. Upon receipt of a proposed regulation, OAL has 30 working days to conduct its review and determine whether it demonstrates that the agency satisfied the procedural requirement of the APA, and review the proposed regulations for compliance with the six legal standards set forth in the APA. According to DPH, their experience is that a relatively simple regulation packet could move through the process in as few as 15-18 months, while regulations pertaining to more complicated subject matter can sometimes take several years, depending on the volume of public comments.
5. DPH and troubled history of adopting regulations. There has been a longstanding problem in DPH of ignoring mandates to adopt regulations. In 2008-09, the Legislative Analyst’s Office, in analyzing the health and social services budget, reported that “the Department of Public Health is slow to promulgate regulations and consequently, state laws are not being enforced or applied consistently across the state. We recommend the department report at budget hearings on the status of the development and promulgation of unissued regulations.” This problem has affected health care facilities, labs, pharmacies, and narcotic treatment facilities, among others. There have been a number of bills that have come through this Committee to work around outdated regulations, without leaving facilities unregulated entirely. Those bills have been drafted to address specific instances in which an outdated regulation was limiting the ability of providers to practice in the most effective manner. For example, federal regulations were amended in 2001 to allow for Sunday or holiday closure of methadone clinics in certain cases while state regulations have not been updated for over 20 years and require methadone clinics to be open seven days a week. There are take-home doses of methadone available that are safe to use, ensuring that patients do not have a break in treatment if a facility were closed one day a week. Another bill heard by this Committee permits pharmacy technicians, rather than pharmacists, to check expiration dates on the labels of drugs in a hospital pharmacy – something currently prohibited by a regulation not updated since its promulgation in 1986.
   
   However, while it has taken a long time, new regulations are moving forward. According to DPH, its CHCQ reorganized its Policy and Enforcement Branch in 2015 to create a regulations unit in the Policy Section. The unit is staffed by four full-time Associate Governmental Program Analysts and one Staff Services Manager I, all of whom work exclusively on regulations development. DPH reports that it is currently working on 21 regulatory packages that are at different stages in the development process, including regulations on hospice providers, certified hemodialysis technician training programs, intermediate care facility/developmentally disable-nursing facilities, pediatric day health facilities, skilled nursing facilities 3.5 direct care hours, and certified nursing assistant and home health aide training, among others. There are currently 12 regulatory packages which have not been started, including several updates to standards of care for specified general acute care hospital services, an update to requirements establishing minimum, specific, and numerical nurse-to-patient ratios for direct care givers in acute psychiatric hospitals, and regulations that are needed to establish standards that govern Congregate Living Health Facilities. DPH states that the last regulatory package in the work plan is scheduled to be filed at the Secretary of State office in 2024, and as new laws are chaptered requiring clarification, Title 22 will continue to be updated.
6. Related legislation. AB 2679 (O’Donnell) requires DPH to amend specified regulations related to the laundry process for hospital linens, by January 1, 2020, to reflect modern advancements in linen laundry processes. AB 2679 passed the Senate Health Committee by a vote of 8-0 on June 20, 2018.
7. Prior legislation. AB 614 (Brown, Chapter 435, Statutes of 2015) permits DPH, without taking regulatory action, to update references in the California Code of Regulations (CCR) to health care standards of practice adopted by a recognized state or national association when the state or national association and its outdated standards are already named in the CCR.

AB 2425 (Quirk, Chapter 570, Statutes of 2014) provides for a temporary exemption from complying with existing regulations for law enforcement laboratories engaging in forensic alcohol analysis tests if the laboratory is accredited and provides the exemption only until DPH updates their existing regulations.

AB 1822 (Bonta of 2014) would have allowed certain health care providers to store unused tissue without being licensed as a tissue bank, provided they maintain the tissue in accordance with the manufacturers' instructions and the tissue is regulated by the federal Food and Drug Administration. AB 1822 was vetoed by the Governor.

AB 1312 (Brown of 2013) would have authorized DPH, without taking regulatory action, to update references in regulations to health care standards of practice adopted by a recognized state or national association. AB 1312 was held in the Assembly Health Committee.

SB 534 (Hernandez, Chapter 722, Statutes of 2013) required four types of health facility categories to comply with facility-specific federal certification requirements to meet state licensing requirements until DPH adopted state regulations.

