New Regulations Require Easy-To-Understand Summaries Of Health Coverage.

The Obama Administration issued regulations Thursday "requiring health plans to describe what they cover in clear, standardized language that is understandable to consumers," the Los Angeles Times  (2/10, Levey) reports. The regulations are part of the Administration's effort to "implement a much-anticipated consumer protection in the new healthcare law." Beginning in the fall, "insurers and employers that offer health coverage will have to provide a six-page form that summarizes basic plan information, such as deductibles and co-pays, as well as costs for using in-network and out-of-network medical services."

        Bloomberg News  (2/10, Armstrong) reports that "the form currently provides examples on how much it might cost a patient to get treated for Type 2 diabetes, as well as a normal delivery of a baby." However, "the final draft removed a section providing an example on how much it would cost a patient to be treated for breast cancer, bowing to arguments made by the lobby group America's Health Insurance Plans that the condition was too complex to be easily summarized."

        The Wall Street Journal  (2/10, Radnofsky, Subscription Publication) reports that the deadline for insurance companies to produce the documents and make them available to consumers is Sept. 23. The Journal also adds that while employers and insurance providers say the requirement may be expensive and could lead to confusion, it is popular with consumers. Given the pre-election deadline and the popularity of the provision, the Journal notes that Democratic candidates may tout it on the campaign trail.

        CQ  (2/10, Bunis, Subscription Publication) reports, "On a conference call with reporters Thursday, Steve Larsen, head of the Office of Consumer Information and Insurance Oversight, said that the new effective date would still be in time for most consumers to review the summaries before they had to make decisions about their health insurance for 2013 and that there would be enough time to get the materials ready."

        The AP  (2/10, Alonso-Zaldivar) quotes Medicare chief Marilyn Tavenner, who said, "If an insurance plan offers substandard coverage in some area, they won't be able to hide it in dozens of pages of text." The piece notes that "one shortcoming is that the summaries won't include premiums" because "administration officials said they ran into logistical problems trying to do that," although "premiums should be easily available anyway, either from their employer or directly from a health plan."

        Modern Healthcare  (2/10, Daly, Subscription Publication) reports, "The disclosure requirements, mandated by the Patient Protection and Affordable Care Act, aim to simplify consumer comparisons of various insurance plans, which have used marketing materials to sometimes obfuscate their details, according to HHS officials." Modern Healthcare also points out that during "a call with reporters," Tavenner said, "Markets work best when people have the information they need to make informed decisions."

The effect of combination treatment with aliskiren and blockers of the renin-angiotensin system on hyperkalaemia and acute kidney injury

Harel Z, Gilbert C, Wald R, et al. The effect of combination treatment with aliskiren and blockers of the renin-angiotensin system on hyperkalaemia and acute kidney injury: systematic review and meta-analysis. BMJ. 2012 Jan 9;344:e42. doi: 10.1136/bmj.e42. (Review) PMID: 22232539


 OBJECTIVE: To examine the safety of using aliskiren combined with agents used to block the renin-angiotensin system.
DESIGN: Systematic review and meta-analysis of randomised controlled trials.
DATA SOURCES: Medline, Embase, the Cochrane Library, and two trial registries, published up to 7 May 2011.
STUDY SELECTION: Published and unpublished randomised controlled trials that compared combined treatment using aliskiren and angiotensin converting enzyme inhibitors or angiotensin receptor blockers with monotherapy using these agents for at least four weeks and that provided numerical data on the adverse event outcomes of hyperkalaemia and acute kidney injury. A random effects model was used to calculate pooled risk ratios and 95% confidence intervals for these outcomes.
RESULTS: 10 randomised controlled studies (4814 participants) were included in the analysis. Combination therapy with aliskiren and angiotensin converting enzyme inhibitors or angiotensin receptor blockers significantly increased the risk of hyperkalaemia compared with monotherapy using angiotensin converting enzymes or angiotensin receptor blockers (relative risk 1.58, 95% confidence interval 1.24 to 2.02) or aliskiren alone (1.67, 1.01 to 2.79). The risk of acute kidney injury did not differ significantly between the combined therapy and monotherapy groups (1.14, 0.68 to 1.89).
CONCLUSION: Use of aliskerin in combination with angiotensin converting enzyme inhibitors or angiotensin receptor blockers is associated with an increased risk for hyperkalaemia. The combined use of these agents warrants careful monitoring of serum potassium levels.

Insurers increasingly basing out-of-network reimbursements on Medicare rates.

