Updates on screening age recommendations for mammograms, CDC report on a decline in smoking rates in the country, and regulation of laboratory-developed tests.
Smoking Rates Declining but Disparities Evident: CDC Report
Whether you are privately or federally insured is an important determinant of whether you smoke, according to CDC’s recently released Morbidity and Mortality Weekly Report.1
Results based on the 2014 National Health Interview Survey show that 27.9% of uninsured adults and 29.1% of Medicaid enrollees smoke, compared with 12.9% of privately insured adults and 12.5% of Medicare enrollees who are smokers. Another important finding, other than the insurance-based disparity, is the steady decline in the rate of smoking over a decade (2005 to 2014), from 20.9% to 16.8%—these numbers seem well on target to achieving a smoking rate of 12% or lower by 2020, per the Healthy People 2020 targets.2 The average number of cigarettes smoked per day dropped by about 3 percentage points, from 16.7% to 13.8% during the study period.
• Young adults
• People below the poverty line
• People with a disability
• People with a General Education Development certificate
• People who are lesbian, gay, or bisexual.
The highest smoking rates were observed among:
A press release announcing the results of the study, from the Campaign for Tobacco-Free Kids, says that while the results prove that the fight against this devastating habit has made huge strides, there’s much work needed to meet the goals of “protecting Americans from the number one cause of preventable death.” The organization urges continued national efforts on multiple fronts, including higher taxation on tobacco products, smoke-free laws, and barrier-free health insurance for smoking cessation treatments, among others.
Smoking cessation treatments have gained improved coverage, especially under the Affordable Care Act. A recent report by the CDC, addressing cessation coverage, found that only 9 states cover all 9 evidence-based cessation treatments (individual counseling, group counseling, nicotine gum, nicotine patches, nicotine lozenge, nicotine nasal spray, nicotine inhaler, bupropion, and varenicline).
Praising the findings from the report, CDC Director Tom Frieden, MD, MPH, said, “Smoking kills half a million Americans each year and costs more than $300 billion. This report shows real progress helping American smokers quit and that more progress is possible.”
1. Smoking rates for uninsured and adults on Medicaid more than twice those for adults with private health insurance [press release]. Atlanta, GA: CDC; November 12, 2015. http://www.cdc.gov/media/releases/2015/p1112-smoking-rates.html.
2. Tobacco. HealthyPeople.gov website. http://www.healthypeople.gov/2020/leading-health-indicators/LHI-Infographic- Gallery#May-2015. Accessed November 26, 2015.
Should We Trust Screening Age Recommendations in Cancer
Initiate an active discussion with your clinician about screening at age 40 years if you have an average risk of developing breast cancer, but regular screening mammograms can wait till age 45 years. This is the new evidence- based guidance update provided by the American Cancer Society (ACS), published yesterday in JAMA Internal Medicine.1
The leading cause of cancer death in women in the United States, second to lung cancer, nearly 240,000 women are expected to be diagnosed with the disease this year. Despite increased disease awareness and rapid strides in research and drug development, mortality among breast cancer patients remains high.
The previous ACS recommendations for breast cancer screening were published more than a decade ago and recommended that women at average risk should begin screening at age 40 years.2 A periodic, preferably annual, breast exam was recommended for women 40 years and older. Women at an increased risk of breast cancer, the guidelines recommended, should be offered an earlier screening, shorter screening intervals, and the inclusion of ultrasound or magnetic resonance imaging, along with a physical exam and a mammogram, to their screening modalities.
The updated guideline for women with an average risk of developing breast cancer (ie, women without a personal history of breast cancer, a suspected or confirmed genetic mutation that can increase risk, or a history of chest radiotherapy at a young age) are:
1. Women with an average risk of breast cancer should undergo regular screening mammography starting at age 45 years. (Strong Recommendation)
1a. Women aged 45 to 54 years should be screened annually. (Qualified Recommendation)
1b. Women 55 years and older should transition to biennial screening or have the opportunity to continue screening annually. (Qualified Recommendation)
1c. Women should have the opportunity to begin annual screening between the ages of 40 and 44 years. (Qualified Recommendation)
2. Women should continue screening mammography as long as their overall health is good and they have a life expectancy of 10 years or longer. (Qualified Recommendation)
3. The ACS does not recommend clinical breast examination for breast cancer screening among average-risk women at any age. (Qualified Recommendation)
The article emphasizes the need for a discussion of personal and family medical history with the individual’s physician and a periodic evaluation of whether the risk profile has altered. Additionally, the ACS recommends that women should be informed on the risk factors, risk reduction, benefits, and harms, associated with mammography screening.
1. Oeffinger KC, Fontham ETH, Etzioni R, et al. Breast cancer screening for women at average risk: 2015 guideline update from the American Cancer Society. JAMA. 2015;314(15):1599-1614.
2. Smith RA, Saslow D, Sawyer KA, American Cancer Society. American Cancer Society guidelines for the early detection of cancer, 2003. CA Cancer J Clin. 2003;53(1):27-43.
FDA Regulation of LDTs: A Report Justifies the Need for It
Medicare covers them, private payers cover them, and providers and patients make clinical decisions on the results they generate—isn’t it time to regulate laboratory-developed tests (LDTs), which cost Medicare $9.7 billion in 2012 alone?1 The FDA believes so and, in preparation, has issued a report that details the potential harm to patients resulting from false-negative or false-positive test results.2 This follows a draft guidance issued in October 2014 that included a risk-based framework to define regulatory oversight of LDTs for the clinical laboratories that develop them.
