REGULATORY UPDATE

February 1, 2009

Medicare Conditions for Coverage Changes – Is Your ASC Ready?

With the focus on budget cuts and continued demonstration of quality of care there are several changes to the Medicare ASC Conditions for Coverage standards.

Medicare, the single largest payer for health care services in the United States, assumes a critical responsibility for the quality of care furnished under its programs. Historically, the Medicare program’s quality assurance approach was focused on identifying health care entities that furnish poor quality care or that fail to meet minimum Federal standards. This process has been found to be a problem-focused approach with strict limitations and does not necessarily translate into better care for patients

The current ASC Conditions for coverage were originally published on August 5, 1982, have remained unchanged since that time. The number of ASCs from 1990 to 2000 more than doubled from 1,197 to 2,966 during this ten year period, making ASCs one of the fastest growing facility types in the Medicare program. The annual volume of procedures performed on Medicare and non-Medicare patients have also tripled. Currently, over 4,600 ASCs participate in the Medicare program. The shift to safely prepare to perform the increased volume of procedures and focus on the patient health and safety and patient convenience has paved the way for increasing numbers of procedures to be performed in the ASC. The intent of the new conditions of coverage will strengthen and modernize standards to be more aligned with today’s ASC health care industry. To that end the following interpretations highlight the proposed changes in the Medicare Definitions and Conditions for Coverage as presented in the October 30, 2008 Federal Register. These Regulations will be effective May 18, 2009.  

Medicare Deemed Status
The goal of Medicare is to utilize the accreditation agencies to perform Medicare surveys in states where there is little or no oversight by the state agencies. There is also the objective to measure quality of care as the agency looks to develop a survey tool to monitor quality of care.
Effective August 4, 2008 the window for unannounced surveys was expanded from 30 days to 90 days. This will be the same for all agencies surveying for Medicare certification. There are four Medicare approved national accreditation organizations: The Joint Commission; American Association for Accreditation of Ambulatory Surgical Facilities (AAAASF); Accreditation Association for Ambulatory Health Care (AAAHC); and the American Osteopathic Association (AOA).

Ambulatory Surgical Center Definition
Ambulatory surgical center or ASC would mean any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization; and in which the expected duration of services would not exceed 24 hours following an admission. The entity must have an agreement with CMS to participate in Medicare as an ASC, and meets the conditions set forth in subparts B and C of the Conditions of Coverage.

Governing Body and Management Oversight
The ASC must have a governing body that assumes full legal responsibility for determining, implementing, and monitoring policies governing the ASC’s total operation. The governing body has oversight and accountability for the quality assessment and performance improvement program, ensures that facility policies and programs are administered so as to provide quality health care in a safe environment, and develops and maintains a disaster preparedness plan. Contract services are provided through a contract with an outside resource in a safe and effective manner.

Emergency Transfer
A written transfer agreement with such a hospital that meets the requirements of a local, Medicare -participating hospital or a local, nonparticipating hospital that meets the requirements for payment for emergency services. Ensure that all physicians performing surgery in the ASC have admitting privileges at such a hospital that –participates in Medicare or a local, nonparticipating hospital that meets the requirements for payment for emergency services

Disaster Preparedness Plan.
The ASC must maintain a written disaster preparedness plan that provides for the emergency care of patients, staff and others in the facility in the event of fire, natural disaster, functional failure of equipment, or other unexpected events or circumstances that are likely to threaten the health and safety of those in the ASC. The ASC coordinates the plan with State and local authorities, as appropriate. The ASC conducts drills, at least annually, to test the plan's effectiveness. The ASC must complete a written evaluation of each drill and promptly implement any corrections to the plan.

Patient Discharge
Before discharge from the ASC, each patient must be evaluated by a physician or by an anesthetist in accordance with applicable State health and safety laws, standards of practice, and ASC policy, for proper anesthesia recovery. The statement regarding all patients discharged are in the company of a responsible adult, except those exempted by the attending physician was deleted as part of the standard.

Quality Assessment and Performance Improvement.
The ASC, with the active participation of the medical staff, must conduct an ongoing, comprehensive self-assessment of the quality of care provided, including medical necessity of procedures performed and appropriateness of care, and use findings, when appropriate, in the revision of center policies and consideration of clinical privileges. develop, implement and maintain an ongoing, data-driven quality assessment and performance improvement program. The program must include, but not be limited to, an ongoing program that demonstrates measurable improvement in patient health outcomes, and improves patient safety by using quality indicators or performance measures associated with improved health outcomes and by the identification and reduction of medical errors.
The ASC must measure, analyze, and track quality indicators, adverse patient events, infection control and other aspects of performance that includes care and services provided in the surgery center. The program must include quality indicator data, including patient care and other relevant data regarding services furnished in the ASC. The ASC must use the data collected to:

The ASC must set goals for its performance improvement activities that focus on high risk, high volume, and problem-prone areas. The activities should consider incidence, prevalence, and severity of problems in those high risk, high volume, and problem prone areas. Indicators that affect health outcomes, patient safety, and quality of care should be monitored. Performance improvement measures must track adverse patient events, examine their causes, implement improvements, and ensure that improvements are sustained over time. The ASC must implement preventive strategies throughout the facility targeting adverse patient events and ensure that all staff is familiar with these strategies. The number and scope of distinct improvement studies conducted annually must reflect the scope and complexity of the ASC’s services and operations. The ASC must document the studies that are being conducted. The documentation, at a minimum, must include the reason(s) for implementing the study, and a description of the study’s results. It is the governing body’s responsibility to ensure that the Quality Assurance/Performance Improvement Program is:

Radiologic Services.
The ASC must have procedures for obtaining radiological services from a Medicare approved facility to meet the needs of patients. Radiologic services must meet the hospital conditions of participation for radiologic services specified.

