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Scientists indicate HIPAA privacy rule has had negative ...
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Scientists indicate HIPAA privacy rule has had negative ...

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  • 1. November 14, 2007 Scientists indicate HIPAA privacy rule has had negative influence on health research About two-thirds of clinical scientists surveyed report that the HIPAA Privacy Rule for patients has had a negative influence on the conduct of health research, often adding uncertainty, cost and delays, according to a study in the November 14 issue of JAMA. The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule was intended to strike a balance between protecting the privacy of individually identifiable health information and preserving the legitimate use and disclosure of this information for important social goals, according to background information in the article. However, many researchers have expressed concerns that since implementation in April 2003, the Privacy Rule has adversely affected the progress of biomedical research. Roberta B. Ness, M.D., M.P.H., of the University of Pittsburgh, PA, and colleagues with the Joint Policy Committee, Societies of Epidemiology, conducted a survey to determine the degree, type, and variability of influence from the HIPAA Privacy Rule experienced by epidemiologists conducting research on U.S. human subjects (participants). Thirteen societies of epidemiology distributed a national Web- based survey and 1,527 eligible professionals anonymously answered questions. The researchers found that regarding general perceptions of the HIPAA Privacy Rule, a majority of respondents reported that the degree to which the rule made research easier was low, at 1 to 2 (84.1 percent) on a 5-point scale (with 1 = none, 5 = a great deal), and that the degree to which the rule made research more difficult was high (67.8 percent), at 4 to 5 on the scale. Almost 40 percent indicated that the Privacy Rule increased research costs in the high range of 4 to 5, and half indicated that the additional time added by the rule to complete research projects was high. Almost half indicated that the Privacy Rule had affected research related to public health surveillance at the high level. The perceived benefit of the rule with respect to strengthening public trust was reported as high by only 10.5 percent of respondents, and only 25.9 percent believed that the rule had enhanced participant confidentiality/privacy in the high range of 4 to 5. Respondents also indicated that the proportion of institutional review board applications in which the Privacy Rule had a negative influence on human subjects (participants) protection was significantly greater than the proportion in which it had a positive influence. Probe finds 30,000 Medicaid providers cheating on taxes More than 30,000 Medicaid providers in seven states failed to pay more than $1 billion in federal taxes last year, but the government can’t trim healthcare payments in order to collect, according to a report to be released today. In its fifth report to a Senate panel investigating tax cheats that do business with the government, the Government Accountability Office (GAO) says that about 5% of Medicaid providers in the seven states cheat on their taxes, particularly payroll taxes collected from employees. Some of the more flagrant violators had multimillion dollar homes, along with fancy cars and boats, the report says. Others were guilty of patient abuse or other healthcare violations. None of the doctors or providers was identified in the report. “These doctors are supposed to be serving the most needy. Instead, they are cheating taxpayers in order to line their pockets,” said Sen. Norm Coleman, R-MN, who initiated the tax-delinquency investigations four years ago. The latest report follows others that detailed how tens of thousands of defense and other government contractors and Medicare providers also cheated on their taxes. All told, the reports show, nearly $10 billion went uncollected. Since the inquiry began in 2003, the government has reduced payments in order to recover about $122 million in back taxes. The most has come from defense contractors: $78 million, including $31 million last year. The original goal of the Senate Permanent Subcommittee on Investigations was to go after “waste, fraud and abuse.” As tax cheats were forced to pay by having their payments reduced, it also became a way for the Internal Revenue Service to close a tiny portion of the “tax gap,” an estimated $400 billion or more that goes uncollected each year. “You have a unique opportunity with somebody you’re paying to say, ‘Wait a minute, does he owe me anything?’” said Mark Greenblatt, the Senate panel’s Republican staff director. With Medicaid, however, it won’t be easy to collect. The federal government pays about 57% of the $324 billion cost for the federal- state healthcare program, but it is run through the states. “The federal tax levy program is designed to make sure that folks who get paid with taxpayer dollars get a portion of those dollars withheld if they have outstanding tax debt,” said Sen. Carl Levin, D-MI, the panel’s chairman. “We need to figure out how to … stop those Medicaid medical providers from putting taxpayer dollars into one pocket while stiffing Uncle Sam by dodging their taxes.” The GAO conducted in-depth probes of 25 tax cheats and found “abusive and related criminal activity” in every case. Among those detailed in the report, which studied California, Colorado, Florida, Maryland, New York, Pennsylvania and Texas: The owner of a chain of nursing homes who owed more than $14 million in taxes had a $2 million home decorated with crystal chandeliers, porcelain china and Oriental rugs. The owners of a hospital who owed $5 million in payroll taxes purchased a vacation home worth about $1 million. A medical-clinic owner who owed more than $1 million had a $4 million house, luxury vehicles and a pleasure boat. (USA Today)
