Pope Calls for Protecting the Environment
During his trip to Australia in July 2008, Pope Benedict XVI made several calls to protect the environment. Environmentalism is part of a deeper spiritual shift away from what the pope called the "folly of consumerism" toward a lifestyle rooted in traditional virtues of self-sacrifice and solidarity. Care for the Earth is part of a continuum of moral truths, including defense of human life and dignity. At the Vatican, Benedict authorized installation of more than 1,000 solar panels atop the Paul VI audience hall to provide electrical current, light, heating and cooling. The Vatican also inked an agreement to become the first "carbon-neutral" state in Europe. (National Catholic Reporter, Aug. 8, 2008)
Health 'Credit Reports' Help Insurers Assess Risk
Health and life insurance companies have a powerful new tool for evaluating whether to cover individual consumers: a health "credit report" drawn from databases containing prescription drug records on more than 200 million Americans. Traditionally, insurance companies have judged an applicant's risk by obtaining records from physicians' offices. The new electronic tools are fast and cheap with the potential to improve health care and reduce costs. However, privacy and consumer advocates fear the trend is taking place largely outside the scrutiny of federal health regulators and lawmakers. Privacy advocates say the practice illustrates how data gathered for one purpose can be used and marketed for another, often without consumers' knowledge. (washingtonpost.com, Aug. 4, 2008)
President's Council Considers Health Reform
The President's Council on Bioethics, established by President Bush in 2001, is slated to issue a report after the November election endorsing some form of social obligation for health reform. Current council chairman, Edmund G. Pellegrino, MD, said the goal is not to recommend any political party's plan but to "lay out in an orderly, systematic and critical way" the ethical implications of various approaches to access to care, medical innovation, and individual freedom and responsibility. Recognized as the father of bioethics, Pellegrino is the founding editor of the Journal of Medicine and Philosophy. However, not all members of the conservative-leaning council agree. "Health system reform is 'a black hole' — once you get in it, you never get out," said Gilbert Meilaender, Ph.D., professor of Christian ethics at Valparaiso University in Indiana. "The more we try to fully elaborate all the principles that might be involved in reforming the health care system, the more hopeless and black hole-ish things get." (American Medical News, Aug, 4, 2008)
More Women Consider Becoming Egg Donors or Surrogates
In Chicago, there has been a rise in the number of women contacting fertility clinics to inquire about becoming egg donors or surrogates. With compensation for egg donation around $7,000 and surrogates earning up to $30,000, some say that the economic downturn has drawn women to see this as a viable option for financial security. Typically summer is a slow time for donation but the number of calls at Alternative Reproductive Resources has been higher than normal. (Chicago Sun-Times, Aug. 1, 2008)
Consumers Cut Back Health Care Spending
As the economy tightened, people are cutting back spending on health care. Studies show that even those who have coverage are postponing doctor's visits, preventive tests, surgeries and prescription refills in order to save money. There is a concern among health policy experts that short-term cutbacks, such as not taking prescription medicines on schedule, could cause more advanced medical problems in the near future which may lead to higher numbers of emergency room visits. As insurance out-of-pocket costs rise and the economy slips, people are reconsidering their need for insurance against their ability to afford high premiums and co-pays. (The Wall Street Journal, Sept. 22, 2008)
Illinois Passes Law Giving Discounts to Uninsured
A new law concerning discounts to uninsured consumers passed the Illinois House and Senate unanimously following an amendatory veto by Gov. Rod Blagojevich. The bill requires that hospitals give uninsured consumers a discount, making their cost equal to actual cost of care plus a 35 percent markup. This discount will apply to families earning up to 600 percent of the federal poverty level for a family of four in urban areas and families earning up to 300 percent of the federal poverty level for a family of four in rural areas. This would include about 775,000 families in Illinois. The legislation also caps the amount of money an uninsured consumer can spend at a hospital at 25 percent of gross income. Discounts will begin at the end of March 2009. (Chicago Tribune, Sept. 24, 2008)
Rape Victim Care Can Be Improved
