BILL ANALYSIS Ó SENATE COMMITTEE ON HEALTH Senator Ed Hernandez, O.D., Chair BILL NO: SB 483 --------------------------------------------------------------- |AUTHOR: |Beall | |---------------+-----------------------------------------------| |VERSION: |April 22, 2015 | --------------------------------------------------------------- --------------------------------------------------------------- |HEARING DATE: |April 29, 2015 | | | --------------------------------------------------------------- --------------------------------------------------------------- |CONSULTANT: |Vince Marchand | --------------------------------------------------------------- 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 SB 483 (Beall) Page 2 of ? 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 SB 483 (Beall) Page 3 of ? 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 SB 483 (Beall) Page 4 of ? 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 SB 483 (Beall) Page 5 of ? 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 SB 483 (Beall) Page 6 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 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, SB 483 (Beall) Page 7 of ? 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 SB 483 (Beall) Page 8 of ? 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. SB 483 (Beall) Page 9 of ? 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 SB 483 (Beall) Page 10 of ? 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 SB 483 (Beall) Page 11 of ? 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 -- END --