An attempt to save money by using mandatory practice guidelines in france
BMJ 1997; 315 doi: https://doi.org/10.1136/bmj.315.7113.943 (Published 11 October 1997) Cite this as: BMJ 1997;315:943
- Isabelle Durand-Zaleski (zaleski{at}lmm.jussieu.fr), assistant professorb,
- Cyrille Colin, assistant professorc,
- Claudine Blum-Boisgard, professorc
- a Department of Public Health, Henri Mondor Hospital, Paris, France
- b Claude Bernard University, Lyon I, Lyon, France
- c René Descartes University, Paris V, Paris, France
- Correspondence to: Dr Isabelle Durand-Zaleski HITEQ, Henri Mondor Hospital, 51 Avenue du Maréchal de Lattre deTassigny, 94010 Créteil, France
- Accepted 25 April 1997
Introduction
In the five years up to 1996, expenditure on healthcare in France increased at an average yearly rate of 4-5%; by 1996 it amounted to about 10% of the gross domestic product.1 2 Various cost containment programmes have been proposed and implemented, many assuming that high costs are a result of unnecessary tests and treatments. We describe and make a preliminary assessment of the latest of these, introduced in France from 1994 onwards, which combines mandatory practice guidelines on procedures and drug prescribing with a system of fines for doctors who do not comply.
Background
Two thirds of French doctors are in private practice and are paid on a fee for service basis. The French social security administration provides medical cover for 99.6% of the population, and 80% of the fee the patient pays to a private physician is reimbursed by social security. Private insurance companies reimburse the remaining portion for most people. The social security administration and the doctors' unions have negotiated contractual medical fees and these are paid to most general practitioners and to 60% of specialists. Basic fees per consultation in 1997 were F110 (£11) for a general practitioner and F150 (£15) for a specialist but additional fees could be claimed for medical or surgical procedures performed during the consultation. Thus, physicians receive most of their income from social security.2
The French healthcare system has historically provided freedom of choice for patients and doctors. Patients can see any general practitioner or specialist they choose, with no limit to the number of doctors seen or the frequency of visits. Doctors have been free to request any investigations or procedures and have prescribed as they pleased—with the exception of a few drugs restricted to hospital use. This combination of freedom of choice, the high proportion of medical expenditure covered by social security, and the higher costs associated with medical advances inevitably resulted in increased expenditure.
Traditional cost containment measures, including capping total hospital expenditure, reviewing prescribing practices, and asking patients to contribute to costs, combined with continuing medical education and consensus conferences,3 4 5 6 have not controlled the increases in expenditure in France, in particular those of medical care outside hospital.2
Medical practice guidelines
Summary points
Mandatory practice guidelines were introduced from 1994 and 1995 as a way of cost containment and of standardising patient care
The system was developed by an independent agency after 1994 and agreed by representatives of the profession, the French social security administration, and the government
Practice guidelines apply to medicine and surgery, diagnosis and treatment but hospital practice is excluded
Doctors who do not comply can be fined up to £2000; in 1996, 186 were investigated and 75 were fined
The rate of increase of expenditure on medical services outside hospital has decreased since the system was introduced
Limitations include the lack of outcome assessment, possible shifts in expenditure from outpatient to inpatient services, and the fact that enforcement is difficult and costly
A containment policy for healthcare expenditure became law in August 1993 (Loi Teulade 93-8). This introduced mandatory medical practice guidelines, known as références médicales opposables. These form a negotiated contract signed by the social security administration and unions representing doctors in private practice outside hospital. The guidelines aimed to limit the prescription of redundant and costly drugs, tests, and procedures by fining physicians who overprescribed and to improve the quality of care.
French doctors who do not follow prescribing guidelines can be fined
FLORENCE DURAND/REX FEATURES
Redundant prescribing meant either that a harmless prescription was not required, given the patient's condition, or that the benefit did not justify the risk of harmful side effects. The costliness of a prescription was considered from the viewpoint of the payer. The guidelines attached two indices to each item, one for redundancy or harm and the other for direct cost.7 8 9
The first guidelines, published in 1994, were produced solely by the health department of the social security administration. New guidelines were developed in 1995 and 1996, using a scientifically validated procedure.10 11 Their development was supervised by an independent organisation, Agence Nationale pour le Développement de l'Evaluation Médicale (ANDEM). ANDEM assessed the scientific evidence and professional consensus for each guideline but did not consider the economic implications of practices or set the level of fines for non-compliance. Thus, a clearer distinction was made between scientific and economic issues. Altogether 147 guidelines covering medical and surgical topics, diagnosis and treatment were issued in 1994 and 1995 (see box).