A recent study shows that care for sexual assault and rape victims in hospitals may not be as complete as necessary. The study looked at Illinois emergency rooms and found that only two-thirds offered crisis counseling, 40 percent offered emergency contraception, two-thirds tested and treated sexually transmitted disease and less than one-third provided precautionary HIV treatment. Treatment of physical injuries, possible disease and psychological and legal counseling are crucial. Emergency departments often refer victims to other facilities for the services they do not provide. This referral is not as effective because many women do not have the ability, financially or emotionally, to go to a second facility. (Los Angeles Times, Oct. 6, 2008)
Education Helps Decision Regarding Testing for Breast Cancer Gene in Children
As tests for breast cancer gene mutation reached 100,000 last year, questions arise concerning the gene testing of minors. Medical experts advise against testing before the age of 25. Interviews by the Associated Press show that many people who have the gene, and their children, believe testing minors is the correct course of action. When the faulty gene is present, treatments to combat the increased risk of cancer include administering anti-estrogen drugs or removing the breast and ovaries. These drastic treatments are not advised in young women. Counseling is suggested before making to decision to be tested. (The Associated Press, Sept. 21, 2008)
Report Grades Palliative Care in Each State
A new state-by-state report on the availability and quality of palliative care was recently released. According to R. Sean Morrison, MD, professor of geriatrics and palliative care at Mount Sinai School of Medicine, palliative medicine focuses on improving quality of life for seriously ill patients by addressing pain and the emotional and practical needs of the patient. Vermont, Montana and New Hampshire received an "A" in the ranking while Alabama, Mississippi and Oklahoma received an "F". Grades were given based on the percentage hospitals with palliative care programs that appropriately met the needs of the seriously ill. About one-half of the nation's hospitals have palliative care programs. To increase the number of palliative care programs, Morrison advocates lobbying for state funding. (Health Day, Oct. 2, 2008)
Uninsured Spend $30 Billion for Medical Expenses
A study by researchers at George Mason University and the Urban Institute shows that uninsured Americans will spend about $30 billion out-of-pocket for medical expenses. The cost to cover all the uninsured will be $208.6 billion this year. The study also reveals that the government pays about 75 percent of the bill that the uninsured cannot pay. (The Wall Street Journal, Aug. 25, 2008)
The following information was provided by the Center for Health Law Studies at Saint Louis University School of Law. Kelly Dineen, assistant dean for academic affairs and instructor of health law, supervised the contributions of health law student Phillip Terrell (JD/MHA anticipated '11).
Study Shows Flaws in Merck's Testing of Vioxx
In a study published in the Aug. 19 Annals of Internal Medicine, researchers concluded that a clinical trial "which tested the drug's safety in the stomach, was primarily crafted by Merck's marketing department to get doctors to prescribe Vioxx." Using about 600 carefully selected family doctors relatively new to clinical research (but who had appreciable influence over other physicians and could boost Vioxx's general prescription rate), Merck granted each a stipend and fees for recruiting a "handful" of patients. Normally in major clinical trials, only a few academic clinicians are selected, with each gathering hundreds of patients to form a viable sample for making a proper determination as to the drug's efficacy and safety. Drug companies have long been suspected in this type of activity, but "there has been no 'smoking gun' proving as such until now." (The Wall Street Journal, August 19, 2008)
Reimbursement Rates Fall for Ten Conditions
Beginning Oct. 1, hospitals no longer receive the higher DRG rate of reimbursement for patients with ten specific conditions that develop during their stay in the hospital. These include: Stage III, IV pressure ulcers; fall or trauma resulting in serious injury; vascular catheter-associated infection; catheter-associated urinary tract infection; foreign object retained after surgery; certain surgical site infections; air embolism; blood incompatibility; certain manifestations of poor blood sugar control; certain deep vein thromboses or pulmonary embolisms. Hospitals will still be reimbursed for the patient's initial diagnosis and associated treatment, but will receive no additional reimbursement if these conditions arise during the patient's course of treatment. Physician reimbursement will remain unaffected. The Centers for Medicare & Medicaid Services project this rule will save approximately $21 million annually, which some note is but a fraction of actual expenses incurred by patients with such complications. However, CMS Acting Administrator Kerry Weems emphasized that the reforms concern more than just spending reductions: "This is really about making hospitals and the health system just a safer place to be." (American Medical News, Aug. 25, 2008).
