BILL ANALYSIS                                                                                                                                                                                                    Ó



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

          BILL NO:                    SB 1076             
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          |AUTHOR:        |Hernandez                                      |
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          |VERSION:       |February 16, 2016                              |
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          |HEARING DATE:  |April 13, 2016 |               |               |
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          |CONSULTANT:    |Vince Marchand                                 |
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           SUBJECT :  General acute care hospitals:  observation services

           SUMMARY  :  Establishes new requirements for observation services provided  
          by a hospital, including that observation services provided in  
          an outpatient observation unit comply with the same  
          nurse-to-patient ratios as emergency services, requiring  
          patients to receive written notice immediately upon placement  
          into observation status, and requiring data on observation  
          services to be reported separately from other outpatient  
          services 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," for purposes of this bill, as  
            outpatient services provided by a general acute care hospital  
            to those patients 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. 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  
            inpatient admission to the hospital.

          2)Requires observation services provided by a general acute care  
            hospital in an outpatient observation unit, including the  
            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 that prohibit the state from  
            enforcing higher standards for outpatient services located in  
            a freestanding physical plant of a hospital than is required  
            for licensed clinics.

          3)Requires a patient receiving observation services to receive  
            written notice immediately upon admission for observation  








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            services or placement into observation status, or immediately  
            following a change from inpatient status to observation  
            status, that his or her care is being provided on an  
            outpatient basis, and that this may affect reimbursement by  
            Medicare, Medi-Cal, or private payers of health care services,  
            or cost-sharing arrangements through his or her health care  
            coverage.

          4)Requires observation units not provided in inpatient beds or  
            attached to emergency services to be marked with signage  
            identifying the area as an outpatient area. Requires this  
            signage to use the term "outpatient" in the title of the  
            designated area to indicate clearly to all patients and family  
            members that the observation services provided in the center  
            are not inpatient services.

          5)Requires observation services to be deemed outpatient or  
            ambulatory services that are revenue-producing cost centers  
            associated with hospital-based or satellite services locations  
            that emphasize outpatient care. Specifies that identifying an  
            observation unit by another name or term does not exempt the  
            general acute care hospital from compliance with the  
            requirements of this provision.

          6)Revises OSHPD reporting requirements to require hospitals to  
            exclude observation service visits from the number of  
            outpatient visits that they report to OSHPD, and instead  
            separately report the number of observation service visits and  
            number of hours of observation services provided. Requires  
            hospitals to also report total observation service gross  
            revenues by payer, including Medicare, Medi-Cal, county  
            indigent programs, other third parties, and other payers.

           FISCAL  
          EFFECT  :  This bill has not been analyzed by a fiscal committee.
           
          COMMENTS  :
          1)Author's statement.  According to the author, this bill is  
            intended to address problems associated with the growing trend  
            of patients being treated under "observation status," as an  
            outpatient, for extended periods of time. Outpatient services  
            are not subject to many of the laws and regulations designed  
            to ensure patient safety and adequate staffing standards in  
            acute care hospitals.  Often, patients are not even aware they  
            have not been admitted to the hospital, even when they have  








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            been moved outside of the emergency room into a hospital bed  
            and kept overnight. Additionally, hospitals are not required  
            to report data to the state on observation service  
            utilization, which leaves the public with a lack of  
            information on how often and for what reasons outpatient  
            observation services are used.  
             
           2)Medicare's two-midnight rule. California law has long drawn a  
            distinction between outpatient medical care, which is care  
            provided for less than 24 hours, and inpatient medical care,  
            which is when a patient is formally admitted and will be  
            spending at least one night in the hospital. However,  
            third-party payers are increasingly unwilling to authorize  
            inpatient admissions for patients who are not expected to have  
            an extended stay at the hospital, and asking instead that  
            these patients be kept in the hospital under "observation," as  
            an outpatient. This has been driven, in part, by a Medicare  
            policy known as the "two-midnight rule," which 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 two-midnight rule. In response to  
            numerous complaints, in early 2014, announced that it would  
            delay enforcement of the rule through September 2014, and this  
            delay was subsequently extended several times. Beginning in  
            January of this year, enforcement by recovery audits could  
            proceed, but only for those hospitals that have been referred  
            by a Quality Improvement Organization as exhibiting persistent  
            noncompliance with the two-midnight rule.

            The two-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 the  
            Center for Medicare and Medicaid Services (CMS) pushing  








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            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.

          3)Federal NOTICE Act. Federal legislation passed last year, the  
            Notice of Observation, Treatment, and Implication for Care  
            Eligibility (NOTICE) Act, requires Medicare patients to be  
            notified when they are being held for observation rather than  
            admitted. Under the NOTICE Act, the hospital is required to  
            give each individual Medicare patient who receives observation  
            services as an outpatient for more than 24 hours an adequate  
            oral and written notification within 36 hours after the  
            beginning of the observation service. Requires this oral and  
            written notification to:

               a)     Explain the individual's status as an outpatient and  
                 not as an inpatient and the reasons why;
               b)     Explain the implications of that status on services  
                 furnished (including those furnished as an inpatient), in  
                 particular the implications for cost-sharing requirements  
                 and subsequent coverage eligibility for services  
                 furnished by a skilled nursing facility;
               c)     Include appropriate additional information;
               d)     Be written and formatted using plain language and  
                 made available in appropriate languages; and,
               e)     Be signed by the individual or a person acting on  
                 the individual's behalf to acknowledge receipt of the  
                 notification.

