BILL ANALYSIS Ó SB 534 Page 1 Date of Hearing: September 10, 2013 ASSEMBLY COMMITTEE ON HEALTH Richard Pan, Chair SB 534 (Ed Hernandez) - As Amended: September 4, 2013 SENATE VOTE : Not relevant. SUBJECT : Health and care facilities. SUMMARY : Requires, until the California Departments of Public Health (DPH) and Developmental Services (DDS) adopt regulations for licensure for Intermediate Care Facilities for the Developmentally Disabled - Nursing (ICF/DD-N), these facilities comply with applicable federal certification standards. Requires chronic dialysis clinics, surgical clinics, and rehabilitation clinics to comply with federal certification standards until DPH has adopted regulations for those facilities. Creates a specific exemption to current law, which requires congregate living health facilities (CLHFs) to be freestanding, that allows for multiple CLHFs to exist in one multifloor building if certain requirements are met. Specifically, this bill : 1)Requires, until DPH adopts regulations relating to the provision of services by a chronic dialysis clinic, a surgical clinic, or rehabilitation clinic, the following facilities licensed or seeking licensure to comply with the following federal certification standards in effect immediately preceding January 1, 2013: a) Requires a chronic dialysis clinic to comply with applicable federal certification standards for an end stage renal disease clinic; b) Requires a surgical clinic to comply with applicable federal certification standards for an ambulatory surgical clinic (ASC); and, c) Requires a rehabilitation clinic to comply with applicable federal certification standards for a comprehensive outpatient rehabilitation facility. 1)Requires until the DPH and DDS adopt regulations pursuant to existing law, relating to services by ICF/DD-N, licensed SB 534 Page 2 facilities to comply with applicable federal certification standards in effect immediately preceding January 1, 2013. 2)Creates a specific exemption to current law, which requires CLHFs to be freestanding, that allows for multiple CLHFs to exist in one multifloor building if all of the following requirements are met: a) Each facility meets other applicable building standards not related to multiple floors; b) Each facility is separated by a wall, floor, or other permanent partition but may share an elevator, stairs, or stairwell, and need not be freestanding; c) The proposal to develop proximate CLHFs is supported by the county health department and the board of supervisors in the county in which the facilities are proposed for one of the following locations: i) McClellan Air Force Base Building No. 522, located at 3201 James Way, McClellan, California; ii) McClellan Air Force Base Building No. 523, located at 3207 James Way, McClellan, California; iii) McClellan Air Force Base Building No. 524, located at 5621 Dudley Blvd, McClellan California; and, iv) McClellan Air Force Base Building No. 525, located at 5327 Dudley Blvd, McClellan, California. 4)Adds finding and declarations that this is a special law and is necessary and a general law cannot be made applicable within the meaning of the California Constitution because of the unique circumstances relating to the need for CLHFs in and around Sacramento County. EXISTING LAW : 1)Establishes licensure for specified clinics by DPH, including primary care clinics as well as specialty clinics which include: surgical clinics, chronic dialysis clinics, and rehabilitation clinics. 2)Requires DPH to adopt reasonable rules and regulations as may SB 534 Page 3 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 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. 5)Requires DPH and DDS to jointly develop and implement licensing regulations appropriate for ICF/DD-N and ICF/DD-CN facilities. Requires, among other things, that the regulations ensure that residents of an ICF/DD-N and 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. 6)Defines a CLHF as a residential home with a capacity of no more than 12 beds that provides inpatient care, including the following basic services: medical supervision, 24-hour skilled nursing and supportive care, pharmacy, dietary, social, and recreational. 7)Requires CLHFs to provide one of the following services: a) Services for mentally alert, physically disabled persons who may be ventilator dependent; b) Services for persons who have a diagnosis of terminal illness, a diagnosis of a life-threatening illness, or both; or, SB 534 Page 4 c) Services for persons who are catastrophically and severely disabled. 8)Requires a CLHF license to specify which of the types of persons described in 7) above to whom a facility is licensed to provide services. 