BILL ANALYSIS                                                                                                                                                                                                    �






                             SENATE COMMITTEE ON HEALTH
                          Senator Ed Hernandez, O.D., Chair

          BILL NO:       SB 1269
          AUTHOR:        Beall
          INTRODUCED:    February 21, 2014
          HEARING DATE:  April 30, 2014
          CONSULTANT:    Marchand

           SUBJECT  :  General acute care hospitals.
           
          SUMMARY  :  Requires a general acute care hospital that provides  
          observation services, as defined, to apply for approval from the  
          California Department of Public Health to provide the services  
          as a supplemental or special service, as specified; limits  
          observation service to less than 24 hours; requires this  
          observation service to have the same staffing, including  
          nurse-to-patient ratios, as emergency services; and, includes  
          data on observation service in the reports that hospitals are  
          required to make to the Office of Statewide Health Planning and  
          Development.

          Existing law:
          1.Licenses general acute care hospitals under the California  
            Department of Public Health (CDPH). Defines general acute care  
            hospitals as hospitals that provide 24-hour inpatient care,  
            including the following basic services: medical, nursing,  
            surgical, anesthesia, laboratory, radiology, pharmacy, and  
            dietary services.

          2.Permits general acute care hospitals, in addition to the basic  
            services all hospitals are required to offer, to be approved  
            by CDPH to offer special services, including, but not limited  
            to, a radiation therapy department, a burn center, an  
            emergency center, a hemodialysis center or unit, psychiatric  
            services, intensive care newborn nursery, cardiac surgery,  
            cardiac catheterization laboratory, and renal transplant.

          3.Permits general acute care hospitals to apply to CDPH for  
            approval of supplemental outpatient clinic services. Limits  
            the outpatient clinic services to providing nonemergency  
            primary health care services in a clinical environment to  
            patients who remain in the outpatient clinic for less than 24  
            hours. 

          4.Requires CDPH to adopt regulations that establish  
                                                         Continued---



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            nurse-to-patient ratios by hospital unit for all general acute  
            care hospitals, all acute psychiatric hospitals, and all  
            special hospitals, as defined. Defines "hospital unit" as a  
            critical care unit, burn unit, labor and delivery room,  
            post-anesthesia service area, emergency department, operating  
            room, pediatric unit, step-down/intermediate care unit,  
            specialty care unit, telemetry unit, general medical care  
            unit, subacute care unit, and transitional inpatient care  
            unit.

          5.Establishes the Office of Statewide Health Planning and  
            Development (OSHPD), and designates OSHPD as the single state  
            agency to collect specified health facility or clinic data for  
            use by all state agencies. Requires hospitals to make  
            specified reports to OSHPD, including quarterly summary  
            financial and utilization data that includes the number of  
            discharges, the number of inpatient days, the number of  
            outpatient visits, total operating expenses, and inpatient and  
            outpatient gross revenues by payer.
          
          This bill:
          1.Defines "observation services" as outpatient services provided  
            by a general acute care hospital to patients, as specified,  
            who have unstable or uncertain conditions potentially serious  
            enough to warrant close observation, but not so serious as to  
            warrant inpatient admission to the hospital.

          2.Requires a general acute care hospital that provides  
            observation services to either apply for approval from CDPH to  
            provide the services as a supplemental service, as specified,  
            or apply for a special permit from CDPH to provide the  
            services as a special service, as specified. Adds observation  
            services to the list of special services for which general  
            acute care hospitals may apply, and be approved by CDPH, to  
            provide in addition the basic services required of all  
            hospitals.

          3.Requires CDPH to adopt standards and regulations for the  
            provision of observation services under a special permit and  
            as a supplemental service under the general acute care  
            hospital's license.

          4.Permits observation services to include the use of a bed,  
            monitoring by nursing and other staff, and any other services  
            that are reasonable and necessary to safely evaluate a  
            patient's condition or determine the need for a possible  




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            inpatient admission to the hospital.

          5.Limits observation services to a period of no more than 24  
            hours.

