Historically, the American healthcare delivery system has rewarded providers for the number of patients seen and procedures performed. For example, seeing twice as many patients in a day resulted in more income for providers; and admitting more patients to a hospital enabled the hospital to collect more money. Today, the American healthcare delivery system is transitioning from a volume-based approach to a value-based approach. As this transition progresses, providers increasingly will be rewarded for the quality of care provided as measured by patient outcomes; ePatients are now one of the major forces driving this transition.
This Column - Part II is the second of a three-part series dealing with ePatients and implications for nursing. Part 1 of the series described the concept of ePatients. Part II explores the role of the United States (U.S.) federal government in empowering ePatients. Even the discussion below only begins to touch the tip of the iceberg in considering the federal government's efforts to empower patients.
The Role of the U.S. Federal Government
A full discussion of the role of the U.S. Federal Government, including the roles of all of its various agencies and departments, regarding the empowering of patients would be a textbook in itself and well beyond the scope of this column. This column, Part II, is limited to specific informatics examples demonstrating how the Federal Government moves from legislation to regulations to empowering ePatients.
The column uses two key examples, to demonstrate the vital role the government is playing in empowering patients by requiring that patients be provided with access to their health information. These examples include:
- Regulations developed by the Office for Civil Rights in response to the Health Insurance Portability and Accountability Act (HIPAA) of 1996
- Regulations developed by The Centers for Medicare and Medicare Services (CMS) in cooperation with the Office of the National Coordinator for Health Information Technology (ONC) in response to the Health Information Technology for Education and Clinical Health Act (HITECH) included in the American Recovery and Reinvestment Act of 2009 (Stimulus Act) and the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)
The Health Insurance Portability and Accountability Act of 1996 (HIPAA)
Most, if not all, healthcare providers are well aware that HIPAA was designed to protect the privacy of individual medical records. But what is much less understood is that HIPAA was also created to provide individual patients with important rights to access their medical record. The 'P' in HIPAA stands not for 'privacy,' but rather for portability. As the previous U.S. Department of Health and Human Services Secretary, Kathleen Sebelius, stated, “The right to access personal health information is a cornerstone of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule,” (U.S. DHHS, 2014). This includes the right for patients, and/or a person(s) designated by the patient, to:
- access and obtain a copy of their information from all covered entities (with a few exceptions) including the right to receive a copy of the information in electronic format if the information is maintained in that format. This right also includes access to a provider’s psychotherapy notes, which prior to 2014 could be excluded from the information provided. Even if the individual has not paid, personally, for these services, the provider cannot deny the individual a copy of his or her records;
- have inaccurate or incomplete information in the medical record corrected. If the patient asks for a correction, the healthcare provider or plan must respond; if they disagree with the request, the individual has the right to submit a statement of disagreement that must be added to their record (Health Information Policy, n.d. a); and
- obtain test reports/results directly from a clinical laboratory. Patients may continue to obtain their test results from their physician’s office, but are no longer required to use only this option (U.S. DHHS, 2014).
Additional information about a patient’s rights to access their health information under HIPAA is provided by the U.S. DHHS Office for Civil Rights (Health Information Policy, n.d. b).
Health Information Technology for Economic and Clinical Health Act (“HITECH”) and Meaningful Use (MU)
The term meaningful use (MU) refers to the use of certified electronic health record technology (CEHRT) to achieve specific objectives and measures that are required for eligible professionals (EPs) and hospitals to receive incentive payments from the CMS. The MU objectives are grouped into five domains. Information about these domains and the related objectives is provided by the ONC (Office of the National Coordinator for Health Information Technology, 2013). With hyperlinks leading to additional details the URL for this reference provides an excellent overview of the five MU domains and related objectives. The criteria for achieving each objective are divided into three stages with each stage building on the requirements of the previous stage. The opportunity to participate in Stage 1 began in 2010 with the first payment in 2011.
The domain of interest to this discussion is D2: Engage Patients and Families. In 2012, CMS announced that the Meaningful Use Stage 1 objective and measures related to this domain would be replaced with the following objective and measure in 2014:
Objective: Provide patients the ability to view online, download, and transmit their health information within 4 business days of the information being available to the EP.
Measure 1: More than 50 percent of all unique patients seen by the EP during the EHR reporting period are provided timely (within 4 business days after the information is available to the EP) online access to their health information, subject to the EP's discretion to withhold certain information.
