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Medicare and Medicaid programs; hospital conditions of participation: requirements for history and physical examinations; authentication of verbal orders; securing medications; and postanesthesia evaluations. Final rule.

In this rule, we finalize changes to four of the current requirements (or conditions of participation (CoPs)) that hospitals must meet to participate in the Medicare and Medicaid programs. Specifically, this final rule revises and updates our CoP requirements for: Completion of the history and physical examination in the medical staff and the medical record services CoPs; authentication of verbal orders in the nursing service and the medical record services CoPs; securing medications in the pharmaceutical services CoP; and completion of the postanesthesia evaluation in the anesthesia services CoP. We also respond to timely public comments submitted on the proposed rule published in the March 25, 2005 Federal Register (70 FR 15266). The changes specified in this final rule are consistent with current medical practice and will reduce the regulatory burden on hospitals.

Anesthesia↗

Preparing for the brave new world, Part 4: "Minimum necessary" disclosures under HIPAA.

"Minimum information given with maximum politeness," Jacqueline Kennedy once directed a White House press secretary. Decades later, a pending federal health-privacy rule says nothing about courtesy but does explicitly require a "minimum necessary" standard for most disclosures of personally identifiable information. Physician practices that understand these two key words will have a head start in complying with the privacy regulations, which were published in December 2000 under authority of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This article, the final installment of a four-part series on how the HIPAA privacy rule will affect the day-to-day lives of physicians and their staffs, focuses on what the U.S. Department of Health and Human Services (DHHS) means by "minimum necessary."

Confidentiality↗

Nutrition education materials from the National Institutes of Health: development, review, and availability.

Many of the institutes, centers, and offices (ICOs) within the National Institutes of Health (NIH) develop and disseminate nutrition education materials for the general public. These materials provide information about the relationship of diet to health and about associations between diet and specific diseases. The materials, which are drafted by the NIH or contract science writers, go through pretesting (for literacy level and appropriateness for target audiences) and ICO clearance (for scientific accuracy). To further ensure scientific and technical accuracy and consistency with the Dietary Guidelines for Americans, the materials then go through a two-tiered governmental review system. The first review is through the Nutrition Education Subcommittee (NES) of the NIH Nutrition Coordinating Committee. The second review, which is required for federal nutrition education materials, is conducted jointly by the Department of Health and Human Services (DHHS) Nutrition Policy Board Committee on Dietary Guidance and by the US Department of Agriculture (USDA) Dietary Guidance Working Group. The review process helps ensure consistency in nutrition messages within the NIH ICOs and among government agencies. The pretesting, ICO clearance, NES review, and joint DHHS/USDA review result in materials for nutrition educators that are high in quality, low in cost or free, easily accessible, appropriate for the intended target audience, and consistent with the Dietary Guidelines for Americans.

Government Publications as Topic↗

Surveillance guidelines for smallpox vaccine (vaccinia) adverse reactions.

CDC and the U.S. Food and Drug Administration rely on state and local health departments, health-care providers, and the public to report the occurrence of adverse events after vaccination to the Vaccine Adverse Event Reporting System. With such data, trends can be accurately monitored, unusual occurrences of adverse events can be detected, and the safety of vaccination intervention activities can be evaluated. On January 24, 2003, the U.S. Department of Health and Human Services (DHHS) implemented a preparedness program in which smallpox (vaccinia) vaccine was administered to federal, state, and local volunteers who might be first responders during a biologic terrorism event. As part of the DHHS Smallpox Preparedness and Response Program, CDC in consultation with experts, established surveillance case definitions for adverse events after smallpox vaccination. Adverse reactions after smallpox vaccination identified during the 1960s surveillance activities were classified on the basis of clinical description and included eczema vaccinatum; fetal vaccinia; generalized vaccinia; accidental autoinoculation, nonocular; ocular vaccinia; progressive vaccinia; erythema multiforme major; postvaccinial encephalitis or encephalomyelitis; and pyogenic infection of the vaccination site. This report provides uniform criteria used for the surveillance case definition and classification for these previously recognized adverse reactions used during the DHHS Smallpox Preparedness and Response Program. Inadvertent inoculation was changed to more precisely describe this event as inadvertent autoinoculation and contact transmission, nonocular and ocular vaccinia. Pyogenic infection also was renamed superinfection of the vaccination site or regional lymph nodes. Finally, case definitions were developed for a new cardiac adverse reaction (myo/pericarditis) and for a cardiac adverse event (dilated cardiomyopathy) and are included in this report. The smallpox vaccine surveillance case definitions presented in the report can be used in future vaccination programs to ensure uniform reporting guidelines and case classification.

