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.

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.  

Did You Know The EEOC Enforces Complaints About Employers' Misuse of Genetic Information?

Many people know that the U.S. Equal Employment Opportunity Commission(EEOC) investigates claims of workplace discrimination related to an employee's race, gender, age, etc.  But most of the public does not realize that the EEOC also enforces discrimination related to an employee's genetic information.  To help spread the word, the information below is based upon the EEOC's guidance on this relatively new and far-reaching prohibition.

The EEOC investigates complaints under Title II of the Genetic Information Nondiscrimination Act of 2008 (GINA), which became effective in 2009.  While the EEOC handles employment-related claims under GINA, the law also prohibits discrimination based on genetic information when it comes to insurance, over which the Departments of Labor, Health and Human Services, and Treasury have jurisdiction.

The full Forbes 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.  

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.  

More Telehealth Benefits Coming To Medicare Advantage Plans In 2020

Access to telehealth services for seniors got another boost Friday when the Centers for Medicare & Medicaid Services said it would allow private Medicare Advantage plans to offer additional access to virtual doctors in their basic benefit packages.

The so-called final rule will bring new benefits to seniors in 2020 as part of their Medicare Advantage plans. Such coverage is growing rapidly and expected to account for half of Medicare beneficiaries in the coming years, some analysts say.

The full Forbes article can be viewed at this link.  

Presentation slides from Karen Sealander, James Cannatti, and Scott Weinstein of McDermott Will & Emery at eHI's March 14, 2019 event on Capitol Hill.

Presentation slides from Tom Schankweiler and Karen Mandelbaum of CMS at the eHI's March 14, 2019 event on Capitol Hill. 

There’s a Proven Public Health Strategy We Could Use to Encourage Vaccination

A well-funded public health campaign focusing on the real-life health consequences of underimmunization could have an enormous impact. Images of children with the measles—febrile, splotchy, eyes red, congested and miserable—would grab more attention than any cheerfully sanitized infographic. Interviews with people suffering the long-term chronic consequences of the diseases routine immunizations prevent could highlight the complications we have the luxury of rarely encountering. Male infertility as a result of mumps infection. Brain swelling from the chicken pox. Infant death after infection with the flu virus. An ad simply showing 30 seconds of raw footage of a toddler with whooping cough—hacking and gasping and struggling to breathe—could turn the focus of fear away from the vaccines and toward the disease in a way that the sterile regurgitation of facts and recommendations never could.

Stronger messaging about the dangers of vaccine-preventable diseases wouldn’t make headway on income or geographic disadvantages, which are the top two barriers to accessing immunization services. However, such a public health campaign could increase the urgency with which people seek out this form of preventative care. We already know that patients will go to greater efforts—wait longer, travel farther distances, research alternate resources—when a health threat is perceived to be dire or the need for a certain service is felt to be high. While the larger societal issues that stand in the way of improving health care access overall are vast and will involve slow, incremental change and a large investment of resources, a well-endowed, unapologetically graphic anti-disease campaign in the model of “Tips From Former Smokers” could yield cost-effective results relatively rapidly.

Starkly clinical images might indeed be difficult to see, but they’d help the vaccine-hesitant fully understand what they’re opting into by forgoing immunization. And if those types of realistic medical images are simply too uncomfortable, too gruesome, or too tragic to witness, it may well encourage people not to re-create them with the choices they make for their own children.

The full Slate article can be viewed at this link.