1. Support. The Nursing Leadership Coalition of the Central San Joaquin Valley (NLC) states in support that this bill requires DPH to focus efforts on updating regulations, including those that reference roles and equipment in cardiac care flows that have not existed in years. NLC points out that three cardiac surgeons are no longer required for an open heart procedure, nor would it be a good use of this expert clinician time. This bill is supported by Tenet Healthcare states in support that their hospitals each maintain a dozen or more flex plans, with a large number filed for the purpose of allowing the hospital to follow current law or medical best practices that are at odds with the outdated Title 22. Tenet states that regulatory flexibility should serve to address unique situations, yet the historical lack of timely updates to Title 22 has created an administrative burden for both hospitals and DPH. Tenet strongly supports the prioritization of Title 22 updates to focus on eliminating the needs for routine flex plans. Valley Children’s Healthcare states that despite many Title 22 codes and regulations being decades old, there is no formal process that DPH must undertake to evaluate whether a regulation from the 1970s or 80s still makes sense in 2017. Community Medical Centers states in support that Title 22 needs updating in order to accommodate the ever-changing healthcare environment. The California Physical Therapy Association states in support that regulations are important for patient safety, and it is important that periodically there is a process in which DPH evaluates the regulations and best practices given the changing landscape of healthcare delivery.
2. Opposition. DPH is opposed to this bill, stating that it has already instituted a multi-year plan to revise Title 22 regulations. According to DPH, it has recently implemented new strategies to increase its ability to complete and update regulations, which include reorganizing the Center for Health Care Quality’s Policy and Enforcement Branch in 2015 to create a regulations unit in the Policy Section. DPH states that the staff in this unit works exclusively on regulations development. DPH states that part of the regulation development for the modernization of Title 22 regulations includes examining those regulations that receive a high number of program flex requests, and revising these regulations as necessary. Because DPH frequently reports, upon request, to various committees the status of regulation packages pertaining to Title 22, DPH states a statutory reporting requirement is also unnecessary, and that existing law already requires health facilities to post program flexes next to their license so the public has the opportunity to review and inspect the facility’s approved program flexes.

SUPPORT AND OPPOSITION:

Support: California Hospital Association

California Physical Therapy Association

Central Valley Pharmacist Association

Community Centers of Fresno

Nursing Leadership Coalition of the Central San Joaquin Valley

Sierra View Medical Center

Tenet Health

Valley Children’s Healthcare

Oppose: California Department of Public Health

-- END --

SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: AB 1225

SUBJECT: State Department of Public Health: regulations and program flexibility

SUMMARY:

Requires the Department of Public Health (DPH) to report to the Legislature annually on its efforts to update regulations regarding health facilities, and also on its use of program flex waivers, and requires DPH to prioritize the adoption of regulations that receive the highest number of program flex waivers once all outstanding regulatory packages have been completed.

Existing law:

1. Licenses and regulates various types of health facilities by DPH, including hospitals, long-term care facilities, primary care clinics, and specialty clinics, among others.
2. Requires DPH to adopt reasonable rules and regulations as may be necessary to enable DPH to carry out the purposes of provisions of law governing the various types of facilities licensed by DPH.
3. Establishes, under the Administrative Procedures Act (APA), a process for adopting, amending, or repealing regulations through the Office of Administrative Law (OAL).
4. Permits DPH to approve the use of program flexibility to permit facilities to use alternate methods of compliance with regulations, with the prior written approval of DPH.

This bill:

1. Requires DPH to report to the Legislature annually on its efforts to update or modernize its regulations under Division 5 of Title 22 of the California Code of Regulations to better reflect modern day best practices and technologies with regard to DPH’s administration of those codes and also its use of program flex waivers. Requires this report to be submitted in compliance with specified requirements in law governing legislative reports.
2. Requires DPH, once all outstanding regulatory packages have been completed, to thereafter focus on, and prioritize, the adoption of amendments to regulations that tend to receive the highest number of program flex waivers, as reported pursuant to this bill, for purposes of updating those regulations and avoiding overuse of the program flex waiver.
3. Requires a licensed health facility, which has been granted program flexibility by DPH, to post a notice immediately adjacent to the public posting of the health facility’s license, stating that program flexibility has been approved and is available for inspection. Requires the notice to also state where the documents are available for inspection, and specifies that the facility is not required to post the documents requesting or granting program flexibility.

