Thank you for allowing Validic™ the opportunity to submit comments in response to the Inpatient Prospective Payment System (IPPS) Rule. Overall, we support CMS in its goal of reducing physician burden and promoting interoperability to support improvements in healthcare and health outcomes. As such, we firmly believe that patient-generated health data (PGHD) should be maintained as an important component of the Promoting Interoperability program.
At Validic, our mission is to improve the quality of human life by building technology that makes personal data actionable. To achieve this goal, Validic partners and integrates with over 350 home health devices and applications, delivering patient-generated data seamlessly into existing clinical workflows at the nation’s top healthcare systems.
Over the last five years, Validic has witnessed and helped accelerate the momentum and impact of PGHD. We help guide health systems through the complexities of operationalizing these data for remote care and population health initiatives. Often, this means addressing the challenges provider institutions face when trying to access, integrate, share, and utilize these data as part of care management. Our pilot demonstration to support the use of PGHD, conducted on behalf of Accenture Federal Services with the Office of the National Coordinator for Health IT, further proved the clinical efficacy of such data. Our results demonstrated the ways in which PGHD can increase insight into treatment effectiveness and adherence, expand care manager capacity, and prevent negative health outcomes.
Additionally, through this pilot demonstration, we were able to see the frustrations patients experienced in attempting to share their biometric and physiologic data with their care team or physician. One such patient, Steve, was diagnosed with Type II diabetes at age 40. After frequent office visits and more than a decade after being diagnosed, Steve still struggled to manage his weight, a1c, and overall health. So, before each visit, Steve would fax a copy of his glucose readings and insulin dosage to his doctor. But, with no clinical protocol or system in place to manage Steve’s data, the endocrinologist would promptly discard Steve’s readings. This caused a frustrated Steve to leave his provider and seek treatment with a new kind of program, one that would integrate the data he generated daily to better manage his condition.
We applaud the administration’s efforts to make healthcare more manageable by updating and streamlining the EHR Incentive Program, renamed “Promoting Interoperability.” We understand that CMS proposes to modernize the program and reduce the number of requirements facing clinicians, and we certainly agree with those goals and the intended outcome. To this end, we support the intentional, meaningful focus on interoperability as the means to improve the exchange of and access to data in healthcare.
However, for patients like Steve and the millions more suffering from chronic conditions, the inability to share data with a physician will make achieving better outcomes more difficult. In response to CMS’s proposed removal of PGHD from the Promoting Interoperability program, we are expressing our sincere concerns regarding the negative impact this could have on patients and providers alike. We implore CMS to focus on creating new communication and data access pathways for the patient; to prioritize interoperability between the patient and provider; and to incentivize the use of such data in care.
CMS states that removing the PGHD measure will “reduce complexity and focus on the goal of using advanced EHR technology and functionalities to advance interoperability and health information exchange.” It also asserts that the measure does not align with the new program’s goals of “improving interoperability, prioritizing actions completed electronically and use of advanced CEHRT functionalities.” The proposed removal would eliminate the Coordination of Care Through Patient Engagement objective, including view/download/transmit, secure messaging, and PGHD measures that support this objective. Validic asserts that the removal of PGHD does not advance interoperability, but rather limits the scope of it to provider-to-provider communication. Instead, we maintain that PGHD reduces provider burden, positions the patient as a key stakeholder in healthcare, and is a critical component to true healthcare interoperability.
Validic offers the following response to this proposal.
1. Using PGHD can significantly reduce provider burden and expand clinician capacity. We, and the companies with which we integrate, enable health systems to ingest information created, recorded, or gathered from patients to support their health. This data may include biometric data, symptoms, and lifestyle information. By bringing this data to the point of care, in a way that is easily understandable and actionable for providers, we, and other innovators, are supporting care delivery models that reduce the burdens associated with chronic conditions.
Consider the endocrinologist or care manager who is trying to monitor her diabetic patients. Every day or week, the provider goes to her alphabetical list of patients and commences the routine of calling people – starting with patients’ whose last names begins with ‘A.’ Information or updates from each patient may be relayed via phone calls, causing the patient to wait or the provider to sort through voicemails. The provider must then take handwritten notes or actively type every piece of information the patient shares into the EHR. With this approach, the most at-risk patients often go overlooked as there is no way to identify or focus limited resources on those with the greatest needs. The process requires unnecessary manual work, such as typing patient data into the EHR, that could instead be automated to prevent errors or redundant tasks.
Conversely, utilizing PGHD and remote monitoring tools, the endocrinologist can leverage a patient’s continuous data with an analytics engine to identify which patients require immediate intervention or attention. The physician is able to prioritize patients in need of engagement and intervention while empowering those patients who are self-managing effectively to continue to do so. The provider is, therefore, not responsible for outreach to every patient in the program, and instead, focuses efforts on those presenting at-risk. Furthermore, with the use of automation, the provider can create alerts to trigger when a patient submits a reading that falls outside a set threshold, further enhancing patient safety and preventing Emergency Department visits.
A compilation of clinician feedback suggests remote care programs driven by PGHD help providers:
- Build trust with patients through data exchange – providing a shared language through which they can review accurate and regularly captured health information.
- Improve support of patients – helping them better set, track, and attain goals, giving providers the ability to make a greater impact on patients’ day-to-day outcomes.
- Improve the management of patients – by elevating the critical data that enables clinicians to provide better prioritization and personalization of outreach.
- Improve the clinical performance of care teams – by providing the real-time data needed to make critical treatment improvements and medication adjustments over time – enhancing the effectiveness of clinicians in improving patient outcomes.
- Manage chronic conditions before they become comorbid – as a means to prevent conditions from becoming uncontrolled and progressing into other related ailments.
