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CLIA program; fee schedule revision--HCFA. General notice with comment period.

This notice updates the certificate fees for laboratories established under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) consistent with the methodology set forth in 42 CFR part 493. Section 353 (m) of the Public health Service Act requires that fees be collected to recoup costs of general administration of the CLIA Program. By economizing at every opportunity, the CLIA program has managed to maintain the fees established in 1992 and has absorbed all increases in costs. Revisions to the fees are necessary because the current fees are no longer sufficient to support the administration of the CLIA program. This restructuring of fees will move equitably distribute fees across all sizes and complexity of laboratories. For purposes of simplification, this notice announces a flat fee of $100 for a certificate of registration.

Centers for Disease Control and Prevention, U.S.↗

Fees: are they getting out of hand?

In the past, Medical Economics has conducted an annual survey of fees charged by office based physicians in general practice, family and internal medicine, obstetrics-gynecology and pediatrics, and general surgery. This year, the data-base was expanded to include six other specialties. The article provides a series of tables exhibiting the fees charged by physicians for first office visits, return visits, history and physical exams, and other general procedures specific to particular specialties. It is pointed out that the fee for return office visits has doubled in eight years. The increase in costs of routine services accounts for much of the 9.6% increase in physicians' fees during the last year. Primary care doctors have initiated the highest fee hikes for 1978. This is attributed to young physicians entering the field and charging more than their older colleagues. Surgical fees have doubled in cost in the last ten years. For the past three years, physicians' fees have increased at the average rate of 9.5%, usually exceeding the Consumer Price Index. Physician services only account for 20% of the entire health care bill, but due to their visibility, they are subject to criticism and careful review. Since the pressure is on for health care cost containment, the author advises physicians to think again before raising their fees in the near future.

Economics, Medical↗

Medicare program; replacement of reasonable charge methodology by fee schedules for parenteral and enteral nutrients, equipment, and supplies. Final rule.

This final rule implements fee schedules for payment of parenteral and enteral nutrition (PEN) items and services furnished under the prosthetic device benefit, defined in section 1861(s)(8) of the Social Security Act. The authority for establishing these fee schedules is provided by the Balanced Budget Act of 1997, which amended the Social Security Act at section 1842(s). Section 1842(s) of the Social Security Act specifies that statewide or other area wide fee schedules may be implemented for the following items and services still subject to the reasonable charge payment methodology: medical supplies; home dialysis supplies and equipment; therapeutic shoes; parenteral and enteral nutrients, equipment, and supplies; electromyogram devices; salivation devices; blood products; and transfusion medicine. This final rule describes changes made to the proposed fee schedule payment methodology for these items and services and provides that the fee schedules for PEN items and services are effective for all covered items and services furnished on or after January 1, 2002. Fee schedules will not be implemented for electromyogram devices and salivation devices at this time since these items are not covered by Medicare. In addition, fee schedules will not be implemented for medical supplies, home dialysis supplies and equipment, therapeutic shoes, blood products, and transfusion medicine at this time since the data required to establish these fee schedules are inadequate.

Centers for Medicare and Medicaid Services, U.S.↗

Using Medicaid claims data to evaluate a large physician fee increase.

