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GENERAL HEALTH CARE NEWS

05-19-2017

Health and Human Services Secretary Tom Price, M.D. today selected five entrepreneurial projects for investment by the Secretary’s Ventures Fund (HHS Ventures).

Price chose projects from across HHS that are part of the latest round of funding and support designed to advance the Department’s innovation agenda.

HHS Ventures is a highly competitive effort that provides growth-stage funding and support to HHS employees with proven ideas for how to improve their office, agency, or the Department’s ability to carry out its mission.

This year, HHS Ventures is supported by funding from the Office of the Secretary, the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Centers for Medicare & Medicaid Services (CMS).

The projects selected by HHS Ventures represent critical areas of opportunity in improving the efficiency of the Department and include:

Optimizing Cyber-Molecular Surveillance of Viral Hepatitis

The CDC’s Division of Viral Hepatitis designed and implemented the Global Hepatitis Outbreak and Surveillance Technology (GHOST), the CDC’s first cloud-based surveillance and analysis system. GHOST is a virtual diagnostic system that extracts epidemiological intelligence from next-generation sequencing data.

GHOST provides a surveillance and analysis system for state laboratories to perform independent, inexpensive, and accurate outbreak investigations and then enabling collaboration and coordination across the public health system through a cloud-based system. Moreover, the modular structure and automation tools for GHOST are readily scalable to cyber-molecular surveillance of other viral infections.

The Fight against Zika: Leveraging Health Information Technology

The Office of the National Coordinator for Health Information Technology (ONC) and CDC are partnering to combat the devastating effects of the Zika virus. An important part of a patient’s care can be the lab testing and results that accompany a visit to a clinician. While most systems have the ability to establish contact between commercial labs and providers, public health laboratories do not have the ability to exchange this information electronically. Almost all Zika tests are performed at public health laboratories and, because the information can’t be transmitted electronically, the orders, test results, and additional information (such as pregnancy status) are either sent via paper form or telephone.

This project would enable efficient data transmission and improve care for patients by transmitting orders and results in a faster and more efficient way. It would serve as an extension of existing electronic test order and result technology. Additionally, this would build the capacity of public health laboratories to respond and manage future changes in testing requirements guidance from public health authorities.

Internet Devices to Improve Animal Care

Millions of rodents are used in HHS research labs each year to both understand mechanisms of disease and develop new therapies. Monitoring the health of these animals is critical for ensuring that research studies produce quality data and research animals are treated humanely.

Currently, trained specialists monitor the health of these animals with daily checks of each cage. This is both time consuming and expensive. To improve health monitoring, a team from NIH and the FDA developed an internet-enabled device that turns a conventional rodent cage into a “smart cage”. The “smart cage” assesses food and water intake and sends high-resolution data to an online server in real-time. This project represents a novel effort to understand rodent care and processes for monitoring rodent health. It has the potential to reduce the costs of health monitoring while improving the quality of care for research animals.

Electronic Signature Capture and Data Transfer

The Indian Health Service’s Phoenix Indian Medical Center (PIMC) has over 1,000 patient visits daily. Many of these patients need to complete insurance verification forms and multiple signatures are required for treatment and billing. In the past, paper forms were printed, verified by the patient or amended, and signed by the patient. Hospital staff then transported the signed forms to a separate building with a medical records facility, where they were scanned and stored. This process is cumbersome and inefficient.

In an effort to reduce labor and equipment costs and improve patient care, PIMC has tested and is adopting an electronic signature pad to capture patient signatures electronically. This system would create electronic forms and upload the signed forms directly into the network safely and efficiently.

Streamlining Acquisition of Lab Supplies

HHS currently purchases laboratory supplies using a variety of methods that are expensive, inefficient, and duplicative. The HHS Program Support Center is developing an end-to-end process to acquire laboratory supplies by creating an online marketplace to be used by laboratories across HHS. By applying proven supply chain and category management methodologies along with state of the art technology, HHS can reduce inefficiencies, improve consumer satisfaction, and enhance business processes. This approach is scalable to other commodities purchased across HHS and the federal government.

For more information on HHS Ventures, visit https://www.hhs.gov/about/agencies/octo/index.html

 

 

On May 17, 2017, the Centers for Medicare & Medicaid Services (CMS) announced a new streamlined and simplified direct enrollment process for consumers signing up for individual market coverage through Exchanges that use HealthCare.gov.

