2022 Recap & Look at the Future of Health IT

By Tony Schueth, CEO and Founding Partner

2022 in Review

This year has brought hope for progress as health care organizations prepare to meet upcoming cost transparency and burden reduction requirements. While it seems like the regulatory landscape of 2022 lacked the teeth and/or incentives required to spur immediate changes, there were some bright spots. For one, we saw states double down on federal policy by passing data and patient cost transparency laws with consequences to noncompliant organizations. There are organizations and accelerators providing standards that exceed current requirements and offer competitive advantages. Here’s a brief overview of what’s happened in 2022 so far and what we think the future may hold.

No Surprises and Transparency in Coverage Rules

The No Surprises Rules went into effect January 2022, although enforcement of some aspects is still pending. The provisions that began this year include advanced cost estimates and no balance billing for all insured patients as well as good-faith estimates (GFEs) of costs for self-pay and uninsured patients.

The Transparency in Coverage (TiC) Rule also went into effect January 1st but was not enforced until July 1, 2022, requiring all payers to provide machine-readable files in preparation for upcoming price transparency tools and advanced explanation of benefits (AEOB) that will require data exchange between payers and providers and among multinetwork provider groups. Requirements coming in 2023 include publishing pricing on 500 covered items and services, as well as out-of-network historical allowed amounts and billed changes and in-network negotiated rates.

Together, these cost transparency regulatory activities are empowering consumers to make better informed health care choices. The early iterations of TiC Shopping Tools and other payer-developed cost estimators have limited functionality, but patients are growing accustomed to having options for their care and medications. A complete AEOB at the point of care for patients is not due until mid-year 2023 and may be further delayed. Currently, The American Medical Association and other medical entities have united to file a lawsuit via amicus brief against the No Surprises provisions of the Consolidated Appropriations Act of 2021, claiming the dispute resolutions process therein unfairly favors payers over providers. While lack of enforcement has meant a slow start to adherence, there was a recent impact report issued by Turquoise Health that shows:

• 65% of hospitals have published negotiated rates.
• 76% of hospitals have posted machine readable files.
• 63% of hospitals have posted cash rates.

These regulations have led to improvements for patients as hospitals, provider groups and payers readjust their contracts and negotiate lower payment structures to remain competitive.

What Does the Future Hold? 

The Centers for Medicare & Medicaid Services (CMS) recently released a Request for Information (RFI) on AEOBs and GFEs for covered individuals. Comments are due November 15, 2022.

Some questions raised in the RFI were in key areas in which we engage, inform and have subject matter expertise and should be noted by the industry:

• FHIR APIs – The RFI asked several questions related to leveraging FHIR in the exchange of AEOB and GFE data. The questions asked to indicate several policies are under consideration that will require use of FHIR application programming interfaces (APIs), but will exceptions be given and how might new rules impact existing certification requirements or result in new ones?
• Privacy – Privacy is a concern that will continue until the end of time, so it’s no surprise there were questions about how more fluid exchange of AOEB and GFE data might impact privacy. One could argue that electronic consent should be part of that discussion to provide a consistent, standard means by which consumers/patients may readily manage who has permission to view, access, use or exchange which portions of their data.
• Health Equity – Several questions sought insight into ensuring underserved communities are aware they can access AOEB and GFE data and are educated on what it means and how to use them to build trust among patients and their care team and take definitive steps to improve their health in a marked way.
• Impact on Burden – Several questions related to weighing the benefit resulting from requirements under consideration with the possible increased burden to providers, plans, facilities, issuers and carriers.

Burden Reduction Rule and Prior Authorization

2022 included waiting for reemergence of the Burden Reduction Rule, which was shelved in 2020. The shelved rule built on the CMS Patient Access API Rule to improve the prior authorization (PA) process and reduce burden, requiring CMS-regulated payers to implement APIs that increase patient access to their electronic health data and improve data exchange among payers, providers and patients. It included four proposals that directly outlined requirements for electronic prior authorizations (ePAs):

1. Patient Access APIs – Would have required payers to include real-time information about active and pending PA decisions so patients are aware of progress.
2. Claims & Encounter Data – Would have required the development and use of provider access APIs for claims and encounter data sharing that includes real-time information on PA status for individuals and groups of patients. The intent was to ease the initiation of PA requests and speed communication of approval status.
3. Documentation and PA Burden Reduction Through APIs – The proposed requirement states that payers must develop and maintain FHIR-enabled, workflow-friendly APIs to enable document requirement searches within electronic health records (EHRs) and other ePA support functions. The use of APIs will help payers meet the new timeframes that were proposed: up to 72 hours for urgent requests and seven days for routine requests.
4. Payer-to-Payer Data Exchange – Intended to ease information sharing when a patient changes carriers or plans. When a policy or coverage transition takes place, during open enrollment or otherwise, patients could request that their existing PA data be exchanged between their former and new payer to potentially eliminate the need to repeat the PA process.

