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Lessons Learned from the Trenches of Healthcare Policy

November 15, 2017
by Rajiv Leventhal
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One policy expert discusses the many layers of healthcare federal rulemaking

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.

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