By Jennifer Viegas*
November 20, 2009
Radiologists Criticize New Mammogram Guidelines
The American College of Radiology has criticized a new set of breast cancer screening recommendations from a federal advisory board that suggest women ages forty to forty-nine with no family history or predisposition for breast cancer no longer undergo routine mammography.
In a news release, the radiology trade group said that the recommendations were created without input from radiologists, and that the suggestions could reverse a two-decade decline in breast cancer mortalities if clinicians and insurance companies adopt them as guidelines.
The recommendations, published in the Annals of Internal Medicine, were developed by the U.S. Preventive Services Task Force after review and analysis of eight clinical trials on breast cancer screening and survival rates. The independent advisory group, made up of primary-care physicians, found that while mammography screening reduced breast cancer rates by 15% in women ages thirty-nine to forty-nine false-positive results, and overdiagnosis of existing breast cancers were more likely to occur in women under fifty.
In addition to advising that women delay mammography screenings until age fifty, the new recommendations also suggested women ages fifty to seventy-four only undergo mammograms every two years. The advisory board also found no clinical evidence that the test was beneficial to women older than seventy-four.
Shawn Rhea, Radiologists Criticize New mammogram Guidelines, Modern Healthcare's Daily Dose (Nov. 17, 2009) (note: registration is required to view this content).
FDA Panel Votes in Favor of New Strep Pneumoniae Vaccine
A U.S. Food and Drug Administration (FDA) advisory panel has voted to recommend approval of an updated version of the Streptococcus pneumoniae vaccine Prevnar.
In a ten-to-one vote, the Vaccines and Related Biologics Committee said Pfizer's new Prevnar 13 is effective against thirteen strains of invasive pneumococcal disease. With the same numbers, the panel then voted to support the safety profile of the vaccine, which protects against six more serotypes than the current Prevnar vaccine.
The FDA does not have to follow the advice of its advisory committees, but it usually does. Since it was first approved in 2000, Prevnar has been highly successful against the seven serotypes that, at the time, accounted for more than 80% of invasive pneumococcal disease in infants and toddlers.
By 2007, rates of invasive disease caused by serotypes covered by Prevnar had declined by 99%, and overall rates of invasive pneumococcal disease had dropped by 76%. However, overall rates began to level off because of an increase in invasive disease caused by non-Prevnar serotypes, in particular type 19A. Prevnar 13 targets strain 19A, along with an additional five strains.
According to the Centers for Disease Control and Prevention, the new vaccine is expected to protect against between 80% and 90% of the serotypes seen in the some fourteen million cases of pneumococcal disease each year worldwide.
According to Pfizer, if approved, the new vaccine would prevent 111,000 cases of pneumococcal disease and 9,800 more deaths than the original vaccine. Prevnar 13 is a four-dose regimen for infants and toddlers, with scheduled injections at two, four, six, and twelve to fifteen months.
The positive vote came after committee members decided that the vaccine offered protection against a wider array of serotypes than the earlier vaccine, despite the fact that action against two of the new strains failed to meet clinical endpoints for efficacy in Pfizer's clinical trials. No other vaccines are approved to protect against the same strains of invasive pneumococcal disease.
The FDA panel did not seem convinced, however, that the new vaccine would prevent otitis media. The current version was approved for the otitis media indication, but Pfizer did not provide any new data on Prevnar 13's efficacy in preventing the condition.
According to study data presented to the panel, the safety profile of Prevnar 13 was similar to that of its predecessor. However, infants and toddlers given Prevnar 13 were more likely to experience irritability and fever than those who received the original Prevnar.
There were four deaths--three in the Prevnar 13 group and one in the Prevnar 7 group--that were classified as sudden infant death syndrome.
Emily P. Walker, FDA Panel Votes in Favor of New Strep Pneumoniae Vaccine, MedPage Today (Nov. 18, 2009).
Catholic Bishops Strengthen Life-Support Guidelines
By a 214 to four majority, the United States Conference of Catholic Bishops voted to strengthen its requirement that Roman Catholic hospitals insert and maintain nutrition and hydration tubes for patients in persistent vegetative states.
Prior to the amendment, the bishops' Ethical and Religious Directives for Catholic Healthcare Services told caregivers at U.S. Catholic hospitals to use a presumption in favor of using the life-sustaining technologies. The new rule incorporates the stronger position of the conference's Committee on Pro-Life Activities that all patients in vegetative states receive life support except those "close to inevitable death" from underlying conditions.
The bishops' directives forbid euthanasia, and allow Catholic hospitals to disregard the wishes of patients if they are contrary to Catholic moral teaching. One in six patients in the United States receives their care in Catholic hospitals, according to the Catholic Health Association.
Joe Carlson, Catholic Bishops Strengthen Life-Support Guidelines, Modern Healthcare's Daily Dose (Nov. 18, 2009) (note: registration is required to view this content).
Medicare Paid More than $92 Million in Incentives Under 2008 Physician Reporting Initiative
Centers for Medicare & Medicaid Services (CMS) announced more than 85,000 physicians and other eligible professionals who successfully reported quality-related data to Medicare under the 2008 Physician Quality Reporting Initiative (PQRI) received incentive payments totaling more than $92 million, much higher than the $36 million paid in 2007.
