News in Brief: Week of June 2-6

June 06, 2014 09:15 am News Staff

This roundup includes the following news briefs:

FDA Reclassifies Sunlamps, Adds Black-box Warning

On May 29, the FDA issued a final order reclassifying sunlamp products and ultraviolet (UV) lamps intended for use in sunlamp products from class I (general controls) to class II (special controls) devices, according to an FDA news release(www.fda.gov). The reclassification means that manufacturers of the devices, which were previously exempt from premarket review, will now have to submit premarket notification information and receive clearance from the agency before marketing the products.

The FDA also will now require all sunlamp products to carry an easy-to-read black box warning that states the products should be used only by people 18 or older.

Sunlamp products include tanning beds and booths that emit UV radiation, which can cause skin cancer. According to the American Academy of Dermatology, people who have been exposed to UV radiation from indoor tanning experience a 59 percent increase in the risk for melanoma -- a risk that increases with additional use of these devices.

"The FDA has taken an important step today to address the risk to public health from sunlamp products," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health. "Repeated UV exposure from sunlamp products poses a risk of skin cancer for all users -- but the highest risk for skin cancer is in young persons under the age of 18 and people with a family history of skin cancer."

More Work Ahead for Million Hearts

In the May 30 issue(www.cdc.gov) of the CDC's Morbidity and Mortality Weekly Report (MMWR), the CDC examined the progress of the Million Hearts(millionhearts.hhs.gov) initiative and found that further reductions of cardiovascular disease (CVD) risk factors will be needed to meet the campaign's stated goal of preventing 1 million heart attacks and strokes by 2017.

When Million Hearts launched in 2011, the campaign set population-level prevalence targets of 65 percent or higher for each ABCS clinical measure, as well as a 20 percent reduction in sodium intake (to approximately 2,900 mg/day) and a 10 percent reduction in current tobacco product smoking prevalence (to approximately 23.6 percent).

According to the MMWR article, from 2005-06 to the period with the most current data for each of the Million Hearts campaign's four "ABCS" clinical measures (i.e., aspirin, blood pressure, cholesterol and smoking), analysis showed:

  • no statistically significant change in the prevalence of aspirin use for secondary prevention (53.8 percent in 2009-10),
  • an increase to 51.9 percent in the prevalence of blood pressure control in 2011-12,
  • an increase to 42.8 percent in the prevalence of cholesterol management in 2011-12), and
  • no statistically significant change in the prevalence of smoking assessment and treatment (22.2 percent in 2009-10).

In addition, analysis of two community-level indicators found:

  • a decrease in current tobacco product smoking prevalence to 25.1 percent in 2011-12, and
  • only minimal change in mean daily sodium intake, which remained at 3,594 mg/day in 2009-10.

"Additional focus on both clinical-level efforts that support consistent and coordinated patient care and community-level efforts that promote environments that encourage healthy behaviors and reduce unhealthy exposures is needed to continue progress towards meeting Million Hearts goals by 2017," said the article.

Survey Shows Most Patients Want Electronic Access to Health Records

According to a new survey(www.accenture.com) conducted by Accenture, a global management consulting, technology services and outsourcing firm, more than half of U.S. consumers with chronic medical conditions think the benefits outweigh the risks when it comes to accessing their personal medical information electronically.

In addition, 87 percent of those same consumers said it was important to have control over their health information, but about 50 percent thought that they had little or no control at all. Of those consumers who said they didn't electronically access their medical records, 55 percent claimed they didn't know how to do so; another 17 percent chose the answer, "I trust that my medical records are accurate, so I don't need to access them."

The 2014 Accenture Patient Engagement Survey analyzed data collected from 2,000 U.S. consumers.

CMS Expands Demo Requiring Prior Authorization for Power Mobility Devices

CMS recently announced plans to expand what it deemed a "successful demonstration" launched in 2012 that requires prior authorization for power mobility devices.

According to a May 22 press release(www.cms.gov), claims data from September 2013 show that monthly expenditures for certain power mobility devices decreased from $12 million in September 2012 to $4 million in August 2013 across the original seven demonstration states (California, Florida, Illinois, Michigan, New York, North Carolina and Texas).

Based on those savings, CMS will extend the demonstration to 12 additional states: Arizona, Georgia, Indiana, Kentucky, Louisiana, Maryland, Missouri, New Jersey, Ohio, Pennsylvania, Tennessee and Washington. According to CMS, prior authorization does not create additional documentation requirements or delay medical service; it requires the same information currently necessary to support Medicare payment but requires that information earlier in the process.

In the same release, CMS announced a proposed rule that would a establish prior authorization process for certain durable medical equipment, prosthetics, orthotics and supply items that the agency said are "frequently subject to unnecessary utilization." That proposal was published in the May 28 Federal Register(www.federalregister.gov).

$300 Million in Grants Available to Expand Services in CHCs

HHS announced a $300 million grant program(www.hhs.gov) that will help the nation's community health centers offer increased access to comprehensive primary health care services. The grant program is part of the Patient Protection and Affordable Care Act.

Grant funding can be used to expand service hours; hire more medical professionals; and add oral health, behavioral health, pharmacy and vision services at existing health center sites. Applicants for the grants should demonstrate how they will expand services for underserved populations in their community. Applications for expanded services funding are due by July 1.

An estimated 1,300 health centers operate more than 9,000 service delivery sites that provide care to over 21 million patients in every state.

More information about the funding opportunity(www.hrsa.gov), including application requirements, is available from HHS.


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