CMS Regulations: In the Best Interest of Patient Care or the Industry?

By James Hlavenka

Photo by Badger 151

Suppose you are an uninsured individual who has been severely injured in a car accident.  After the accident, you are rushed to a hospital with a dedicated emergency room, subject to the requirements of the Emergency Medical Treatment and Active Labor Act of 1986 (”EMTALA”).  Upon being screened, the hospital learns that you need further, immediate treatment to be stabilized.  After admitting you as an inpatient for further stabilization purposes, the hospital discovers that you have severed a critical nerve in your spine.  The hospital is incapable of stabilizing your emergency medical condition and appropriately attempts to transfer you to an available specialty hospital two towns over that specializes in nerve repair.  Under EMTALA and the 2003 Centers for Medicare and Medicaid Services (”CMS”) regulations, there was no direct answer addressing whether the specialty hospital was required to accept your transfer from the original hospital and stabilize your emergency medical condition.

In 2008, CMS proposed rule 73 FR 23669 containing significant policy changes relating to the requirements of EMTALA to address the obligations of specialty hospitals.  Under the proposed 2008 CMS rule, the answer would have been clear: assuming the specialty hospital was subject to EMTALA, it must accept your transfer.  The proposed rule would have clarified the interaction of EMTALA’s transfer provisions with the 2003 CMS regulations that hold EMTALA obligations cease when an individual is admitted into a hospital as an inpatient.  The proposed 2008 CMS rule ensured that EMTALA’s primary purpose of patient stabilization under its transfer provisions would not be contravened by the 2003 CMS regulations.  After solicitation of comments on the proposed 2008 rule, however, CMS ultimately declined to adopt this critical policy clarification in its 2009 Final Rule, CMS-1390-F.

Background

In general, EMTALA imposes specific obligations on certain Medicare-participating hospitals to both screen and stabilize individuals who visit those hospitals’ emergency departments.  For a comprehensive, attorney-prepared EMTALA FAQ page, please click here. After a hospital screens an individual and determines that the individual has an emergency medical condition, it is obligated to provide that individual with necessary stabilizing treatment or provide an appropriate transfer to another medical facility that can achieve stabilization.

EMTALA’s transfer provisions are contained within the “specialized care” requirements of Section 1395dd(g).  Section 1395dd(g) requires a receiving hospital with specialized capabilities to accept a request to transfer an individual with an unstable emergency medical condition as long as the hospital has the capacity to treat that individual and regardless of whether the individual had been an inpatient at the admitting hospital.  These provisions would seem to answer the above hypothetical without the need for any further clarification.  In 2003, however, CMS muddied the answer with a new Final Rule.

In 2003, CMS published Final Rule 68 FR 53263 regarding the applicability of EMTALA requirements to inpatients.  The 2003 CMS rule amended section 489.24(d)(2)(i) of CMS regulations to state that a hospital’s obligations under EMTALA cease when the hospital admits an individual with an unstable emergency condition as an inpatient, so long as the admission is in good faith.  CMS reasserted that EMTALA was not intended to be a federal malpractice statute and that after admission inpatients are protected by State malpractice laws and Medicare Conditions of Participation (”CoPs”).  The 2003 CMS rule was entirely silent, however, as to how EMTALA’s specialized care requirements would continue to apply to inpatients, if EMTALA obligations cease upon admission.

As a result, in 2008, CMS proposed a rule amending Section 489.24(f) of the CMS regulations.  The amendment added a provision requiring a receiving hospital with “specialized capabilities or facilities” to accept an unstabilized inpatient with an emergency medical condition from an admitting hospital, thereby continuing the specialty hospital’s obligation under Section 1395dd(g) of EMTALA.  Thus, when the 2008 proposed CMS rule was analyzed in conjunction with the 2003 Final Rule, EMTALA obligations would not end for all hospitals once an individual is admitted as an inpatient.  Rather, EMTALA obligations would cease only at the hospital where the individual is first admitted as an inpatient.  EMTALA’s transfer provisions would continue to apply, however, to all other participating hospitals with higher levels of care, should an inpatient need to be transferred for stabilization of the original emergency medical condition.