OBJECTIVE: This study demonstrates the use of Medicaid claims data in order to evaluate a threefold fee increase in physician fees for deliveries ($265 to $795), which the Maryland Medicaid program implemented in 1986. DATA SOURCES AND STUDY SETTING: The study used Maryland Medicaid claims data for years of service 1985-1988, and was done at the Maryland Department of Health and Mental Hygiene with the help of a Robert Wood Johnson, Health Care Financing and Organization (HCFO) grant. STUDY DESIGN: Overall, our design is that of a pre-test, post-test with multiple observation points both before and after the fee increase. We measured participation in three ways, corresponding to three different units of analysis. With the county-quarter year as unit of analysis, we followed a panel of providers over 16 quarters for each county in the state to determine changes in the number of delivering providers. With the individual provider as the unit of analysis, we identified effects on their Medicaid caseload between years that may have been influenced by the fee increase. Finally, we looked at continuously enrolled Medicaid women who delivered to determine the effects of the fee increase on site and volume of prenatal care. DATA COLLECTION/EXTRACTION METHODS: Analytic files for each unit of analysis were compiled from previously extracted Medicaid claims files using standard statistical software packages. PRINCIPAL FINDINGS: Using techniques described, we were able to get an in-depth picture of overall responsiveness to the intervention. We found a moderate influence of the fee increase on overall participation, less than what we would have predicted. CONCLUSIONS: Administrative data can be used to construct efficient, yet sophisticated evaluations of major policy changes. Findings from our evaluation suggest a moderate effect of the fee increase on overall participation. However, raising fees to the level of private third party payers does not in itself guarantee equal access to private physician health care for Medicaid mothers.

Adolescent↗

The prescription Drug User Fee Act of 1992 and the new drug development process.

The Prescription Drug User Fee Act of 1992 (PDUFA) authorizes the US Food and Drug Administration (FDA) to levy user fees on manufacturers who submit applications to the agency. Revenues are dedicated to the achievement of a set of specific performance goals, documented by the FDA Commissioner and referenced in the Act. The FDA currently credits PDUFA with the agency's success in reducing new drug review times and eliminating the formidable new drug application (NDA) backlog. To provide an independent assessment of PDUFA's impact on the new drug development process, the Tufts Center for the Study of Drug Development established an annual user fee survey of over 50 major pharmaceutical and biotechnology firms with operations in the United States. As of December 31, 1996, survey data have been collected for fiscal years 1994, 1995, and 1996. Data from a cohort of user fee drugs approved in 1993-1996 were compared with data from all non-user fee drugs approved in 1990-1992. Whereas the mean approval phase (NDA submission to approval) for the user fee drugs was considerably shorter than that for the non-user fee drugs (14.5 versus 31.0 months, respectively), the mean clinical phase (investigational new drug application filing to NDA submission) was somewhat longer (88.0 versus 81.1 months, respectively). As a result, the total time from the start of clinical testing to drug approval (total phase) was only marginally shorter for the user fee drugs (102.0 versus 112.1 months, respectively). These results highlight the need for efforts to reduce lengthy drug development times.

Biotechnology↗

The case for differential capitation fees based on age in British general practice.

A study was performed to assess whether the existing differential capitation fees for general practitioners accurately assess differential workloads. Data from the third morbidity study in general practice were used to compare capitation fees with relative workload in differing age and sex groups. The population mix which determined the payment by capitation for the 143 principals in the study provided the basis for examining the advantage or disadvantage the general practitioner got from the existing system. Capitation fees for the elderly underestimated the increased workload by 21% for those aged 65-74 and by 54% for those aged 75 or over but overestimated the workload for male adults aged up to 65. Nevertheless, 60% of the participating general practitioners were not advantaged or disadvantaged by more than 2.5% of their capitation fees (450 pounds a year for the average practitioner with a list of 2000 patients). Similarly 88% were not advantaged or disadvantaged by more than 5%; none were advantaged or disadvantaged by more than 10%. A three scale capitation fee for the age groups 0-64, 65-74, and 75 or over should be applied in the ratio of 3:5:7 rather than in the present ratio of 3:4:5, but given the present population mix in practices there is no case for differential capitation fees by sex or differential fees for the age group 0-4 years.

Adolescent↗

Defining the practice population in fee-for-service practice.