The number of eligible professionals who earned an incentive payment in 2008 increased by one-third from 2007, when 56,700 eligible professionals earned an incentive payment. In 2007, eligible professionals only could participate in the program during a six-month reporting period; however, the program was expanded in 2008 to allow reporting for either a six-month or a twelve-month period.
Established in 2006 by the Tax Relief and Health Care Act, PQRI is a voluntary program that allows physicians and other eligible healthcare professionals to receive incentive payments for reporting data on quality measures related to services furnished to Medicare beneficiaries. In the initial program years, individuals who satisfactorily submitted quality data for covered professional services furnished in the applicable reporting period were able to receive an incentive payment of 1.5% of the total estimated allowed charges under Medicare Part B for covered professional services.
Individuals who satisfactorily reported PQRI quality measures data and thus qualified for an incentive payment for the 2008 PQRI received their payments this fall. The average incentive amount for individual professionals is more than $1,000, with the largest payment to an eligible professional totaling more than $98,000.
More than 153,600 professionals participated in the 2008 PQRI, CMS said. Of those, more than 85,000 physicians and other eligible professionals met statutory requirements for satisfactory reporting for the 2008 reporting period and are receiving incentive payments.
In 2008, Congress extended the PQRI under the Medicare Improvements for Patients and Providers Act (MIPPA; Pub. L. No. 110-275) and authorized incentive payments through 2010. While the 2008 PQRI program included positive changes to ease the reporting of quality measures, the 2009 PQRI program provides enhancements that will make it even easier for physicians and other healthcare professionals to participate, CMS said.
Beginning in 2009, Congress increased the incentive that eligible professionals could receive for satisfactorily reporting data from 1.5% to 2% of the estimate of the allowed charges under Medicare Part B for all such covered professional services furnished during the applicable reporting period for 2009 and 2010.
CMS also added fifty-two new quality measures for the 2009 PQRI year, raising the total number of measures to 153. These new measures cover all types of healthcare professionals who provide services to Medicare beneficiaries and address areas such as osteoarthritis, back pain, coronary artery disease, and HIV/AIDS, as well as eighteen measures that must be reported exclusively through PQRI-qualified registries.
Medicare Paid More than $92 Million in Incentives Under 2008 Physician Reporting Initiative, BNA'S HEALTH L. REP. (Nov. 19, 2009) (note: registration is required to view this content).
Guidelines Push Back Age for Cervical Cancer Tests
New guidelines for cervical cancer screening say women should delay their first Pap test until age twenty-one, and be screened less often than recommended in the past. The advice from the American College of Obstetricians and Gynecologists (College) is meant to decrease unnecessary testing and potentially harmful treatment, particularly in teenagers and young women. The group's previous guidelines had recommended yearly testing for young women, starting within three years of their first sexual intercourse, but no later than age twenty-one.
Arriving on the heels of hotly disputed guidelines calling for less use of mammography, the new recommendations might seem like part of a larger plan to slash cancer screening for women. But the timing was coincidental, according to the College.
The College believes the argument for changing Pap screening is more compelling than that for cutting back on mammography--which the obstetricians' group has staunchly opposed--because there is more potential for harm from the overuse of Pap tests. The reason is that young women are especially prone to develop abnormalities in the cervix that appear to be precancerous, but that will go away if left alone. But when Pap tests find the growths, doctors often remove them with procedures that can injure the cervix and lead to problems later when a woman becomes pregnant, including premature birth and an increased risk of needing a Caesarean.
There are 11,270 new cases of cervical cancer and 4,070 deaths per year in the United States. One to two cases occur per one million girls ages fifteen to nineteen--a low incidence that convinces many doctors that it is safe to wait until age twenty-one to screen.
The College also felt it was safe to test women less often because cervical cancer grows slowly, so there is time to catch precancerous growths. Cervical cancer is caused by a sexually transmitted virus, human papillomavirus, which is practically ubiquitous. Only some people who are exposed to it develop cancer; in most, the immune system fights off the virus. If cancer does develop, it can take ten to twenty years after exposure to the virus.
The new guidelines say women thirty and older who have three consecutive Pap tests that were normal and who have no history of seriously abnormal findings can stretch the interval between screenings to three years.
In addition, women who have a total hysterectomy (which removes the uterus and cervix) for a noncancerous condition and who had no severe abnormalities on previous Pap tests can discontinue having the tests entirely.
The guidelines also say that women can stop having Pap tests between sixty-five and seventy if they have three or more negative tests in a row and no abnormal test results in the last ten years.
The changes do not apply to women with certain health problems that could make them more prone to aggressive cervical cancer, including HIV infection or having an organ transplant or other condition that would lead to a suppressed immune system.
It is by no means clear that doctors or patients will follow the new guidelines. Medical groups, including the American Cancer Society, have been suggesting for years that women with repeated normal Pap tests could begin to have the test less frequently, but many have gone on to have them year after year anyway.
Denise Grady, Guidelines Push Back Age for Cervical Cancer Tests, N.Y. TIMES (Nov. 20, 2009).
*We would like to thank Jennifer P. Viegas, Esquire (Hall Render Killian Health & Lyman PC, Troy, MI), for providing this week's update.
AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers Weekly and appropriate AHLA Practice Groups.