Statement from CMS region 4 office could have far-reaching implications for EDs nationwide
On Jan. 18, 2013, the South Carolina Hospital Association requested an opinion from its CMS Regional Office regarding the use of “pain posters” (Prescribing Pain Medication in the Emergency Department) that were developed for posting in emergency department waiting rooms and treatment areas. Despite the fact that these posters were well intentioned and proposed to deter inappropriate opioid drug seeking, concerns about CMS’s perspective and compliance issues with EMTALA must have been contemplated. Otherwise, why would such an opinion be requested? In summary, the CMS Chief Medical Officer for the Atlanta Regional office (region 4) responded—to the surprise of many. Dr. Rick Wild responded on behalf of CMS Region 4 making several observations and providing words of caution, strongly discouraging the use of such postings. In his response, Dr. Wild stated the following (summarized):
- The definition of an “Emergency medical condition” is a medical condition manifesting itself by acute symptoms of sufficient severity including severe pain, psychiatric disturbances, and/or symptoms of substance abuse.
- “Reasonable registration processes may not unduly discourage individuals from remaining for further evaluation.”
- “Accordingly, the language regarding, ‘Prescribing Pain Medication in the Emergency Department,’ which you have provided and any similar language, which the hospital might choose to post in patient waiting rooms or treatment rooms, might be considered to be coercive or intimidating to patients who present to the ED with painful medical conditions, thereby violating both the language and the intent of the EMTALA statute and regulations.”
These statements have generated a great deal of debate and discussion. Some say, “Well this is just an opinion.” Others have said, “This only impacts Region 4,” and yet some have said, “We’ll just word ours a little better.”
To help clarify the implications of this statement, I have asked Dr. Wild and CMS to clarify their opinion, which they have done with the written interview responses below.
—Kevin M. Klauer, DO, EJD, FACEP, Medical editor in chief, ACEP Now
1) Can you tell us about CMS EMTALA enforcement policy and the CMS Region 4 letter dated Feb. 6, 2013 regarding “Prescribing Pain Medication in the Emergency Department” (in general)?
CMS is responsible for the enforcement of and issuance of regulations, guidance, and policies pertaining to the Emergency Medical Treatment and Labor Act (EMTALA) (Sec. 1867 of the Social Security Act, 42 U.S.C.1395dd). The CMS Central Office in Baltimore has the overall responsibility for issuing regulations, guidance and policy, and each of the ten (10) CMS regional offices are responsible for the enforcement of the EMTALA law within their areas of jurisdiction and for responding to questions regarding EMTALA enforcement policy. The individual CMS regional offices regularly communicate with CMS Central Office and also conduct regular conferences between the central office and across all the regions to ensure that CMS policies are implemented and enforced in as uniform manner as possible. Each CMS regional office works with their respective state survey agencies and quality improvement organizations (QIOs) in each enforcement investigation and action. EMTALA enforcement is complaint-driven, i.e., investigations occur in response to complaints, which suggest violations of EMTALA. Each case is investigated and decisions are rendered based on the unique facts and circumstances of that case. Each CMS region is responsible for the final determination of whether EMTALA was violated, for issuing notices of termination from the Medicare and Medicaid programs, and for approving plans of correction submitted by hospitals to avoid termination. Additionally, each region refers cases to the HHS Office of the Inspector General (OIG) for consideration of possible imposition of civil monetary penalties when appropriate.
a. History of why and when the CMS Region 4 letter regarding “Prescribing Pain Medication in the Emergency Department” was drafted?
Region 4 was made aware of instances or proposals to post signage in emergency department waiting areas and distribution of informational materials pertaining to “Prescribing Pain Medication.” The Region 4 letter was written in response to an inquiry from a state hospital association regarding these practices and their possible violation of the EMTALA statute and regulations. Subsequently the same issue has been arising in other CMS Regions.
The Region 4 response represents current national CMS policy. This is not a new policy, but the application of the current law, regulations, and CMS policies to this particular situation.
b. What are the concerns of CMS?
CMS shares the concerns of public health organizations and the hospital industry about prescription drug abuse and its harmful effects. We understand that hospital EDs face considerable challenges in dealing with individuals seeking pain medication and controlled substances for non-legitimate purposes. We emphasize that it is within the bounds of reasonable professional judgment and discretion for a physician or other licensed healthcare practitioner to provide or withhold opioids and/or other methods of pain control, depending on the specific clinical circumstances of an individual’s presentation.
However, the posting in an ED of signs and/or distribution of brochures emphasizing that certain types of pain medications will not be prescribed appears designed to indiscriminately discourage any individual seeking treatment for pain from remaining in the ED for a medical screening examination or from coming to that ED in the future. Furthermore, such signage or brochures raise questions about whether the hospital would provide stabilizing treatment in cases in which administration of opioids might be clinically appropriate. In summary, hospitals, which employ such signage or disseminate similar brochures, are at risk of being found noncompliant with EMTALA requirements.
