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EMTALA Update Kansas Hospital Association Wichita Airport Hilton Executive Conference Center Wichita, Kansas March 5, 2009 Matthew C. Hesse, Esq. Associate General Counsel Via Christi Health System, Inc. EMTALA • • • • • • Emergency Medical Treatment Active Labor Act Evolution of EMTALA • • • • • • • • • • • • • 1985–EMTALA enacted (42 U.S.C. §1395 dd) 1989–Statutory “enhancements” 1990–More statutory “enhancements” 1994–Interim final Regulations 1998–HCFA Interpretative Guidelines to Surveyors 1999–Special Advisory Bulletin (OIG/HCFA) 2000–Outpatient Prospective Payment System Regulations 2001–OPPS Q & A 2002–CMS Guidance Letter, Proposed Regulations 2003–Final Rules and Regulations 2004–Revised CMS Interpretive Guidelines 2005–EMTALA Technical Advisory Group 2008–Revised CMS Interpretive Guidelines Penalties for Violation of EMTALA • Stakes are high for both hospitals and physicians Penalties for Violations – Penalties for Hospitals: $50,000 civil monetary penalty (CMP) for each negligent violation ($25,000 for a hospital with less than 100 beds); Civil liability to any individual who suffers harm as a direct result of a hospital’s violation; Civil liability to any medical facility that suffers a financial loss as a direct result of a hospital’s violation (transferee hospital who receives an inappropriately transferred patient); Possible termination of hospital’s Medicare Conditions of Participation Provider Agreement Penalties for Violations – Penalties for Physicians: $50,000 CMP for a physician who commits: A negligent violation (exclusion from Medicare for gross and flagrant or repeated violations) including: » Verifies transfer certification knowing or should have known that risks outweigh the benefits of transfer; » Misrepresents individual’s medical condition or other information, including hospital’s obligations under EMTALA » Failure to appear to stabilize a medical emergency within a reasonable time and the ED physician orders transfer of the patient because without services of the on-call specialty physician, the benefits of transfer outweigh the risks of transfer; Penalties Office of Inspector General News Office of Inspector General Department of Health and Human Services 330 Independence Avenue, SW Washington, DC 20201 Administrative Law Judge Upholds HHS-OIG’s $50,000 Civil Monetary Penalty Against St. Joseph’s Medical Center For Violating EMTALA 88-Year-Old Man Died in Emergency Room Without Treatment EMTALA Basics • EMTALA requires Medicare participating hospitals having a Dedicated Emergency Department (ED) to: – Provide appropriate medical screening examination (MSE) to anyone who comes to an ED and requests examination or treatment of a medical condition – Provide necessary stabilizing treatment to an individual with an EMC or an individual in labor – Provide an appropriate transfer if either the individual requests it or the hospital does not have the capability or capacity to stabilize the EMC EMTALA Definitions Important • • • • • • • • • • “Comes to Emergency Department” “Dedicated Emergency Department” “Emergency Medical Condition” “Hospital” “Hospital Property” “Inpatient” “Labor” “Participating Hospital” “To Stabilize” “Transfer” Medical Screening Examination Requirement • MSE is the process required to determine whether an individual has an emergency medical condition (EMC) or not. • Triage ≠ MSE (triage determines order in which patients are seen, not presence of EMC) • CMS says MSE an ongoing process rather than an isolated event • Documentation is key in determining whether an appropriate MSE was performed Medical Screening Examination Requirement (cont.) • “Appropriate medical screening exam” is a screening to determine the existence of an EMC which is the same or similar to the screening provided to all patients presenting to the ER complaining of the same condition or exhibiting the same symptoms or condition (non-discriminatory) • EMTALA governs non-uniform treatment, not incorrect treatment • EMTALA is not a malpractice law. Misdiagnosis is judged in state courts under state negligence rules Medical Screening Examination Requirement (cont.) • “Emergency Medical Condition” means: 1. A medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonable be expected to result in: i. Placing the health of the individual (or with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy, ii. Serious impairment to bodily functions, or iii. Serious dysfunction of any bodily organ or part; or Medical Screening Examination Requirement (cont.) 2. With respect to a pregnant woman who is having contractions i. That there is inadequate time to effect a safe transfer to another hospital before delivery, or ii. That transfer may pose a threat to the health and safety of the woman or unborn child Medical