OBJECTIVE: To develop and validate a technique for defining a practice population of discrete individuals based on multiyear family practice fee-for-service billings data. DATA SOURCES/STUDY SETTING: Nineteen family physicians in Ontario, Canada who converted from fee-for-service to capitation payment. Data sources were fee-for-service billings data for the three-year period prior to the conversion from fee-for-service to capitation payment and the rosters of enrolled patients for the first and third years after the change to capitation payment. STUDY DESIGN: The billings-based definition of the physician's practice population was compared against the Year 1 roster. We also compared the billings-based practice population and the Year 1 roster to the physician's Year 3 roster to identify patients who might have been missed during the roster development process. Our principal analyses were an assessment of the sensitivity of the billings-based definition of the practice population (EPP), the positive predictive value of EPP, and the agreement between EPP and the rostered patient population (RPP). We also examined the ratio between EPP and RPP to determine EPP's accuracy in estimating the practice denominator. DATA COLLECTION/EXTRACTION METHODS: The practice population for each physician at the time of conversion from fee-for-service to capitation payment was defined as (a) all persons for whom the physician billed the provincial health insurance plan for at least one visit during the year immediately prior to joining the capitation-funded program; and (b) all additional patients for whom the physician billed the plan for at least one service in each of the two preceding years. Data extraction was carried out within the Ministry of Health in order to preserve the anonymity of patients and physicians. Data were provided to the investigators stripped of patient and physician identifiers. PRINCIPAL FINDINGS: The mean sensitivity and positive predictive value of EPP were 95.3 percent and 87.4 percent, respectively. The level of agreement between EPP and RPP averaged 84.4 percent. The mean ratio of EPP to RPP was 1.21 (95 percent C.I. 1.030-1.213). Correction for roster false-negatives increased the sensitivity, positive predictive value, and agreement between EPP and the practice population, and reduced the mean ratio of EPP to the practice population to 1.068 (95 percent C.I. 1.010-1.127). CONCLUSIONS: The practice population can usefully be defined in fee-for-service family practice on the basis of multiyear fee-for-service billings data. Further research examining alternative encounter-based practice population definitions would be valuable.

Adolescent↗

The revenue generating potential of user fees in Kenyan government health facilities.

This paper develops and implements a methodology for estimating the total revenue that would result from a system of user fees for health services provided by public facilities in a developing country. After setting out a set of principles based on efficiency, equity, and administrative goals upon which the user fees should be founded, a formula for estimating total revenue generated is presented which reflects six different factors affecting total revenues. These factors include reductions in demand due to imposing fees, exemption of selected services from any fees, forgiving fees from those unable to pay, and 'leakage' of revenue due to bribes, etc. Three specific fee structures are then examined for Kenya, and the total revenue to be generated is predicted. The revenue totals are large, on the order of 10-22% of the government's total recurrent health costs, suggesting that even modest user fees can make a significant contribution to public health costs.

Delivery of Health Care↗

Understanding the impact of eliminating user fees: utilization and catastrophic health expenditures in Uganda.

There is currently considerable discussion between governments, international agencies, bilateral donors and advocacy groups on whether user fees levied at government health facilities in poor countries should be abolished. It is claimed that this would lead to greater access for the poor and reduce the risks of catastrophic health expenditures if all other factors remained constant, though other factors rarely remain constant in practice. Accordingly, it is important to understand what has actually happened when user fees have been abolished, and why. All fees at first level government health facilities in Uganda were removed in March 2001. This study explores the impact on health service utilization and catastrophic health expenditures using data from National Household Surveys undertaken in 1997, 2000 and 2003. Utilization increased for the non-poor, but at a lower rate than it had in the period immediately before fees were abolished. Utilization among the poor increased much more rapidly after the abolition of fees than beforehand. Unexpectedly, the incidence of catastrophic health expenditure among the poor did not fall. The most likely explanation is that frequent unavailability of drugs at government facilities after 2001 forced patients to purchase from private pharmacies. Informal payments to health workers may also have increased to offset the lost revenue from fees. Countries thinking of removing user charges should first examine what types of activities and inputs at the facility level are funded from the revenue collected by fees, and then develop mechanisms to ensure that these activities can be sustained subsequently.

Adolescent↗

Ministry of Health user fees, equity and decentralization: lessons from Honduras.