9)Requires a CLHF to have a non-institutional, homelike environment. 10)Prohibits, pursuant to state regulations, a license from being issued to any skilled nursing facility which does not conform to the State Fire Marshal's requirements on fire and life safety, state requirements on environmental impact, and to local fire safety, zoning, and building ordinances. FISCAL EFFECT : As amended, this bill has not been analyzed by a fiscal committee. COMMENTS : 1)PURPOSE OF THIS BILL . According to the author, this bill would require four health facility categories currently regulated by DPH to comply with facility-specific federal certification requirements to meet state licensing requirements until DPH adopts state regulations. These facilities are already required to meet federal requirements in order to receive Medicare and Medicaid funding; this bill gives authority to state regulators to enforce these standards until such time that DPH adopts regulations specific to these facilities. According to the author, McClellan Business Park wishes to establish CLHFs within the former McClellan Air Force Base in North Highlands in Sacramento County. The health care facilities would be housed initially in two three-story buildings that were formerly used to house military personnel. There are two more buildings in close proximity that could be used for CLHFs at a later date. Each floor would be separately licensed, there would be no co-mingling of patients between floors, and all facilities would provide a home-like environment for residents. However, current law requires CLHFs to be "freestanding." SB 534 Page 5 According to the author McClellan Business Park believes that it can comply with all CLHF requirements except for the requirement to be "freestanding" as interpreted by DPH and this legislation is needed to grant such authority in this very limited situation. This bill only grants the authority for the four specific buildings described by their addresses. 2)BACKGROUND . According to DPH, as of April 2, 2013, there are 173 designated health care facilities that have been issued a state license. This includes 98 chronic dialysis clinics, 57 ICF/DD-N's, 16 surgical clinics, and two rehabilitation clinics. Among these four facility types, 166 facilities (96%) had an active license while the rest, seven (4%) did not. To date, DPH has not adopted state regulations for these facilities, but relies on the federal certification standards to determine licensure. DPH is currently in the process of drafting regulations for the ICF/DD facilities, however, the Committee staff is not aware of any regulations in process for the surgical clinics, chronic dialysis clinics, and rehabilitation clinics. With regard to CLHFs, California Health and Safety Code (Section 1267.15) states that CLHFs shall be freestanding, but this does not preclude their location on the premises of a hospital. Congregate living health facilities shall be separately licensed. According to DPH, because neither code nor regulation defines "freestanding" DPH defers to the common dictionary definition of freestanding which is "standing alone, on its own foundation, free of support or attachment." 3)FEDERAL REGULATORY STANDARDS . The federal regulatory standards for chronic dialysis clinics (referred to as End Stage Renal Centers in federal regulations), surgical clinics (referred to as ASC in federal regulations), and rehabilitation clinics, among other things, set forth the various standards required at each facility in order to qualify for Medicare and Medicaid 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 SB 534 Page 6 rights, the administration of anesthesia, if applicable, medical records, privacy, and infection control. The federal regulatory standards for ASCs also include as part of their requirements for coverage with CMS that the ASC must comply with state licensure requirements. 4)SUPPORT . DPH, in support of the prior version of this bill, states that this bill will enable it to adopt existing federal regulatory standards as the state licensing standards for chronic dialysis clinics, rehabilitation clinics, surgical clinics, and ICF/DD-Ns. DPH states that it functions as the regulatory agency for approximately 30 different types of health care facilities and clinics. DPH states that it does not have state licensing standards in place for chronic dialysis clinics, rehabilitation clinics, surgical clinics, and ICF/DD-Ns. Federal standards for these facilities exist, but DPH lacks the statutory authority to enforce the standards. In the absence of such authority, DPH states that it may only recommend action