Topics selected for mandatory practice guidelines
Methodology
Selecting topics
The social security administration and representatives of doctors' unions had the sole responsibility for selecting topics. The criteria set for selecting topics were medical and economic, and included high cost, high prevalence, high risk, and high variation in practice patterns.
Reviewing the evidence
Practice guidelines were established by ANDEM with reference to published work.12 13 14 15 16 17 Medical societies, university physicians, and experts were charged with reviewing and editing the final wording. The social security administration then selected those that were most feasible and relevant to medical practice outside hospital.
Implementing the guidelines
The first group of guidelines was published as bylaws in March 1994, six moths after the Loi Teulade. The indices of medical redundancy or harm and of cost were published together with fines for non-compliance as part of the bylaw. The index value of redundancy/harm could be 0.5 (redundant but no iatrogenic risk), 1, or 1.5 (presence of appreciable iatrogenic risk). The index of costliness could be 1, 1.25, and 1.5, corresponding to three levels of increasing expense.
The guidelines were applied immediately after their publication and the enforcement procedures after a two month observation period. The number of violations per doctor was determined by doctors from the health department of the social security administration, who sampled prescriptions over two months.
Each fine, varying from F1562 to F11 250 (£156-£1125), was determined by a weighted combination of the indices of redundancy or harm and cost and of the total number of violations. The number of violations by each doctor was estimated for the doctor's entire patient population (roughly 4500 consultations per year). A threshold for the minimum number of violations needed for legal action against a doctor was established for each guideline. The lowest threshold before a lawsuit (three violations in two months) concerned prescriptions of non-steroidal anti-inflammatory drugs and sulphonamides. The highest threshold (13 violations) concerned requests for investigations: full blood investigations, ultrasound performed more than three times during a normal pregnancy, repeated thyroid tests in the absence of clinical symptoms or signs, repeated electrocardiography in patients with moderate hypertension, repeated blood cholesterol and triglyceride determinations in patients with no risk factors or in those on cholesterol lowering treatment whose cholesterol concentrations were stable, and preoperative tests (blood work, electrocardiograms, and chest x rays).
1994 guidelines on ulcer treatment
“Ulcer treatment” was covered by three practice guidelines on drugs for and duration of treatment (all categories of anti-ulcer drugs were allowed but all antacids were excluded). There are no grounds for:
Simultaneous prescription of two anti-ulcer drugs
Prescribing a treatment for duodenal ulcer for more than six weeks except when symptoms persist
Prescribing anti-ulcer drugs for chronic gastritis
For all three guidelines the index of redundancy or harm was 0.5 and the cost index was 1.25. This meant that doctors who violated guidelines 9-16 times (for their entire patient population) in a two month period would be liable to pay a maximum of £400; for 17-24 violations the fine would be £800; and for were more than 24 violations it would be £1200.
Treatment for Helicobacter pylori was not mentioned; this was included in the recommendations of the October 1995 consensus conference held in Paris.
Evaluation
Compliance
Doctors were asked to indicate on every prescription form whether or not the item was covered by a guideline. A total of 13 000 doctors (roughly 10%) was surveyed over two years. Altogether 1278 were peer reviewed, and proceedings were taken out against 186; 75 were eventually fined.18
Expenditure
The average increase in expenditure for health services outside hospital was 2.3% per year in 1994 and 1995 compared with 6% previously. Total pharmacy expenditure rose by 1.3%, compared with 7.4% in 1993, and the total volume of tests requested fell by 15% (tests had increased by 1% in 1993). Volumes of medical and surgical procedures were not studied. Expenditure actually changed in 1993, when the decision about forthcoming medical practice guidelines was announced. We believe that doctors anticipated the controls and voluntarily limited their prescriptions.
