When it comes to federal regulations, healthcare providers often question the process behind the rulemaking, with many showing concern regarding federal leaders’ willingness, or lack thereof, to change regulations based on stakeholder opinion.
But one policy expert with experience serving as the associate director for health in the White House’s Office of Management and Budget (OMB) disagrees with that narrative. Indeed, at the OMB, Julian Harris, M.D., oversaw $1 trillion in spending and policy for a range of federal healthcare programs, including Medicare, Medicaid, the Centers for Medicare & Medicaid Services (CMS) Innovation Center, and more.
Harris, a primary care physician, is currently the president of CareAllies, a Philadelphia-based service company launched by Cigna that partners with providers to improve the quality and affordability of healthcare. Harris recently spoke with Healthcare Informatics Managing Editor Rajiv Leventhal about what goes into federal rulemaking, the future of CMS’ Innovation Center, and if the push toward value-based care has been slowed at all in recent months. Below are excerpts of that interview.
Tell me a bit about yourself and what you’re working on today as it relates to furthering the industry’s push toward a value-based care system?
CareAllies is a company that focuses at its core on helping providers make their journey towards value-based care and getting reimbursed for those efforts. We have about 15 years of experience working with large physician groups and health systems, helping them to approach population health and value-based care in a Medicare Advantage context, and expanding to commercial. We also have a business that was one of the first Medicare accountable care organization (ACO) enablement companies to be formed after the Affordable Care Act (ACA) passed, and we have 13 Medicare Shared Savings Program (MSSP) ACOs with almost 200,000 beneficiaries that we support through the MSSP. We also have a business that helps providers and health plans in Medicare Advantage (MA) and Medicaid support seniors who need home-based care and support.
One of the things that has been helpful for us is that while it is important to bring the right tools and technology, it is just as important to bring a team working shoulder-to-shoulder with physicians, nurses, care managers, and others, to understand what it means to make population health real and how we can leverage data and insights to direct that change.
Julian Harris, M.D.
At OMB, what is the process like for oversight on CMS regulations? How involved were you during your time there?
OMB oversees all regulations that come out of federal agencies, including CMS, as a part of an approval process. OMB, in many cases, plays a role well before approval, providing guidance and oversight. I left in May 2015 and so the final rule for Medicare Access and CHIP Reauthorization Act (MACRA) was not released at that point, though it had passed with overwhelming bipartisan Congressional support by that point.
What were the core lessons learned from your time in government as it relates to how the feds construct rules and regulations for value-based programs?
I think one thing that’s important for people to have context for, before any rule is [released], there’s an enormous amount of outreach to stakeholders, and the current base case for a particular area is examined. In the case of MACRA for instance, what was the regulatory structure regarding what preceded MACRA, like the Sustainable Growth Rate (SGR) and meaningful use (MU)? Before the rule is released there would be a significant amount of outreach and input. Then there’s a comment period after the rule is released when the public can weigh in, and you see a lot of input from a variety of stakeholders including associations who represent various aspects of healthcare. But also individual organizations and sometimes individual physicians and nurses will comment too. That feedback is reviewed by CMS and that informs the final rule.
There is also an annual rulemaking process looking at the areas that might have been more challenging or successful in the subsequent year and revising the rules where there are opportunities. So there are ongoing opportunities to work with CMS to try and ensure that as the context evolves and more information about the impact of regulations and more data on the outcomes of programs become available, that those things can inform future versions from a design and regulatory perspective.
How do you see things today, with talk about cancelling some mandatory bundled payment programs and also with the skepticism around the Centers for Medicare and Medicaid Innovations (CMMI)?
I think CMMI is incredibly important as an organization with both resources and authority that gives the administration of CMS and Health and Human Services (HHS) Secretary the flexibility they need to test and learn in the context of a payment and delivery landscape that is dynamic. The innovation center at its creation was developed in part because there was a recognition that even in the past when new payment models were developed and demonstrated to be effective, it was very difficult to take those models to scale.