Screening Examination Requirement (cont.) • Which hospitals must comply with EMTALA? – Any Medicare participating hospital (Medicare Provider Agreement) – Includes a Critical Access Hospital (CAH) Medical Screening Examination Requirement (cont.) • Critical Access Hospitals that operate Dedicated Emergency Department must comply with EMTALA. • If facility designated CAH meets certain criteria including: – Located more than a 35 mile drive from any other hospital – Maintains CoP, including requirement to make available 24 hour emergency services 7 days per week • In the revised SOM (2008), there are now separate D. Tag numbers for regular hospitals (A), and for Critical Access Hospitals (C) Medical Screening Examination Requirement (cont.) • Deficiency Tags Used for Citing Violations • • • • • • • • • • • • A-2400;C-2400 Policies/procedures which address anti-dumping A-2401;C-2401 Receiving hospitals must report inappropriate transfers A-2402;C-2402 Posting signs A-2403;C-2403 Maintain Transfer Records (5 years) A-2404;C-2404 On-Call Physicians A-2405;C-2405 Logs A-2406;C-2406 Appropriate Medical Screening Examination A-2407;C-2407 Stabilizing treatment A-2408;C-2408 No delay in exam or treatment to inquire about payment A-2409;C-2409 Appropriate transfer A-2410;C-2410 Whistleblower Protection (retaliation) A-2411;C-2411 Recipient Hospital’s responsibilities (nondiscrimination) Medical Screening Examination Requirement (cont.) • Hospitals that do not have EDs are required to have policies and procedures to assess presenting emergencies, provide immediate assistance and arrange transport to an appropriate hospital. Such hospitals must accept an appropriate transfer if they have the capacity or capability that a transferring hospital lacks. Medical Screening Examination Requirement (cont.) • EMTALA protections apply to all persons (not just Medicare patients) who come to the ED that operates a dedicated emergency department • Under Born Alive Infants Protection Act of 2002, this includes every infant member of the species homo sapiens who were born alive at any stage of development • Illegal immigrants are also covered by EMTALA Medical Screening Examination Requirement (cont.) • What does “comes to the Emergency Department” mean? – Patient presents to Dedicated Emergency Department (DED) and requests care – Patient is outside the DED but on hospital property within 250 yards of main building with an EMC – Patient is in hospital-owned and operated ambulance for EMC and treatment even if ambulance not on hospital property; or – Patient is in non-hospital owned ambulance on hospital property for examination and treatment at DED Medical Screening Examination Requirement (cont.) • Did patient request treatment? – Verbal request by patient or by someone else on behalf of the patient – Individual presents to DED and a prudent lay person observer would believe that the individual needs treatment for perceived emergency condition – Patient presents elsewhere on hospital campus and prudent lay person observer would believe the individual needs emergency care Medical Screening Examination Requirement (cont.) • Does your hospital have a DED? Must meet one of the following requirements: – Licensed by the state as an ER/ED – Held out to the public as a place that provides care for EMCs; or – During the calendar year preceding at least 1/3 of all outpatient visits for treatment of EMCs on an urgent, unscheduled basis • May include labor and delivery department, psychiatric unit, urgent care center or other departments meeting one of three definitions • May also include specialty hospital Medical Screening Examination Requirement (cont.) • EMTALA does not apply to: – Individuals who present to non-hospital-owned structures within 250 yards – Patients who come to the hospital for routine outpatient care – Inpatients (CMS cautions that a patient must be admitted in good faith for further necessary medical care admitted as expected the patient will be admitted at least over night). – Off-campus departments without a DED (however, such departments must train staff and have appropriate protocols for handling emergency cases or contact emergency personnel at the main hospital campus, or call 911) Medical Screening Examination Requirement (cont.) • Prisoners should receive an EMTALA screen and stabilizing treatment if law enforcement request clearance for incarceration or after accident to determine if emergency exists • EMTALA is not applicable if individual is brought to ED by law enforcement to request blood draw for BAT (drunk driving) Medical Screening Examination Requirement (cont.) • Who can perform the medical screening exam? – Licensed physician – Qualified Medical Personnel (QMP) as noted in hospital bylaws or rules and within the scope of practice and approved by the hospital