FISCAL EFFECT:

According to the Assembly Appropriations Committee, minor and absorbable costs to DPH to comply with this bill (Licensing and Certification Program Fund).

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, this bill is needed to bring healthcare regulations up to date with modern day practices. Title 22 – the regulatory body of codes and regulations that DPH adheres to regulate hospitals and other facilities – has not kept up in recent decades with the technological advancements made in the healthcare industry. Despite the codes and regulations being decades old, there is no formal process that the department must undertake to evaluate whether a regulation from the 1970s or 80s still makes sense in 2017. Technological and healthcare advancements have modernized the manner of which institutions can provide healthcare. Regulations, especially in healthcare, are important for patient safety however it is important that there is a process in which DPH periodically evaluates the regulations and best practices given the changing landscape of healthcare delivery. This bill is needed to ensure that regulations that are out of date are being examined by the DPH in order to update them into a dynamic 21st century healthcare delivery system.
2. Title 22 and program flex. Division 5 of Title 22 contains the regulations that govern the different types of health facilities, home health agencies and clinics. However, there a number of places in the Health and Safety Code which permit DPH to grant “program flexibility” to comply with the law in an alternate manner. For example, in the statutes governing primary and specialty clinics, the statutes permit applications for program flexibility for the use of “alternate concepts, methods, procedures, techniques, equipment, personnel qualifications, bulk purchasing of pharmaceuticals, or conducting of pilot projects as long as statutory requirements are met and the use has the prior written approval” of DPH. With regard to hospitals, there is similar explicit author to permit DPH to grant program flexibility with regard to hospital building code requirements, among other provisions of law. DPH has a form on its website for facilities to request program flexibility, which simply asks what section of Title 22 is being requested for program flexibility, and what is the proposed alternate method for meeting the intent of the regulations. According to DPH, since January 1, 2012, DPH as approved 962 program flexes, received from 13 types of facilities, for more than 140 types of regulations. DPH reports that most (66%) of the program flexes were requested by general acute care hospitals, followed by skilled nursing facilities (15%) and home health agencies (10%). DPH states that on average, 192 program flexes have been approved per year.
3. Regulatory process. According to OAL, the regulatory process is designed to provide the public with a meaningful opportunity to participate in the adoption of regulations or rules that have the force of law and to ensure the creation of an adequate record for the public, OAL, and judicial review. OAL is responsible for reviewing administrative regulations proposed by over 200 state agencies for compliance with the standards set forth in the APA. To initiate a rulemaking action, an agency first issues a public notice, and has one year within which to complete the rulemaking and submit to OAL. The APA requires a minimum of 45-days comment to the agency, in writing, on the proposed regulation. After the initial public comment period, changes to the initial proposal may be made. Agencies must make each substantial, sufficiently related change available for public comment for at least 15 days before adoption. Upon receipt of a proposed regulation, OAL has 30 working days to conduct its review and determine whether it demonstrates that the agency satisfied the procedural requirement of the APA, and review the proposed regulations for compliance with the six legal standards set forth in the APA. According to DPH, their experience is that a relatively simple regulation packet could move through the process in as few as 15-18 months, while regulations pertaining to more complicated subject matter can sometimes take several years, depending on the volume of public comments.
4. DPH and troubled history of adopting regulations. There has been a longstanding problem in DPH of ignoring mandates to adopt regulations. In 2008-09, the Legislative Analyst’s Office, in analyzing the health and social services budget, reported that “the Department of Public Health is slow to promulgate regulations and consequently, state laws are not being enforced or applied consistently across the state. We recommend the department report at budget hearings on the status of the development and promulgation of unissued regulations.” This problem has affected health care facilities, labs, pharmacies, and narcotic treatment facilities, among others. There have been a number of bills that have come through this Committee to work around outdated regulations, without leaving facilities unregulated entirely. Those bills have been drafted to address specific instances in which an outdated regulation was limiting the ability of providers to practice in the most effective manner. For example, federal regulations were amended in 2001 to allow for Sunday or holiday closure of methadone clinics in certain cases while state regulations have not been updated for over 20 years and require methadone clinics to be open seven days a week. There are take-home doses of methadone available that are safe to use, ensuring that patients do not have a break in treatment if a facility were closed one day a week. Another bill heard by this Committee permits pharmacy technicians, rather than pharmacists, to check expiration dates on the labels of drugs in a hospital pharmacy – something currently prohibited by a regulation not updated since its promulgation in 1986.
   
