EMTALA Update 2021
of 160
/160
Embed Size (px)
Transcript of EMTALA Update 2021
Slide 1Labor Act Part 1 of 3
2
Speaker
1621 York Street
Denver, Colorado 80206
Email questions to CMS at: Critical Access Hospitals: qso[email protected] or Acute hospitals: [email protected].
3
www.beckershospitalreview.com/eds/maine-hospitals-
turned-mental-health-patients-away-from-er-state-
finds.html
4
www.modernhealthcare.com/article/20170705/
NEWS/170709977
5
https://drme.org/blog/2018-08-30
6
www.beckershospitalreview.com/patient-flow/30-of-
hospitals-have-violated-emtala-investigation-
Survey memo June 4, 2019
Revised the EMTALA manual
Chapter 5 re: complaint investigations
Prior regulation - time frame to investigate EMTALA complaints or patients who die from restraints was 5 working days
Changed to two business days if serious - immediate jeopardy possible
The regional office triages complaints
Non-IJ can be done in 45 days 8
9
OIG issued final rules that became effective January 6, 2017
Published in the Federal Register
Changed the civil monetary penalty (CMP) or “fine” for violating the federal EMTALA law
Also clarified liability under EMTALA
These are not in the CMS EMTALA manual
11
12
www.federalregister.gov/documents/2016/12/07/2016-28293/medicare-and-state-health-care-
programs-fraud-and-abuse-revisions-to-the-office-of-inspector
Updates
OIG will review the violation on a case-by-case basis
This includes if there is a pattern
Removed the section on mitigating factors when deciding how much to fine the hospital for an EMTALA violation
Will also evaluate if the hospital took appropriate action when it discovered an EMTALA violation
13
14
Gross, flagrant violation or repeated violations of EMTALA
Removed outdated references to the pre-1991 “knowing scienter” requirement
“Responsible physician” – revised
The on-call physician at the hospital is subject to EMTALA
15
Clarified:
An on-call physician who fails to show up within a reasonable time when requested violates EMTALA and can be fined
Includes
– Where a patient may need to be transferred
– The on-call physician to accept the transfer when they have specialized capabilities
Will consider if CMS was notified in advance
16
Fines
Request for payment prior to screening or treating
Patient harm which could include premature discharge
May fine a physician for making misrepresentation on the patient’s condition
Also – a penalty may be assessed if the patient is kept there an unreasonable amount of time and leaves
17
Use a form that sets out questions to ask
It is 11 pages long
It includes name of the patient, DOB, name of the hospital, both sending and receiving
It asks the physician to document their rationale for the findings and to make summary comments
www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/downloads/som107_exhibit_138.pdf
Asks:
Did the hospital provide a medical screening exam (MSE) to determine if an emergency medical condition (EMC) existed?
Was the MSE appropriate considering the patient’s complaints and signs and symptoms?
Was there any inappropriate long delay?
If there was an EMC was the patient stabilized?
If transferred to another hospital were qualified staff and equipment used?
CMS Surveyor Course on EMTALA
CMS Surveyor Training Website
As of March 22, 2013 – can access hospital complaint data
Includes acute care and CAH hospitals
Does not include the plan of correction but can request
Questions to [email protected]
27
Hospital Complaint Data
A list that includes the hospital’s name and the different tag numbers that were found to be out of compliance
Many on restraints and seclusion, EMTALA, infection control, patient rights including consent, advance directives and grievances
EMTALA – one of the most common deficiencies
4,472 deficiencies in January 2019 – increase of 442 from 2018
5,052 in January 2020 – up 580 from 2019
5,325 in November 2020 – up 273
28
Tag 2404 On call physician 235
32
2409 Appropriate Transfer 676
2410 Capability & Lateral Transfers
37
38
39
www.cms.gov/files/document/a
ppendices-table-content.pdf
OIG Monetary Penalties
Factors Zuabi N, Weiss L, Langdorf M. Emergency Medical Treatment and Labor Act (EMTALA) 2002-15:
Review of Office of Inspector General Patient Dumping Settlements. West J Emerg Med. 2016;17(3):245-251.
% of Settlements
Failure to stabilize a patient with EMC 42.7%
Patient turned away for insurance or financial status 15.6%
Inappropriate discharge of patient with EMC 14.5%
Hospital failed to accept transfer in of patient with EMC 13%
Inappropriate transfer of a patient with EMC 11.4%
Failed to transfer a patient with EMC 11.4%
Patient in active labor 6.7%
On-call physician refused to see patient with EMC 6.2%
No specialist physician available upon arrival of patient with EMC 2%
Hospital had capacity but still refused 2%
ED on ambulance diversion 1.5% 40
CMS Regions in US
Posting signs regarding narcotic policy might be considered coercive or intimidating to patients who present to the ED with painful medical conditions
Violates both the language and intent of the EMTALA statute and regulation
Patients with legitimate need for pain control might be coerced to leave the ED before receiving an appropriate medical screening exam
Consider removing the ED guidelines that may be posted in your ED
Still follow standard of care
42
Penalties have increased – doubled
Due to the Federal Civil Penalties Inflation Adjustment Act of 2015
From $50,000 to $103,139.00 for hospitals with 100 beds or more and Feb 2017 inflation to $104,826
From 25,000 to $51,570 hospitals less than 100 with Feb 2017 inflation to $52,421
44
Question #1
Our facility provides routine education to physicians and staff regarding EMTALA obligations.