In 1995, data were drawn from a sample of 2300 doctors participating in a four year survey (1992-5) of prescribing practice and included the name, type, and dosage of all drugs prescribed as well as diagnostic codes (international classification of diseases, 9th revision).19 The annual total of prescriptions collected varied between 154 000 and 218 000 yearly. The number of drugs prescribed per doctor, the name of the drug, and costs were determined for the drugs covered by the guidelines before and after they became law. The cost study covered both the reduction in prescriptions and the possible substitution of drugs not included in the guidelines. The overall net reduction in drug expenditure, extrapolated to the entire country, was estimated to be about F337m (£34m). It was estimated, however, that if practice guidelines had been applied scrupulously by all doctors the estimated savings for drugs prescribed outside hospital would have been F1.16bn (£116m). Compliance was best for antibiotics and non-steroidal anti-inflammatory drugs (40-45 % of prescriptions were written according to the references), and worst for antihypertensive drugs, corticosteroids, and drugs for diabetes (5-15%).
Cost shifting
These guidelines do not apply to hospital practice, which means that the current system does not address the issue of continuity of care; inpatient and outpatient budgets and practices are clearly separated. The increase in hospital expenditure was reduced by government decree from 6% to 4% in 1994 and to 3% in 1995. There may have been “cost shifting” to hospital services after the implementation of the guidelines but the current information system does not permit cross checking between patients' data and resource use. However, because hospital expenditure was capped there was no change in the trend after the guidelines were introduced.1
Quality of care
No means of measuring the effects of the guidelines on patients' outcome and satisfaction were planned. Laws (ordonnances) signed in April 1996 mean, however, that healthcare providers must present data on quality of care; a yearly regional assessment of the state of health is to be implemented via medical surveys and questionnaires.
Issues for debate
The main principle behind the guidelines was that reduction in prescribing would cut costs while maintaining the same level of effectiveness of patient care, a concept that needed the support of strong scientific evidence to make it acceptable to the medical profession and the public.20 21 None the less, enforcement was also considered necessary because doctors did not seem to have sufficient trust in guidelines or had incentives to disregard them.21 22
Legitimacy
The legitimacy practice guidelines being issued by the body that is paying for medical care could be questioned. The first guidelines in 1994 were criticised because of methodological flaws and possible conflicts of interest. The second group, issued in 1995 and 1996, were written by panels of experts in each field and appeared first as scientific recommendations. The procedures that rendered the guidelines mandatory were the sole responsibility of the social security administration and doctors' unions. In total 147 practice guidelines have been published, 90 of them derived from the clinical practice guidelines published by ANDEM.
A survey commissioned by the social security administration found that doctors considered that guidelines could be useful in explaining to patients why tests or drugs could not be given and to counterbalance any pressure from patients and their families. Medical unions expressed the discontent among doctors in private practice, but doctors who protested against the reform had little leverage, as they were paid by the social security administration.
Difficulties and costs of enforcement
As French law forbids collecting data on health that could be traced back to an individual, details of tests and drugs may not be entered on computerised patients' records. All checks on the implementation of the guidelines had to be performed manually on a sample of prescriptions written by doctors being surveyed. All reimbursement claims sent to the social security archives are matched against the original prescription. To check the prescriptions written by one doctor in two months took two months' full time work (300-350 hours). This underestimates the true costs: it does not include the time spent retrieving claims and covers only drug prescriptions, not requests for tests.
Expansion and revision
The rapid change in medical knowledge and technology limits the credibility and medical relevance of the guidelines and the validity of enforcing their use. For example, the 1994 guideline for ulcer treatment (based on 1993 scientific data) had to be revised after the importance of treatment for H pylori was acknowledged in 1995. Published guidelines need continuous revision; each year new guidelines addressing 20-30 new topics should be commissioned.
Will it work elsewhere?
The extension of mandatory guidelines to hospital medicine is under study; most guidelines issued in 1995 were considered suitable for hospital practice. Government policy was the route chosen for Implementing change in physicians' behaviour because of the centralised financing system in France. Replication in other countries with centralised financing could be possible; in some countries the regional level might be more appropriate. Only a centralised healthcare system with relatively weak medical unions could introduce such a system since guidelines have to be universal and the paymaster has to have both leverage over doctors and government support. This may apply to some European countries, but is more of a political than a medical issue.
Acknowledgments
We are indebted to Professor A Durocher and to Dr H Maisonneuve, ANDEM, as well as to Dr C Sermet and Dr P Le Fur from CREDES for their helpful comments on the manuscript. We also acknowledge the contributions of the anonymous reviewers.