The rise of the hybrid operating room

Recent advancements in heart valves and minimally invasive surgery technology have paved the way for even more patients to qualify for endovascular/interventional procedures.  Yet these patients present with very complex medical conditions and are at a high risk for poor outcomes. In an effort to improve these poor outcomes and accommodate surgeon and interventionist needs, many hospitals have implemented hybrid operating rooms (typically an OR with a fixed C-arm angiographic system), and many more are considering it.

Hybrid ORs come with steep price tags—some may cost more than $2 million. Add on another $3 million or more for the appropriate OR equipment, integration systems, and facility renovation costs, and your project may now cost north of $5 million.

Cardiac surgeons clearly have a vested interest in hybrid ORs. But how can a hospital ensure that other physicians, their support staff and senior hospital/system leadership are also engaged in the planning of this very complex set-up?

Every successful project starts with an actively engaged foundational team. A hybrid OR project team should include vascular, neurovascular, and cardiothoracic surgeons; interventional cardiologists; interventional radiologists; OR nursing staff; cath lab nursing staff; and the radiology technicians from both the cath lab and interventional radiology. Involvement by the IT team is essential, as they will be key personnel in the integration of equipment booms, the system’s table, and the video monitors. The biomedical engineering department should be part of this initial team as well — they will be the “first responders” whenever there’s a technical glitch. Finally, administrative leaders from the surgical, cardiac, and radiology departments need to be on board as volume projections must be made and Finance has to be engaged to determine if the cost can be justified.

Managing this very large team is challenging with so many different opinions and interests to consider.  Each clinical specialty has somewhat unique needs requiring specific equipment placements.  While room drawings from various suppliers are helpful, only the most adept clinical user generally has the ability to imagine what they mean for your planned space. The 2-dimensional AutoCAD drawings an architect might develop during the planning stages are tough to interpret if you are not used to reading them. While 3-dimensional and REVIT models are more useful than the 2-D ones, an actual live space—or even a mock-up—really allows clinicians to understand the spatial relationships much more clearly.

One of the best ways to see how hybrid ORs work in actual practice is to visit clinical sites where they are currently installed and talk with frontline staff about their specific challenges. Ask users how they changed the room’s configuration when new clinical services began using the room. Delve into how they manage consumable supplies and where they are stored. Where are their video monitors placed? Are there any limitations due to the size of the room? Did they choose a floor-mounted or a ceiling-mounted C-arm? Why? Ask why they selected their particular angiographic system and how they coordinated the various installation efforts. In addition to all your fact-finding, you must keep your CEO, COO, and other leadership up-to-date with your progress. This may be one of the largest capital expenditures of the year, and in some hospitals it may be the largest of the decade.

After all the fact-finding and installation challenges, your hybrid OR is almost ready. But before it’s fully operational, conduct some role-playing exercises to ensure that staff are well versed in how things will work in advance of the first official hybrid procedure. You may want OR staff to observe a cath procedure and for cath lab staff to observe an OR procedure. Slight differences – or actually major differences—in practice can create cause a great deal of confusion when staff expectations are mixed in a hybrid OR.  Make sure credentialing and quality criteria are in place.

Once the hybrid OR is finally in full swing, monitor surgeon and interventionalist usage—monitor “actual” versus “projected” in the number of procedures to assure that goals are met.

With proper planning, a hybrid OR benefits both patients and your hospital’s performance. You may be so successful that you have to start all over again—with planning a second hybrid OR.


What’s Next for CHIP?


The Children’s Health Insurance Program (CHIP) offers a critical health insurance pathway for children living in families with modest means. These families’ incomes exceed the basic Medicaid eligibility standard for children but they lack access to employer insurance for their children, either because none is offered or because of a phenomenon known as the “family glitch,” which bars working parents with affordable employer coverage for themselves from getting marketplace subsidies for their children.

CHIP fills these gaps, reaching nearly 9 million children. And because of its popularity, as well as a streamlined enrollment process built into the original law in 1997 and expanded under Affordable Care Act, CHIP has had a remarkable impact on children’s access to health insurance. By 2016, just 4 percent of U.S. children lacked health insurance. Yet Congress has still not reauthorized federal funding for this program.

Unlike Medicaid, which rests on a permanent federal funding authorization, CHIP funding authority must be periodically renewed. Administering CHIP is complex for states because they typically offer CHIP in two forms: coverage through Medicaid for children with incomes just above the Medicaid eligibility cutoff and a separate, companion program for children living in families with slightly higher incomes. As a result, there is a need to transition children between two sources of insurance coverage (and potentially separate managed care plans and provider networks) as family incomes fluctuate.

Fundamental to smooth program operation is reliable federal funding, which accounts for the lion’s share of CHIP program costs. The most recent federal extension came in 2015 as part of legislation that extended funding through September 30, 2017. Congress has therefore known about CHIP’s 2017 funding cliff for more than two years.  States have been unequivocal about the need for steady financing in order to avert coverage interruptions. In the face of continued financial instability, their agencies may need to cease enrollment and freeze coverage — and therefore access to care — for children already enrolled (along with some 370,000 pregnant women also covered through CHIP).

Congress failed to take up CHIP in advance of the deadline because the winter, spring, and summer were consumed by the ACA repeal-and-replace battle. CHIP never was part of this fight; none of the bills considered — even the proposals that would have fundamentally impaired Medicaid’s ability to function effectively for the nation’s 36 million poorest children — proposed to end CHIP. Indeed, the Graham-Cassidy bill would have built on CHIP. But only at the end of September, when the Senate set aside Graham-Cassidy, did Congress return to CHIP.

