People seem occupied with the war in Iraq on a daily basis. While this threat is real, especially to those living in the immediate surrounding region, a greater, and far more “realistic” threat remains hidden behind closed doors. While people are killed in the blink of an eye during battle, the drawn out debate over the status of “brain death” appears to have long-term effects on the lives of human beings. The far-reaching discussion around the end of life and the moment thereof has brought to light great uneasiness.
The difficult issue may be tackled from a variety of perspectives, each presenting a case for or against the use of the phrase “brain death” when defining the end of human life. This article focuses on the legal and ethical concerns. Specifically, by pointing to numerous problematic issues surrounding brain death, it calls for caution when using a cortical definition of death. The medical declaration of brain death seems to overturn otherwise tested and needed medical measures and precautions, especially those of advanced medical directives and informed consent, and ethical considerations regarding autonomy and personhood.

Inevitably, one interested in the medical definition of death has to encounter the limitations on the definition that have been established by the law. Physicians may have personal beliefs about the constituent elements of death, but the law limits the implementation of these personal opinions. Oftentimes, the law rightfully sets limits for the medical field; overzealous physicians, in their effort to help others, as well as patients in vulnerable circumstances, need a protective mechanism that will help avoid further complications and injury. Baumgartner clearly understands the crucial role of the law in the medical field when he states, “What physicians need is a clear legal framework to be able to deal with difficult and often extremely conflicting clinical decisions consistently”1.

In the definition of brain death, the law throughout the world has come up short. Surely, the law has established certain criteria for the determination of brain death as written in the Uniform Declaration of Death Act, but in essence, it has allowed physicians the freedom to interpret and implement the law in ways they personally deem acceptable2. The problem with testing for brain death may also stem from the fact that most states in America “.. .require no special qualifications or training, beyond a general medical license for the individual performing brain death examinations”2. If physicians do not obtain special training that thoroughly explains the legal criteria for brain death, the methods available for its testing, and the social and ethical dilemmas involved, then a physician may use his/her preconceived understanding of brain death and perhaps wrongfully diagnose death.

Additionally, one can see evidence of laxity in American law in the fact that most states do not specify medical tests necessary for confirming brain death. Many physicians realize that the nature of the law established to direct medical practice, specifically dealing with brain death, forces physicians to seek answers to their legal dilemmas beyond the American legal system. Physicians in the United States have consequently begun to refer to literature from around the world, and have made the mistake of implementing many of the legal practices of foreign countries within America. Because of this international conversation, “…the practice of many physicians declaring brain death in the United States may have changed from the Uniform Determination of Death Act of the 1980s, although medical and legal definitions of brain death in the United States have not changed”3.

Advanced Directives

A possible answer to the entire brain death issue includes advanced medical directives (AMDs). As Finnerty states, “An advance directive is an individual’s legal way to document wishes for medical care in advance of loss of capacity from illness or injury”4. Although advance directives protect an individual’s right to make personal decisions about the care that s/he desires, especially in the event when one loses the capacity for conscious decision-making, they do not have the same function in cases of brain death. If medicine believes that a brain dead person ceases to exist, then that person-already viewed as deceased-in effect loses all rights that s/he previously possesses.

Advanced directives do offer insight into whether or not a person wants to donate his/her organs, and it may even prohibit the use of life support. In the later case, brain death does not become an issue because the person will eventually die from cardiac and pulmonary failure. Although advanced directives may prevent the initiation of life-support, physicians and family members run into problems when the person requests to remain on life-support regardless of his/her medical condition. In cases where people find themselves in a vegetative state; i.e., where the person shows signs of cortical activity, physicians and the law cannot ignore such a request. On the other hand, one wonders if a brain dead person’s wish has the same legal and medical stance. If one supports Beresford’s statement that, “Brain death is synonymous with death of the person and has legal significance,”5 then a conflict arises between personal rights and the medical definition of death6. One can therefore conclude that although advanced directives provide some legal and medical insight in brain death cases, they have little to offer once the person has died.