2009 CMS Final Rule 1390-F

Upon review of solicited comments, CMS ultimately decided not to adopt the 2008 proposed rule clarifications in its 2009 Final Rule regarding transfer and inpatient care requirements under EMTALA.  Instead, in the 2009 Final Rule, CMS stated that under EMTALA individuals can only be appropriately transferred to another hospital for specialized stabilizing care where two requirements are met: (1) The individual must have an emergency medical condition that requires specialized stabilizing treatment not available at the hospital where the individual is first screened, and (2) The individual has not already been admitted as an inpatient.

Understandably, commenters disagreed about the possible effects of the proposed 2008 CMS rule.  Both opponents and proponents ultimately offered patient-centered rationales for their  policy perspectives.  When read in conjunction with EMTALA as a whole, however, those in favor of the proposed 2008 rule seem to have stayed most true to EMTALA’s original intent–to provide emergency care to all individuals who are determined to have an emergency medical condition.  The commenters’ statements below can be found within the final rule, here.

Opponents of the proposed 2008 CMS rule

The majority of the concerns raised by the dissenting commenters, which ultimately swayed CMS not to adopt the proposed 2008 rule, can be placed into three categories, each to be discussed in turn:

(1) Patient Dumping

Commenters highlighted the danger of patient dumping at hospitals with specialized facilities.  Of particular concern to one commenter was that a hospital, acting in bad faith, could choose to transfer only “medically complex patients requiring extensive lengths of stay, patients who are uninsured, and patients who have been subject to a medical error” and unresolved medical conditions.  Also of concern was that such transfers would be made as a “convenience measure and not a necessity.”  These particularly strong arguments were not overlooked by CMS when proposing the 2008 rule.  It is true that hospitals can act in bad faith, however such actions would violate both EMTALA and the CMS regulations.  Commenters also emphasized that allowing transfer of inpatients may allow hospitals to transfer unstable individuals before using all available resources in an attempt to stabilize the individual.  Again, while entirely possible, this argument is based in an assumption of bad faith, which in itself is a violation of EMTALA and medical ethics.

(2) Patient Care

Commenters expressed concern about how the proposed rule would affect patient health and safety.  Specifically, commenters were concerned that patients’ physical and psychological health could deteriorate as a result of the potential increase in inappropriate and unnecessary transfers mentioned above.  Commenters noted that referring hospitals may transfer patients who deteriorate following admission, thereby risking the life of the patient.  These arguments must raise concern, as any increase in danger to an individual already suffering an emergency medical condition is unwarranted.  These arguments do not seem overly persuasive, however, when read in conjunction with the safety measures already in place under EMTALA to ensure that transfers only occur when the benefit outweighs the risk to an individual.

(3) Futility

Commenters also asserted that the proposed 2008 rule was largely unnecessary for various reasons.  First, it was stated that it is unlikely that a hospital would knowingly admit an individual with an unstabilized emergency medical condition if the hospital did not have the capability to stabilize the individual.  This argument is not particularly strong.  While it is likely that a hospital would not knowingly do so, in daily practice errors can easily occur.  Therefore, there is no harm to ensuring that if such a mistake does occur, it will not adversely affect the suffering individual.  Along the same lines, a commenter stated that “all hospitals which have emergency departments are capable of evaluating an individual who presents to the emergency department and if the hospital does not have the capability to appropriately care for the individual, the hospital should transfer, rather than admit the individual.”  For the same reasons stated above, while a hospital may have the capability to do so, that does not mean that the hospital will make a correct decision every time.