On October 4, committees in both the House of Representatives and the Senate completed their work on a CHIP extension. Both the House and Senate measures would extend federal CHIP funding for five years and both sides are in agreement on the proper federal CHIP funding level. In other words, the two committees are aligned on the policy.

The House CHIP measure also contains provisions to address other pressing matters such as a delay in scheduled reductions in federal Medicaid payments to hospitals that treat a disproportionate percentage of low-income patients and an increase in federal Medicaid payments to Puerto Rico to help the Commonwealth’s recovery from Hurricane Maria. The House CHIP measure is also part of a suite of other noncontroversial bills expected to move at the same time, including extension of the Health Center Grant Fund, which provides basic grant funding to the nation’s nearly 1,400 federally funded community health centers.

Congress still needs to determine the final contours of the bill, including whether to proceed with the controversial spending offsets the House has identified, in particular a $6.3 billion cut over 10 years to the Prevention and Public Health Trust Fund, which supports core public health services. As yet there is no word on next steps, even as states begin to fall over the edge of the fiscal cliff. Children covered through Medicaid CHIP are safe for the moment, although declining CHIP funding for Medicaid-enrolled children can be expected to trigger other offsetting Medicaid program cuts. But coverage for approximately 4 million children enrolled in separate CHIP programs is very much on the line.

Many hard decisions in a jam-packed fall schedule await Congress. Given the strong bipartisan support for CHIP and its totally predictable expiration, it is surprising — and unfortunate — that CHIP remains on the Congressional docket.

ACA Waiver Changes

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In broad strokes, the bipartisan deal from Senators Alexander and Murray would restore cost-sharing payments through 2019 in exchange for some amendments to the rules governing ACA waivers. Now that we have the bill text, we can start to wrap our hands around the practical effects of those waiver changes.

Most importantly, the bill would relax one of the guardrails governing state waivers. In its current form, section 1332 of the ACA requires any waiver to include cost-sharing protections that are “at least as affordable” as those in the ACA. Under the new bill, the waiver would just have to provide “cost sharing protections against excessive out-of-pocket spending that are of comparable affordability, including for low-income individuals with serious health needs, and other vulnerable populations.”

To my eyes, that’s a pretty modest change. The category of waivers with cost-sharing protections that are “of comparative affordability” to those in the ACA, but are not “at least as affordable,” is tiny. The new language may signal that HHS could approve waivers where the states would offer protections are slightly less robust than what we’ve already got under the ACA. But that’s it.

There’s been some talk that the language change might allow the approval of Iowa’s waiver. I don’t see it. As I understand it, Iowa wants to undo cost-sharing protections for its residents.* [See the update below; Iowa’s position has softened from its original waiver proposal.] How is an absence of cost-sharing protections the same as “cost sharing protections … that are of comparable affordability” to those in the ACA? I’ve explained before that the decision to grant a waiver can be challenged in court. If Iowa’s waiver wasn’t viable before, it won’t be viable even if the Alexander-Murray bill becomes law.

Apart from the guardrail change, the bill would require HHS to decide on waivers within 90 days, not 180 days, which should speed processing. Of particular relevance to Iowa’s waiver, the bill also creates an expedited approval pathway of 45 days for “urgent situations.”

What’s an urgent situation? It’s one where the Secretary determines that all or part of a State is “at risk for excessive premium increases or having no health plans offered.” But there’s less than meets the eye here. An urgent waiver isn’t automatically granted when that time has elapsed: the Secretary still has to approve an urgent waiver before it can take effect. The default is still “no.”

Of perhaps greater significance, the bill would prohibit HHS from yanking a state waiver for six years “unless the Secretary determines that the State materially failed to comply with the terms and conditions of the waiver.” That last clause means that, if a state’s waiver is approved, the next Secretary of HHS can’t terminate the waiver—even if it turns out that the waiver doesn’t comply with the guardrails.

It’s not hard to see how that change might make a difference if a Democrat takes office in 2020. Still, it’s a far cry from changes to the waiver rules in previous Republican bills, which would have outright prohibited HHS from terminating waivers for eight years, however recklessly or foolishly states spent their ACA money.

Finally, the legislation would undo HHS guidance and regulations pertaining to waivers. The Obama administration, for example, declined to allow states to package their 1332 waivers with Medicaid waivers, and use savings from one waiver to offset an increase in spending from the other. The field would be clear for the Trump administration could revisit that. Then again, the Trump administration could have revisited those Obama-era rules anyhow, so I can’t see why vacating the regulations and guidance makes much of a difference.

All in all, the changes to the waiver rules are real but minor. To borrow from Hamilton, it looks like Senator Murray got more than she gave, and wanted what she got.

* Update: David Anderson has pointed me to an October 5 revision that Iowa made to its waiver request that would extend cost-sharing protections to individuals up to 200% of the poverty line (the ACA affords protection up to 250%). With those protections in place, Iowa says that people up to 150% of poverty “will not see an increase in their out-of-pocket costs,” and that people between 150% and 200% of poverty will have a “lower average total cost of care,” taking into account premiums and out-of-pocket spending. Those in the 200% to 250% range won’t receive out-of-pocket protections.

Are Iowa’s revised cost-sharing protections comparably affordable to those under the ACA? The protections are certainly thinner, and for people in the 200% to 250% range, nonexistent. Whether that package as a whole is “comparable” is a question of degree: I can see an argument either way. Which is to say that the revised Iowa waiver might be approved under the new standard, but I wouldn’t be surprised to see a lawsuit over any such approval.