As of Jan. 1, SB 1076 requires hospitals to provide a written notice to certain patients receiving observation services. Beginning March 8, CMS will require hospitals to provide the Medicare Outpatient Observation Notice (MOON) and verbal notification to Medicare beneficiaries receiving outpatient observation services. Both state and federal notice requirements pose significant challenges for hospitals. CHA will hold a webinar on Feb. 14 from 10 a.m. to noon to explain the new requirements and provide guidance on operational considerations. For more information or to register, go to www.calhospital.org/observation-services-notification-web.
The California Department of Public Health has released the attached All-Facilities Letter outlining compliance requirements for licensed primary care clinics (PCCs) under AB 2053 (Chapter 639, Statutes of 2016), which took effect Jan. 1. AB 2053 established consolidated licensure for PCCs, allowing eligible clinics to add additional physical plants to their current license maintained and operated on separate premises. A PCC or affiliate clinic may add additional locations that are no more than one-half mile from the licensed clinic adding the additional physical plant. A licensing fee is required for each additional physical plant approved on the license. For more information, see the attached letter.
February 14, 2017
10:00 a.m. – 12:00 p.m., Pacific Time
As of Jan. 1, SB 1076 requires hospitals to provide a written notice to certain patients receiving observation services. Beginning March 8, CMS will require hospitals to provide the Medicare Outpatient Observation Notice (MOON) and verbal notification to Medicare beneficiaries receiving outpatient observation services. Register online now to learn what you need to know about the new requirements and how to comply.
On Nov. 18, the Centers for Medicare & Medicaid Services (CMS) released a memorandum providing an update on its three-year pilot to improve assessment of infection control and prevention regulations in hospitals and long-term care facilities, as well as during transitions of care. Now in its second year, the pilot seeks to identify new surveyor infection control tools and develop survey processes that can be used to optimize future assessment of new and proposed infection control regulations.
In 2017, CMS will select 40 hospitals nationwide to receive a draft survey, using updated surveyor infection control worksheets that are based on the new long-term care regulation. CMS does not indicate how it will choose hospitals for participation in the pilot. Surveys will be conducted by contractors, who should have appropriate credentials and proper identification. No citations will be issued unless an immediate jeopardy deficiency is identified, which would then be reported to the California Department of Public Health. Surveys are intended to educate hospitals and pilot the survey tools, which address areas not included in the existing CMS survey process, including drug diversion, water quality outbreaks and infection prevention during transitions of care. The worksheets to be used for the pilot survey are attached to CMS’ memo.
The Board of Registered Nursing (BRN) has determined that certain registered nurses do not have both Department of Justice (DOJ) and Federal Bureau of Investigation (FBI) fingerprint results on file with the BRN. LiveScan testing incorporates both DOJ and FBI requirements; however, if the LiveScan technology did not produce clear results or an outdated method of fingerprinting was used, the RN may not have acceptable fingerprints on file.
The BRN is working to contact all affected RNs via mail and/or email with instructions. To avoid potential delays in license renewal or other action, RNs should read the information carefully and respond accordingly. In most cases, RNs will be required to submit fingerprints within 60 days of notification or risk citation, fines or referral to the Attorney General’s office for possible disciplinary action.
Senate Finance Committee Chairman Orrin Hatch (R-Utah) and Ranking Member Ron Wyden (D-Ore.) this week issued a report detailing the practices of concurrent and overlapping surgeries where lead doctors at teaching hospitals perform multiple surgeries at the same time. The report, titled “Concurrent and Overlapping Surgeries: Additional Measures Warranted,” outlines a number of shortfalls at the federal level in monitoring and auditing teaching hospitals to ensure they comply with Medicare billing restrictions. It also makes a number of recommendations for hospitals and regulators to ensure patient safety and improve transparency. The report’s findings stem from a letter the committee sent 20 teaching hospitals in February, questioning them about these practices in their institutions. Report findings include:
The Centers for Medicare & Medicaid Services (CMS) has posted its updated version of the Medicare Outpatient Observation Notice (MOON), a standard notice that all hospitals and critical access hospitals must provide to Medicare beneficiaries who receive outpatient observation services for more than 24 hours. The federal Notice of Observation Treatment and Implication for Care Eligibility Act requires that hospitals provide oral and written notice to beneficiaries within 36 hours after observation services are initiated, or sooner if the individual is transferred, discharged or admitted as an inpatient. The notice informs patients that they are an outpatient receiving observation services, not an inpatient, and outlines the associated implications for cost-sharing and eligibility for Medicare coverage of skilled-nursing facility services.
