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2018 Regulatory Relief

Challenges and opportunities lie ahead.

GEORGE A. WILLIAMS, MD

Like many physicians in other fields, retina specialists are struggling with an increasing regulatory burden that can interfere with their patient care. This burden depletes the critical resources of physicians’ time and money with no apparent clinical benefit. The goal of programs such as the Quality Payment Program (QPP) of the Medicare Access and CHIP Reauthorization Act (MACRA) is to improve quality of care and lower costs.

Advocacy Efforts

Since the onset of the Affordable Care Act (ACA) in 2010 and MACRA in 2015, the American Academy of Ophthalmology (AAO) has looked for opportunities to diminish this regulatory burden and remove roadblocks to efficient, patient-centered care. In 2017, these efforts were rewarded with some, albeit insufficient, relief.

The AAO’s advocacy efforts resulted in substantial reductions to potential penalties in 2018 related to 2016 performance under the Physician Quality Reporting System (PQRS), electronic health record (EHR) meaningful use, and value-based modifier (VBM) programs.

For PQRS, the quality measure reporting requirement was decreased from nine required measures to six, and the need to report National Quality Strategy Domains was eliminated. The value of Qualified Clinical Data Registries (QCDRs), such as the AAO’s Intelligent Research In Sight (IRIS) Registry, was confirmed by the elimination of the requirement for IRIS participants to report high-priority measures.

Additionally, reporting requirements were decreased for meaningful use, and, importantly, the penalties of the VBMs were eliminated for physicians who successfully reported the six required PQRS measures, and the penalties were cut in half for others.

For small practices (those consisting of nine physicians or less), the VBM penalty was cut to 1% and PQRS to 2%. For practices with more than nine physicians, the penalties were cut to 2% for both VBM and PQRS. Again, these changes were for 2018 payments based on 2016 performance. Such retroactive changes to a federal program are unusual.

Measured by MIPS

In 2017, most physicians were measured under the Merit-based Incentive Payment System (MIPS) of the QPP. MIPS compares physicians across four categories with differential allocations that combine to create a single score between 1 and 100 that determines bonuses or penalties. The four categories are: quality (replacing PQRS), advancing care information (replacing meaningful use), clinical practice improvement, and cost.

The graphic on the next page shows the allocations for these four categories in 2017, 2018, and 2019. Performance in 2017 will be reflected in the 2019 payments. The Centers for Medicare and Medicaid Services (CMS) recognized the difficulty of transitioning to such a complex system, and 2017 penalties could be avoided simply by reporting one quality measure on one patient one time under what CMS termed “Pick Your Pace.”

The burden for reporting in 2018 has increased. While the allocations for advancing care information and clinical practice improvement will remain the same, cost will now account for 10% of performance and quality will drop to 50%. In 2019, the percentages could be adjusted further. Originally predicted to increase to 30%, the cost component for 2019 may remain at 10%. The future is uncertain, however, and the official allocations may vary.

The MACRA statute required that penalties and bonuses (5% in 2018) be applied to all Part B physician payments, including those for drugs. Like many other groups, including members of Congress, the AAO believed that the application of these penalties and bonuses was not the intent of Congress and was able to have them eliminated.

Beyond Medicare

Regulatory issues are not confined to the Medicare program, however. Increasingly, retina specialists are burdened by commercial payers, including Medicare Advantage plans, using inconsistent preauthorization requirements, step therapy for drugs, limited networks, and arbitrary payment policies for office examinations and imaging.

Preauthorization consumes an increasing amount of staff resources. It often delays care, and, even after preauthorization, denials are not uncommon. The AAO is advocating for a standardized process for preauthorization and assurance that preauthorization means payment.

Step therapy for retina specialists usually requires the use of bevacizumab (Avastin, Genentech) prior to the approval of more expensive drugs. Although bevacizumab is often an appropriate and effective therapy, patients are best served when they have access to all proven treatments.

Limited networks not only deny patients choices in their treatment, but they can also be confusing both to patients and to retina specialists who may be unaware of the restrictions.

Increasingly, retina practitioners are experiencing arbitrary restrictions on evaluation and management services for intravitreal injections through limitation or denial of use of modifier -25. The AAO has a long-standing, consistent position that modifier -25 is an appropriate and common standard of care, and we will be continuing the discussion of modifier -25 with CMS and commercial payers in 2018.

Last year, CMS announced a new initiative titled Patients over Paperwork. This is an encouraging development that suggests there are opportunities to address frustration with the current regulatory morass. The goals of this initiative are to streamline quality measures, reduce the regulatory burden, and promote patient-centered innovation.

A Work in Progress

I believe that the current MIPS program is too complex and is destined to fail both patients and doctors. New approaches to improving quality and containing costs are required. One solution is to increase the role of QCDRs such as IRIS. These registries can address quality and costs in real time and can have a profound impact on clinical care. AAO has advocated that successful participation in IRIS should fulfill all MIPS reporting requirements. As IRIS continues to grow, the value of registry reporting will become increasingly apparent.

Another critical component of patient-centered care is to have ophthalmologists develop more clinically relevant quality measures to improve outcomes. Recently, CMS announced the acceptance of five new retinal QCDR measures developed by ophthalmologists for use by both EHR and non-EHR IRIS participants. With these additions, retina specialists now have the most clinically relevant measures of any ophthalmic subspecialty.

Moving forward, our advocacy to-do list is long. It includes dropping Part B drug payments from MIPS penalties, returning to a zero-cost measure for 2018, improving preauthorization requirements, and enhancing integration of IRIS into QPP. Achieving any of these changes will help us to provide improved patient-centered care. Despite the continuing regulatory challenges, there is an opportunity to create significant improvement—particularly if CMS is serious about the Patients over Paperwork initiative.