   However, while it has taken a long time, new regulations are moving forward. According to DPH, its CHCQ reorganized its Policy and Enforcement Branch in 2015 to create a regulations unit in the Policy Section. The unit is staffed by four full-time Associate Governmental Program Analysts and one Staff Services Manager I, all of whom work exclusively on regulations development. DPH reports that it is currently working on 20 regulatory packages that are at different stages in the development process, include regulations on hospice providers, certified hemodialysis technician training programs, intermediate care facility/developmentally disable-nursing facilities, pediatric day health facilities, and certified nursing assistant and home health aide training, among others. There are currently 12 regulatory packages which have not been started, including several updates to standards of care for specified general acute care hospital services, an update to requirements establishing minimum, specific, and numerical nurse-to-patient ratios for direct care givers in acute psychiatric hospitals, and regulations that are needed to establish standards that govern Congregate Living Health Facilities. DPH states that the last regulatory package in the work plan is scheduled to be filed at the Secretary of State office in 2024, and as new laws are chaptered requiring clarification, Title 22 will continue to be updated.
   
5. Prior legislation. AB 614 (Brown, Chapter 435, Statutes of 2015) permits DPH, without taking regulatory action, to update references in the California Code of Regulations (CCR) to health care standards of practice adopted by a recognized state or national association when the state or national association and its outdated standards are already named in the CCR.

AB 2425 (Quirk, Chapter 570, Statutes of 2014) provides for a temporary exemption from complying with existing regulations for law enforcement laboratories engaging in forensic alcohol analysis tests if the laboratory is accredited and provides the exemption only until DPH updates their existing regulations.

AB 1822 (Bonta of 2014) would have allowed certain healthcare providers to store unused tissue without being licensed as a tissue bank, provided they maintain the tissue in accordance with the manufacturers' instructions and the tissue is regulated by the federal Food and Drug Administration. AB 1822 was vetoed by Governor Brown.

AB 1312 (Brown of 2013) would have authorized DPH, without taking regulatory action, to update references in regulations to health care standards of practice adopted by a recognized state or national association. AB 1312 was held in Assembly Health Committee.

SB 534 (Hernandez, Chapter 722, Statutes of 2013) requires four types of health facility categories to comply with facility-specific federal certification requirements to meet state licensing requirements until DPH adopted state regulations.

1. Support. This bill is supported by Tenet Healthcare states in support that their hospitals each maintain a dozen or more flex plans, with a large number filed for the purpose of allowing the hospital to follow current law or medical best practices that are at odds with the outdated Title 22. Tenet states that regulatory flexibility should serve to address unique situations, yet the historical lack of timely updates to Title 22 has created an administrative burden for both hospitals and DPH. Tenet strongly supports the prioritization of Title 22 updates to focus on eliminating the needs for routine flex plans. Valley Children’s Healthcare states that despite many Title 22 codes and regulations being decades old, there is no formal process that DPH must undertake to evaluate whether a regulation from the 1970s or 80s still makes sense in 2017. The Nursing Leadership Coalition of the Central San Joaquin Valley states that they have experienced the impact of trying to honor the regulations of Title 22 while administering their respective duties and responsibilities to provide safe, cost effective, quality care. Community Medical Centers states in support that Title 22 needs updating in order to accommodate the ever-changing healthcare environment. The California Physical Therapy Association states in support that regulations are important for patient safety, and it is important that periodically there is a process in which DPH evaluates the regulations and best practices given the changing landscape of healthcare delivery.
2. Opposition. DPH is opposed to this bill, stating that it has already instituted a multi-year plan to revise Title 22 regulations. According to DPH, it has recently implemented new strategies to increase its ability to complete and update regulations, which include reorganizing the Center for Health Care Quality’s Policy and Enforcement Branch in 2015 to create a regulations unit in the Policy Section. DPH states that the staff in this unit works exclusively on regulations development. DPH states that part of the regulation development for the modernization of Title 22 regulations includes examining those regulations that receive a high number of program flex requests, and revising these regulations as necessary. Because DPH frequently reports, upon request, to various committees the status of regulation packages pertaining to Title 22, DPH states a statutory reporting requirement is also unnecessary, and that existing law already requires health facilities to post program flexes next to their license so the public has the opportunity to review and inspect the facility’s approved program flexes.
3. Policy comment. As the author notes, Title 22 has not been kept up to date with advancements made in the health care industry. The lack of regulations being adopted by DPH has not gone unnoticed, and has been the subject of criticism from everyone from the regulated industries, the Legislative Analyst’s Office, both the Senate and Assembly Budget Committees, and both the Senate and Assembly Health Committees. However, after many years of frustration, DPH has recently made progress, with the creation of a dedicated unit focused on promulgating regulations, with a plan to finish updating all regulations by 2024. Additionally, DPH has been responsive to requests by Committee staff for regular updates of the progress made on regulations. With regard to prioritizing regulations based on the number of program flexes approved related to that regulation, it is unclear if this will always be the best way to prioritize regulations. DPH may need the flexibility to prioritize regulatory packages that have a greater effect on the health and safety of patients, regardless of whether or not program flexibility is granted on the subject of the regulation. DPH also states that the frequency of program flexes is factored into their plan for modernizing Title 22.