Adverse Drug Reaction Reporting Systems↗

Application of the HIPAA privacy rule to employer benefit plans and a compliance theory of statutory interpretation.

The application of the federal privacy regulations promulgated pursuantto the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to employer benefit plans is arguably the most conceptually difficult area of a complex law. A purely textual reading of the Rule, when applied to employer plans, results in varying interpretations on some significant issues and puzzling results on others. This Article offers a practical approach for interpreting the rule when clear-cut answers are not provided by the text and DHHS guidance is nonexistent or unclear. In addition, this approach can be applied to the interpretation of other statutes and regulations.

Confidentiality↗

Toward standardization of health information.

NCVHS has made recommendations to the DHHS to standardize 42 core health data elements, a number of which relate to medical conditions and services. The committee has asked the DHHS Data Council to actively promote, both within the department and externally, standardization of data elements and definitions where substantial consensus already exists. For those elements that have been recognized as significant core data elements, but for which there is not consensus on approach or definition, the NCVHS is recommending that the Data Council support the formation of a public-private working group to conduct further study and evaluation. This group, or a separate group, could also be the focus for evaluating additions to the list of core data elements and for setting up methods for testing and promulgating the final products. The coming 12-18 months will be exceedingly important for health data standardization efforts in the US as the DHHS responds to both the NCVHS recommendations and the legislation recently enacted by Congress.

Abstracting and Indexing↗

HIPAA privacy: the compliance challenges ahead.

This Article reviews the HIPAA Privacy Standards' impact on healthcare organizations. It discusses whether a healthcare organization is a "Covered Entity" under the regulations, what information the Privacy Standards protect, what restrictions the regulations place on the use and disclosure of protected health information, what individual rights the Privacy Standards create, and what agreements they require between healthcare organizations and their business associates. The author provides relatively extensive guidance to organizations that are embarking upon their voyage of compliance with these broadly applicable regulations, but notes that the full extent of necessary compliance remains unclear, pending DHHS issuance of the next iteration of the rulemaking in this area. The Article was finalized in January 2002, before HHS issued any modifications to the Privacy Standards.

Access to Information↗

The Institute of Medicine's report on non-heart-beating organ transplantation.

In December 1997, the Institute of Medicine (IOM) released a report on medical and ethical issues in the procurement of non-heart-beating organ donors. This report had been requested in May 1997 by the Department of Health and Human Services (DHHS). We will here describe the genesis of the IOM report, the medical and moral concerns that led the DHHS to sponsor it, the process of producing it, and its conclusions. The analyses, findings, and recommendations of the report are also reviewed, in particular the central issues that led to suggestions for policy changes.

Cadaver↗

Baby doe redux? The Department of Health and Human Services and the Born-Alive Infants Protection Act of 2002: a cautionary note on normative neonatal practice.