          6.Limits appropriately licensed practitioners to ordering  
            observation services for only the following:

                  a.        A patient who has received triage services in  
                    the emergency department but has not been admitted as  
                    an inpatient;
                  b.        A patient who has received outpatient surgical  
                    services and procedures;
                  c.        A patient who has been admitted as an  
                    inpatient and is discharged to an observation center;  
                    or,
                  d.        A patient previously seen in a physician's  
                    office or outpatient clinic.

          7.Requires observation services provided by a general acute care  
            hospital, including services provided in a freestanding  
            physical plant, to comply with the same staffing standards,  
            including licensed nurse-to-patient ratios, as supplemental  
            emergency services, notwithstanding provisions of law ensuring  
            outpatient services provided in a freestanding building of a  
            hospital are not held to higher standards than clinics.

          8.Requires a patient receiving observation services be provided  
            with a written notice that his or her care is being provided  
            in an outpatient setting, and that this may impact  
            reimbursement by Medicare, Medi-Cal, or private payers of  
            health care services, or cost-sharing arrangements through his  
            or her health care coverage.

          9.Requires all areas in which observation services are provided  
            to be marked by signage identifying the area as an outpatient  
            area. Requires this signage to use the term "outpatient" in  
            the title of the area to clearly indicate to all patients and  
            family members that the observation services provided in the  
            center are not inpatient services.

          10.Requires observation services to be deemed outpatient or  
            ambulatory services that are revenue-producing cost centers  
            associated with hospital-based or satellite service locations  
            that emphasize outpatient care. Specifies that identifying an  




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            observation service by a different name or term does not  
            exempt the hospital from the requirement of providing  
            observation services as a distinct supplemental service or a  
            distinct special permit service, as applicable.

          11.Adds the number of observation service visits and number of  
            hours of observation services provided, as well as total  
            observation service gross revenues by payer, to the list of  
            summary financial and utilization data that hospitals are  
            required to report quarterly to OSHPD.

          12.Excludes observation service visits from the number of  
            outpatient visits that hospitals are already required to  
            report to OSHPD, to ensure outpatient visits are counted  
            separately.

          13.Requires CDPH to adopt and enforce staffing standards for  
            supplemental outpatient surgical services provided in a  
            general acute care hospital, or in a freestanding physical  
            plant of a general acute care hospital, or in an ambulatory  
            surgery center of a general acute care hospital, that are  
            consistent with the staffing standards for inpatient surgical  
            services and post-anesthesia care provided in hospitals and  
            that will apply when the freestanding physical plant provides  
            outpatient services and administers anesthesia, except local  
            anesthesia or peripheral nerve blocks, in doses that have the  
            probability of placing a patient at risk for loss of the  
            patient's life-preserving protective reflexes.

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

           COMMENTS  :  
           1.Author's statement.  According to the author, more and more,  
            hospitals are placing patients who cannot be safely discharged  
            to their homes in "observation units" as an alternative to  
            hospital admission.  In these settings, patients are sometimes  
            placed for prolonged periods of time. Outpatient services are  
            not subject to many of the laws and regulations designed to  
            ensure patient safety and adequate staffing standards.   
            Additionally, hospitals are not required to report data to the  
            state on observation service utilization, which leaves the  
            public with a dearth of information on how often and for what  
            reasons outpatient observation services are used.  The  
            increasing use of these settings for patients in need of  
            inpatient care raises serious concerns about patient access to  




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            safe levels of care and services.  Changes in hospital trends  
            should not impact patient care and safety.

          2.Existing regulations require patients who stay longer than 24  
            hours to be admitted. Existing California regulations that  
            govern health facilities include a definition of a patient. As  
            part of this definition, an "inpatient" is defined as "a  
            person who has been formally admitted for observation,  
            diagnosis or treatment and who is expected to remain overnight  
            or longer." An "outpatient" is defined as "a person who has  
            been registered or accepted for care but not formally admitted  
            as an inpatient and who does not remain over 24 hours."  
            According to CDPH, unless it has granted a hospital  
            flexibility from this regulation, it would not be legal for a  
            hospital to keep a patient more than 24 hours without formally  
            admitting that patient as an inpatient.
               