Yes
No
Hospitals that participate in the Medicare program must
Provide a medical screening exam to
Determine if the patient is in an emergency medical condition (EMC)
If so – must provide stabilizing treatment or transfer
Rationale:
– Prevent hospitals from denying care to anyone in an emergency, not just pregnant woman
– To prevent hospitals from transferring patients before they were adequately stabilized
49
To Brookside Hospital ED on 1-28-85
Had penetrating stab wound to scalp and the neurosurgeon refused to come
Called 3 other hospitals and refused to take
Finally sent to San Francisco General four hours after arrival but patient died
50
William Jenness – to hospital after auto accident
Hospital asked for $1,000 deposit in advance before they would treat
Patient could not pay so transferred to a county hospital
It took four hours before he reached the operating room
Died six hours after the accident
51
Anna Grant – went to private hospital in labor
Was kept in a wheelchair for 2 hours and 15 minutes
Checked only once
No test done
If tests had been completed – would have shown fetus to be in severe distress
Patient was told to get herself to the county hospital
Baby stillborn at the county hospital
52
49-year-old patient complained of chest pain, nausea, and SOB
Waited in emergency department lobby for 2 hours
Her daughter, a nurse, went to the staff 5 times and asked to evaluate her mom
Nurse went to get patient and she was leaning on her side unconscious with no pulse
Lake County coroner rules that the death a homicide
53
https://myheartsisters.org/2012/01/20/beatrice-vance/
55
56
OIG: Office of Inspector General
QIO: Quality Improvement Organization
Investigate discrimination based on age, sex, disability, national origin, etc.
State survey agencies: abbreviated SA
Example is the Department of Health
In SD – Department of Health
57
History
EMTALA: Emergency Medical Treatment and Labor Act
Note the word “ACTIVE” is no longer a part of the name
58
History
Initially referred to as “COBRA”
More commonly called EMTALA
Also known as the Patient Transfer Act or the Anti- dumping Law (SSA, Section 1867)
59
Website lists resources on this issue
Includes CMS guidance to state survey agency directors and CMS regional offices
Includes information about the Technical Advisory Group (TAG), complaint procedures, EMTALA survey and certification letters, transmittals, etc.
Available at http://www.cms.gov/EMTALA/
CMS EMTALA Website
Payment for EMTALA
Amendment July 2010 and July 2019
Amended Tag 2406 on waivers in 2010
Provider agreement under SSA
62
63
www.cms.gov/Regulations-and-
Guidance/Guidance/Transmittals/2019Downloads/R191SOMA.pdf
Updated chapter five in the complaint manual to include EMTALA
The State agency may show up at the hospital’s door within two business days if it is a serious EMTALA allegation such as where it could constitute immediate jeopardy (IJ)
All allegations of EMTALA violations are sent to the regional office including children’s, cancer, psych, LTC, acute care, CAH, and rehab hospitals
64
July 2019 Changes
Allegations of EMTALA noncompliance may be assigned a priority – if can establish immediate jeopardy
If the problem was found to be true and uncorrected:
Would result in substantial noncompliance with at least one condition level deficiency
Reason to correct problems timely
CMS has a separate manual on immediate jeopardy
Updated in March 2019
Will review at least 20 records in depth
On return visit: will look at 10 additional
– Ensure plan of correction is being followed
Review transfers of ED patients in the last 6 months
– Ensure stabilizing treatment was provided
Focus primarily on the issue related to the complaint
– Can review non-related case to assess compliance with all the EMTALA requirements
Will punt to the OCR if find discrimination based on age, sex, or national origin etc.
66
Other Changes
Added that surveyors are to review the central log and to look at cases
Suicidal ideation
67
Other Changes – cont’d
The surveyor may provide preliminary findings at the exit conference but must not tell the hospital if it is a violation
The regional office (RO) is the one that decides this
The RO can decide if the case needs to be referred to the QIO
Age, sex, national origin etc., complaints are referred to the OCR
68
69
www.cms.gov/SurveyCertificatio
http://www.cms.hhs.gov/SurveyCertificationGenInfo /PMSR/list.asp#TopOfPage
www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions
78
www.cms.gov/SurveyCertificationGe
Every hospital with a DED:
Must conduct an appropriate MSE on all patients
Includes patients suspected of having been exposed to Ebola
All EDs are expected to be able to apply appropriate Ebola screening
If necessary - isolate and notify state agency
81
If patient has Ebola – must follow current guidelines
If any complaints – CMS to consider public health guidance in effect at the time
CMS received several inquiries from hospitals regarding their EMTALA obligations
EMS or public health departments may develop community wide protocols for bringing patients to specified hospitals if suspected of having Ebola
82
83
84
www.cdc.gov/vhf/ebola/clinicians/index.html
CMS welcomes the use of telemedicine by CAH
CAH not required to have a doctor to appear when patient comes to the ED
PA, NP, CNS, or physician with emergency care experience must show up within 30 minutes
If MD/DO does not show up:
Must be immediately available by phone or radio 24 hours a day
Can be met by use of telemedicine physician or the physician on site
85
Addressed payor requirements and collection practices
EMTALA is a federal law and pre-empts any inconsistent state law
Some proposed or existing payment policies of third-party payors of hospital services are in violation of the federal EMTALA law
86
After an appropriate MSE completed
Stabilizing treatment has been initiated
ACA provided several provisions:
Required certain insurers to cover emergency services including stabilization, without preauthorization
CMS asked to intervene if a patient believes a state Medicaid policy conflicts with EMTALA
CMS will only approve ones that do not conflict with EMTALA
87
Study findings:
People who got a surprise bill for emergency care were more than 10x higher than those by other patients
https://www.cms.gov/newsroom/fact-sheets/requirements-related-surprise-billing- part-i-interim-final-rule-comment-period.