Proponents of the proposed 2008 CMS rule

Commenters in favor of the proposed 2008 CMS rule focused upon the stabilization and safety of individuals suffering from emergency medical conditions.  Overall, commenters in favor of the proposed 2008 rule stated that the policy clarifications were in the best interests of patient care and should be implemented.  A particularly strong argument by one commenter was that inpatient admission status should be irrelevant in determining whether the individual has an emergency medical condition and whether the admitting hospital has the capability to provide the necessary care. The commenter noted that such requirements are “the only operative criteria to whether the transfer is justified under EMTALA” and as a result, EMTALA and CMS regulations must be read in harmony to achieve such a result.  The commenter stressed that EMTALA was enacted because “Congress recognized that patients needing transfers were being denied access to higher levels of care.”  This argument is very strong.  By failing to adopt the proposed 2008 rule clarifications, the will of Congress was hindered in part.

Of particular concern to other commenters were individuals who suffer emergency medical conditions in rural areas.  Such commenters stated that the proposed rule was “especially important for individuals living in rural areas because those individuals are routinely denied transfer to a regional facility for definitive care based on the conclusion that the individuals are already at a ‘hospital.’”  Given that much of our country is comprised of rural areas, such concerns should not have been minimized.  Last, a proponent addressed the concern of inappropriate transfers by suggesting that the clarified process could be adequately monitored for abuse and bad faith.  This suggestion is sound, as such monitoring is already required under the 2003 Final Rule regarding admission into hospitals to end EMTALA requirements.

Did CMS Get it Right?

CMS should have adopted the proposed 2008 rule.  Although finalizing the proposed 2008 rule may have resulted in an increase in inappropriate transfers to hospitals with specialized capabilities, arguments based on an assumption of bad faith should not outweigh the legitimate concerns voiced by many commenters.  Hypothetical risks of inappropriate transfers are always a possibility.  Regardless of whether an individual is admitted as an inpatient, both the admitting/transferring hospital and receiving hospital must comply with the stringent transfer requirements under EMTALA, namely, the requirements contained within 42 USC § 1395dd(c)(1), (2).  These provisions require a treating physician to certify that the medical benefits of the transfer to another medical facility will outweigh the increased risks to the individual.  Further, the receiving hospital must have both available space and qualified personnel for the treatment of the individual, and must have agreed to accept transfer of the individual and to provide the appropriate medical treatment.

As a result of these safeguards, the argument that individuals could suffer greater physical and psychological harm as a result of inappropriate transfers under the proposed rule equally falls flat.  If both hospitals follow the strict transfer requirements already contained within EMTALA, the risk of patient harm should be no greater or less than already present. Contrary to what CMS and industry commenters have stated, CMS has arguably increased the potential for individual physical and psychological harm by failing to adopt the proposed 2008 rule.

The primary concern of physicians within emergency departments should be focused on patient care, and not whether admitting that patient for crucial stabilizing treatment may extinguish the individual’s right under EMTALA to be transferred to an appropriate hospital.  Surely it is not always possible to give a thorough examination and attempt to stabilize a patient in the emergency room setting and thus, a hospital’s attempt to stabilize a patient through admission (even if ultimately futile because the hospital lacks the ability to do so) should not detrimentally extinguish the ability to appropriately transfer that individual under EMTALA.  As the rule currently stands, once a hospital decides to admit a patient for stabilization purposes, it automatically extinguishes its right to transfer that inpatient.  This right is extinguished even if the hospital later learns it is incapable of stabilizing a potentially life threatening emergency medical condition.

Commenters argue that a hospital should know whether or not it has the capacity to stabilize an individual prior to admission.  Theory, however, does not always equal practice.  In the fast paced, hectic setting of emergency rooms across the country, such accurate assessments may not always be possible for obvious reasons.  CMS was wrong to render this crucial transfer provision of EMTALA inoperable simply because of the technicality of inpatient admission.  Patient care and stabilization must be the focal point of this statute, and not a bright line test of patient admission and hospital liability.  CMS should reconsider harmonizing EMTALA’s original transfer provisions with its 2003 Final Rule regarding EMTALA requirements after inpatient admission.

