BILL ANALYSIS                                                                                                                                                                                                    Ó



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

          BILL NO:                    SB 483    
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          |AUTHOR:        |Beall                                          |
          |---------------+-----------------------------------------------|
          |VERSION:       |April 22, 2015                                 |
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          |HEARING DATE:  |April 29, 2015 |               |               |
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          |CONSULTANT:    |Vince Marchand                                 |
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           SUBJECT  :  General acute care hospitals: observation services.

           SUMMARY  :  Requires a general acute care hospital that provides  
          observation services in an observation unit, as defined, to  
          apply for approval from the California Department of Public  
          Health for observation services as a supplemental service, as  
          specified; limits observation services in an observation unit to  
          24 hours; requires observation services in an observation unit  
          to have the same staffing requirements as emergency services;  
          and, requires hospitals to report observation service data 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  







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            hours. 

          4.Requires CDPH to adopt regulations that establish  
            nurse-to-patient ratios by hospital unit for all general acute  
            care hospitals. 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.Defines "observation unit" as an area where observation  
            services are provided in a setting outside of an inpatient  
            unit of a general acute care hospital.

          3.Requires a general acute care hospital that provides  
            observation services in an observation unit to apply for  
            approval from CDPH to provide the services as a supplemental  
            service, as specified. 

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

          5.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.

          6.Limits observation services in observation units, as defined  
            by this bill, to a period of no more than 24 hours.

          7.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.

          8.Requires observation services provided by a general acute care  
            hospital in an observation unit, 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.

          9.Requires a patient receiving observation services to receive a  
            written notice that his or her care is being provided on an  
            outpatient basis, 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.

          10.Requires observation units 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.

          11.Requires observation services to be deemed outpatient or  
            ambulatory services that are revenue-producing cost centers  
            associated with hospital-based or satellite service locations  








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            that emphasize outpatient care. Specifies that identifying an  
            observation unit by a different name or term does not exempt  
            the hospital from the requirement to obtain approval from CDPH  
            to provide observation services as a distinct supplemental  
            service when observation services are provided in a setting  
            outside of an inpatient unit of a general acute care hospital.

          12.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.

          13.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.

           FISCAL  
          EFFECT  :  This bill has not been analyzed by a fiscal committee.
           
          COMMENTS  :
          1.Author's statement.  According to the author, the Patient  
            Protection and Affordable Care Act (ACA) imposes new  
            requirements that general acute care hospitals have to meet,  
            which will likely result in hospitals making significant  
            organizational changes in order to promote the goals of the  
            ACA to lower health care costs.  These organizational changes  
            may range from reducing readmission rates, changing the ways  
            in which patient acuity is assessed, and making more efficient  
            use of bed space.  The use of outpatient services is expected  
            to increase as hospitals adapt to payment models that  
            incentivize avoidance of hospital readmission. Trends in the  
            use of outpatient settings for the provision of acute care to  
            patients are already underway.  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, even longer than 72 hours.  
            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 service. SB 483 is needed to address  
            the problem of a lack of staffing and other standards in  
            observation units.

          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, based on this regulation, 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.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 rule, 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. 

          This has been very controversial within the hospital community.  
            The rule had been enforced by contractor audits that reviewed  
            records of patients, and revoked payment for inpatient stays  
            that did not meet the CMS 2-midnight rule. In response to  
            numerous complaints, in early 2014, CMS announced that it  
            would delay enforcement of the rule through September 2014,  
            and this delay was subsequently extended several times. Most  
            recently, as part of the "Medicare Access and CHIP  
            Reauthorization Act of 2015" that President Obama signed into  
            law on April 16, 2015, the delay on enforcement was extended  
            through September 30, 2015.

            While enforcement through revenue recovery audits has been  
            suspended, the rule remains in place, and has had a number of  








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            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  
            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.

          4.Prior legislation. SB 1269 (Beall, 2014), was very similar to  
            this bill. SB 1269 was held on the Senate Appropriations  
            Committee Suspense File.

          SB 1238 (Hernandez), would have required an outpatient to either  
            be discharged or admitted to inpatient status after no more  
            than 24 hours, but permitted an outpatient stay of longer than  
            24 hours when discharge was imminent under certain specified  
            circumstances, including when admission to inpatient status  
            would directly conflict with federal Medicare reimbursement  
            requirements. SB 1238 was held on the Senate Appropriations  
            Committee Suspense File.

