Who should determine when health care is medically necessary?
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Biomedical subjects
Publications and source records attributed to L N Newcomer.
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With the profusion of new medical technology, managed care organizations are faced with the challenge of determining which medical devices and services warrant health benefits coverage. To aid in this decision-making process, managed care companies turn to technology assessment, a process that differs from the Food and Drug Administration's review of medical devices. Health plans typically use a structured approach to implementing coverage requirements in employer group benefits contracts and use technology assessment to evaluate the scientific evidence of effectiveness to support coverage decisions. Also important is the societal context for decisions regarding coverage for new technologies and the options being considered by policy makers for accountability in technology assessment by private insurers and health plans.
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For the health-care market, like the deodorant market, the message is clear: Add value or your product will not be competitive. For physicians of all specialties, the best way to add value is to measure and improve performance. Performance measurement is critical to improvement in health care. Without measurement, there can be no improvement in quality. Without improvement in quality, there is no added value. Oncologists can take at least two actions to add value for their health plans: (1) measure practice performance and demonstrate a quality improvement; and (2) become the personal-care physician for cancer patients.
OBJECTIVE: Our purpose was to measure cardiologists' level of adherence to guidelines for long-term use of beta-adrenergic blocker therapy after acute myocardial infarction. BACKGROUND: Beta-blocker therapy after acute myocardial infarction has been shown to reduce the incidence of reinfarction and associated mortality. To learn about cardiologists' use of this therapy after hospital discharge and their level of adherence to American College of Cardiology guidelines, we analyzed insurance claims from 17 network-model health plans located throughout the United States. METHODS: The study group included 150 cardiologists who had contracts with one of the health plans and their 280 patients who were plan members (excluding Medicare enrollees) and received inpatient treatment for acute myocardial infarction that did not include revascularization during 1992. These patients accounted for 307 separate hospital admissions. Insurance claims were used to measure beta-blocker usage and to identify possible contraindications. RESULTS: Forty-three percent of the cases (131 of 307) involved apparent deviations from the guidelines: 11% of cases (35 of 307) involved possible errors of commission (beta-blocker given in the presence of a contraindication) and 31% (96 of 307) errors of omission (beta-blocker not given in the absence of a contraindication). Of the 185 patients who were eligible for the therapy (no contraindications), only 48% (89 of 185) were treated. CONCLUSIONS: Cardiologists currently exhibit a low level of compliance with their specialty's guidelines for postinfarction beta-blockade. Slightly fewer than 50% of the study patients who were eligible for treatment actually received a beta-blocker after hospital discharge. This result, combined with the drug's known level of effectiveness in preventing recurrent myocardial infarction, suggests that increased use could avert approximately 1,900 deaths annually nationwide.
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Thirty-one patients with advanced malignancy received vinblastine as an iv bolus at 0 and 48 hours of a 21-day cycle. Divided-dose vinblastine may be given with acceptable toxicity in heavily pretreated patients; leukopenia and neuropathy were the dose-limiting toxic effects. One patient with breast cancer and one with ovarian cancer responded. Serum vinblastine levels with this program approximate those achieved by a 5-day continuous infusion of vinblastine in standard dose.
A patient with advanced breast cancer who died of septicemia associated with aminoglutethimide induced agranulocytosis, is reported. Aminoglutethimide is effective and widely used in the treatment of metastatic adenocarcinoma of breast. Thrombocytopenia, leukopenia, or pancytopenia have been reported as complications of therapy in 1.6% of 1345 patients treated in recently published clinical trials employing aminoglutethimide; and this may underestimate the true incidence of this drug side effect. Implications for clinical research and clinical practice are discussed.
