Episode 23: 2022 Health IT Regulatory & Policy Landscape


Pooja Babbrah, filling in as host for Ken Kleinberg, kicked off this first episode of 2022 by welcoming guest, Kim Boyd, industry consultant, regulatory and standards and Health IT expert. This episode will cover the regulatory landscape in health IT and what may be coming in 2022 from new rules to compliance and enforcement.

Jocelyn Keegan, senior consultant with Point-of-Care Partners, chimed in to explain she and Kim Boyd have had a chance to work with each other on the National Council for Prescription Drug Programs, (NCPDP) electronic prior authorization (ePA) task group and that she has such admiration for her and her work.

Kim Boyd then introduced herself and described how she got into regulation. She explained that while she does have a law background, having served as a paralegal in the United States Airforce, that’s not where her love for policy started. In reality, the policy bug bit her in a chance encounter with a couple of entrepreneurs who mentored her and taught her their business from the ground up.

In 2001, California proposed a regulation that would have been detrimental to their business, and she was asked to go up to Sacramento and talk to the regulatory bodies and legislature about why the policy wasn’t good for patients or business. She was hooked from there.

Pooja reaffirmed how important policy and regulation are in Health IT and pivoted the conversation by asking Kim her take on what could be expected in 2022 after several very active rules and policy years.

Kim explained that many are of the mindset that Centers for Medicare & Medicaid Services (CMS) and The Office of the National Coordinator for Health Information Technology (ONC) will continue to build on the endeavors we saw over the last several years. The focus will continue to be on interoperability, data fluidity, transparency, and other areas that have already been a major focus of the industry. She went on to explain that the pandemic really helped underline the importance of solving some of these industry challenges.

Kim went on to say that there is so much work left to be done to move toward full interoperability in healthcare and a merging of the clinical, administrative, and financial data. She added that she is really excited by the ONC Health Interoperability Health Outcomes 2030 initiative, stating that we need to strive toward truly collaborative and coordinated care and maybe we’ll finally succeed in getting rid of faxes once and for all.

Pooja followed up by asking about whether there were any pieces of legislation that have enough bipartisan support to get passed.

Kim explained that there is so much we need to accomplish and, thankfully, there are a couple of areas that seem to have bipartisan support. One of those areas is health equity. Legislation looking at reimbursement models leveraging social determinants of health data and funding around standards development around social determinants of health (SDOH) are up for consideration. Kim added that she saw at least 99 pieces of legislation related to health equity for congress to take action on.

Pooja then asked Jocelyn if there are any rules she hopes get published or if she has a policy wish list.

Jocelyn responded by agreeing with Kim that there is so much activity going on in the policy space. One of the things near and dear to her heart is prior authorization. She recounted that at the end of 2021, ONC was making progress in certifying people around prior authorization. CMS signaled via the unified agenda that they plan to pick back up the rules that were tabled during the administration transition. Jocelyn went on to say that she hopes to see rules that align the   industry on a shared path forward around prior authorization. A certain level of certainty is needed by the industry — from a policy perspective—to help spur them to pick up the implementation guides and work coming out of Da Vinci and other FHIR accelerators.

Pooja asked Kim to weigh in on the future of prior authorization, specifically automating PA based on her work with CoverMyMeds and on the NCPDP ePA task group.

Kim said that Jocelyn is on point. There has been an evolution in the healthcare ecosystem, especially on the medications front. CoverMyMeds has done a lot of work to move away from faxes, that there are still smaller payers that just aren’t yet on board with ePA, but the needle is moving. This will be really important to ease the administrative burden for providers. If regulatory bodies require certification for ePA, that will help move the needle even further. She went on to say that as the standards bodies are evolving in their approach to automating PA, the regulatory bodies are paying attention and will hopefully issue policy that will support that work.

Pooja then asked Jocelyn to weigh in on how creators of these tools can drive adoption and use outside of policies or rules to require use whether through user-based designs, establishing strong value models, or other methods.

Jocelyn responded by saying that Kim touched on one of the topics earlier, which is to look at all the workflows holistically and make sure the tool being created is solving immediate problems faced by providers and giving them more information and transparency around eligibility and benefits for their patients. Before providers adopt a new tool, they are asking themselves “is this going to be better than what I’m using now?” The creators of these tools should also be evaluating their tools over time to determine what’s working and what isn’t and iteratively improving them.

Jocelyn added that, ultimately, adoption is really a one butt in the seat at a time. It’s important that any policy doesn’t add additional burden to providers but, outside of policy, the creators of these tools need to ensure they are being mindful of the providers’ workflows, and that the tool is usable and solving real problems. Ultimately, the reason we are in 2022 and still using faxes is that they solve the provider’s immediate problem.