Kimberly-Clark has launched a marketing campaign in which two million subscribers have received a full-page, custom printed sheet of Viva brand paper towel inserted into the June issues of Reader’s Digest and Every Day with Rachael Ray magazines. The print ad included a six-page advertising insert, which sandwiched a sheet of viva paper towels between advertising copy, as well as a $1.00 coupon.

In addition to the towel insert, Viva 30-second television spots are running on numerous cable channels, including The Food Network, Fine Living, The Travel Channel and Home.

Mohawk Fine Papers has relaunched Beckett Expression and Beckett Concept. The relaunch includes new shades, digital papers and expanded basis weights, including extra heavy cover weights. In addition to enhancing the look and performance of the papers, Mohawk has made Beckett Concept and Beckett Expression environmentally responsible premium papers. The entire Expression and Concept product lines are now FSC certified, manufactured with wind-generated electricity and made carbon neutral, meaning they are made entirely with renewable energy. Other key features include refined vellum finish, dense uniform center core with a soft, toothy surface, 98 bright white shade and new colors, including earth tones.

Neenah Paper’s promotion for Classic Linen Papers, “Renew,” introduces a new finish to graphic designers. The finish focuses on the resurgence of using texture in a blend of modern designs. The textural, lush images of the promotion campaign lend themselves to the luxury market and fields that cater to the richness of living such as the health and beauty, and hospitality industries. “Renew” is meant to encourage graphic designers to look at the printability of Classic Linen and its tactile nature and consider it as a new paper alternative.

Neenah Paper has also released the first revision of its two-year-old Eames Paper Collection. This is the first complete line of papers from a major mill in more than ten years. The revisions and additions are in direct response to changes suggested by designers. Changes include the addition of Neenah’s Solar White, double thick cover weights and the addition of a vellum sheet.

Background: Sleeping sickness (human African trypanosomiasis) is a parasitic infection transmitted by day-biting tsetse flies. The diagnostic standard is microscopy of blood, lymph node aspirates, or cerebrospinal fluid. The disease is invariably fatal if not treated. There are >300,000 new cases of sleeping sickness each year and ~100,000 deaths. Case Presentation: We describe a British soldier who acquired sleeping sickness in Malawi. He gave no history of a painful insect bite but presented with classic early signs of sleeping sickness (a primary chancre, regional lymphadenopathy, circinate erythema, and a cyclical fever pattern). His condition worsened in the next week, and trypanosomes were observed in a blood sample. The patient was aeromedically evacuated to Johannesburg, where stage 1 Trypanosoma brucei rhodesiense infection was confirmed; he also had renal and liver failure, pancytopenia, and heart block. He was treated with intravenously administered suramin, and he recovered fully over the next 5 months. Recommendations: Medical officers deploying to eastern and southeastern Africa must be familiar with the common presenting signs and symptoms of T. b. rhodesiense sleeping sickness and should have 24-hour access to a reliable, local, clinical microscopy service. Confirmed sleeping sickness requires immediate transfer to a tertiary diagnostic and treatment center, where suramin (for T. b. rhodesiense infection), pentamidine (for Trypanosoma brucei gambiense infection), and melarsoprol (for stage 2 disease) must be immediately available.

Human African trypanosomiasis, or sleeping sickness, affects one-half of Africa’s continental land mass. The disease is considered to have had a greater negative  impact on the economic development of central Africa than any other.1 There are >300,000 new cases of sleeping sickness each year and -100,000 deaths.2·3 Since 1990, the rate of infection has risen tenfold.4

Sleeping sickness is confined to the equatorial region and occurs in a patchy distribution throughout central and southeastern Africa, including Malawi.5 During a 3-year period of national surveillance (November 1986 to September 1989), 33 cases of sleeping sickness were recorded from the Kasungu National Park.6 The greatest risk of acquiring sleeping sickness in Malawi is during the dry season, which in most years runs from May to October.5