SUPPORT AND OPPOSITION:

Support: California Physical Therapy Association

Central Valley Pharmacist Association

Clovis Community Medical Center

Nursing Leadership Coalition of the Central San Joaquin Valley

Tenet Health

Valley Children’s Healthcare

Oppose: California Department of Public Health

-- END --

Date of Hearing: May 3, 2017

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez Fletcher, Chair

ABPCA Bill Id:AB 1225

Author:(Patterson) – As Amended Ver:April 20, 2017

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

SUMMARY:

This bill contains provisions related to California Department of Public Health (CDPH) facility licensure regulations. Specifically, this bill:

1. Requires CDPH to report to the Legislature annually on its efforts to update or modernize its facility licensing regulations.
2. Requires CDPH, once outstanding regulatory packages are completed, to prioritize the adoption of amendments to regulations that tend to receive the highest number of "program flexibility" waivers, for purposes of minimizing the overuse of such waivers.
3. Requires a health facility that has been granted program flexibility by the department to post a notice to that effect, as well as a notice that related documents are available for inspection.

FISCAL EFFECT:

Minor and absorbable costs to CPDH to comply with this bill (Licensing and Certification Program Fund).

COMMENTS:

1. Purpose. According to the author, this bill is needed to bring healthcare regulations up to date with modern practices. The author states CDPH regulations have not kept up in recent decades with the technological advancements made in the healthcare industry.
2. Background. CDPH is responsible for regulatory oversight of health care facilities. CDPH licenses and certifies for Medicare participation over 7,500 health care facilities and agencies in California within 30 different licensure and certification categories. In order to ensure compliance with federal and state laws, it conducts periodic inspections and complaint investigations of health care facilities, including hospitals, skilled nursing facilities, community clinics, and others. In addition to enforcing compliance with applicable laws and regulations, CDPH has authority to grant program flexibility ("program flex") which allows DPH to recognize new alternatives, approaches, and techniques that meet the intent of the regulation and are preferable to strict compliance. This bill requires CDPH prioritize the update of regulations for which large numbers of such waivers are granted, once pending regulation packages are complete.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: April 18, 2017

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 1225

Author:(Patterson) – As Amended Ver:April 17, 2017

SUBJECT: State Department of Public Health: regulations and program flexibility.

SUMMARY: Requires the Department of Public Health (DPH) to annually report to the Legislature regarding its efforts to update or modernize regulations, and on the use of program flexibility (program flex) waivers. Specifically, this bill:

1. Requires DPH, after the report has been submitted, to thereafter focus on, and prioritize, the adoption of amendments to regulations that tend to receive the highest number of program flex waivers, for purposes of updating those regulations and avoiding overuse of the program flex waiver.
2. Specifies that a health facility, as defined, that has been granted program flex by DPH, must post a notice adjacent to the public posting of the health facility's license, stating that program flex has been approved and is available for inspection. Requires the notice to state where the documents are available for inspection.