  • 2. Four transplant recipients contract H.I.V. Four transplant recipients in Chicago have contracted H.I.V. from an organ donor, the first known cases in more than a decade in which the virus was spread by organ transplants. The organs also gave all four patients hepatitis C, in what health officials said was the first reported instance in which the two viruses were spread simultaneously by a transplant. Though exceedingly rare, this type of transmission highlights a known weakness in the system for checking organ donors for infection: the most commonly used tests can fail to detect viral diseases if they are performed too early in the course of the infection. Officials say the events in Chicago may lead to widespread changes in testing methods. “There are important policy implications,” said Dr. Matthew Kuehnert, director of the Office of Blood, Organ and Other Tissue Safety at the federal Centers for Disease Control and Prevention, which is investigating the case. “Clearly, the organ transplant community is going to think about the issues raised by this, and we look forward to being involved in those discussions.” The cases were first reported yesterday by The Chicago Tribune. Two patients were infected at the University of Chicago Medical Center, and one each at Rush University Medical Center and Northwestern Memorial Hospital. The transplants were coordinated by an organization called the Gift of Hope of Elmhurst, IL. Officials would not say what organs were transplanted, but a transplant expert not connected with the case said they were most likely the kidneys, liver and either the heart or lungs. Only four organs, and no other tissue, were taken from the donor. The University of Chicago said that the operations took place in January, and that the donor was an adult who died in an Illinois hospital “three days after traumatic injury.” Neither the donor’s age nor sex were disclosed. The other hospitals declined to discuss what happened, except to confirm that each had an infected patient. The situation came to light earlier this month when one of the recipients, who was being evaluated for a retransplant, tested positive for H.I.V. and hepatitis C. At that point, blood preserved from the donor was given a highly sensitive test for viruses, and the infection was found. Dr. J. Michael Millis, the chief of transplantation at the University of Chicago, said the diseases were treatable. Initially, the donor had tested negative for H.I.V. and hepatitis C, apparently because the infection was too recent to be detected by commonly used blood tests. Those tests do not find the virus itself, but instead look for the body’s reaction to the infection, the antibodies produced by the immune system. But the body takes time to react, and if the test is done too soon, within 22 days of H.I.V. infection or 82 days for hepatitis C, antibodies may not yet be detectable. Doctors say that is what probably occurred in Chicago. It has always been known that this kind of transmission was theoretically possible, but it was considered highly unlikely. Since 1994 nearly 300,000 transplants from cadavers have occurred without any reported cases of H.I.V. transmission. Another more sensitive type of test can pick up viral infections earlier, but was not used. That test looks for evidence of the virus itself, and can reduce the “window,” the early period in which the test does not work, to 12 days for H.I.V. and 25 days for hepatitis C. That test, the nucleic acid amplification test, or Naat, is not widely available, and doctors said it was more difficult and time-consuming than other tests, and there is usually no time to spare with transplants because organs deteriorate quickly when the donor dies. Another concern is that the test is more likely than others to give false- positive results, and lead to the needless destruction of healthy organs, a scarce resource. According to the University of Chicago, the organ donor in Illinois was known to be “high risk,” based on a risk factor revealed by a close friend who provided “a health and social history.” The exact nature of the risk was not disclosed. Dr. Millis said that he did not know whether the patients there had been informed of the donor’s status. About 9 percent of organ donors qualify as high-risk based on behaviors like prostitution or drug use with needle-sharing.(The New York Times) To read the original article see http://www.nytimes.com/2007/11/14/health/healthspecial/14hiv.html? _r=1&th&emc=th&oref=slogin HHS unveils plan to strengthen, update food safety efforts HHS Secretary Mike Leavitt announced a comprehensive initiative by the Food and Drug Administration designed to bolster efforts to better protect the nation’s food supply. The Food Protection Plan proposes the use of science and a risk-based approach to ensure the safety of domestic and imported foods eaten by American consumers. The Food Protection Plan, which focuses on both domestic and imported food, complements the Import Safety Action Plan delivered by Secretary Leavitt to the President earlier today that recommends how the U.S. can improve the safety of all imported products. This year, $2 trillion worth of goods will be imported into the U.S., and experts predict that amount will triple by 2015. The Import Safety Action Plan lays out a road map with short- and long-term recommendations to enhance product safety at every step of the import life cycle. Taken together, the two plans will improve efforts by the public and private sector to enhance the safety of a wide array of products used by American consumers. Advances in food production technology, rapid methods of