Unsurprisingly, private sector development of solutions has outpaced government policy. CoverMyMeds, ExpressScripts, Cambia and Surescripts already use ePAs to alleviate provider workload and reduce delays in delivery of care. Many EHRs and health systems are working to implement their own ePA features.

What Does the Future Hold?

The big news is that the officially named “Interoperability and Prior Authorization for MA Organizations, Medicaid and CHIP Managed Care and State Agencies, FFE QHP Issuers, MIPS Eligible Clinicians, Eligible Hospitals and CAHs (CMS-0057)” is now sitting with the Office of Information and Regulatory Affairs, Office of Management and Budget. What this means is that within the next 90 days, the industry can expect to see this issued once again as a Notice of Proposed Rulemaking (NPR) and be given the ability to comment.

It is currently unclear how the new proposed rule will differ from the original; however, based on the time that’s passed, we feel that is a good indication some modifications have been made. Only time will tell what exceptions or exclusions might be made or incentives that might have been added.

The abstract states:

“This proposed rule would place new requirements on Medicare Advantage (MA) organizations, Medicaid managed care plans, Children’s Health Insurance Program (CHIP) managed care entities, state Medicaid and CHIP fee-for-service (FFS) programs, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs) to improve the electronic exchange of health care data and streamline processes related to prior authorization, while continuing CMS’ drive toward interoperability and reducing burden in the health care market. This proposed rule would also add a new measure for eligible hospitals and critical access hospitals under the Medicare Promoting Interoperability Program and for Merit-based Incentive Payment System (MIPS) eligible clinicians under the Promoting Interoperability performance category of MIPS. These policies taken together would play a key role in reducing overall payer and provider burden and improving patient access to health information.” 

The previous rule was estimated to save between $1 billion and $5 billion over the next 10 years.

We expect the private sector to continue accelerated progress and implementation of ePA-related implementation guides from the Da Vinci Project and development of ePA solutions.

How are state and federal data/cost transparency legislative activity impacting your organization? 

HIPAA 2.0

The Health Insurance Portability and Accountability Act (HIPAA) is 26 years old and has not been updated since 2013, when changes were made to reflect new requirements in the Health Information Technology for Economic and Clinical Health Act. Technology has evolved and new interpretations and requirements are needed that provide patient data security without limiting data sharing. The Office for Civil Rights (OCR) with the Department of Health and Human Services is responsible for HIPAA regulation and compliance. The OCR issued a Notice of Proposed Rulemaking (NPRM) to modify HIPAA in January 2021 and received stakeholder input until the end of March 2021, the Department of Health and Human Services (DHHS) released an RFI seeking input for developing a “settlement sharing” provision that would allow civil monetary claims for victims of HIPAA-related security breaches. This will lead to additional NPRMs and eventually consequences for noncompliance.

What Does the Future Hold?

Many expected a Final Rule on proposed HIPAA changes before the end of 2022, but we have yet to see additional signals of a forthcoming rule; even if there was a HIPAA 2.0, enforcement deadlines would likely be months or years away. Proposed changes are expected to improve patient access to their own health care data by shortening the required request response time from 30 to 15 days. It is expected that patients will be allowed to view and photograph their medical records at all providers and can request access to their electronic personal health information (PHI) via an API or Internet portal. For payers and providers, the biggest changes involve security frameworks to protect against data breaches while allowing for patient-approved data sharing, and lack of clarity regarding settlement sharing and security auditing.

Patients of all ages use their mobile phones to log into their portal and view notes from their doctor or request medication refills. Proposed updates will address the use of digital technology and must cover electronic consent, telemedicine, privacy standards for PHI, and use of de-identified health data.

What’s unknown is how the next iteration of HIPAA will align with current technologies or if any additional certification requirements will follow.

TEFCA

Version 1 of the Trusted Exchange Framework, Common Agreement (TEFCA) was finally published January 19, 2022, after what felt like an eternity of buzz about it. As the latest and most ambitious attempt at promoting/enabling a national network, the goal of TEFCA is to create a universal floor for interoperability, with simplified connectivity for exchange (a single on-ramp) and the ability for individuals to gather their health information. TEFCA intends to establish the infrastructure model and rules that will govern how different networks and their stakeholders (including providers, payers and public health) securely share clinically relevant information with each other. The Trusted Exchange Framework refers to the foundational principles, and the Common Agreement is the contract that “super nodes” called qualified health information networks (QHINs) will sign.² QHINs will communicate with each other in a highly standardized way, and will each have participants (and sub-participants) that will be subject to flow-down provisions. Anyone connected to the network will have greater access to information, including PHI, across health systems and state lines.