Medicare administrative contractor Noridian has updated its website with important information about patient order authentication requirements. With input from CHA, the site now reflects the current medical records condition of participation, which allows physician authentication orders to be signed by another practitioner who has responsibility for a patient, rather than only by the ordering physician.
Noridian previously published a response in one of its FAQ documents stating, “Orders may be accepted and put in writing by personnel authorized to do so by applicable State and Federal laws and regulations. The order must be countersigned and dated by the ordering physician within an acceptable timeframe.”
The statement now correctly reiterates, “All orders, including verbal orders, must be dated, timed, and authenticated promptly by the ordering practitioner or by another practitioner who is responsible for the care of the patient only if such a practitioner is acting in accordance with State law, including scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and regulations.”
The Centers for Disease Control and Prevention (CDC) has released guidance for improving antibiotic prescribing in outpatient settings, focusing on commitment, action for policy and practice, tracking and reporting, and education and expertise. The guidance supplements previously released guidance and is intended for clinicians in primary care, outpatient specialty and subspecialty clinics, as well as emergency departments, nurse practitioners, physician assistants and health care systems. The CDC recommends implementing at least one policy aimed at improving antibiotic prescribing and encourages clinicians to educate patients on appropriate antibiotic use.
The California Public Protection and Physician Health, Inc. (CPPPH), in collaboration with several other stakeholder groups, is seeking review and comment on recently published draft guidelines for medical staff and groups. Titled Behaviors that Undermine a Culture of Safety — Policies and Procedures for Medical Staffs and Medical Groups, the guidelines are intended to assist in identifying policies and procedures that support professional behavior, as well as maintaining a culture of safety and professionalism within medical staff and the medical centers. CPPPH asks that those interested in reviewing the document send their comments by Dec. 5 to firstname.lastname@example.org.
Last month, the National Quality Forum (NQF) launched the Medicaid Innovation Accelerator Project, which will identify and recommend a set of Medicaid-relevant performance measures, measure concepts, or measures under development to the Medicaid Innovation Accelerator Program (IAP). The IAP targets four main program areas: reducing substance use disorders; improving care for Medicaid beneficiaries with complex care needs and high costs; promoting community integration for beneficiaries using long-term services and supports; and integration of physical and mental health.
The Centers for Disease Control and Prevention (CDC) today announced that Stӧckert 3T Heater-Cooler devices manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH) may have been contaminated with Mycobacterium chimaera (M. chimaera) in the manufacturing process, and that patients for whom these devices were used during cardiac surgery may be at risk of developing infections. As reported previously in CHA News, M. chimaerahas been the subject of an ongoing investigation by the California Department of Public Health.
CDC advises providers to alert patients who have had open heart surgery involving one of these devices, and has released a toolkit to assist hospitals in their outreach, including a sample notification letter, a letter for clinicians and a questions-and-answers document. Also today, the Food and Drug Administration issued a Safety Communication providing further recommendations for providers.
The California State Board of Pharmacy has finalized regulations governing the preparation of compounded drugs by pharmacies, culminating a major effort to strengthen the oversight and enforcement of pharmacies that produce or ship compounded drug products. The new regulations have been approved by the Office of Administrative Law and will take effect on Jan. 1, 2017.