88
https://www.cms.gov/newsroom/fact-sheets/requirements-related-surprise-billing-part-i-interim-final-rule-comment-period
Summary
If a plan/coverage provides/covers any benefit for emergency services requires coverage
Without prior authorization
Regardless of any term/condition of plan or coverage other than:
– Exclusion/coordination of benefits
Summary – continued
Limits cost sharing for out-of-network to no higher than in-network levels
Cost sharing to count toward any in-network deductibles and out-of-pocket maximums
Prohibits balance billing
90
Required to do an appropriate MSE
Regardless of whether they walk in or come in by squad
Expected to be able to screen for COVID-19
Must be able to identify and isolate such patients
Keep 6 feet away from other patients
91
Covid-19 and EMTALA Memo
Can contact the state or local health department for next steps for patients with the coronavirus
Hospitals are expected to follow the current guidance from the CDC
CMS will take into consideration the public health guidance that is in effect when evaluating if a complaint is lodged
Need to provide appropriate isolation required to stabilize and accept patients when transfers are appropriate
Cannot put up signage in the ED that is designed to put up barriers for patients coming into the ED
92
93
www.cdc.gov/coronavirus/2019-ncov/infection-
control/control-recommendations.html
Covid-19 and EMTALA Memo
Hospitals need to determine if they have the capability to take care of a patient with the coronavirus
Must immediately isolate and follow the CDC isolation guidelines
www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/index.html
The March 2020 memo* set out what a hospital needs to do related to the coronavirus
If patient comes to the ED coughing put a mask on them
Isolate them and don’t allow them to sit in the waiting room
94
Hospitals may screen patients at offsite location
Cannot be inconsistent with state’s emergency preparedness/pandemic plan
Special waivers:
Transfer of individual who has not been stabilized – if transfer arises out of an emergency
Redirection to another location to receive MSE under state emergency preparedness/pandemic plan
Cannot discriminate at as to payor/ability to pay
95
Question #2
We have seen a decrease in routine ED visits since March due to fears of COVID-19
Yes
No
CMS Memo Hospitals & the Coronavirus
Contact your local health department if patient or healthcare provider has COVID-19
Monitor staff
Ill staff need to be sent home immediately if symptoms and place a mask on
Patients who arrive who are coughing should have a mask put on
In isolating patient – make sure the door is closed
In some settings patient may be able to wait in their personal vehicle or outside the facility and can call them on their cell phone when it is their turn
98
Covid-19 and EMTALA Memo
Hospitals must accept transfers of patient with COVID-19 if a CAH or small and rural hospital that does not have sufficient isolation or equipment to meet the patient’s needs
Some may just need a private room
May not need a negative pressure room (airborne infection isolation room or AIIR) unless patient undergoing aerosol generating procedures
MSE does not always have to take place in the ED- can set up an alternative site on the hospital’s campus to perform
Need to ask about foreign travel during triage
99
Covid-19 and EMTALA Memo
Person directing patient movement after the patient is logged in must be qualified – such as an RN
MSEs must be conducted by qualified personnel
I.e. physicians, NPs, PAs, or RNs
Trained to perform MSEs and
Acting within the scope of their State Practice Act
Cannot send a patient off campus for screening*
Can encourage the public to go to these facilities
Some facilities have large tents in parking lot for testing
100
101
#1 Issued September 20, 2007, No. 07-10
#2 Issued May 21, 2009, No. 09-05
OIG agrees not to prosecute a hospital for paying for certain on call services for on call physicians
Physicians agree to take call rotation on even basis
http://www.oig.hhs.gov/fraud/docs/advisoryopinions/2007/AdvOpn07-10A.pdf
106
Physicians are paid a rate for each day on call
18 days a year are gratis
Rate based on specialty and whether coverage is weekday or weekend, likelihood to be called, severity of illness, degree of inpatient care required
Rates provided at fair market value
Program open to all
OIG Advisory Opinion #2
Addressed a 400-bed nonprofit general hospital with only provider in that county area for acute care services
Many times, no one on call and had to transfer patients out
Proposed to allow on-call doctors to submit claims for services rendered to indigent and uninsured patients presenting to the ED
Signed an agreement that this was payment in full and would show up in 30 minutes
109
Fees:
$350 for primary surgeon and physician doing an endoscopic procedure
OIG approved: did not include any of the four
problematic compensation structures and presented a low risk of fraud and abuse
Payments were fair market value without regard to referrals or other business generated by the parties
110
Paying for On-Call Physicians
Arrangement does not consider the value or volume of past or future referrals
Every arrangement must be based on the totality of its facts and circumstances
Safe harbor for personal services (contract, over one year) but does not fit squarely since aggregate amount can not be set in advance
Arrangement in this case presents low risk of fraud and abuse
111
What You Should Consider
Have a process to support the rationale for paying physicians for on-call services
Be able to justify the reasonableness of the amount of the payments
Attempt to obtain on-call payment arrangements to fit within the fraud and abuse laws to satisfy the OIG
112
Review your obligations under this federal law
When to do a medical screening exam
When patient has an emergency medical condition
Know screening can not be delayed to inquire about method of payment or insurance
Available at http://oig.hhs.gov/fraud/complianceguidance.asp
113
OIG Compliance Program Guidance
Even if on divert and patient shows up – they are yours
Do not transfer a patient unless there is a transfer agreement for unstable patients with benefits and risks
Provide stabilizing treatment to minimize the risks of transfer
Medical records must accompany the patient
Understand specialized capability provision
Must provide screening and treatment within full capability of hospital including staff and facilities
Includes on call specialist
On call physicians need to be educated on their responsibilities
Including responsibility to accept transferred individuals from other facilities
Must have policies and procedures
Periodic training for persons working in the ED of EMTALA obligations and hospital’s P&Ps
115
The previous guidelines for CMS surveyors contain an EMTALA trigger
Are not in the 2019 changes
These apply to all facilities that receive Medicare/Medicaid reimbursement
Including Critical Access Hospitals
2019 changes
Did not list the prior EMTALA specifics
Mentions the RO makes the final decision and not the SA, so it is preliminary
Refers the surveyor to other resources and manuals
Failure to perform medical screening exam as required by EMTALA or to stabilize or provide safe transfer
Individual turned away from the emergency department without a medical screening exam
118
Examples of Immediate Jeopardy
Failure to perform medical screening exam as required by EMTALA or to stabilize or provide safe transfer
Individual turned away from the ED without an MSE
Women with contractions not medically screened for status of labor
Absence of ED or OB medical screening documentation
Failure to stabilize emergency medical condition
Failure to appropriately transfer an individual with an unstable medical condition
119
The time and means of arrival to the ED
If the patient left AMA
All orders, progress notes, medication given, informed consent, use of interpreters, adverse drug reactions
Records of communication with patients including telephone calls such as abnormal test results from the ED or emails
120
Summary of care provided and emergency treatment prior to arrival
Conclusion reached at the termination of care in the ED
The patient’s final disposition
Condition
121
CMS Regional Offices (RO)
The RO evaluates all complaints and refers that warrant SA investigation (state agency)
SA or RO send a letter to complainant
Acknowledging receipt of complaint
Let person know if investigation is warranted
Will look to see if violation of the Provider agreement or related Special responsibilities in emergency cases
122
See list at end of addresses of all ROs
RO gives initial verbal authorization for investigation
Then prepares Form for Request for Survey (1541B)
Copy available at; http://www.cms.hhs.gov/cmsforms/downloads/cms1541a.pdf
Determine allegation
Source of complaint, date received etc.