Decentralization is commonly championed as a means for achieving equity. To date, however, there has been little discussion of the mechanisms underlying this relationship, and several of the few empirical investigations that have addressed the topic have found the converse; that decentralization has exacerbated inequalities. This article examines the performance and equity in financing of the Honduras Ministry of Health's (MOH) decentralized user fee system. The MOH of Honduras established a national user fee policy in 1989. It provided a framework of rules and regulations and decentralized administration of the system to the regional offices. A survey conducted under the auspices of this study provided detailed information about the structures and operations of MOH user fee systems. The survey revealed that the systems vary markedly by region, creating horizontal inequities, and that they have numerous other shortcomings. The average price of a consultation is low, US dollars 0.16, and revenues have consistently equalled just 2% of MOH expenditures. The systems' administrative costs are equal to 67% of their revenues. Eliminating the user fee systems in all but the national and regional hospitals would actually save money and/or enable the MOH to provide more care. Average consultation prices are highest in health posts, intermediate in centres and lowest in the national hospitals, thereby encouraging the inappropriate use of the MOH's pyramidal referral system and fostering MOH inefficiency. Fee levels and exemption practices are horizontally and vertically inequitable. The likelihood of paying for an ambulatory visit is highest at a health post, 89%, and lowest at a hospital, 49%. Individuals from the poorest one-fifth of households are the most likely to have to pay for care. Honduras' experience demonstrates that a decentralized user fee system is not necessarily equitable, and that, more generally, the gains that can be realized from decentralizing user fee systems are not automatic. They must be anticipated, planned for and cultivated by a well-designed and well-implemented initiative that is not a single, one-time event, but rather a dynamic, on-going enterprise.

Ambulatory Care Facilities↗

A comparison of the effects of sociodemographic factors and health status on use of outpatient mental health services in HMO and fee-for-service plans.

The authors compared the effects of age, sex, socioeconomic status, and mental and physical health status on the use of outpatient mental health services in one well-established health maintenance organization (HMO) and in fee-for-service plans. In the Seattle site of the Rand Health Insurance Study (HIS), families were randomly assigned to HMO or fee-for-service coverage. Adults incur much greater expense for outpatient mental health services than children in both an HMO and a fee-for-service plan with identical coverage (i.e., free care). However, the difference in use between adults and children is significantly greater for the fee-for-service plan than the HMO (P less than 0.01). Similarly, education has significantly greater effects on use for the fee-for-service than the HMO plan. Increased income has a significant negative effect on use in both the HMO and fee-for-service plans. Mental and physical health status have similar large effects on use in both fee-for-service and HMO plans.

Adult↗

Medicare breast surgery fees and treatment received by older women with localized breast cancer.

OBJECTIVE: To determine whether area-level Medicare physician fees for mastectomy and breast conserving surgery were associated with treatment received by Medicare beneficiaries with localized breast cancer and to compare these results with an earlier analysis conducted using small areas (three-digit zip codes) as the unit of observation. DATA SOURCE: Medicare claims and physician survey data for a national sample of elderly (aged 67 or older) Medicare beneficiaries with localized breast cancer treated in 1994 (unweighted n = 1,787). STUDY DESIGN: Multinomial logistic regression analysis was used to estimate a model of treatment received as a function of Medicare fees, controlling for other area economic factors, patient demographic and clinical characteristics, physician experience, and region. PRINCIPAL FINDINGS: In 1994, average Medicare fees (adjusted for the effects of modifiers and procedure mix) for mastectomy (MST) and breast conserving surgery (BCS) were 904 dollars and 305 dollars, respectively. Holding other fees and factors fixed, a 10 percent increase in the BCS fee increased the odds of breast conserving surgery with radiation therapy relative to mastectomy to 1.34 (p = 0.02), while a 10 percent decrease in the MST fee increased the odds of breast conserving surgery with radiation therapy to 1.86 (p < 0.01). CONCLUSIONS: Among older women with localized breast cancer, financial incentives appear to influence the use of mastectomy and breast conserving surgery with radiation therapy. This finding is consistent with the hypothesis that physicians are responsive to financial incentives when the alternative procedures have clinically equivalent outcomes and the patient's clinical condition does not dominate the treatment choice. We also find that the fee effects derived from this analysis of individual data with more precise measurement of both diagnosis and treatment are qualitatively similar to the results of the small-area analysis. This suggests that the earlier study was not severely affected by ecological bias or other data limitations inherent in Medicare claims data.

