BILL ANALYSIS Ó SENATE COMMITTEE ON HEALTH Senator Ed Hernandez, O.D., Chair BILL NO: AB 1177 --------------------------------------------------------------- |AUTHOR: |Gomez | |---------------+-----------------------------------------------| |VERSION: |July 8, 2015 | --------------------------------------------------------------- --------------------------------------------------------------- |HEARING DATE: |July 15, 2015 | | | --------------------------------------------------------------- --------------------------------------------------------------- |CONSULTANT: |Vince Marchand | --------------------------------------------------------------- SUBJECT : Primary care clinics: written transfer agreements. SUMMARY : Prohibits a primary care clinic, notwithstanding current regulations or any other law, from being required to enter into a written transfer agreement with a nearby hospital as a condition of licensure. Existing law: 1)Licenses and regulates primary care clinics and specialty clinics by the Department of Public Health (DPH). Primary care clinics are either "community clinics" or "free clinics," while specialty clinics include surgical clinics, chronic dialysis clinics, rehabilitation clinics, and alternative birth centers. 2)Defines "alternative birth center" as a clinic that is not part of a hospital and that provides comprehensive perinatal services and delivery care to pregnant women who remain less than 24 hours at the facility. Alternative birth centers can be specifically licensed as a specialty clinic, or can be provided as a permitted service by a licensed primary care clinic. 3)Prohibits physicians from performing procedures in an outpatient setting using anesthesia, except local anesthesia or peripheral nerve blocks, or both, complying with the community standard of practice, in doses that, when administered, have the probability of placing a patient at risk for loss of the patient's life-preserving protective reflexes, unless in one of the following outpatient settings: a) An ambulatory surgical center that is CMS-certified; AB 1177 (Gomez) Page 2 of ? b) A tribal clinic, as specified; c) A clinic operated directly by the United States or any of its departments; d) A clinic licensed by DPH; e) A health facility licensed as a general acute care hospital; f) A dental office using anesthesia pursuant to specified provisions of law; or, g) An outpatient setting that has been accredited by an accreditation agency that is approved to issue certificates of accreditation to outpatient settings by the Medical Board of California (MBC). 4)Requires MBC to adopt standards for accreditation and, in approving accrediting agencies to perform accreditation of outpatient settings, to ensure that the certification program, at a minimum, includes specified standards, including requiring the accredited outpatient setting to do one of the following: a) Have a written transfer agreement with a local hospital; b) Permit surgery only by a licensee who has admitting privileges at a local hospital, with the exception that licensees who may be precluded from having admitting privileges by their professional classification are required to have a written transfer agreement with licensees who have admitting privileges at a local hospital; or c) Submit for approval by an accrediting agency a detailed procedural plan for handling medical emergencies that is required to be reviewed at the time of accreditation, and prohibits any reasonable plan from being disapproved by the accrediting agency. 5)Defines "conscious sedation," in the Dental Practice Act, as a minimally depressed level of consciousness produced by a pharmacologic or nonpharmacologic method, or a combination thereof, that retains the patient's ability to maintain independently and continuously an airway, and respond appropriately to physical stimulation or verbal command. Existing Title 22 regulations: 1)Requires primary care clinics to maintain written transfer agreements, which include provisions for communication and AB 1177 (Gomez) Page 3 of ? transportation, with one or more nearby hospitals and other inpatient health facilities as appropriate to meet medical emergencies. Requires essential personal, health and medical information to either accompany the patient upon transfer or be transmitted immediately by telephone to the receiving facility. 2)Permits primary care clinics, except for those providing abortion or birthing services, to request that DPH waive the written transfer agreement requirement above. Requires the clinic to demonstrate to DPH that all nearby hospitals and other inpatient health facilities, as appropriate to meet medical emergencies have refused to enter into transfer agreements. This bill: 1)Prohibits primary care clinics, notwithstanding a current regulation or any other law, from being required to enter into a written transfer agreement with a nearby hospital as a condition of licensure, except as provided in 2) below. 