            The NOTICE Act is scheduled to take effect in August of this  
            year, and CMS is currently preparing rulemaking to implement  
            this law.
          
          4)Prior legislation. SJR 8 (Hernandez, Resolution Chapter 135,  








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            Statutes of 2015), urged Congress and the President of the  
            United States to reform short stay hospital admissions  
            criteria to more accurately reflect the clinical needs of a  
            patient as determined by a physician and to discontinue the  
            so-called "two-midnight rule."

          SB 483 (Beall, 2015), would have required a general acute care  
            hospital that provides observation services in an observation  
            unit, as defined, to apply for approval from the CDPH for  
            observation services as a supplemental service, as specified;  
            limited observation services in an observation unit to 24  
            hours; required observation services in an observation unit to  
            have the same staffing requirements as emergency services;  
            and, required hospitals to report observation service data to  
            the Office of Statewide Health Planning and Development. SB  
            483 was held on the Senate Appropriations Committee Suspense  
            File.

            SB 1269 (Beall, 2014) was very similar to SB 483. SB 1269 was  
            held on the Senate Appropriations Committee Suspense File.

            SB 1238 (Hernandez, 2014), 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.
            
          5)Support. This bill is sponsored by the California Nurses  
            Association (CNA), which 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. CNA states that many patients are not aware that  
            they are in observation, leaving them to believe they are  
            admitted as inpatients. According to CNA, outpatient units are  
            not subject to many of the laws and regulations designed to  
            ensure patient safety and adequate staffing standards.  
            Additionally, CNA states that 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 address these concerns by  
            doing the following: requiring hospitals to require  








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            observation units to meet the nurse-to-patient staffing ratios  
            as emergency rooms, or the applicable ratio wherever the  
            observation bed is placed; requiring hospitals to provide  
            notice to patients that observation services are "outpatient"  
            and that third-party reimbursement may be impacted; and,  
            requiring hospitals to report observation services to OSHPD.

          The California Labor Federation (CLF) states in support that  
            hospitals have increased their use of observation services as  
            a strategy to improve care, contain costs, control  
            readmissions, and reduce emergency room overcrowding. However,  
            CLF states that state and federal laws have not kept up with  
            the dramatic increase in the use of observation units, and  
            that the impact on patients of the misuse of observation units  
            can be devastating. Noting that observation services are  
            considered outpatient care, CLF states that 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 that patients might not even  
            know they are in observation.

          6)Opposition. This bill is opposed by the California Chapter of  
            the American College of Emergency Physicians (CalACEP), which  
            states that this bill requires that a patient receive notice  
            that they are receiving observation services immediately upon  
            receiving those services, which is inconsistent with the  
            federal NOTICE Act and therefore sets up a conflict. CalACEP  
            states that requiring notification at the moment a patient's  
            status is changed is onerous and difficult to implement in the  
            emergency department, and that this measure will place  
            additional stress on California's overcrowded and burdened  
            emergency departments.
          
          7)Oppose unless amended. The California Hospital Association  
            (CHA) is opposed to this bill unless amended, stating that the  
            decision for inpatient hospital admission is a complex medical  
            decision based on the physician's judgment and the patient's  
            medical care needs. CHA points out that the federal NOTICE Act  
            will take effect in July, which will require hospitals to  
            provide written notification and a related oral explanation to  
            beneficiaries receiving outpatient observation services, and  
            strongly believes any notification requirement should be  
            consistent with forthcoming standards for the NOTICE Act. CHA  
            states that this bill should be amended to specify that  
            observation services begin when it is ordered by a provider  








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            according to hospital policy, modify the required notification  
            to the patient that they are on "observation status" and that  
            it could impact their coverage reimbursement, and make other  
            clarifying changes.

          Tenet Health also opposes this bill unless amended, stating that  
            it would add additional and potentially conflicting rules that  
            Medicare is currently contemplating regarding the use of  
            observation, which is required by Medicare for many short-stay  
            patients. Tenet states that it has been lobbying the federal  
            government to change the current "two-midnight rule" that is  
            the root of the spike in observation, and that it believes the  
            federal rule often supplants clinical decisions relating to  
            the appropriateness of hospital admissions. Tenet states that  
            it does not believe that adding additional, duplicative  
            mandates on hospitals here does anything to solve the  
            observation dilemma. Tenet states that any state notice follow  
            CMS requirements and is implemented subsequent to the  
            implementation of the Medicare notice, so hospitals do not  
            have to provide two separate notices. Tenet also considers  
            observation unit requirements in this bill to be unnecessary  
            in light of already-existing requirements permitting hospitals  
            to request program flex for an observation unit that is  
            located in a separate physical location from the emergency  
            room or other units of the hospital. Finally, Tenet states  
            that it supports inclusion, as part of the "Other Utilization  
            Statistics," of the already collected observation hours that  
            are reported through financial reporting forms, rather than  
            the new reporting requirements in this bill.

           

          SUPPORT AND OPPOSITION  :
          Support:  California Nurses Association (sponsor)
          California Labor Federation
                    California Psychiatric Association
                    California School Employees Association
          
          Oppose:   California Chapter of the American College of  
                    Emergency Physicians
          California Hospital Association (unless amended)
          Tenet Health (unless amended)

                                      -- END --
          








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