Consumers applying for individual market coverage during the upcoming open enrollment period through direct enrollment partners will now be able to complete their application using one website. This reduces needless regulatory burden for businesses that provide direct enrollment services and offers consumers easier access to healthcare comparisons and shopping experiences for coverage offered through HealthCare.gov.

In prior years, consumers who signed up for health coverage using a third party website were redirected to HealthCare.gov to complete their application. Consumer feedback showed that the process was confusing and made it harder to finish the application. The new process allows consumers to start and finish their application through the third-party website of direct enrollment partners approved to use the proxy direct enrollment pathway.

The guidance announced today is part of a larger CMS effort intended to stabilize the health insurance market by providing more ways for consumers to access coverage. To read more about the guidance, visit: https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/Guidance-for-the-Proxy-Direct-Enrollment-Pathway-for-2018-Individual-Market-Open-Enrollment-Period.pdf

 

05-12-2017

The Centers for Disease Control and Prevention (CDC) issued a Health Alert Notice with updated guidance for healthcare professionals to interpret Zika test results for women who live in, or frequently travel (daily or weekly) to areas with a CDC Zika travel notice.

This change is being made because CDC’s Zika testing guidance for pregnant women relies, in part, on a test [Zika virus Immunoglobulin M (IgM) ELISA] to detect Zika antibodies or proteins that the body makes to fight Zika infections. New data suggest that Zika virus infection, similar to some other flavivirus infections, may result in Zika antibodies staying in the body for months after infection for some individuals. As a result, results of these tests may not be able to determine whether women were infected before or after they became pregnant.

Specifically, CDC recommends the following guidance for healthcare professionals evaluating women without symptoms who had potential Zika exposure—particularly women who live in or frequently travel (daily or weekly) to areas with CDC Zika travel notices. Use of these tests may be helpful, but may not always be conclusive, in distinguishing how recent the infection is.

Screen pregnant women for risk of Zika exposure and symptoms of Zika. Test pregnant women promptly, using nucleic acid testing (NAT), if they develop symptoms at any point during pregnancy or if their sexual partner tests positive for Zika virus infection;

Consider NAT testing at least once during each trimester of pregnancy to detect evidence of Zika virus, unless a previous test has been positive;

Consider testing specimens obtained during amniocentesis to detect evidence of Zika virus if amniocentesis is performed for other reasons;

Counsel all pregnant women each trimester about the limitations of Zika testing.

For women planning to become pregnant who might have been exposed to Zika previously, healthcare professionals can consider testing for Zika antibodies before pregnancy. Antibody test results before pregnancy should not be used to determine if it is safe for a woman to become pregnant. Rather, testing before pregnancy can help determine whether a woman becomes infected during pregnancy. For example, if a woman has a negative result before pregnancy and a positive result when she is tested during pregnancy, it is more likely that the woman experienced an infection during pregnancy.

For information on geographic areas with Zika transmission, visit Areas with Risk of Zika. For the most current information about Zika virus, visit http://www.cdc.gov/zika/. Also, to see a searchable database of specialists available in several states, the U.S. Virgin Islands, and Puerto Rico, visit http://www.zikacareconnect.org/.

 

05-12-2017

The Centers for Disease Control and Prevention (CDC) issued a Health Alert Notice with updated guidance for healthcare professionals to interpret Zika test results for women who live in, or frequently travel (daily or weekly) to areas with a CDC Zika travel notice.

This change is being made because CDC’s Zika testing guidance for pregnant women relies, in part, on a test [Zika virus Immunoglobulin M (IgM) ELISA] to detect Zika antibodies or proteins that the body makes to fight Zika infections. New data suggest that Zika virus infection, similar to some other flavivirus infections, may result in Zika antibodies staying in the body for months after infection for some individuals. As a result, results of these tests may not be able to determine whether women were infected before or after they became pregnant.

Specifically, CDC recommends the following guidance for healthcare professionals evaluating women without symptoms who had potential Zika exposure—particularly women who live in or frequently travel (daily or weekly) to areas with CDC Zika travel notices. Use of these tests may be helpful, but may not always be conclusive, in distinguishing how recent the infection is.

Screen pregnant women for risk of Zika exposure and symptoms of Zika. Test pregnant women promptly, using nucleic acid testing (NAT), if they develop symptoms at any point during pregnancy or if their sexual partner tests positive for Zika virus infection;

Consider NAT testing at least once during each trimester of pregnancy to detect evidence of Zika virus, unless a previous test has been positive;

Consider testing specimens obtained during amniocentesis to detect evidence of Zika virus if amniocentesis is performed for other reasons;

Counsel all pregnant women each trimester about the limitations of Zika testing.