2)Requires a primary care clinic where anesthesia is used in compliance with the community standard of practice, in doses that when administered have the probability of placing a patient at risk for loss of the patient's life-preserving protective reflexes, to do one of the following: a) Have a written transfer agreement with a local accredited or licensed acute general care hospital; b) Permit procedures requiring this level of anesthesia to be performed only by a licensee who has admitting privileges at a local accredited or licensed general acute care hospital, except that a licensee who may be excluded from having admitting privileges due to his or her professional classification or other administrative limitations is required to have a written transfer agreement with a licensee who has admitting privileges at a local accredited or licensed acute care hospital; or, c) Submit for approval from an accrediting agency a detailed procedural plan for handling medical emergencies that is required to be reviewed at the time of accreditation. Prohibits a reasonable plan from being disapproved by the accrediting agency. AB 1177 (Gomez) Page 4 of ? 3)Exempts a primary care clinic from the requirement in 2) above if it submits to DPH any competent evidence that demonstrates to DPH that at least one nearby hospital, as defined, or other inpatient health facility has elected to not enter into a transfer agreement with that primary care clinic. Defines "competent evidence" as evidence that is relevant and of such a nature that it can be received by a court of law, and includes an affidavit of someone with the legal authority to bind the clinic operation. 4)Specifies that primary care clinics are not required to have a hospital transfer agreement with a nearby hospital, if that clinic provides only the following types of analgesia and sedation services: a) Local anesthesia; b) Peripheral nerve blocks; c) A combination of both local anesthesia and peripheral nerve blocks; or, d) Conscious sedation, as defined in existing law. 5)Requires DPH to repeal, no later than July 1, 2016, specified Title 22 regulations that require primary care clinics to have a written transfer agreement with a hospital. FISCAL EFFECT : According to the Assembly Appropriations Committee analysis of the introduced version of this bill, it would have negligible state fiscal effect. PRIOR VOTES : ----------------------------------------------------------------- |Assembly Floor: |51 - 28 | |------------------------------------+----------------------------| |Assembly Appropriations Committee: |12 - 5 | |------------------------------------+----------------------------| |Assembly Health Committee: |14 - 5 | | | | ----------------------------------------------------------------- COMMENTS : 1)Author's statement. According to the author, under current AB 1177 (Gomez) Page 5 of ? California law, clinics are obliged to obtain a hospital transfer agreement (HTA) from a nearby hospital as a condition of licensure in order to begin performing services. DPH regulations allow clinics who cannot get an HTA from a nearby hospital to apply for a waiver to this requirement. However, clinics that provide abortions or birthing services are not allowed to apply for a waiver, even if a local hospital won't agree to enter into an HTA. The author states that this effectively allows a hospital that does not want to enter into an HTA to prevent an abortion clinic from opening. The author notes that if this bill is enacted, this regulation will be repealed and unenforceable, and will give Californians equal access to reproductive services and the ability to choose. 2)Hospital transfer agreements. The requirement for a written transfer agreement between primary care clinics and a local hospital, which is the subject of this bill, is contained in the Title 22 regulations governing primary care clinics. There are also a handful of places where written transfer agreements are statutorily required, and would not be affected by this bill. For example, a rural general acute care hospital that does not provide surgical and anesthesia services is required to maintain a written transfer agreement with one or more general acute care hospitals that provide surgical and anesthesia services. A mobile health care services unit (generally speaking, a bus outfitted as a mobile clinic that is operated by a licensed clinic or hospital) is required to maintain written transfer agreements that include provisions for communication with, and transportation to, one or more nearby hospitals as needed to meet medical emergencies. Finally, as discussed in existing law above, an accredited outpatient surgical setting, which uses general anesthesia, is required to either have a written transfer agreement with a hospital, only permit surgery by physicians who have admitting privileges at a hospital, or have a "detailed procedural plan for handling medical emergencies" that is approved by the accrediting agency. While written transfer agreements can vary by hospital, DPH provides on its website an example of a transfer agreement that meets its requirements. This form is two pages long, with 11 itemized requirements, such as a requirement that transferring institutions send with the patient forms that include information on the medical course of treatment followed by the transferring institution and other pertinent medical, administrative, and social information. Other AB 1177 (Gomez) Page 6 of ? requirements include ensuring that the hospital make available its diagnostic and therapeutic services, and to be accountable for the recognition of need for social services. The form also specifies that charges for services performed are to be collected by the institution rendering services, and that neither facilities has any liability to the other for such charges. 