What Does the Future Hold?

TEFCA is moving forward. Nine organizations have provided letters of intent to the Sequoia Project, the recognized coordinating entity on behalf of the Office of the National Coordinator for Health Information Technology (ONC), to apply to become QHINs. These include EHR vendors such as Epic and Nextgen, national networks such as the eHealth Exchange and the CommonWell Health Alliance, and tech vendors such as Health Gorilla. We expect more organizations will apply and those that are accepted will probably not shock the industry; however, the identity of the application status of these groups will be carefully controlled by Sequoia as onboarding and testing take place. In fact, it's possible that some QHINs may be designated by the end of 2022, with live data exchange between QHINs in 2023.

It will be interesting to see how successful TEFCA will be in incorporating FHIR into the framework over the next few years (there is a roadmap that includes facilitated and brokered FHIR exchange) and the RCE recently sought feedback on the draft TEFCA Facilitated FHIR Implementation Guide. Much of the TEFCA infrastructure is currently based on IHE (Integrating the Healthcare Enterprise) document query and exchange. There is much to be gained by having TEFCA aligned with the strategic priorities of CMS, ONC and other DHHS agencies to leverage FHIR to progress interoperability efforts. We hope to see TEFCA also collaborating and aligning with the FHIR at Scale Taskforce, which is focused on FHIR infrastructure.

Another area to watch is the future of health information exchanges (HIEs). Which HIEs will apply to become QHINs? Will we see HIEs merge before applying? Will QHINs disintermediate some HIEs or make some HIEs redundant?

Expanding Role of Pharmacists in the Care Team

Throughout the pandemic we saw pharmacists stepping up to close gaps in care and improve community health. Pharmacists are trusted contributors to patient care. With supportive technology, training and improved access to clinical data, they can expand their patient care capabilities and help address gaps. In a recent study by Columbia University and Express Scripts, 77.3% of patient respondents agreed that the pharmacist is an integral part of the care team.¹ Pharmacists should be included in value-based agreements to help payers and providers achieve cost and quality goals. 83.7% of providers whose practice is part of a value-based payment model agreed that pharmacists should be regularly included in multidisciplinary teams that collaborate on patient care.¹

What Does the Future Hold?

The industry will develop standards to share clinical data between pharmacists and other members of the care team, coordinating on care holistically to close gaps in care. Additional training programs, quality measures and new technology standards should be developed to facilitate the evolution of pharmacy to a higher level of patient care.

We expect to see EHR software developed for the pharmacy setting, advancing the convergence of clinical and administrative data use, access, storage, and exchange for pharmacists practicing clinically, in addition to payers developing pay structures to support services pharmacists can and already have been performing. We’ve seen state-level activity expanding prescribing roles of pharmacists and we expect this trend to continue. This should be of special interest to life sciences companies as they establish strategies for new product launches.

Health Equity Is and Will Continue to Be a Top Priority

The pandemic provided overwhelming evidence of inequities in our health system. There is a united effort that includes government entities, health systems, pharmaceutical companies, private payer groups and community organizations working together to overcome disparities. This requires improved access to shared clinical and social needs data. Health disparities related to chronic conditions are more common and tend be diagnosed later for particular groups, including people of color, people with low incomes, the disabled, those in rural communities, older adults and people who identify as lesbian, gay, bisexual or transgender. Health equity solutions must meet the needs of different populations.

Payers especially are driving health equity programs and supporting community-level services. These programs are multipronged, including initiatives to help improve capturing the social determinants of health Z code data by providers in ways that don’t disrupt workflow and can be collected once and reused.

What Does the Future Hold?

The industry will continue to embark on programs that improve health equity, including incorporating equity quality measures in value-based agreements. What remains to be seen is how the efficacy of various programs can and are being measured so they can be modeled in other communities.

What is clear is that lip service to health equity will not meet muster. Organizations will be expected to reflect real-world changes and improvements through data.

If you have questions about upcoming regulations or want help developing a detailed plan of action for your 2023 interoperability goals, please reach out to me at tonys@pocp.com.

1. McHugh J et al. The Prescription of Trust, Pharmacists Transforming Patient Care. https://www.publichealth.columbia.edu/sites/default/files/the_prescription_of_trust_final.pdf
2. Office of the National Coordinator for Health Information. Trusted Exchange Framework and Common Agreement (TEFCA) | HealthIT.gov