Archive for February, 2013

Feb 28 2013

New Recommendation from EGAPP Working Group

Published by under Announcements

The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group recently published a new recommendation regarding genetic testing for patients with metastatic colorectal cancer. After reviewing the evidence, the EGAPP Working Group found that, for those patients being considered for treatment with cetuximab or panitumumab, there is convincing evidence to recommend clinical use of KRAS mutation analysis to determine which patients are KRAS mutation positive and therefore unlikely to benefit from these agents before initiation of therapy. The EWG found insufficient evidence to recommend for or against BRAF V600E testing, NRAS testing, PIK3CA testing, and loss of expression of PTEN or AKT proteins for the same clinical scenario.

For more information, go to: http://www.egappreviews.org/recommendations/EGFR.htm

For the EGAPP publication, go to: http://www.nature.com/gim/journal/vaop/ncurrent/full/gim2012184a.html

 

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Feb 22 2013

American Public Health Association’s Health Reform Update

Published by under Announcements

The U.S. Department of Health and Human Services recently revamped its official health reform websites (healthcare.gov and cuidadodesalud.gov), and released several new resources for educating the public about the health insurance marketplaces. Also known as exchanges, the marketplaces will open for enrollment in October and new plans and benefits will begin as early as January 2014. Several great new resources are:

New regulations and recommendations

An important part of implementing the Affordable Care Act is the federal rulemaking process, in which executive agencies issue guidance and invite public comment on the details of how the law will work. In the months since the November elections, a number of new regulations have been issued by the departments of Health and Human Services, Labor and Treasury. For brief explanations of each rule, to see other rules recently released and to learn more about the rulemaking process, visit our ACA Implementation page at http://www.apha.org/advocacy/Health+Reform/implementation/.

New “streamlined applications for health insurance”

Also recently released for public review are drafts of new streamlined applications for health insurance, which are intended to be “single points of entry” to various coverage options. The applications are meant to allow people to purchase private insurance in the individual or small business marketplaces, and at the same time to assess their eligibility for assistance through Medicaid, the Children’s Health Insurance Program or the advanced payment of tax credits — subsidies to purchase coverage in the Marketplaces. The Centers for Medicare and Medicaid Services is inviting public comment on the individual, small business owner and small business employee applications. To demonstrate the user experience, CMS has posted two videos of the application being completed, one by an individual and one by a family of three.

State decisions on coverage expansions, marketplaces and essential benefits

While the federal government has been busy issuing regulations, resources and more over the past several months, the states have had some big decisions to make.

Medicaid expansion:

Last summer the Supreme Court upheld the Medicaid expansion but restricted the federal government from penalizing states that don’t expand their programs. The states that do opt in will receive generous federal funding to expand eligibility to nearly all residents with incomes up to 133 percent of the federal poverty level, starting in January 2014. As of Feb. 9, 24 states will expand or are likely to, 20 won’t expand or are not likely to, and seven are still undecided. To track the status of your state, you can go to the following websites:

Insurance marketplace design:

States have several options for setting up the new health insurance marketplaces, also known as “exchanges”: they can run their own state-based marketplace; opt for a state-federal partnership or largely opt out and request a federally-facilitated marketplace. States had until Dec. 14 to choose a state-based model; 17 states and the District of Columbia are doing this. In January, $1.5 billion in new grants went to 11 states working to establish their exchanges. Feb. 15 is the deadline for states to choose a partnership model; seven states have done so as of Feb. 8. So far, 26 states will default to federally-facilitated marketplaces, but this number may change as states finalize their decisions and HHS reviews their plans. The Kaiser Family Foundation is tracking this information at http://statehealthfacts.kff.org/comparetable.jsp?ind=962&cat=17&sub=205&yr=1&typ=5#notes-1.

Essential health benefit “benchmark” plans:

Regardless of what type of marketplace a state chooses, each state has also had to choose one of several types of insurance plan to indicate to insurers the “benchmark” for required coverage of ten categories of essential health benefits. States had until Dec. 26 to choose their benchmark or default to the benchmark plan by the federal government. Kaiser Family Foundation has more information on EHB and the states’ decisions at: http://www.kff.org/healthreform/quicktake_essential_health_benefits.cfm

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Feb 22 2013

NIH-NICHD Initiative: Pilot Newborn Screening Studies of Novel Technologies in a High Throughput Environment

Published by under Announcements

It has become evident that a major impediment to implementing new technologies in high throughput newborn screening laboratories is the ability to provide evidence of the feasibility of the assay, both scientifically and logistically, in a timely manner. This is especially apparent when screening for rare diseases where the likelihood of detecting cases during standard newborn screening in a single laboratory is low. Collaborative efforts, implemented across multiple states or newborn screening laboratories, are necessary for the successful development and implementation of new assays.

The purpose of this initiative is to establish a resource to be used to support the development of novel technologies in newborn screening by providing access to a pool of high throughput newborn screening laboratories (state or private) with the capacity to screen a large number of newborns in relatively short periods of time (12-18 months).

It is the intent of this initiative to encourage collaboration with other Federal agencies with each agency focusing on their areas of expertise in the field. The project will also leverage resources that are part of NICHD’s Newborn Screening Translational Research Network (NBSTRN) including access to the Laboratory Performance Program developed to collect, aggregate, and analyze de-identified screening data.

Requirements:

To be deemed capable of being included in the pool, the offeror must submit a written capability statement that clearly demonstrates their experience and ability to provide the following capabilities:

  • Technical expertise and large-scale capacity to test for NICHD in identified newborn dried blood spots using appropriate screening technology either immediately or with a short set up period (less than3 months).
  • Ability to provide efficient confirmatory testing procedures for presumed positive results.
  • The capacity and resources needed for tracking positive cases and arranging for appropriate follow up care and referral of identified newborns who have screened positive for pilot disorders care in a timely manner.
  • An administrative structure that is conducive to prospective, rather than retrospective, pilot testing (including documentation of ability to obtain human subjects approval within 6 months of being presented with an NICHD nominated condition).
  • Adequate quality assurance and quality control procedures in place for accurate assessment of findings.

AT THIS TIME THE NICHD IS REQUESTING CAPABILITY STATEMENTS FROM ALL QUALIFIED BUSINESSES. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSAL.

All qualified businesses who believe that they have the capabilities described above are encouraged to submit two copies of a written capability statement to attention of Katharine Minker, Contracting Officer, at the address provided by 3:00 PM local time on March 15, 2013. The address where capability statements should be mailed to is: NIH, NICHD Office of Acquisitions, 6100 Executive Blvd., Room 7A-07 MSC 7510, Bethesda, Maryland 20892-7510. The Capability Statement should be limited to no more than 15 pages and it should clearly address each of the competencies stated above.

For more information, go to: https://www.fbo.gov/index?s=opportunity&mode=form&id=33e1a9673e0fe9705b20498c52933ceb&tab=core&_cview=0

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