Reflections about the discussion note on the Reform of the Diagnosis and Treatment of Sleep Apnea (RDTSA), published by the Health Care Service of the RIZIV/INAMI.
SleepOnline Schelde Maas Moselle1 .
Introduction : The RDTSA discussion note.
The current regulation of the RIZIV/INAMI concerns the conditions for the treatment of sleep apnea by physical means: ventilation in Positive pressure by nCPAP (nasal Continuous Positive Airway Pressure) and the mandibular advancement orthosis – OAM.
The KCE 330 report considering the increasing number of patients diagnosed as « Obstructive Sleep Apnea Syndrome (OSA) » and treated by nCPAP, or alternatively, by OAM, is concerned with maintaining access to care for the highest number of people. With this in mind, it considers the interest, in the future of a wider involvement of general practitioners, of the realization of polysomnography at home (PSGhome) and of the involvement of Service Companies (Distributors of devices for diagnosis such as PSG and treatments by nCPAP or OAM).
The RIZIV/INAMI, in this discussion note (RDTSA), echoes the KCE report, emphasizing the goal « that all patients who suffer from sleep apnea, be diagnosed as soon as possible, so that they can be efficiently treated. » (RDTSA, page 4). It then assesses 3 points raised by the KCE: 1) role of general practitioners; 2) role of home sleep recordings and 3) role of Service Companies (private companies).
This note also underlines the interest and the necessity of a drastic reduction of the number of hospitalizations.
Some basic remarks.
For our part, we should be thinking about the following facts:
A) Sleep medicine is still not recognized, in Belgium, neither as a specialty nor as a specific subspecialty, despite the recommendations of the two Academies of Medicine (January 27, 2007). This field is currently represented by a panel of specialists, pulmonologists, neurologists, psychiatrists, neuropsychiatrists, ENT specialists, pediatricians, under the vigilant interest of cardiologists, endocrinologists, geriatricians, and general practitioners (i.e., physicians who usually refer patients to the various Sleep Medicine Centers). The INAMI did temporarily solve this problem with a « portfolio », i.e. it has defined a competence of the physicians for the practice in sleep medicine and in particular in OSA pathology. This terminology is used hereafter under the term « Sleep Specialists Portfolio ».
B) Obstructive Sleep Apnea and Hypopnea Syndrome (OSA) is a chronic condition that primarily affects the upper airway. It begins with mouth ventilation during sleep, snoring, increased resistance of the upper airway, then in repeated collapses of the upper airway spontaneously resolved by sleep fragmentation (under the effect and cost of central nervous system activations). OSA is exacerbated by truncal obesity, by age, male sex, patent or discreet morphological damage to the facial architecture, by pathologies of the central nervous system or pathologies of the upper airway. OSA is a very long-term degenerative pathology, similar to diabetes, kidney failure or multiple sclerosis. OSA in turn, generates pathological consequences linked to sleep fragmentation, repeated arterial oxygen desaturations, hypercapnia, the cardiology effects specific to apneas and consequent activations during sleep.
C) To deal with OSA, a complex chronic disease, lately discovered (1968), skills are needed; for diagnosis as well as for specific therapeutic choices. It needs also a long-term medical follow-up, by a specialist, whether he is a general practitioner or another kind of specialist, carrying, as of now, an adequate portfolio issued by INAMI/RIZIV (pending decision of the Superior Council of the SPF. This doctrine of the necessity of a specialist prevails in many other fields (diabetes, renal failure, multiple sclerosis, etc.).
D) Service Companies are companies that stock and supply treatment devices, and more rarely that manufacture and stock diagnostic devices. In a liberal country, respectful of private property and market mechanisms, they are driven by financial profit. In the medical field, they always rely on the progress of world medicine. On this strict basis, they develop devices of ever better quality, ensuring the patient comfort, durability of the equipment, reliability, flexibility of use, safety and quality. (allowing long-term treatment monitoring). This is true for the nCPAP devices themselves, but also for their accessories (masks, harnesses, hoses, humidifiers) and for the OAM devices. They provide these devices to the physicians for their treatment, in a spirit of healthy competition between them. Beyond this approach, it is perfectly acceptable that they remain driven by their right and natural tendency to ensure increased profits and consumption of the materials they sell.
These basic remarks allow us to address the points in the report that we consider questionable because they are detrimental, in particular, to the objectives of the RIZIV/INAMI.
1. On the issue of the respective qualities of hospital polysomnography (PSGhosp) and home polysomnography (PSGhome), the latter performed with type II screening devices, according to the 1994 ASDA nomenclature.
In the RDTSA document, the advantages of PSGhome compared to PSGhosp are presented as a formal impression, tinged with common sense, and therefore little criticism: « The patient sleeps better at home. The examination performed in the hospital is more expensive. »
Our perception and experience are different:
A PSGhome (type II ASDA) involves electronic monitoring for at least 8 hours at night. This PSGhome must have at least 7 parameters, i.e. 12 sensors. Neither the position of the patient (standing, lateral or dorsal decubitus), nor the measurement of light in the room, nor interventions are required.
