Why FDA’s Scott Gottlieb Wants to Create a ‘National Utility’ for Real-World Evidence | David Raths | Healthcare Blogs Skip to content Skip to navigation

Why FDA’s Scott Gottlieb Wants to Create a ‘National Utility’ for Real-World Evidence

July 12, 2018
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FDA has put forward a $100M proposal to build a system that would rely on EHR data from about 10 million lives

Over the last year or so I have written several articles about health systems running pragmatic clinical trials. These are designed to reflect “real-world” medical care by recruiting broad populations of patients, embedding the trial into the usual healthcare setting, and leveraging data from health systems to produce results that can be readily used to improve patient care.

For instance, I wrote about a presentation by Russell Rothman, M.D., the vice president for population health research at Vanderbilt University Medical Center, in which he described some of the informatics infrastructure of one PCORI-funded study, ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness).

ADAPTABLE is a $14 million, three-year pragmatic clinical trial that is comparing the effectiveness of two different daily doses of aspirin widely used to prevent heart attacks and strokes in individuals living with heart disease. Its goal is to enroll 20,000 patients. For that project, the Mid-South Clinical Data Research Network (CDRN) takes EHR data from health systems and transforms it into a common data model to run queries against. 

The U.S. Food and Drug Administration (FDA) has been at the center of much of this work. In its Sentinel project, queries go from one organization to the distributed network and curated results are returned, using the same agreed-upon data model. Its National Evaluation System for health Technology (NEST) is designed to generate evidence across the total product lifecycle of medical devices by leveraging real-world evidence and applying advanced analytics.

Now the FDA is signaling its intent to expand its work to get real-world data from EHRs and other data sources to assess product efficacy and safety. I think this is a valuable role for the FDA to play in building a nationwide learning health system.

In a recent blog post, FDA Commission Scott Gottlieb, M.D., stated that real-world evidence can help the FDA gain a deeper understanding of a medical product’s safety and benefits, its additional treatment implications, and its potential limitations. “By better leveraging this information, we can also enable more efficient medical product development by integrating greater complements of safety and benefit information gleaned from clinical care. This is especially true when it comes to our important obligation to continue to evaluate products in the post-market setting.”

Gottlieb mentions that as part of the President’s Fiscal Year 2019 Budget, the FDA has put forward a $100 million medical data enterprise proposal to build a modern system that would rely on the electronic health records from about 10 million lives. This system would expand the data enterprise the FDA already maintains by incorporating new information from EHRs and other sources that would allow it to more fully evaluate medical products in the post-market setting.

Gottlieb noted that previous investments in post-market data have mostly focused on systems to consolidate and analyze information derived from  payer claims, but the capacity to use clinical data derived from EHRs allows for faster reporting on the performance of medical products in real-world medical settings.

He pointed to a few limitations with claims data, including an inherent lag between when a medical event occurs and when it’ll show up in payer claims. Plus, he wrote, it is not always clear, by looking at claims data alone, what actually happened to the patient and whether the medical product was a factor. So the fiscal 2019 budget request seeks to address some of these limitations by giving the agency the ability to access the clinical medical information contained in de-identified electronic health records.

Interestingly, Gottlieb envisions the system created as a “national utility” for improving medical care, and allowing the FDA to optimize its regulatory decisions. “It would give patients and providers the access to near-real-time, post-market information that can better inform their decisions,” he wrote. “Such an enterprise can not only support our evaluation of safety and benefit using data derived from real-world settings, but it can also make the development of new innovations more efficient. If we have more dependable, near-real-time tools for evaluating products in real-world settings, we can allow key questions to be further evaluated in the post-market setting. This can allow some of the cost of development to be shifted into the post-market, where we can sometimes access better information about how products perform in real-world settings.

Real-world data can come from other sources such as product and disease registries, patient-related activities in outpatient or in-home use settings, and mobile health devices. So Gottlieb stressed that it is key that the sources of these data elements, such as different health care systems, be able to communicate electronically. “This requires full interoperability and the elimination of any silos. The FY 2019 Budget request seeks to establish these building blocks, and assemble the data into an interoperable platform. There are several foundational steps that we’re already undertaking to build a strong programmatic basis for using real world data and evidence.”

Some health IT leaders on Twitter responded to the blog post with enthusiasm. HL7 CTO Wayne Kubick called it a “vision which can be rapidly achieved by leveraging APIs powered by the HL7 FHIR standards, which are becoming widely available under 21st Century Cures.”

 

 

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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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