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Washington Debrief: Direct Guidance Released for Stage 2 Assistance

June 4, 2013
by Jeff Smith, Director of Public Policy at CHIME
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Jeff Smith, Director of Public Policy at CHIME

ONC Unveils Direct Guidance to Help Providers in Stage 2

Recently, Office of the National Coordinator for Health IT (ONC) released programmatic guidance for State HIE grantees who act as Health Information Service Providers (HISPs) for providers to engage in Direct, point-to-point, exchange.  According to ONC, they have found that HISPs are deploying Direct in a way that “enables exchange within a given HISP’s boundaries while not offering mechanisms or supporting policies that enable exchange with other HISPs.”  This guidance is meant to address this problem.  The document defines and recommends guidelines for:

  •          Security and Trust Agents (STAs), another designation for HISPs, that facilitate Direct exchange services;
  •          Registration Authorities (RAs) that establish the identity of providers and;
  •          Certificate Authorities (CAs) that issue certificates.

“ONC believes that adoption of these consensus policies…will enable providers to easily and securely exchange patient health information using Direct irrespective of organizational and vendor boundaries to meet Stage 2 Meaningful Use exchange requirements and overall care coordination needs” [emphasis added].  And this is why it matters: Direct will most likely be the most viable way for many providers to meet exchange requirements under Stage 2, but the task is not as simple as its early cheerleaders would have you believe (especially in moving information across vendor boundaries).  ONC has tapped DirectTrust to “establish and promote the adoption of security and trust ‘rules of the road,’ including the guidelines issued by ONC for Direct exchange, operationalized via accreditation,” ONC’s Kory Mertz wrote in a Buzz Blog.  According to DirectTrust CEO, Dr. David Kibbe, they’re getting engaged with the vendor community and the HISPs, but many providers have not yet clued into the importance of Direct governance. 

This is an important conversation for CHIME members to engage as they prepare for Stage 2.  And expect more practical Direct implementation advise from ONC and CMS – instead of just extolling Direct’s virtues – moving forward.

House Committee Unveils Draft Legislation to Repeal SGR

The House Energy and Commerce Committee unveiled draft legislation to repeal the current Sustainable Growth Rate (SGR) system recently.  The draft legislation is the latest step to reform the system and reward providers for delivering high-quality, efficient health care.  On February 7, the Energy and Commerce and Ways and Means Committees outlined a framework to reform the current Medicare system that is fiscally responsible and free of politics.  Committee leaders sought feedback and in early April outlined additional details of a proposal to repeal and replace the current SGR.  Missing from this draft legislation was how the Committee was thinking about paying for the permanent fix; an update to how much a fix would cost or what the quality / alternative payment structure would look like.

Several groups, Republicans and Democrats, in both the House and Senate are focused on ways to repeal the SGR and phase in a reimbursement model that leads providers away from fee-for-service.  This draft legislation joins a bill, HR 574offered by House Representatives Allyson Schwartz (D-PA) and Rep. Joe Heck (R-NV) that would repeal the SGR, while also incentivizing innovative payment and delivery models.  So far, these are the only pieces of legislation – draft or otherwise – up for debate.  But there will be more to follow.

The Energy & Commerce Subcommittee on Health has scheduled a hearing on the draft legislation for June 5 and is requesting feedback by June 31.

ONC Asks for Public Input on FDASIA Workgroup Deliberations

On Thursday of this week, ONC released a request for comment (RFC) asking for input “on the elements we should consider as we develop a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework for health IT, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.”  The three-question RFC asks:

  1. What types of health IT should be addressed by the report developed by FDA, ONC, and FCC?
  2. What are the risks to patient safety posed by health IT and what is the likelihood of these risks?  What factors or approaches could be included in a risk-based regulatory approach for health IT to promote innovation and protect patient safety?
  3. Are there current areas of regulatory overlap among FDA, ONC, and/or FCC and if so, what are they? Please be specific if possible.  If there are areas of regulatory overlap, what, if any, actions should the agencies take to minimize this overlap? How can further duplication be avoided?

These wide-reaching questions mirror those that a 30-member FDASIA Workgroup was asked to answer over the summer.  While the official deadline is August 31, the RFC reads, “For commenters that wish to have their comments considered by the FDASIA Workgroup, we encourage you to submit your comments as early as possible and preferably before June 30, 2013.”  Several groups in Washington have convened in an effort to inform FDASIA Workgroup deliberations.

CHIME StateNet to Tackle Patient Matching, Consent Policy through New Workgroups

CHIME Members and CHIME Foundation Firm members:  We would like to invite you to join our StateNet workgroups!  We are looking for health IT stakeholders with experience working on patient matching and consent policy.  The workgroups will have a teleconference/phone call component and an online component through CIO StateNet.  After joining StateNet, we invite you to join the Patient Matching Group and/or the Consent Policy Group.  To begin, each workgroup will perform an environmental scan to better understand where gaps in policy and technology exist.  Then, each group will evaluate existing or possible solutions for recommendation to the StateNet Board.

In the coming weeks, we will be inviting vendors, HIEs, RECs, and other stakeholders to join these groups.  Please invite any colleagues you have that have experience with these issues.  To come up with viable solutions, we need insight from all stakeholders.


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