July 3, 2002 Mr. Stephen Heffler Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-1203-P P.O. Box 8010 Baltimore, MD 21244 Re: Federal Register Vol. 67, No. 90, Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2003 Rates Dear Mr. Stephens: On behalf of the American Health Quality Association (AHQA), the membership organization of state-based Quality Improvement Organizations (QIOs), thank you for the opportunity to provide comments on the proposed revisions to the Emergency Medical Treatment and Active Labor Act regulatory framework. AHQA is concerned that the May 9, 2002, proposed rule does not address changes to the EMTALA regulatory framework that are necessary to improve the current process related to peer review of EMTALA complaints by QIOs. We recommend five specific changes to the section of this rule pertaining to EMTALA: Recommendation 1: To improve the consistency of EMTALA enforcement across ten CMS regions throughout the United States, CMS should expand the role of the Boston, Kansas City, Dallas, and Seattle CMS Regional Offices. These offices should monitor and oversee EMTALA investigations in the other six CMS Regional Offices. Among the most common complaints from QIOs, providers, and practitioners is the lack of consistency in how the 10 CMS Regional Offices enforce EMTALA laws and regulations. There is evidence that each one of the CMS Regional Offices handles peer review of medical deficiency EMTALA allegations differently. For example, hospitals and practitioners who practice in the San Francisco Region rarely receive the benefit of peer review of EMTALA allegations prior to a compliance decision. The QIOs in those states have not received a single 5-day peer review request in several years. In the Kansas City region, hundreds of cases are referred for peer review prior to a finding of non-compliance. As we research the inconsistency of Regional Office activities related to EMTALA enforcement we have found that the Regional Offices in Boston, Kansas City, Dallas, and Seattle are more likely to follow the prescribed process for enforcing EMTALA than the other six regional offices. This is most likely due to the fact that these four offices are intimately familiar with the QIOs because they support the QIO Medicare contract in every state. The other six regional offices only get involved with the QIOs for the purposes of enforcing EMTALA, and are therefore less familiar with the regulation and process outlined in the EMTALA review section of the QIO manual. Since CMS has already built in administrative efficiencies by employing four of the ten Regional Offices to support the QIO Medicare contracts, it would make sense to use a similar model for support of EMTALA peer review requirements. However, if CMS believes that EMTALA peer review requirements should continue to be run by local Regional Offices, then it is reasonable to create a mechanism that would allow the Boston, Kansas City, Dallas, and Seattle regional office to monitor and oversee EMTALA enforcement activities that would result in greater consistency from region to region. Recommendation 2: CMS must request a 5-day QIO review of all EMTALA cases alleged to involve a clinical concern. Peer review, when it is performed prior to the issuance of a violation, provides for due process and protects hospitals and physicians from dealing with unfounded violations. Because the QIOs are required to perform a 60-day peer review of all EMTALA violations after CMS issues a citation, the QIOs frequently find cases that, in the opinion of the peer reviewer, did not contain a medical deficiency or quality of care concern. This is unfortunate, because at this stage the hospital, or practitioner, has no recourse to seek a remedy for the incorrect finding. The provider or practitioner in these cases can only hope that the OIG will not impose a civil monetary penalty nor recommend Medicare participation termination. By requiring a 5-day peer review of all EMTALA cases alleged to have a medical deficiency before the issuance of a violation, providers and practitioners would have some degree of confidence that a peer weighed in on the matter. In addition to providing improved due process, a 5-day peer review mandate would enhance the consistency of Regional Office interpretation of when to engage the QIO before a violation is issued. The Secretary’s Advisory Committee on Regulatory Reform has communicated its intention to support this recommendation in their final report due this fall. At the June 10, 2002 meeting of the Committee in Minnesota, Mr. Dennis proposed the following addition to the report that was adopted through a Committee vote: "[W]e added something to it, and that was that we foster appropriate consultation with and involvement by PROs [QIOs], peer review organizations [quality improvement organizations], appropriate due process for hospitals and health care professionals before CMS can issue a public notice of termination and proceed with the termination letter." (Transcript of June 10, 2002 meeting of the Secretary’s Advisory Committee on Regulatory Reform) Recommendation 3: If a QIO determines that no clinical concern is present in an EMTALA case, CMS should not be able to issue an EMTALA violation for clinical concerns. In some cases, particularly in the Atlanta region, QIOs are asked to perform a 5-day peer review of the clinical care issues contained in an EMTALA allegation but then the CMS office occasionally chooses to ignore the peer reviewers’ findings. Sometimes the peer review expert is unable to find a medical deficiency that is alleged in an EMTALA complaint. At this point, it seems unreasonable for CMS to pursue the case any further unless there are underlying administrative EMTALA violations that must be cited. Nonetheless, because QIOs are required to review all EMTALA cases following the issuance of a violation we find cases that were ruled non-compliant despite the peer reviewer’s analysis. Recommendation 4: CMS should be held to reasonable deadlines for completing various stages of the EMTALA investigation. QIOs are held to strict 5-day and 60-day deadlines for their work. It is unreasonable for a QIO to receive a case that is several years old. There is no statutory or regulatory deadline for CMS to address EMTALA violations. Last month the a Regional Office sent several cases to a QIO for a 5-day peer review that were over 2 years old. This is not uncommon. It is difficult to review very old cases. The medical record may be unavailable, the practitioners involved may have left the facility and are difficult to track down, and memories of the principals in the cases are fuzzy and unreliable. Sometimes, especially when old cases are referred to the QIO, the cases come in "batches" and increase the workload on the QIO as it struggles to meet the strict 5- or 60-day deadline for review. If cases are forwarded as they enter the system, the workload is spread out over time. A requirement for timely evaluation and referral will address this problem. Recommendation 5: CMS should communicate publicly accessible information about progress and outcomes of EMTALA cases with all stakeholders. Of significant concern to providers, practitioners, QIOs, patients, and other stakeholders is the lack of information regarding the outcome of EMTALA cases. Because CMS is not held to specific deadlines for disposing of cases, the stakeholders are frequently in the dark regarding the process and potential liabilities they may face due to an allegation. Summary. The original intention of the EMTALA law (passed by Congress in 1985) is becoming lost in present day enforcement of the law. The primary legislative intent of EMTALA was simple: ensure that patients who require emergent medical treatment receive it regardless of their ability to pay. Seventeen years later, physicians and hospitals are drowning in a sea of unintended consequences resulting from the EMTALA law. Providers and physicians are routinely presented with EMTALA compliance determinations that may be unfounded and face a growing concern that Quality Improvement Organizations are not utilized by CMS appropriately. Hospitals are spending tens of thousands of dollars on OIG fines and untold resources on corrective action plans mandated by CMS that may not be warranted. Meanwhile, cases are often referred to QIOs for investigation years after the patient has sought timely action. Our recommendation for early QIO involvement in EMTALA cases is supported by the Secretary’s Advisory Committee on Regulatory Reform. Since their final report is not scheduled for publication until late this fall, we would encourage you to review our recommendations with Dr. Wood, Chairman of the Committee. In addition, the recommendation that a 5-day peer review of all EMTALA allegations with medical deficiency questions be performed prior to a CMS compliance determination is supported in House legislation (H.R. 4954) recently passed by the Ways and Means and Energy and Commerce Committees. For questions regarding our comments, feel free to contact Mark Boesen, Pharm.D. at the address or phone number on our stationery or by e-mail at mboesen@ahqa.org. Sincerely, David G. Schulke Executive Vice President