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With Passage of the 21st Century Cures Act, Interoperability Moves to the Front Lines

December 16, 2016
by Rajiv Leventhal
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The health IT provisions of the law have garnered plenty of industry buzz

With President Barack Obama’s signature earlier this week, the landmark 21st Century Cures Act was passed into law. The massive 996-page bill covers a wide array of healthcare issues, perhaps most notably focusing on medical research and changing the approval process for new drugs and medical devices.

But the bill also contains a number of provisions directly impacting the healthcare technology industry. As previously reported by Healthcare Informatics, some of the core health IT components of the legislation, as read in the “Title IV—Delivery” section of the law, include encouraging interoperability of electronic health records (EHRs) and patient access to health data, discouraging information blocking, reducing physician documentation burden, as well as creating a reporting system on EHR usability.

Drilling down, the interoperability and information blocking components of the legislation have seemed to garner the most buzz so far. The bill specifically defines interoperability as: (A) enables the secure exchange of electronic health information with, and use of electronic health information from, other health information technology without special effort on the part of the user; (B) allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law; and (C) does not constitute information blocking as defined in section 3022(a).

To this end, information blocking is defined in the law as, with respect to a health information technology developer, exchange, or network, business, technical, or organizational practices that, “except as required by law or specified by the Secretary, interferes with, prevents, or materially discourages access, exchange, or use of electronic health information; and the developer, exchange, or network knows, or should know, are likely to interfere with or prevent or materially discourage the access, exchange, or use of electronic health information.” And with respect to a healthcare provider, “such provider knows that such practice is unreasonable and is likely to interfere with, prevent or materially discourage access, exchange or use of electronic health information.”

What’s more, the act creates the EHR Reporting Program which will consist of reporting criteria on the product’s security, user-centered design, interoperability, and conformance to certification testing; among other categories, according to a College of Healthcare Information Management Executives (CHIME) handy crosswalk of the bill’s health IT provisions.


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The Cures Act legislation doesn’t come without consequence or penalty, either: regarding information blocking, developers, exchanges, and networks found to have engaged in data blocking and who have submitted a false attestation would be subject to civil monetary penalties not to exceed $1 million per violation.

Certainly, industry stakeholders are paying attention to the bill’s “teeth” around interoperability, as they should be, says Mandy Long, chair of the Healthcare Information and Management Systems Society (HIMSS) EHR Association Clinician Experience Workgroup and vice president of product management at Boca Raton, Fla.-based vendor Modernizing Medicine. “It’s really about the ability and risk of the vendor, because if you are a vendor seen as [engaging] in data blocking, you are able to receive a penalty up to $1 million on a per violation basis. That’s really significant,” Long says. “And there is also the ability to potentially lose your [EHR] certification if you’re not seen as interoperable. Those are very real ramifications and big incentives for vendors do right by their clients. You have an entire client base that’s reliant on you to participate in these quality programs. Vendors will need to make sure they’re listening and acting,” she says.

To this end, Long says that the provider community is well aware of the impact of a product they are using becoming de-certified. “So they’re focused on pushing to make sure their vendors are submitting reporting criteria, listening, and acting so they can continue to leverage that technology. It’s not as simple as switching vendors, which is cost-prohibitive, time-incentive, and challenging to take a legacy system that has decades of patient data and convert that to a new platform. If I were a provider I would be nervous about that,” she says.

Back to the vendor side, Long says that most of vendors she speaks to “know and act on the need to support and empower providers and patients through interoperability,” referring to the many vendors that are in the CommonWell and Carequality data sharing initiatives. She also brings up the newly-created Health Information Technology Advisory Committee that will merge and replace the existing Health IT Policy and Standards Committees. The bill calls for this committee to have “no less than 25 members, no fewer than two who are advocates for patients or consumers of health information technology.” Long asks, “What’s the composition of the group? And what’s the language to look and defer to the standards committees that already exist, and what standards may or may not already be in flight? Will we see them truly leverage some of the things that have been worked on with standards? That remains to be seen,” she says.