Aged↗

Medicaid physician fees, 1993.

In 1993 Medicaid physician fees were about 73 percent of Medicare payment levels and about 47 percent of private physician fees. Overall Medicaid fees grew by 15 percent from 1990 to 1993, slightly faster than Medicare or private-sector fees. However, there were considerable differences in fees across the states (from fourfold to thirty-ninefold between the lowest and highest states). Fees for maternity services varied the least. Medicaid fees generally were highest in Alaska, Arizona, Arkansas, Nevada, and Wyoming; they were lowest in New Jersey, New York, and Rhode Island.

Data Collection↗

Dentists' participation and children's use of services in the Indiana dental Medicaid program and SCHIP: assessing the impact of increased fees and administrative changes.

BACKGROUND: The authors conducted a study to evaluate whether administrative changes, including higher fee schedules for dental services in the Indiana dental Medicaid program and the State Children's Health Insurance Program (SCHIP), were associated with improved dentist participation and utilization of dental services by children. METHODS: The authors evaluated dentists' participation and children's use of services for the two years before fees were increased to 100 percent of the 75th percentile of usual and customary fees, compared with two years after the increase. They obtained administrative data from the Indiana Department of Family and Social Services Administration and the Indiana Department of Public Health to determine participation rates and service use. RESULTS: The number of dentists seeing a Medicaid-enrolled child increased from 770 in fiscal year (FY) 1997 to 1,096 in FY 2000. The number of Medicaid-enrolled children with any dental visit increased from 68,717 (18 percent) to 147,878 (32 percent), with little difference between children enrolled through the Medicaid-SCHIP and traditional Medicaid programs by FY 2000. The mean number of visits per child per year and the mean number of procedures per child per year remained relatively constant. The cost per enrolled child increased from dollars 1.70 to dollars 6.70 per month, while the cost per child with a visit increased from dollars 9 to dollars 21 per month. CONCLUSION: The increase in fees and changes in administration of the Indiana dental Medicaid program were positively associated with improved dentist participation and children's use of dental services. PRACTICE IMPLICATIONS: Changes beyond increasing fees to 100 percent of the 75th percentile may be needed if Medicaid-enrolled children are to have access to dental care commensurate with their lower oral health status and greater need for services. Sustained fee increases also are important. As of 2003, no increase in dental fees had occurred in the Indiana Medicaid program since the increase in FY 1998.

Attitude of Health Personnel↗

Medical devices; Mammography Quality Standards Act of 1992; inspection fees--FDA. Notice.

The Food and Drug Administration (FDA) is announcing the new fees the agency will assess for inspections of mammography facilities starting on February 13, 1998. The Mammography Quality Standards Act of 1992 (the MQSA) requires FDA to assess and collect fees from mammography facilities to cover the costs of annual inspections required by the MQSA. Because these costs have increased since inspections began in 1995, FDA is raising the fees accordingly. This notice explains which facilities are subject to payment of inspection fees, provides information on the costs included in developing inspection fees, and provides information on the inspection, billing, and collection processes. This is the first increase in inspection fees under the MQSA since the initial fee was established in 1995.

Accreditation↗

A comparison of functional outcomes after hip fracture in group/staff HMOs and fee-for-service systems.