by CMS to stop Medicare and Medicaid program funding if the health care facility is out of compliance. McClellan Business Park supports the recent amendment which would help to establish CLHFs within the former McClellan Air Force Base in North Highlands (Sacramento County), stating, current law requires CLHFs to be "freestanding" but does not define whether this means having separate foundations or, as is used more commonly, independently standing relative to a hospital. By defining the term "freestanding" for McClellan Business Park only, this bill will help DPH to determine whether this project should go forward based on its merits. The Sacramento County Public Health Officer, Olivia Kasirye, MD, MS, writes in support of this bill that with the implementation of the Patient Protection and Affordable Care Act and changes to requirements for hospitals to take measures to prevent readmission of patients, the CLHFs will provide much needed services for those patients that still require skilled nursing care, while at the same time help free up hospital beds and prevent readmissions. Phil Serna, District 1 Supervisor for Sacramento County, which includes McClellan Business Park, also supports this bill, stating, it has been demonstrated that injuries sustained by service men and women in the Iraq and Afghanistan conflicts coupled with California's aging demographics, and advances in SB 534 Page 7 medical care, have all increased the demand for CLHFs. 5)RELATED LEGISLATION . AB 1312 (Brown) of 2013 authorizes 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. 6)PREVIOUS LEGISLATION . a) The California Ambulatory Surgery Association has sponsored several bills intended to establish state-specific licensure criteria for ASCs: i) AB 2308 (Plescia) of 2006, would have required the Department of Health Services (now DPH) to convene a workgroup to develop licensure criteria to protect patients receiving care in ASCs and to submit workgroup conclusions and recommendations to the appropriate policy committees of the Legislature no later than March 1, 2007. AB 2308 was vetoed by the Governor. ii) AB 543 (Plescia) of 2007 would have established licensing requirements for surgical clinics and would have required, effective January 1, 2008, that all surgical clinics meet specified operating and staffing standards. AB 543 was vetoed by the Governor. iii) AB 2122 (Plescia) of 2008 would have established the California Outpatient Surgery Patient Safety and Improvement Act which would have required surgical clinics to meet prescribed licensing requirements and standards, including compliance with Medicare Conditions of Participation. AB 2122 was held in the Assembly Appropriations Committee. b) AB 832 (Jones) of 2009, was also sponsored by DPH and would have required DPH to convene a workgroup, no later than February 1, 2010, to consider and develop recommendations for state oversight and monitoring of ASCs, to ensure public health and safety. AB 832 was held in the Assembly Appropriations Committee. c) SB 135 (Ed Hernandez), Chapter 673, Statutes of 2012, establishes a new health facility licensing category of SB 534 Page 8 hospice facility, and permits a licensed and certified hospice services provider to provide inpatient hospice services through the operation of a hospice facility, either as a free-standing health facility, or adjacent to, physically connected to, or on the building grounds of another health facility or a residential care facility d) SB 177 (Strickland), Chapter 331, Statutes of 2011, raises the bed limit for congregate living health facilities that serve terminally ill patients in counties that have populations of more than 400,000 but less than 500,000 persons. e) SB 666 (Aanestad), Chapter 443, Statutes of 2005, increases the capacity of a CLHF from no more than six beds to no more than 12 beds. Maintains an exception to allow CLHFs which serve terminally ill patients and which are located in counties with 500,000 or more persons to have 25 beds. f) AB 3535 (Wright), Chapter 1459, Statutes of 1986, creates the CLHF licensure category, and defines a CLHF as a residential home with a capacity of no more than six beds, which provides inpatient care to mentally alert, physically disabled residents, who may be ventilator dependent. REGISTERED SUPPORT / OPPOSITION : Support Olivia Kasirye, MD, MS, Sacramento County Public Health Officer Phil Serna, District 1, Sacramento County Supervisor California Department of Public Health (prior version) McClellan Business Park Sacramento County Board of Supervisors Opposition None on file. Analysis Prepared by : Lara Flynn / HEALTH / (916) 319-2097 SB 534 Page 9