FDA OKs Noninvasive Test for Organ Rejection in Heart Transplant Patients
XDx Inc.'s AlloMap, "a noninvasive test that assists doctors in managing heart-transplant patients post-surgery for potential organ rejection," has been given marketing clearance by the Food and Drug Administration. Based upon genetic information within a transplant recipient's white blood cells, the test generates a score measuring whether they are likely to reject a transplanted organ. While the test was legally approved for use in 2005 under other federal laws governing clinical labs, XDx chief medical officer James Yee hopes that the FDA's clearance will speed its adoption by heart transplant centers on a larger scale. (The Wall Street Journal/Associated Press, Aug. 28, 2008)
Number of Prescriptions Falls for First Time in Ten Years
A tracking firm's analysis between Jan. and Aug. 2008 revealed a decrease in the number of prescriptions dispensed compared to the same period in 2007. This is the first decline in more than a decade. Faced with tighter budgets, more consumers are cutting the amount of prescription medications they use to trim household expenditures. Some people take less than the recommended dosage to delay refilling the order, or physically split the pills. Others forgo the purchase of medication altogether. The dilemma is especially pronounced for those with compound disorders requiring multiple medication — e.g., diabetes, where insulin cannot be sacrificed, but other medications might be perceived by patients as "less necessary," such as cholesterol-reducing drugs. Medicare Part D beneficiaries also encounter severe difficulties upon reaching the $2,510 "doughnut hole." Many Medicare recipients find it all but impossible to meet the next approximately $3,000 in drug costs until coverage resumes without some form of subsidy. The effects of this reduced consumption may be far-reaching according to some public health experts. Those with chronic disorders will experience a worsening of conditions and will require more costly treatment later. However, others note that "over prescription" has always been an issue within American medicine. Despite drug makers' and doctors' opinions that medications are one of the most crucial components in overall treatment of illness, patients and their families will continue to act upon their own perception of marginal benefits when times are hard. (New York Times, Oct. 22, 2008)
California Supreme Court Prohibits Discrimination in Treatment of Gay and Lesbian Patients
North Coast Women's Care Medical Care Group, Inc., et al. v. San Diego County Superior Court, 189 P.3d 959 (Cal. 2008), decided by the California Supreme Court on Aug.18, 2008, found that doctors with religious objections to gay or lesbian patients must treat them identically to other patients or find another physician who will treat them without objection. The lawsuit was filed by a lesbian couple seeking artificial insemination at a San Diego fertility clinic. "This isn't just a win for me personally and for other lesbian women," said plaintiff Guadalupe Benitez. "Anyone could be the next target if doctors are allowed to pick and choose their patients based on religious views about other groups of people." Citing a 2004 opinion involving Catholic Charities which applied a law requiring company-sponsored health plans to offer contraception for women, the ruling held that doctors may refuse a particular form of treatment to patients in general but may not specifically single out gay or lesbians for refusal. Notably, the doctors could have based their refusal upon a general policy that denies treatment to unmarried couples. The clinic's legal counsel is considering an appeal of the decision to the United States Supreme Court. (San Francisco Chronicle, Aug. 19, 2008)
Provena Challenges Claims About Charity Care
Following a state appellate court ruling which could jeopardize Provena Covenant Medical Center's tax-exempt status based on community benefit-directed care, the hospital's attorneys announced plans to seek certification and review of the matter before the Illinois Supreme Court. At a time when the charitable practices of not-for-profit tax-exempt health care centers are under scrutiny on a national level, the outcome of this case — if indeed it is accepted by the high court — could set the stage for similar litigation. Provena denies it has administered insufficient care to the poor and uninsured. A Supreme Court decision will frame the methodologies by which not-for-profit centers handle bills of patients who cannot afford to pay for services. (Chicago Tribune, Sept. 10, 2008)
Many Health Care Staff Forgo Flu Shots