May complete Request for Validation of Accreditation survey for hospital
State Agency does not notify hospital in advance
Only CMS does EMTALA investigations and not AOs
Is a CoP (Condition of Participation)
Hospitals agree to comply with the provisions by accepting Medicare payments
Hospitals should maintain a copy of these interpretative guidelines
Recommend hospitals have a resource book on EMTALA in ED, OB, and behavioral health units
127
Then CMS adds interpretive guidelines and survey procedure
128
Examples of Tag number: A-2403/C-2403
“A” indicates a hospital standard
“C” is for Critical Access Hospitals
Starts with Tag 2400 and goes to Tag to 2411 so 12 tag numbers
Part I - the investigative procedures, entrance conference, record review, exit conference etc.
129
Interpretive Guidelines
Part II is the section on responsibilities of Medicare Participating Hospitals in Emergency Cases
Includes on-call physician requirements
Includes stabilization and transfer requirements
130
Two Other Important Laws
There are also two other important laws that address EMTALA issues
First: Basic Commitment Section 1866
Agreement with Providers (42 U.S.C. 1395cc)
Is relevant to the second one
Also referred to the Essential of Provider Agreement
Second: Section 1867 (42 U.S.C. 1395dd)
Examination and Treatment for an Emergency Medical Condition (EMC)
Basic Commitments & Special Responsibilities
Basic Section 2400
Defines hospital to include CAH so all hospitals are governed by EMTALA
Requires:
A medical screening exam (MSE) be given to any patient who comes to the ED
That any patient with an EMC or in labor be provided necessary stabilizing treatment
Hospital to provide an appropriate transfer such as when patient requests or hospital does not have the capability or capacity to provide the necessary treatment
134
A list of physicians
On call for duty after the initial examination
To provide treatment necessary to stabilize an individual with an emergency medical condition
Maintain medical records for five years from date of transfer
Provider Agreement
To post conspicuously in any emergency department
Specifying the rights of individuals with respect to exam and treatment for EMC and for women in labor
Must be one specified by the secretary
Must say if you participate or not in the Medicaid program
More information on EMTALA sign in section 2402
Sign must be clearly visible from 20 feet
At least 18” by 20”
Unless in posted in small room
137
138
Hospitals who participate in the Medicare
EMTALA is a condition of participation (CoP)
Is not limited to Medicare patients
Includes any individual who comes to the ED requesting care
If no verbal request is made it would include if a reasonable prudent layperson observer would conclude they need emergency care (not breathing)
Present themselves to an area of the hospital that meets the definition of dedicated emergency department or DED
139
Holds self out to public as providing emergency care
During preceding calendar year, provided at least 1/3 of its outpatient visits for treatment of EMC
Example: hospital has an emergency department (ED), or trauma center
It covers all individuals regardless of payment source
140
To Whom Does EMTALA Apply?
Patients in a car at the ED doors trying to access the ED
Patients anywhere on hospital property seeking emergency care
For example: they come in the wrong entrance to the hospital and are looking for the ED
Non-citizens of the US and minors
Does not cover people on the phone
Question #3
We encourage our staff to be on the alert for persons who may call with healthcare-related questions and to advise them to seek immediate care if they feel they are having a medical emergency.
Yes
No
141
142
No Delay in Exam or Treatment 2400
Hospitals may not delay an appropriate MSE to inquire about the individual’s method of payment or insurance status
CMS and OIG issue a special advisory bulletin on November 10, 1999 (Fed Reg. Volume 64, No. 217, 61353) – still relevant today
Every hospital should read this to understand how to meet compliance with this section
Discussion
SE County is a 25-bed CAH. 50 miles away is Central Hospital – an 80-bed facility. 63-year-old Pt. A was injured in a farm accident 40 miles from SE County and 90 miles from Central. He fell from a barn roof. His wife calls SE County asking whether Pt. A should be brought into the hospital for examination. He is breathing short, grunting breaths which the ED nurse can hear over the phone. Pt. A is holding his left rib cage and reports hitting his head at some point.
EMTALA activated?
1621 York Street
Denver, Colorado 80206
https://www.cms.gov/Medicare/Provider-Enrollment-and- Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Certification-State- Agency-Contacts.pdf.
146
https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Certification-State-Agency-Contacts.pdf
147
https://public.govdelivery.com/accounts/USGPOO
FR/subscriber/new
148
Special Responsibilities of Medicare Hospitals in Emergency Cases EMTALA is located at 42 C.F.R. 489.24
Federal Register and CFR are available free off internet at http://www.gpoaccess.gov/fr/index.html
Available at http://ecfr.gpoaccess.gov/cgi/t/text/text- idx?c=ecfr&sid=c07ae216364917a701e2426eb3f1419c&rgn=div8&view=t ext&node=42:4.0.1.5.27.2.212.5&idno=42
149
LABOR, YOU HAVE THE RIGHT TO RECEIVE,
within the capabilities of this hospital's staff
and facilities:
Necessary STABILIZING TEATMENT
An appropriate TRANSFER to another facility
Even if YOU CANNOT PAY or DO NOT HAVE
MEDICAL INSURANCE
This hospital (DOES/DOES NOT) participate in the Medicaid Program
153
159
https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-
waivers.pdf
2
Speaker
1621 York Street
Denver, Colorado 80206
Email questions to CMS at: Critical Access Hospitals: qso[email protected] or Acute hospitals: [email protected].