food distribution, and globalization have transformed supermarket shelves and restaurant menus, broadened the tastes of consumers, and challenged the existing food protection framework. The plan is premised on preventing harm before it can occur, intervening at key points in the food production system, and responding immediately when problems are identified. Within these three overarching areas of protection, the plan contains a number of action steps as well as a set of legislative proposals. Taken together, these efforts will provide a food protection framework that ensures that the U.S. food supply remains safe. To strengthen its efforts to prevent contamination, FDA plans to strengthen support of food industry efforts to build safety into products manufactured either domestically or imported. The FDA will work with industry, state, local, and foreign governments to identify vulnerabilities and will look to industry to mitigate those vulnerabilities, using effective methods such as preventive controls. The plan’s intervention element emphasizes focusing inspections and sampling based on risk at the manufacturer and processor level, for both domestic and imported products, that will help verify the preventive controls. This approach is complemented by targeted, risk-based
  • 3. inspections at the points where foreign food products enter the United States, including ports. The plan calls for enhancing FDA’s information systems related to both domestic and imported foods to better respond to food safety threats and communicate during an emergency. The Food Protection Plan’s three core elements, prevention, intervention, and response, incorporate four cross-cutting principles for comprehensive food protection along the entire production chain: Focus on risks over a product’s life cycle from production to consumption; Target resources to achieve greatest risk reduction; Use interventions that address both food safety (unintentional contamination) and food defense (deliberate contamination); and Use science and employ modern technology, including enhanced information technology systems. The Food Protection Plan is available at http://www.fda.gov/oc/initiatives/advance/food/plan.html. Number of cases of most vaccine-preventable diseases in US at all-time low A comparison of illness and death rates for 13 vaccine-preventable diseases in the U.S., before and after use of the vaccine, indicates there have been significant decreases in the number of cases, hospitalizations and deaths for each of the diseases examined, according to a study in the November 14 issue of JAMA. In the United States, vaccination programs have made a major contribution to the elimination of many vaccine-preventable diseases and significantly reduced the incidence of others. “Vaccine-preventable diseases have societal and economic costs in addition to the morbidity and premature deaths resulting from these diseases—the costs include missed time from school and work, physician office visits, and hospitalizations,” the authors write. National recommendations provide guidance for use of vaccines to prevent or eliminate 17 vaccine-preventable diseases. Sandra W. Roush, M.T., M.P.H., of the Centers for Disease Control and Prevention, Atlanta, and colleagues with the Vaccine-Preventable Disease Table Working Group, examined the illness and death rates before and after widespread implementation of national vaccine recommendations (in place before 2005) for 13 vaccine-preventable diseases. The diseases were diphtheria, pertussis, tetanus, poliomyelitis, measles, mumps, rubella (including congenital rubella syndrome), invasive Haemophilus influenzae type b (Hib), acute hepatitis B, hepatitis A, varicella (chickenpox), Streptococcus pneumoniae and smallpox. For eight diseases for which a vaccine was licensed or recommended prior to 1980, the comparison of the period before national vaccination recommendations vs. the 2006 number of reported cases shows greater than 99 percent declines in the number of cases for diphtheria (100 percent), measles (99.9 percent), paralytic poliomyelitis (100 percent), rubella (99.9 percent), congenital rubella syndrome (99.3 percent), and smallpox (100 percent). Smallpox has been eradicated worldwide, and endemic transmission of poliovirus, measles virus, and rubella virus has been eliminated in the United States. There were no reported deaths due to diphtheria, measles, mumps, paralytic poliomyelitis, or rubella; deaths due to congenital rubella syndrome are not reported. The decline in cases of mumps was 95.9 percent, of tetanus 92.9 percent, and of pertussis 92.2 percent. The decline in tetanus deaths was 99.2 percent and in pertussis deaths 99.3 percent. For five diseases for which a vaccine was licensed or recommended after 1980 but before 2005, cases of invasive Hib disease declined 99.8 percent or greater and deaths declined 99.5 percent or greater; for hepatitis A, reduction in cases was 87.0 percent, deaths 86.9 percent; a decrease of 80.1 percent in cases and 80.2 percent in deaths for acute hepatitis B; a decline of 34.1 percent in cases and 25.4 percent in deaths for invasive pneumococcal disease; and a reduction of 85.0 percent in cases and 81.9 percent in deaths for varicella. Hospitalizations declined by 87.0 percent for hepatitis A, 80.1 percent for acute hepatitis B, and 88.0 percent for varicella. “The number of cases of most vaccine-preventable diseases is at an all-time low; hospitalizations and deaths from vaccine-preventable diseases have also shown striking decreases. These achievements are largely due to reaching and maintaining high vaccine coverage levels from infancy throughout childhood by successful implementation of the infant and childhood immunization program,” the authors write. “Continued efforts to improve the efficacy and safety of vaccines and vaccine