3)Related legislation. SB 396 (Hill), would require a surgical clinic to be eligible for licensure by DPH regardless of physician ownership, deems a surgical clinic to have met licensure requirements if they are federally certified, requires inspections of accredited outpatient surgical settings to be unannounced, and requires both accredited and federally certified surgical settings to be subject to the same reporting requirements to the Office of Statewide Health Planning and Development as licensed surgical clinics. SB 396 passed the Senate Health Committee by a vote of 9-0 on April 29, 2015, and is pending in the Assembly Appropriations Committee. AB 941 (Wood), would exempt, from licensure and regulation, by DPH any clinic operated by a federally recognized Indian tribe under a contract with the United States pursuant to the Indian Self-Determination and Education Assistance Act, regardless of the location of the clinic. AB 941 passed the Senate Health Committee by a vote of 8-0 on June 24, 2015, and is pending in the Senate Appropriations Committee. AB 1130 (Gray), would expand the licensure exemption for intermittent clinics that are operated by licensed clinics on separate premises by permitting these intermittent clinics to be open for up to 30 hours per week, instead of only 20 hours per week. AB 1130 passed the Senate Health Committee by a vote of 8-0 on June 24, 2015, and is pending in the Senate Appropriations Committee. 4)Prior legislation. AB 980 (Pan, Chapter 663, Statutes of 2013), required the California Building Standards Commission (CBSC) to adopt emergency regulations to delete a provision of the 2013 California Building Standards Code that established building standards for primary care clinics that provide abortion services, and prohibited the CBSC from adopting any building code standards for clinics providing medication or aspiration abortion services that differ from construction AB 1177 (Gomez) Page 7 of ? standards applicable to other primary care clinics. Required DPH, no later than July 1, 2014, to repeal or revise regulations relating to abortion services in primary care clinics to ensure that any requirements specific to abortion services are consistent with applicable law and medical standards of care. 5)Support. This bill is sponsored by Planned Parenthood Affiliates of California (PPAC), which states that this bill would delete an obsolete regulation that restricts abortion clinics from obtaining an exemption if they cannot enter into a transfer agreement with a local hospital. PPAC states that the Legislature vested DPH with the authority to regulate and license clinics, but by requiring hospital transfer agreements as a condition of licensure, DPH has essentially delegated some of its licensure authority to the hospitals. PPAC states that any hospital corporation with either a moral objection or a desire to secure a competitive edge can refuse to sign a transfer agreement and bring a clinic's license application to a halt. PPAC states that the existing regulations around the hospital transfer agreement acts like a targeted restriction on abortion providers, or a TRAP law. Community clinics that provide abortion services, like Planned Parenthood, are singled-out and in this case are unable to file for an exemption from the hospital transfer agreement requirement. According to PPAC, although California's laws and regulations tend to be progressive around abortion and comprehensive reproductive health care, this bill will address some of the last remaining policies that single out abortion providers. The California Family Health Council also supports this bill, stating that this bill would expand access to essential sexual and reproductive health care by removing barriers to primary clinics from getting licenses to operate. The Community Clinic Association of Los Angeles County states in support that the decision of whether to grant a license to a clinic should rest exclusively with the state and should not hinge upon securing an agreement with an independent entity that, for a variety of reasons, may or may not be cooperative. 