3
www.beckershospitalreview.com/eds/maine-hospitals-
turned-mental-health-patients-away-from-er-state-
finds.html
4
www.modernhealthcare.com/article/20170705/
NEWS/170709977
5
https://drme.org/blog/2018-08-30
6
www.beckershospitalreview.com/patient-flow/30-of-
hospitals-have-violated-emtala-investigation-
Survey memo June 4, 2019
Revised the EMTALA manual
Chapter 5 re: complaint investigations
Prior regulation - time frame to investigate EMTALA complaints or patients who die from restraints was 5 working days
Changed to two business days if serious - immediate jeopardy possible
The regional office triages complaints
Non-IJ can be done in 45 days 8
9
OIG issued final rules that became effective January 6, 2017
Published in the Federal Register
Changed the civil monetary penalty (CMP) or “fine” for violating the federal EMTALA law
Also clarified liability under EMTALA
These are not in the CMS EMTALA manual
11
12
www.federalregister.gov/documents/2016/12/07/2016-28293/medicare-and-state-health-care-
programs-fraud-and-abuse-revisions-to-the-office-of-inspector
Updates
OIG will review the violation on a case-by-case basis
This includes if there is a pattern
Removed the section on mitigating factors when deciding how much to fine the hospital for an EMTALA violation
Will also evaluate if the hospital took appropriate action when it discovered an EMTALA violation
13
14
Gross, flagrant violation or repeated violations of EMTALA
Removed outdated references to the pre-1991 “knowing scienter” requirement
“Responsible physician” – revised
The on-call physician at the hospital is subject to EMTALA
15
Clarified:
An on-call physician who fails to show up within a reasonable time when requested violates EMTALA and can be fined
Includes
– Where a patient may need to be transferred
– The on-call physician to accept the transfer when they have specialized capabilities
Will consider if CMS was notified in advance
16
Fines
Request for payment prior to screening or treating
Patient harm which could include premature discharge
May fine a physician for making misrepresentation on the patient’s condition
Also – a penalty may be assessed if the patient is kept there an unreasonable amount of time and leaves
17
Use a form that sets out questions to ask
It is 11 pages long
It includes name of the patient, DOB, name of the hospital, both sending and receiving
It asks the physician to document their rationale for the findings and to make summary comments
www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/downloads/som107_exhibit_138.pdf
Asks:
Did the hospital provide a medical screening exam (MSE) to determine if an emergency medical condition (EMC) existed?
Was the MSE appropriate considering the patient’s complaints and signs and symptoms?
Was there any inappropriate long delay?
If there was an EMC was the patient stabilized?
If transferred to another hospital were qualified staff and equipment used?
CMS Surveyor Course on EMTALA
CMS Surveyor Training Website
As of March 22, 2013 – can access hospital complaint data
Includes acute care and CAH hospitals
Does not include the plan of correction but can request
Questions to [email protected]
27
Hospital Complaint Data
A list that includes the hospital’s name and the different tag numbers that were found to be out of compliance
Many on restraints and seclusion, EMTALA, infection control, patient rights including consent, advance directives and grievances
EMTALA – one of the most common deficiencies
4,472 deficiencies in January 2019 – increase of 442 from 2018
5,052 in January 2020 – up 580 from 2019
5,325 in November 2020 – up 273
28
Tag 2404 On call physician 235
32
2409 Appropriate Transfer 676
2410 Capability & Lateral Transfers
37
38
39
www.cms.gov/files/document/a
ppendices-table-content.pdf
OIG Monetary Penalties
Factors Zuabi N, Weiss L, Langdorf M. Emergency Medical Treatment and Labor Act (EMTALA) 2002-15:
Review of Office of Inspector General Patient Dumping Settlements. West J Emerg Med. 2016;17(3):245-251.
% of Settlements
Failure to stabilize a patient with EMC 42.7%
Patient turned away for insurance or financial status 15.6%
Inappropriate discharge of patient with EMC 14.5%
Hospital failed to accept transfer in of patient with EMC 13%
Inappropriate transfer of a patient with EMC 11.4%
Failed to transfer a patient with EMC 11.4%
Patient in active labor 6.7%
On-call physician refused to see patient with EMC 6.2%
No specialist physician available upon arrival of patient with EMC 2%
Hospital had capacity but still refused 2%
ED on ambulance diversion 1.5% 40
CMS Regions in US
Posting signs regarding narcotic policy might be considered coercive or intimidating to patients who present to the ED with painful medical conditions
Violates both the language and intent of the EMTALA statute and regulation
Patients with legitimate need for pain control might be coerced to leave the ED before receiving an appropriate medical screening exam
Consider removing the ED guidelines that may be posted in your ED
Still follow standard of care
42
Penalties have increased – doubled
Due to the Federal Civil Penalties Inflation Adjustment Act of 2015
From $50,000 to $103,139.00 for hospitals with 100 beds or more and Feb 2017 inflation to $104,826
From 25,000 to $51,570 hospitals less than 100 with Feb 2017 inflation to $52,421
44
Question #1
Our facility provides routine education to physicians and staff regarding EMTALA obligations.