coverage among all age groups will provide overall public health benefit. The challenges in vaccine development, vaccine financing, surveillance, assessment, and vaccine delivery are opportunities for the future,” the authors conclude. Premier healthcare alliance lays out principles for improved quality and greater transparency in healthcare In policy principle papers released today, the Premier healthcare alliance called for greater transparency in healthcare and improved quality of care through comparative effectiveness research and prevention of healthcare-associated infections (HAIs). In three separate papers developed by Premier’s board of directors and committees comprised of CEOs from alliance member hospitals, Premier offers specific recommendations on: Quality and pricing transparency in healthcare http://www.premierinc.com/about/advocacy/issues/07/other/Policy_Principles_Qualityand_Pricing_transparency.pdf Preventing healthcare-associated infections http://www.premierinc.com/about/advocacy/issues/07/other/Policy_Principles_Healthcare_Associated_Infections.pdf Support for comparative effectiveness research http://www.premierinc.com/about/advocacy/issues/07/other/Policy_Principles_Comparative_effectiveness.pdf To increase the transparency of healthcare, information on both quality and cost for all providers should be made publicly available and be
  • 4. designed specifically to enable patients to make informed decisions, the Premier principles state. Supporting steps which many Premier hospitals at the forefront of infection control are already taking, Premier calls for transparent, evidenced-based strategies to reduce identifiable, measurable and preventable HAIs. “Premier supports public reporting that is intended to provide a basis for the collection of HAI information that will be useful to improve patient safety and healthcare outcomes,” the principles suggest. Premier further states that any legislative or regulatory effort to require public reporting of HAIs should recognize the need for improved data resources and infection surveillance, education for healthcare teams and the costs of infection control efforts to healthcare providers. Helping hospitals in their commitment to providing treatments to their patients with the safest and most effective medical devices and medicines will require more scientific, evidence-based data on which to make the best clinical decisions, Premier states in its principles. To address this information gap, Premier supports the establishment of a federally sanctioned organization that is independent and its processes transparent in identifying priority areas of comparative clinical research. For more information, see http://www.premierinc.com/ Amerinet announces 2007 Supplier Performance Award Winners Amerinet, a national group purchasing organization for the healthcare industry, announced the winners of its 2007 Supplier Performance Awards. Each year, Amerinet recognizes its suppliers for delivering quality products and services to health care providers across the nation. “Amerinet continually strives to work with our suppliers to enhance savings opportunities for our members,” said Allen Dunehew, Amerinet’s chief contracting officer. “Through the Amerinet supplier awards, we recognize our suppliers’ efforts for delivering high-performance supply chain and workforce solutions to our members.” This year’s Supplier Performance award winners are: ASD Healthcare – Distributor over $25 Million in Amerinet Sales volume. Healthcare organizations nationwide rely on ASD Healthcare for albumin, immune globulins, hyper-immune globulins, antihemophilic factors, influenza vaccine and other specialty pharmaceutical products. See https://www.asdhealthcare.com/. Graybar – Distributor under $25 Million Amerinet Sales Volume. Graybar, a Fortune 500 company, specializes in supply chain management services and is a leading North American distributor of high-quality components, equipment and materials for the electrical and telecommunications industries. See http://www.graybar.com/. Philips Medical Systems – Manufacturer over $25 Million in Amerinet Sales Volume. Philips portfolio of medical systems includes best-in- class technologies in X-ray, ultrasound, magnetic resonance, computed tomography, nuclear medicine, PET, radiation oncology systems, patient monitoring, information management and resuscitation products. See http://www.medical.philips.com/index.html. Kellogg’s Food Away from Home – Manufacturer under $25 Million in Amerinet Sales Volume. Kellogg’s Food Away From Home provides business-building solutions for health care foodservice or vending operations. See http://www.fafh.com/ MedAssets Supply Chain Systems signs contract with IMS for instrument services IMS, the InstrumentReady company, has announced that MedAssets Supply Chain Systems has awarded IMS a multi-year contract to provide surgical instrument repair, minimally invasive surgical support and central sterile process improvement to MedAssets’ customers nationwide. MedAssets Supply Chain Systems is one of the largest group purchasing organizations in the U.S. and builds customized solutions encompassing procurement of common medical supplies, pharmaceuticals, physician preference supplies, food/nutrition items, and capital equipment. “The value of proactively managing instrument repair costs was a key component in the selection of IMS,” said Karlee Koenig, Director, Clinical Supply Chain, MedAssets Supply Chain Systems. “Our goal is to help healthcare providers improve their margins, and IMS brings a refreshing approach to cost containment by being proactive and helping hospitals eliminate the causes of instrument repair.” To learn more see http://www.imsready.com/ or http://www.medassets.com/EnterpriseSolutions/home.aspx

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