To this end, Christine Tremblay, director of product management at West Warwick, R.I.-based vendor Amazing Charts, notes that ONC’s 2015 Edition EHR Certification requires that vendors publish an open application programming interface (API), but no single standard is offered in that rule. In contrast, says Tremblay, “The Cures Act calls for a national API standard that covers authentication, security, auditability, and much deeper data interoperability. Curiously, the act mandates that stakeholders come together and publish API standards in one year. This deadline is simply too aggressive given the time and effort that will be required just to form a public-private partnership of stakeholders,” she adds.

Indeed, although most industry stakeholders and experts have reacted positively to the legislation, there are questions about how aggressive it is in parts. Law firm McDermott Will & Emery released a statement this week that said the health IT provisions “impose challenging requirements on industry participants, and it remains to be seen how the next Secretary of HHS will interpret and comply with those requirements.”

Lisa Schmitz Mazur, who is also a health law partner at McDermott, added in a statement, “Should Congressman Price be confirmed as Secretary of HHS, the industry can likely expect HHS to use the new authority provided to it under the Cures legislation to reduce requirements of the Meaningful Use and Advancing Care Information programs, electronic clinical quality measure reporting requirements and other federal requirements relating to HIT that are perceived to make providers less efficient without improving quality or reducing costs.”

And, in a review of the Cures Act on his blog, John Halamka, M.D., CIO of Boston-based Beth Israel Deaconess Medical Center, wrote, “I’ve written in the past that interoperability really means getting the information necessary for coordination of care to those who need it without too much difficulty. You could read the Cures language as making available every data element for every purpose to every stakeholder with no effort.  That is just not realistic.” Halamka added that he recently spoke with the CEO of an EHR company who said he has “committed 600 person years of resources to support the healthcare regulations already issued in the past 10 months.” Halamka further opined, “Asking the EHR vendors to do something vague like support all registries and provide for ‘complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law’ is like boiling the ocean with a lighter.”

David Levine, medical director and vice president of advanced analytics and informatics at Irving, Texas-based consultant Vizient, adds, “The legislation takes some measured steps aiming to improve interoperability, but whether it goes far enough, and actually stimulates interoperability remains to be seen.” 

Long further notes some of the Act’s vagueness, saying that the way information blocking is defined in the law, it gets to both the developer, through the technology itself via an health information exchange (HIE) or EHR vendor, and the providers.“[Vendors] try to make the ability to get data out of a system flexible no matter who is going to consume it—a patient, an HIE or a provider. So the guidance that comes out after this bill will be interesting. How do they further define data blocking beyond ‘likely to interfere,’ because that’s relatively nebulous,” she says.

Nonetheless, Tremblay notes that the Cures Act also brings a higher level of transparency than has ever been seen before in heath IT. “It proposes a reporting mechanism where information can be published about usability, interoperability, and other measurable criteria by which provides can choose which solution is best for their practice.  What’s most interesting about the self-reporting is that vendors can no longer simply say they are interoperable, they also need to provide a real-world example of interoperability, which is much higher bar to reach,” she says.

Long adds that the usability and user-centered design reporting is a big thing she will look for even though not much was written about it. “That is the key to all of it; if you achieve interoperability, that’s one thing, but if you can’t create a user experience that’s intuitive, evolving and serves up that data in a way that makes sense to the user, then it doesn’t work,” she says. “That’s what I keep calling out—it’s critical that we solve both problems at the same time, or we won’t have solved anything.”

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EHR-Compatible Pharmacist Care Plan Standard Opens the Door to Cross-Setting Data Exchange

September 14, 2018
by Zabrina Gonzaga, R.N., Industry Voice
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Pharmacists drive information sharing towards quality improvement

Pharmacists work in multiple environments—community, hospital, long term care, clinics, retail stores, etc.—and consult with other providers to coordinate a patient’s care.  They work with patients and caregivers to identify goals of medication therapy and interventions needed, and to evaluate patient outcomes.  Too often, pharmacy data is trapped in a silo and unavailable to other members of the care team, duplicated manually in disparate systems which increases clinical workloads without adding value.