The Born-Alive Infants Protection Act (BAIPA), passed by Congress in 2002, has attracted little publicity. Its purposes were, in part, "to repudiate the flawed notion that a child's entitlement to the protections of the law is dependent on whether that child's mother or others want him or her." Understood as antiabortion rhetoric, the bill raised little concern among physicians at the time of legislative hearings and passed in both Houses by overwhelming majorities, hardly suggesting contentious legislation. After its signing into law, the Neonatal Resuscitation Program (NRP) Steering Committee issued an opinion stating that "[BAIPA] should not in any way affect the approach that physicians currently follow with respect to the extremely premature infant." This interpretation of the law, however, may have been short sighted. In April 2005, the US Department of Health and Human Services (DHHS) brought life to the BAIPA, announcing: "As a matter of law and policy, [DHHS] will investigate all circumstances where individuals and entities are reported to be withholding medical care from an infant born alive in potential violation of federal statutes." The agency issued instructions to state officials on how the definitional provision within the BAIPA interacts with the Emergency Medical Treatment and Labor Act (EMTALA) and the Child Abuse Prevention and Treatment Act (CAPTA). These interagency memoranda potentially resurrect dormant governmental oversight of newborn-treatment decisions and thus may have influence over normative neonatal practice. Under the BAIPA, the DHHS interprets EMTALA to protect all "born-alive" infants; hospitals and physicians violating regulatory requirements face agency-sanctioned monetary penalties or a "private right of action by any individual harmed as a direct result." According to its memorandum, the DHHS will investigate allegations of EMTALA violations whenever it finds evidence that a newborn was not provided with at least a medical screening examination under circumstances in which a "prudent layperson observer" could conclude from the infant's "appearance or behavior" that it was "suffering from an emergency medical condition." The memorandum fails to clarify which observers qualify as prudent, what infant appearance or behavior is relevant, or what defines an emergency medical condition. Because these evaluative criteria are not constrained by reference to relevant standards of medical care, the agency arguably substitutes a nonprofessional's presumed sagacious assessment of survivability for reasonable medical judgment. Indeed, under a straightforward reading of the instruction, a family member could conceivably trigger an investigation after observing a relative deliver a 20-week fetus who maintains a heartbeat for an hour before its death. Most physicians would not consider this an emergency medical condition and, rather than perform a screening examination, would provide comfort for the newborn and support for the family. The guideline, however, does not state that professional acumen trumps the layperson's observations in these instances; thus, physicians are left unclear about whether screening examinations are required for all newborns regardless of a priori, reasoned considerations of survivability. In this context, the NRP Steering Committee opinion states that "at the time of delivery... the medical condition and prognosis of the newly born infant should be assessed. At that point decisions about withholding or discontinuing medical treatment that is considered futile may be considered by... providers in conjunction with the parents acting in the best interest of their child." However, most pediatricians skilled in screening and resuscitation are not currently called on to perform this function when the gestational age of a nonviable fetus is reasonably certain before delivery. If under the law screening is now required at any gestational age, professional procedure immediately after previable births may need modification. More worrisome, threatened aggressive investigations of alleged EMTALA violations at the soft edges of viability, where futility remains a matter of debate, jeopardize the normative ethical practice of offering discretionary palliative care. The DHHS sent its other instruction to state child protective services agencies responsible for implementing CAPTA regulations; it reiterates the limited situations in which physicians may withhold medical treatment from infants and reemphasizes the local role of "individuals within health care facilities" to notify authorities of suspected infractions. Its real import, however, is insistence on local execution of legal remedies to prevent nontreatment decisions deemed impermissible by the 1984 Baby Doe rules. Because this new directive encourages governmental oversight of treatment decisions involving imperiled newborns, a period of benign regulatory neglect seems to be over. The federal CAPTA rules arguably remove quality-of-life considerations from the decision-making calculus and therefore may conflict with the best-interests paradigm advocated by the American Academy of Pediatrics and NRP. How courts will respond to the DHHS interpretation of EMTALA and CAPTA under the BAIPA remains unclear. Federal courts have yet to authoritatively examine alleged EMTALA violations involving newborn treatment decisions at the limits of viability. The Wisconsin Supreme Court has permitted an EMTALA claim to go to trial where physicians allegedly did not screen or resuscitate a 22-week newborn delivered in an emergency department, and a lower appellate court has relied on CAPTA to hold that parents do not possess the right to choose against resuscitating an extremely premature newborn. The Texas Supreme Court recently granted physicians the paternalistic prerogative to resuscitate imperiled newborns without attention to parental preference under a common law doctrine of "emergent circumstances." These judicial decisions undermine the ethical discretion parents are typically afforded in decision-making before and after delivery in these morally complex situations. The DHHS interpretation of the BAIPA may encourage jurisdictional creep of these kinds of pronouncements as the agency seeks to expand legal protections for born-alive infants. The US Supreme Court has stated that "courts must presume that a legislature says in a statute what it means and means in a statute what it says there"; thus, judges interpret law by analyzing "concrete statutory language, not by reference to abstract notions of generalized legislative intent." The BAIPA indiscriminately defines "born alive" to include an infant "at any stage of development... regardless of whether the expulsion or extraction occurs as a result of natural or induced labor, cesarean section, or induced abortion," and it makes no reference to standards of care or best interests, nor does it specifically protect a parent's decision-making authority. Under the law's strict logic, an 18-week miscarried fetus with a detectable heart beat after delivery is entitled to the full protections of the law as determined by "any Act of Congress, or any ruling, regulation, or interpretation of the various administrative bureaus and agencies." Before concluding that the BAIPA would not affect normative neonatal practice, the NRP Steering Committee should have analyzed the act's actual statutory language and avoided relying heavily on imprecise legislative intent. The BAIPA's congressional sponsors did claim that the law "will not mandate medical treatment where none is currently indicated," but such political rhetoric is often not sufficient to render law innocuous years after separation from its legislative history. Besides, nowhere in the House record does the majority explicitly acknowledge that discretion to decide the fate of imperiled newborns invests in parents, in consultation with physicians; indeed, the bill's stated purpose was to repudiate that notion. At best, legislators recognized that physicians disagree about the efficacy of resuscitating at the limits of viability, and therefore the current standard of care permits doctors to deem resuscitation a futile endeavor. However, judges may resist characterizing resuscitation as futile, given its poor analytical fit, and substantial public-policy concerns regarding discrimination against future disabled individuals could easily tip a court to preserve incipient, at least, physiologic life under the BAIPA's all-encompassing definition of born alive.