Sleeping sickness is transmitted by tsetse flies of the genus Glossma and is caused by two different parasite subspecies, that is, Trypanosoma brucei rhodesiense, which causes acute sleeping sickness, and Trypanosoma brucei gambiense, which causes a more-chronic disease presentation.7 Key differences between the two forms of the disease are summarized in Table I. Game animals and cattle are the natural reservoirs of T. b. rhodesiense, and humans, domestic pigs, and some wild mammals are the natural reservoirs of T. b. gambiense.8

The survival of Trypanosoma brucei in mammalian hosts derives from its ability to very readily alter its antigenic profile.9 The bloodstream forms of T. brucei are covered with a dense coat of highly immunogenic glycoproteins, which stimulate the production of specific antibodies, mainly of the IgM subclass.10 Approximately 2% of each new T. brucei generation expresses a different surface glycoprotein, thus stimulating the production of a new IgM population; this process enables the parasite to elude the host immune response. ‘ ‘ Over time, trypanosomes are able to penetrate the central nervous system (CNS), probably through damage to and breakdown of the choroid plexus.” Death is most commonly attributable to neurological involvement, leading to neglect, malnutrition, infection, and eventual coma.7·11

Clinical Presentation

The early symptoms of sleeping sickness can be nonspecific, and it is essential for medical officers in disease-endemic areas to consider trypanosomiasis in the differential diagnosis of any patient with a febrile illness.12 Tsetse bites can be quite painful, and they often leave a small, self-healing mark.13 Wien trypanosomal infection follows a tsetse bite, a more-pronounced, longerlasting, local reaction occurs, with injected trypanosomes multiplying at the bite site.

A small red papule develops after ~5 days, expanding over the next 7 to 10 days to a hard, painful, round, pruritic nodule, the “erythematous pseudo-furuncle” (up to 3 cm in diameter).13 At this stage, the lesion usually is warm, painful, and somewhat tender (although it is painless in some cases) and typically is surrounded by an intense erythematous tissue reaction, with local edema; the whole complex is called a primary chancre, or trypanosomal chancre.2 The chancre usually persists for ~3 weeks and then subsides spontaneously, to be replaced by a hyperpigmented, painless, nontender eschar (Fig. I).7 During this time, lymph nodes in the region of the bite may become enlarged as drainage from the bite site occurs.

More than three years after the National Electronics Product Stewardship Initiative (NEPSI) met for the last time, one of its stakeholders has proposed a framework for federal electronics recycling legislation that addresses the contentious issue of how to finance such an effort.

The Electronic Industries Alliance (EIA), Arlington, Va., is a trade organization representing U.S. electronics manufacturers. The EIA counts as its members 1,300 companies that manufacture everything from small electronic components to complex systems used by defense, space and industry, as well as a full range of consumer electronic products.

In September of 2006, a Congressional e-waste working group held a stakeholder meeting in which manufacturers and retailers agreed to find a financing solution for the hill and other stakeholders to consider, Rick Goss, EIA vice president of environmental affairs, says. The EIA’s Environmental Issues Council, which is made up of representatives from 64 companies, including major IT and consumer electronics manufacturers, debated the framework, with the EIA executive committee voting to accept the framework in late May.

The legislative framework EIA has proposed is based on a bifurcated financing system that distinguishes televisions from IT equipment. “The key point is that televisions and IT equipment need to be treated differently,” Goss says. He adds that the major market and life cycle differences between televisions and IT equipment call for different funding mechanisms.

FUNDING A SOLUTION. Goss says that the state laws concerning electronics recycling that have been passed each provide different financing mechanisms to fund the collection and recycling of televisions and IT equipment, creating an uneven playing field for the electronics industry’s various manufacturers depending on their product range. According to Goss, advanced recovery fees or producer responsibility funding mechanisms create winners and losers when applied to electronics manufacturers as a whole. Instead, he says, the EIA’s proposed bifurcated financing system provides a “fair and equitable” financing solution to the industry’s manufacturers.