Pooja then asked Jocelyn and Kim on how they would advise payers who work to adhere to new policies but are just checking the box and then asking “now what?”

Jocelyn stated that the shift to standards-based design is a game changer. With the iterative approach of standards development at NCPDP and HL7, the standards development process is much more collaborative and iterative than in the past. Additionally, more testing is being done so the standards have already been road-tested before being named in policy. That makes it easier to meet some of these new rules. Ultimately, many of these new policies intend to unlock data, and stakeholders who are going to be successful will go beyond checking the box and will think more broadly about how this additional data can be leveraged across their organization. It’s really about stakeholders mastering their data and how to best leverage the shift to APIs. Those that can take the time to do that planning, rather than just trying to meet deadlines of a new rule or piece of legislation, will be most successful.

Kim agreed with Jocelyn’s points, adding that while we’re trying to make more data available for decision support, further upstream we’re also talking about transparency. Data has to be usable and real time. The requirements from the CMS transparency & coverage final rule, the Medicare hospital outpatient perspective rule, and the No Surprises Act are all catalysts to improve the patient experience: the intent being to make us all more informed consumers. Operators in this space have a real opportunity to not only make this data more readily available to consumers but to help them understand it. We have a real health literacy issue in this country. Plans and providers need to factor this into their strategic initiative and position themselves as trusted resources for patients to better understand their data as a means to build brand loyalty.

Jocelyn chimed in to say that back in July, payers all scrambled to meet the patient access API deadline. Some leapt across the line, some dragged themselves across the line. Everyone was at a different point when they started the work to meet this policy but they all met it. This step was one building block in building how we do business for the next several decades. The industry needs to take a collective breath and consider how we can set ourselves up for success and how can we move forward to make sure that each additional block we put in place is incrementally better.

Jocelyn added that she and Kim both testified to a sub-group under National Committee on Vital and Health Statistics (NCVHS) on the intersection of clinical and administrative information and talked about the needs to bring these two worlds back together. Everything ties back to the fact that to provide care, you’ve got to understand what the patient’s coverage is. There is a relationship between care, quality, and the cost of the care. This isn’t going to get fixed overnight. The idea of transparency is good but it has real-world implications on how we all do business.

Pooja then shifted the discussion to cover compliance and enforcement. She mentioned that there has been a lot of shifts in deadline and delays in enforcement. Pooja asked Kim to weigh in on these shifts and changes and what stakeholders need to know.

Kim relayed that although there have been delays in several rules, the policy teams and strategy teams should still be dedicated to evaluating and planning to comply. They should also be thinking about how to not only comply, but also factoring in how they can comply and how to leverage those rules to support more cost-effective use of healthcare services by both patients and providers. They should also be thinking about value-add services through these initiatives that will help build brand loyalty. Ultimately, stakeholders should be working to stay ahead of deadlines and moving forward in good faith.

Jocelyn chimed in to say that many times policy guidance following legislation is really important to get the industry out of limbo. Many times, there might be abhorrent behavior as stakeholders try to meet a piece of legislation when they’ve misunderstood the intent or ways to really address it in a real-world setting. We should be recognizing that new policy and legislation are coming and to not panic until the final rule comes out. Because ONC and CMS are much more involved and providing some funding for some standards development, there are fewer shocks and surprises in recent policies.

In an effort to close out the episode, Pooja asked both Kim and Jocelyn for last thoughts to leave with the audience.

Kim conveyed that she advises everyone to just keep on pressing. If you have a policy team, work with them to align your strategic goals with policy requirements. Bring your SMEs to the table, highlight your organization successes out in the industry, work to educate and assist regulators to better understand the challenges and solutions that have shown promise. Also, work with the standards organizations and influence the standards development process which ultimately influences policy.

Jocelyn’s last thoughts were to point out that as the industry evolves, we are moving away from a place where only a small group of people within an organization are considered experts or in the know about interoperability but moving toward a reality where interoperability is just how we get things done. The organizations who are looking at interoperability holistically and doing the training across their organization are tightening partnerships, and really getting everyone in their organization ready to solve problems and respond to regulations. It’s a much easier task when everyone in the organization has the understanding and can contribute to the solution.

Pooja then closed out the first episode of 2022 by thanking Kim Boyd for joining us and to the audience for listening. She reminded the audience they can find past and future episodes on Spotify, Google Podcasts as well as HealthcareNOW Radio and other podcast carriers.










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"The Dish on Health IT"

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