On a larger scale, President Obama, members of Congress, and the American electorate have, for years, agreed that our country needs to reduce its national debt and control spending. For just as many years, little has been done because no one can agree on how to achieve these goals.


Published 6/1/2013
Joshua J. Jacobs, MD

The Devil Is in the Details

The new frontier of “regulatory advocacy”

We all know how challenging it can be to find solutions to difficult problems. In the clinical arena, for example, a patient and a physician might agree that the patient’s weight is a factor in recurring knee pain. But determining the next steps is problematic. The physician may recommend a change in eating habits, non–weightbearing exercises such as swimming, and a follow-up visit in 6 weeks. The patient may push back with, “Can’t you just give me a prescription painkiller?” or “If I had a knee replacement, it would be easier for me to exercise.”

Joshua J. Jacobs, MD

In the healthcare arena, the passage of the Affordable Care Act (ACA) signaled recognition that rising healthcare expenditures needed to be brought under control and that the issue of uninsured and under-insured people needed to be addressed. But the passage of that legislation in 2010 was just the beginning.

This legislation touches each citizen and will have a profound effect on an economic sector (health care) that already accounts for 17 percent of our nation’s gross domestic product. Although it does provide coverage for an increasing number of Americans, it is an extraordinary complex piece of legislation that many believe will fail.

The ACA includes a broad array of experiments in medical care delivery and payment reform whose success is highly uncertain. It is the rulemaking by various agencies at the state and federal levels that will determine how the new law is implemented and whether it will be effective. And those regulations currently number in the thousands of pages.

It is those rules that will have the most impact on our practices and our patients. The devil is in those details.

Regulatory advocacy
Making sure that those details don’t adversely affect orthopaedic patients and practices is a primary function of “regulatory advocacy.” Regulatory advocacy is a new paradigm in the advocacy arena. It arises from the realization that passing legislation is just the beginning.

Regulatory advocacy can be defined as an attempt to communicate with and inform federal regulatory agencies about our issues so that they don’t develop rules and regulations in a vacuum. The American Association of Orthopaedic Surgeons (AAOS) does this in a variety of ways, from responding to requests for information during the rulemaking process to consulting with regulatory staffers to participating on federal panels.

On a larger scale, President Obama, members of Congress, and the American electorate have, for years, agreed that our country needs to reduce its national debt and control spending. For just as many years, little has been done because no one can agree on how to achieve these goals.

Regulatory agencies have a wide array of motivations, influences, and structures. It is essential that we understand who the key players are and how the rules are made. Each regulatory advocacy strategy may be different; some may result in instant successes and others will take time.

Our Association has been proactive in its advocacy activity to date, integrating regulatory and legislative analyses. These efforts will need to be intensified as the ACA is implemented during the coming years. The AAOS has recently begun to increase our efforts in the regulatory advocacy space by redeploying dedicated staff members in the office of government relations. And we have already had some successes.

For example, we coordinated a letter from members of Congress to the Centers for Medicare & Medicaid Services (CMS) requesting a stop to the practice of denying total joint replacement claims that did not meet the non–evidence-based criterion of 12 weeks of prior physical therapy. Most importantly, CMS responded favorably.

Every piece of legislation is accompanied by hundreds of pages of rules and regulations; regulatory advocacy helps ensure that these rules are not created in a vacuum.
Courtesy of Thinkstock

Other meetings with CMS have focused on changes to the relative value units (RVUs) allocated to certain procedures. In some cases, we have been able to reduce the impact of these changes; in other cases, we have been able to prevent changes.

We have also met with representatives from the U.S. Food and Drug Administration (FDA) on the issue of custom devices. During the Congressional debate on the Medical Device User Fee Act, our efforts—in conjunction with a coalition of medical and patient groups—resulted in the inclusion of specific language to allow greater flexibility in the FDA’s custom device exemption. Specifically, it broadened the exemption to include devices that are modifications of existing devices and to allow for production of up to five units of a particular device. It also defined custom device more broadly to allow use of a “customized device” or the modification of a pre-approved device, as well as a device that is essentially made from scratch.

Engagement is effective
The effectiveness of these efforts was seen last month during the National Orthopaedic Leadership Conference (NOLC) in Washington, D.C. Attendees heard from and were able to ask questions of three top regulators: Richard Gilfillan, MD, director of CMS’s Center for Medicare and Medicaid Innovation; Jeffrey E. Shuren, MD, JD, director of the FDA’s Center for Devices & Radiological Health; and Jonathan Blum, CMS’s acting principal deputy administrator. All three will play significant roles in making the rules that will affect orthopaedic practices in the future, and all three heard our concerns.

Going forward, we will continue to implement strategies and tactics to be effective in the regulatory advocacy space. The AAOS office of government relations and the Council on Advocacy will maintain awareness of new and upcoming regulations as well as track and prioritize them by measuring their potential impact.

In consultation with staff and our members, we will craft our messages directly to regulators, using grassroots tools, when appropriate, to manage the messaging. We will continue to meet with career staff or political appointees and, when appropriate, to reach out to the White House and Congress. I ask you, my colleagues, to connect with us, to learn what we are doing, and to get involved.