Patient Rights
The ASC must inform the patient or the patient’s representative of the patient’s rights, and must protect and promote the patients rights. The ASC must provide the patient or the patient’s family with verbal and written notice of the patient’s rights in advance of the day of the procedure, in a language and manner that the patient or the patient and family understand. In addition, the ASC must post a written notice of patient rights in a place or places within the ASC likely to be noticed by patients (or their family, if applicable) while waiting for treatment. The ASC’s notice of rights must include the name, address, and telephone number of a representative in the State agency to whom patients can report complaints, as well as the Web site for the Office of the Medicare Beneficiary Ombudsman. The ASC must also disclose, when applicable, physician financial interests or ownership in the ASC facility. Disclosure of information must be in writing and furnished to the patient in advance of the surgery date.

Advance Directives
The ASC must provide the patient or, as appropriate, the patient’s representative in advance of the date of the procedure, with information concerning its policies on advance directives, including a description of applicable State health and safety laws and, if requested, official State advance directive forms. The patient or the patient’s family must be informed as appropriate the patient’s right to make informed decisions regarding the care. Documentation must be performed in a prominent part of the patient’s current medical record, whether or not the individual has executed an advance directive.

Submission and Investigation of Grievances.
The ASC must establish a grievance procedure for documenting the existence, submission, investigation, and disposition of a patient’s written or verbal grievance to the ASC. All alleged violations/grievances relating, including, mistreatment, neglect, verbal, mental, sexual, or physical abuse, must be  documented. All alleged violations/grievances must be immediately reported to a person in authority in the ASC. Substantiated allegations must be reported to the State authority or the local authority, or both. The grievance process must specify timeframes for review of the grievance and the provisions of a response. The ASC, in responding to the grievance, must investigate all grievances made by a patient or the patient’s representative regarding treatment or care that is (or fails to be) while admitted to the ASC. The ASC must document how the grievance was addressed, as well as provide the patient with written notice of its decision. The decision must contain the name of an ASC contact person, the steps taken to investigate the grievance, the results of the grievance process, and the date the grievance process was completed. The patient has the right to exercise his or her rights without being subjected to discrimination or reprisal, voice grievances regarding treatment or care that is (or fails to be) furnished and be fully informed about a treatment or procedure and the expected outcome before it is performed. If a patient is determined to be incompetent under applicable State health and safety laws by a court of proper jurisdiction, the rights of the patient are exercised by the person appointed under State law to act on the patient’s behalf. If a State court has not determined a patient incompetent, any legal representative designated by the patient in accordance with State law may exercise the patient’s rights to the extent allowed by State law.

Confidentiality of Clinical Records
The ASC must comply with the Department’s rules for the privacy and security of individually identifiable health information, as specified at 45 CFR parts 160 and 164. §416.51

Infection Control
The ASC must maintain an infection control program that seeks to minimize infections and communicable diseases. The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice. The ASC must maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. The infection control and prevention program must include documentation that the ASC has considered, selected, and implemented nationally recognized infection control guidelines. The infection control program is

Patient Admission, Assessment and Discharge.
The ASC must ensure each patient has the appropriate pre-surgical and post-surgical assessments completed and that all elements of the discharge requirements are completed. Each patient shall have not more than 30 days before the date of the scheduled surgery, a comprehensive medical history and physical assessment completed by a physician or other qualified practitioner in accordance with applicable State health and safety laws, standards of practice, and ASC policy. Each patient must have a pre-surgical assessment completed by a physician or other qualified practitioner in accordance with applicable State health and safety laws, standards of practice, and ASC policy that includes, at a minimum, an updated medical record entry documenting an examination for any changes in the patient’s condition since completion of the most recently documented medical history and physical assessment, including documentation of any allergies to drugs and biologicals. The patient’s medical history and physical assessment must be placed in the patient’s medical record prior to the surgical procedure. The patient’s post-surgical condition must be assessed and documented in the medical record by a physician, other qualified practitioner, or a registered nurse with, at a minimum, post-operative care experience in accordance with applicable State health and safety laws, standards of practice, and ASC policy. Post-surgical needs must be addressed and included in the discharge notes. The ASC must provide each patient with written discharge instructions and overnight supplies. When appropriate, the surgery center will make a follow-up appointment with the physician, and ensure that all patients are informed, either in advance of their surgical procedure or prior to leaving the ASC, of their prescriptions, post-operative instructions and physician contact information for follow-up care. Each patient has a discharge order, signed by the physician who performed the surgery or procedure in accordance with applicable State health and safety laws, standards of practice, and ASC policy. Ensure all patients are discharged in the company of a responsible adult, except those patients exempted by the attending physician. The word “ensure” has been added to this statement.

Summary
It may appear that as an accredited organization the standards that are changed are currently implemented in the ASC. Keep in mind they are implemented to the degree that the accreditation requires and not Medicare. Medicare is always the tighter standard with which to implement so policy review, staff education and involvement and program modification is going to be important as May approaches.