Goss points out that the life span of a television is generally 15 years, while the life span of IT equipment, especially personal computers and laptops, tends to be much shorter, in the range of six-to-eight years. Technological innovations help to speed the obsolescence of personal computers and laptops as well as to serve as a barrier to entering the industry. However, Goss says, a smaller barrier to entry exists in the television manufacturing sector, meaning that companies, particularly overseas firms, can easily set up manufacturing facilities. “Our members are getting competed to death by foreign competitors, particularly Chinese competitors,” he says. “We don’t know if these companies will be around in 15 years. They are virtual companies with virtually no permanent presence in the U.S.” Goss adds that there is a “huge risk” these foreign competitors may not be around 15 years in the future, which would leave EIA member companies to foot the bill for the recovery and recycling of their competitors’ televisions. “We see a higher orphan rate for TVs than for computer monitors,” he adds.

The bifurcated financing solution the EIA has proposed separates televisions from desktop computers, laptops and computer monitors to reflect their different business models, market composition and consumer base, according to the organization. The collection and recycling of televisions would be conducted through an industry-sponsored, third-party organization and initially supported by a nominal advance recovery fee at the time of purchase. The fee would expire once a significant portion of legacy televisions have been recovered and then revert to a producer responsibility funding mechanism.

Goss says many EIA members are extremely concerned about legislation that calls for manufacturers to fund the recovery and recycling of their branded products in light of the volume of televisions in the market, their longevity and the number of manufacturers entering and leaving the market, all of which contribute to considerable legacy issues. “Long-standing manufacturers have a huge and retroactive responsibility,” he adds, while “virtual” manufacturers can evade their responsibilities by closing down their operations in 10 years and reopening under a different name in the future.

IT equipment manufacturers would start a convenient and free consumer program to recover and recycle their products, according to the EIA framework. IT manufacturers would have to offer such a program to do business.

In a press release announcing the framework, Goss says, “Across the board, manufacturers made concessions to produce this consensus agreement. We sincerely hope that other stakeholders will be motivated by the same spirit of compromise as we seek a uniform recycling program that our country wants and needs.”

We report a case of a 34-year-old woman who received cefuroxime, a second-generation cephalosporin, as treatment for mastitis. She subsequently developed a serum sickness-like reaction (SSLR) with a generalized pruritic rash, joint pains, and fever. She improved upon treatment with systemic steroids. SSLR is well-described to cefaclor, a second-generation cephalosporin. However, there is a paucity of reports of SSLR to other cephalosporins such as this case.

A 34-year-old Caucasian woman presented to the dermatology clinic with a 2-week history of mastitis. The patient was breast-feeding following delivery of her sixth child 7 weeks earlier. She had no other significant past medical history. She was treated with 500 mg of oral cefuroxime (Ceftin[R]) twice daily and had completed the 10-day prescribed course. Six days into the course of treatment, she developed a rash on the scalp, which generalized over a 5-day time span to involve extensive areas of the trunk, arms, legs, and face. The rash was very pruritic, and individual lesions, which lasted less than 24 hours, were migratory. The patient also complained of intermittent fevers to 101[degrees]F and joint pains of the elbows, knees, and smaller joints of the hands. She specifically denied wheezing or shortness of breath. Her other current medications included prenatal vitamins. At the time of her delivery, 7 weeks previous, she had received pain medications, but no antibiotics. Acetaminophen and diphenhydramine, which she had tolerated well in the past, were taken orally as needed for the rash. Her reported allergies included tetracycline, penicillin, and erythromycin, all of which had caused skin rashes. As the rash continued to worsen in extent and severity, even after the antibiotic was completed, she was treated with oral methylprednisolone for 3 days, then one dose of oral prednisone 30 mg without improvement. She was then referred to the dermatology clinic.

The patient was a thin woman who scratched frequently, but otherwise was in no apparent distress. Skin examination revealed multiple confluent and extensive blanching urticarial plaques with dermatographism on the arms, legs, trunk, and face. No mucosal erosions were present, and there was no edema of the face or extremities. No cervical, occipital, axillary, or inguinal lymphadenopathy was noted. Pulmonary and cardiac examination was unremarkable. She had no swelling or erythema of the joints. The elbows, knees, and joints of the hands exhibited full range of motion. Laboratory studies, including a complete blood count, comprehensive metabolic panel, urinalysis, erythrocyte sedimentation rate, and C3, C4, and CH50 were all within the normal limits.

