eHI's Policy Guy Talks TEFCA & 21st Century Cures

Over the past two months, the federal government has issued two major proposals to implement interoperability elements of the 2016 21^st Century Cures legislation (Cures) that are of great importance to the eHealth Initiative and its members.

Late in February 2019, the Office of the National Coordinator for Health IT (ONC) released a proposed rule to implement multiple health IT-related elements of Cures, including provisions on information blocking and certification of health IT using standards-based open application programming interfaces (APIs).  On April 19, ONC released an updated second draft of its Trusted Exchange Framework and Common Agreement (TEFCA), first released in January 2018 and also required by Cures. Taken together, these documents seek to accelerate and reshape the U.S. interoperability landscape.

ONC and CMS Information Blocking and Interoperability Proposed Rules

The ONC proposed rule would implement congressional prohibitions in the Cures legislation on information blocking with associated penalties, while identifying seven exceptions for practices that would otherwise be considered information blocking but will not be subject to penalties if they meet one of these exceptions (e.g., preventing harm to a patient).  In implementing these provisions, ONC seeks to require a broad spectrum of information sharing across organizations and individuals while also limiting the fees, contracts and other potential barriers to data access that can be implemented for various interoperability elements named in the proposed rule (e.g., hardware, software, technical specification, or license used for interoperability). 

ONC also seeks, along with a companion proposed rule from the Centers from Medicare and Medicaid Services (CMS) focused primarily on health plans, to advance the use of open APIs based on the HL7® FHIR® standard. Its goal is to expand data access for patients and other authorized individuals and organizations through apps and applications that would use these APIs to gain secure access to electronic health information (EHI). As with information blocking, ONC proposes significant limitations and requirements for API pricing, contracts and transparency.

While the information blocking provisions apply to a very broad definition of EHI, the API certification provisions apply to a narrower, standards-based U.S. Core Data for Interoperability (USCDI). The USCDI, which will replace the ONC Common Clinical Data Set (CCDS), is intended to expand over time toward the Cures definition of interoperability, which calls for access to all EHI. Although the technical scope of the API certification provisions is narrower than that of information blocking (e.g., read access to the USCDI vs. access, exchange, and use of EHI), its transparency and fee provisions are stricter.

Trusted Exchange Framework and Common Agreement (TEFCA)

The proposed TEFCA seeks to complement the API data access model by creating a framework for trusted exchange that knits together the organizations, health information exchanges, networks, and frameworks that are increasingly exchanging health information. The TEFCA would use a consistent, standards-based trust framework that enables nationwide organizational and individual queries for health information as well as the ability to push health information messages to targeted locations.

This new TEFCA process would be overseen by a private-sector Recognized Coordinating Entity (RCE) to be selected by ONC and operated through a cooperative agreement. The building block of this model would be the Qualified Health Information Network (QHIN). QHINS would have participants (e.g., HIEs), which in turn have members (e.g., medical groups, hospitals, individuals, payers).  This model would be intended to permit nationwide queries for health information consistent with HIPAA privacy and security rules as well as pushed messages.

The TEFCA starts with the Trusted Exchange Framework (TEF)—principles to facilitate trust between QHINs and their members and participants that will be the foundation of the Common Agreement that will govern exchange. The Common Agreement builds on the TEF and will include Minimum Required Terms and Conditions (MRTCs)—mandatory terms and conditions that QHINs agree to follow and additional required terms and conditions developed by the RCE. In addition, the QHIN Technical Framework (QTF), which would include technical requirements and standards, would be incorporated by reference in the Common Agreement.

Implications for eHealth Initiative Members

ONC and CMS goals in putting forth these proposals include:

• Improving the interoperability of electronic health information;
• Enhancing care coordination; and
• Promoting patient access to and control over their health information.

Achieving these milestones can modernize and move healthcare forward. As we think about these proposals, however, it is also important to be alert to potential unintended consequences as we enhance interoperability nationwide, through open, FHIR-based APIs and wider use of trusted exchange models. For example, initial reactions to the ONC proposed rule, in addition to recognizing the value of increased data liquidity, have highlighted the potential complexity and associated compliance costs, broad definitions of such concepts as Health Information Networks and Electronic Health Information, and how concepts in the proposed rule may interact to add to its complexity and reach, including challenges to existing market forces and investments in interoperability.

In the second draft of the TEF, ONC clearly listened to comments received on the first draft and has made changes to simplify and refine its approach. ONC is to be applauded for such efforts and for providing an additional opportunity for public input.

Comments for these proposals remain open. The comment period for the ONC proposed rule has been extended by one month to June 3. Comments on the TEFCA are open until June 17. The eHealth Initiative will be submitting comments developed by its Policy Steering Committee and many other organizations and individuals will be commenting as well. Please let your voice be heard!
 