          3.Nurse to patient ratios.  In 2004, regulations implementing  
            nurse-to-patient ratios in California hospitals pursuant to AB  
            394 (Kuehl), Chapter 945, Statutes of 1999, went into effect.   
            The regulations implementing the AB 394 nurse-to-patient  
            ratios law set the minimum ratio of licensed nurses to patient  
            by unit, including one-to-two in intensive care units, and  
            one-to-five in general medical-surgical units. Licensed  
            nurses, generally speaking, can include both registered nurses  
            and licensed vocational nurses, except where specified, but  
            limits licensed vocational nurses to only 50 percent of the  
            required licensed nurses for each unit. For hospitals  
            providing basic emergency services or comprehensive emergency  
            services, the regulations require the nurse-to-patient ratio  
            in the emergency department to be one-to-four or fewer at all  
            times that patients are receiving treatment, and requires no  
            fewer than two licensed nurses to be physically present in the  
            emergency department when a patient is present. The ratio for  
            a "surgical service operating room" is one registered nurse  
            assigned to the duties of the circulating nurse and a minimum  
            of one additional person serving as a scrub assistant for each  
            patient-occupied operating room, which may be a licensed nurse  
            or an operating room technician, but cannot be a licensed  
            health professional who is assisting in the performance of the  
            surgery.

          4.Medicare "2-Midnight Rule."  On August 2, 2013, the Centers  
            for Medicare and Medicaid Services (CMS) issued a final rule  
            updating its Medicare payment policies. This final rule,  




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            commonly known as the "2-Midnight Rule," states that inpatient  
            admission, and therefore payment under Medicare Part A, is  
            generally only appropriate when the physician expects the  
            patient to require a stay that crosses at least two midnights  
            and admits the patient based on that expectation. If the  
            physician does not expect the patient to stay in the hospital  
            for at least two midnights, the expectation is that the  
            patient will be treated as an outpatient, under "observation,"  
            and Medicare will reimburse providers under Part B. The rule  
            is enforced by contractor audits that review records of  
            patients, and revoke payment for inpatient stays that did not  
            meet the 2-midnight rule.

          This has been very controversial within the hospital community,  
            and earlier this year, CMS announced that it would delay  
            enforcement of the rule through this September. Earlier this  
            month, the American Hospital Association (AHA), along with a  
            number of other named plaintiffs, filed a lawsuit against this  
            2-midnight rule, arguing in part that CMS has long recognized  
            that the decision to admit a patient to the hospital is a  
            complex judgment call that involves consideration of various  
            factors. AHA asserts that in the past, CMS has instructed  
            hospitals and physicians that "generally, a patient is  
            considered an inpatient if formally admitted as an inpatient  
            with the expectation that he or she will remain at least  
            overnight and occupy a bed, even if it later develops that the  
            patient can be discharged or transferred to another hospital  
            and not actually use a bed overnight." AHA states that this  
            2-midnight rule has deprived hospitals of Medicare  
            reimbursement for reasonable, medically necessary care they  
            provide to patients, and that the rule is arbitrary. AHA  
            asserts that most importantly, this rule defies common sense:  
            the word "inpatient" simply doesn't mean "a person who stay in  
            the hospital until Day 3," and CMS is not at liberty to change  
            the meaning of words to save money.

          This 2-midnight rule has had a number of repercussions. One  
            issue that has been widely reported is that in order to  
            qualify for skilled nursing care, Medicare beneficiaries have  
            to spend three days in the hospital as an inpatient. With CMS  
            pushing hospitals to treat shorter-stay patients as  
            outpatients under "observation," many Medicare patients are  
            finding that one or more of their days spent in the hospital  
            was as an outpatient, and despite spending more than three  
            days in the hospital, are not qualified to receive skilled  
            nursing care upon discharge. Additionally, if services  




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            received in a hospital are billed under Part B as an  
            outpatient, the Medicare beneficiary is likely to have to  
            shoulder much higher out-of-pocket costs. Finally, many  
            hospitals and other providers are reporting that observation  
            care is increasing across all types of payers, not just for  
            Medicare patients. Medicare is frequently a trend-setter, and  
            may be setting a trend of increasing use of outpatient  
            "observation care," even for patients who spend 48 hours or  
            more in a hospital.

