The new EMTALA regulations and the on-call physician shortage: in defense of the regulations

This Article examines the new Emergency Medical Treatment and Labor Act (EMTALA) regulations, focusing on the on-call provisions, in light of the practical realities of the on-call physician shortage. It provides an historical account of issues surrounding the delivery of emergency care by on-call physicians and the legal background of EMTALA insofar as it relates to on-call physicians. Ultimately, the author concludes that, although the current shortage of on-call physicians has caused hospitals to anticipate EMTALA liability and advocate for more specific regulations, a closer look reveals that hospitals' fears are overstated. As long as hospitals have proper procedures in place, the new regulations will not put them in violation of EMTALA.     

EMTALA: dedicating an emergency department near you

Congress enacted the Emergency Medical Treatment and Labor Act (EMTALA) in 1986 to prohibit patient dumping. Subsequent to its passage, however, issues concerning the application of EMTALA have vexed hospitals, patients, regulators, and courts. In an attempt to clarify these issues, the Centers for Medicare & Medicaid Services (CMS) recently promulgated new EMTALA regulations. This Article reviews the basic requirements of EMTALA and highlights the statutory definitions critical to its proper interpretation and application. The article then analyzes the impact of the new regulations, particularly in five major areas: where and when the statute applies, on-call physician requirements, hospital-owned ambulances, managed care, and bioterrorism. It concludes with a discussion of the implications of the new regulations for hospitals and their counsel.     

Medicare program; clarifying policies related to the responsibilities of Medicare-participating hospitals in treating individuals with emergency medical conditions. Final rule

This final rule clarifies policies relating to the responsibilities of Medicare-participating hospitals in treating individuals with emergency medical conditions who present to a hospital under the provisions of the Emergency Medical Treatment and Labor Act (EMTALA). The final rule responds to public comments received on a May 9, 2002 proposed rule (67 FR 31404) that both reiterated the agency's interpretations under EMTALA and proposed clarifying changes relating to the implementation of the EMTALA provisions. These reiterations and clarifying changes related to, among other areas, seeking prior authorization from insurers for services, emergency patients presenting at off-campus outpatient clinics that do not routinely provide emergency services, the applicability of the EMTALA provisions to hospital inpatients and outpatients, the circumstances under which physicians must serve on hospital medical staff "on-call" lists, and the responsibilities of hospital-owned ambulances. These reiterations and clarifying changes are needed to ensure uniform and consistent application of policy and to avoid any misunderstanding of EMTALA requirements by individuals, physicians, or hospital employees.     

HIPAA privacy: "individual rights" and the "minimum necessary" requirements

This Article focuses on two key aspects of the proposed regulations related to health information privacy published by the Department of Health and Human Services ("DHHS") pursuant to the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"). These two aspects, the provisions regarding individual rights and the provisions requiring use of the minimum amount of information necessary to accomplish a given purpose, will be particularly burdensome for the healthcare industry. Furthermore, they are likely to generate a significant number of complaints to the DHHS Secretary relating to alleged violations of the regulations. This Article analyzes the proposed regulations governing these two issues and offers practical advice regarding steps that entities should take in anticipation of the final regulations.     

Debarment, suspension, and ineligibility--DHHS. Proposed rule

The Office of the Secretary, Department of Health and Human Services, is proposing to amend 41 CFR 3-1.6, Debarred, Suspended, and Ineligible Bidders, to implement the provisions of Federal Procurement Regulations [FPR] Temporary Regulation 65, Debarment, Suspension and Ineligibility of Government Contractors.     

Debarment, suspension, and ineligibility of contractors--DHHS. Final rule

The Office of the Secretary, Department of Health and Human Services, is amending the HHS Acquisition Regulation, Title 48 CFR Chapter 3, by adding a new subpart concerning debarment, suspension, and ineligibility of contractors. This new subpart will implement the provisions of Subpart 9.4, Debarment, Suspension and Ineligibility, of the Federal Acquisition Regulations.     

