Existing law establishes the State Department of Public Health and sets forth its powers and duties, including, but not limited to, the licensure and regulation of primary care clinics and specialty clinics. Existing law authorizes the department to adopt regulations to implement these provisions. Violation of these provisions is a crime.

Existing law, which became operative on January 1, 2018, provides that all regulations relating to licensed clinics in effect on December 31, 1977, which were adopted by the department, remain in full force and effect until altered, amended, or repealed by the department.

This bill would make those provisions inoperative until January 1, 2020, and until that date, would instead require those clinics to comply with specified federal certification standards until regulations are adopted by the department. By expanding the scope of a crime, the bill would impose a state-mandated local program.

Existing law, which became operative on January 1, 2018, requires the State Department of Public Health and the State Department of Developmental Services to jointly develop and implement licensing regulations appropriate for an intermediate care facility/developmentally disabled-nursing and an intermediate care facility/developmentally disabled-continuous nursing, as specified.

This bill would make those provisions inoperative until January 1, 2021, and until that date, would instead require those facilities to comply with specified federal certification standards until regulations are adopted by the departments. By expanding the scope of a crime, the bill would impose a state-mandated local crime.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

This bill would declare that it is to take effect immediately as an urgency statute.

Date of Hearing: April 11, 2018

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez Fletcher, Chair

ABPCA Bill Id:AB 2476

Author:(Rubio) – As Introduced Ver:February 14, 2018

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

SUMMARY:

This urgency bill restores authority that lapsed January 1, 2018, for the California Department of Public Health (CDPH) to use federal certification standards until state regulations are adopted for the following facility types: end-stage renal disease facilities (ESRDs or dialysis clinics), ambulatory surgery centers (ASCs), comprehensive outpatient rehabilitation facility (CORFs), intermediate care facilities/developmentally disabled-nursing (ICF/DD-Ns), and intermediate care facilities/developmentally disabled-continuous nursing (ICF/DD-CNs).

It includes a sunset of January 1, 2021, for the authority related to ICF/DDs and a sunset of January 1, 2020, for the authority related to other facility types.

FISCAL EFFECT:

Negligible.

COMMENTS:

1. Purpose. According to the author, this bill ensures the state can continue to enforce federal standards for those licensed clinics and developmentally disabled nursing facilities in absence of state-specific standards. Dialysis clinics support this bill, and it has no opposition.
2. Background. CDPH licenses a variety of health facility types. Federal certification, which is also enforced by the state, allows these same facilities to receive reimbursement from federally funded health care programs. Federal certification generally constitutes a minimum set of standards, but states can go beyond these standards to define state-specific licensure standards. CDPH's failure to issue state-specific standards for several facility types law has been a topic of discussion and oversight for several years. In September 2016, CDPH released an academic report produced by researchers at University of California, Davis addressing whether federal standards are sufficient as a basis for a state license. The study found California's use of federal standards is consistent with standard practice across the nation. The study concludes that expanded state-specific regulations for ASC, CORF, and ESRD facilities would be of uncertain marginal value and better compliance with existing federal regulations would address many documented quality problems. CDPH indicates the ICF-DD/N regulations are in initial development stages.
3. Related Budget Trailer Bill Language (TBL). The administration has proposed TBL that would allow the department to use the federal certification standards in perpetuity for ASCs, CORFs, and ESRDs in lieu of writing state-specific regulations, and would similarly require ICF/DD-Ns to comply with federal certification standards for intermediate care facilities for individuals with intellectual disabilities. Unlike this bill, the TBL does not encourage the department to issue regulations by a date certain.
4. Prior Legislation. SB 534 (Ed Hernandez), Chapter 722, Statutes of 2013, required the four types of health facility categories subject to this bill to comply with facility-specific federal certification requirements to meet state licensing requirements until CDPH adopted state regulations. It also required the CDPH-commissioned report discussed earlier. The provisions of SB 534 sunset on January 1, 2018.

AB 251 (Bonta), introduced in 2017, would have extended the sunset of SB 534 until January 1, 2019. That bill was later amended to deal with a different subject matter.

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

Date of Hearing: April 3, 2018

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 2476

Author:(Rubio) – As Introduced Ver:February 14, 2018

SUBJECT: Health and care facilities.

SUMMARY: Requires, until January 1, 2020, specified licensed clinics to comply with federal certification standards until regulations are adopted by the Department of Public Health (DPH). Requires intermediate care facilities for the developmentally disabled, until January 1, 2021, to comply with specified federal certification standards until regulations are adopted by DPH and the Department of Developmental Services (DDS). Contains an urgency clause to ensure that the provisions of this bill go into immediate effect upon enactment. Specifically, this bill:

1. Requires, until DPH adopts regulations relating to the provision of services by a chronic dialysis clinics, also known as end stage renal disease facilities (ESRD), ambulatory surgical clinics (ASC), or comprehensive outpatient rehabilitation facility (CORF), the clinics, licensed or seeking licensure, to comply with federal certification standards in effect immediately preceding January 1, 2013. Specifies that these provisions remain in effect only until January 1, 2020, and as of that date are repealed, unless a later enacted statute deletes or extends that date.
2. Requires DPH and DDS to jointly develop and implement licensing regulations appropriate for an intermediate care facility/developmentally disabled-nursing (ICF/DD-N) and an intermediate care facility/developmentally disabled-continuous nursing (ICF/DD-CN).
3. Requires the regulations adopted pursuant to 2) above ensure that residents of an ICF/DD-N and an ICF/DD-CN receive appropriate medical and nursing services, and developmental program services in a normalized, least restrictive physical and programmatic environment appropriate to individual resident need.
4. Requires licensed ICF/DD-Ns, until the DPH and DDS adopt the regulations, to comply with federal certification standards for intermediate care facilities for individuals with intellectual disabilities as specified in the Code of Federal Regulations.