She was diagnosed with a serum sickness-like reaction (SSLR) to cefuroxime and admitted for 100 mg of intravenous methylprednisolone daily and oral antihistamines. Her symptoms and rash improved within 24 hours, and she was discharged on an extended tapering dose of prednisone starting at 40 mg daily, in addition to oral hydroxyzine, oral doxepin, and topical emollients. She experienced slow but steady resolution of her symptoms over the following 4 weeks.

Discussion

SSLR is a specific type of drug reaction so named because of its clinical similarity to serum sickness. True serum sickness is a type III hypersensitivity reaction in which clinical signs and symptoms result from deposition of immune complexes in the skin, joints, and other organ systems. In contrast, SSLR is not associated with demonstrable circulating immune complexes. The reaction is acute, self-limited, and has been described in association with a variety of different medications. Although many drugs have been reported to cause SSLR, antibiotics are the major group of offending agents, particularly beta-lactam and sulfonamide antibiotics.

In most cases, signs and symptoms appear about a week after initiation of therapy.  The most frequent finding is cutaneous involvement, typically in the form of erythema and urticarial lesions that are often migratory. In the series reported by Hebert et al, many of the urticarial wheals had dusky to purple centers, which were morphologically suggestive of erythema multiforme (EM).

The other primary clinical feature is joint involvement. Pain and swelling of the joints is a typical finding, and is usually polyarticular. Affected joints commonly include wrists, ankles, hips, and knees,  which can become so severe that patients are unable to walk.

Although fever may occur, other systemic findings are less common. In contrast to true serum sickness, renal and hepatic involvement is rare.

Despite the impressive cutaneous findings and joint symptoms, a hallmark of SSLR is the benign outcome, although some patients do require hospitalization due to their severe symptoms. Treatment is typically symptomatic, usually with antihistamines and analgesics. The use of systemic corticosteroid treatment has been described in retrospective medical record reviews and in a number of case reports, although there is no accepted standardized therapy. Reports of SSLR describe benign outcomes with no sequelae.

LIKE A. K. M. ADAM (”Collared,” May 31), I am an Episcopal priest. I too generally wear clerical garb when I am serving in liturgical or educational ministries. I like his conception of the collar as a “uniform” much like that of the UPS driver. I wear mine in the same spirit, particularly when I know I will need to visit parishioners in the hospital or nursing home. Ideally, the collar will help the healthcare workers identify me as a person with a necessary function.

Unlike Adam, however, I am a female Episcopal priest. And what I have discovered as I wear my clericals in medical facilities and other public settings is that the collar can be a source of confusion. I have been called “Father.” I have been called “Sister” and asked if I am a nun.
But most baffling to me is when people just won’t see it. Because I am a woman: they can’t associate me with a clerical collar. And so they simply don’t.

“You’re here to visit Miss X?” some bright young attendant asks. “Yes,” I say. “And you are …?”

“I’m her pastor.” I point to the collar. And wait. And wait some more. Then I watch as the expression folds and wrinkles in perplexity.

“Oh. I thought you were just wearing a really interesting blouse.”

As mentioned previously in Washington Report, the push is on to reduce medical errors in the US. The focus has now shifted to Congress. A bipartisan coalition of senators recently urged lawmakers to approve a bill to require healthcare facilities to establish safety procedures and report instances of serious error. The bill’s sponsors, Senators Charles Grassley, R-IA; Joseph Lieberman, D-CT; Bob Kerrey, D-NE; and Richard Bryan, D-NV, want to reduce the medical error rate by 50% over the next 5 years.
The measure known as SAFE (Stop All Frequent Errors in Medicare and Medicaid Act of 2000) is based on recommendations from the Institute of Medicine report published last November. Among other things, the institute found that as many as 98,000 patients die every year because of medical mistakes.