The EMTALA statute requires that any individual who comes to the emergency department for a medical condition must be provided an appropriate medical screening examination (not merely a triage exam) by an appropriately credentialed and qualified medical professional to determine whether or not an emergency medical condition exists. It is significant that the statute defines “emergency medical condition” to include symptoms such as severe pain. Additionally, the Medicare provider agreement statute (Section 1866(a)(1)(N)(iii)) requires hospitals to post conspicuously in any emergency department a sign that specifies the rights of individuals under EMTALA with respect to examination and treatment for emergency medical conditions and women in labor. Signs that announce restrictions on treatments, regardless of the facts of an individual’s case, appear to be at odds with the signage hospitals are required by law to post in their EDs.
Further, federal EMTALA regulations (42 CFR 489.24) reiterate and expand upon these statutory requirements. For example, 42 CFR 489.24(d)(4)(iv) states that “Reasonable registration processes may not unduly discourage individuals from remaining for further evaluation.” Although certain signs and literature posted and distributed in emergency department waiting areas may be intended to “educate patients,” they nevertheless may have the real or perceived effect of discouraging an individual from remaining for further evaluation, or stabilizing treatment and thus be in violation of EMTALA. It should also be noted that EMTALA is a federal statute, which supersedes state laws, regulations, or municipal ordinances which are in conflict with EMTALA.
In some cases, CMS is asked to pre-approve or endorse specific or “model” language for waiting room signs or handout materials. However, as a matter of policy, CMS does not provide prior approval to any individual hospital’s policies and procedures, nor does it review a hospital’s EMTALA policies and procedures outside the context of a specific investigation of an EMTALA complaint. Each EMTALA case complaint or investigation will be judged based on the particular facts of each case. Certain signs or materials posted or distributed in ED waiting rooms may be determined in the course of such investigation to be inconsistent with the EMTALA signage requirements and/or to have the potential to discourage individuals from remaining in the ED.
c. What was the process of drafting the Region 4 letter of Feb. 6, 2013, pertaining to “Prescribing Pain Medication in the Emergency Department?
The Region 4 response was drafted by me, the CMS Atlanta regional chief medical officer, who is a board certified emergency medicine specialist, in consultation with the federal statutes, regulations, and sub-regulatory guidance and with specific consultation with the CMS central office and other regional offices. The Region 4 response represents current national CMS policy. This is not a new policy, but the application of the current law, regulations, and CMS policies to this particular situation.
2) Many have reported that this is only a Region 4 opinion and have stated it is only an opinion and not policy and that this is not the position of all CMS regions. Can you speak to that?
As stated above, this letter was developed in consultation with CMS’s central office, has been shared with all CMS regional offices, and is being followed by CMS regional offices. However, given the frequency with which the issue is now arising and the questions about whether this letter represents CMS policy, CMS may issue a national memorandum on the topic.
3) Do you see alternatives to ED waiting room patient signage and flyers for chronic opiate needs when patients present to the ED?
Yes. In accordance with standard accepted medical practices and in accordance with the provisions of EMTALA, every individual who presents to the emergency department for any medical condition or complaint should first receive an appropriate medical screening exam by a properly trained and credentialed qualified medical professional. This exam is not a triage exam but is explicitly tailored to address the particular signs and symptoms of the patient. An appropriate medical screening exam uses all the available resources of the emergency department, which are appropriate to determine whether an emergency medical condition exists. After an appropriate medical screening exam is conducted, it is within the bounds of professional medical judgment and discretion for an appropriately licensed physician or other health care practitioner to provide or to withhold narcotic or other methods of pain control in a particular patient depending on the specific clinical circumstances. It is also left to the judgment of the provider as to how best to give specific patient-centered education, including handouts, policies, and institutional protocols. But again, it is emphasized that patient education should take place after a patient focused medical screening exam is completed and not by posting general policies and procedures or displaying such materials in the waiting area.
Richard E. Wild, MD, JD, MBA, FACEP, has degrees in business and law and has practiced as a health-care attorney with a large Boston law firm representing hospitals, physicians, skilled nursing facilities, and a major Boston teaching hospital. He was medical director of Medicare’s direct fiscal intermediary in Baltimore and also the CMS (then HCFA) chief medical officer for reimbursement policy during the initial implementation of the Hospital Prospective Payment (DRG) system. He subsequently served on the Medicare Prospective Payment Assessment commission staff (now MEDPAC). He has also served as past president of the Rhode Island ACEP Chapter, alternate delegate to the Council, past national Chair of ACEP’s National Reimbursement Subcommittee of Government Affairs, and member national Government Affairs Committee and NEMPAC Board. Dr. Wild served a three-year term as ACEP’s representative to the AMA CPT-4 Editorial Advisory Board, was one of four ACEP representatives to the Harvard Relative Value study, and participated in ACEP’s national Coding and Nomenclature Committee. He is currently a member of the Georgia Chapter of ACEP and national ACEP. He has also been continuously certified by ABEM since 1985.