EXISTING LAW:

1. Establishes DPH to, among other functions, through the Licensing and Certification Program (L&C) ensure health care facilities comply with state laws and regulations, and oversee the certification of nurse assistants, home health aides, hemodialysis technicians, and the licensing of nursing home administrators.
2. Requires DPH to adopt, amend, or repeal, any reasonable rules and regulations necessary or proper to carry out the purposes and intent of existing law related to the licensing of health facilities and to enable DPH to exercise the powers and perform the duties conferred upon it, as specified.
3. Establishes, under the Administrative Procedures Act (APA), a process for adopting, amending, or repealing regulations through the Office of Administrative Law (OAL).
   
4. Provides DPH, through regulation, with the ability to approve the use of alternate concepts, methods, procedures, techniques, equipment, personnel qualification, or the conduction of pilot projects provided such exceptions are carried out with the provisions for safe and adequate care and with the prior written approval of DPH, also known as program flexibility.
5. Defines a health facility as all of the following:
   1. General Acute Care Hospital (GACH) means a health facility having a duly constituted governing body with overall administrative and professional responsibility and an organized medical staff that provides 24-hour inpatient care, including the following basic services: medical; nursing; surgical; anesthesia; laboratory; radiology; pharmacy; and, dietary services. A GACH includes in the definition a rural GACH, which is not required to provide surgery and anesthesia services;
   2. Acute Psychiatric Hospital (APH) is a facility that provides 24-hour inpatient care for persons with mental health disorders;
      
   3. Skilled Nursing Facility (SNF) means a facility that provides skilled nursing care and supportive care to patients whose primary need is for availability of skilled nursing care on an extended basis;
      
   4. Intermediate Care Facility (ICF) means a facility that provides inpatient care to ambulatory or non-ambulatory patients who have recurring need for skilled nursing supervision and need supportive care, but who do not require availability of continuous skilled nursing care;
   5. ICF/Developmental Disabled (DD) habilitative means a facility with a capacity of four to 15 beds that provides 24-hour personal care, habilitation, developmental, and supportive health services to persons with developmental disabilities who have intermittent recurring needs for nursing services, but have been certified by a physician as not requiring the availability of continuous skilled nursing care;
      
   6. Special Hospital means a facility that provides inpatient or outpatient care in dentistry or maternity;
   7. ICF/DD means a facility that provides 24-hour personal care, habilitation, developmental, and supportive health services to persons with developmental disabilities;
   8. ICF-DD-Nursing means a facility with a capacity of 4 to 15 beds that provides 24-hour personal care, developmental services, and nursing supervision for persons with developmental disabilities;
   9. Congregate living health facility means a residential home with a capacity of no more than 18 beds, that provides inpatient care;
   10. Correctional treatment center means a health facility operated by the California Department of Corrections and Rehabilitation (CDCR), the CDCR Division of Juvenile Facilities, or a county, city, or city and county law enforcement agency that provides inpatient health services to the portion of the inmate population who do not require a GACH level of basic services;
   11. Nursing Facility means a facility that is certified to participate as a provider of care as a skilled nursing facility in the federal Medicare or Medicaid Programs; and,
   12. ICF/DD – Continuous Nursing means a homelike facility with a capacity of four to eight beds that provides 24-hour personal care for person with developmental disabilities who need continuous skilled nursing care.

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

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, this bill is needed to bring healthcare regulations up-to-date with modern day practices. The author states that Title 22, the regulatory body of codes and regulations that DPH adheres to regulate hospitals and other facilities, has not kept up in recent decades with the technological advancements made in the healthcare industry. The author notes that, despite the codes and regulations being decades old, there is no formal process that DPH must undertake to evaluate whether a regulation from the 1970s or 80s still makes sense in 2017, and technological and healthcare advancements have modernized the manner of which institutions can provide healthcare. The author concludes that regulations, especially in healthcare, are important for patient safety however it is important that there is a process in which DPH periodically evaluates the regulations and best practices given the changing landscape of healthcare delivery.
   
