Download Opposition to CMS Mandating Treatment Expectations

PLEASE NOTE: THIS RESOLUTION WILL BE DEBATED AT THE 2016 COUNCIL MEETING. RESOLUTIONS ARE NOT
OFFICIAL UNTIL ADOPTED BY THE COUNCIL AND THE BOARD OF DIRECTORS (AS APPLICABLE).
RESOLUTION:
18(16)
SUBMITTED BY:
Texas College of Emergency Physicians
SUBJECT:
Opposition to CMS Mandating Treatment Expectations
PURPOSE: Oppose overstep of CMS mandated reporting standards requiring potential harm to patients without
recognition of appropriate physician assessment and evidence based goal directed care of patients. Actively
communicate to members and the public the dangers of CMS overstep of physician responsibility to patients for
quality indicators. Communicate to hospitals the need and options to recognize appropriate physician treatment.
FISCAL IMPACT: Budgeted staff resources.
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WHEREAS, It is the goal of physicians to provide quality evidenced based care to individual patients based
upon their varied acute medical conditions and underlying co-morbidities; and
WHEREAS, It is the appropriate responsibility of the federal Center for Medicare and Medicaid Services
(CMS) to oversee the quality and effectiveness of care paid for by the federal government; and
WHEREAS, It is NOT appropriate for CMS to mandate clinical treatment for all patients, in all circumstances
regardless of the patient’s condition or comorbidities, such as mandating reporting of administration of 30cc/kg of
crystalloid fluids for all patients with potential serious infections, regardless of circumstance or comorbidities; and
WHEREAS, Administration of 30cc/kg of crystalloid fluids for all patients with potential serious infections,
regardless of circumstance, acuities and comorbidities can lead to intentional harm of patients including loss of
airway, generate complications such as pulmonary edema requiring intubation, and death; and
WHEREAS, Physician treatment that causes intentional (knowingly) harm to a patient is a violation of the
Hippocratic Oath, the Code of Medical Ethics, the Medical Practice Act and would qualify in civil court as “willful
and wanton” negligence; and
WHEREAS, A current CMS mandated reporting quality core (“FAQS: Core Measures 10-1-15 to 6-30-2016”)
measures requires “Resuscitation with 30 ml/kg crystalloid fluids” for patients with potential serious infections,
regardless of their clinical circumstance and the interpretation of these Core Measures Sets
(www.qualitynet.org/hospitals-inpatient/specifications manual) by Quality Net* do not recognize any exception for
congestive heart failure, renal failure, or liver failure or recognize any alternatives such as pressors or intravascular
expansions such as use of albumin in cirrhotic live patients; and
WHEREAS, Individual hospitals can lack the appropriate interpretation of CMS core measures**, resulting in
inappropriate sanctions of physician for appropriate medical care; therefore be it
RESOLVED, That ACEP oppose the overstep of CMS mandated reporting standards that require potential
harm to patients without the recognition of appropriate physician assessment and evidence based goal directed care of
individual patients; and be it further
RESOLVED, That ACEP actively communicate to members and the public the dangers of CMS overstep of
physician responsibility to patients for quality indicators and actively work to communicate to hospitals the need and
options to recognize appropriate physician treatment while avoiding unnecessary harm to patients.
Resolution 18(16) Opposition to CMS Mandating Treatment Expectations
Page 2
*Response from Quality Net (CMS support site):
There are no exclusions to the 30 mL/kg amount based on comorbidities such as heart failure (HF), end stage
renal disease (ESRD) or the patient's weight. The question has been presented to the measure stewards who have
indicated the rationale is based on the sepsis literature. The literature supports addressing the most urgent life
threatening condition first which is severe sepsis with hypotension or lactate >= 4. After this has been stabilized
changes in fluid management to address HF, ESRD or other conditions can be put into place to prevent potential
or developing adverse effects of the fluid volume.
**Investigation results: “it is clear that patient [name] had Cirrhosis and severe anasarca and so can lead to fluid
overload by administering CMS recommended 30ml/kg crystalloid fluids” with a response of “There are no
exclusions to the 30 mL/kg amount based on comorbidities such as heart failure (HF), end stage renal disease
(ESRD) or the patient's weight” and “Effective 07/01/2016: The ONLY acceptable fluids are crystalloid or
balanced crystalloid solutions” and ”Decision is upheld, variance remains.”
Background
The resolution requests ACEP to oppose CMS mandated reporting standards that require potential harm to
patients without the recognition of appropriate physician assessment and evidence based goal directed care of
individual patients; actively communicate to members and the public the dangers of CMS overstep of physician
responsibility to patients for quality indicators; and communicate to hospitals the need and options to recognize
appropriate physician treatment.