EXISTING LAW:

1. Establishes licensure for specified clinics by DPH, including primary care clinics, nonprofit community health centers, nonprofit community clinics, and free clinics.
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 clinics licensed by DPH.
3. Requires those regulations to prescribe the kinds of services which may be provided by clinics in each category of licensure and the minimum standards of adequacy, safety, and sanitation of the physical plant and equipment, minimum standards for staffing with duly qualified personnel, and minimum standards for providing the services offered. Requires these minimum standards to be based on the type of facility, the needs of the patients served, and the types and levels of services provided.
4. Licenses and regulates various types of facilities by DPH, including an ICF/DD-N, which is defined as a facility with a capacity of four to 15 beds that provides 24-hour personal care, developmental services, and nursing supervision for persons with developmental disabilities who have intermittent recurring needs for skilled nursing care but have been certified by a physician as not requiring 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, DPH's authority to enforce federal certification standards at the state level for several types of clinics expired on January 1, 2018. This bill will ensure that the state has authority to enforce federal standards for those licensed clinics and developmentally disabled nursing facilities.
2. BACKGROUND. In 2013, DPH sponsored SB 534 (Ed Hernandez), Chapter 722, Statutes of 2013, which required the four types of health facility categories subject to this bill to comply with facility-specific federal certification requirements to meet state licensing requirements until DPH adopted state regulations. The provisions of SB 534 were to sunset on January 1, 2018. At that time, DPH was in the process of promulgating regulations for the ICF/DD-N's, but still had not begun the process of promulgating regulations for ASCs, CORFs, or ESRDs.
   
   AB 251 (Bonta), introduced in January of 2017, extended the sunset of SB 534 until January 1, 2019, however that bill was later amended to deal with an entirely different subject matter and the provisions allowing DPH to use federal certification requirements in lieu of regulations expired on January 1, 2018, effectively eliminating DPH's authority to enforce federal requirements on clinics in California.
   
   1. University of California, Davis (UCD) review of state licensing standards. SB 534 also required DPH to submit a report to the Legislature by July 1, 2017, that "describes the extent to which federal certification standards are or are not sufficient as a basis for state licensing standards," and if not, what California-specific standards may be necessary. DPH commissioned a study from the UCD, "A Review of Regulatory Standards, Quality of Care Concerns, and Oversight of Ambulatory Surgery Clinics, Comprehensive Outpatient Rehabilitation Facilities, and End-Stage Renal Disease Facilities," (study) and on September 8, 2016, conducted a public hearing to discuss the recommendations from the study.
      
      The study found that California's use of federal certification standards as the basis for state licensure is consistent with standard practice across the nation. California differs from some other states in not requiring accreditation for some ASCs (i.e., California requires accreditation only for those that provide higher levels of sedation) or for CORFs, and in the requirements for specific types of facilities and services, such as adverse event reporting. The study concludes that expanded state-specific regulations for ASC, CORF, and ESRD facilities would be of uncertain marginal value, and that better compliance with existing federal regulations would address many of the documented quality problems that DPH has cited in these facilities.
      
      There is currently language moving through the budget process that would allow DPH to use the federal certification standards for ASCs, CORFs, and ESRDs in lieu of writing state specific regulations, and would require ICF/DD-Ns to comply with federal certification standards for intermediate care facilities for individuals with intellectual disabilities.
      
   2. Federal certification standards. Federal regulatory standards set forth the various standards required at certain facilities in order to qualify for Medicare and Medicaid (Medi-Cal in California) participation by the Centers for Medicare and Medicaid Services (CMS). Depending on the facility in question, the regulations set requirements for the facilities management and governing body, what services may be offered, and safety and cleanliness standards. Standards also include, but are not limited to, requirements covering patient rights, the administration of anesthesia, if applicable, medical records, privacy, and infection control. DPH’s Licensing and Certification Program (L&C) licenses and regulates numerous categories of health facilities and agencies, including hospitals, skilled nursing facilities, and clinics. In addition, CMS contracts with L&C to evaluate facilities to certify that they meet federal requirements to become Medicare and Medi-Cal providers. L&C performs these functions directly, through various field offices, in most of the state, but contracts with Los Angeles County for the licensing and CMS certification function of health facilities located in Los Angeles County. 
   3. DPH efforts to update 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. Currently, DPH is working on 21 regulatory packages that are at different stages in the development process. Some of the regulations are for general acute care hospitals, other packages focus on other facility types or specific requirements based on statutory requirements. DPH provided no timeline for completion of the Title 22 update.
      
      When this committee heard AB 251 in 2017, DPH stated that the ICF/DD-N regulations should be out for public comment in early 2018. According to more recent information received from DPH, they are currently still in the initial development phase. The proposed budget bill language would essentially remove the requirement that those regulations be completed.
3. SUPPORT. DaVita supports this bill stating that it will reauthorize use of federal certification standards until January 1, 2020, allowing time for DPH to develop and promulgate California specific standards. Fresenius Medical Care North America supports extending the legal authority of DPH to enforce federal facility standards. The California Dialysis Council supports this bill and states that it will ensure the state can enforce basic standards of care provided in these clinics and rehabilitation nursing facilities for tens of thousands of California's most vulnerable residents.
4. POLICY COMMENT. This bill and the proposed budget bill language take differing approaches to solving the same problem. Moving forward the author may wish to consider working with DPH to decide which approach is preferred.

REGISTERED SUPPORT / OPPOSITION:

Support

California Dialysis Council
DaVita

Fresenius Medical Care North America

Opposition

None on file.

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