Contract medical care; non-federal hospital payment rates--DVA and HHS. Final regulations

The Department of Health and Human Services (HHS) and the Department of Veterans Affairs (VA) have jointly amended VA's medical series of regulations to carry out provisions of Public Law 99-576, Veterans' Benefits Improvement and Health-Care Authorization Act of 1986. These regulations describe the payment methodology and amounts for non-Federal public and private hospital care provided at VA expense. Payment methodology and amounts will be determined by the Health Care Financing Administration (HCFA) PRICER.     

Miscellaneous amendments to the HHS procurement regulations--HHS. Final rule

The Office of the Secretary, Department of Health and Human Services is amending its procurement regulations by revising and updating the general provisions for use in fixed price and cost-reimbursement type contracts (HHS-314,-315,-315A, and-316) and related miscellaneous amendments. The revisions will result in the consolidation of all additions, removals and revisions to the general provisions. The effect of the amendment will be the updating of the Department's general provisions.     

Notice regarding the Federally Supported Health Centers Assistance Act of 1992--HRSA. Notice

On May 8, 1995, the Secretary of Health and Human Services published a final rule implementing certain provisions of the Federally Supported Health Centers Assistance Act of 1992 (the Act). The Act provides for liability protection for certain grantees of the Public Health Service and for certain individuals associated with these grantees. The Health Resources and Services Administration is the agency within the Department responsible for administering certain aspects of the Act. This notice provides further guidance regarding the final rule.     

Miscellaneous amendments to the HHS procurement regulations--Department of Health and Human Services. Proposed rule

The Office of the Secretary, Department of Health and Human Services is proposing to amend its procurement regulations by revising and updating the general provisions for use in fixed price and cost-reimbursement type contracts (HHS-314, -315, -315A, and -316) and related miscellaneous amendments. The revisions will result in the consolidation of all additions, removals and revisions to the general provisions. The effect of the amendment will be the updating of the Department's general provisions.     

Confidentiality of certain medical records--VA. Final rule

This document establishes Department of Veterans Affairs (VA) regulations to implement specific provisions of the Veterans Omnibus Health Care Act of 1976 and the Veterans' Benefits and Services Act of 1988 concerning the confidentiality of certain medical records. These regulations protect the confidentiality of VA records pertaining to drug abuse, alcoholism or alcohol abuse, infection with the human immunodeficiency virus (HIV), and sickle cell anemia.     

Time is running out--the burdens and challenges of HIPAA compliance: a look at preemption analysis,the "minimum necessary" standard,and the notice of privacy practices

Ms. Guthrie's paper involves the final Privacy Regulations promulgated by the Department of Health and Human Services pursuant to HIPAA. Her thesis highlights three burdensome requirements which remain significant obstacles to the compliance date of April 14, 2003: (1) the need to undertake thorough preemption analyses, (2) lack of clarity surrounding the "Minimum Necessary Standard," and (3) confusion regarding the "Notice of Privacy Practices." Ms. Guthrie provides a close analysis of these three areas and offers several viable and persuasive alternatives to the associated burdens. She concludes that HHS must make several integral modifications and provide substantial and continuing guidance to covered entities in order for the Regulations to effectively achieve their purpose.     

Call 911: psychiatry and the new Emergency Medical Treatment and Active Labor Act (EMTALA) regulations

The Emergency Medical Treatment and Active Labor Act (EMTALA), enacted in 1986 as part of the Consolidated Omnibus Budget Reconciliation Act of 1985, aims to prevent "patient dumping" by requiring hospitals to screen and stabilize patients who come to an emergency room seeking medical attention. For many reasons, recovery under EMTALA is rare, especially when psychiatric treatment is called for. New regulations of EMTALA went into effect on November 10, 2003. These new regulations helpfully clarify the applicability of EMTALA. However, the bias against recovery in cases involving psychiatric emergencies is likely to remain.     