SAFE also would establish a Center for Patient Safety within the Agency for Health Research and Quality. Designed to improve safety and reduce the incidence of medical errors, the Center would conduct research and dispense grants related to medical error reduction. It also would establish national goals for patient safety and mechanisms to track such goals.

The measure would target healthcare purchased through Medicare and Medicaid. Facilities that want to participate in these 2 federal programs, including hospitals, critical access hospitals, skilled nursing facilities, and home health agencies, would have to meet the requirements of the act.
“Through Medicare and Medicaid, we can work to reduce medical errors in almost every health facility in the country,” said Sen. Lieberman.

SAFE would require health institutions to establish a medical safety program that produces measurable reductions in error. The program would require the reporting of deaths and serious injuries and the identification of their causes. Under the proposal, health institutions would have to take steps to prevent further accidents.

When asked about the role of laboratories in all this, American Clinical Laboratory Association president David Sundwall, MD, said, “ACLA is very interested in it. We think it presents an opportunity for labs to get some good press because we have a very good record and a good story to tell.” He added that research indicates that medical errors occur because of system failure. “Laboratories believe they can help with those system problems.”

Under the bill, medical institutions would have to report incidence of errors to state public health departments, Medicare peer review organizations, and relevant accrediting organizations. Facilities would then select one of those three entities to oversee whether they are complying with the law’s requirements. The information concerning errors would be stripped of identifiers, then provided in aggregate form to federal officials for research and other purposes.

The Department of Health and Human Services would not publicize the name of an institution unless the facility demonstrates a pattern of poor performance for more than 2 years, and fails to comply with the reporting requirements and to take steps to address safety problems.

While there is growing public support for efforts to reduce medical mistakes, groups representing physicians and hospitals are concerned that the mandatory reporting of errors would result in additional lawsuits. To win passage, Capitol Hill experts say, lawmakers will have to come up with a way that provides physicians and hospitals with protections from legal action.

Regional carriers still on drawing board

HCFA is indicating that it plans to phase in a regional carrier system to process Medicare Part B laboratory claims as required by the 1997 Balanced Budget Act. But the phase-in is not expected to start until sometime next year. The use of regional carriers as well as uniform lab payment policies are intended to make the handling of lab claims more consistent across carrier areas.

Under the budget act, up to 5 regional carriers were scheduled to be in place by July 1, 1999. But HCFA has taken no action to get the effort going. “We think this is long overdue and we are not happy with the delay,” says ACLA’s Sundwall.

HCFA maintains that the delay was due in part to year 2000 compliance work. But Sundwall says that some HCFA staffers have reservations about the regional carrier requirement. Even so, the HHS Office of Inspector General has said it favors the use of regional carriers to handle lab claims. The OIG believes that the regional carrier approach has worked well for durable medical equipment claims.

Managers in modern business or government environments are all too aware of the potentially disruptive effects that can accompany the implementation of new business processes and technology. A single breakthrough in today’s integrated economy can quickly transform an entire industry. For the manager these external events drive internal decision-making; adjust or risk losing competitive edge. For staff members such events can cause feelings of disequilibrium or even trauma that require different adaptive tactics than those used by the organization. The rethinking of how to sustain value and manage costs puts existing processes, strategies and organizational boundaries under the microscope. How is the organization to cope? Are there approaches that keep the organization flexible and its personnel greased for change? This article reviews experiences and outcomes of a government program as it re-engineered a major business area, military medical logistics - saving millions and improving service effectiveness.
Throughout the 1990s the medical supply chain was immersed in transformation. The emergence of strategic partnerships, network computing, the Internet and electronic commerce (e-Commerce) have combined with radical changes in clinical practice, manufacturing processes and distribution technology to fundamentally alter the economics of the medical supply industry. This industry handles hundreds of billions of dollars in pharmaceuticals, medical supplies and technology, but until recently has operated as a series of more or less independent niche players. Each player - distributors, wholesalers, group purchasing agents, healthcare providers and manufacturers - has worked aggressively to optimize individual segments within the medical supply value chain. However, new technology and business processes are making collaboration and partnerships in the medical supply chain a survival necessity - and that makes big business out of e-Business. Fifteen percent of all medical supplies will be procured electronically next year, according to Deutsche Bank’s consulting arm - up from less than 5 percent just three years ago.