          5.Related legislation. SB 1238 (Hernandez) would require an  
            outpatient to either be discharged or admitted to inpatient  
            status after no more than 24 hours, but permits an outpatient  
            stay of longer than 24 hours when discharge is imminent under  
            certain specified circumstances, including when admission to  
            inpatient status would directly conflict with federal Medicare  
            reimbursement requirements. SB 1238 is also scheduled to be  
            heard in Senate Health Committee on April 30, 2014.

          SB 631 (Beall) of 2013 contained provisions similar to this bill  
            and was referred to Senate Health Committee, but was never set  
            for a hearing.

          6.Support.  This bill is sponsored by the California Nurses  
            Association (CNA), which states that this bill will require  
            observation services to be licensed by CDPH and require  
            outpatient surgical settings to be staffed at the same level  
            of inpatient surgical settings. CNA states that more and more,  
            hospitals are placing patients who cannot be safely discharged  
            to their homes in "observation units" as an alternative to  
            hospital admission. In these settings, patients are sometimes  
            placed for prolonged periods of time, and many patients are  
            not aware that they are in observation, leaving them to  
            believe they are admitted as inpatients. CNA states that this  
            is especially concerning for patients who may need to be  
            discharged to a long-term care facility, as Medicare requires  
            patients to be admitted as inpatients for three days before  
            coverage for long-term care will kick in. CNA states that  
            outpatient services are not subject to many of the laws and  
            regulations designed to ensure patient safety and adequate  
            staffing standards. Additionally, hospitals are not required  
            to report data to the state on observation service  
            utilization, which leaves the public with a dearth of  
            information on how often and for what reasons outpatient  
            observation services are used. CNA states that this bill will  




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            address these concerns by requiring hospitals to obtain  
            approval from the state to provide an observation service,  
            limit the period of time a patient may be placed in  
            observation to 24 hours to make it consistent with time  
            limitations imposed on other outpatient settings, require  
            observation services to meet the same staffing standards as  
            emergency rooms, and require hospitals to provide notice to  
            patients that observation services are "outpatient" services  
            and third-party reimbursement may be affected. Finally, CNA  
            states that along with the general shift of inpatient care to  
            outpatient settings, there is concern over the increased use  
            of outpatient surgical settings for inpatient-level surgeries,  
            and that this bill would take a reasonable approach to ensure  
            safe staffing standards in hospital outpatient surgical  
            settings when general anesthesia is used.

          7.Opposition.  This bill is opposed by the California Hospital  
            Association (CHA), which states that this bill would reduce  
            the quality of patient care, place patient safety at risk,  
            cause California hospitals to forego important Medicare  
            reimbursement, impose burdensome reporting requirements, and  
            increase the costs of care. CHA states that because CMS has  
            classified certain Medicare patients as "observation"  
            patients, this bill would require every hospital in California  
            to apply for this new special permit. CHA states that because  
            "observation" is an outpatient status, this new requirement  
            would require hospitals to convert inpatient beds to  
            outpatient observation beds, reducing the number of inpatient  
            beds and resulting in inpatient bed shortages in some parts of  
            the state. CHA states that requiring all observation patients  
            to be placed only in observation beds would be in direct  
            conflict with the best practice of medicine in which the  
            physician determines, based on patient needs, the appropriate  
            type of bed in which to place a patient. CHA states that  
            prohibiting an observation patient from being on observation  
            for more than 24 hours also conflicts with high quality care,  
            since a physician often uses observation before determining if  
            inpatient care is medically necessary. Setting a strict time  
            limit on how long a patient may remain in observation is not  
            consistent with the time needed to make these determinations.  
            In addition, CHA states that this 24 hour maximum conflicts  
            with the 2-midnight rule established by CMS. If applied, CHA  
            states that the 24 hour limit may cause California hospitals  
            to lose millions of dollars in payments from CMS due to  
            payments for inpatient admissions being denied. Finally, CHA  
            states that if the intent of this bill is to require  