Mark Segal, PhD, FHIMSS, Principal, Digital Health Policy Advisors, LLC. Member and Past Chair of the eHI Policy Steering Committee. April 25, 2019. Twitter @msegal111

eHI thinks Mark Segal is a super cool guy and is providing his opinions for informational purposes only. The opinions presented, do not represent those of eHealth Initiative, our members or the Foundation.

Socioeconomic position and use of healthcare in the last year of life: A systematic review and meta-analysis

We have found consistent evidence from high-income countries that low socioeconomic position (SEP) is a risk factor across several components of service use at the end of life, including dying in hospital rather than at home, receiving acute hospital-based care in the last 3 months of life, and not receiving specialist palliative care in the last year of life. We also found evidence of a pervasive social gradient in place of death and use of specialist palliative care. These findings should stimulate widespread efforts to reduce socioeconomic inequality towards the end of life. We recommend that all research on care received towards the end of life should attempt to account for SEP, end-of-life care interventions should be analysed for their different effects across the social strata, and the planning and provision of end-of-life care services should consider SEP in local populations.

The full article can be downloaded below.  

Three Years Down the Road: The Aftermath of the CDC Guideline for Prescribing Opioids for Chronic Pain

The 2016 CDC guidelines for opioid prescribing by primary care physicians have exposed some shortfalls in our thinking about opioid use and stranded many chronic pain patients with inadequate analgesia. Opioid prescribing rates started to decline in 2012, but still remain high. The response from providers to the 2016 guidelines have led to unintended consequences. Some of the CDC guidance seems arbitrary and not supported by evidence (the 90 MME per day cutoff). Patient and prescriber education, the role of buprenorphine (an atypical Schedule III opioid), and abuse-deterrent opioids are not mentioned at all but could play crucial roles in reducing abuse. Opioid use disorder (OUD) is not defined by the guidance which calls on primary care physicians to recognize and treat it. Opioid withdrawal syndrome is not mentioned and tapering plans, although advised, are not described in a practical way. While the morbidity and mortality associated with OUD are public health crises, so is untreated pain. Chronic pain patients deserve consideration, yet emerge as the silent epidemic within the opioid crisis. To be sure, there is much good in the CDC guidance or any guidelines that urge caution and care in opioid prescribing. Pain specialists must speak out to advocate for patients dealing with pain, to educate patients and prescribers about analgesic options, and to make sure that pain is adequately treated particularly in vulnerable populations.

The full commentary can be downloaded below.  

Priorities and challenges for health leadership and workforce management globally: a rapid review

Health systems are complex and continually changing across a variety of contexts and health service levels. The capacities needed by health managers and leaders to respond to current and emerging issues are not yet well understood. Studies to date have been country-specific and have not integrated different international and multi-level insights. This review examines the current and emerging challenges for health leadership and workforce management in diverse contexts and health systems at three structural levels, from the overarching macro (international, national) context to the meso context of organisations through to the micro context of individual healthcare managers.

A rapid review of evidence was undertaken using a systematic search of a selected segment of the diverse literature related to health leadership and management. A range of text words, synonyms and subject headings were developed for the major concepts of global health, health service management and health leadership. An explorative review of three electronic databases (MEDLINE®, Pubmed and Scopus) was undertaken to identify the key publication outlets for relevant content between January 2010 to July 2018. A search strategy was then applied to the key journals identified, in addition to hand searching the journals and reference list of relevant papers identified. Inclusion criteria were independently applied to potentially relevant articles by three reviewers. Data were subject to a narrative synthesis to highlight key concepts identified.

Sixty-three articles were included. A set of consistent challenges and emerging trends within healthcare sectors internationally for health leadership and management were represented at the three structural levels. At the macro level these included societal, demographic, historical and cultural factors; at the meso level, human resource management challenges, changing structures and performance measures and intensified management; and at the micro level shifting roles and expectations in the workplace for health care managers.

Contemporary challenges and emerging needs of the global health management workforce orient around efficiency-saving, change and human resource management. The role of health managers is evolving and expanding to meet these new priorities. Ensuring contemporary health leaders and managers have the capabilities to respond to the current landscape is critical.

The full article can be downloaded below.  

Opioids and Cancer Pain: Patients’ Needs and Access Challenges

Opioids are a mainstay in the treatment of cancer-related pain and end-of-life symptoms. This class of medications, long used by oncologists, is facing new scrutiny and restrictions as medication and illicit drug abuse in the United States has steadily increased, creating in recent years what has now been termed an “opioid epidemic.” Oncologists experience the opioid epidemic on several fronts: (1) treating patients who have legitimate pain needs in addition to their own addiction issues; (2) seeing patients suffer the repeated heartaches of having a family member struggling with addiction; and (3) now more commonly, facing barriers, restrictions, and hurdles to ensuring that an individual with cancer or cancer treatment– related pain is able to obtain adequate pain control.

