organ transplant

New Regulations for Organ Procurement Organizations Pose Concerns

By Alexandra Glazier

The United States has one of the highest organ donation and transplant rates in the world. A poorly crafted regulatory change could disrupt our world-leading system and put patients at risk.

Recently, new performance regulations for organ procurement organizations (OPOs) were promulgated by CMS in the last stretch of the Trump Administration, which should be reviewed by the incoming Biden Administration.

While there is widespread support for reform to the system of organ donation and transplantation, including consensus that changes to the CMS metrics measuring OPO performance are warranted, there are significant differences in opinion on how that can be accomplished best.

Bipartisan groups and delegations of both Democrats and Republicans, donor families, the medical community, and donation and transplant professionals as well as OPOs have raised a range of concerns about specific aspects of the proposed and final regulations, making suggestions on how the regulations could be improved to achieve the goal of transplanting more patients.

Forced Competition Among Community Based Non-Profits: The Hunger Games of OPOs

The new regulations seek to inject forced competition into a field designed to be run by community-based nonprofits through a network of extensive collaboration.

Under the new regulations, every four years OPOs performing at or above average (but below the top quartile) must compete for their service area, rather than be recertified.

This policy choice is unsupported by any high-functioning deceased organ donation model in the world. Keeping OPOs in “organizational survival mode” – as referenced in the new CMS regulations – will be detrimental to continuous system improvement, which requires longer term strategic planning, resources for innovation, as well as engaged staff (who are difficult to retain if an organization’s future is, by regulatory design, in a constant state of uncertainty).

Forced competition for above-average performing organizations could result in the unproductive expenditure of time and resources and potential disruption to communities served with no evidence of any upside gain in terms of increased system performance improvement.

Voluntary OPO consolidation can be an effective improvement strategy. For example, in New England, two OPOs affiliated and recently merged, resulting in a 108% increase in organs transplanted from donors in the lower-performing OPO’s service area and a savings of $3M in kidney costs to the system. However, healthcare mergers often fail to improve performance – success is rare and requires alignment of goals at all levels, from governance through organizational culture.

The CMS regulations should incentivize OPO consolidation to facilitate this as a successful performance improvement strategy rather than impose a hostile takeover model onto a system of community-based nonprofits.

Performance Threshold Set at Top Quartile Despite Overall Success of System

The U.S. system of deceased donation is among the best in the world; it is second only to Spain in terms of deceased organ donation and transplant rates.

Performance at the mean in a system that is high functioning and has demonstrated year-over-year growth for the past 9 years should be considered acceptable. It is unprecedented and without a rational basis for CMS to define average and above-average performing providers as “underperforming.” OPOs performing at or above the mean should be recertified.

New CMS OPO Metrics Rely on Flawed Data

The CDC data to be utilized in the new CMS regulation to calculate donor potential – the denominator in both the donation and transplant rate – is based on death certificates, which studies show are flawed. The CDC itself acknowledges that 1 in 3 death certificates contain errors.

As a result, there is concern that the new OPO metrics will not, in fact, be an accurate assessment of performance.

While data is always imperfect, pairing a known flawed data source with draconian regulatory consequences is suboptimal, as it may result in identifying OPOs as lower performing that are actually higher performing and vice versa, leading to system disruption without any system benefit.

Instead, hospital patient-level data is available, currently required to be reported to OPOs, and significantly more accurate and granular.

For example, hospital data includes whether the patient died on a ventilator, which is a medical requirement for organ donation to occur, but which is not specified in death certificates. Hospitals could independently report this same patient-level data directly to CMS for use in calculating OPO performance metrics.

Despite claims that this would be too difficult or expensive, every hospital in the New England region (approximately 200, including numerous critical access hospitals in rural areas) currently provides the regional OPO with a defined electronic data set for every inpatient death on a monthly basis. This same electronic reporting process could be scaled nationwide for donor hospitals to report inpatient death data directly to CMS in order to accurately calculate a denominator for OPO performance metrics.

Future Reform: Alignment and Accountability for All Components of System

All components of the organ donation system must be aligned and held accountable in order to realize change and to better serve patients waiting for organ transplants. Ultimately, OPOs do not transplant organs – transplant programs do. Transplant programs make the decision whether to utilize the organs that OPOs make available and are directly responsible for the care of organ failure patients.

Currently there is wide variation nationwide in the rates at which different transplant programs accept organs offered by OPOs for their patients. Transplant programs should be held accountable for access to transplants, including organ offers rejected. Transplant programs should be required to communicate transparently with patients regarding the trade-offs between a less-than-perfect organ versus an extended delay.

The new OPO regulations are specifically pushing OPOs to recover and offer more organs in the exact categories that transplant programs are currently under-utilizing (for example, organs from older donors). This misalignment must be addressed in order to actually benefit patients waiting for transplant.

Good News for Patients Waiting

It should be noted that prior to implementation of these potentially disruptive regulations, OPOs are already on pace to surpass CMS’ own prediction for performance under the new OPO regulations by 4,785 organ transplants.  The OPO community is committed to setting a bold goal and working with all components of the system to exceed even current projections.

The first four-year OPO certification cycle under the CMS new regulations starts in 2022, as required by statute, which provides time for the new administration to make adjustments to ensure this regulation accomplishes its purpose – to help get more patients transplanted.

 

Alexandra Glazier, JD MPH is President & CEO of New England Donor Services, the OPO serving a six-state region and identified under the new CMS regulations as a Tier 1, top performing OPO.

The Petrie-Flom Center Staff

The Petrie-Flom Center Staff

The Petrie-Flom Center staff often posts updates, announcements, and guests posts on behalf of others.

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