The development of a clinical policy ethics assessment tool

Clinical policies control several aspects of clinical practice, including individual treatment and care, resource management and healthcare professionals’ etiquette. This article presents Clinical Policy Ethics Assessment Tool, an ethical assessment tool for clinical policies that could be used not only by clinical ethics committees but also by policy committees or other relevant groups.

The aim of this study was to find or create a tool to identify ethical issues and/or confirm ethical validity in nursing practice policies, protocols and guidelines.

The development of Clinical Policy Ethics Assessment Tool involved first a literature review, followed by modification of the Research Protocol Ethics Assessment Tool, which was created to identify research protocols’ ethical issues, and finally, a trial of Clinical Policy Ethics Assessment Tool to ensure its reliability and validity.

The policies analysed trialling Clinical Policy Ethics Assessment Tool were in the public domain and did not contain any confidential information. Despite that, Clinical Policy Ethics Assessment Tool also had the approval of a research ethics committee.

Research Protocol Ethics Assessment Tool was chosen as the template for a Clinical Policy Ethics Assessment Tool, to which several modifications were added to adapt it to work within a nursing practice context. Clinical Policy Ethics Assessment Tool was tested twice, which resulted in a general test–retest reliability coefficient = 0.86, = 0.84, a1 = 0.817, a2 = 0.824 and interclass correlation coefficient = 0.874.

Contemporary nursing practice in a developed country is often ruled by clinical policies. The use of Clinical Policy Ethics Assessment Tool could confirm the ethical validity of those clinical practice policies, impacting on nurses’ education, values and quality of care.

Clinical Policy Ethics Assessment Tool has the potential to detect ethical issues and facilitate the correction and improvement of clinical policies and guidelines in a structured way. This is especially so as it has shown reliability in detecting issues in clinical policies involving human participants and in encouraging policymakers to consider common ethical dilemmas in nursing practice.

The full article can be downloaded below.  

HHS and ONC sought public comments through a Request-For-Information (RFI) on the EHR Reporting Program established as Section 4002 in the 21st Century Cures Act and codified as Section 3009A in Title XXX of the Public Health Service Act (PHSA). Below is the letter and comments eHI's Policy Steering Committee submitted.

October 17, 2018
 

Don Rucker, MD
National Coordinator
Office of the National Coordinator for Health Information Technology (ONC)
U.S. Department of Health and Human Services (HHS)
Attention: EHR Reporting Program Request for Information
Mary E. Switzer Building, Mail Stop: 7033A​
330 C Street SW
Washington, DC 20201
 

Dear Dr. Rucker:

Enclosed are the focused comments of the eHealth Initiative (eHI) on the Request for Information (RFI) Regarding the 21^st Century Cures Act Electronic Health Record Reporting Program. eHI offers the expertise of our unparalleled multi-stakeholder membership to you as this process continues forward. We are the only independent non-profit, multi-stakeholder coalition dedicated to improving the quality, safety, and efficiency of healthcare through the use of technology and health information. eHI’s work and its membership have built needed coalitions and advanced the health IT field at critical junctures. We look forward to doing so once again.

The RFI seeks input on the EHR Reporting Program established as Section 4002 in the Cures Act and codified as Section 3009A in Title XXX of the Public Health Service Act (PHSA). HHS and ONC seek public comments on a great breadth and depth of issues including:

• Cross-Cutting Priorities:  Priorities at the intersection of health IT product-related reporting criteria and health care provider reporting criteria; and

• Reporting Criteria Categories: Specific categories of prescribed Cures Act EHR reporting criteria (interoperability, usability and user-centered design, conformance to certification testing and other categories as appropriate to measure performance of certified EHR technology).

Nearly 50 questions are posed in this RFI whose answers -- as processed by ONC -- will have far-reaching impacts on health care and the health system as a whole. The information gathering and synthesis required to answer these RFI queries and to put consensus into action, eHI believes, will be a longer-term collaborative process, as suggested. Our organization has been a long time, prominent health IT leader and a historical fulcrum for convening critical consensus-based discussions. We offer eHI’s nationally recognized leadership, expertise and multi-stakeholder forums as this process progresses and would be honored to participate in the ONC criteria development process going forward.  Given the broad landscape of issues raised in the RFI, eHI is in a unique position to offer on-going insight.

