6 days ago
National health coordinator wants to certify how data moves
WASHINGTON WATCH
On the same day last week that the Centers for Medicare and Medicaid Services rolled out plans to ease the flow of health information, the Office of the National Coordinator for Health IT made two fairly significant announcements at an event in the Eisenhower building.
'The first was that we were going to continue our work on certification, and that this was going to include certification of APIs to improve interoperability,' Tom Keane told Ruth. 'The other thing I talked about is how we were going to enforce the information blocking.'
Keane did not specify a timeline for when the agency would start certifying what are known as APIs, which are the means by which information is sent and received between applications. He also didn't provide information about when or how that the ONC would start enforcing information blocking, the practice of preventing payers, patients, and providers from accessing electronic health information. The agency hasn't yet penalized companies that unreasonably limit access to health data.
Ryan Howells, a partner at health care policy consulting firm Leavitt Partners, says that these changes could unclog data congestion and pave the way for better use of technology in health care.
'It will unleash more health care technology innovation than we've ever seen both inside and outside the EHR,' said Howells, a partner at health care policy consulting firm Leavitt Partners, who published a paper earlier this year proposing that the ONC start certifying the way data transfers instead of focusing on EHR features.
He said this will incentivize EHR companies to make it easier to move health data out of the silos it sits in.
ONC also dropped new rules. The finalized rules were a subset of those proposed last year, under former President Joe Biden, that support President Donald Trump's desire to make prior authorization less arduous.
In June, Trump secured commitments from the largest health insurers in the country that they would improve the process of obtaining prior authorization.
Here's what's in ONC's HTI-4 final rule:
— Adds new certification criteria enabling prescribers to check patients' benefit information in real time
— Updates its baseline standard for e-prescribing, for the first time in a decade and requires that prescriber systems support functionality for electronic prior authorization of prescriptions
— Requires electronic health record companies to follow ONC guidelines to help standardize electronic prior authorization
What does all this mean? One big takeaway is that CMS is driving the agenda for how data flows between entities in health care and ONC is playing a supporting role.
Also, despite Trump's overall deregulatory approach, it does seem that the administration is willing to push forward some rules.
Brendan Keeler, interoperability policy lead at tech consultancy HTD Health, told POLITICO he wouldn't discount the industry pledges that Trump has sought as a mere stunt.
'This isn't a pledge, this is a competition,' Keeler said of the Trump executive order unveiled last week. 'If they don't get what they want, it can turn very punitive very quick.'
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The Federal Trade Commission is mapping the future of competition in the drug market. It will host a third and final listening session this afternoon on how the agency can use its authority to help lower drug prices in the U.S.
In April, President Donald Trump signed an executive order urging federal agencies to ensure 'federal health care programs, intellectual property protections, and safety regulations are optimized to provide access to prescription drugs at lower costs to American patients and taxpayers.'
Part of that order gave the FTC 180 days to conduct listening sessions on reducing anticompetitive behavior from drug manufacturers and write a final report.
In its sessions, the FTC has looked at claims that drugmakers stifle generic or biosimilar competition and preserve market dominance through price-fixing, rebates and fraudulent entries in the so-called Orange Book, which lists Food and Drug Administration-approved drugs. The FTC is also reviewing the role of pharmacy benefit managers, which negotiate drug costs for insurers and employers, in drug pricing.
'To promote competitive pharmaceutical markets, we need to identify and eliminate all forms of rent-seeking activity that allow companies to reap financial rewards that are entirely out of proportion to their contribution to genuine innovation in pharmaceuticals,' FTC Chair Andrew Ferguson said during the agency's July 24 session.
He has already initiated antitrust enforcement: In May, the FTC sent letters to Amphastar Pharmaceuticals, Covis Pharma, Mylan Specialty, Novartis and three Teva entities, disputing more than 200 patent listings in the Orange Book.
This third session, titled 'Turning Insights into Action to Reduce Drug Prices,' is expected to include discussions about how the FTC could use its authority to increase market competition and determine what new laws would be needed to support that effort.
