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Health Privacy Rules Become Effective April 14 Final regulations for protecting the privacy of individually identifiable health information under the Health Insurance Portability and Accountability Act (HIPAA) go into effect April 14, with many issues that may affect schools still unclear. Although a new HIPAA-compliance industry has sprung up to provide information about the law, officials and advocates alike concede that many problems will be resolved only in practice, as rulings come down in response to complaints about privacy or security violations. Here are some points to keep in mind as the new law goes into effect:
The Office for Civil Rights in the U. S. Department of Health and Human Services, which has responsibility for enforcing the new HIPAA rules, has not yet published the enforcement procedures it will follow, but the agency has said enforcement will be "complaint-driven," meaning it will act only when a privacy violation is called to its attention. Here are some sources for further information about both HIPAA and FERPA:
An advisory panel of the Institute of Medicine (IOM) told the federal government March 27 that health care workers are declining smallpox vaccination for a number of reasons, including that they don’t feel the nation is at high risk for a smallpox terror attack or believe that if such an attack were to occur vaccinations could be given quickly enough to keep everyone safe. And there are professional concerns; doctors and nurses are aware that, after vaccination and before the scab has fallen off, it is possible for a vaccinated person to pass vaccinia infection on to others, including possibly immune-impaired patients. But the Institute of Medicine made clear in an advisory letter to the Centers for Disease Control and Prevention (CDC) that the biggest obstacle to widespread vaccination of health workers is money. "Recently, there has been a steady increase in evidence that lack of compensation for adverse reactions to the smallpox vaccine is impeding full implementation of the pre-event smallpox vaccination program as originally envisioned. State health departments, hospitals, and individuals have expressed concern over the past two months about the lack of a national compensation program to cover medical expenses for adverse reactions, time lost from work, and (in the worst possible outcomes) permanent disability or death." The CDC is now including a notification on smallpox vaccination consent forms that reads: "Treatment of severe reactions can be very expensive. Workers’ compensation or health insurance may not cover these expenses. There is no federal program to reimburse you for time lost from work, either because of illness due to vaccination or concern about spreading the virus to others." That’s a good move, the IOM said, but the message ought to be in bold type and written in language that would be more easily understood by a "diverse population." The IOM noted that some efforts to remedy the compensation situation are under way or being considered. Secretary of Health and Human Services Tommy Thompson in March asked Congress for legislation that would compensate vaccine-injured health workers at the same rate as injured police and firemen; and more extensive coverage, including compensation for persons infected by vaccinees, has been introduced in Congress. So far, no legislation has been passed, however. There is also another money problem, the IOM notes. The smallpox vaccination program has produced "significant financial worries" among state and local health departments, and in hospitals whose participation in forming health care response teams has been solicited. At the health department level, there has apparently been shifting of "substantial financial and human resources" from essential public health services to smallpox-related activities, and there is concern that hospitals already under financial strain, such as public hospitals, are being overburdened by the costs of smallpox immunization. The IOM committee noted that the Centers for Disease Control and Prevention "has plans for estimating and evaluating the actual costs of the smallpox vaccination program and reasons for regional cost variations, the cost of diverting public health staff, and the opportunity costs of the smallpox vaccination program to other public health programs." That information will be extremely important for determining how the smallpox vaccination program should proceed in the future, the committee said. Editor’s Note: Following the deaths in March of two health care workers who suffered heart attacks after smallpox vaccination, the Centers for Disease Control and Prevention is expected to advise against vaccinating persons with pre-existing heart conditions or diseases related to heart problems, including hypertension and diabetes. Previous restrictions included persons with compromised immune systems or skin ailments such as eczema. The Institute of Medicine is a division of the National Academy of Sciences and is responsible for advising the federal government on health matters. The full text of "Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation," is available online at www.nap.edu/catalog/10657.html?onpi_topnews_032703.
