Healthcare News

U.S. District Judge Christina Snyder has amended her order reversing a 10% reduction in Medi-Cal reimbursement rates for health care providers to require repayment only for services performed on or after Aug. 18, which effectively “spares the state from tens of millions of dollars” in reimbursements, the San Francisco Chronicle reports (Egelko, San Francisco Chronicle, 9/4).

In February, California lawmakers and Gov. Arnold Schwarzenegger (R) approved the reduction as part of an effort to address the estimated $15.2 billion state budget deficit. The reduction took effect on July 1. Snyder on Aug. 18 issued an injunction requiring California to reverse the reduction. According to Snyder, California lawmakers did not consider the effect that the reduction would have on quality and access to care for beneficiaries, as required by federal law (Kaiser Daily Health Policy Report, 8/27). State officials had estimated that the original injunction would cost the state $500 million annually. Under the amended ruling, the state would save an estimated $65 million and the loss to health care providers would total $130 million, according to the Chronicle.

Lynn Carman, a lawyer for pharmacists, patients and community organizations that challenged the cuts, said he would ask the appeals court to enforce Snyder’s original ruling that would have required reimbursement of services from July 1 onward. Norman Williams, spokesperson for the state Department of Health Care Services, said the department has told its workers and contractors to “fully comply with the order” unless Snyder agrees to suspend the injunction during the state’s appeal of the decision (San Francisco Chronicle, 9/4).

This article is republished with kind permission from our friends at The Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery of in-depth coverage of health policy developments, debates and discussions. The Kaiser Daily Health Policy Report is published for Kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. Copyright 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Healthcare News

Many U.S. residents with illnesses who must travel frequently or long distances for treatment are forgoing, cutting back or delaying appointments and support groups or applying for grants to offset high gasoline prices, USA Today reports.

According to USA Today, people who travel for treatment multiple times per week, such as cancer patients undergoing chemotherapy or patients in need of dialysis, are the “hardest hit.” The average price of one gallon of gasoline in the U.S. on Wednesday was $3.68, about 90 cents higher than the price one year ago.

According to USA Today, Paratransit, a Sacramento, Calif.-based ride service for elderly and disabled patients that offers $4 rides to appointments, experienced an 11% increase over the number of projected ride requests. Mary Steinert, Paratransit’s deputy executive director, said, “People are going to depend on us more because their friends and family can’t afford to transport them in their cars.”

The American Kidney Fund, which offers dialysis patients transportation grants up to a maximum of $175 twice annually, has distributed 12,842 grants totaling $2.2 million through July, 31% more than in the same period in 2007. CancerCare, a patient support organization, in the last fiscal year has spent $4.1 million in patient assistance, $500,000 more than the previous fiscal year; 90% of the grants were for transportation. In addition, CancerCare Executive Director Diane Blum said some cancer patients are looking for physicians or treatment centers closer to home.

USA Today also profiled patients with psoriasis and ALS, and the effect higher gas prices has had on their treatments (Bazar, USA Today, 9/4).

This article is republished with kind permission from our friends at The Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery of in-depth coverage of health policy developments, debates and discussions. The Kaiser Daily Health Policy Report is published for Kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. Copyright 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Disease/Infection News

Ghana will receive $1.7 million from UNICEF to increase the distribution of insecticide-treated nets among children younger than age five in the country’s campaign against malaria, UNICEF Executive Director Ann Veneman said Wednesday at the Third High Level Forum on Aid Effectiveness in Accra, Ghana, GNA/My Joy Online reports.

Veneman expressed concern over statistics indicating that the number of children younger than age five in Ghana who sleep under ITNs is less than the number of ITNs distributed in the country. She added that ITNs prevent approximately 80% of malaria cases in Africa by protecting the user from insect bites and killing mosquitoes. “Thousands of children under the age of five die from malaria each year in Ghana,” Veneman said, adding that “it is unacceptable that this preventable disease still claims the lives of so many” (GNA/My Joy Online, 9/3).

During the forum, which took place from Sept. 2 to Sept. 4, government and civil society delegates discussed ways to increase effective use of development aid and create partnerships between donors and recipients (Mannak, Inter Press Service, 9/2). Veneman noted that with “less than eight years left” to achieve the United Nations Millennium Development Goals — which include reversing the spread of malaria by 2015 — the “international community must work together to achieve sustainable results on the ground” (UNICEF release, 9/3).