A timely example of this eHI capability is the work of eHI expert workgroups, which include:

• Value & Reimbursement
• Technology and Analytics
• Workflows to Improve Provider and Patient Experience

The workgroups’ mission includes looking at closing gaps in data, removing barriers to sharing information, educating patients and providers about consent to share data, incentivizing data sharing, remote patient monitoring and patient engagement. Many of these same issues are addressed by ONC’s RFI. On-going eHI workgroup dialogue and products --including best practices and recommendations for policy and industry -- will enable our organization to have valuable insights for ONC on the road ahead.

In addition, eHI’s extensive eHealth Resource Center -- a clearinghouse of success stories, reports, surveys and other material -- can provide important context and guidance as ONC moves forward on issues related to this RFI. This information hub can be accessed at: https://www.ehidc.org/resources.

Lastly, as ONC lays out further requirements and an implementation roadmap for the 21^st Centry Cures Act Electronic Health Record Reporting Program, eHI urges you to recognize we are in a time of both great progress and tremendous regulatory overlay relating to health IT and EHRs.  Acknowledging this reality, eHI recommends a careful, focused and efficient approach that builds on and utilizes existing initiatives and success, rather than duplicating or hindering current work. ONC should create high-value, additive policy and practice. Fundamentally, a focus on identifying and ensuring that gaps are filled should be the ONC approach in evaluating comments received on the RFI. Related to this, we urge ONC to pay careful attention to feedback from providers and developers on issues related to design and implementation of the 21^st Century Cures Act Electronic Health Record Reporting Program.

eHI looks forward to working with you and other key federal government players on these issues.

If you have any questions or need clarification, please contact me at jennifer.covich@ehidc.org

Sincerely,

Jennifer Covich Bordenick
Chief Executive Officer
eHealth Initiative

Slides from September 26, 2018 eHealth Initiative Prior Authorization Workshop by Jocelyn Keegan, Payer Practice Lead, Point of Care Partners.

Presentation reviews near term improvement opportunities and how value based care shifts the role of authorization.

Slides from September 26, 2018 eHealth Initiative Prior Authorization Workshop by Mark Thompson, Executive Director, Medical Society of Delaware.

Presentation reviews a new approach to prior authorization - The Smart Prior Authorization (SPA) Solution developed in partnership of the Delaware Health Information Network (DHIN) and is partnering with HIEs across the country.

Congress recently approved unified legislation to address the national opioid epidemic and the President is expected soon to sign it into law.  Dubbed the SUPPORT for Patients and Communities Act, it contains elements of the original House and Senate opioid bills and some compromises reached through the conference process. An overview and section-by-section details are available here. 

Among provisions not included in the final bill was Jesse’s Law (S. 581), which would have made changes to 42 CFR Part 2 to allow addiction and substance abuse disorder history to be displayed in a patient’s EHR.

Below is a summary of some key provisions in the final legislative package. Health IT relevant sections are given priority.

Included in the SUPPORT for Patients and Communities Act

• S.2904, Medicaid Substance Use Disorder Treatment via Telehealth Act
  
  • CMS is required to develop rules and guidance about how states can obtain federal reimbursement under Medicaid for substance abuse telehealth services.[i]
• HR. 3528, Every Prescription Conveyed Securely Act
  
  • Physicians who are prescribing controlled substances under Medicare part D must electronically prescribe the medication.[ii]
• HR 5797, ‘Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Delivery Act’ (IMD CARE Act)
  
  • Originally, IMD excluded Medicaid from covering patients with substance use disorders who are receiving treatment in a mental health facility with more than 16 beds, because the lawmakers wanted states to primarily cover the price tag. Now, these patients will be given 30 days of residential treatment coverage if they are addicts with Substance Use Disorder[iii]
• S. 372 Synthetics Trafficking and Overdose Prevention (STOP) Act
  
  • Packages going through the postal service will have to provide electronic advance data on where it is going, where it came from, who is receiving it, and what is in it.
• S. 3527, Comprehensive Opioid Recovery Act
  
  • Creates a grant program for comprehensive recovery centers that include housing and job training, as well as mental and physical healthcare.
  • Increases access to medication-assisted treatment that helps people with substance abuse disorders slowly wean themselves off the addicting drug.

eHI has been very active in tracking the opioid debate and is exploring ways to be impactful in best practice and policy. As this package moves to implementation in 2019, we will keep you updated.