Fetal Viability↗

DHHS's final rule on the Quality Assessment and Performance Improvement Program.

All facilities that participate in the Medicare and Medicaid programs must comply with the Quality Assessment and Performance Improvement Program as a condition of participation. Nurse executives need to be familiar with the requirements of this program in order to be able to participate in ensuring the compliance of the facilities with which they work.

Accreditation↗

[Antiretroviral therapy in 2004].

Since its inception, highly active antiretroviral therapy (HAART) has undergone constant further development. The German Aids Society (DIG), but also the British HIV Association (BHIVA) and the North American Department of Health and Human Services (DHHS) have all issued recommendations on HAART. A comparison of these recommendations reveals that despite the many points they have in common, gaps in our knowledge, and shortcomings in both the diagnosis and treatment of HIV infections still persist.

Anti-HIV Agents↗

Maternal-fetal research and human research protections policy.

It may be that the current system of formal definitions, ethical theories, and voluntary professional guidelines to protect patients from unwittingly becoming subjects of research is inadequate to meet the challenge of surgical innovation. Important questions, such as when surgical innovation becomes research involving human subjects or how to distinguish between variations on an existing technique and true innovations, are key. These questions also apply to MFS as an innovative surgical therapy. Now that MFS has been recognized as experimental and formal clinical trials will be conducted, it is important to ensure adequate protection of the pregnant women and fetuses involved as human research subjects. This issue is even more pertinent in light of the new regulations regarding fetuses as research subjects. Those responsible for reviewing study protocols will have to be especially careful when examining the new version of DHHS regulations as they apply to future studies in the field of MFS.

Biomedical Research↗

Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: recommendations from the U.S. Department of Health and Human Services.

The most effective means of preventing human immunodeficiency virus (HIV) infection is preventing exposure. The provision of antiretroviral drugs to prevent HIV infection after unanticipated sexual or injection-drug--use exposure might be beneficial. The U.S. Department of Health and Human Services (DHHS) Working Group on Nonoccupational Postexposure Prophylaxis (nPEP) made the following recommendations for the United States. For persons seeking care < or =72 hours after nonoccupational exposure to blood, genital secretions, or other potentially infectious body fluids of a person known to be HIV infected, when that exposure represents a substantial risk for transmission, a 28-day course of highly active antiretroviral therapy (HAART) is recommended. Antiretroviral medications should be initiated as soon as possible after exposure. For persons seeking care < or =72 hours after nonoccupational exposure to blood, genital secretions, or other potentially infectious body fluids of a person of unknown HIV status, when such exposure would represent a substantial risk for transmission if the source were HIV infected, no recommendations are made for the use of nPEP. Clinicians should evaluate risks and benefits of nPEP on a case-by-case basis. For persons with exposure histories that represent no substantial risk for HIV transmission or who seek care >72 hours after exposure, DHHS does not recommend the use of nPEP. Clinicians might consider prescribing nPEP for exposures conferring a serious risk for transmission, even if the person seeks care >72 hours after exposure if, in their judgment, the diminished potential benefit of nPEP outweighs the risks for transmission and adverse events. For all exposures, other health risks resulting from the exposure should be considered and prophylaxis administered when indicated. Risk-reduction counseling and indicated intervention services should be provided to reduce the risk for recurrent exposures.

Antiretroviral Therapy, Highly Active↗