The HHS Secretary was given authority to work with the CMS Office of the Actuary (OACT), who has a nonpartisan relationship with Congress. And when the Actuary affirms that a payment model has kept cost flat and improved quality, or has reduced cost and kept quality flat, or ideally has reduced cost and improved quality, then that model can become a national payment policy. And we saw that with the diabetes prevention program (DPP). It’s a very unique asset and is part of any administration, regardless of their political orientation or policy perspective on various aspects of care delivery and design. It can be a very valuable tool. I have not personally heard anything of substance that makes me think this administration is anything but a supporter of CMMI. People might have had different perspectives on CMMI historically, but I have not seen anything that has made be question the future existence of CMMI. In fact, Administrator Verma recently outlined a very exciting and bold agenda for CMS and CMMI focused on reducing the regulatory and administrative burden for providers through a "Patients Over Paperwork" initiative, simplifying quality measure to make sure that they are meaningful, and on honing CMMI's focus on leveraging and unleashing innovation from the private sector to achieve a patient-centered system of care within a market-driven health care system. She also highlighted the importance of driving innovation in primary care, prescription drug programs, Medicare Advantage, behavioral health, and addressing opioid addiction, which the President has also called out as a major priority for his Administration.
And do you see the talk around cancelling some mandatory bundled payment programs as a push away from value?
I think, maybe having been there, my take on the rule and the perspective was different from the press coverage. What I took away was that it confirmed that there is some concern about mandatory bundles. To be frank, people have always had different perspectives on whether they should be mandatory. What I took away, which was promising, was that there was at least a signal that there will be ongoing support for Bundled Payments for Care Improvement (BPCI) and for what sounds like the eventual release of regulations for something like an Advanced BPCI that would probably qualify as an Advanced Alternative Payment Models (APM) under MACRA. So that’s promising; it looks like bundles will continue to be a part of the value-based payment landscape.
Also, the Comprehensive Care for Joint Replacement (CJR) [model] was not stopped, halted, or eliminated in its entirety, and in fact, a portion of the participants in that model will continue in a mandatory fashion. And as new groups participate as it expands, it will be optional for them. But for those who are far down the path, they didn’t tell them to stop. So you are seeing some ongoing support for that. People can agree or disagree on the pace at which payment models are taken to mandatory phase, but there was affirmation that voluntary bundles will be a part of value-based payment and that in the case of MACRA, it looks like these programs could scale significantly in regards to BPCI.
What are the biggest challenges that exist today regarding the government making rules and regulations that end-user providers are often very unhappy about?
I can’t speak to this administration, and this is a tough question to answer in broad strokes. There’s a diversity of topics at play. I would say that we have seen an ability to evolve over time. It would be one thing if there were a set of rules that were static and people gave feedback and nothing happened, but that hasn’t been the case. There was an initial round of meaningful use, and some things went well, others didn't, feedback was given, and the approach was revised over time. There’s no such thing as universal consensus around perfection; some groups might think one aspect of a rule is optimal and another group might not like it. So the idea is to be very clear about your goals—and that’s having a high quality healthcare system in America that’s affordable and sustainable, and then work backwards from there. You also want to make sure that you aren’t unnecessarily adding to the complexity of delivering the care to frontline providers who are taking care of patients, and Administrator Verma has made clear that she is going to bring significant focus to this important issue.
There are aspects of complying with various regulations that are, in part, more challenging because of some of the current state of technology, some of the challenges with the structure of electronic health records (EHRs), and the flexibility and the interoperability of those tools. The most important thing is to listen in the first instance and get it as close to right as you can, and then based on data, come back and say “we tried this, either it supported our goals around cost or quality, or it added undue burden for providers, now let’s try to do it in a more streamlined fashion.” And we have seen iterative changes to MU and MACRA. The balance is people might eventually say “stop changing, leave it where it is,” while others will say “we have more work to do.” It’s very difficult to make everyone happy, but you have to at least listen.