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            freestanding surgery centers to comply with staffing ratios,  
            the bill does not adequately address this point. CHA states  
            that freestanding surgery centers are accredited by  
            independent accreditation organizations, and that the Medical  
            Board of California is responsible for monitoring compliance  
            with accreditation standards. Numerous individual hospitals  
            and health systems have also written in opposition, making  
            similar arguments as CHA.

          The California Chapter of the American College of Emergency  
            Physicians (CalACEP) states in opposition that because of the  
            unique crisis in psychiatric inpatient capacity, this bill  
            would reduce payment to hospitals and emergency physicians.  
            CalACEP states that unlike patients with cardiac, neurosurgery  
            or other critical healthcare needs who can be transferred  
            within hours to receive further specialty treatment,  
            psychiatric patients commonly await transfer in emergency  
            departments for days due to the acute shortage of inpatient  
            psychiatric beds statewide. Currently, emergency physicians  
            are able to bill under observation status for the care  
            provided during these days, but if this bill were to become  
            law, emergency physicians would only be reimbursed for the  
            first 24 hours of care they provide to these mental health  
            patients.
            
          8.Policy comments.
               
               a.     Observation services vs. observation unit. Hospital  
                 representatives assert that many patients who are being  
                 treated under "observation care" are assigned to the unit  
                 of the hospital that is most appropriate to the patient's  
                 condition and acuity. Hospitals assert, for example, that  
                 some patients might be assigned to the Intensive Care  
                 Unit, even while in observation status, if there is  
                 concern that the patient might be having a stroke. Other  
                 patients might be in pre-labor, and so are assigned  
                 observation in the Labor and Delivery Unit. 

               The sponsor of this bill has indicated that they did not  
                 intend to limit the ability of hospitals to assign  
                 observation patients to the appropriate unit of the  
                 hospital, but rather to require those hospitals  
                 establishing a special area for observation services to  
                 obtain approval for a supplemental or special service for  
                 that area. If this is the author's intent, this bill  




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                 should be amended to distinguish between "observation  
                 services" and an "observation unit" that would be a  
                 supplemental or special service.  Further, these  
                 amendments should clearly distinguish which of the bill's  
                 provisions - such as signage, notice to patients, the  
                 24-hour time limitation, OSHPD data reporting, etc. -  
                 apply to both observation services and observation units,  
                 or to just one or the other.

               b.     Applying different standards to outpatient  
                 ambulatory surgery centers. The author indicates that the  
                 outpatient and ambulatory surgery staffing provisions of  
                 this bill build on the staffing model used in AB 491  
                 (Ma), Chapter 772, Statutes of 2012, which permitted  
                 qualified hospitals to provide cardiac catheterizations  
                 in an outpatient setting, under specified conditions.   
                 One of the requirements of AB 491 is that the cardiac  
                 catheterization service in the outpatient setting is  
                 required to comply with the same staffing ratios as  
                 inpatient catheterization service.

               However, applying this model to an outpatient surgical  
                 service is different.  In the case of cardiac  
                 catheterization, prior to AB 491, all cardiac  
                 catheterization laboratories were required to be located  
                 in a general acute care hospital.  Outpatient surgery, on  
                 the other hand, is widely available in settings that are  
                 not tied to a hospital license. There are some surgical  
                 clinics that are licensed by CDPH which are not  
                 associated with a general acute care hospital. Far more  
                 common, however, are physician-owned surgery centers that  
                 are accredited by an accreditation agency approved by the  
                 Medical Board of California. These accredited surgical  
                 clinics can perform the same types of surgery as an  
                 outpatient surgical service of a hospital - anything that  
                 requires a stay of less than 24 hours. The committee may  
                 wish to consider whether it is appropriate public policy  
                 to apply a staffing standard to one setting - the  
                 outpatient surgical service of a general acute care  
                 hospital - and not to physician-owned settings that are  
                 permitted to perform the same procedures using the same  
                 level of anesthesia.