Food and Drug Administration-Redesignation of the Department of Health, Education, and Welfare as the Department of Health and Human Services. Final rule

The agency is amending Chapter I of Title 21 of the Code of Federal Regulations to reflect the redesignation of the Department of Health, Education, and Welfare as the Department of Health and Human Services.     

Health and Human Services policy for protection of human subjects research--HHS. Final rule

The Department of Health and Human Services (HHS) is amending its Human Subjects Protection regulations to rescind the provision requiring prior review and advice from an Ethical Advisory Board for research applications and proposals involving in vitro fertilization (IVF) of human ova as a prerequisite to funding by HHS and its components. The provision was nullified by the National Institutes of Health Revitalization Act of 1993. The regulations are being amended to reflect this statutory nullification. Institutional Review Board (IRB) review and approval of applications and proposals involving in vitro fertilization (IVF) of human ova continues to be required in accordance with other provisions of the Human Subjects Protection regulations. Furthermore, the Secretary may still exercise the option of seeking advice from an Ethical Advisory Board on ethical issues, including IVF, raised by research applications and proposals.     

Making sense of referral fee statutes

State and federal prohibitions of referral fees have long plagued the health care sector because their broadly worded provisions threaten established and socially valuable business arrangements. Congress has recently instructed the Department of Health and Human Services to issue regulations that clarify the scope of the most threatening of these prohibitions, the Medicare and Medicaid felony referral fee statute. This article examines three possible analytical models for imposing a limiting construction on referral fee statutes by testing the models against three beneficial practices that the statute jeopardizes: physician recruitment, fee discounting, and efficiency bonuses. The article recommends primary reliance on an earned/unearned analysis that detects a prohibited referral fee by asking whether the fee is fully earned by legitimate, nonreferral services.     

Privacy Act of 1974; exempt record system--HHS. Final rule

The Office of the Secretary of the Department of Health and Human Services is amending its Privacy Act Regulations to exempt the system of records, "Civil and Administrative Investigative Files of the Inspector General, HHS/OS/OIG," from certain provisions of the Privacy Act. This exemption is authorized by subsection (k)(2) of the Privacy Act, which applies to investigative materials compiled for law enforcement purposes. The Office of Inspector General (OIG) is authorized to gather information for Civil and administrative law enforcement purposes under Pub. L. 94-505, establishing the HHS Office of Inspector General, and section 1128A of the Social Security Act, authorizing civil money penalties for the filing of false claims in certain health care financing programs. In order to maintain the integrity of the OIG investigative process and to assure that the OIG will be able to obtain access to complete and accurate information, the Department is exempting this system, under subsection (k)(2), from the notification, access, correction and amendment provisions of the Privacy Act.     

Projects grants for community health services; proposed rulemaking--Public Health Service. Notice of proposed rulemaking

The Assistant Secretary for Health with the approval of the Secretary of Health and Human Services proposes to revise the regulations governing the Community Health Centers grant program. The Health Services and Centers Amendments of 1978 made a number of changes in the statutory requirements governing the operation of the centers. The Amendments, among other things, change pharmacy services from supplemental to primary health services, establish priority for certain supplemental health services, provide an incentive for maximized collection of fees, permit conversion of certain centers from fee for service to prepaid operations, and change the governing board requirements or public centers. The proposed revisions are intended to revise the present regulations consistent with the revised statutory provisions.     

An EMTALA primer: the impact of changes in the emergency medicine landscape on EMTALA compliance and enforcement

Tiana Lee's article provides an overview and update on the latest in the Emergency Medical Treatment and Active Labor Act (EMTALA). Reviewing the history of the statute, explaining some of the relevant regulations, and exploring government enforcements efforts to date, Ms. Lee highlights the benefits and drawbacks of the statute and recommends ways to ameliorate EMTALA's weaknesses.