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

          5.Support.  This bill is sponsored by the California Nurses  
            Association (CNA) which states that because observation units  
            are considered an outpatient services, they are not subject to  
            many of the laws and regulations designed to ensure patient  
            safety and adequate staffing standards. According to CNA, many  
            patients are not aware that they are in observation, leaving  
            them to believe they are admitted as inpatients. CNA states  
            that this bill will address these concerns by requiring  
            observation units to meet the same staffing standards,  








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            including licensed nurse-to-patient ratios, as emergency rooms  
            or the applicable ratio wherever the observation bed is  
            placed. The California Labor Federation states in support that  
            the lack of guidance and regulation governing the use of  
            observation services has created a loophole that can be  
            exploited by hospitals to the detriment of patients. For  
            example, the California Labor Federation states that since  
            observation services are considered outpatient care, patients  
            can be billed for every individual service, test, and drug  
            provided, rather than just paying a single co-pay for  
            inpatient care that includes all services, and patients might  
            not even know they are in observation. The California Alliance  
            for Retired Americans states in support that the use of  
            observation status is an escalating abuse that puts patients  
            at health and financial risk, and is used increasingly to  
            avoid admitting patients in need of more specialized hospital  
            care. The Gray Panthers of San Francisco state in support that  
            patients held under observation for the entire duration of  
            their hospital stay who are then discharged to a nursing home  
            do not qualify for the same Medicare reimbursement, and can  
            face mammoth out-of-pocket costs.

          6.Opposition.  This bill is opposed by the California Hospital  
            Association (CHA), as well as a long list of individual  
            hospitals and health systems. According to CHA, this bill  
            would declare that any outpatient area in a hospital where  
            observation services are provided is an "observation unit,"  
            and would require hospitals to apply for a special permit from  
            CDPH to establish this observation unit. CHA states that it is  
            unclear how this new definition of "observation unit" differs  
            from the hospital's emergency department, where many  
            observation patients are seen. CHA states that every hospital  
            would have to apply for this new special permit, because every  
            hospital in California "observes" patients on an outpatient  
            basis. CHA also states that the prohibition on an observation  
            patient being in an observation unit for more than 24 hours  
            would conflict with high quality patient care. CHA  also  
            states that the 24-hour cap on observation services conflicts  
            with the federal "two midnight" rule established by CMS, and  
            could cause California hospitals to lose millions of dollars  
            in payments from CMS due to payments for inpatient admissions  
            being denied. Finally, CHA states that this bill requires  
            hospitals to collect and process large volumes of data about  
            "observation" patients to OSHPD, yet there is no clear  
            demarcation between an emergency patient and an observation  








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            patient, and hospitals would not know which emergency  
            outpatient visits to report to OSHPD as observation visits.

          This bill is also opposed by the California Chapter of the  
            American College of Emergency Physicians (CalACEP), which  
            states that this bill seeks to restrict observation services  
            to a period of no more than 24 hours, which is inconsistent  
            with the current federal "two midnights" rule and, therefore,  
            sets up a conflict between state and federal law.  
            Additionally, CalACEP states that because of the unique crisis  
            in psychiatric inpatient capacity, unlike patients with  
            cardiac, neurosurgery or other critical healthcare needs who  
            are able to be transferred within hours to receive further  
            specialty treatment, psychiatric patients commonly await  
            transfer in emergency departments for upwards of two to six  
            days. According to CalACEP, emergency physicians are currently  
            able to bill under observation status for the care provided  
            during these days. However, if this bill were to become law,  
            CalACEP states that they would only be reimbursed for the  
            first 24 hours of care they provide to these mental health  
            patients.

          7.Policy comment and suggested amendment. The most recent  
            amendments to this bill apply the 24-hour time limit only to  
            observation services that are provided in an "observation  
            unit." This bill defines observation unit as "an area where  
            observation services are provided in a setting outside of an  
            inpatient unit of a general acute care hospital." According to  
            CDPH, an emergency department is not considered to be part of  
            an inpatient area of a hospital, which means that observation  
            services provided in an emergency department would be limited  
            to 24 hours. According to the author, one of the concerns  
            addressed by this bill is the practice of placing patients in  
            an "observation area," where the patient has not been admitted  
            to the hospital as an inpatient, but the patient is no longer  
            receiving the same level of service as a patient in the  
            emergency department. If the definition of "observation unit"  
            were revised to be "an area where observation services are  
            provided in a setting outside of an inpatient unit,  and that  
            is not part of an emergency department  , of a general acute  
            care hospital," this bill would still correct that problem,  
            while also resolving a concern from hospitals and emergency  
            physicians that patients could not be kept in an emergency  
            department for longer than 24 hours.