To address these issues, Lantana Consulting Group and Community Care of North Carolina (CCNC) developed an electronic document standard for pharmacist care plans—the HL7 Pharmacist Care Plan (PhCP). The project was launched by a High Impact Pilot (HIP) grant to Lantana from the Office of the National Coordinator for Health Information Technology (ONC).

Before the PhCP, pharmacists shared information through paper care plans or by duplicative entry into external systems of information related to medication reconciliation and drug therapy problems. This documentation was not aligned with the in-house pharmacy management system (PMS). The integration of the PhCP with the pharmacy software systems allows this data to flow into a shared care plan, allowing pharmacists to use their local PMS to move beyond simple product reimbursement and compile information needed for quality assurance, care coordination, and scalable utilization review.

The PhCP standard addresses high risk patients with co-morbidities and chronic conditions who often take multiple medications that require careful monitoring. Care plans are initiated on patients identified as high risk with complex medication regimes identified in a comprehensive medication review. The PhCP is as a standardized, interoperable document that allows pharmacist to capture shared decisions related to patient priorities, health concerns, goals, interventions, and outcomes. The care plan may also contain information related to individual health and social risks, planned interventions, expected outcomes, and referrals to other providers. Since the PhCP is integrated into the PMS or adopted by a software vendor (e.g. care management, chronic management, or web-based documentation system), pharmacist can pull this information into the PhCP without redundant data entry.


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The PhCP allows pharmacists for the first time to share information with support teams and paves the way for them to support value-based payment. The project goals align with the Center for Medicare & Medicaid Services’ (CMS’) value-based programs, which are part of the Meaningful Measure Framework of improved care team collaboration, better health for individuals and populations, and lower costs.

Scott Brewster, Pharm.D., at Brookside Pharmacy in East Tennessee, described the PhCP as a tool that helps them enhance patient care delivery. “From creating coordinated efforts for smoking cessation and medication utilization in heart failure patients, to follow up on recognized drug therapy problems, the eCare plan gives pharmacists a translatable means to show their value and efforts both in patient-centered dispensing and education that can reduce the total cost of care.” (The eCare plan reference by Scott Brewster is the local term used in their adoption of the PhCP).

The pilot phase of the project increased interest in exchanging PhCPs within CCNC’s pharmacy community and among pharmacy management system (PMS) vendors. The number of vendors seeking training on the standard rose from two to 22 during the pilot. Approximately 34,000 unique care plans have been shared with CCNC since the pilot launch.

This precedent-setting pilot design offered two pharmacy care plan specifications: one specification is based on the Care Plan standard in Clinical Document Architecture (CDA); the other standard is a CDA-on-FHIR (Fast Healthcare Interoperability Resources). The latter specification directly transforms information shared using the FHIR standard into CDA. FHIR is straight forward to implement than CDA, so this is an appealing option for facilities not already using CDA. The dual offerings—CDA and CDA-on-FHIR with lossless transforms—provide choice for implementing vendors while allowing consistent utility to CCNC.

What’s on the horizon for the pharmacy community and vendors? With the support of National Community Pharmacists Association (NCPA), the draft standards will go through the HL7 ballot process for eventual publication for widespread implementation and adoption by vendors. This project will make clinical information available to CCNC and provide a new tool for serving patients with long-term needs in the dual Medicare-Medicaid program and Medicaid-only program.  This is a story about a successful Center for Medicare and Medicaid Innovation (CMMI)funded project that started out as a state-wide pilot and is now rolling out nationwide as Community Pharmacy Enhanced Service Network (CPESN)USA. 