Measure 2: More than 5 percent of all unique patients seen by the EP during the EHR reporting period (or their authorized representatives) view, download, or transmit to a third party their health information (HealthIT.Gov, 2012).
On October 6, 2015, CMS published its final rule on Stage 3.The new rule merged stages 1 and 2 into a modified Stage 2 with a single set of objectives. The modified Stage 2 criteria are to be used by EPs and hospitals from 2015 to 2017. In 2017, EPs may elect to use Stage 3 Objectives and Measures but they are not required to do so until 2018. With the advent of Stage 3, objectives and measures for domains were again changed. Measure 2, required for Stage 2 and listed above, required that 5 percent of patients actually viewed, downloaded, or transmitted their health information. Many EPs had argued that they had no control over patients’ behavior and should not be held to criteria that made them responsible for decisions that their patients made. In response to this concern the following objective and measures were included in the Stage 3 criteria:
Objective: Provide patients the ability to view online, download, and transmit their health information within 4 business days of the information being available to the provider.
Measure 1: More than 80 percent of all unique patients (or the patient’s authorized representative ) seen by the EP is provided within 48 hours of a patient visit with access to view online, download, and transmit the patient’s health information
Measure 2: In 2015 and 2016, at least one patient must use such functionality and in 2017, more than 5 percent of patients must use such functionality (O’Neill, 2015).
Many people in the connected health community saw the requirement of only one patient as a 'cop-out' and shared that opinion when the regulations were posted for public review. In responding to these comments the CMS provided their rational for limiting the measure to one patient (Office of the Federal Register, 2015). However, progress is being made. In 2013, 33% of physicians gave patients the option to view, download, or transmit their electronic health information. In 2015, this number had increased to 64% (Office of the National Coordinator for Health Information Technology, 2016a). The percentage of hospitals that provide patients the ability to view, download, and transmit their health records online increased from 10% of hospitals in 2013 to 69% of hospitals in 2015 (Office of the National Coordinator for Health Information Technology, 2016b).
Stage 3 is the final phase for the MU incentive program and is now in the process of being replaced by the Medicare Access and Children’s Health Insurance Program Reauthorization Act (MACRA) of 2015.
Medicare Access and Children’s Health Insurance Program Reauthorization Act of 2015
MACRA was passed with strong bipartisan support in both the U.S. House of Representatives and the U.S. Senate and was signed into law on April 16, 2015, by President Obama. The legislation, including the Quality Payment Program, is making significant changes in how Medicare pays healthcare providers. For the purposes of this legislation the definition of healthcare provider was expanded to include a physician, physician assistant, nurse practitioner, clinical nurse specialist or certified registered nurse anesthetist.
MACRA provides meaningful support for and progress toward paying healthcare providers for value of the quality of the care provided rather than the volume of care provided (Madison, 2018). To achieve this goal the Quality Payment Program offers two options for the healthcare provider payment. These are the Advanced Alternative Payment Models (APMs) or the Merit-Based Incentive Payment System (MIPS) (Quality Payment Program, 2017a).
APMs use a payment approach that provides added incentives to clinicians to provide high-quality and cost-efficient care to specific groups of patients. APMs can apply to a specific clinical condition, a care episode, or a population. Examples include Oncology Care Model (OCM) or Next Generation Accountable Care Organization (ACO) Model (American Academy of Family Physicians, 2016). Since CMS estimates that less than 10 % of providers will participate in an APM this column focuses on MIPS (Quality Payment Program, 2017b).
MIPS contains four performance categories, including (a) quality, (b) advancing care information, (c) improvement activities, and (d) cost. Healthcare providers’ performance in these four categories will determine their performance score and their payment rate for the care they have provided. “Measures and objectives in the advancing care information performance category focus on the secure exchange of health information and the use of certified electronic health record technology (CEHRT) to support patient engagement and improved healthcare quality” (Quality Payment Program, 2017b). The performance category of advancing care information includes 15 measures. Four of these measures are specific to patient engagement.
Measure 1: For at least one unique patient seen by the MIPS-eligible clinician: (a) The patient (or the patient-authorized representative) is provided timely access to view online, download, and transmit his or her health information; and (b) The MIPS-eligible clinician ensures the patient's health information is available for the patient (or patient-authorized representative) to access using any application of their choice that is configured to meet the technical specifications of the Application Programming Interface (API) in the MIPS-eligible clinician's certified EHR technology.