ACEP has commented to the Centers for Medicare and Medicaid Services (CMS), the National Quality Forum
(NQF), and the measure stewards numerous times on the merits and deficiencies of the various components of the
sepsis bundles. To support the highest quality of sepsis care, ACEP has developed the Emergency Quality (EQUAL) Network Sepsis Initiative) and the DART tool to assist members to Detect, Act, Resuscitate and Titrate
for patients who develop sepsis, severe sepsis, and septic shock. ACEP has also developed its own sepsis quality
measures (see page 4 of the document) via the Clinical Emergency Data Registry (CEDR) that address care for
patients with sepsis. Specifically, measure #28 addresses fluid resuscitation in these patients. In the ACEP version
of this measure, patients with any of the following are excluded from the measure denominator as follows:
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Transferred into the emergency department from another acute care facility or other in-patient hospital
setting
Left before treatment was complete
Died during the emergency department visit
Cardiac arrest within the emergency department visit
Patient or surrogate decision maker declined care
Advanced directives present in patient medical record for comfort care
Severe Heart Failure (LVEF < 20%)
Left Ventricular Assist Device (LVAD)
Acute pulmonary edema
Toxicological emergencies
Burn
Seizures
Anuria
End stage renal disease
Secondary diagnosis of
- Acute Gastrointestinal Hemorrhage
- Acute Pulmonary Hemorrhage
- Ischemic Stroke
- Hemorrhagic Stroke
- Acute myocardial infarction
- Acute trauma
Resolution 18(16) Opposition to CMS Mandating Treatment Expectations
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Data is being gathered for ACEP’s own version of the measure including the measure exclusions. 2016 is the first
year that ACEP’s CEDR registry will be collecting data on these measures including the abovementioned
exclusions. The 2016 calendar year data can be reported to the CEDR registry through March 31, 2017, and the
data will not be available for analysis and further study until mid- 2017. Therefore, it would be premature to
determine if an adequate sample size of patients would have been excluded for severe heart failure and/or end
stage renal disease to perform a statistically valid study of these particular exclusions.
Based on the input of renowned emergency medicine experts in the identification and treatment of patients with
sepsis, subject matter experts strongly encourage ACEP members to engage with patients and their families to
discuss the benefits and risks of any treatment plan. This is particularly important concerning the fluid
resuscitation of patients with sepsis and co-morbidities such as severe heart failure and end stage renal disease,
which may be relative but not absolute contraindications to fluid therapy. Once informed of the benefits and risks,
the patient and/or family may decline or refuse treatment with the recommended fluid protocol or may work with
the treating physician to alter the suggested treatment based on their particular co-morbidities. Patients declining
or refusing treatment or seeking comfort care measures only are exclusions to the CMS SEP-1 measure. That said,
ACEP does not encourage any of its members to game the system, but instead promotes the highest quality of
care for all patients and their particular and unique circumstances, including patients with sepsis and patients with
co-morbid conditions. ACEP encourages all members to conduct themselves in what they believe is the best
interest of their patients regardless of quality measure score and that shared decision making with patients and
their families is an important component in determining the course of treatment in the best interest of the patient.
This is true not only for patients with sepsis, but for patients with any condition.
Most ACEP member subject matter experts agree, as a matter of principle, to treat the most urgent life threatening
condition first and then manage other co-morbid conditions. However, it also recognized that there would be
circumstances where co-morbid conditions are exacerbated and become urgent and life threatening, as evidenced
by the thousands of people who die in the U.S. each year from both heart failure and end stage renal disease. In
most instances, it is only the examining and treating physician who can determine which condition is the most
urgent and life threatening. More often than not, that condition would be septic shock. This only highlights the
need for assessing the potential benefits and risks of treatment and discussing those options with the patient and
his or her family.
ACEP Strategic Plan Reference
Goal 1 – Reform and Improve the Delivery System for Acute Care
Objective B – Promote quality and patient safety, including development and validation of quality measures.
Fiscal Impact
Budgeted staff resources.
Prior Council Action
None
Prior Board Action
October 2015, approved 2016 Sepsis Measures for CEDR.
Background Information Prepared by: Barbara Tomar
Federal Affairs Director
Reviewed by: James Cusick, MD, FACEP, Speaker
John McManus, MD, FACEP, Vice Speaker
Dean Wilkerson, JD, MBA, CAE, Council Secretary and Executive Director