Yes
No
Hospitals that participate in the Medicare program must
Provide a medical screening exam to
Determine if the patient is in an emergency medical condition (EMC)
If so – must provide stabilizing treatment or transfer
Rationale:
– Prevent hospitals from denying care to anyone in an emergency, not just pregnant woman
– To prevent hospitals from transferring patients before they were adequately stabilized
49
To Brookside Hospital ED on 1-28-85
Had penetrating stab wound to scalp and the neurosurgeon refused to come
Called 3 other hospitals and refused to take
Finally sent to San Francisco General four hours after arrival but patient died
50
William Jenness – to hospital after auto accident
Hospital asked for $1,000 deposit in advance before they would treat
Patient could not pay so transferred to a county hospital
It took four hours before he reached the operating room
Died six hours after the accident
51
Anna Grant – went to private hospital in labor
Was kept in a wheelchair for 2 hours and 15 minutes
Checked only once
No test done
If tests had been completed – would have shown fetus to be in severe distress
Patient was told to get herself to the county hospital
Baby stillborn at the county hospital
52
49-year-old patient complained of chest pain, nausea, and SOB
Waited in emergency department lobby for 2 hours
Her daughter, a nurse, went to the staff 5 times and asked to evaluate her mom
Nurse went to get patient and she was leaning on her side unconscious with no pulse
Lake County coroner rules that the death a homicide
53
https://myheartsisters.org/2012/01/20/beatrice-vance/
55
56
OIG: Office of Inspector General
QIO: Quality Improvement Organization
Investigate discrimination based on age, sex, disability, national origin, etc.
State survey agencies: abbreviated SA
Example is the Department of Health
In SD – Department of Health
57
History
EMTALA: Emergency Medical Treatment and Labor Act
Note the word “ACTIVE” is no longer a part of the name
58
History
Initially referred to as “COBRA”
More commonly called EMTALA
Also known as the Patient Transfer Act or the Anti- dumping Law (SSA, Section 1867)
59
Website lists resources on this issue
Includes CMS guidance to state survey agency directors and CMS regional offices
Includes information about the Technical Advisory Group (TAG), complaint procedures, EMTALA survey and certification letters, transmittals, etc.
Available at http://www.cms.gov/EMTALA/
CMS EMTALA Website
Payment for EMTALA
Amendment July 2010 and July 2019
Amended Tag 2406 on waivers in 2010
Provider agreement under SSA
62
63
www.cms.gov/Regulations-and-
Guidance/Guidance/Transmittals/2019Downloads/R191SOMA.pdf
Updated chapter five in the complaint manual to include EMTALA
The State agency may show up at the hospital’s door within two business days if it is a serious EMTALA allegation such as where it could constitute immediate jeopardy (IJ)
All allegations of EMTALA violations are sent to the regional office including children’s, cancer, psych, LTC, acute care, CAH, and rehab hospitals
64
July 2019 Changes
Allegations of EMTALA noncompliance may be assigned a priority – if can establish immediate jeopardy
If the problem was found to be true and uncorrected:
Would result in substantial noncompliance with at least one condition level deficiency
Reason to correct problems timely
CMS has a separate manual on immediate jeopardy
Updated in March 2019
Will review at least 20 records in depth
On return visit: will look at 10 additional
– Ensure plan of correction is being followed
Review transfers of ED patients in the last 6 months
– Ensure stabilizing treatment was provided
Focus primarily on the issue related to the complaint
– Can review non-related case to assess compliance with all the EMTALA requirements
Will punt to the OCR if find discrimination based on age, sex, or national origin etc.
66
Other Changes
Added that surveyors are to review the central log and to look at cases
Suicidal ideation
67
Other Changes – cont’d
The surveyor may provide preliminary findings at the exit conference but must not tell the hospital if it is a violation
The regional office (RO) is the one that decides this
The RO can decide if the case needs to be referred to the QIO
Age, sex, national origin etc., complaints are referred to the OCR
68
69
www.cms.gov/SurveyCertificatio
http://www.cms.hhs.gov/SurveyCertificationGenInfo /PMSR/list.asp#TopOfPage
www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions
78
www.cms.gov/SurveyCertificationGe
Every hospital with a DED:
Must conduct an appropriate MSE on all patients
Includes patients suspected of having been exposed to Ebola
All EDs are expected to be able to apply appropriate Ebola screening
If necessary - isolate and notify state agency
81
If patient has Ebola – must follow current guidelines
If any complaints – CMS to consider public health guidance in effect at the time
CMS received several inquiries from hospitals regarding their EMTALA obligations
EMS or public health departments may develop community wide protocols for bringing patients to specified hospitals if suspected of having Ebola
82
83
84
www.cdc.gov/vhf/ebola/clinicians/index.html
CMS welcomes the use of telemedicine by CAH
CAH not required to have a doctor to appear when patient comes to the ED
PA, NP, CNS, or physician with emergency care experience must show up within 30 minutes
If MD/DO does not show up:
Must be immediately available by phone or radio 24 hours a day
Can be met by use of telemedicine physician or the physician on site
85
Addressed payor requirements and collection practices
EMTALA is a federal law and pre-empts any inconsistent state law
Some proposed or existing payment policies of third-party payors of hospital services are in violation of the federal EMTALA law
86
After an appropriate MSE completed
Stabilizing treatment has been initiated
ACA provided several provisions:
Required certain insurers to cover emergency services including stabilization, without preauthorization
CMS asked to intervene if a patient believes a state Medicaid policy conflicts with EMTALA
CMS will only approve ones that do not conflict with EMTALA
87
Study findings:
People who got a surprise bill for emergency care were more than 10x higher than those by other patients
https://www.cms.gov/newsroom/fact-sheets/requirements-related-surprise-billing- part-i-interim-final-rule-comment-period.