The full article can be downloaded below.  

Will A Medicine Work For You? A Simple Test Might Tell - Pharmacogenetics

A simple test using a swab of cells from the inside of your cheek can dramatically improve your medical treatment. The test can predict whether a drug will help, if you need a different dosage, or if you are at risk of severe side effects.

This testing is called pharmacogenetics or pharmacogenomics. This means studying the interactions of drugs (pharma-) and an individual’s genes (genom-). Genes control how drugs are metabolized and may be different in different people. Treatment can be personalized, or individualized for some classes of drugs.

The full Forbes article can be viewed at this link.  

County Jails Struggle With A New Role As America's Prime Centers For Opioid Detox

Faced with a flood of addicted inmates and challenged by lawsuits, America's county jails are struggling to adjust to an opioid health crisis that has turned many of the jails into their area's largest drug treatment centers.

In an effort to get a handle on the problem, more jails are adding some form of medication-assisted treatment, or MAT, to help inmates safely detox from opioids and stay clean behind bars and after release.

But there are deep concerns about potential abuse of the treatment drugs, as well as worries about the efficacy and costs of programs that jails just weren't designed or built for.

The full NPR article can be viewed at this link.  

US Healthcare Trends and Contradictions in 2019

Over the past several years, many healthcare trends have been identified as micro rather than macro as incremental year-to-year changes dominated the US healthcare market. Looking at 2019 and toward 2020, the shift to macro-level trends returns, reflecting market transformation during the Trump administration. For example, many 2017 and 2018 trends were a continuation of micro themes, such as benefit design offerings, care delivery initiatives, contracting, or early technologies for monitoring personal health status.

Now, structural and broader market changes are part of a bigger economic transformation that includes healthcare as a major beneficiary. As a result, in 2019 many trends are macro-focused, in addition to some continuing micro aspects, all of which are being transformed in parallel. Much of the innovation efforts to date have led to trends that move us from micro to macro perspectives on change.

The forecasted trends identified in this article focus on the macro and micro levels that may emerge or are just emerging, depending on your perspective. Furthermore, some trends may be opposing to other trends, which reflects the uncertainty along with the diversity of change in healthcare, globally and nationally.

The full article can be downloaded below.  

Real world usage characteristics of a novel mobile health self-monitoring device: Results from the Scanadu Consumer Health Outcomes (SCOUT) Study

A wide range of personal wireless health-related sensor devices are being developed with hope of improving health management. Factors related to effective user engagement, however, are not well-known. We sought to identify factors associated with consistent long-term use of the Scanadu Scout multi-parameter vital sign monitor among individuals who invested in the device through a crowd-funding campaign. Email invitations to join the study were sent to 4525 crowd-funding participants from the US. Those completing a baseline survey were sent a device with follow-up surveys at 3, 12, and 18 months. Of 3872 participants receiving a device, 3473 used it during Week 1, decreasing to 1633 (47 percent) in Week 2. Median time from first use of the device to last use was 17 weeks (IQR: 5–51 weeks) and median uses per week was 1.0 (IQR: 0.6–2.0). Consistent long-term use (defined as remaining in the study at least 26 weeks with at least 3 recordings per week during at least 80% of weeks) was associated with older age, not having children in the household, and frequent use of other medical devices. In the subset of participants answering the 12-month survey (n = 1222), consistent long-term users were more likely to consider the device easy to use and to share results with a healthcare provider. Thirty percent of this subset overall reported improved diet or exercise habits and 25 percent considered medication changes in response to device results. The study shows that even among investors in a device, frequency of device usage fell off rapidly. Understanding how to improve the value of information from personal health-related sensors will be critical to their successful implementation in care.

The full article can be downloaded below.  

Improving the Patient Protection and Affordable Care Act's Insurance Coverage Provisions: A Position Paper From the American College of Physicians

The coverage reforms of the Patient Protection and Affordable Care Act have fundamentally changed the U.S. health care system. The law's health insurance regulations, which include protections for persons with preexisting conditions, have made health insurance more accessible. The premium tax credit and cost-sharing subsidies have made nongroup coverage more affordable. The essential health benefit package and coverage for preventive services without cost sharing have made insurance more comprehensive. Perhaps most important, the Medicaid expansion extended coverage to millions of low-income adults. Despite these gains, more needs to be done to bring the United States closer to achieving universal coverage. In this position paper, the American College of Physicians recommends action to enhance and expand eligibility for health insurance financial subsidies; stabilize health insurance marketplaces; provide sustained funding for outreach, education, and enrollment assistance activities; test and implement a mechanism to encourage enrollment; expand Medicaid in all states; and establish a public insurance option to increase competition.

The full position paper can be downloaded below.