The PhCP is based on a CDA Care Plan standard that is part of ONC’s Certified EHR Technology requirements, so it can be readily implemented into EHRs. This makes the pharmacist’s plan an integral part of a patient’s record wherever they receive care. 

Adoption of the PhCP brings pharmacies into the national health information technology (HIT) framework and electronically integrates pharmacists into the care planning team, a necessary precursor to a new payment model and health care reform. In addition, receiving consistently structured and coded pharmacy care plans can augment data analysis by going beyond product reimbursement to making data available for, utilization review, quality assurance and care coordination.

Troy Trygstad, vice president for Pharmacy Provided Partnerships at CCNC, described the strategic choice now available to pharmacists and PMS vendors. “Fundamentally, pharmacy will need to become a services model to survive. Absent that transformation, it will become a kiosk next door to the candy aisle. The reasons vendors are buying into the PhCP standard for the first time ever is that their clients are demanding it for the first time ever."

The move to value-based payment will continue to drive the need for pharmacists, as part of care teams, to provide enhanced care including personal therapy goals and outcomes. Sharing a medication-related plan of care with other care team members is critical to the successful coordination of care for complex patients.

Zabrina Gonzaga, R.N., is principal nurse informaticist and director of health informatics at Lantana Consulting Group and led the design and development of the PhCP standard. 

Email:  zabrina.gonzaga@lantanagroup.com

Twitter: @lantana_group


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Health IT Now Pushes for Information Blocking Regulation, Says Administration “Must Uphold its End of the Bargain”

September 13, 2018
by Rajiv Leventhal, Managing Editor
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The executive director of Health IT Now, a coalition of healthcare and technology companies, is again criticizing the Trump administration for not yet publishing any regulation on information blocking, as required by the 21st Century Cures Act legislation.

In an op-ed published recently in STAT, Health IT Now’s Joel White wrote, “More than 600 days after the enactment of the Cures Act, not a single regulation has been issued on information blocking.” White added in frustration, “Health IT Now has met with countless officials in the Trump administration who share our commitment to combat information blocking. But those sentiments must be met with meaningful action.”

The onus to publish the regulation falls on the Office of the National Coordinator for Health IT (ONC), the health IT branch of the federal government that is tasked with carrying out specific duties that are required under the 21st Century Cures Act, which was signed into law in December 2016. Some of the core health IT components of the Cures legislation include encouraging interoperability of electronic health records (EHRs) and patient access to health data, discouraging information blocking, reducing physician documentation burden, as well as creating a reporting system on EHR usability.

The information blocking part of the law has gotten significant attention since many stakeholders believe that true interoperability will not be achieved if vendors and providers act to impede the flow of health data for proprietary reasons.

But ONC has delayed regulation around information blocking a few times already, though during an Aug. 8 episode of the Pulse Check podcast from Politico, National Coordinator for Health IT Donald Rucker, M.D., said that the rule is "deep in the federal clearance process." And even more recently, a bipartisan amendment to the U.S. Senate's Department of Defense and Labor, Health and Human Services, and Education Appropriations Act for Fiscal Year 2019 includes a requirement for the Trump administration to provide Congress with an update, by September 30.

White, in the STAT piece, noted a June Health Affairs column in which Rucker suggested that implementation of the law’s information blocking provisions would occur “over the next few years.” White wrote that this is “a vague timeline that shows little urgency for combating this pressing threat to consumer safety and stumbling block to interoperability.”

Health IT Now is not alone in its belief that the rule should have been published by now, nor is it the first time the group is bringing it up. Last month

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By the end of this year, ONC’s implementation and interpretation of data blocking will also be published and available for comment, as was the case with the TEFCA proposed rule. The TEFCA final rule is also anticipated by the end of 2018.

HOWEVER…there’s still time to prepare for TEFCA and the data blocking regulation, and final rules for both in the coming months will set concrete timelines, and for TEFCA it will be interesting to see how ONC reacts to stakeholder comments, internal and external.

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