BILL ANALYSIS SENATE HEALTH COMMITTEE ANALYSIS Senator Elaine K. Alquist, Chair BILL NO: SB 442 S AUTHOR: Ducheny B AMENDED: August 12, 2010 HEARING DATE: August 19, 2010 4 CONSULTANT: 4 Chan-Sawin/cjt 2 PURSUANT TO S.R. 29.10 SUBJECT Clinic corporation: licensing SUMMARY Streamlines the administrative requirements for a clinic corporation to apply for licensure for an affiliate primary care clinic or a mobile health care unit operated as a primary care clinic (collectively known as affiliate clinics). CHANGES TO EXISTING LAW Existing law: Defines a primary care clinic as an outpatient health facility, operated by a nonprofit corporation, which provides direct medical, surgical, dental, optometric, or podiatric advice, services, or treatment to patients who remain less than 24 hours. Requires that primary care clinics be licensed by the California Department of Public Health (DPH) and approved for operation by DPH prior to obtaining a Medi-Cal provider number or providing services. Requires DPH to issue a provisional license, upon approval Continued--- STAFF ANALYSIS OF SENATE BILL SB 442 (Ducheny) Page 2 of a primary care clinic's initial licensure application, which is good for six months from the date of issuance. DPH is then required to conduct an on-site survey of the clinic within 30 days prior to the expiration of the provisional license and, if the clinic meets all licensure requirements, issue a regular license. Permits a primary care clinic that has held a valid and unsuspended license for at least the preceding five years, with no history of repeated or uncorrected violations of law or regulation that pose immediate jeopardy to a patient and has no pending suspensions or revocation actions, to apply to establish an affiliate clinic at an additional site. Requires DPH to issue a regular license to an affiliate clinic within 30 days, without first conducting an on-site survey, if: 1. The parent primary care clinic has submitted a completed application for licensure for the affiliate clinic; 2. The parent and affiliate clinics' corporate officers are the same, and the clinics are owned and operated by the same nonprofit organization; 3. The parent and affiliate clinic's operational policies and procedures, and staff training are substantially the same; and, 4. The parent clinic has submitted evidence to DPH establishing compliance with the minimum construction standards of adequacy and safety of the affiliate's physical plant as prescribed by the Office of Statewide Health Planning and Development. Authorizes DPH to conduct a licensing inspection at any time after receipt of the affiliate clinic licensing application; Defines a mobile health care unit, commonly referred to as a "mobile clinic," as a commercial coach that is licensed by DPH as an independent freestanding clinic, or approved by DPH as an adjunct of a licensed parent health facility or clinic, and that provides medical, diagnostic, and treatment services in order to ensure the availability of quality health care services for patients in remote or underserved areas, and patients who need specialized types STAFF ANALYSIS OF SENATE BILL SB 442 (Ducheny) Page 3 of medical care. Authorizes DPH to issue a special permit to a clinic approved to provide one or more specified specialized services, such as birthing services, for which the state has established separate standards. Authorizes DPH to take various types of enforcement actions against a primary care clinic that has violated state law or regulation, including imposing fines, sanctions, civil or criminal penalties, and suspension or revocation of the clinic's license. This bill: Makes findings and declarations regarding the current system for licensing affiliate clinics and the need to streamline administrative processes through paperwork reduction and elimination of duplication in the application process. Clarifies that a clinic corporation can apply to establish affiliate clinics on behalf of a primary care clinic, as specified. Defines "clinic corporation" as a nonprofit organization that operates one or more affiliate clinics, and makes other definitions, as specified. Adds, to the conditions already established in existing law under which DPH is required to approve a license for an affiliate clinic without first conducting an initial onsite survey, that the clinic corporation and affiliate clinic have the same medical director or directors and medical policies, procedures, protocols, and standards. Requires the affiliate clinic licensure application to consist solely of a simple form and supporting documents containing: the names, addresses and contact information of the clinic corporation and affiliate clinic's administrative officers; the affiliate clinic location and hours of operation; evidence of compliance with minimum safety standards related to the affiliate clinic's physical plant; and, other pertinent information, as specified. Requires the affiliate clinic application to be signed by STAFF ANALYSIS OF SENATE BILL SB 442 (Ducheny) Page 4 an officer of the clinic corporation's board of directors, or the clinic corporation's chief executive officer or executive director. Requires the clinic corporation, in order to reduce paperwork, eliminate errors, and streamline communications between DPH and a clinic corporation that operates one or more affiliate clinics, on behalf of all of the licensed clinics