Healthcare industry stakeholders made their case to leaders in President Donald Trump's health department last week about the need to improve the nation's health information technology infrastructure.
The request for information garnered just over 1,300 comments from trade groups, provider and hospital associations, individual companies, payers, patients and providers. The comment letters spanned the gamut of traditional health IT issues, such as issues with the Trusted Exchange Framework and Common Agreement (TEFCA) and weak enforcement of information blocking rules.
The Centers for Medicare & Medicaid Services (CMS) and the Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator of Health IT (ASTP/ONC) issued the RFI May 13, seeking public comment on how to ease data exchange among the healthcare ecosystem for patients, providers, payers, vendors and value-based care organizations.
The comment letters, reviewed by Fierce Healthcare, balanced the ongoing needs of the healthcare technology ecosystem with the policy priorities already forged by Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., CMS Administrator Mehmet Oz, M.D., and Department of Government Efficiency acting Administrator Amy Gleason, who have voiced commitments to revamping the nation's healthcare system to serve patients.
RFK Jr. has made clear he plans to use artificial intelligence to help complete the task, and he reiterated this focus to the House Energy and Commerce Committee during a hearing Tuesday morning.
At an event with roughly 100 stakeholders to discuss the RFI on June 3, the CMS announced five initiatives that it would take on: a national provider directory, a modern identity verification solution, expanded patient access via APIs, general availability of its Data at the Point of Care pilot and CMS participation in a trusted data exchange.
Attendees at the event said remarks from RFK Jr., Oz and other federal healthcare leaders signaled the HHS is committed to ending the outstanding issues with interoperability since the adoption of electronic health records.
“We don’t want to continue interoperability, we want to end it,” Gleason said at the event, according to an attendee's post on LinkedIn. Gleason, a nurse and healthcare data professional who formerly worked at the U.S. Digital Service, has long been an advocate for data record access for patients.
In addition to airing traditional concerns about health technology policies, many commenters on the CMS/ASTP RFI addressed the new initiatives laid out by the CMS on June 3, with mixed reaction.
National provider directory
Many commenters provided feedback on the CMS’ proposal to create a national provider directory. Commenters pointed out issues with the creation of a national provider directory and failed attempts at doing so in the past by Medicare Advantage organizations and payers. The issues included keeping the directories updated and accurate and incentivizing use by commercial health plans.
“Steps must be taken to ensure that the Provider Directory API does not simply become an additional data source available to patients without sufficiently addressing how or why it differs from the myriad provider directories already in existence, and to ensure that it does not complicate patients’ abilities to access accurate information,” the American Hospital Association said.
The benefits of a national provider directory include less burden on providers to report information to the multiple existing directory systems like the Provider Enrollment, Chain, and Ownership System and the National Plan and Provider Enumeration System and promote knowledge of community resources and social services.
“The development of an NHCD presents a unique opportunity for the federal government to collect and disseminate information that would directly assist underserved and disadvantaged communities,” the Workgroup for Electronic Data Interchange (WEDI) wrote in its comment letter. “Collecting information on such entities as food banks, mental health services, transportation assistance programs, and other social services and then making that information available to consumers, organizations that assist underserved and disadvantaged, providers, health plans, and API developers would be extremely beneficial.”
TEFCA
Organizations expressed support for TEFCA and urged its continued adoption. Commenters agreed, though, that TEFCA has not yet been fully realized and that policy barriers prevent its full adoption.
“If TEFCA can truly deliver on scalable, standards-based exchange, it could reduce duplicative infrastructure investments across the ecosystem,” the Electronic Health Record Association (EHRA) wrote.
Commenters asked for payers—including the CMS—to be fully brought into TEFCA. Several organizations, including the Connected Health Initiative (CHI), voiced concerns that ASTP/ONC policy has not fully addressed the needs of payers to be able to participate.
“From a policy standpoint, [payers] find the benefits of TEFCA unclear, especially since its requirements are still evolving and do not yet fully address key payer needs such as prior authorization, risk adjustment, or quality reporting. The high infrastructure demands, requiring substantial investments in technology, security, and ongoing compliance, further add to their hesitation," the organization wrote.
The American Medical Informatics Association (AMIA) wrote that “the limited transparency around actual data exchange volumes and patterns through TEFCA networks makes it difficult to assess its effectiveness. Current barriers include concerns about patient matching accuracy, potential HIPAA liability for incorrect matches, and the need for federated identity solutions.”
Premier wrote that the CMS joining a trusted exchange framework could help address information blocking by participants and to answer requests for CMS health plan data.