USA Today /Kaiser Health News (2/9, Appleby) discusses "a new twist" to the cost of out-of-network healthcare: "a growing number of insurers have changed the way they calculate reimbursements to shift more of the expense to patients. Now, instead of paying a percentage of the 'usual and customary' charges from physicians and other providers, insurers are basing reimbursements on a percentage of what Medicare pays, which can be much less." Insurers argue that "the new approach offers greater consistency and thwarts efforts to game the system," citing cases "'where 98% of the physicians would charge $5,000, but some outlier would decide to charge $50,000,' which would drive up the average."

Lawmakers call on FDA to set standards for arsenic, lead levels in fruit juices.

CQ (2/9, Ferguson, Subscription Publication) reports that Reps. Rosa DeLauro (D-CT) and Frank Pallone Jr. (D-NJ) "say they are alarmed by a respected consumer group's findings of high arsenic and lead levels in fruit juices and worried that the Food and Drug Administration will not set federal limits for the toxic metals if left on its own." They "said they are particularly concerned about a lack of enforceable federal standards for the two chemicals because fruit juices are heavily consumed by young children." The lawmakers "said they would introduce legislation requiring the FDA to act."

Y Chromosome Variants May Play Role In Heart Disease.

The New York Times  (2/9, A13, Kolata, Subscription Publication) reports that a study published in The Lancet suggests "the Y chromosome, the one chromosome unique to men," may play a role in heart disease.

        HealthDay  (2/9, Preidt) reports that investigators "analyzed DNA from more than 3,000 biologically unrelated men in the United Kingdom and found that 90 percent had variants of Y chromosomes belonging to one of two major groups -- haplogroup I and haplogroup R1b1b2." Individuals "with a Y chromosome from haplogroup I have a 50 percent higher risk of coronary artery disease than other men, and that risk is independent of risk factors such as smoking, high blood pressure and high cholesterol, the researchers found."

        WebMD  (2/9, Goodman) reports, "Haplogroup I was the third most powerful predictor that men would develop heart disease, behind their HDL...cholesterol levels, and whether or not they were taking cholesterol-lowering drugs. Experts estimate that about 20% of men in Europe and 10% of men in the US belong to haplogroup I."

        BBC News  (2/9, Roberts) reports that lead researcher Dr. Maciej Tomaszewski "said, ultimately, the discovery could lead to new ways to treat and prevent heart disease in men, as well as a genetic test to spot those greatest risk."

        HeartWire  (2/9, Nainggolan) reports, "In an accompanying comment, Dr. Virginia M Miller (Mayo Clinic Rochester, MN) says the new research 'provides insight into genetic variants and potential new approaches to the understanding of inheritable coronary artery disease in men.'"

        The UK's Telegraph  (2/9, Smith) reports, "The study...was conducted by a team at University of Leicester and University of Ballarat in Australia and may also help explain why heart disease is more common in northern European countries compared with the south as the Y variation is more common there." The UK's Press Association  (2/9) also covers the story.

        Large Ex-NFL Players May Face Higher Risk Of Dying From Heart Disease. Reuters  (2/9, Norton) reports that, according to research published in the American Journal of Cardiology, the largest professional football players may face a higher risk of dying from heart disease. Investigators looked at data on about 3,400 former NFL players. Those who were the largest during their playing years faced an increased risk of death from stroke or heart disease. Specifically, defensive linemen faced a 42 percent higher risk of dying from heart disease compared with US males overall.

ACP: Best practice for diabetes is diet, then metformin, then any second drug

New diabetes guidelines from the American College of Physicians recommend prescribing a drug when lifestyle changes don't lower hyperglycemia. Specifically, start with metformin first and then add any second oral agent.
The three recommendations are:

• Add oral pharmacologic therapy in patients diagnosed with type 2 diabetes when diet, exercise and weight loss fail to improve hyperglycemia (Grade: strong recommendation; high-quality evidence). There are no best data on when to start drugs, so consider life expectancy, whether there are vascular complications, and the risk for adverse events.
• Prescribe monotherapy with metformin for initial pharmacologic therapy to treat most patients with type 2 diabetes (Grade: strong recommendation; high-quality evidence). It's cheaper than most other drugs, is more effective, has fewer side effects and does not result in weight gain.
• Add a second agent to metformin to treat patients with persistent hyperglycemia when lifestyle modifications and monotherapy with metformin fail to control hyperglycemia (Grade: strong recommendation; high-quality evidence). Adding a second drug can lower hyperglycemia by about 1 more percentage point. No evidence supports using one combination therapy over another.