By definition, an LDT is an in vitro diagnostic that is designed, manufactured, and used within a single laboratory. A test that is even partially designed outside the laboratory that offers or uses it no longer falls within the class. This definition is site-restricted. For example, if several clinical labs form a network within an entity, an LDT developed by one of these laboratories cannot be used by another lab within that network. If a component used within the test is manufactured for the lab by a third party, the FDA will cease to consider the device an LDT.
Lakshman Ramamurthy, PhD, vice president at Avalere Health, wrote in a blog that LDTs, also known as “home-brewed” tests, are created in response to unmet clinical needs. However, the tests have come a long way. “LDTs have expanded in their reach and are purchased by and shipped to nationwide laboratories and utilized across the country,” he writes.3
The new FDA report provides case studies that underscore the importance of regulating LDTs beyond the current requirements of the CMS-developed Clinical Laboratory Improvement Amendments (CLIA) and the Federal Food, Drug, and Cosmetic Act. The report claims that events associated with 20 case studies presented in the report resulted from adherence of the test developers to the minimum requirements of CLIA. The following TABLE includes a few examples from the report. “As this report demonstrates, strengthening the FDA’s oversight over LDTs is critical to protect both patients and the public health,” wrote Peter Lurie, MD, MPH, the FDA’s associate commissioner for public health strategy and analysis, in his blog post published November 16, 2015. In April of this year, the FDA and CMS announced the formation of a task force to avoid duplication of efforts by the agencies.4
Although CMS, through CLIA, ensures quality of the lab processes used to develop the tests, the FDA plans to enforce the premarket review requirements to confirm both the analytical and clinical validity of the tests.
1. Borden A, Showalter D, Storchan G, Hughes K. The diagnosis for diagnostics: changes to Medicare payment and coverage of clinical laboratory tests. Am J Manag Care. 2015;21(SP12):SP407-SP408.
2. Office of Public Health Strategy and Analysis. The public health evidence for FDA oversight of laboratory developed tests: 20 case studies. FDA website. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/ UCM472777.pdf. Published November 16, 2015. Accessed November 17, 2015.
3. Ramamurthy L. Industry awaits FDA’s final guidance regulating laboratory developed tests - what does it mean and where do we go next? Avalere website. http://avalere.com/expertise/life-sciences/insights/industry-awaits-fdas-finalguidance- regulating-laboratory-developed-tests-w. Published October 9, 2015. Accessed November 17, 2015.
4. Shuren J, Conway PH. FDA and CMS form task force on LDT quality requirements. http://blogs.fda.gov/fdavoice/ index.php/2015/04/fda-and-cms-form-task-force-on-ldt-quality-requirements/. Published April 16, 2015. Accessed November 17, 2015.
Absence of Prescription Coverage Could Prove Catastrophic in Cancer
A study conducted among patients who had breast cancer found that in the absence of prescription drug coverage, patients—especially from the low-income strata—make harmful clinical decisions.1 Published in Breast Cancer Research and Treatment,2 the study involved a retrospective analysis based on surveys filled out by 712 women diagnosed with breast cancer. The women were approached by the researchers 9 months following their diagnosis and again at the 4-year mark. The primary outcome being evaluated was initiation and continuation of prescribed hormonal therapy (usually administered for 5 to 10 years), which reduces the risk of cancer recurrence in women with estrogen- or progesterone-positive breast cancer by as much as 50%.
The study’s results showed that 90% of women who were eligible for prescription drug coverage started their recommended hormonal treatment as prescribed; however, that number dropped to 81% by the end of the study period. Of the cohort whose insurance plan did not include prescription drug coverage, 82% started hormonal therapy (requiring them to cover the cost out-of-pocket), but by 4 years, only 66% remained on the treatment. Overall, the authors observed a significant influence of family income on the women’s decision to initiate and continue hormonal therapy. Women with an annual household income of less than $40,000 were about 40% as likely as women with an annual household income of more than $70,000 to continue treatment.
Lead author Cathy J. Bradley, PhD, said in a press release, “What this research says is that general health insurance isn’t enough. You have to have prescription drug coverage.”1 Bradley is associate director for Population Studies at the CU Cancer Center and professor in the Colorado School of Public Health. “When someone thinks about coverage for high-cost care, they’re usually thinking about that trip to the hospital that costs $80,000 that could leave them bankrupt. But, the fact is that the cost of prescription medicines—even fairly lowcost medications—can also be ‘catastrophic.’”
With President Obama’s renewed attention to precision medicine and provisions of the Affordable Care Act, changes within insurance benefits are imminent. However, there are certain caveats. For example, in addition to being expensive, many of the targeted agents are oral medications to be self-administered at home, as opposed to an infusion that requires a patient to visit the clinic. This can result in adherence issues. Patients can skip doses or not fill a prescription, which can result in poor outcomes.
Pointing out that there’s plenty of evidence showing that if people feel that a drug is too expensive, they stop taking it, Bradley says, “This study suggests that reluctance to insure prescription drugs may result in increased recurrence and poor survival among women with breast cancer, one of the largest groups of cancer survivors.”
1. Without prescription coverage, some cancer patients do without even low-cost drugs [news release]. Denver, CO: EurekAlert!; November 18, 2015. http://www.eurekalert.org/pub_releases/2015-11/uoca-wpc111815.php. Accessed November 18, 2015.
2. Bradley CJ, Dahman B, Jagsi R, Katz S, Hawley S. Prescription drug coverage: implications for hormonal therapy adherence in women diagnosed with breast cancer. Breast Cancer Res Treat. 2015;154(2):417-422.