Despite recommendations by the Centers for Disease Control that all health care staff receive annual flu vaccine injections, statistics show that 60 percent of health care workers either neglect or refuse to have the shots for fear of contracting the illness through the dormant virus in the vaccine. William Schaffner, president-elect of the National Foundation for Infectious Diseases and chairman of the Department of Preventive Medicine at Vanderbilt University, considers this widespread trend troubling. According to Schaffner, getting a flu shot should be standard procedure for hospital workers, much as washing one's hands. The injection also helps prevent spread of the disease to patients. CDC recommendations stipulate that all health care facilities offer free flu vaccinations to employees annually. Vaccination patterns and policies at health care centers across the country vary, with some mandating that all employees with direct patient contact get an injection or present a physician exemption (for those with allergic reactions). Other policies are broader, with all personnel including pharmaceutical representatives and volunteers, required to be vaccinated unless they apply for an exception on a religious or medical basis. Joyce Lammert, MD at Seattle's Virginia Mason Medical Center said her facility lost seven employees when such a policy was enacted four years ago, but "[n]ow, the culture has really changed to thinking about patients. This is what we do to protect our patients." (USA Today/Associated Press, Oct. 16, 2008)
Medicare Reimbursement Gap May Affect Participation in Cancer Clinical Trials
Older Americans wishing to take part in clinical trials of cancer treatments may be discouraged. Medicare rules prevent Medicare health maintenance organizations from covering the difference between the cost of care and actual Medicare reimbursement when the patient is enrolled in a clinical trial. A report from researchers at the University of Pittsburgh Cancer Center at the meeting of the American Society for Therapeutic Radiology and Oncology illustrated the gap in coverage. Chyongchiou Lin, Ph.D., said, "Medicare HMOs cover the 20 percent difference between Medicare reimbursement and the cost of care," but, "if patients take part in a so-called 'qualifying' clinical trial," the 20 percent compensation fades away. As a result those enrolled in clinical trials and Medicare HMOs may face as much as a $3,000 increase in out-of-pocket costs. Given the rising number of Medicare HMO participants, this could become a more prevalent problem. Study authors indicated the coverage discrepancy could influence clinical trial results, as samples will be skewed toward those who can afford to participate. (MedPage Today, Sept. 23, 2008)
Government Uncovers Fraudulent Claims by Makers of Medical Supplies and Drugs
After reviewing millions of claims submitted by sellers of wheelchairs, drugs, and other medical supplies, the Senate Permanent Subcommittee on Investigations determined that many were suspect or potentially fraudulent for lack of proper diagnosis codes which could be used to match the claim with a patient's related medical condition. The subcommittee urged the Centers for Medicare and Medicaid Services to craft better policies that would either reject claims outright if they lack proper diagnosis codes and to cross-reference present codes with patients' actual diagnoses for viable usage of the goods whose reimbursement is being sought. CMS claims it already has certain safeguards in place, including "red flag warnings" which draw attention to claims for specifically unusual or pricey items. (USA Today/Associated Press, September 24, 2008)
FDA Finds Two Widely Used Treatments Pose Risks to Patients
A number of companies selling a Food and Drug Administration-unapproved eyewash and a papaya-based skin cream have recently come under the agency's scrutiny. The eyewash (balanced salt solution, used to keep the eyes moist during surgery) is marketed by two companies with FDA approval, while similar offerings from three other firms have no such safety and effectiveness backing by the FDA. Papain, the skin cream used for treating skin ulcers from diabetes and other causes, has no FDA approval for marketing whatsoever; nor have any products containing Papain obtained FDA approval yet. The FDA has received more than 300 reports of serious reactions to the eyewash, and about 40 reports on the papaya creams. Some stated that the ointment offered no marked benefit to patients, and others described having suffered life-threatening allergic reactions. According to the FDA, "Companies must stop making the unapproved drugs ... by November 24 and stop shipping them by January 21." (Bloomberg/Associated Press, September 24, 2008)
Blood Thinner Errors In Hospitals Could Lead to JCAHO Accreditation Revocation
The Joint Commission on Accreditation of Healthcare Organizations informed hospitals on September 24 that "strict measures" should be adopted to prevent medical errors in the administration of blood thinners including heparin. Such mistakes have been documented 60,000 times and have caused numerous deaths.