The guideline is based on a 2011 review of the literature from 1966 through April 2010. It expands on a 2007 evidence report from the Agency for Healthcare Research and Quality that discussed drug therapy's effect on mortality, microvascular and macrovascular outcomes, intermediate outcomes and adverse effects. The 2011 review focuses on head-to-head comparisons and includes direct comparisons for monotherapy and dual therapy regimens. The College's recommendations appear in the Feb. 7 Annals of Internal Medicine.
In developing the recommendations, experts considered outcomes including all-cause mortality, cardiovascular morbidity and mortality, cerebrovascular morbidity, neuropathy, nephropathy and retinopathy.
Most diabetes medications reduced A1c levels to a similar degree, the authors noted. In most cases, metformin was more effective than other medications as a monotherapy and when used in combination therapy to reduce A1c levels, body weight, and plasma lipid levels. But it was difficult to draw conclusions about the comparative effectiveness of type 2 diabetes medications on all-cause and cardiovascular mortality, cardiovascular and cerebrovascular morbidity, and microvascular outcomes because of low-quality or insufficient evidence, the guideline writers said.
High-quality evidence shows that the risk for hypoglycemia with sulfonylureas exceeds the risk with metformin or thiazolidinediones and that the combination of metformin plus sulfonylureas is associated with six times more risk for hypoglycemia than the combination of metformin plus thiazolidinediones, the authors noted.
Moderate-quality evidence shows that the risk for hypoglycemia with metformin and thiazolidinediones is similar. But metformin is associated with an increased risk for gastrointestinal side effects, thiazolidinediones are associated with an increased risk for heart failure, and rosiglitazone and pioglitazone are contraindicated in patients with serious heart failure.

Physicians self-report overuse of ovarian cancer screening while recommended cancer screening remains underused

Many physicians report screening low- and medium-risk women for ovarian cancer despite evidence-based guidelines recommending against routine screening, a new study found.
Researchers sent 3,200 family physicians, general internists and obstetrician-gynecologists a questionnaire with vignettes about women's annual examinations. The responses of 1,088 physicians were included in the study. Physicians were asked about their use of transvaginal ultrasonography (TVU) and cancer antigen 125 (CA-125), neither of which is recommended as an effective screening tool by current guidelines. The results appear in the Feb. 7 Annals of Internal Medicine.
When asked about their screening practices for low-risk women, 28% of the physicians said they would order the tests at least sometimes, and 65.4% would use them for women at medium risk for ovarian cancer. Smaller percentages reported routinely using the tests for these patients (6% for low-risk women and 24% for medium-risk). However, a full third of the surveyed physicians believed that the TVU or CA-125 was an effective screening test.
Evidence-based reviews have documented that both tests cause more harm than benefit, the study authors noted. Multiple professional societies and the U.S. Preventive Services Task Force (USPSTF) have publicly concluded that ovarian cancer screening incurs more risk than benefit for low- and medium-risk women, the researchers added. Extrapolating their findings over the population of the U.S., they concluded that as many as 1.2 million women may be unnecessarily screened at a potential cost of $18 to $360 million.
Younger physicians, those in group practices, and physicians who listed the USPSTF as one of their main sources of screening recommendations were less likely to screen excessively, the study found. The authors noted that the USPSTF has issued more declarative guidelines on the subject than other organizations. The American Cancer Society, for example, does not publish ovarian cancer screening guidelines. The authors called for wider dissemination of guidelines and interventions that encourage interaction between diverse physicians to remedy this problem.
In contrast, screening rates for several other types of cancer are still falling short of Healthy People 2020 targets, according to an analysis from the Centers for Disease Control and Prevention, published in the Jan. 27 Morbidity and Mortality Weekly Report.
The USPSTF recommends mammography every two years for women 50 to 74, and the goal is to have 81.1% of eligible patients screened by 2020. However, according to the 2010 National Health Interview Survey (NHIS), the breast cancer screening rate was only 72.4%, which represented no improvement over year 2000 statistics. For cervical cancer, the recommendation was a Pap test every three years for women 21 to 65, and the goal was screening 93% of the population. The 2010 NHIS found a rate of 83%, which was a slight drop from 2000.
Colorectal cancer screening rates improved over the decade but still fell short of the goal of 70.5%. Overall, 58.6% of respondents between the ages of 50 and 75 met the recommendation of having 1) annual high-sensitivity fecal occult blood testing (FOBT), 2) sigmoidoscopy every five years combined with FOBT every three years, or 3) colonoscopy every 10 years. Asian people were less likely to have received any type of screening and Hispanic patients were less likely to have received cervical or colorectal screening. The researchers called for overall improvements in the use of the tests as well as efforts targeted at particularly underscreened populations.