U.S. National Health IT Week (NHIT Week) is a nationwide awareness week focused on catalyzing actionable change within the U.S. health system through the application of information and technology. Founded by HIMSS and the Institute for e-Policy in 2006, the week-long celebration is comprised of partner-driven activities and events led by the efforts of national health stakeholders. Participants range from the Administration, congressional, federal and state agencies, providers, non-profit organizations and more. Virtually, in Washington DC and beyond, National Health IT Week stakeholders collaborate towards actionable outcomes which demonstrate the power information and technology has to transform health in the U.S., and its wide-reaching global impact.

Clinical Research and Data: HIPAA, the Common Rule, the General Data Protection Regulation, and Data Repositories

The inexorable march of Moore’s Law has resulted in changes in all areas of our lives, including how we do clinical research. Researchers and patients are more connected. We store, access, and manipulate data in different ways; we conduct studies in multiple countries sharing data and samples around the world; and cybersecurity and hacking are a reality. This article touches on different legal aspects arising at the intersection of technology, data, and clinical research— specifically HIPAA (the Health Insurance Portability and Accountability Act), human subjects research, the European data law (the General Data Protection Regulation), and data repositories. It attempts to explain how two different law-making bodies, the US and the EU, have tried to balance the necessity of using data for research purposes that benefit society with the privacy issues and risks of that same data.

The full article can be downloaded below.  

Conceptualising production, productivity and technology in pharmacy practice: a novel framework for policy, education and research

People and health systems worldwide face serious challenges due to shifting disease demographics, rising population demands and weaknesses in healthcare provision, including capacity shortages and lack of impact of healthcare services. These multiple challenges, linked with the global push to achieve universal health coverage, have made apparent the importance of investing in workforce development to improve population health and economic well-being. In relation to medicines, health systems face challenges in terms of access to needed medicines, optimising medicines use and reducing risk. In 2017, the International Pharmaceutical Federation (FIP) published global policy on workforce development (‘the Nanjing Statements’) that describe an envisioned future for professional education and training. The documents make clear that expanding the pharmacy workforce benefits patients, and continually improving education and training produces better clinical outcomes.

The opportunities for harnessing new technologies in pharmacy practice have been relatively ignored. This paper presents a conceptual framework for analysing production methods, productivity and technology in pharmacy practice that differentiates between dispensing and pharmaceutical care services. We outline a framework that may be employed to study the relationship between pharmacy practice and productivity, shaped by educational and technological inputs.

The analysis is performed from the point of view of health systems economics. In relation to pharmaceutical care (patient-oriented practice), pharmacists are service providers; however, their primary purpose is not to deliver consultations, but to maximise the quantum of health gain they secure. Our analysis demonstrates that ‘technology shock’ is clearly beneficial compared with orthodox notions of productivity or incremental gain implementations. Additionally, the whole process of providing professional services using ‘pharmaceutical care technologies’ is governed by local institutional frames, suggesting that activities may be structured differently in different places and countries.

Addressing problems with medication use with the development of a pharmaceutical workforce that is sufficient in quantity and competence is a long-term issue. As a result of this analysis, there emerges a challenge about the profession’s relationship with existing and emerging technical innovations. Our novel framework is designed to facilitate policy, education and research by providing an analytical approach to service delivery. By using this approach, the profession could develop examples of good practice in both developed and developing countries worldwide.

The full article can be downloaded below. 

Video recording of October 1, 2018 Capitol Hill Lunch Briefing on Technologies to Address the Opioid Crisis. Hosted by Health Tech Strategies in collaboration with American Telemedicine Association, Connected Health Initiative, eHealth Initiative, Health IT NOW, and HIMSS.

Slides are available for download in eHI's resource center under Policy: https://www.ehidc.org/resources/policy 

Presentation slides by Neal Neuberger of Health Tech Strategies from October 1, 2018 Opioid Crisis Hill Lunch Briefing. Slides outline the meeting's agenda, major bills and agency activities, and policy take aways.