Update: After publication of this story, BCBS clarified that the contract with Palmetto GBA is not yet finalized for 2017.
NEW YORK (GenomeWeb) – Evidence Street, the Blue Cross Blue Shield Association's web-based evidence review platform for medical products that's been operational for around 15 months, is continuing to grow its influence within the diagnostics sector and among payors.
Several molecular diagnostics companies, which as a sector generally cite reimbursement coverage as one of its biggest headaches, recently touted Evidence Street opinions on their tests as milestones. Moreover, MolDx, a program run by Medicare contractor Palmetto GBA that evaluates the clinical utility of molecular tests and determines coverage, may soon be using Evidence Street's assessments.
"At Evidence Street, our expertise is evidence review. We don't make coverage decisions," said Suzanne Belinson, the BCBS executive director who manages the platform, in an interview. "And in fact, in 2017, MolDx is going to stop doing evidence reviews and leverage ours." BCBS clarified after publication of this story that the contract with Palmetto is not yet finalized for 2017.
The arrangement evolved out of a pilot that MolDx conducted with Evidence Street last year. Belinson explained that MolDx, as well as the 36 independent, community-based plans under BCBS that determine coverage for 106 million Americans, will continue to be responsible for making local coverage decisions, but they can use Evidence Street opinions as part of the process for determining coverage.
According to experts knowledgeable of the process, Evidence Street evaluates peer-reviewed publications, summarizes the data, and makes a judgement as to whether the published literature provides "strong evidence" for a particular technology, and notes for example, if there are biases in the clinical studies conducted.
Using this information, the plans "have total latitude to make their own coverage decision," Belinson said. "Coverage is more complex than just a review of the evidence. It's one piece."
Outsourcing technology assessments in this manner isn’t unusual. For example, CMS has commissioned national technology assessments through the Agency for Healthcare Research & Quality, which in turn has contracted out to other evidence review centers, such as BCBS's Technology Evaluation Center.
"The science is the science," said Louis Jacques, chief clinical officer at consulting firm ADVI and previously the director of the Centers for Medicare & Medicaid Services' Coverage and Analysis Group. "It seems inefficient to have every payor in the country separately review the same scientific material."
"Evidence Street will not be writing Medicare policy," Jacques added, but he agreed with Belinson that the arrangement with Evidence Street could free up MolDx to focus more of its resources on developing and maintaining local coverage determinations.
"They still have to go through advisory committees, give public notice, and publish draft and final policies." he said. "LCD development is a heck of a lot of work." Moreover, having Evidence Street do a technical assessment wouldn't preclude MolDX from doing its own technical reviews if necessary to address questions that specifically arise from the Medicare program rules or the special needs of the beneficiary population.
Nonetheless, Evidence Street's assessments carry weight, not just among BCBS member plans, but in the broader payor community. The biggest insurers in this country, such as Aetna and Cigna, cite its opinions in their coverage decisions. Belinson noted that CMS' Medicare Evidence Development & Coverage Advisory Committee has referenced its work.
Her hope is that Evidence Street will have a broad impact. "That's exactly the vision," she said. "The vision is that there be a standard, common evidence review that has had an opportunity to have input from multiple stakeholders, meaning payors, manufacturers, clinical experts, and that evidence review could then be picked up and utilized by any decision maker … and leveraged within the local coverage process."
Stakeholders can access Evidence Street opinions through its website, which requires a password for access under a subscription agreement. Depending on the type of organization, some subscribers will pay more than others, and some may get free access.
Regardless of Evidence Street's subscription model, if Palmetto is planning to use that information in its Medicare coverage decisions, then the content of those technology assessments may have to be more widely accessible, Jacques predicted, because of Medicare requirements for public transparency and stakeholder input in coverage policymaking.
"People who aren't Evidence Street subscribers are going to have to be able to look at the scientific rationale supporting a local coverage determination," Jacques said. "They're going to have to get a look behind the curtain. I have no reason to believe that public participation in the LCD process or submission of a dossier for technical review would require subscription or payment."
Meanwhile, the subscription model provides a revenue stream for BCBS and allows Evidence Street to provide added services. "There has to be a business model behind it because we are providing additional services to generate efficiencies for the manufacturers that subscribe, but the review itself is the same regardless," Belinson said, adding that the subscription agreement terms allows users to share the assessments.
The advantage to a drug or test manufacturer that pays for a subscription to Evidence Street is that they can receive information about the timing of a review, use a structured format for submitting evidence, access Evidence Street's assessments, and importantly, receive feedback from experts about the evidence they included and excluded, as well as the gaps in the current evidence. Â
Insurers' evidence evaluation processes can be an enigma, particularly for developers of genetic and molecular tests employing relatively new technologies and complex algorithms, which insurers can be reticent to cover. Insurers usually want to see that a medical intervention has clinical utility, measured ideally in terms of a survival advantage, which is a challenge for diagnostics to demonstrate. Device and test makers often struggle to figure out just what it will take to appease insurers' technology assessment groups.
Evidence Street provides opportunities for engagement in this regard. Recently, several molecular diagnostic companies announced they had received positive assessments for their tests from Evidence Street, including Exact Sciences, Interpace Diagnostics, and Myriad Genetics.
Molecular tests are a growing part of the technologies that Belinson's team reviews. Evidence Street takes up approximately 460 evidence reviews per year with each review containing multiple technologies. Approximately one-fifth of those reviews, which are initiated by BCBS, are in the genetics and molecular diagnostics space, according to Belinson.
During Myriad Genetics' second quarter earnings call this week, CEO Mark Capone highlighted the progress the firm's EndoPredict breast cancer prognostic test has made in securing managed care coverage. "Evidence Street ... issued a favorable recommendation for the test, that was followed by favorable coverage decisions from 19 payors, bringing total coverage to over 70 million patients," Capone said during the call.
Similarly, Exact Sciences in January received what it characterized as a "positive review" from Evidence Street for Cologuard, a screening test that analyzes elevated levels of altered DNA in stool samples associated with colon cancer or pre cancer.
Exact engaged with BCBS's Center for Clinical Effectiveness (an earlier iteration of Evidence Street) before the company garnered FDA approval for Cologuard in 2014, and has continued to submit data from clinical trials as it emerged. Once Evidence Street came online, Exact became a subscriber. "Prior to Evidence Street there wasn't a true vehicle for having a conversation back and forth" with an evidence evaluation group, Exact CEO Kevin Conroy said. "Evidence Street allows a thoughtful, systematic way for companies with new technologies to engage with the center."
Before receiving the positive opinion for Cologuard from Evidence Street, 23 BCBS plans had already decided to cover the test. Conroy believes that the remaining 13 BCBS plans will weigh Evidence Street's opinion favorably the next time they consider coverage for colon cancer screening technologies, and it may also have sway with other insurers.
"They are very influential," Conroy said of Evidence Street. "They are highly regarded."