This article is republished with kind permission from our friends at The Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery of in-depth coverage of health policy developments, debates and discussions. The Kaiser Daily Health Policy Report is published for Kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. Copyright 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Healthcare News

The Wall Street Journal on Thursday examined the record of Republican vice presidential nominee Alaska Gov. Sarah Palin on health care and other issues as mayor of Wasilla, Alaska, and as governor of the state.

As governor, “Palin didn’t make health care one of her top priorities, but where she did take a strong stand on health, it was for the free market,” with her “overall approach” similar to the position of presumptive Republican presidential nominee Sen. John McCain (Ariz.) — “loosen government regulations to allow for greater competition, along with more information for patients to make good choices,” according to the Journal. Palin in January said, “Health care must be market- and business-driven, rather than restricted by government.”

According to the Journal, expansion of health insurance “was less of an issue for Gov. Palin, much as it is less significant for Sen. McCain,” as she “was reluctant to support a significant expansion” of Denali KidCare, the state version of SCHIP. Palin increased the eligibility requirement for Denali KidCare to children in families with annual incomes up to 175% of the federal poverty level — “stingy compared with other states,” the Journal reports.

Palin does not support embryonic stem cell research, which McCain has said he supports (Carlton et al., Wall Street Journal, 9/4).

Opinion Piece

A report released recently by the U.S. Census Bureau offers the latest indication that “rising health spending is eroding take-home pay” and that “immigrants are boosting both poverty and the lack of health insurance,” but neither McCain nor Democratic presidential nominee Sen. Barack Obama (Ill.) “seriously [address] these problems,” Washington Post columnist Robert Samuelson writes. “Unless we control health spending and immigration, the economic report card will continue to disappoint,” according to Samuelson.

“Low-skilled immigrants, concentrated among Hispanics, outnumber the high-skilled,” and they “drag down median incomes and raise poverty and the number of uninsured” because they “can’t get well-paid jobs with insurance,” Samuelson writes. He adds, “Immigration’s effects on poverty and health insurance coverage are greater,” as “immigrants represented 55% of the increase of the uninsured from 1994 to 2006.”

Samuelson writes, “If health care spending remains uncontrolled, Americans will see more of their compensation diverted from take-home pay into insurance that mainly benefits (as insurance should) a small proportion of very sick people,” and “if the immigration of low-skilled workers continues unabated — whether they’re legal or illegal — the ranks of the poor will swell, as will the uninsured or the costs of providing government insurance” (Samuelson, Washington Post, 9/3).

This article is republished with kind permission from our friends at The Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery of in-depth coverage of health policy developments, debates and discussions. The Kaiser Daily Health Policy Report is published for Kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. Copyright 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Child Health News

CMS on Wednesday announced that it has updated its Hospital Compare Web site to include information on 30-day mortality rates for the pneumonia and inpatient asthma treatment for children, CQ HealthBeat reports.

In a statement to the press, the agency said it marks the first time that the Web site has offered information on children’s health care.

Hospital Compare — which has been viewed more than 20 million times this year — now offers data on 26 process of care measures, three outcome of care measures, two children’s asthma care measures and 10 patient experience measures, CQ HealthBeat reports. According to CMS, visitors to the site are able to determine if individual hospitals’ mortality rates for pneumonia, heart attacks and heart failures are “Better than,” “No different,” or “Worse than” the national mortality rates for those conditions.

The Web site since last summer also has offered 30-day mortality rates for heart failure and heart attacks. The agency reported that the national 30-day heart attack mortality rate since that time has dropped from 16.3% to 16.1%, while the discrepancy in heart attack mortality rates between individual hospitals also has reduced. The Web site’s rates are risk-adjusted based on the condition of patients at the time of admission and offers consumers the interval estimate and the number of eligible cases for each hospital, CMS said. The agency urged consumers not to “shop” for a hospital based on a single process or outcome measure.

In a statement, HHS Secretary Mike Leavitt said, “Expanding the scope of measures is making Hospital Compare a more valuable tool” (Straus, CQ HealthBeat, 9/3).

This article is republished with kind permission from our friends at The Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery of in-depth coverage of health policy developments, debates and discussions. The Kaiser Daily Health Policy Report is published for Kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. Copyright 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Disease/Infection News

Thousands of African refugees have been released from the Ketziot detention center in the Negev region of Israel without being tested for tuberculosis or receiving preventive treatment despite a rise in TB cases among detainees, Haaretz.com reports.

