The peril of inadequate evidence.

With 2 other members of Physical Therapy's Editorial Board, I attended a fascinating workshop sponsored by the National Institutes of Health (NIH). The goal of this meeting, held in February, was to recommend to the US federal government a research agenda on appropriate settings for the provision of rehabilitation services. The workshop was initiated at the request of the Centers for Medicare and Medicaid Services (CMS), following their imposition of restrictions on eligibility for inpatient rehabilitation care for patients in selected diagnostic groups.

In 1984, CMS (then HCFA, the Health Care Financing Administration) published a new regulation: "Medicare Program: Prospective Payment for Medicare Inpatient Hospital Services" (1) (49 FR 234), commonly referred to as the "75% rule." Under this rule, whose enforcement had been limited until July 1, 2004, rehabilitation units that are part of an acute care hospital or a stand-alone rehabilitation hospital and classified as inpatient rehabilitation facilities (IRFs) had their Medicare reimbursement shifted to the prospective payment system (PPS). Under these Medicare regulations, such facilities are required to show that, during their most recent 12-month cost-reporting periods, they served an inpatient population of whom at least 75% required intensive rehabilitation services for identified serious medical conditions. These conditions include stroke, spinal cord injuries, amputations, major multiple trauma, brain injuries, polyarthritis, and neurological disorders. (2)

At the NIH meeting, clinicians, administrators, and researchers from rehabilitation and related fields listened to summaries of recently conducted critical reviews of the worldwide inpatient rehabilitation literature, and we deliberated for 2 days on the current state of scientific evidence and future priorities for research regarding the most appropriate settings for the provision of effective and efficient rehabilitation care. Members of the workshop panel and various observers who were in attendance spoke passionately about the unfairness of the 75% rule and expressed their sincere concerns that, by enforcing this regulation, CMS was denying critically needed inpatient rehabilitation services to patients who previously were eligible to receive them. Clinicians on the panel spoke eloquently of their conviction that valuable inpatient rehabilitation care also was being denied to new and emerging patient groups that did not exist back in 1984 when the rule was first written, such as patients who have received major organ transplants and patients who are severely deconditioned due to major medical conditions.

As a researcher participating in this discussion and priority setting, I was most struck by the glaring paucity of research evidence that could be cited to support the appropriateness and effectiveness of inpatient rehabilitation services in lieu of rehabilitation care provided in less intensive and less costly alternative settings. The refrain heard repeatedly throughout the meeting was that the evidence on the appropriateness and necessity of inpatient rehabilitation care for numerous diagnostic groups simply did not exist. In the span of 20 years since the initial introduction of the 75% rule, surprisingly little progress had been made in developing an evidence base for inpatient rehabilitation services.

This NIH workshop underscores the peril that the physical therapy profession faces if it continues to practice with inadequate evidence in the contemporary health care policy environment in the United States. In response to escalating health care costs and a tight budgetary climate, both the US federal government and other health care insurers are increasing their scrutiny of the level, intensity, and duration of rehabilitation services that they are willing to reimburse. In the absence of convincing empirical evidence that demonstrates the cost-effectiveness of providing rehabilitation services in inpatient rehabilitation settings, the likely trend will be additional reimbursement restrictions and continuation of a policy that favors service provision in less costly settings.

As I reflect on how the physical therapy profession has evolved during the past 20 years, I am impressed by the considerable progress that has been made in building an evidence-based foundation for physical therapy. For instance, the profession has taken important steps to strengthen its evidence base through the creation of the Foundation for Physical Therapy Research. The Foundation has provided critically important doctoral research training for physical therapists and has directly funded clinical research centers and networks and numerous individual investigator projects. The American Physical Therapy Association (APTA) has spearheaded the development and dissemination of a clinical research agenda; has collected, via Hooked on Evidence, data from studies published on physical therapy interventions; and has supported the dissemination of research and scholarship through the peer-reviewed journal Physical Therapy. The number of physical therapist scientists actively engaged in research today is impressive and is vital to ensuring a healthy future for the profession.

Yet we must make no mistake about how vulnerable the physical therapy profession remains to challenges to justify--through research evidence--the type, intensity, and duration of services we provide to our patients. Health care insurers increasingly recognize that there is much geographic variation in the frequency with which physical therapy services are provided, in the management of patients with a given disease, in patient outcomes, and in costs of care--variations that cannot be explained by patients' demographic or clinical characteristics. A growing number of payers are concerned that some of the physical therapy care being provided and reimbursed may bring little or no benefit to patients.

In the 20 years since the introduction of the 75% rule, our colleagues in the inpatient rehabilitation industry lost a valuable opportunity to expand the evidence base for their services. The meeting that I attended at NIH would have had a very different tenor and sense of urgency if we had more evidence on which to base recommendations for setting research priorities.

The physical therapy profession needs to respond proactively and aggressively over the next 5, 10, and 20 years. We need to redouble our efforts to secure funding at all levels for a new generation of clinical and health services research ventures--both to investigate the evidence base of the interventions we provide today and to develop theory-grounded, more effective treatments for tomorrow. Working together toward this goal is the only way that we can avoid the peril of inadequate evidence.

References

(1) Medicare program: prospective payment for medicare inpatient hospital services (49 FR 234)--HCFA. 49 Federal Register 23010-23014 (1984).

(2) Medicare Inpatient Facility Classification Requirements. Medlearn Matters. July 2004. Available at: http://www.cms.hhs.gov/medlearn/matters/mmarticles/2004/MM3334.pdf. Accessed March 4, 2005.

Alan M Jette, PT, PhD

Acting Editor in Chief

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