Medical Screening Examination Requirement (cont.) • A hospital may not delay a medical screening examination or treatment to inquire about individual’s method of payment or insurance • Hospital may not seek authorization from a patient’s insurance company until after the MSE and stabilizing treatment • A DED physician or extender may contact individual’s physician regarding medical history and needs as long as such consult does not delay exam or treatment Medical Screening Examination Requirement (cont.) • Hospitals may follow reasonable registration processes for individuals where MSE or treatment is required, including asking about insurance as long as the inquiry does not delay screening or treatment • Registration processes may not unduly discourage individuals from remaining for further evaluation • If patient inquires about financial liability, staff should indicate regardless of patient’s ability to pay, the hospital stands ready and willing to provide screening or stabilization services Medical Screening Examination Requirement (cont.) • Hospitals offering part-time emergency services enjoy an exception from EMTALA obligations at times when emergency services are not available. • Hospitals without DEDs must still comply with EMTALA’s requirements if it has the ability to treat patients with EMCs Medical Screening Examination Requirement (cont.) • Effective October, 2007, CMS requires Critical Access Hospitals and other hospitals that do not have physicians on duty 24/7 to provide the patient written notice of that fact and what the hospital plan is to deal with emergencies when a physician is not on the premises Medical Screening Examination Requirement (cont.) • A minor child can request an exam and/or treatment for an EMC and the MSE should not be delayed by waiting for parental consent. Under EMTALA, a minor can be examined, treated and even appropriately transferred to another hospital without parental consent • Patient “parking.” As soon as ambulance arrives on hospital property, regardless of whether the patient remains on the ambulance stretcher or transferred to a hospital cart, EMTALA obligations are triggered Stabilizing Treatment Requirement • Hospital’s duty to stabilize arises when it detects an emergency medical condition • If MSE detects EMC, three ways for hospitals to discharge duty: 1. Provide treatment necessary to stabilize condition; 2. Admit the patient as an inpatient for further stabilizing care; or 3. If unable to stabilize, transfer patient appropriately to facility capable of stabilizing patient Stabilizing Treatment Requirement (cont.) • Documentation of presence or absence of EMC is very important – Presence of EMC triggers all EMTALA requirements, obligations, certifications, penalties and liabilities – Absence of EMC releases physician, hospital, on-call specialist from EMTALA requirements – Recommend notation in chart: “no emergency medical condition exists” (or “emergency medical condition is stabilized”) Stabilizing Treatment Requirement (cont.) • Any woman in active labor is considered unstable under EMTALA, preventing discharge or transfer, unless the transferring hospital has absolutely no capability to deliver the baby safely. • Benefits of transfer must outweigh the risks • Hospitals not capable of handling high risk deliveries of high risk infants should have written transfer agreements with facilities with such capabilities. Stabilizing Treatment Requirement (cont.) • Once a patient’s labor is determined to be false, she is stable and EMTALA no longer applies – As of August, 2006, CMS allows a nurse midwife or other qualified medical practitioner (QMP) other than a physician to make the false labor determination QMPs must be acting within the scope or practice as defined in hospital medical staff bylaws and state law – Hospital boards must approve the category and practitioners allowed to perform MSE and stabilize (physician must certify diagnosis of false labor by QMP) Stabilizing Treatment Requirement (cont.) • Hospital is not liable for an EMTALA violation if it had no actual knowledge that an EMC existed – Hospital must demonstrate it provided appropriate MSE – Hospital must show it provided patient with exam comparable to one offered to any other patient presenting with similar symptoms – Tenth Circuit ruled that a hospital had no liability under EMTALA because of an absence of actual knowledge of an a EMC (Urban vs. King; Green vs. Reddy) Stabilizing Treatment Requirement (cont.) • “To Stabilize” means with respect to an EMC, to provide such medical treatment of the condition necessary to assure within reasonable medical probability, but no material deterioration of the condition is likely to result from or occur during a transfer of the individual from a facility or that, with respect to an EMC, the woman has delivered