88
https://www.cms.gov/newsroom/fact-sheets/requirements-related-surprise-billing-part-i-interim-final-rule-comment-period
Summary
If a plan/coverage provides/covers any benefit for emergency services requires coverage
Without prior authorization
Regardless of any term/condition of plan or coverage other than:
– Exclusion/coordination of benefits
Summary – continued
Limits cost sharing for out-of-network to no higher than in-network levels
Cost sharing to count toward any in-network deductibles and out-of-pocket maximums
Prohibits balance billing
90
Required to do an appropriate MSE
Regardless of whether they walk in or come in by squad
Expected to be able to screen for COVID-19
Must be able to identify and isolate such patients
Keep 6 feet away from other patients
91
Covid-19 and EMTALA Memo
Can contact the state or local health department for next steps for patients with the coronavirus
Hospitals are expected to follow the current guidance from the CDC
CMS will take into consideration the public health guidance that is in effect when evaluating if a complaint is lodged
Need to provide appropriate isolation required to stabilize and accept patients when transfers are appropriate
Cannot put up signage in the ED that is designed to put up barriers for patients coming into the ED
92
93
www.cdc.gov/coronavirus/2019-ncov/infection-
control/control-recommendations.html
Covid-19 and EMTALA Memo
Hospitals need to determine if they have the capability to take care of a patient with the coronavirus
Must immediately isolate and follow the CDC isolation guidelines
www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/index.html
The March 2020 memo* set out what a hospital needs to do related to the coronavirus
If patient comes to the ED coughing put a mask on them
Isolate them and don’t allow them to sit in the waiting room
94
Hospitals may screen patients at offsite location
Cannot be inconsistent with state’s emergency preparedness/pandemic plan
Special waivers:
Transfer of individual who has not been stabilized – if transfer arises out of an emergency
Redirection to another location to receive MSE under state emergency preparedness/pandemic plan
Cannot discriminate at as to payor/ability to pay
95
Question #2
We have seen a decrease in routine ED visits since March due to fears of COVID-19
Yes
No
CMS Memo Hospitals & the Coronavirus
Contact your local health department if patient or healthcare provider has COVID-19
Monitor staff
Ill staff need to be sent home immediately if symptoms and place a mask on
Patients who arrive who are coughing should have a mask put on
In isolating patient – make sure the door is closed
In some settings patient may be able to wait in their personal vehicle or outside the facility and can call them on their cell phone when it is their turn
98
Covid-19 and EMTALA Memo
Hospitals must accept transfers of patient with COVID-19 if a CAH or small and rural hospital that does not have sufficient isolation or equipment to meet the patient’s needs
Some may just need a private room
May not need a negative pressure room (airborne infection isolation room or AIIR) unless patient undergoing aerosol generating procedures
MSE does not always have to take place in the ED- can set up an alternative site on the hospital’s campus to perform
Need to ask about foreign travel during triage
99
Covid-19 and EMTALA Memo
Person directing patient movement after the patient is logged in must be qualified – such as an RN
MSEs must be conducted by qualified personnel
I.e. physicians, NPs, PAs, or RNs
Trained to perform MSEs and
Acting within the scope of their State Practice Act
Cannot send a patient off campus for screening*
Can encourage the public to go to these facilities
Some facilities have large tents in parking lot for testing
100
101
#1 Issued September 20, 2007, No. 07-10
#2 Issued May 21, 2009, No. 09-05
OIG agrees not to prosecute a hospital for paying for certain on call services for on call physicians
Physicians agree to take call rotation on even basis
http://www.oig.hhs.gov/fraud/docs/advisoryopinions/2007/AdvOpn07-10A.pdf
106
Physicians are paid a rate for each day on call
18 days a year are gratis
Rate based on specialty and whether coverage is weekday or weekend, likelihood to be called, severity of illness, degree of inpatient care required
Rates provided at fair market value
Program open to all
OIG Advisory Opinion #2
Addressed a 400-bed nonprofit general hospital with only provider in that county area for acute care services
Many times, no one on call and had to transfer patients out
Proposed to allow on-call doctors to submit claims for services rendered to indigent and uninsured patients presenting to the ED
Signed an agreement that this was payment in full and would show up in 30 minutes
109
Fees:
$350 for primary surgeon and physician doing an endoscopic procedure
OIG approved: did not include any of the four
problematic compensation structures and presented a low risk of fraud and abuse
Payments were fair market value without regard to referrals or other business generated by the parties
110
Paying for On-Call Physicians
Arrangement does not consider the value or volume of past or future referrals
Every arrangement must be based on the totality of its facts and circumstances
Safe harbor for personal services (contract, over one year) but does not fit squarely since aggregate amount can not be set in advance
Arrangement in this case presents low risk of fraud and abuse
111
What You Should Consider
Have a process to support the rationale for paying physicians for on-call services
Be able to justify the reasonableness of the amount of the payments
Attempt to obtain on-call payment arrangements to fit within the fraud and abuse laws to satisfy the OIG
112
Review your obligations under this federal law
When to do a medical screening exam
When patient has an emergency medical condition
Know screening can not be delayed to inquire about method of payment or insurance
Available at http://oig.hhs.gov/fraud/complianceguidance.asp
113
OIG Compliance Program Guidance
Even if on divert and patient shows up – they are yours
Do not transfer a patient unless there is a transfer agreement for unstable patients with benefits and risks
Provide stabilizing treatment to minimize the risks of transfer
Medical records must accompany the patient
Understand specialized capability provision
Must provide screening and treatment within full capability of hospital including staff and facilities
Includes on call specialist
On call physicians need to be educated on their responsibilities
Including responsibility to accept transferred individuals from other facilities
Must have policies and procedures
Periodic training for persons working in the ED of EMTALA obligations and hospital’s P&Ps
115
The previous guidelines for CMS surveyors contain an EMTALA trigger
Are not in the 2019 changes
These apply to all facilities that receive Medicare/Medicaid reimbursement
Including Critical Access Hospitals
2019 changes
Did not list the prior EMTALA specifics
Mentions the RO makes the final decision and not the SA, so it is preliminary
Refers the surveyor to other resources and manuals
Failure to perform medical screening exam as required by EMTALA or to stabilize or provide safe transfer
Individual turned away from the emergency department without a medical screening exam
118
Examples of Immediate Jeopardy
Failure to perform medical screening exam as required by EMTALA or to stabilize or provide safe transfer
Individual turned away from the ED without an MSE
Women with contractions not medically screened for status of labor
Absence of ED or OB medical screening documentation
Failure to stabilize emergency medical condition
Failure to appropriately transfer an individual with an unstable medical condition
119
The time and means of arrival to the ED
If the patient left AMA
All orders, progress notes, medication given, informed consent, use of interpreters, adverse drug reactions
Records of communication with patients including telephone calls such as abnormal test results from the ED or emails
120
Summary of care provided and emergency treatment prior to arrival
Conclusion reached at the termination of care in the ED
The patient’s final disposition
Condition
121
CMS Regional Offices (RO)
The RO evaluates all complaints and refers that warrant SA investigation (state agency)
SA or RO send a letter to complainant
Acknowledging receipt of complaint
Let person know if investigation is warranted
Will look to see if violation of the Provider agreement or related Special responsibilities in emergency cases
122
See list at end of addresses of all ROs
RO gives initial verbal authorization for investigation
Then prepares Form for Request for Survey (1541B)
Copy available at; http://www.cms.hhs.gov/cmsforms/downloads/cms1541a.pdf
Determine allegation
Source of complaint, date received etc.