Preventive measures could include barcoding medications, or utilizing computerized drug orders. Moreover, adult-strength heparin should be stored nowhere near units designated for children. Patients on such drugs should be closely monitored. Mark Chassin, Joint Commission President, said that commission investigators would be making unannounced visits to ensure hospitals are adopting tighter measures to stifle blood thinner mistakes. Hospitals, which do not demonstrate preventive measures, could have JCAHO accreditation revoked. (Associated Press, September 24, 2008)
Off-label Use of Medtronic's Infuse During Surgery Linked to Serious Complications
The Food and Drug Administration issued warnings to surgeons earlier this year concerning risks associated with Medtronic Inc.'s Infuse Bone Graft, a biologically engineered liquid. Life-threatening complications, mainly swelling of the neck and throat tissue leading to compression of the airway and other structures in the neck, have mostly occurred when the liquid was used "off-label" during surgeries on the cervical portion of the spine. The FDA has tracked cases over the past four years, with 38 reports of the above side effects in that period. Positive experiences with such off-label usage of Infuse have been documented in medical journals, websites and at educational meetings by doctors in business relationships with Medtronic. Litigation involving allegations that Medtronic financially induced their products' use by physicians has already led to multi-million dollar settlements in two cases. A remaining lawsuit claims Medtronic "illegally marketed Infuse for off-label purposes through doctors who were paid inflated consulted fees and bogus royalty payments." Producers according to FDA regulations may not market drugs' possible off-label uses. (Wall Street Journal, September 4, 2008)
Stryker Corp. Payouts to Physicians Under DOJ Investigation
$40 million in payments made by Stryker Corp. (the third-largest manufacturer of hip and knee replacement components) to almost 200 doctors during 2007 have caught the attention of the Department of Justice, which is now investigating whether the firm illegally paid surgeons to entice usage of their products. A government lawsuit filed Aug. 26 places at issue the nature of the payments made through "consulting agreements and other financial relationships," and whether the anti-kickback statute was violated in the process. Under the statute both direct and indirect remuneration in any form to health care providers by suppliers is strictly prohibited. Included among court documents is a note that Stryker is being investigated for violation of the U.S. False Claims Act for possibly fraudulent Medicare and Medicaid reimbursement claims. (Bloomberg, September 4, 2008
Survey: One-Half of U.S. Doctors Use Drugs for Placebo Effect
Placebos now come in more "flavors" than sugar pills, at least according to a report published by the British Medical Journal, which found through a national survey of United States physicians that 46 to 58 percent admitted using placebos regularly, with only five percent explicitly telling their patients that they were doing so. Usually associated with inert treatments such as sugar or salt pills, or saline injections, the report notes that placebos in reality are any treatment whose physiological efficacy remains unproven. Thus, doctors now admit to using more "active" placebos including vitamins, over-the-counter painkillers, sedatives and antibiotics.
The American Medical Association takes a disapproving stance to placebo use without patient knowledge. Other experts and bioethicists find their use improper due to the deceit involved. At the same time, others find such "benevolent deception" acceptable, as there is the off chance the treatment might actually work (scientifically or not). A number of studies have found that patients respond positively to placebos upwards of 30 percent of the time. Two-thirds of doctors report they would inform patients that a treatment being recommended to them is not typically used for their condition. Some physicians stand firmly against giving a patient any medication without informing them of their doubts as to its efficacy; these same physicians have used placebos before, however, in cooperation with patients who firmly believe the treatment will be successful. Garlic, for example, is typically thought to have positive effects against cholesterol. "I don't believe the garlic will physically help the patient, but it may motivate them to comply with the rest of my recommended regimen, and that's a good thing," said Dr. Matthew Johnson of Park Forest. (Chicago Tribune, October 23, 2008)
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