Is a National Joint Registry in Our Future?

Martin Gold

In October, I had the honor of speaking at the Orthopedic Design & Technology Conference and Exhibition held in Ft. Wayne, Indiana, home to three of the five biggest orthopedic device manufacturers. The general theme of the conference was innovation, growth and the future of orthopedics. The industry is on the verge of many exciting new technologies that increase the longevity of implants and provide for faster healing rates. While we immediately assume innovation is a good thing, Medicare and private payers have very different concerns.

The Economic Dilemma of Orthopedics

The rapid rate of growth in the number of hip implants, and associated expenses, has caused third party payers to consider the financial implications of an aging baby boomer population. As the single largest payer of joint implant procedures, much of that financial burden will continue to fall on Medicare. Although private payers are picking up a slightly greater portion of the cost burden compared to previous years, recent data show Medicare accounted for 63.4% of hip payments in 2004.

This slight shift in payer category indicates that some patients may be receiving implants at a younger age. Whether this is an increasing trend still remains to be seen.

The two primary issues that payers are currently struggling with relate to the longevity of the implant and the cost-benefit of new joint technologies. With all the recent innovations in bearing surfaces, coatings and alloys and the accompanying increases in cost, it has been difficult for payers to determine the true clinical benefit of the technological improvements. Many private payers are questioning the appropriateness of device selection, especially for older patients, and whether certain patients truly benefit from a joint that offers increased mobility or reduced wear.

How Are Payers Responding?

In a Clinical Policy Bulletin, Aetna, Inc. clearly delineates what it believes to be the appropriate utilization of various hip joint technologies. In a very simplified approach, Aetna has determined that it will not reimburse hip implant procedures that use metal-on-metal or ceramic-on-ceramic hip implants for patients older than 70 years. While at first blush this would appear to be a clear case of ageism, Aetna justifies this controversial selection criterion using accepted evidence-based medicine principles. Its medical policy states that as of the date of the publication of the policy, “available studies of metal-on-metal and ceramic-on-ceramic total hip implants primarily involve cohorts of younger, more active patients. The chief advantage of these hip implants over standard metal-on-polyethylene hip implants is their greater longevity. There is no adequate evidence that metal-on-metal or ceramic-on-ceramic total hip implants offer clinically significant benefits over standard metal-on-polyethylene hip implants for older patients.”

While Medicare has not taken Aetna’s aggressive approach to hip joint selection, the Centers for Medicare and Medicaid Services (CMS), the agency responsible for administering the Medicare program, has begun tracking the bearing surfaces of joints implanted in Medicare patients. Last year, a new set of ICD-9 procedure codes were added to the coding system that are to be used by hospitals to report the bearing surface of hip implants:

•    00.74 – Hip replacement bearing surface, metal on polyethylene
•    00.75 – Hip replacement bearing surface, metal-on-metal
•    00.76 – Hip replacement bearing surface, ceramic-on-ceramic
•    00.77 – Hip replacement bearing surface, ceramic-on-polyethylene

These codes will allow Medicare and other payers to review claims submitted by hospitals and determine the type of technology used on various patients. They also will allow payers to assess which types of implants are more prone to fail and require revisions. This linkage is now possible as a result of another significant coding change that occurred last year. The DRG code used to report hip and knee implants and revisions, DRG 209, was eliminated and replaced with two new DRGs, DRG 544 Major Joint Replacement or Reattachment of Lower Extremity, to be used to identify an initial implant and DRG 545, Revision of Hip or Knee Replacement to be used to report a revision.

When performing a joint revision, hospitals are required to include the procedure codes that identify the component of the joint that required revision:

•    00.70 – Revision of hip replacement, both acetabular and femoral components
•    00.71 – Revision of hip replacement, acetabular component
•    00.72 – Revision of hip replacement, femoral component
•    00.73 – Revision of hip replacement, acetabular liner and/or femoral head only
•    00.80 – Revision of knee replacement, total (all components)
•    00.81 – Revision of knee replacement, tibial component
•    00.82 – Revision of knee replacement, femoral component
•    00.83 – Revision of knee replacement, patellar component
•    00.84 – Revision of knee replacement, tibial insert (liner)
•    81.53 – Revision of hip replacement, not otherwise specified
•    81.55 – Revision of knee replacement, not otherwise specified

While this might seem Machiavellian, ultimately, Medicare and other payers are attempting to gain a better understanding of the differences between implants and the long-term effectiveness of the devices. Currently available performance and outcomes data, resulting from properly structured clinical trials, often are limited to a 10-year period. This limitation raises the question of the longer-term performance of the implants, beyond 10 years, where the true economic value of the newer technologies becomes evident.

What Changes Might We Expect?

The United States is not alone in its efforts to better understand this compelling clinical and financial puzzle. The United Kingdom already has established guidelines for hip implant use by surgeons. In its guidance document, titled Guidance on the Selection of Prostheses for Primary Total Hip Replacement, the country’s National Institute for Clinical Excellence (NICE) states, “Using the most recent available evidence of clinical effectiveness, the best prostheses (using long term viability as the determinant) demonstrate a revision rate (the rate at which they need to be replaced) of 10% or less at 10 years. This should be regarded as the current ‘benchmark’ in the selection of prostheses for primary Total Hip Replacement.”

While NICE indicated that it would be beneficial to study outcomes data beyond the 10-year benchmark, it recognized that the cost to manufacturers to collect these data might be too burdensome—“More evidence of the performance of hip prostheses over longer periods of follow-up is required. It is recognized that long-term evaluation is costly and by its very nature, may inhibit innovation.” As a result, NICE recommended that a national joint registry be established to collect longer-term outcomes data. The United Kingdom, indeed, did adopt the recommendation of NICE and currently maintains a national data repository, “The National Joint Registry,” to track the performance of various implants. The United Kingdom is just one of several European countries that have established such databases—Finland, Sweden and Scotland also have established similar registries.

What does the future hold for orthopedics in the United States? If we look to the cardiac rhythm management industry as an example, we might expect to see the development of a national joint registry for hip implants. In 2005, Medicare agreed to expand its coverage criteria for implantable cardioverter defibrillators, but only with the condition that Medicare patients receiving them be entered and tracked in a CMS-mandated national registry. The expansion of the national coverage policy contained a stipulation that failure to list the patient in the registry would result in a denial of coverage and, of course, a denial of payment.

While CMS’s efforts to link coverage and payment to clinical outcomes are still in formative stages, I believe the economics of hip implants is compelling enough to warrant closer scrutiny and future action by CMS.

Martin Gold is a principal at Technology Access Partners and eMedLearn, a Suffern, NY-based consulting firm that specializes in designing and implementing reimbursement and training solutions for medical device companies. He can be reached at (845) 369-9833 or by e-mail at [email protected].