it operates, to act as the administrative headquarters for purposes of receiving from, and submitting to, DPH communications, as specified. Requires DPH to maintain a complete corporate file containing information about each clinic corporation operating one or more affiliate clinics, and for the file to include specified information. Prohibits a clinic corporation from being required to resubmit information, materials, or documents, as specified, as part of an affiliate clinic application, unless the information, materials, or documents are necessary to complete the corporate file. Requires a clinic corporation to submit to DPH, on behalf of all licensed affiliate clinics operated by the clinic corporation, a single report of change that is applicable to all affiliate clinics operated by the clinic corporation, including a change in a principal officer or general manager of the governing body, the medical director, and the clinic administrator, as required by law. Permits a clinic corporation to submit to DPH, on behalf of all licensed affiliate clinics operated by the clinic corporation that are within the same license renewal month, a single payment for all affiliate clinic licensure renewal fees. Makes other technical and clarifying changes. FISCAL IMPACT According to the Assembly Appropriations Committee analysis, minor absorbable workload to DPH to continue oversight of licensing and certification of health clinics. STAFF ANALYSIS OF SENATE BILL SB 442 (Ducheny) Page 5 BACKGROUND AND DISCUSSION According to the author, primary care clinics are at the core of the state's health care safety net and primary care delivery systems. The author asserts that the current system for licensing and certification of clinics is outdated and inefficient, which causes providers and the state to waste scarce financial and human resources. The author states that most clinic organizations operate multiple clinic sites, ranging in numbers from 2 to 25, under the governance of a single board of directors and medical director, using common business practices, policies, procedures, and medical oversight. Despite this, under current law, each clinic site must be separately licensed, which requires clinics to often submit the same information on separate licensing applications, even when the information is identical or unchanged. The author believes that this process is not only administratively burdensome and duplicative, it does not account for the role of the governing clinic organization, and that the delays in the processing of licensing applications often inhibit clinics from providing and/or billing for much-needed services in their communities. The author states that, to avoid the state licensing process, many clinics are opting to open "intermittent clinics," which operate at or less than 20 hours per week, and do not require state licensure. According to the author and sponsors, the parent primary care clinic or clinic corporation is currently required, in its application for affiliate clinic licensure, to submit approximately 210 pages of duplicative information, with original signatures of each corporate officer, board member, and clinic manager for every new clinic application, including: clinic corporation's organizational chart; copy of the non-profit corporation filing statement from the California Secretary of State; Articles of Incorporation; corporation bylaws; copy of the Internal Revenue Service letter of determination acknowledging tax-exempt nonprofit corporation status; list of all clinics operated by the clinic corporation, including name, address, and contact information; administrative organization; and, an applicant's individual information form which must be completed and signed by each STAFF ANALYSIS OF SENATE BILL SB 442 (Ducheny) Page 6 board member, the corporation's President/CEO, the officers of the corporation, and the clinic manager, often resulting in a minimum of six pages per individual. The author and sponsor maintain that the supporting documents that will remain required under the provisions of this bill include, but are not limited to: certificate of occupancy from a local authority; grant deed, bill of sale, or sublease or rental agreement of the clinic location; proof that the clinic meets Title 24 building standard requirements; transfer agreement between the affiliate clinic and a local hospital; fire safety inspection request; and, services to be provided at the clinic. Primary care clinic licensure in California According to DPH, there are currently 972 primary care clinics currently licensed in California. In order to obtain a license, a primary care clinic must submit an application and fee to DPH, and pass an initial licensure survey conducted by DPH. Upon receipt of a completed application for a clinic license, DPH has up to 100 days to either grant or deny the license. Existing law requires DPH to issue a provisional license, good for six months from the date of issuance, to a clinic that has not been previously licensed. DPH is required to inspect the clinic within 30 days prior to the termination of the provisional license, and, if the clinic meets all licensure requirements, issue a regular license. Clinics that do not meet the requirements for licensure, but make progress toward meeting the requirements, may have their provisional license renewed by DPH for another six months. Already established