Preventing and Treating Diabetes in Female Adolescents As part of a major initiative aimed at reducing the incidence of diabetes in women of all ages, the Centers for Disease Control and Prevention (CDC) is calling attention to a growing incidence of diabetes in young adolescent females (ages10 to 17). Most adolescents with diabetes have type 1, an autoimmune form of the disease in which the pancreas produces little or no insulin—more than 60,000 girls younger than 20 years, 92 percent of them white, 4 percent black, and 4 percent Hispanic and Asian American-- are believed to have type 1. And although many type 1 teens have been dealing with insulin injections and blood sugar monitoring for many years, the physical and mental changes involved in puberty can make managing and controlling the illness harder, putting both boys and girls at risk of acute complications such as ketoacidosis (acid buildup in the blood) or hypoglycemia (extremely low blood sugar). The CDC also points out that another form of diabetes appears to be increasing in the adolescent population. That’s type 2—once referred to as "adult-onset" because it usually develops after age 40--in which the body loses its ability to use insulin. Complications from type 2 closely resemble those from type 1 diabetes. This form is associated with obesity and physical inactivity, and the increased prevalence of obesity among adolescents may be playing a role in the growth of the illness. What to Do Given the public health implications of a growing number of adolescent diabetics, and the importance of early intervention and treatment in improving their lives, the CDC urges emphasis in the adolescent years on girls already diagnosed or at high risk for developing diabetes (girls with a family history of diabetes, for example). But there are some major challenges to be overcome, including:
Especially for adolescents, caregivers should be aware of the comorbidity of eating disorders and depression with diabetes, and the need to give positive messages about self-care and self-image. And the CDC points out that health care providers need better practice guidelines geared to adolescents in clinical settings, and better risk assessment and diagnostic tools. For schools, the CDC urges dialogue about diabetes among relevant constituencies—boards of education and school nurses, for example, and counselors, administrators, food service providers, and students and their parents. It would be useful, the CDC suggests, to develop a diabetes guide for school personnel. The CDC also offers some encouragement. "Hope for the future is bolstered by recent school policy changes and better models for physical education and health education curriculum. Success with other diseases and health problems that might benefit diabetes prevention (for example, no-smoking campaigns), as well as more effective media messages and campaigns to raise awareness of and promote healthy life styles, and advances in electronic and computer technology as teaching tools all provide opportunities for prevention." The Reproductive Years "The burden of diabetes for women is unique because the disease can affect mothers and their unborn children," the CDC points out. In the years following adolescence—the reproductive years, roughly 18 to 44—women need to be informed about preconception planning to prevent diabetes anomalies in their offspring, and about the risk of developing gestational diabetes, a form of glucose intolerance that is diagnosed in some women during pregnancy. In gestational diabetes, treatment is required to normalize maternal blood glucose levels and to avoid complications for the infant. The Statistics From various surveys conducted by the Department of Health and Human Services, and from census data, the CDC estimates that 11 million people of all ages in the United States have been diagnosed with diabetes, and another 5.9 million persons have the disease but do not know it. Some 151,000 persons under the age of 20 are diabetic. One in every 400-500 children and adolescents has type 1 diabetes. After type 2 diabetes kicks in, usually in mid-life, the numbers go up sharply—it’s estimated that one in every five persons 65 or older has diabetes. In addition to the personal costs of diabetes, in terms of quality of life and the burden of ongoing treatment, the CDC says there is a public health interest in reducing incidence of the disease. The current cost of diabetes to the U.S., taking into account the cost of treating the disease and the dollar value of productive time lost to illness and disability, is estimated to be $132 billion annually. The National Public Health Initiative on Diabetes and Women’s Health is available at www.cdc.gov/diabetes/pubs/english.htm or through the American Diabetes Association at www.diabetes.org.