Managers in modern business or government environments are all too aware of the potentially disruptive effects that can accompany the implementation of new business processes and technology. A single breakthrough in today’s integrated economy can quickly transform an entire industry. For the manager these external events drive internal decision-making; adjust or risk losing competitive edge. For staff members such events can cause feelings of disequilibrium or even trauma that require different adaptive tactics than those used by the organization. The rethinking of how to sustain value and manage costs puts existing processes, strategies and organizational boundaries under the microscope. How is the organization to cope? Are there approaches that keep the organization flexible and its personnel greased for change? This article reviews experiences and outcomes of a government program as it re-engineered a major business area, military medical logistics - saving millions and improving service effectiveness.

The Prospective Payment System (PPS) for Medicare home health services was implemented in October 2000. The PPS replaced the Interim Payment System (IPS), which was implemented in 1997 as part of the Balanced Budget Act of 1997 (BBA). The IPS placed stringent limits on the Medicare cost based reimbursement system then in effect. Both IPS and PPS were intended to constrain Medicare home health expenditures, which had increased rapidly in the preceding decade (from $2 billion to over $17 billion between 1988 and 1997 [MedPAC 1998]). IPS was associated with dramatic expenditure and visit reductions between 1997 and 1999. Medicare expenditures declined 53 percent to $7.9 billion (CMS 2003), still comprising about 5 percent of total Medicare expenditures. Two recent articles estimate that home health visits per user declined by about 40 percent (Komisar 2002; McCall et al. 2003).
Whether the reduction in visits per user under IPS affected patient outcomes is uncertain. McCall et al. (2002) found mixed results based on selected utilization measures derived from Medicare claims data as proxy outcome indicators. Based on multivariate analyses for fiscal years 1997 and 1999, in the 120 day period after home health admission, hospital admissions decreased while skilled nursing facility admissions, emergency room use, and mortality increased. Although the study authors urge caution in attributing the changes to IPS, it is possible that the stringency of IPS resulted in a decline in patient outcomes.
The PPS encouraged further visit reductions. Under PPS, a prospectively determined per-episode payment rate is case-mix adjusted using 80 mutually exclusive Home Health Resource Groups (HHRGs). Each Medicare episode is classified into an HHRG using a subset of items from the Outcome and Assessment Information Set (OASIS), which has been collected by all Medicare-certified home health agencies since mid-1999 (HCFA 1999a). The PPS creates strong financial incentives to minimize service provision because per-episode payments do not vary according to the quantity or mix of services provided. A study by the U.S. General Accounting Office (USGAO 2002) found that average visits per episode declined by 24 percent (29-22 visits) from just prior to PPS to the first half of 2001. The reduction in visits per episode under PPS compounded the already substantial decline under IPS and raises the possibility of poorer outcomes under PPS. Alternatively, if PPS outcome changes are minimal, then the visit reductions may represent a gain in the overall efficiency and cost-effectiveness of home health care. The OASIS data provide uniform, standardized outcome measures to test these possibilities. (The late-IPS period must be used as the baseline, since national OASIS data were not collected earlier.)

METHODS AND DATA

The objective of this analysis was to determine the changes in outcomes between the pre-PPS (1999-2000) and initial PPS (2001) periods, focusing on home health-care episodes of Medicare beneficiaries aged 65 years and over (the main Medicare group to which per-episode PPS payments apply or would apply in the case of pre PPS episodes). Changes in visits per episode also were analyzed, both to check the above-mentioned GAO finding of fewer visits under PPS and to obtain a preliminary indication of possible changes in the system-level efficiency of Medicare home health care provision under PPS by examining visit and outcome changes for the same samples. The analyses compared random samples of Medicare home health care episodes for the two periods. In order to assess the impact of PPS based on measurement yardsticks that are in current use, we employed the outcome measures and risk factors adopted by CMS for reports to agencies and public reporting.