primary care clinics that wish to establish additional clinic sites, referred to as "affiliate clinics," are granted an expedited licensure process to open additional "affiliate clinics." Affiliate clinics are eligible for licensure based upon their parent clinic's compliance history. In order to apply to establish an affiliate clinic, a parent clinic is required to have held a valid, unrevoked, and unsuspended license for the preceding five years. In addition, the parent clinic must have no demonstrable history of repeated or uncorrected violations that pose immediate jeopardy to patients, as well as no pending action to suspend or revoke STAFF ANALYSIS OF SENATE BILL SB 442 (Ducheny) Page 7 the parent clinic's license. The parent clinic is required to submit a completed application and an application fee, establish that the parent clinic and the affiliate clinic have the same corporate officers and are owned and operated by the same organization with the same board of directors, and provide evidence of compliance with minimum safety standards related to the affiliate clinic's physical plant. If the parent clinic meets these requirements, DPH is required to issue a license to the affiliate clinic within 30 days. Affiliate clinics are exempt from provisional licensure requirements, and are not required to be surveyed to qualify for licensure. However, affiliate clinics must still pay license fees. Arguments in support According to Planned Parenthood Affiliates of California (PPAC), one of the co-sponsors of this bill, under current law, each time a clinic corporation applies for a new affiliate clinic license; numerous documents must be submitted to DPH. PPAC states that many of these documents are duplicates of papers already on file with DPH from the clinic corporation, and this bill simply streamlines the current overlyburdensome process and eliminates the duplicate submissions of information currently required. PPAC further argues that this bill modernizes the current affiliate clinic licensure process so that primary care clinics can more efficiently open their doors and meet the growing needs of individuals and families in their communities. Prior legislation AB 2010 (DeSaulnier), Chapter 90, Statutes of 2008, exempts affiliate clinics from provisional licensure requirements. SB 1213 (Ducheny), Chapter 360, Statutes of 2008, requires mobile clinics to notify DPH at least 24 hours prior to providing services at a new site, and waives any notice requirement in the event the mobile clinic is responding to federal, state, or local public health emergencies. SB 937 (Ducheny), Chapter 602, Statutes of 2003, revises provisions relating to the licensure and operation of clinics, and authorizes a primary care clinic that has been STAFF ANALYSIS OF SENATE BILL SB 442 (Ducheny) Page 8 licensed and in good standing for five years to file an application to establish an affiliate clinic at an additional site. AB 2404 (Reyes), Chapter 111, Statutes of 2002, prohibits the Department of Health Services (DHS), now DPH, from requiring the licensure of each site where a mobile clinic provided services, and instead requires a mobile clinic to report to DHS at least 15 days prior to its first visit to a new site, and to report to local authorities to obtain necessary approvals AB 951 (Florez), Chapter 525, Statutes of 2001, requires DHS (now DPH), to establish a centralized licensing application unit to review applications, and train clinic surveyors in order to process license applications in a more timely, uniform, and cost-effective manner. AB 2259 (Woodruff), Chapter 1020, Statutes of 1993, provides for the licensure of mobile clinics to ensure the availability of quality health care services for patients in remote or underserved areas, and imposed various licensure requirements and safety standards on mobile clinics. SB 1140 (Royce), Chapter 1456, Statutes of 1987, requires provisional licensure for clinics, and other types of health facilities. COMMENTS 1. Bill reflects recent amendments When the bill was heard in Senate Health Committee on April 22, 2009, it proposed a new single, consolidated license structure and process for clinic corporations and their affiliated clinics. The amendments taken in the Assembly, as reflected in the current version, instead proposed to streamline the existing affiliate clinic licensing process, to decrease the administrative burdens faced by clinics and clinic corporations when establishing a new affiliate clinic site. PRIOR ACTIONS Senate Health: n/a (prior version) Senate Appropriations:n/a (prior version) STAFF ANALYSIS OF SENATE BILL SB 442 (Ducheny) Page 9 Senate Floor: n/a (prior version) Assembly Health: 19-0 Assembly Appropriations: 17-0 Assembly Floor: 74-0 POSITIONS Support: California Family Health Council, Inc. (cosponsor) California Primary Care Association (cosponsor) Planned Parenthood Affiliates of California (cosponsor) Central Valley Health Network Community Clinic Association of Los Angeles County Family Health Centers of San Diego Family HealthCare Network Mountain Health & Community Services, Inc. Planned Parenthood Advocacy Project, Los Angeles County Planned Parenthood Mar Monte Planned Parenthood of Orange and San Bernardino Counties Planned Parenthood of San Diego & Riverside Counties Planned Parenthood of Santa Barbara, Ventura and San Luis Obispo Counties Oppose: None received -- END --