2. BACKGROUND.
   1. L&C. According to the L&C Annual Report for fiscal year 2015-16, it is responsible for regulatory oversight of licensed health care facilities and health care professionals to ensure safe, effective, and quality health care for all Californians. L&C licenses and certifies over 7,500 health care facilities and agencies in California in 30 different licensure and certification categories. In order to ensure compliance with federal and state laws, it conducts periodic inspections and complaint investigations of health care facilities. Facilities regulated by L&C include, but are not limited to, nursing homes, general and psychiatric hospitals, acute care hospitals, special hospitals, community clinics, congregate living health facilities, SNFs , surgical clinics, rehabilitation clinics, dialysis clinics, correctional treatment centers and ICFs. L&C also certifies nurse assistants, home health aides, and hemodialysis technicians and licenses nursing home administrators.
   2. Regulatory process. According to the OAL, the regulatory process is designed to provide the public with a meaningful opportunity to participate in the adoption of regulations or rules that have the force of law and to ensure the creation of an adequate record for the public, OAL, and judicial review. The OAL is responsible for reviewing administrative regulations proposed by over 200 state agencies for compliance with the standards set forth in the APA. To initiate a rulemaking action, an agency first issues a public notice, and has one year within which to complete the rulemaking and submit to OAL. The APA requires a minimum of 45-days comment to the agency, in writing, on the proposed regulation. After the initial public comment period, changes to the initial proposal may be made. Agencies must make each substantial, sufficiently related change available for public comment for at least 15 days before adoption. Upon receipt of a proposed regulation, OAL has 30 working days to conduct its review and determine whether it demonstrates that the agency satisfied the procedural requirement of the APA, and review the proposed regulations for compliance with the six legal standards set forth in the APA. According to DPH, their experience is that a relatively simple regulation packet could move through the process in as few as 15-18 months, while regulations pertaining to more complicated subject matter can sometimes take several years, depending on the volume of public comments.
   3. Program flexibility. This bill requires DPH to focus on, and prioritize the adoption of amendments to regulations that tend to receive the highest number of program flex waivers. L&C has no authority to waive laws and regulations, regardless of whether or not they are outdated or obsolete as a result of changes in technology or procedures. However, in order to serve patients in health care facilities, L&C has a statutorily authorized concept called “Program Flexibility,” which recognizes that regulations cannot keep pace with modern technology and that often new alternatives, approaches, and techniques which meet the intent of the regulation is preferable to strict compliance. Program flex allows DPH to provide an exception to regulation upon request and supportive documentation. DPH's Center for Health Care Quality (CHCQ) has two Policy and Procedures (P&P) that provide guidance to L&C staff on granting program flexes for granting exemptions to Programs of All-Inclusive Care for the Elderly from licensing laws and regulations, and another to create consistency in processing a program flexibility request for the one year nursing experience requirement for home health agencies. According to DPH, L&C is currently preparing a comprehensive P&P on the topic of program flex. Currently, DPH does not track the review of program flex requests as a separate function and does not have data on the amount of time spent on that specific task. Most program flex requests are reviewed by staff in DPH district offices, while regulations are drafted by headquarters based staff.

• 1. Title 22 Code of Regulations Division 5 (Title 22). The California Code of Regulations (CCR) is a compilation of all state regulations under a single rubric. The CCR replaced the California Administrative Code in 1988. Title regulations under the code include rules and regulations regarding Education, Motor Vehicles, and Crime Prevention and Corrections. Within Title 22, 14 divisions of the code encompass those relating to Social Security. Regulations under Title 22 apply to a wide array of agencies and services provided or licensed by the state. For example, Title 22 contains rules concerning community care facilities in the state. Childcare and residential care facilities fall under the purview of the Community Care Licensing Division and must follow these regulations. Title 22 also provides information about nurse-to patient ratios, licensing and certification of health facilities, home health agencies, clinics, and referral agencies, which are overseen by DPH.
     
  2. DPH efforts to update Title 22. Over the last several years, as noted in 6) below, there have been several bills sponsored by various organizations in response to out-of-date or non-existent regulations. According to DPH, it has developed a multi-year plan for completing a comprehensive update of the Title 22 regulations within its authority and has dedicated resources assigned to completing this task. According to DPH, its CHCQ reorganized its Policy and Enforcement Branch in 2015 to create a regulations unit in the Policy Section. The unit is staffed by four full-time Associate Governmental Program Analysts and one Staff Services Manager I, all of whom work exclusively on regulations development. DPH states that the last regulatory package in the work plan is scheduled to be filed at the Secretary of State office in 2024, and as new laws are chaptered requiring clarification, Title 22 will continue to be updated.
     

Currently, DPH is working on 20 regulatory packages that are at different stages in the development process. Some of the regulations are for GACHs, for example there are pending changes to regulations regarding infection control, inpatient treatment of eating disorders, and change of ownership. Other packages focus on other facility types, such as Pediatric Day Health Facilities, ICF/DD facilities or specific requirements based on statutory requirements, such as revisions to the definition of Social Workers.