“Until TEFCA provides a functional, efficient route for all stakeholders—especially payers—we’re essentially asking the industry to follow rules for infrastructure we haven’t actually built,” HTD Health, a technology consulting firm, wrote.
Patient-facing apps
The RFI skewed heavily toward improving the patient and caregiver experience of accessing personal health records and toyed with the idea of a new type of patient portal or digital navigator that makes all health data available to patients.
Commenters generally expressed support in their responses to the questions about patient-facing apps with access to all data.
“CMS should support the adoption of unified digital front doors that aggregate scheduling, pre-visit intake, results, and messaging, and bi-directionally sync with EMRs,” the General Catalyst Institute (GCI) wrote. “These platforms should also surface patient-generated data and support two-way communication for Medicaid, SNAP, WIC, and other programs.”
The AMIA advocated for user-centered design, care coordination features and integrated personal health records. To create longitudinal patient records, the AMIA suggests “mandating API-accessible, computable full EHI export aligned with industry specifications” and “requiring certified self-service portals that allow electronic patient requests for EHI access.”
HTD Health recommended the CMS and the ASTP/ONC expand the types of data patients can access through a centralized system to include price transparency, billing data, appointment scheduling and communications.
The WEDI suggested the CMS may need to give out incentives for patients and providers to use digital health apps.
“CMS should consider options they have to incentivize patients to use apps and products, either directly through Medicare such as a discount on their Medicare premium, decrease in their co-insurance amount, rewards card, etc., or through incentivizing providers,” the WEDI wrote.
Groups urged the CMS to increase reimbursement for digital health products covered by Medicare and to modify CPT codes for remote monitoring and telehealth. The Consumer Technology Association advocated that the CMS expand its payment rules to allow for payment for novel and innovative technologies, including digital therapeutics. The CHI expressed frustration that many digital health technologies cannot integrate with EHRs due their excessive requirements.
Comments that addressed increasing access to consumer digital health products also urged the CMS and the ASTP/ONC to engage in foundational issues consumers face like lack of broadband infrastructure, Wi-Fi access and digital literacy.
Digital identity
The CMS and ASTP/ONC RFI also asked stakeholders about the benefits and drawbacks of digital identities for patients and how the identification shift would impact the ecosystem. While stakeholders seemed to agree that the proposal could benefit patients, the implementation could be complicated.
“The enrollment process for digital identity solutions can be perceived as complex or intimidating, especially if it involves multiple steps, document uploads, or multifactor authentication,” the CHI wrote. “Concerns about privacy, data security and the potential misuse of sensitive information could also deter some users.”
The CHI suggested the CMS and payers set standards for digital identity, use reimbursement to incentivize adoption and educate patients on the benefits and process. The AMIA suggested a slew of technical specifications that the industry could adopt to enable digital identity securely.
The GCI, the policy shop for the venture capital firm General Catalyst, supported the implementation of the technology and envisioned a role where it could help with many issues in the healthcare ecosystem. “CMS should establish a federated digital identity ecosystem enabling seamless authentication and access for patients, providers, and caregivers … organizations can reduce IT, compliance, and legal overhead while empowering beneficiaries to permission their data for care, analytics, or research,” the GCI said.
Information blocking
Many organizations urged the HHS' health AI arm to strengthen enforcement of information blocking rules because the practice is still common in the healthcare industry, despite existing rules.
Several comment letters stated that EHR companies and other health IT developers have incentives to not share data because it is a valuable “competitive advantage,” as the CHI wrote. Data are “ trapped in a limited number of competing vendor ecosystems,” Premier said. Premier wrote that large EHR companies force digital health tools to undergo rigorous technical and procedural processes to connect their applications which is a form of anti-competitiveness with their own native applications.
“The lack of enforcement of information blocking provisions has encouraged organizations to invest in lawyers to argue exceptions and technicalities rather than invest in good-faith interoperability efforts,” Premier wrote.
The CHI suggested the ASTP should investigate information blocking complaints and publish the results to discourage bad practices. It also suggested the CMS tie information blocking compliance to the ability to participate in Medicare or other federal healthcare programs.
The EHRA commented that the ONC should maintain key exceptions to information blocking rules and “prioritize stability” in the regulations. While it suggested some small changes to the rules, the association argued for continuity of the current framework.
Data privacy and cybersecurity also emerged as themes of the RFI responses. Commenters urged the new administration to consider patient data privacy and the cybersecurity of systems required to share information through CMS or ASTP/ONC programs.