Policy, Standards & Implementations: Where the Rubber Hits the Road

By Jocelyn Keegan, Payer Practice Lead    By Vanessa Candelora, Senior Consultant

As the new year gets under way and health care leaders take a fresh look at project roadmaps, many – if not all – will wonder how they and their teams will manage to get everything done. 

Payers, providers and health information technology (health IT) developers alike are no doubt sifting through the spate of federal notices of proposed rulemaking and requests for information that have come out over the past several months, considering if they already have or where they’ll find the resources necessary to meet mandated requirements for programs with specific standards and deadlines. From interoperability among payers, Fast Healthcare Interoperability Resources (FHIR) application programming interfaces (APIs) within certified electronic health records (EHRs), improved electronic prior authorization processes, and improving regulations governing the confidentiality of substance use disorder records to adopting standards for health care attachments transactions and developing companion standards for electronic signatures, the number of comment periods, deadlines and proposed enforcement time frames will no doubt give stakeholders pause regarding what to tackle first. 

Stakeholders would be quite right in thinking that the past year has been one of the busiest on record for the Centers for Medicare and Medicaid Services (CMS) and Office of the National Coordinator for Health IT (ONC) in terms of educating and guiding the health care industry toward meaningful interoperability, value-based care, cost transparency and easier and more timely access to electronic medical records. But the seemingly frenzied pace at which these government bodies have churned out proposed rules is, in truth, the culmination of federal efforts that have been attempting to drag health care into the digital age since the HITECH Act was passed 14 years ago. 

If one looks closer, that pace has, in fact, set those organizations striving to stay ahead of the innovation curve up for successful, on-time development and implementation of required standards, APIs, and/or compliance with the latest certifications. When it comes to resource allocation, those forward-thinkers should quickly realize the building blocks are already there for their next government project. Those who have dragged their organization’s strategic and technological feet, however, hoping to squeak by on the bare technological minimum, will realize over the coming months – as comment periods end and federal due dates loom – that their competitors will have the upper, more interoperable and cost-effective hand.

As National Coordinator, Micky Tripathi, has emphasized, stakeholders should be assessing, building and implementing in anticipation of final rules being passed and implemented rather than waiting for enforcement of penalties to push the industry into action. The industry has moved well beyond the era of version 1 EHR implementations and is now poised to truly take advantage of all the work that has been put into setting up interoperable systems. The policy, standards and implementations rubber has hit the road, and now it’s time for health care stakeholders to assess how they can zoom forward in the name of better, affordable and more accessible patient care.

Step One: Evaluate

Taking stock of the tools, processes, expertise and other resources already in place within an organization may seem like low-hanging fruit, but the act of inventory can actually yield surprising benefits. Perhaps your team has already developed patient-access APIs, built out the backbone of price transparency solutions or fully integrated FHIR APIs into the latest version of that cloud-based EHR. The tools used to build those solutions, as well as the solutions themselves, can now be reassessed as potential building blocks for near- and long-term projects. Understanding what an organization has already accomplished for previous projects – even for solutions put on the backburner – will likely uncover a plethora of valuable resources waiting to be repurposed in innovative ways.

Take, for example, telehealth. The idea of consulting with a physician via video chat was once the stuff of science fiction. Today, however, virtual consults have become fairly commonplace thanks to the quick pivot providers and their health IT partners made during the pandemic. Health care organizations took what was already available, whether that be consumer-facing tools like Facetime and Zoom or business-to-business solutions like WebEx, and used them to meet an immediate need. As demand increased, developers took a step back and began to tweak their existing technologies to accommodate the telehealth needs of providers and patients. Federal telehealth waivers and relaxed Health Information Portability and Accountability HIPAA regulations gave stakeholders even more freedom to rethink how virtual consults could best meet the needs of their patients and members. Apart from a few bad actors, telehealth solutions have quickly become de facto, readily available as part of practice management and EHR systems, offered as part of health insurance plans and even touted as an employment perk. 

Forward-thinking organizations have repurposed telehealth strategies originally created to handle COVID patients into more robust remote patient monitoring programs for pediatric patients with respiratory syncytial virus (RSV) and adult patients with chronic conditions, as well as hospital-at-home programs that have enabled postoperative patients to recover more comfortably and quickly with less chance of readmission than patients with no follow-up. Technology that once served as the backbone for practical applications like Facetime has been recreated to help health care stakeholders meet immediate patient and member needs and repurposed to launch projects that were pie-in-the-sky ideas five years ago.  