For women planning to become pregnant who might have been exposed to Zika previously, healthcare professionals can consider testing for Zika antibodies before pregnancy. Antibody test results before pregnancy should not be used to determine if it is safe for a woman to become pregnant. Rather, testing before pregnancy can help determine whether a woman becomes infected during pregnancy. For example, if a woman has a negative result before pregnancy and a positive result when she is tested during pregnancy, it is more likely that the woman experienced an infection during pregnancy.

For information on geographic areas with Zika transmission, visit Areas with Risk of Zika. For the most current information about Zika virus, visit http://www.cdc.gov/zika/. Also, to see a searchable database of specialists available in several states, the U.S. Virgin Islands, and Puerto Rico, visit http://www.zikacareconnect.org/.

 

05-05-2017

The Food and Drug Administration (FDA) released unpublished Interim Final Rule (IFR) on May 1 (and scheduled to be published in the Federal Register on May 4), which delays the compliance date for its regulations governing calorie labeling for menus and menu boards at restaurants and similar retail food establishments.

In the notice, FDA states that it will delay the compliance date for menu labeling from May 5, 2017 to May 7, 2018. The Agency is reconsidering certain aspects of the menu labeling regulations and requesting comments from industry and other stakeholders. FDA says it is “taking this action to enable [FDA] to consider how we might further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objectives, in keeping with the Administration’s policies.”

The delay in the compliance date will be effective immediately upon formal publication of the IFR in the Federal Register. FDA cites the good cause exception of the Administrative Procedure Act (5 U.S.C. 553(b)(B)) as its basis for not following notice and comment rulemaking before issuing the delay. Specifically, the Agency says that because “a number of regulated establishments continue to raise numerous, complex questions about applicability of the menu labeling requirements and about how to implement them, we have decided that providing an opportunity for public comment would be impracticable and contrary to the public interest.”

FDA is particularly interested in “approaches to reduce the regulatory burden or increase flexibility with respect to:

Calorie disclosure signage for self-service foods, including buffets and grab-and-go foods;

Methods for providing calorie disclosure information other than on the menu itself, including how different kinds of retailers might use different methods; and

Criteria for distinguishing between menus and other information presented to the consumer.

FDA is requesting that comments be submitted within 60 days after the IFR is published, i.e., by July 3, 2017.

 

The Centers for Disease Control and Prevention announced that the death rate for African-Americans (blacks) has declined 25 percent from 1999 to 2015. 

The study finds there are still disparities between blacks and whites. Although blacks as a group are living longer, their life expectancy is still 4 years less than that of whites.

Disparities in all age groups are narrowing because death rates are declining faster among blacks than among whites. The overall disparity in death rates between these two races for all causes of death in all age groups was 33 percent in 1999 but fell to 16 percent in 2015.  The racial death rate gap closed completely for deaths from heart disease and for all causes of death among those 65 years and older.

Of concern, the study also found that blacks in their 20s, 30s, and 40s are more likely to live with or die from conditions that typically occur at older ages in whites, including heart disease, stroke, and diabetes. Risk factors for some diseases, such as high blood pressure, may go unnoticed and untreated during these early years. Notably, the death rates for homicide among blacks did not change over the 17 years of the study.

The report also describes improvements in other causes of death, such as a dramatic decrease of about 80 percent in HIV deaths among 18- to 49-year-olds from 1999-2015. Dramatic drops in HIV deaths were also seen among whites. Still, a wide disparity remains with blacks seven to nine times more likely to die from HIV.

Among the key findings from the report:

Blacks ages 18 to 64 are at higher risk of early death than whites.

Disparities in the leading causes of death for blacks compared with whites are pronounced by early and middle adulthood, including homicide and chronic diseases such as heart disease and diabetes.

Blacks ages 18-34 years and 35-49 years are nine times and five times, respectively, as likely to die from homicide as whites in the same age groups.

Blacks ages 35-64 are 50 percent more likely to have high blood pressure than whites.

Blacks ages 18-49 years, are two times as likely to die from heart disease as whites.

Blacks have the highest death rate for all cancers combined compared with whites.

The federal government collects data on prevention measures and risk factors that impact health through programs such as Healthy People 2020. For more information on CDC efforts to reduce disparities through prevention and removing barriers to health equity, visit www.cdc.gov/healthequity.

 

 

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