2. PGHD is critical to Promoting Interoperability and patient-centered care. Interoperability is defined as “health information technology that enables the secure exchange of electronic health information with, and use of electronic health information from, other health information technology without special effort on the part of the user; allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law; and does not constitute information blocking.”  [emphasis added]
This definition does not define the “user” as the healthcare provider, nor does it limit the scope of interoperability to provider-to-provider communication. It advocates for secure access, exchange, and use of all health data. As we leverage Health IT for efficiency improvements and learn about the role of patient engagement in health outcomes, interoperability does, and must, include the exchange of data from providers to patients and from patients to providers. Excluding patients from this definition would marginalize their importance as a stakeholder in healthcare interoperability and suggests that the voice of the patient is less a priority than that of the provider. We know this is not the intent of CMS; however, we strongly believe this is an unintended and dangerous message to the market – and a hindrance to the progress that has been made to bring patients to the forefront of care. Similarly, exclusion of PGHD from “Promoting Interoperability” is inconsistent with statutory requirements regarding interoperability in the 21st Century Cures Act.
Steve is one such patient that benefited directly from the use of PGHD in his care program. Steve regularly captured his blood glucose and blood pressure readings, weight, activity, and nutrition. This data was passively collected and integrated into his electronic health record and regularly reviewed by his care manager. As part of the data review, Steve and his care manager discovered a previously overlooked snacking trend. This nightly snack was enough to regularly spike his blood glucose at the start of each day and contribute to worsening symptoms. Through regular, proactive condition management using patient-generated health data, Steve’s a1c went from 8.9 to 6.5; he lost 50 pounds; he no longer suffers from atrial flutter; he reduced his blood pressure below the industry standard; and, he no longer has to work part-time due to low energy levels or the joint and back pain that extended from his diabetes. Steve credits the use of PGHD as helping him – along with his care team – finally manage his diabetes.
There are a growing number of patients that are seeking a different relationship and method of engagement with their care providers. These people are aware that they can collect and use PGHD to take greater ownership over their health. And, they increasingly expect their care team to engage with them on interpreting this data and giving feedback on progress against their care plan goals. It is our collective responsibility to support these patients in the most effective and efficient means possible. This means leveraging PGHD in support of patients, acknowledging its value to healthcare, and incentivizing its use among providers.
3. There are standards for PGHD. Validic has committed to using the Fast Healthcare Interoperability Resources (FHIR) standard to support the exchange of remote monitoring data from patients to health care providers. Many innovative developers are using advanced technologies, including those encouraged by CEHRT, to bring PGHD into the EHR. CMS states that although this measure requires use of the 2015 Edition, it does not require key updates to functions and standards of health IT. Indeed, the current PGHD certification criterion is very broad and flexible, allowing for the use of structured formats in addition to attachments, links, or text references which do not require the use of CEHRT. We recognize the intent of ONC and CMS to focus on interoperability, including the use of structured formats and industry-recognized standards where possible – and we agree with those goals.
In the 2015 Certification Program Final Rule, ONC signaled that FHIR could be the future application programming interface (API) standard for EHRs but it was still in the experimental or pilot phase. Much has changed in the market since the publication of the 2015 Edition. Today, many of the software applications and remote monitoring tools that integrate with our platform are voluntarily using the Fast Healthcare Interoperability Resources (FHIR) standard. FHIR is now recognized as a notable industry default for standardized, interoperable APIs. ONC’s Interoperability Proving Ground database has over 70 projects relating to the use of FHIR across the country. Government agencies are also embracing FHIR to exchange federally-held health data, including the CMS Blue Button 2.0 project, the National Institutes of Health, and the Veterans Administration. We urge CMS to work together with ONC to determine whether the PGHD measure could be more closely tied to the FHIR standard where appropriate to resolve CMS’s stated concern about interoperability of PGHD.
Based on our above commentary and stated response to the proposed removal of PGHD from Promoting Interoperability, we make the following recommendations to CMS.
- Maintain the PGHD measure in the Promoting Interoperability program. As stated above, PGHD can be exchanged in an interoperable way using government-endorsed standards. Using PGHD in the clinical setting will reduce provider burden and improve health outcomes.
- Publish a clear and consistent message on PGHD. Right now, hospitals and eligible clinicians are incentivized to use PGHD through both the EHR Incentive Program and the Quality Payment Program. CMS has also unbundled coverage of the 99091 CPT code for remote monitoring starting this year, an encouraging step toward greater adoption of these innovations.
If the new Promoting Interoperability program removes PGHD as a measure, one of these incentives is lost – and hospitals will spend their valuable time complying with the many other regulatory requirements that they face. Even if providers realize the benefit of PGHD, if they are not receiving credit for the measure, it may be pushed to the bottom of their priorities – to the detriment of patients and clinicians. This would be an unfortunate consequence, given that the use of PGHD is helping hospitals transition to value-based care.
If CMS does choose to eliminate PGHD as a measure under the Promoting Interoperability program, we urge the agency to issue an explanation and subsequent guidance that addresses the points made above, and that underscores the importance of PGHD in supporting value-based care while providing a single, consistent agency policy view regarding PGHD.
 Pub.L. 114-255.
 80 FR 62676; see: https://www.federalregister.gov/d/2015-25597/page-62676
 ONC Interoperability Proving Ground: https://www.healthit.gov/techlab/ipg/
 Sync for Science: http://syncfor.science/
 “VA Announces Launch of Lighthouse Lab at Health Information & Technology Conference,” March 7, 2018: https://www.va.gov/opa/pressrel/pressrelease.cfm?id=4021. See also “VA Lighthouse API Platform with FHIR Enables Health Data Access,” March 16, 2018: https://healthitanalytics.com/news/va-lighthouse-api-platform-with-fhir-enables-health-data-access