6)Oppose unless amended. The California Chapter of the American College of Emergency Physicians (California ACEP) states that they are opposed unless amended to make all clinics equal by allowing community clinics providing birthing or abortion services to apply for an exemption from the written transfer agreement requirement. According to California ACEP, while it AB 1177 (Gomez) Page 8 of ? supports the goal of removing barriers to licensing for clinics offering reproductive services, it is opposed to the solution offered in this bill of eliminating transfer agreements with a local hospital for all community clinics as a condition of licensure. California ACEP states that transfer agreements between community clinics and one or more nearby hospitals are important to ensuring that clinics can adequately coordinate care for patients facing medical emergencies. California ACEP states that while it is of course true that a patient can always be transported to an emergency department by ambulance without accompanying medical information, it is always better for the patient if the treating emergency physician has access to personal, health, and medical information. California ACEP notes that under current law, clinics may ask DPH to waive the transfer agreement requirement, as long as those clinics do not provide birthing or abortion services. Rather than eliminate transfer agreements for all community clinics, California ACEP states that this bill should be amended to make all clinics equal by allowing community clinics providing birthing or abortion services to apply for an exemption. The California Medical Association also opposes this bill unless amended with the same amendment requested by California ACEP. 7)Oppose. This bill is opposed by Concerned Women for America (CWA), which states that operators of abortion clinics would benefit from the passage of this bill since abortion facilities would be able to open without the requirement of having to get a transfer agreement with a local hospital. CWA states that in El Centro, a Planned Parenthood recently opened, and that after months of public outcry by thousands of Imperial County residents to dissolve a transfer agreement between El Centro Regional Medical Center, suddenly this bill makes its way through the California Legislature. CWA states that women will be endangered further if abortion facilities are not required to have a transfer agreement with a local hospital, and that loosening the reins on abortion clinics will lead to serious injury and death for women. The California Right to Life Committee (CRLC) also opposes this bill, stating that primary care clinics are a benefit to their communities, so one would assume that the medical personnel would want to include transfer agreements as an important and valid component of licensure. CRLC states that it has read about serious situations developing when such facilities have not had such transfer agreements. AB 1177 (Gomez) Page 9 of ? 8)Proposed amendments. a) Recent amendments to this bill generally incorporate the same transfer requirements that apply to accredited outpatient surgical settings where general anesthesia is used to those primary care clinics that use the same level of general anesthesia. These amendments were in response to a suggestion from committee staff that while most primary care clinics do not perform procedures utilizing general anesthesia, to the extent that they do, they should meet the same requirements the law imposes on accredited outpatient surgical settings. Following further discussions between committee staff, author and sponsor, the author will propose amendments that further refine these provisions by, among other things, simplifying the language, and by requiring these clinics to attempt to obtain a transfer agreement from two hospitals, instead of just one, before being exempted from the transfer requirement. b) The American Congress of Obstetricians and Gynecologists, District IX (ACOG, expressed concern to the author and committee staff that in deleting the transfer agreement requirement, this bill would also apply to primary care clinics that are approved by DPH to be an alternative birth center as a special service. According to ACOG, written transfer agreements are part of the standard of care for birthing centers, and while standards of care do not always have to be written into the law, it is different when it has been the law and is being expressly deleted. To address this concern, the author has proposed amendments to specifically require alternative birth centers that are licensed as primary care clinics to maintain a written transfer agreement with a hospital. SUPPORT AND OPPOSITION : Support: Planned Parenthood Affiliates of California (sponsor) California Family Health Council Community Action Fund of Planned Parenthood Orange and San Bernardino Counties Community Clinic Association of Los Angeles County AB 1177 (Gomez) Page 10 of ? Planned Parenthood Action Fund of Santa Barbara, Ventura, and San Luis Obispo Counties Planned Parenthood Action Fund of the Pacific Southwest Planned Parenthood Advocacy Project Los Angeles County Planned Parenthood Mar Monte Planned Parenthood Northern California Action Fund Planned Parenthood Pasadena and San Gabriel Valley Oppose: California Chapter of the American College of Emergency Physicians (unless amended) California Medical Association (unless amended) California Right to Life Committee Concerned Women for America of California -- END --