Health Care Reform & Undocumented Aliens

Hemodialysis Machine, New. Photo by Patrick Ganz

Several commentators have already observed the absence of any discussion of undocumented aliens in the discussion about health care reform.  And yet, the issue is huge, particularly for those ten or so states in which these individuals disproportionately live and work.  The June 2009 issue of American Journal of Kidney Disease includes an article on a survey of nephrologists^[1] who report an increasing number of undocumented aliens with End Stage Renal Disease (ESRD).  Unsurprisingly, access to care for these individuals is inadequate and shrinking, with about one third of physicians reporting undocumented patients to be wholly reliant on emergency dialysis, which carries with it higher cost and morbidity; 67%, however, reported availability of long-term dialysis care.

A significant minority of physicians reported advising their undocumented patients to move to another state or country to access care, even though accessing appropriate renal care is difficult due to scarcity in Mexico, the native country of the majority of undocumented aliens in the United States.^[2] On the other hand, undocumented aliens present much younger (40’s) with ESRD, which causes many nephrologists to argue that provision of kidney transplants would be a much less costly care approach, long-term.  Federal law prohibits use of Medicaid funds for transplants for this population.^[3]

Many hospitals find themselves “stuck” with chronically ill patients who no longer require acute care, but require discharge to nursing homes or rehabilitation facilities because their debilitation is so severe.  These include victims of car accidents and crimes, for example.  These patients originally appear in hospital emergency rooms in acute distress, thereby requiring the hospital to treat and stabilize pursuant to their EMTALA obligations.  Medicaid has in the past made some monies available to reimburse hospitals for this episode of care (although it was never enough, according to the hospitals, and while the most recent authorization law expired in 2008, funds remained for distribution into 2009).  Further, hospitals are required by Medicare Conditions of Participation to prepare and implement an appropriate discharge plan.  This becomes impossible to accomplish if there is no hope of reimbursement for the subsequent care facility.

Assuming there are Medicaid monies to be had for the emergency care of this population, courts have been split over the question of whether the Medicaid emergency services coverage provision covers the long-term and chronic aftermath of an acute situation.  Specifically, the question is whether the reimbursement is limited to the treatment required to stabilize the patient with leukemia, ESRD, or brain injury, or whether it extends to the post-stabilization care required to prevent a future emergency condition.   Greenery Rehabilitation Group v. New York City Human Resources Administration, 150 F.3d 226 (1998), concluded that if the patients’ post-emergency injuries were properly classified as chronic rather than acute, they do not qualify for Medicaid coverage.  Scottsdale Healthcare Inc., v. Arizona Health Care Cost Containment Syst. Admin., 75 P.3d 91 (D.C. Ariz. 2003), rejected the Second Circuit’s focus on stabilization as too narrow, holding instead that the “focus must be on whether the patient’s current medical condition–whether it is the initial injury that led to admission, a condition directly resulting from that injury, or a wholly separate condition–is a non-chronic condition presently manifesting itself by acute symptoms of sufficient severity that the absence of immediate medical treatment could result” in an emergency condition. Id. at 98.  The issue has also been taken up in the last few years by the Connecticut and North Carolina Supreme Courts, in which both plaintiffs’ received emergency room diagnoses of leukemia and sought coverage of their subsequent chemotherapy treatments — these Courts also split on the issue.

These cases are merely a snapshot of a much larger issue.  A health care reform bill that doesn’t address the health care of both legal and illegal aliens will be inadequate, and adversely and disproportionately affect the several states where large numbers of immigrants live, work, and school their children.  The solution must address access to primary and emergency care as well as treatment for chronic conditions.  Those states whose workers compensation systems are inadequate in their coverage of immigrants disabled in the course of their employment might also ameliorate the crisis presented by this population by reform in this area as well.

[2] Id. at 947.

[3] CMS Uniform Policy Manual § 3000.01