The comprehensive changes to regulations cover a broad range of topics related to general drug compounding, including requirements for recordkeeping, labeling, policies and procedures, maintaining facilities and equipment, staff training and quality assurance. The regulations have also been amended to expand sterile compounding requirements to drug products that are produced for administration by inhalation or into the eye as well as by injection. CHA’s sterile compounding web page includes several tools that hospitals might find helpful in planning to comply with the new regulations. The full text of the final requirements is available on the Board of Pharmacy website.
The Centers for Medicare & Medicaid Services (CMS) issued the attached survey and certification memo in May, clarifying requirements for providing services to justice-involved individuals in skilled-nursing facilities, nursing facilities, hospitals, psychiatric hospitals, critical access hospitals and intermediate care facilities for individuals with intellectual disabilities. CHA has reviewed the memo and is seeking information on how these changes might affect member organizations, as well as non-compliance citations that might be issued. More information, when available, will be shared with members through CHA News.
In response to the 2012 New England Compounding Center tragedy — where contaminated injections led to 64 deaths and hundreds of illnesses nationwide — federal and state laws have been reexamined to provide increased oversight and better safeguards for compounded pharmaceuticals. To meet the new federal and state requirements, CHA urges hospital leaders and pharmacists in charge (PICs) to review the new regulations immediately, perform a gap analysis and develop a plan to meet federal and state requirements.
The California Department of Public Health — in consultation with the California Conference of Local Health Officers — has updated the list of diseases that health care professionals and laboratories must report to their local health departments within a specified time frame, as required by the California Code of Regulations Title 17, Division 1, Chapter 4, Subchapter 1, Article 1, Section 2500 (reporting from providers to local health departments) and Section 2505 (reporting from laboratories to local health departments). The changes, effective May 24, are summarized below.
On May 13, the Centers for Disease Control and Prevention (CDC) issued interim guidance that recommends diagnosing Zika virus via real-time reverse transcription–polymerase chain reaction, a highly specific method that can be performed rapidly. Based on new data, CDC recommends testing urine collected less than 14 days after symptom onset, along with patient-matched serum samples collected less than seven days after symptom onset. CDC will continue to review and update guidance for Zika virus testing as new data becomes available.
The Clinical Infectious Disease journal has published guidelines for implementing an antibiotic stewardship program, authored by the Infectious Disease Association of America and the Society for Healthcare Epidemiology of America. Developed by a multidisciplinary expert panel including clinicians and investigators representing internal medicine, emergency medicine, microbiology, critical care, surgery, epidemiology, pharmacy, and adult and pediatric infectious diseases specialties, the guidelines address the best approaches for antibiotic stewardship programs to influence the optimal use of antibiotics.
The U.S. Food and Drug Administration (FDA) last week issued an emergency use authorization for a Zika virus diagnostic tool that will be distributed to qualified laboratories. The Centers for Disease Control and Prevention (CDC) will begin distributing the test during the next two weeks to qualified laboratories in the Laboratory Response Network; the test will not be available in U.S. hospitals or other primary care settings. The tool — Trioplex Real-time RT-PCR Assay — allows doctors to tell if an individual is currently infected with chikungunya, dengue, or Zika using one test, instead of having to perform three separate tests to determine which infection a patient might have. More information is available on the CDC website.
The Center for Disease Control and Prevention (CDC) this week issued guidance recommending standard health care precautions – including the use of personal protective equipment (PPE) – in all health care settings to prevent potential spreading of Zika virus. The guidance notes the precautions should be in place at all times, regardless of whether infection has been confirmed, because individuals infected with the virus are often asymptomatic. The guidance also details standard precautions and other prevention strategies specific to labor and delivery settings. Based on the premise that all body fluids might contain transmissible infectious agents, the standard precautions include hand hygiene, use of PPE, respiratory hygiene and cough etiquette, safe injection practices and safe handling of potentially contaminated equipment or surfaces. Additionally, CDC directs health care providers to use soap and water or alcohol-based products before and after a patient contact and after removing PPE, including gloves.