the child and placenta • A patient can be in critical condition but still be considered stabilized for EMTALA purposes • Attending physician should be the person completing transfer certificate setting forth risks and benefits of transfer Stabilizing Treatment Requirement (cont.) • A patient may refuse an MSE and stabilization treatment. The hospital must: – Offer examination and treatment – Inform the patient (or surrogate) of risks and benefits of MSE and stabilizing treatment; and – Take reasonable steps to secure patient’s (or surrogate’s) written informed consent to refuse examination and treatment – Burden of proof is on the hospital to prove that a patient affirmatively revoked his or her request for examination and treatment – DOCUMENT - DOCUMENT - DOCUMENT Stabilizing Treatment Requirement (cont.) • A gatekeeper physician or managed care organization has no authority to deny care. They can refuse to pay for care, but they may not deny it. Hospital must do MSE and, if necessary, stabilizing treatment • EMTALA obligations end for an Emergency Department patient once the patient is admitted to the hospital Appropriate Transfers • Physician certification of the risks/benefits of transfer is a critical element of an appropriate transfer and CMS specifies a narrative particularized to the specific patient involved in his or her circumstances Transfer Requirements • EMTALA governs transfer of patients from a Dedicated Emergency Department • A hospital can provide an appropriate transfer of an unstabilized individual to another medical facility if and only if: 1) The individual, after being informed of risks and hospital’s obligations, requests a transfer 2) Physician signs certification that benefits of the transfer to another facility outweigh the risks or QMP signs certification after a physician, in consultation with that QMP, has made the determination that benefits of transfer outweigh risks and physician countersigns certification in a timely manner Transfer Requirements (cont.) 3) Pertinent medical records regarding MSE or stabilizing treatment must be sent to receiving hospital; 4) Obtain the consent of receiving hospital to accept transfer; 5) Insure that transfer of unstabilized individual is effected through qualified personnel and transportation equipment, including use of medically appropriate life support measures Transfer Requirements (cont.) • Only two instances in which an unstable patient may be transferred: – When hospital does not have the capacity or capability to stabilize the patient, and the benefits to be received by transfer to another hospital outweigh the risks of transfer, and – When the patient insists on transfer even after being informed of the risks of transfer and the hospital’s obligations under EMTALA. Transfer Requirements (cont.) • A hospital with specialized capabilities or facilities (burn units, NICU, shock trauma units, regional referral centers) may not refuse to accept an appropriate transfer of an individual who requires specialized capabilities or facilities if the hospital has the capacity to treat the individual. A refusal under such circumstances would be considered “reverse dumping” Transfer Requirements (cont.) • EMTALA requires an express written certification for all unstabilized transfers setting forth the risks and benefits analysis and rationale for transfer • Physician at the sending hospital has the responsibility of determining appropriate mode, equipment and attendants for transfer – Transportation by an inadequately equipped ambulance will violate EMTALA Transfer Requirements (cont.) • “Transfer” means the movement (including discharge) of an individual outside of hospital’s facilities at the discretion of any person employed by hospital, but does not include movement of an individual who: – Has been declared dead, or – Leaves the facility without permission of any person • Movement of a patient from one area of the hospital to another contiguous with the hospital campus is not a transfer • If MSE reveals EMC and the individual is told to wait for treatment, but individual leaves hospital, hospital did not dump patient, unless: – Individual left ED based on a “suggestion by the hospital,” and/or – The individuals condition was emergent, but hospital was operating beyond its capacity and did not attempt to timely transfer the individual to another facility Transfer Requirements (cont.) • If a transfer is “appropriate,” the only valid reason for a transferee hospital to refuse the transfer is if it lacks the specialized capabilities to treat the patient. • Hospitals may not refuse a transfer because of other issues such as alien status, payment issues, or location. Transfer Requirements (cont.) • A receiving hospital is mandated to report any transfers perceived to be in violation of EMTALA • Required to