There are currently 12 regulatory packages which have not been started, including several updates to standards of care for specified GACH services including Nursing, Surgical & Anesthesia, and Patient Rights, an update to Title 22 regulatory requirements establishing minimum, specific, and numerical nurse-to-patient ratios for direct care givers in APHs by licensed nurse classification and by unit, and regulations that are needed to establish standards that govern Congregate Living Health Facilities.

1. SUPPORT. The California Hospital Association (CHA) supports this bill and states that, unfortunately, much of the current regulation is outdated and no longer relevant to current hospital delivery of care. CHA contends that the process of requesting program flexibility is time consuming for hospital staff and for DPH staff. CHA notes that program flexes are required to be posted adjacent to a facility's license, which is challenging because hospitals often have multiple binders of approved program flexes, and in fact must request a program flex to allow for only one notice listing all approved program flexes and the location where program flexes can be viewed by the public.
   
   Clovis Community Medical Center supports this bill, stating that it is important that there is a process in which DPH evaluates the regulations and best practices given the changing landscape of healthcare delivery.
2. RELATED LEGISLATION. AB 251 (Bonta) extends from January 1, 2018, to January 1, 2019, the requirement that chronic dialysis, surgical, and rehabilitation clinics comply with federal certification standards pending the adoption of regulations by DPH. Extends from January 1, 2018, to January 1, 2020, DPHs' and the Department of Developmental Services’ authority to use federal certification standards as the state licensure standard for intermediate care facilities serving developmentally disabled persons (ICF/DD-N), and to jointly adopt regulations relating to licensure of ICF/DD-N facilities. AB 251 is pending a vote on the Assembly Floor.
3. PREVIOUS LEGISLATION.
   1. AB 614 (Brown), Chapter 435, Statutes of 2015, permits DPH, without taking regulatory action, to update references in the California Code of Regulations (CCR) to health care standards of practice adopted by a recognized state or national association when the state or national association and its outdated standards are already named in the CCR.
   2. AB 2425 (Quirk), Chapter 570, Statutes of 2014, provides for a temporary exemption from complying with existing regulations for law enforcement laboratories engaging in forensic alcohol analysis tests if the laboratory is accredited and provides the exemption only until DPH updates their existing regulations.
      
   3. AB 1822 (Bonta) of 2014 would have allowed certain healthcare providers to store unused tissue without being licensed as a tissue bank, provided they maintain the tissue in accordance with the manufacturers' instructions and the tissue is regulated by the federal Food and Drug Administration. AB 1822 was vetoed by Governor Brown.
      
   4. AB 1312 (Brown) of 2013 would have authorized DPH to, without taking regulatory action, update references in regulations to health care standards of practice adopted by a recognized state or national association. AB 1312 was held in Assembly Health Committee.
      
   5. SB 534 (Hernandez), Chapter 722, Statutes of 2013, requires four types of health facility categories to comply with facility-specific federal certification requirements to meet state licensing requirements until DPH adopted state regulations.
4. POLICY COMMENT. While it is encouraging that DPH is currently engaged in an effort to update Title 22 regulations, it is troubling that the update is estimated to take seven years to complete. DPH should also examine what the barriers have been to using the APA process in an effort to ensure future required regulations are promulgated in an efficient and timely manner.
5. SUGGESTED AMENDMENTS.
   1. As currently drafted this bill references Title 22 regulations in its entirety. In order to more clearly capture the author's intent to monitor the updating of regulations related to health facilities, the Committee may wish to amend the bill to refer to Title 22, Division 5 of the California Code of Regulations.
   2. As currently drafted this bill requires DPH to annually report to the Legislature and thereafter prioritize the adoption of amendments to regulations that tend to receive the highest number of program flexibility waivers. Given that DPH still has 12 mandated regulatory packages that have not been started, the Committee may wish to amend the bill to clarify that amendments to regulations receiving program flexibility will not be prioritized until the outstanding regulatory packages have been completed.

REGISTERED SUPPORT / OPPOSITION:

Support

California Hospital Association
California Physical Therapy Association
Clovis Community Medical Center
Nursing Leadership Coalition of the Central San Joaquin Valley

Tenet Healthcare
Valley Children's Healthcare

Opposition

None on file.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097