In Congress Congress is sidestepping controversy in reauthorizing IDEA; a senator tries again to insure all children at birth; and Congress is asked to add health and social services to "Leave No Child Behind." A bill to reauthorize sections of the Individuals with Disabilities Education Act (IDEA) that have expired was introduced in the House of Representatives March 19, after months of negotiation between the House and Senate on whether the reauthorization should also make changes in Part B, the section that provides funds to local education agencies for special education. Part B is permanently authorized, so doesn’t need reauthorization, but Congress usually tinkers with the local education agency provisions when it reauthorizes expiring programs such as services to infants and toddlers and personnel development. What has emerged in the House bill, H.R. 1350, is a simple basic reauthorization of those expired programs, with the bill’s sponsors conceding that they expect amendments to be offered when the bill comes to the floor. Controversy over IDEA centered this year on three questions: should children with disabilities be disciplined differently than regular students when they commit similar infractions; whether the federal government will provide a promised 40 percent of the added cost of educating children with disabilities; and whether children with disabilities should receive public money to attend private schools. A Senate bill is expected shortly, and the House and Senate are due to act on the measures later in this session of Congress. ------------------------------ MediKids Universal Health Insurance Senator Jay Rockefeller (D-WV) conceded that a bill he introduced in the Senate March 11 and companion legislation introduced in the House by Representative Pete Stark (D-CA) are "ambitious" and "idealistic," but he said the bills are "a deliberate effort to try to ignite a national commitment to the goal of insuring all of our children." Rockefeller re-introduced the MediKids Health Insurance Act, which has failed to pass in previous sessions of Congress, arguing that "it is important not to lose sight of the ideal of the United States of America joining every other industrialized nation by ensuring that its citizens have basic health insurance." The bill would automatically enroll every child at birth into a new, comprehensive federal safety net health insurance program, beginning in 2004. Like Medicare, the program would be independently financed and would offer guaranteed, automatic health coverage to all children, as Medicare does for older Americans. A small monthly premium would be collected from parents at tax filing, with discounts to low-income families phasing out at 300 percent of poverty. Families would be exempt from the premium if they could prove they have other health insurance. "By the year 2020, every child in America would be able to grow up with consistent, continuous health insurance coverage," Rockefeller said. The MediKids Health Insurance Act of 2003, S. 588, has been referred to the Senate Committee on Finance. ------------------------------ Leave No Child Behind, Health and Social Services Version In an obvious play on the Bush administration’s education reform law passed two years ago, a bill, H.R. 936, introduced in the House in February incorporates the MediKids Health Insurance proposal and adds a wide range of health and social services aimed at improving children’s health and ability to learn. Included are:
You can follow the progress of these and other bills by logging on to THOMAS, a daily report about Congress on the Internet, at http://thomas.loc.gov.
Worth Noting Study Will Assess St. Johns Wort for Minor Depression The U.S. National Institutes of Health (NIH) has launched a four-year study to determine the safety and effectiveness of St. Johns wort, a common herbal supplement, as a treatment for minor depression. Three hundred persons with minor depression will participate in a 12-week, double-blind clinical trial in which they will receive either the supplement or a medicine often prescribed for depression or a placebo. Researchers will assess changes in their symptoms, functioning, and quality of life. NIH notes that minor depression affects about 7.5 percent of Americans and is a risk factor for major depression, but is often under-diagnosed and under-treated. It can cause sleep difficulties, fatigue or loss of energy, diminished ability to concentrate, and recurrent thoughts of death or suicide. ------------------------------ Growth Hormone Not Recommended for Short Adolescents Treatment for from three to five years with a "lutenizing hormone-releasing hormone" had only minimal effect on the adult height of girls and boys who were shorter than average as adolescents, according to a study reported in the March 6 issue of The New England Journal of Medicine. Adult height (defined as bone age of 16 years in girls and 17 years in boys, when the rate of growth was less than 1.5 centimeters per year) was somewhat greater when adolescents received the treatment, but this was accompanied by substantial decreases in bone mineral density, and the hormonal treatment "cannot be normally recommended to augment height in adolescents with normally timed puberty," researchers concluded. Reprints of the New England Journal of Medicine article are available from yanovski@mail.nih.gov. ------------------------------ The following information appeared during the month of March in the News Alerts section of this website. HHS Proposes Smallpox Vaccination Compensation Plan U.S. Secretary of Health and Human Services Tommy Thompson announced March 6 that he will propose to Congress creation of a compensation program to cover public health and medical response teams members who suffer adverse effects after receiving smallpox