promptly report the incident to CMS or state agency within 72 hours of the occurrence. If recipient hospital fails to report an improper transfer, the hospital may be subject to termination of its provider agreement. Transfer Requirements (cont.) • Specialty hospitals (participating in Medicare) without dedicated Emergency Departments must accept appropriate transfer requests. • EMTALA TAG Group recommended that such hospitals are bound by the same responsibility to accept transfers under EMTALA as hospitals with DED. On-Call Physician Issues • Much contention, confusion and controversy • Hospitals must maintain an on-call list of physicians on its Medical Staff in a manner that best meets the needs of its patients receiving services required under EMTALA in accordance with the resources available to the hospital, including availability of on-call physicians On-Call Physician Issues (cont.) • EMTALA mandates hospitals to provide and confirm on-call schedules, but does not require physicians to provide such services • Physicians are required to participate in EMTALA call as a condition of Medical Staff for clinical privileges On-Call Physician Issues (cont.) • Medical Staff bylaws or policies/procedures must define responsibility of on-call physicians to respond, examine, and stabilize/treat patients with EMCs • Best practice = if particular services are generally available to the public, they should be available through on-call coverage of the ED • Some physicians are dropping privileges (decredentialing) or resigning privileges altogether to avoid call responsibilities On-Call Physician Issues (cont.) • CMS allows hospitals “flexibility to comply with EMTALA obligations by maintaining a level of call coverage within its capability” – CMS does not require specialists to be on-call at all times – On-call physicians may continue to see patients in private practice and perform elective surgery unless the physician is reimbursed for being on-call at a Critical Access Hospital (42 C.F.R. 413.70) – CMS allows valid excuses for not being able to respond to call – On-call physicians should have backup if s/he is in surgery with own patients On-Call Physician Issues (cont.) – The amount of on-call coverage depends on hospital physician resources available. Surveyors will consider all relevant factors: Number of physicians on staff Number of physicians in a specialty Other demands on physicians Frequency with which patients require on-call physicians Vacations, conferences, and days off Hospital situations in which physician is not available or the on-call physician is unable to respond • CMS does not require certain levels of on-call coverage. (No rule of 3 – no predetermined ratio of days per number of physicians in certain specialty) On-Call Physician Issues (cont.) • When specialists services cannot be provided, the hospital should have transfer policies or transfer agreements with other hospitals that have the capability to accommodate the needs of a patient • Hospital may exempt members of Medical Staff from EMTALA call (i.e., senior staff (age) or number of years on staff) as long as exemption does not affect patient care adversely. CMS will carefully scrutinize overly generous exemptions On-Call Physician Issues (cont.) • Specialists may provide on-call coverage simultaneously for more than one hospital as long as policies address back-up coverage or transfers when on-call physician is unavailable • Physicians may not refuse to be on the call list, then selectively see private patients in the hospital • Non-physician practitioners may respond to a call from the ED if the on-call physician determines it is appropriate based on medical needs of the patient and capabilities of hospital. (Board must determine if non-physicians can provide stabilization services). However, if ED physician disagrees with on-call physician, the on-call physician must personally appear to stabilize On-Call Physician Issues (cont.) • Generally not appropriate to send a patient to an on-call physician’s office for services. In determining whether a hospital has appropriately moved a patient to the on-call physician’s office, surveyors will consider the following: – All persons with same medical condition are moved in such circumstances regardless of ability to pay for treatment; – There is a bona fide medical reason to move the patient. (Specialized equipment in physician’s office); and – Appropriate medical personnel accompany the patient • Never make a transfer for the convenience of the specialist – CMS will view this an endangering an unstable patient. On-Call Physician Issues (cont.) • Telemedicine – no EMTALA provision against using telemedicine to examine patients. Remote consultations are allowed, including at Critical Access Hospitals • CMS wants to see hospitals enforce their EMTALA