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U.S. House Passes 21st Century Cures Legislation

November 30, 2016
by Heather Landi
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The legislation will now move to the Senate and could be voted on next week.
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The U.S. House of Representatives today passed sweeping, bipartisan legislation, called the 21st Century Cures Act, comprised of a $6.3 billion package of medical innovation bills including $4.8 billion to the National Institutes of Health as well as $1 billion in state grants to fight opioid abuse. The legislation, which passed by a vote of 392-26, will now move to the Senate and could be voted on next week.

The legislation, which was included as an amendment to H.R. 34, also includes changes to the mental health system and could enact regulatory changes for drugs and medical devices.

Healthcare stakeholders have touted the health IT provisions of the bill, particularly regarding the Food and Drug Administration’s (FDA) oversight of the sector, as well as encouraging interoperability of electronic health records (EHRs) and patient access to health data, and discouraging information blocking.  

Rep. Erik Paulsen (R-MN) called the legislation “an innovation game-changer” during the debate prior to the House vote, noting that it “supports more NIH research, gives patients more input into the healthcare delivery process and important reforms to mental health.”

During the debate on the House floor, Rep. Pat Tiberi (R-Ohio) said the bill “provides regulatory relief to providers” and “gets America back in the driver’s seat with medical innovation.”

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The legislation will provide $4.8 billion to NIH, including: $1.4 billion for President Obama’s Precision Medicine Initiative; $1.8 billion for Vice President Biden’s Cancer Moonshot; and $1.6 billion for the BRAIN initiative. The legislation also provides $1 billion to states to supplement opioid abuse prevention and treatment activities, such as improving prescription drug monitoring programs (PDMPs). The bill also includes $500 million in funding to the FDA over 10 years with the aim of moving drugs and medical devices to patients more quickly. Additionally, with regard to mental health, the bill aims to strengthen the enforcement of the mental health parity law which requires insurers to cover mental illness as they would treatment for other diseases.

As previously reported by Healthcare Informatics, House and Senate health committee leaders released a final version of the legislation over the holiday weekend, on Friday, Nov. 25th. In a statement, House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Senate HELP Chairman Lamar Alexander (R-TN) said the legislation will “advance President Obama’s personalized medicine initiative, Vice-President Biden’s cancer moonshot, Alzheimer’s research and move many treatments and cures more rapidly and safely through the regulatory process and into doctors’ offices. It will address the needs of the one in five adult Americans who suffer mental illness.”

Regarding the health IT components of the bill, Jeffrey Smith, vice president of public policy at the American Medical Informatics Association (AMIA), said, “Essentially what this legislation does is give matching orders to both the public and the private sectors towards trying to improve the state of health IT and interoperability and usability.”

Smith continued, “One of the unknowns, heading into a new Administration and a new Congress, is the status of precision medicine, and the Cancer Moonshot, and the BRAIN initiative, in addition to the opioid and mental health legislation. I think that this legislation is incredibly important to try to assuage those who are concerned about the unknowns of the Trump administration, and the willingness of the 115th Congress, to fund what is really seen as a game of catch-up in terms of funding the NIH and research.”

The bill has many health IT-related provisions, including instructing the Secretary of HHS to work with healthcare providers, payers and vendors to reduce regulatory and administrative burdens relating to the use of electronic health records. The bill also authorizes $15 million for ONC’s certification process to improve interoperability and fight information blocking. The legislation would establish a grant program to create an unbiased reporting system to engage stakeholders and gather information about EHR usability, interoperability, and security to help providers better choose EHR products.

What is missing from the updated 21st Century Cures Act is the three-star grading system established in Sen. Bill Cassidy’s Trust IT Act (S. 2141). Earlier this week, before the House vote, Smith said, “The star rating system that was part of the Senate language, it was more of a report card approach to improving the performance of health IT and what this new language will do is essentially use a mechanism of transparency. Rather than grading each of the electronic health records (EHRs) on how they perform vis-à-vis usability, security and interoperability, this language just basically says they have to report on how they perform and then these would need to be made publicly available,” Smith says.

Smith added, “There are still some very consistent structural pieces in the legislation and how they define interoperability is more consistent with what the House is thinking. However, I think it remains to be seen exactly what impact the definition will have in a practical way.”

In a statement, Russell Branzell, president and CEO of the College of Healthcare Information Management Executives (CHIME), applauded the health IT provisions in the 21st Century Cures Act. Branzell said the “landmark legislation” would “significantly improve the ability of hospitals and other providers to exchange accurate patient data and advance personalized care.”

“CHIME is especially encouraged that in a number of sections the bill addresses the critical issues of accurately identifying patients and matching them to their health records. The absence of national solutions for patient identification and patient matching not only pose serious risks to patient safety, but also lead resources being wasted on cleaning up duplicative medical records, as well as creating other inefficiencies. Among other things, the legislation would direct the Government Accountability Office to evaluate the current state of patient matching and determine what steps the Department of Health and Human Services could take to better ensure that patients are linked to their records. We believe that accurate patient identification is central to improving patient matching.”

Additionally, Branzell said in his statement, “The bill, which has bipartisan support, also reflects the growing need to develop a standards-based information exchange infrastructure. If we are going to improve information exchange and interoperability, we need to begin the hard work of finalizing a set of standards that will help providers share patient information in a seamless manner.”


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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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