Step Two: Balance Short-Term Objectives with Long-Term Goals

As inventory is taken, begin plotting out what can be done with existing resources and what needs to be developed in house or purchased from a third-party, all while keeping short- and long-term goals in mind and leaving wiggle room for unexpected shifts in priorities. As the health care industry has seen over the past several years, the best-laid plans can be sidelined by epidemics, staffing shortages, ransomware attacks, financial difficulties and shifts in industry and cultural expectations.

In the near term, leverage value by using existing solutions in as many places as possible, learning how and where things fit and where they may be underutilized. Understanding the nuts and bolts of how one innovation works in several different settings will increase an organization’s chances of using that solution in additional, meaningful ways in the future. What was developed for one project in the early days of 2022 may just be integral to meeting a final rule’s requirement in 2026.

Stakeholders should build in ample time to project road maps so strategists and developers can focus on incremental steps rather than scorched-earth approaches. As the days of meaningful use have shown us, projects and compliance always take longer than anticipated. Headlines have shown us, too, that cutting corners in a rush to meet requirements and check regulatory boxes can easily turn into spending hundreds of millions of dollars to settle federal allegations related to dodgy certifications and customer kickbacks. 

As Massachusetts Health Data Consortium (MHDC) Executive Director and CEO Denny Brennan advised in a recent Point-of-Care Partners (POCP) podcast, organizations should start with small, incremental steps and work from there. He emphasized that when it comes to formulating short-term goals with an eye to long-term achievements, it’s important that organizations recognize they won’t know everything when starting out and may not even fully know where a project will end up. Rather than taking a “ready, aim, fire” approach to meeting project goals, MHDC takes the iterative approach of “aim, fire, get ready again, aim, fire, get ready again.”

The consortium’s effort to develop a prototype for automated prior authorization (PA) that can eventually be replicated and scaled across multiple payers and providers is a useful example of taking an incremental approach with an eye to long-lasting value and potential for additional, innovative uses. 

MHDC’s Automation Advisory Group, in partnership with the Network for Excellence in Health Innovation, is initially working with one payer, one provider and one health IT vendor to take that first bite out of prototype development. The group, comprising nearly 50 stakeholders across the industry, will work with state and federal regulators over the next two years to eventually implement the automated solution across Massachusetts, ultimately serving as a testing ground that will allow other organizations to see how the solution can be leveraged and which business and government processes come into play along the way. 

Brennan emphasized that PA is a major point of focus for MHDC because, while it’s a bone of contention for everyone, it is ultimately a business process that, when automated, will enable organizations to automate other processes that are far less complex. MHDC’s project will, in the short term, lead to automated PA processes and all of their attendant benefits. In the long term, technology developed for the project may just help to alleviate the pervasive problem of surprise billing – a win for patients/members, providers and payers. 
As Brennan stressed toward the end of the podcast, whether it’s a PA project or complying with FHIR API development requirements, “try out something on a smaller scale, see what works and build on it. Just take a bite out of the problem.”

Step Three: Avoid Inertia

Health care stakeholders may have the best intentions when it comes to getting the ball rolling on projects with deadlines that are years away. But as those working in the trenches can attest, other, more immediate technological fires have a way of springing up, diverting resources and expertise until they can be put out. It is essential, therefore, that organizations anticipate these very real needs when framing project road maps across the span of several years. As the pandemic has shown us, IT project timelines have a way of getting interrupted by unforeseen circumstances.

We understand the challenge of competing priorities and fighting for resources to meet those priorities; however, it is important to resist the temptation to deprioritize and table certain federal compliance projects to take advantage of perceived longer timelines. Development and implementation teams will require ample time to meet both internal and external needs. Many recent notices of proposed rulemaking (NPRMs) are very transparent in the direction and requirements that will likely be included in final rules. 

Development teams, for example, should begin using ONC-recommended FHIR implementation guides, anticipating that FHIR will very likely evolve with corresponding version certifications. FHIR API implementation ahead of the December 31, 2022 deadline offers a compelling example of the benefit to moving forward before a final rule is published or a deadline hits. Roughly 5% of certified health IT developers had updated their technology to certified API technology ahead of the December 31 deadline. While that figure may seem small, it belies the fact that those organizations support the interoperability efforts of 66% and 77% of inpatient and outpatient users, respectively, nationwide.

Actively monitor communications from CMS and ONC with regard to advice and tips on how to achieve and maintain compliance, all while anticipating more nuanced final rules, additional certifications, etc. As meaningful misusers have discovered, these federal entities work hand in hand with the Office of Inspector General to ensure that bad actors face the very public consequences of noncompliance. Don’t be the bad example they use to get the industry’s attention. 