According to a custody tribunal, which works with migrants, 12 cases of active TB have been reported among refugees who were once held at Ketziot, and the percentage of all active TB cases in Israel among refugees has doubled from 14% in 2006 to 28% in 2008. According to the tribunal, the rate of active TB among detainees at Ketziot is 13.3 times greater than the rate in 1997. In addition, Israel’s Prisons Service and Ministry of Health at the end of July reported that 22 TB cases have been detected this year among refugees detained at Ketziot. Among the 22 people, four had active TB and were transferred to a medical facility (Reznick, Haaretz.com, 9/3). Although Itamar Grotto, head of public health for the health ministry, told the tribunal that the ministry’s recommendations include “filling a medical questionnaire” and “conducting a chest X-ray for every inmate,” the tribunal has called the ministry’s response “wrong and misleading” (Reznick, Haaretz.com, 9/4).

In response to the increase in reported TB cases among refugees, the tribunal declared that several tests and vaccinations, including TB screenings, be administered to all detainees before their release from the facility. The tribunal also criticized the lack of TB screenings by appropriate authorities. “Despite the significant rise in the number of active TB patients among the refugees, the health ministry is responding late to events and is not providing the solutions that show the epidemic has been stopped,” the tribunal said. The tribunal added that the “main challenges to ensuring public health in Israel, and particularly in controlling TB, were not medical but political and administrative.”

According to the tribunal, the Ministry of the Interior and Israel Defense Forces on March 31 released refugees from Ketziot to make room for new detainees, and those released did not undergo medical tests before moving to population centers in Israel. The tribunal said the ministry’s “massive and unmonitored releases” were made without “good judgment with regard to the welfare and health of the public.” Daniel Shem-Tov, head of the Health Ministry’s TB and AIDS Department, in May testified before the tribunal that the lack of testing constitutes a “danger to public health” (Haaretz.com, 9/3).

This article is republished with kind permission from our friends at The Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery of in-depth coverage of health policy developments, debates and discussions. The Kaiser Daily Health Policy Report is published for Kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. Copyright 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Healthcare News

Fifty-nine percent of U.S. businesses in 2009 intend to increase employees’ deductibles, copayments or out-of-pocket spending limits, according to preliminary data of a national survey released on Thursday by Mercer, the AP/Houston Chronicle reports.

The preliminary results included the responses of about half of the 3,000 large companies surveyed who responded, but preliminary data have “historically been in line with final results,” the AP/Chronicle reports.

The survey found that health care costs for workers and employers will increase by an estimated 5.7% in 2009, the same rate as this year. According to Mercer, health care cost growth has been about 6% since 2005, and while the rate is lower than the double-digit increases in previous years, it still is growing at a faster rate than inflation or workers’ wages. Blaine Bos, the author of the survey, said, “It’s not something to cheer about, especially since costs are getting passed on to employees.”

The survey also found that 47% of the companies are encouraging enrollment in health plans with lower premiums and higher deductibles, and that 19% intend to offer consumer-directed health plans with employee-controlled spending accounts. According to Mercer, the average deductible for a single person between 2003 and 2007 increased from $250 to $400 and from $1,000 to $1,500 for a family for the same period (Choi, AP/Houston Chronicle, 9/3).

This article is republished with kind permission from our friends at The Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery of in-depth coverage of health policy developments, debates and discussions. The Kaiser Daily Health Policy Report is published for Kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. Copyright 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Women’s Health News

Black women who undergo a lumpectomy surgery to treat early-stage breast cancer are less likely than their white counterparts to receive the recommended follow-up radiation therapy treatments, according to study released on Wednesday, Reuters/Boston Globe reports. Standard care after a lumpectomy includes a series of radiation treatments to ensure that all cancerous cells have been treated.

The study, led by Grace Li Smith, a postdoctoral fellow in radiation oncology at the University of Texas M.D. Anderson Cancer Center, looked at 37,305 women ages 65 and older who had undergone lumpectomy surgery to remove cancerous tumors from their breasts. Of the women, 34,024 were white and 2,305 were black. Researchers found that 65% of black women received radiation therapy after the surgery, compared with 74% of white women. The disparities were more prevalent on the West Coast, in the South and the Northeast, while certain regions — including the West and Midwest — showed no racial disparities, according to the study (Dunham, Reuters/Boston Globe, 9/3).