           SUPPORT AND OPPOSITION  :
          Support:  California Nurses Association (sponsor)





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          Oppose:   Adventist Health - Central Valley Network
                    Alhambra Hospital Medical Center
                    Arroyo Grande Community Hospital
                    Bakersfield Memorial Hospital
                    Banner Lassen Medical Center
                    Barton Health
                    California Chapter of the American College of  
                    Emergency Physicians
                    California Hospital Association
                    Children's Hospital Central California
                    Citrus Valley Health Partners
                    Colusa Regional Medical Center
                    Community Medical Centers
                    Community Memorial Health System
                    Cottage Health System
                    Delano Regional Medical Center
                    Dignity Health
                    Dignity Health - California Hospital Medical Center
                    Dignity Health Dominican Hospital
                    Frank R. Howard Memorial Hospital
                    Glendale Memorial Hospital and Health Center
                    Henry Mayo Newhall Memorial Hospital
                    Hi-Desert Medical Center
                    John Muir Health
                    Kaiser Permanente
                    Mark Twain Medical Center
                    Mercy Hospital of Folsom
                    Mercy General Hospital
                    Mercy Hospital of Bakersfield
                    Mercy Medical Center
                    Mercy Medical Center Mt.Shasta
                    Mercy Medical Center Redding
                    Mercy San Juan Medical Center
                    Methodist Hospital of Sacramento
                    Methodist Hospital of Southern California
                    Northern California Network of Adventist Health
                    Northridge Hospital Medical Center
                    Oroville Hospital 
                    Providence Health and Services
                    Providence Holy Cross Medical Center
                    Redlands Community Hospital
                    San Gabriel Valley Medical Center
                    Sequoia Hospital
                    Sierra Nevada Memorial Hospital
                    Simi Valley Hospital




          SB 1269 | Page 12




                    St. Elizabeth Community Hospital
                    St. John's Hospital
                    St. Joseph's Behavioral Health Center
                    St. Joseph's Medical Center
                    St. Mary's Medical Center
                    Sutter Health
                    Alhambra Hospital Medical Center
                    Banner Lassen Medical Center
                    Barton Health
                    Cedars-Sinai Medical Center
                    Centinela Hospital Medical Center
                    Central Valley Network/Adventist Health
                    Children's Hospital Central California
                    Citrus Valley Health Partners
                    Colusa Regional Medical Center
                    Community Medical Centers
                    Community Memorial Health System
                    Cottage Health System
                    Delano Regional Medical Center
                    Dignity Health
                    Frank R. Howard Memorial Hospital
                    Good Samaritan Hospital, San Jose
                    Henry Mayo Newhall Memorial Hospital
                    Hi-Desert Medical Center
                    John Muir Health
                    Long Beach Memorial / Community Hospital Long Beach
                    Methodist Hospital of Southern California
                    MemorialCare Health System
                    Natividad Medical Center
                    NorthBay Healthcare
                    Northern California Network of Adventist Health
                    O'Connor Hospital / Saint Louise Regional Hospital
                    Olympia Medical Center
                    Orange Coast Memorial
                    Oroville Hospital
                    Palomar Health
                    Pomona Valley Hospital
                    Providence Health & Services Southern California
                    Providence Holy Cross Medical Center
                    Redlands Community Hospital
                    Saddleback Memorial Medical Center
                    Saint Francis Memorial Hospital
                    St. Helena Hospital Region/Adventist Health
                    San Gabriel Valley Medical Center
                    Sharp Healthcare
                    Simi Valley Hospital/Adventist Health




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                    Sierra View District Hospital
                    Sonora Regional Medical Center
                    Stanford Hospital & Clinics
                    Sutter Health
                    White Memorial Medical Center
                    Woodland Healthcare




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