A study of 22 patients with sclerosing variants of follicular center cell lymphoma (FCCL) presenting as a retroperitoneal mass is reported. These FCCL variants comprise 74% of retroperitoneal non-Hodgkin's lymphoma presentations. A partial intranodal follicular growth pattern was present in each case, and marked sclerosis of a distinctive pattern was associated with extensive perinodal lymphomatous infiltration. Small cleaved cells (SCC) predominated in five cases, large cleaved cells (LCC) in 14, and large noncleaved cells (LNCC) in three. Eighty percent of patients with SCC predominance were Stage I-II, compared to 50% of those with LCC predominance; all three LNCC cases were Stage IV. High stage was attained primarily by renal invasion or infiltration out the mesenteric root into gut or omentum; only three patients had biopsy proven extraabdominal disease. Combined modality therapy achieved an 88% complete or partial remission rate in patients with SCC and LCC predominance; all three LNCC patients died.
Twenty-nine patients with Stage III and IV diffuse histiocytic lymphoma (DHL) were treated prospectively with cyclophosphamide, hydroxydaunorubicin, vincristine, prednisone and bleomycin (CHOP-B) or hydroxydaunorubicin, cyclophosphamide, vincristine, methotrexate with leucovorine rescue and cytosine arabinoside (ACOMLA). Twenty-six evaluable patients were reclassified blindly by the Lukes-Collins classification with five large noncleaved follicular center cell (FCC), six large cleaved FCC, three large cell unclassified, seven B-immunoblastic sarcoma and five T-immunoblastic sarcoma patients identified. There was no significant survival advantage between the two combination chemotherapy programs. Survival of the immunoblastic sarcoma patients was inferior to that of the FCC lymphoma patients (P = 0.02). There were no significant survival differences between the large cleaved FCC and noncleaved FCC subtypes. Immunoblastic sarcomas, B- and T-cell types, appear to be more resistant to standard combination chemotherapy programs and new approaches may warrant more aggressive therapy in future protocols. The large cell FCC lymphomas have an excellent prognosis.
Eighteen patients with osseous involvement were identified from a series of 124 consecutive patients treated with combined-modality therapy with advanced-stage or relapsing Hodgkin's disease. Multiple lesions were seen as frequently as were solitary lesions. Nodular sclerosing histology was as prevalent as mixed cellularity disease. However, those five cases initially diagnosed at protocol entry were predominantly mixed cellularity (80%) with multiple lesions (80%). Sites of involvement included: the spine, 24; pelvis, 8; ribs, 4; femur, 3; skull, 1; and shoulder 1. Actuarial survival for these patients was 84% at nine years. Only three patients were induction failures and no patient has had a relapse. Patients with bone lesions had favorable responses to combined-modality therapy.
One hundred twenty-four patients with advanced Hodgkin's disease were treated uniformly with combination chemotherapy and radiotherapy. Splenectomy was not performed in 32 patients due to obvious stage IV disease, a medical contraindication, or patient refusal. Comparison of the splenectomy and nonsplenectomy patients revealed no differences in nadir white blood cell counts, platelet counts, or the total dosages of drugs that were administered. Survival and disease free survival curves with a 5-year median follow up also failed to show any difference in the two groups. Splenectomy does not offer a therapeutic advantage in those patients whose treatment would not be altered by splenic histology.
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Two combination chemotherapy programs, ACOMLA (doxorubicin, cyclophosphamide, vincristine, methotrexate and leucovorin rescue, and cytarabine) and CHOP-B (cyclophosphamide, doxorubicin, vincristine, prednisone, and bleomycin), were evaluated in 29 prospective randomized patients with advanced diffuse histiocytic lymphoma. A complete response was achieved in 13 of the 15 patients (87%) treated with CHOP-B and in nine of the 14 patients (64%) treated with ACOMLA. The overall complete response rate was 75%. Two patients treated with ACOMLA and none of the CHOP-B-treated patients have relapsed. Median followup is 32 months for ACOMLA patients and 26 months for CHOP-B patients. Actuarial freedom from relapse at 2 years is 49.9% for ACOMLA and 93.3% for CHOP-B (P = 0.04). Toxicity was substantial, with eight nonfatal episodes of sepsis and three drug-related deaths. There have been no central nervous system relapses. Although patients treated with CHOP-B have a better response rate, the small numbers of patients treated to date preclude definitive conclusions.
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