Measure 2: During the performance period, at least one unique patient (or patient-authorized representative ) seen by the MIPS-eligible clinician actively engages with the EHR made accessible by the MIPS-eligible clinician. MIPS-eligible clinicians may meet the measure by either(a) viewing, downloading or transmitting to a third party their health information; or (b) accessing their health information through the use of an API that can be used by applications chosen by the patient and configured to the API in the MIPS-eligible clinician's certified EHR technology; or (c) a combination of (a) and (b).
Measure 3: The MIPS-eligible clinician must use clinically relevant information from certified EHR technology to identify patient-specific, educational resources and provide electronic access to those materials to at least one unique patient seen by the MIPS-eligible clinician.
Measure 4: Patient-generated health data or data from a non-clinical setting is incorporated into the certified EHR technology for at least one unique patient seen by the MIPS eligible clinician during the performance period (Quality Payment Program, n.d.).
As noted earlier, MACRA offers two options for healthcare providers to receive payment for care provided to patients. The goal in both cases is to provide incentives for healthcare providers to change their approach to the practice of patient care moving from quantity-based care provided to individuals to quality-based care provided to populations of patients. Foundational to this transition are patients who are equipped, enabled, empowered, and engaged in decisions about their health and healthcare (Okun & Caligan, 2018).
Government-sponsored programs now make up over 50% of healthcare spending in the U.S. (James & Hughes, 2015). This means that the federal government is a major if not THE major driving force setting healthcare policy and in turn healthcare practice across the country. “The federal government is committed to stimulating the development and use of policy, standards, and technology to advance individuals’ rights to securely access, amend, and make choices for the disclosure of their electronic health information” (ONC, 2015). The Figure, provided in the Federal Health IT Strategic Plan, demonstrated this commitment by making this the first objective of the Plan.
Figure: Strategic Plan Federal
Source: U.S. DHHS: The Office of the National Coordinator for Health Information Technology (ONC). (2015). Federal health IT strategic plan 2015-2020. Retrieved from https://www.healthit.gov/sites/default/files/9-5-federalhealthitstratplanfinal_0.pdf
To be an ePatient – that is equipped, enabled, empowered, and engaged in one’s health and healthcare decisions, patients must have complete access to their health information. In this Part II of this series, we have explored two examples of the U.S. federal government’s role in supporting the equipped, enabled, empowered, and engaged ePatient. The Table provides other examples to reinforce the fact that this Column Part II has just touched the tip of the iceberg when considering the federal government’s efforts to empower patients. However, ePatients still face a number of challenges that limit their complete access to their health information. Part III in this series will explore these challenges.
Table. Other Examples of Government Efforts to Increase Patient Engagement
The Blue Button symbol signifies that a site has functionality for customers to go online and download health records.
Enhancing Patient Engagement Efforts Across the Food and Drug Administration
The Food and Drug Administration (FDA) is establishing a public docket to solicit input regarding ongoing efforts to enhance mechanisms for patient engagement at the Agency. This site will be open for comment until June 12, 2017.
The Role of the Patient in Safety
Agency for Healthcare Research and Quality (AHRQ): Patient Safety Network includes primers related to patient safety. This specific primer describes patients' roles in ensuring their safety in healthcare settings.
Health Care Providers & Facilities
U.S. DHHS maintains a site where patients and providers can locate and compare local healthcare providers and facilities in terms of quality and services offered.
Ramona Nelson PhD, RN-BC, ANEF, FAAN
Dr. Nelson holds a baccalaureate degree in nursing from Duquesne University, and master’s degrees in both nursing and information science, as well as a PhD in education, from the University of Pittsburgh. Prior to her current position as President of her own consulting company, she was Professor and Chair of the Department of Nursing at Slippery Rock University in Pennsylvania. In the early 1980’s, one of Dr. Nelson’s employee benefits, while teaching at the University of Pittsburgh, was the opportunity to take university courses for only $5.00 a credit. After taking courses in computer assisted instruction and theory for information science, she recognized these tools (computers) just might be somewhat useful at the bedside and in the classroom. She has been exploring and discovering just how useful they can be ever since.
