Life-Altering Information, or Just For Fun?

Posted by Nancy Ledbetter, Research Analyst on August 22, 2017

Helix, a company formed by Illumina in 2015, has drawn a new section on the blurry line between healthcare and entertainment using direct-to-consumer (DTC) genetic tests. For the surprisingly low price of $80, Helix will sequence a person’s exome, using the same Illumina machines most researchers use. After a one-time saliva submission, Helix clients can choose from a menu of existing analyses from outside vendors that vary from < $100 to about $250. Currently, the Helix website lists 19 different options for clients to learn about their DNA. They include one that uses DNA information to inform which wines are likely to be appealing and another for learning carrier status for a host of mutations that are associated with disease (e.g., cystic fibrosis) for future children if both parents are carriers. As Helix adds more vendors, clients will have the opportunity to order additional analyses to learn more information around their genetic make-up.

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Topics: Hayes Blog, Healthcare Evidence, Genetic Testing, Consumers

Evidence Provides a Framework for Genetic Testing

Posted by The Evidence Blog on July 20, 2017

Clinical applications of genetic/genomic testing are potentially important but, as others have observed, “the current knowledge base . . . to turn the promise of genomic medicine into reality is severely limited.”

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Topics: Hayes Blog, Genetic Testing

Value Analysis and Bundled Payments at the AHRMM17 Conference

This summer, we have been fortunate enough to have been asked to speak at the 2017 Association of Healthcare Resource and Materials Management conference (AHRMM17). The organization is the premier membership group for healthcare supply chain professionals and we’re honored to have been invited back to speak. This year, we will present “Value Analysis and Evidence: The Keys to Bundled Payment Success."

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Topics: Hospitals, Hayes Blog, Health Technology Assessments,

FDA Announces New Premarket Notification Exemptions

On July 11, 2017, the FDA announced Exemptions from Premarket Notification: Class II Devices. The list, which includes more than 1,000 class II devices, includes genomic platforms and tools:

  • High-throughput DNA sequence analyzer
  • DNA genetic analyzer
  • Mass spectrometer for clinical multiplex test systems
  • Real-time nucleic acid amplification system
  • Complete gene expression profiling accessory reagents
  • Quality control DNA materials 

 So what does this mean for genetic tests?

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Topics: Hayes Blog, Genetic Testing

How Do You Make Your Health Technology Acquisition Decisions?

Despite the instability facing the American healthcare landscape at present, there continues to be growing focus on value. The Patient Protection and Affordable Care Act (ACA) has placed an increased emphasis on healthcare quality and patient satisfaction, especially with regard to Medicare reimbursement. Private payers are also seeking payment structures based on patient outcomes. In the face of such economic pressures, deciding which technologies to incorporate into patient care is a challenge, and will continue to be so in the future as new health technologies and brands enter the market. To meet clinical as well as financial goals, providers need to make sure that the health technologies they adopt are safe and have proven benefit, and are cost-effective.

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Topics: Health Technologies, Hospitals, Hayes Blog, Healthcare Evidence

Abstracts Are Not Evidence

We get it. Time is valuable. Particularly your own. Whether you are a payer, a healthcare provider, or a supply chain or value analysis professional, you have to make the most of the time you have to get your job done. When it comes to your search for evidence to determine whether a medical technology is safe, efficacious, and the best option, maybe you only read the abstract of an original research article for a quick overview of the results. Perhaps you couldn’t access the full text of the article without incurring a charge. The truth is, we have all done it at one point or another, primarily because we believe that the abstract provides an accurate synopsis of the highlights of the study.

In many cases, however, it doesn’t.

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Topics: Hayes Blog, Healthcare Evidence, Health Technology Assessments,

Solving Your Coverage Policy Challenges with Evidence: A Hayes Webinar

Posted by Maura Connor, Chief Operating Officer on June 22, 2017

When it comes to making any coverage policy determination, payers must consider answers to the following questions:

Does the technology work?

Is it safe?

For whom does it work?

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Topics: Payers, Hayes Blog

Questions About Genetic Test Coverage? We’ve Got Answers.

The rapid rise in the number of commercially available genetic tests, along with the growth of a genomic approach to healthcare, can make you feel as though you are standing at the entrance to a complicated maze. Not only are there currently more than 65,000 tests available, but many of these tests have their twists and turns in the form of classifications and subdivisions, with little to no quality research to prove their reliability, safety, and efficacy. This raises doubts not only about the ethics of performing some of these tests, but about which tests to cover.

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Topics: Payers, Hayes Blog, Genetic Testing, Health Technology Assessments,

Getting to Know Hayes: Marco Angeli, Innovation Product Owner

Posted by The Evidence Blog on June 20, 2017

Hayes is a company of real people. We’d like you to get to know us and the ways we strive to provide personalized service to you, our clients. This month, let us introduce you to another valuable contributor to the Hayes mission of providing fiercely-unbiased evidence, and our product owner of client-led product innovation. Meet Marco Angeli.

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Topics: Hayes Blog, Innovation

Origins of Opioid Epidemic Linked to Weak Evidence

With the recent and controversial proposed changes to the American healthcare system looming large, one narrative has been at the forefront: how will these changes affect the battle being waged against the opioid addiction epidemic?

The statistics surrounding the widespread damage caused by opioid abuse and addiction are staggering. According to the American Society of Addiction Medicine (ASAM):

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Topics: Hayes Blog

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