obligations • For the Hospital Compensation Committee: Improper structure of payments to on-call specialists for on-call services may violate the anti-kickback law. (See OIG Advisory Opinion, September 2007) On-Call Physician Issues (cont.) • CMS has authorized voluntary community call plans developed by 2 or more hospitals if the following elements are met: – Clear delineation of on-call coverage responsibilities; – Applicable geographic area as specified; – Signed by authorized representative of each participating hospital; – Insure that EMS systems are aware of the arrangement; – Patients arriving at hospital without designated call responsibilities are still screened and stabilized; – Annual reassessment of programs is performed by participating hospitals. Psychiatric Emergencies • Psychiatric disturbances and symptoms of substance abuse can cause an EMC • CMS classifies suicidal and homicidal tendencies as psychiatric emergencies • Mental harm is more difficult to quantify than physical harm • If hospital lacks capabilities to perform mental health exams, EMTALA does not apply Psychiatric Emergencies (cont.) • Psych patients present ED physician with dual duty: – MSE must be adequate to reveal emergent psychiatric condition, and – Physical medical emergency conditions (appropriate lab and radiology testing) • Medical record should indicate assessment or suicide or homicide attempt or risk, disorientation, or assaultive behavior that indicates danger to self or others Psychiatric Emergencies (cont.) • ED physician must use good medical judgment in attempting to stabilize psych EMC - no guidance from CMS on this point • Hospital must attempt to stabilize to the best of hospital’s capability • Patient may lack understanding or capacity to communicate regarding exam, treatment or transfer • Consent is presumed in the event of an emergency Psychiatric Emergencies (cont.) • A psychiatric patient is considered stable for transfer when, by use of either medication or physical restraints, the patient can be protected from hurting himself or herself or others • ED physicians should document in chart the patient is stable for psychiatric transfer because of – Medical evaluation, – Chemical restraints, or – Physical restraints Psychiatric Emergencies (cont.) • Provider must affirmatively document that no less restrictive measures are feasible under the circumstances (CMS patient rights – restrictions on use of restraints and seclusion) Psychiatric Emergencies (cont.) • If, after MSE, hospital does not find an EMC, and hospital is not aware of any EMC, the patient is stable for discharge • For purposes of discharging a psychiatric patient, the patient is considered to be stable when s/he is no longer considered to be a threat to him or herself or to others • Documentation of the MSE exam of psychiatric patient is key Psychiatric Emergencies (cont.) • Examples of psychiatric and EMCs offered by CMS (unofficial) – Impending delirium tremens, detox, or seizures – Expressions of suicidal or homicidal thoughts or gestures – Intoxicated individuals – Delusions, severe insomnia, or helplessness – Self-mutilative or destructive behavior – History of drug ingestion and patient with coma – Inability to maintain nutrition with altered mental status – Psychotic behavior Technical Advisory Group • Technical Advisory Group recommended – Insertion of language “gravely disabled” or danger to self or others, and who have an EMC, requiring hospitals with specialized behavioral health capabilities to accept such transfers when transferring hospital does not have capability to provide stabilizing care; – Clarify that chemical or physical restraints alone do not stabilize psychiatric EMCs; – More changes expected on handling Psychiatric EMCs Enforcement • CMS enforcement methodology: – EMTALA enforcement is a complaint-driven process – Even if complaint allegation is determined unfounded by CMS, CMS instructs surveyors that they must still be assured that the hospital’s policies and procedures, physician certifications of transfer, etc. are in compliance with law – See attachment regarding EMTALA Complaint and investigation Helpful Sources • Emergency Medical Treatment and Active Labor Act (EMTALA) 42 U.S.C. §1395dd • EMTALA Regulations 42 C.F.R. 489.24 • U.S. Department Health & Human Services Medicare/Medicaid State Operations Manual (SOM): Provider Certification Appendix V – Interpretive Guidelines – Responsibilities of Medicare Participating Hospitals in Emergency Cases (Rev. 1, 05-21-04) Helpful Sources (cont.) • Revised State Operations Manual, Interpretive Guidelines, Part II, (revised 3-212008) • CMS.gov – Regulations and Guidance • Final Report of the EMTALA Technical Advisory Group (April, 2008) and Recommendations of TAG, 1 through 55, and Chart with Recommended Order of Priority for CMS