`Medical Necessity' Definition Could Set Harmful Precedent
Tennessee state officials have developed a definition of the term“ medical necessity” that could weaken federal requirements concerning access to care through its Medicaid program called TennCare.
At the urging of Gov. Phil Bredesen (D), the legislature passed a bill in May that would result in copayments of $1 to $40 for certain services for most beneficiaries, cap coverage at six prescription drugs a month, and require most beneficiaries to use the cheapest prescription drugs available. It would also limit days of hospitalization and doctor's visits annually, according to<www.kaisernetwork.org> (June 30).
Before implementation, those changes must be approved by the Centers for Medicare and Medicaid Services (CMS) as a waiver.
The limitations proposed are not new, although the combination exceeds the cost cutting measures undertaken in most states.
The real threat to access, notes the National Health Law Program (NHLP), is the unprecedented definition of “medical necessity” contained in the legislation. The NHLP is a public interest law firm in Washington, D.C., that focuses on health issues for the poor.
The new definition contains four parts, all of which must be met for the patient to receive care.
“Part 1—[A medical item or service] must be required in order to diagnose or treat an enrollee's medical condition.” NHLP argues that the requirement to diagnose or treat could eliminate preventive screening, such as pap smears and blood tests for lead, and preventive care, such as immunizations. The definition could also exclude services such as personal care and home health aid services for elderly patients with Alzheimer's disease and therapy services for children with cerebral palsy. Pain medications, such as those used to ease the suffering of terminally ill individuals, could be excluded because they are used to treat a symptom rather than a medical condition. | |||||
“Part 2—[A medical item or service] must be safe and effective.... [T]he reasonably anticipated medical benefits of the item or service must outweigh the reasonably anticipated medical risks based on the enrollee's condition and scientifically supported evidence.” NHLP argues that “safe and effective” are terms of art within the medical community that have been limited in use to the rigorous evaluative process for new drugs and devices and that it is not clear how they would apply to a service like a physician's visit. NHLP also said standards of practice often have not developed from clinical trials or from determinations of safety and efficacy. Tennessee has not defined “scientifically supported evidence” and thus constrains the ability of health care providers to apply new research before a clinical study has been completed. | |||||
“Part 3—[A medical item or service] must be the least costly alternative course of diagnosis or treatment that is adequate for the medical condition of the enrollee.... Where there are less costly alternative courses of diagnosis or treatment, including less costly alternative settings that are adequate for the medical condition of the enrollee, more costly alternative courses of diagnosis or treatment are not medically necessary. An alternative course of diagnosis or treatment may include observation, lifestyle or behavioral changes, or, where appropriate, no treatment at all.” NHLP points out that when considered in combination with the previous two parts, this part forecloses any treatment that is not the cheapest, regardless of efficacy, and goes on to claim that the likely result is a reliance on observation or lifestyle changes rather than testing and treatment. “Adequate” is not a medical term and implies treatment of a lesser standard than “most appropriate” or even “most cost effective.” Under the new TennCare law, physicians will no longer be guaranteed reimbursement for care they are ethically required to prescribe and will realistically be limited to offering treatments that are reimbursable but fall short of the prevailing standard of care. | |||||
“Part 4—[A medical item or service] must not be experimental or investigational.... This standard is not satisfied by a provider's subjective clinical judgment on the safety and effectiveness of a medical item or service or by a reasonable medical or clinical hypothesis based on an extrapolation from use in another setting or from use in diagnosing or treating another condition.” According to NHLP, this definition runs counter to existing definitions of medical necessity, which recognize a variety of acceptable justifications for treatment including scientific evidence, professional standards, and expert opinion. | |||||
Psychiatrists React
Peter Frizzell, M.D., president of the Tennessee Psychiatric Association, told Psychiatric News that there was concern among psychiatrists about the proposed definition.
Karen Rhea, M.D., vice president for medical services for Centerstone, gave Psychiatric News the following statement. Centerstone is a multisite community mental health center in Tennessee.
“The rising role of the uninsured defines our national health care crisis. Tennessee through TennCare has approached more closely than any other state, except Hawaii, the goal of universal health insurance coverage. We do understand, however, that there are budgetary constraints, which will precipitate tradeoffs between coverage and scope of benefits.
“We are especially concerned about the patient population with serious and persistent mental illness and their potential for recovery with continued access to cutting edge pharmacotherapy and efficacious psychosocial services. However, we are cautiously optimistic and have been promised the opportunity to participate as providers in the dialogue, which will define the working details of medical necessity.”
Forensic psychiatrist and former APA president Paul Appelbaum, M.D., identified several problems with the proposed definition (Original article: see box).
David Fassler, M.D., a child psychiatrist in Vermont and member of APA's Board of Trustees, told Psychiatric News, “The proposal appears particularly problematic with respect to child and adolescent psychiatric treatment. Under the revised definition of medical necessity, many of our routine clinical interventions would be classified as `experimental' and thereby excluded from coverage. In an attempt to save money, the legislation would create barriers to access. Whatever modest savings might be achieved likely will be more than offset by increased spending on special education, juvenile justice, and social service programs.
“In addition, while the legislation purports to emphasize `evidence-based medicine,' it imposes random and arbitrary limits on monthly prescriptions and annual visits, procedures, or lab tests. The primary emphasis clearly is on cost containment, as opposed to access to necessary and appropriate clinical services.”
What's at Stake?
Ron Pollack, executive director of Families USA, and other health care advocates fear that approval of the definition by the CMS eventually could result in a weakening of federal requirements nationally concerning care for Medicaid beneficiaries.
Senate Majority Leader Bill Frist (R-Tenn.) backs the change, according to an article in the July 7 USA Today.
Reporter Skip Cauthorn speculated in the Nashville City Paper on July 6 that the proposal would be particularly appealing to Republicans as a way of setting a precedent because it was developed by a Democratic governor and supported by a Democratic state legislature.
The Bush administration, in early 2003, proposed changes to Medicaid that would have given states greater flexibility in terms of cutting beneficiaries and services in exchange for a short-term infusion of funds. The proposal was withdrawn when it failed to secure support from the National Governors Association (Psychiatric News, March 7, 2003). ▪