Dr. Nelson’s more recent research and publications focus on the specialty area of health informatics. Her latest book, the second edition of Health Informatics: An Interprofessional Approach (Nelson & Staggers, 2018), co-authored with Nancy Staggers, received the first place American Journal of Nursing Book of the Year award in 2013 for Information Technology/Informatics. It continues today as a primary textbook in the field of health informatics. Based on her contributions to nursing and health informatics she has been inducted into both the American Academy of Nursing and the first group of fellows in the National League for Nursing Academy of Nursing Education. She has also been recognized as a pioneer within the discipline by the American Medical Informatics Association. Her goal in serving as Editor of OJIN’s Informatics Column is to open a discussion about how we as nurses in the inter-professional world of healthcare can maximize the advantages and manage the challenges that computerization bring to our practice.
American Academy of Family Physicians. (2016). Executive summary of the MACRA final rule. Retreived from http://www.aafp.org/dam/AAFP/documents/advocacy/payment/medicare/ES-MACRAFinal-102416.pdf
Health Information Policy. (n.d. a). Your Health Information privacy Rights. Retrieved from http://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/understanding/consumers/consumer_rights.pdf
Health Information Policy. (n.d. b). Individuals’ right under HIPAA to access their health information 45 CFR § 164.524. Retrieved from https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access
HealthIT.Gov. (2012). Step 5: Achieve meaningful use stage 2. Retrieved from http://bit.ly/1MXSCd9
James, E., & Hughes, M. (2015, Jul 29). Government-sponsored programs make up 52% of what we spend on healthcare. Forbes. Retrieved from https://www.forbes.com/sites/realspin/2015/07/29/for-the-first-time-government-programs-make-up-the-majority-of-u-s-health-spending/#493b3331137f
Madison, M. P. (2018). The Health Information Technology for Education and Clinical Health (HITECH) Act, Meaningful Use, and Medicare Access and CHIP Reauthorization Act of 2015. In R. Nelson, & N. Staggers (Eds.), Health Informatics, An Interprofessional Approach (pp. 455-473). St. Louis: Elsevier.
O’Neill, T. (2015, Oct 28). Primer: EHR stage 3 meaningful use requirements. Retrieved from http://americanactionforum.org/research/primer-ehr-stage-3-meaningful-use-requirements#_edn1
Office of the Federal Register. (2015, Oct 16). Medicare and Medicaid Programs; Electronic health record incentive program-stage 3 and modifications to meaningful use in 2015 through 2017. Retrieved from http://bit.ly/2ofgd4n
Okun, S., & Caligan, C. (2018). The Evolving ePatient. In R. Nelson, & N. Staggers, Health Informatics: An Interprofessional Approach (2nd ed., pp. 204-219). St Louis: Elsevier, Inc.
Office of the National Coordinator for Health Information Technology. (2016a). Office-based physician electronic patient engagement capabilities. Retrieved from https://dashboard.healthit.gov/quickstats/pages/physicians-view-download-transmit-secure-messaging-patient-engagement.php
Office of the National Coordinator for Health Information Technology. (2016b, Sept.). Retrieved April 14, 2017, from U.S. Hospital Adoption of Patient Engagement Functionalities,' Health IT Quick-Stat #24. Retrieved from: https://dashboard.healthit.gov/quickstats/pages/FIG-Hospital-Adoption-of-Patient-Engagement-Functionalities.php
Office of the National Coordinator for Health Information Technology (ONC). (2015). Federal health IT strategic plan 2015-2020. Retrieved from https://www.healthit.gov/sites/default/files/9-5-federalhealthitstratplanfinal_0.pdf
Office of the National Coordinator for Health Information Technology. (2013). Step 5: Achieve meaningful use stage 1. Retrieved from: http://bit.ly/1RyRzGR
Quality Payment Program. (n.d.). Advancing care information. Retrieved from https://qpp.cms.gov/measures/aci
Quality Payment Program. (2017a). The quality payment program: Overview fact sheet. Retrieved from https://qpp.cms.gov/docs/Quality_Payment_Program_Overview_Fact_Sheet.pdf
Quality Paument Program. (2017b). Executive summary. Retrieved from https://qpp.cms.gov/docs/QPP_Executive_Summary_of_Final_Rule.pdf
U.S. DHHS. (2014, February 3). HHS strengthens patients’ right to access lab test reports. Retrieved from https://wayback.archive-it.org/3926/20150618190209/http://www.hhs.gov/news/press/2014pres/02/20140203a.html