CONTEXT: Previous studies examining differences in the quality of care between capitated and fee-for-service payment systems have focused on the care delivered in a single setting. No study to date has compared outcomes over an entire episode of care delivered across multiple settings. OBJECTIVE: To compare outcomes of care for patients receiving institutional rehabilitation for hip fracture in fee-for-service and group/staff HMO delivery systems. DESIGN: One-year prospective inception cohort. SETTING: Six hospital-based, integrated care systems paid on a traditional fee-for-service model and five group/staff HMOs (paid fixed capitation rate by Medicare). The 11 delivery systems were selected because of their commitment to geriatric rehabilitation. PATIENTS: 196 fee-for-service and 140 group/staff HMO patients with acute hip fracture were identified on admission to inpatient rehabilitation. MEASURES: Four primary outcomes--recovery of activities of daily living, improvement in ambulation, return to community living, and mortality--were measured at 3, 6, 9, and 12 months. Service utilization was assessed in the acute-care hospital setting, rehabilitation setting, and at each 3-month follow-up interval. Risk adjustment was performed by using multiple and logistic regression. RESULTS: Overall, no differences were found between patients in group/staff HMOs and fee-for-service patients. Group/staff HMO patients experienced improved functional recovery at 6 months (P < 0.01) and improved ambulation at 12 months (P = 0.05) compared with fee-for-service patients, although these were isolated findings. With regard to utilization, group/staff HMO delivery systems used physician services less intensively and substituted less-skilled allied health personnel. CONCLUSION: Compared with fee-for-service delivery systems, with a similar commitment to excellence in geriatric rehabilitation, group/staff HMOs can achieve equivalent outcomes in older patients recovering from hip fracture with less-intense service utilization.

Aged↗

[Fees and compensation for therapy in foreign populations. A contribution to medical ethics from the history of medicine and ethnomedical point of view].

The 'Human Relations Area Files' (Yale) have been looked through in respect of the medical data on 220 peoples, tribes or ethnic groups. Concerning our theme data for 162 ethnies (73.6%) were available. In 26 ethnies of 162 ethnies (16%) no compensation has been demanded but in 11 ethnies gifts were accepted. Only 15 ethnies or less than 1/10 do not know any compensation for therapy. Payment is mentioned with 144 ethnies (89%). This outspoken opinion of the Ojibwa near the great lakes of Canada is widespread in the world: "You can't have anything for nothing". (1932) In 55 ethnies (34%) a 'very high' fee was paid, with another 47 ethnies (29%) a 'fair' fee was paid, this is altogether about 2/3. In 21 ethnies (13%) only a 'small' fee was paid. With another 30 ethnies (19%) the compensation could not be rated. In 43 ethnies (27%) a fee was paid only in case of success, this is more than 1/4. 12 times deposits are reported, this is especially common in central and southern Africa. 4 times refusal of payment is reported. Recourse (Regress) was positively absent in 9 ethnies but reported with 39 ethnies, this is 1/4 (24%). In 24 ethnies (15%) the recourse turns out sometimes or mostly with the death of the therapist, this is 1/6. This deadly recourse is obviously more common in the New World. Simple recourse or recourse with strokes were reported with 25 ethnies (15%). Because mortal and non-mortal recourses were reported twice with 10 ethnies the total of recourses is 39. Recourse does not depend on any fee at all. In the Middle East and in islamic Africa fees in general are small. There is a tendency towards very high fees in the less civilized ethnic groups. Typical in this respect is an observation in the bushnegroes of Guayana in Latin-America, where with free medical aid the reputation of the (white) doctor dwindles to the mind of everyone (1948).

Africa↗

Effects of health insurance on physicians' fees.

According to conventional wisdom, the growth of health insurance is partly responsible for the rise in physicians' fees; however, to date, convincing empirical evidence is lacking. A standard model of physician fee determination yields unambiguous predictions about insurance effects on fees. Empirical evidence, based on national interview surveys of physicians, shows insurance does affect fees in the predicted direction. Insurance parameter estimates imply that a $1.00 increase in an insurer's fee schedule raises physicians' fees somewhere between $0.13 and $0.35 on average. The higher fees could be associated with higher quality, an issue discussed in the last section.

Economics, Medical↗