May complete Request for Validation of Accreditation survey for hospital
State Agency does not notify hospital in advance
Only CMS does EMTALA investigations and not AOs
Is a CoP (Condition of Participation)
Hospitals agree to comply with the provisions by accepting Medicare payments
Hospitals should maintain a copy of these interpretative guidelines
Recommend hospitals have a resource book on EMTALA in ED, OB, and behavioral health units
127
Then CMS adds interpretive guidelines and survey procedure
128
Examples of Tag number: A-2403/C-2403
“A” indicates a hospital standard
“C” is for Critical Access Hospitals
Starts with Tag 2400 and goes to Tag to 2411 so 12 tag numbers
Part I - the investigative procedures, entrance conference, record review, exit conference etc.
129
Interpretive Guidelines
Part II is the section on responsibilities of Medicare Participating Hospitals in Emergency Cases
Includes on-call physician requirements
Includes stabilization and transfer requirements
130
Two Other Important Laws
There are also two other important laws that address EMTALA issues
First: Basic Commitment Section 1866
Agreement with Providers (42 U.S.C. 1395cc)
Is relevant to the second one
Also referred to the Essential of Provider Agreement
Second: Section 1867 (42 U.S.C. 1395dd)
Examination and Treatment for an Emergency Medical Condition (EMC)
Basic Commitments & Special Responsibilities
Basic Section 2400
Defines hospital to include CAH so all hospitals are governed by EMTALA
Requires:
A medical screening exam (MSE) be given to any patient who comes to the ED
That any patient with an EMC or in labor be provided necessary stabilizing treatment
Hospital to provide an appropriate transfer such as when patient requests or hospital does not have the capability or capacity to provide the necessary treatment
134
A list of physicians
On call for duty after the initial examination
To provide treatment necessary to stabilize an individual with an emergency medical condition
Maintain medical records for five years from date of transfer
Provider Agreement
To post conspicuously in any emergency department
Specifying the rights of individuals with respect to exam and treatment for EMC and for women in labor
Must be one specified by the secretary
Must say if you participate or not in the Medicaid program
More information on EMTALA sign in section 2402
Sign must be clearly visible from 20 feet
At least 18” by 20”
Unless in posted in small room
137
138
Hospitals who participate in the Medicare
EMTALA is a condition of participation (CoP)
Is not limited to Medicare patients
Includes any individual who comes to the ED requesting care
If no verbal request is made it would include if a reasonable prudent layperson observer would conclude they need emergency care (not breathing)
Present themselves to an area of the hospital that meets the definition of dedicated emergency department or DED
139
Holds self out to public as providing emergency care
During preceding calendar year, provided at least 1/3 of its outpatient visits for treatment of EMC
Example: hospital has an emergency department (ED), or trauma center
It covers all individuals regardless of payment source
140
To Whom Does EMTALA Apply?
Patients in a car at the ED doors trying to access the ED
Patients anywhere on hospital property seeking emergency care
For example: they come in the wrong entrance to the hospital and are looking for the ED
Non-citizens of the US and minors
Does not cover people on the phone
Question #3
We encourage our staff to be on the alert for persons who may call with healthcare-related questions and to advise them to seek immediate care if they feel they are having a medical emergency.
Yes
No
141
142
No Delay in Exam or Treatment 2400
Hospitals may not delay an appropriate MSE to inquire about the individual’s method of payment or insurance status
CMS and OIG issue a special advisory bulletin on November 10, 1999 (Fed Reg. Volume 64, No. 217, 61353) – still relevant today
Every hospital should read this to understand how to meet compliance with this section
Discussion
SE County is a 25-bed CAH. 50 miles away is Central Hospital – an 80-bed facility. 63-year-old Pt. A was injured in a farm accident 40 miles from SE County and 90 miles from Central. He fell from a barn roof. His wife calls SE County asking whether Pt. A should be brought into the hospital for examination. He is breathing short, grunting breaths which the ED nurse can hear over the phone. Pt. A is holding his left rib cage and reports hitting his head at some point.
EMTALA activated?
1621 York Street
Denver, Colorado 80206
https://www.cms.gov/Medicare/Provider-Enrollment-and- Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Certification-State- Agency-Contacts.pdf.
146
https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Certification-State-Agency-Contacts.pdf
147
https://public.govdelivery.com/accounts/USGPOO
FR/subscriber/new
148
Special Responsibilities of Medicare Hospitals in Emergency Cases EMTALA is located at 42 C.F.R. 489.24
Federal Register and CFR are available free off internet at http://www.gpoaccess.gov/fr/index.html
Available at http://ecfr.gpoaccess.gov/cgi/t/text/text- idx?c=ecfr&sid=c07ae216364917a701e2426eb3f1419c&rgn=div8&view=t ext&node=42:4.0.1.5.27.2.212.5&idno=42
149
LABOR, YOU HAVE THE RIGHT TO RECEIVE,
within the capabilities of this hospital's staff
and facilities:
Necessary STABILIZING TEATMENT
An appropriate TRANSFER to another facility
Even if YOU CANNOT PAY or DO NOT HAVE
MEDICAL INSURANCE
This hospital (DOES/DOES NOT) participate in the Medicaid Program
153
159
https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-
waivers.pdf