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           SUPPORT AND OPPOSITION  :
          Support:  California Nurses Association (sponsor)
                    California Alliance for Retired Americans
                    California Senior Leaders Alliance
                    California Labor Federation
                    Gray Panthers of San Francisco
                    National Union of Healthcare Workers
          
          Oppose:   Adventist Health
                    Adventist Medical Center - Hanford
                    Adventist Medical Center - Reedley
                    Adventist Medical Center - Selma
                    Alhambra Hospital Medical Center
                    Arroyo Grande Community Hospital
                    Association of California Healthcare Districts
                    Banner Lassen Medical Center
                    Barton Memorial Hospital
                    California Chapter of the American College of  
                    Emergency Physicians
                    California Hospital Association
                    Cedars-Sinai Medical Center
                    Central Valley General Hospital
                    Citrus Valley Health Partners
                    Coalinga Regional Medical Center
                    Colusa Regional Medical Center
                    Community Hospital of the Monterey Peninsula
                    Community Hospital Long Beach
                    Cottage Health System
                    Delano Regional Medical Center
                    Dignity Health California Hospital Medical Center in  
                    Los Angeles
                    Dignity Health Community Hospital of San Bernadino
                    Dignity Health Dominican Hospital
                    Dignity Health Glendale Memorial Hospital and Health  
                    Center
                    Dignity Health St. Bernardine Medical Center
                    Dignity Health St. Mary Medical Center, Long Beach
                    Feather River Hospital
                    French Hospital Medical Center
                    George L. Mee Memorial Hospital
                    Glendale Adventist Medical Center
                    Good Samaritan Hospital
                    Hazel Hawkins Memorial Hospital
                    Hemet Valley Medical Center
                    Henry Mayo Newhall Hospital








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                    John Muir Health
                    Kern Valley District Hospital
                    Loma Linda University Health
                    Long Beach Memorial
                    Mad River Community Hospital
                    Marian Regional Medical Center
                    Menifee Valley Medical Center
                    Mercy General Hospital
                    Mercy Hospitals
                    Mercy Hospital of Folsom
                    Mercy Medical Center
                        Mercy Medical Center Mt. Shasta
                    Methodist Hospital of Sacramento
                    Miller Children's and Women's Hospital Long Beach 
                    Natividad Medical Center
                    NorthBay Healthcare
                    Northern Inyo Hospital
                    Northridge Hospital Medical Center
                    Palmdale Regional Medical Center
                    Palomar Health
                    Parkview Community Hospital Medical Center
                    Pomona Valley Hospital Medical Center
                    Providence Health and Services
                    Providence Little Company of Mary Medical Center San  
                    Pedro
                    Ridgecrest Regional Hospital
                    Riverside Community Hospital
                    Saddleback Memorial Medical Center
                    Salinas Valley Memorial Healthcare System
                    San Gabriel Valley Medical Center
                    San Gorgonio Memorial Hospital
                    Sequoia Hospital
                    Sharp HealthCare
                    Shasta Regional Medical Center
                    Sierra Nevada Memorial Hospital
                    Sierra View Local Healthcare District
                    Simi Valley Hospital
                    Sonoma Valley Hospital
                    Sonora Regional Medical Center
                    Southern Mono Healthcare District dba Mammoth Hospital
                    Southwest Healthcare System-Inland Valley Medical  
                    Center
                    Southwest Healthcare System-Rancho Springs Medical  
                    Center
                    Stanford Health Care








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                    St. John's Pleasant Valley Hospital
                    St. John's Regional Medical Center
                    St. Joseph's Behavioral Health Center
                    St. Joseph's Medical Center
                    Sutter Delta Medical Center
                    Sutter Health
                    Temecula Valley Hospital
                    Ukiah Valley Medical Center
                    Watsonville Community Hospital
                    White Memorial Medical Center
                    One individual

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