While it’s tempting to wait and see how others do it before devoting time and money to checking that regulatory box, don’t fall into the habit of lagging behind. Brennan puts it this way: “Health care is an industry that is governed in many respects by followership. Nobody wants to be the first to fall off the pier and land on their heads. They want to see other organizations do it successfully first and then follow in a tidal shift of adoption.”

Stakeholders will gain that much-needed competitive advantage by starting down the path of compliance sooner rather than later. While organizations like MHDC run some risk in tackling automated PA before the associated final rule is published, the risk of failure to implement is greater than that of being out in front. If your organization chooses to do a risk assessment, you will likely find there is greater risk in doing nothing than in taking on incremental projects, incurring some risk but moving the needle forward. What is the risk to your organization not investing in APIs, getting PA rules codified, preparing customer-friendly language for patient cost estimates and enabling all your internal teams with information about their role and responsibility in this new, interoperable and transparent world aligned with coming regulations? 

Organizations that choose to rest on their laurels and wait for policy to force change will be at a huge disadvantage as they may see customers, members and patients jump ship to more forward-thinking, consumer-friendly competitors.

They will also face potentially big fines, as was the case with two Georgia hospitals that failed to comply with price transparency laws that had gone into effect in 2021. Two Northside Hospital facilities were fined more than $1 million combined for their lack of readily available, consumer-friendly, Web-based standard charges. While the health system may consider those fines the cost of doing business, patients likely saw the news and gave serious thought as to whether or not the hospitals put profits over helping patients understand the cost of treatments.

Step Four: Gather Your Champions and Allies

As priorities, roadmaps and timelines fall into place, project champions and allies should be identified and brought into the organizational fold. Being an effective champion for change can be difficult, as it often feels like you are the lone sailor on a massive ship that must be nimbly turned around. While comparisons to the Titanic or Lusitania may be a stretch, it’s no secret that gaining buy-in for change in health care can be a monumental task.

Focus on building strategic allies within your organization, even across departments, by making a compelling case for why moving forward now is key to maintaining that competitive advantage and avoiding fines later for noncompliance. As previously noted, meet short-term goals for the “wins” that will ultimately build to foundations for longer-term projects. Team members will likely be more open to smaller changes and steps that give them an opportunity to work with a new approach/system and identify additional needs or pain points. The incremental approach will also enable a champion’s team to discover unexpected benefits associated with efficiencies, improved user satisfaction, financial savings etc. These small “wins” can buoy team members into looking beyond the technology to the long-term, innovative change and benefits their project will bring to customers, members and patients.

Step Five: Consider a “Fresh Eyes” Approach

Recognize that the fresh eyes of an objective outsider may help take existing ideas and projects to the next “ready for prime time” level. An external review across all your interoperability and clinical data projects may create an opportunity to adopt a dispassionate view of where an organization is now and where it needs to go using proven methodologies – messaging that can be delivered to leadership in a way that garners more support for projects that may have previously languished for months in the land of watercooler chitchat or cocktail napkin scribbles.

An outside thought partner can help project evangelists and their allies:
•    Drive an outside-in view of what is happening in larger markets and create the pause needed to look across wider swath of activities and goals.
•    Develop a strategic plan with input from the entire organization, yielding added buy-in.
•    Validate and optimize existing plans that may need a few extra tweaks to close gaps or align timing.
•    Uncover what is possible versus getting bogged down in the details of “how things have always been done.”
•    Compassionately navigate the cross-functional change management that will be necessary to get the job done.

Step Six: Let the Work Begin…and Don’t Forget the Beneficiaries

With organizational ducks in a row, health care stakeholders can readily position themselves to tackle the requirements of the steady stream of NPRMs. It may be tempting to blaze forward to check those regulatory boxes, but don’t let first-blush enthusiasm hamper the intent to take a steady, incremental approach to successfully meeting these deadlines, however far away they may seem right now.

Always keep in mind that these evolving standards, APIs, certifications, and frameworks are in service of end users – overworked providers, frustrated patients and other health care stakeholders who often aren’t given a voice until after technologies have been implemented and processes put in place. 

As noted in a recent Dish on Health IT podcast, health care stakeholders who leverage existing assets as part of forward-thinking projects will transform their organizations by how they work and view their relationships with industry partners. They will come through the curve of innovation faster, gaining that competitive edge with deadlines met and infrastructure already in place for the next round of government-encouraged innovation.

For support in performing an objective gap analysis, understanding appropriate implementation guides you can leverage and prioritizing next steps in your interoperability roadmap, reach out to us at jocelyn.keegan@pocp.com and vanessa.candelora@pocp.com. POCP helps our clients across the healthcare ecosystem to leverage regulatory compliance to attain competitive advantage.