The study did not look at the reasons for the findings, but Smith noted that possible reasons black women are not receiving follow-up treatment include doctors not offering them the treatment, black women declining the treatment or being unable to complete the entire treatment series because of other health problems. The study looked at Medicare beneficiaries, of whom all had insurance coverage for lumpectomy and radiation, so access to care was not a significant factor, the Chronicle reports.

David Wetter, chair of M.D. Anderson’s Health Disparities Research department, said, “Physicians have a lot of unconscious biases about who’s likely to comply with or accept treatment, and some patient populations are more likely to be suspicious of radiation’s effectiveness or side effects.”

Eric Winer, a Harvard University professor of medicine and director of the Dana-Farber Cancer Institute’s Breast Oncology Center, said, “When women have the two-step treatment of lumpectomy and radiation, it’s possible for some to fall through the cracks,” but “there’s absolutely no reason it should be happening more frequently to black women.” Wetter added, “It’s clear that there’s a whole lot going on in clinical encounters that needs to be examined more.”

The study will be presented on Friday at the Second Annual American Society of Clinical Oncology Breast Cancer Symposium (Ackerman, Houston Chronicle, 9/3).

This article is republished with kind permission from our friends at The Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery of in-depth coverage of health policy developments, debates and discussions. The Kaiser Daily Health Policy Report is published for Kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. Copyright 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Pharmaceutical News

The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs’ prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died.

The four drugs, known as tumor necrosis factor alpha blockers (TNF-alpha blockers), which suppress the immune system, are approved to treat a variety of conditions which may include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn’s disease.

FDA today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 to require manufacturers of TNF inhibitors to make safety-related changes to prescribing information, or labeling.

“Under the FDA’s new authorities, we can require safety label changes and a risk evaluation and mitigation strategy, known as REMS, when the agency becomes aware of new safety information,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Rheumatology Products, Center for Drug Evaluation and Research. “Requiring the risks to be highlighted will help health care professionals be more vigilant in watching for these adverse events, and is necessary to ensure that the benefits of these drugs outweigh their risks.”

Since the initial approval of the four TNF blockers, the prescribing information for these drugs has included information about the risk of serious infections, including fungal infections. However, based on reports reviewed by FDA, health care professionals are not consistently recognizing cases of histoplasmosis and other invasive fungal infections, leading to delays in treatment.

Patients taking TNF blockers should be aware that they are more susceptible to serious fungal infections. Those who develop a persistent fever, cough, shortness of breath, and fatigue should promptly seek medical attention. To assist in the diagnosis, those being treated with TNF blockers should tell their health care professionals where they live and what areas they have recently visited. Patients who develop a fungal infection may be advised to stop the TNF blocker until they recover.

FDA has reviewed 240 reports of histoplasmosis, an infection caused by the fungusHistoplasma capsulatum, in patients being treated with Enbrel, Humira, or Remicade. The majority of the reports involved people in the Ohio River and Mississippi River valleys (the fungus is commonly found in those areas). In at least 21 of the reports, histoplasmosis was initially not recognized by health care professionals, and antifungal treatment was delayed. Twelve of those patients died.

The FDA reviewed one reported case of histoplasmosis in a patient taking Cimzia. The FDA also has received reports of cases of coccidioidomycosis and blastomycosis, including deaths, in patients treated with TNF blockers.

TNF blocker manufacturers are required to submit safety labeling changes, including strengthened warnings and revisions to the Medication Guides to the FDA within 30 days or to provide a reason why they do not believe labeling changes are necessary.

If they do not submit new language, or if the FDA disagrees with the new language the company proposes, the Food and Drug Administration Amendments Act of 2007 provides strict timelines for resolving the labeling changes and allows the agency to issue an order directing the labeling change as deemed appropriate to address the new safety information.

Medication Guides will become part of a REMS for Humira and Remicade and are already part of a REMS for Enbrel and Cimzia. The manufacturers for all four of these drugs will also be required to educate prescribers about the risks.

For more information: http://www.fda.gov/cder/drug/InfoSheets/HCP/TNF_blockersHCP.htm

http://www.fda.gov