vaccinations. The plan would be similar to one already in place for police officers and firefighters and would provide permanent and total disability and death benefits; of up to $262,100, and temporary or partial disability benefits of up to $50,000. HHS would compensate individuals for "reasonable" out-of-pocket expenses for other minor injuries, secondary to any health insurance benefit that might be available to the individual, and HHS would provide compensation to third parties who contract vaccinia from vaccinated individuals. "We are asking these health professionals to perform a vital public duty, so we are proposing to provide them the same sort of benefits that we provide our public safety officers when they are injured on the job," said Dr. Julie Gerberding, director of the Centers for Disease Control and Preventin. JAMA Urges Legislation to Regulate Dietary Supplements Dietary supplements sold over the counter in health food and drug and grocery stores should be evaluated and regulated with at least the same degree of oversight currently given over-the-counter medications, and some supplements should have the same oversight currently given prescription drugs, the editors of the Journal of the American Medical Association said in the March 12, 2003, issue of the Journal. Noting that supplements currently are "subject to less regulation than virtually any other products available for human consumption," the editors called on Congress to reconsider a law passed in 1994 that exempted dietary supplements from regulation by the federal Food and Drug Administration. "Manufacturers of dietary supplements are trying to have it both ways," the Journal editorial said. "They claim their products are powerfully beneficial, on the one hand, but harmless on the other. To claim both makes no sense, and to claim either without trials demonstrating safety and efficacy is deceptive. The public should wonder why dietary supplements have effectively been given a free ride." Dietary supplements include a wide range of products, including vitamins and minerals such as folate and calcium; herbal therapies and botanical agents such as ephedra and gingko biloba; and enzymes or extracts from organ or glands such as some hormone preparations. They are used by millions of people every day and account for billions of dollars in sales annually. The corresponding editor for the Journal editorial can be contacted by e-mail at phil_fontanarosa@ama-assn.org. Study Finds Antibody Reduces Peanut Sensitivity A study of 84 patients 12 to 60 years of age with a history of peanut allergy found that injection into the skin once a month of an antibody called TNX-901 increased the threshold of sensitivity to peanuts from the equivalent of half a peanut to as much as almost nine peanuts, an effect that should protect against most accidental ingestion. The average amount of peanut consumed in an accidental exposure is believed to be no more than one or two peanuts, and in patients with peanut allergy there is currently no adequate treatment or protection against such accidental ingestion, noted researchers who reported the TNX-901 test results in the March 13 issue of The New England Journal of Medicine. "For children and adults with peanut allergy, hypervigilance has become a way of life," said commenter Beverly Merz. "Food label scrutiny is second nature, and sampling dishes of unknown provenance is verboten. Despite such precautions, the average patient with peanut allergy will have a clinical reaction every three to five years owing to inadvertent exposure. As a result, patients are commonly advised to wear Medic Alert bracelets, to carry epinephrine for self-injection, and, in acknowledgement of the risk of a biphasic reaction, to follow each epinephrine injection with an emergency room visit. They live in fear." The threshold-reducing antibody is not yet available to the public and may not be for some time. In September 2002 the federal Food and Drug Administration gave TNX-901 fast-track status, which is intended to speed its review for approval, but further investigation has come to a halt pending resolution of litigation between three companies that were partners in developing the drug. OCR Answers Frequently Asked Questions about HIPAA The Office for Civil Rights in the U.S. Department of Health and Human Services posted on its website March 13 answers to almost two hundred of the questions it has received about privacy provisions of the Health Insurance Portability and Accountability Act (HIPAA). The privacy rules are scheduled to go into effect April 14 for most health care providers. The list of frequently asked questions can be accessed at www.hhs.gov/ocr/hipaa. House Passes Medical Liability Limits A bill passed by the U.S. House of Representatives March 13 would limit the amount of punitive damages that could be recovered in any health care lawsuit to $250,000. The legislation, House bill H.R. 5, also specifies that punitive damages may be awarded only if there is "clear and convincing" evidence that the health care provider "acted with malicious intent to injure" or "deliberately failed to avoid unnecessary injury." Punitive damages, often referred to as compensation for the "pain and suffering" experienced by injured patients, have resulted in multi-million-dollar payments in some highly publicized lawsuits and are blamed by insurers for recent sharp increases in liability insurance premiums being charged to doctors. The House bill places no limits on the amount that an injured patient can recover for actual economic losses suffered as a result of alleged medical mistakes, an amount that is usually far less than the punitive award. The House bill must be passed by the Senate and signed by the President before it becomes law.
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