In our experience, this type of examination, which is quite complex, is very often a worry for the patient : (« Does it work with all these sensors? »). This is especially true since the practitioner cannot correct anything, either during or after the recording, except for errors limited to the software. He cannot correct problems at the level of the recording equipment, at the level of physical contacts and electrodes that come unstuck…). This is the difference with the PSGhosp.
This type of examination requires paramedical trained staff for the nomenclature object entitled 477374 – 477385, only readable by specialists in internal medicine or in neuro-psychiatry, according to this nomenclature.
The quality criteria for the reading of PSGhome (type II ASDA) implies a) an approval by a specialist, trained and accustomed to the reading of polysomnography issued by a particular brand. Indeed, the representation of tracings varies significantly from one mark to another; b) night and remote monitoring during PSG, by trained paramedics.
Here again, from the staff’s point of view, what corrective interventions are then possible? The solution proposed by the RDTSA report is, in case of failure, the repetition of a new PSGhome (type II ASDA), and then, for a minority of cases, of a PSGhosp. This solution is likely to be costly.
The « portfolio sleep physician » must be able to access the raw signal regardless of the particular brand of polygraph used. This is the only way to judge the quality of the recording and to reject any recording that is defective.
This remark also concerns the systems’ ability to detect important elements of the diagnosis. These elements are recognized as imperative by the 3rd edition of the International Classification (2014): « Are countable as obstructive accidents apneas, obstructive hypopneas, RERA, per hour of sleep. » The potential risks of systematic errors are numerous and increase with even partially automated analyses.
2. The question of the cost of a PSGhome.
The billing of a PSGhosp is today insufficient, in particular since an arbitrary levy carried out in the nineties, for the reimbursement of liaison psychiatry. The price charged for this examination is almost a third of the real value of the investment it requires, both in terms of equipment and personnel. Until now, the financing of this examination was in a way « covered by the Convention ».
However, this has the perverse effect of favoring sleep explorations when they are limited to the diagnosis of sleep apnea, while many other diagnoses for other sleep pathologies, sometimes concomitant risk being overlooked.
The cost of the PSGhosp should be revalued. As for the PSGhome (type II ASDA), it would not be surprising if its cost were even higher, since there are also expenses for the travel of personnel over variable distances, even in Belgium, insurance costs, data transfer and security, etc.
3. On the specific problem of polysomnography subcontracted by the Service Companies.
This orientation leads to a conflict of financial interest because the Service Companies, which are driven by a concern for community service and by the search for profits, cover under their umbrella both diagnostic devices (polygraphs, screening devices) and treatment devices (nCPAP and OAM). This is not a question of intention, but a statement that has been made many times before. Only the « portfolio sleep specialists » can represent a barrier to this drift. They represent an independent third party between Service Companies on the one hand and patients associated with their general practitioner on the other hand.
4. On the role of general practitioners.
The great diversity of the care provided by the general practitioners, their relative isolation in their relationship with the Service Companies, rather peripheral for them, as the monitoring of the quality of the treatment will essentially be the monopoly of the Service Companies. These companies will, condemn them to accept all their recommendations, even if the INAMI/RIZIV rules will try to limit the drifts of this situation. As for the « portfolio sleep specialists », who will be attached to the « industrial » protocols of the PSGhome provided by the Service Companies, they will be forced to make decisions based on very limited, impersonal knowledge of the patients. The RDTSA report will not be able to rule out the use of formatted histories and structured questionnaires, which are currently rejected by scientific articles publications because they only provide insufficient sensitivity and specificity for the decisions to carry out (and even to read) PSGhome (type II ASDA).
5. On the follow-up of nCPAP and OAM treatments.
It is important to keep in mind the very notion of OSA, a long-term disease, very dependent on lifestyles and likely to contribute to the development of a considerable number of co-morbidities: degenerative diseases of the cardiovascular systems, degenerative endocrine diseases (diabetes), degenerative rheumatic diseases (fibromyalgia), neurological diseases (Alzheimer’s dementia…), psychiatric diseases (severe depression…) Of course, the general practitioner, duly trained, can recognize such links better than anyone else, but the portfolio sleep specialist, to which should be added the ENT doctor, the dentist and the orthodontist, if necessary, from a systematic consultation of the treated patients, can also recognize in a very sharp way, all the causes of alteration of the long-term treatments.
For nCPAP, the publication of Professor Bertien Buysse, from the KUL, is largely indicative of the fact that compliance with the follow-up defined by the RIZIV/INAMI is significantly higher in Belgium than in countries where such regulations do not apply.
It can be stated that the portfolio sleep specialist is a creation of the RIZIV/INAMI, for long term follow-ups, with the consequence that even incidental decisions, at first sight, on the renewal of devices (nCPAP and OAM), on the types of masks (oral, nasal-oral, nostrils) or on the humidifiers or on the types of orthesis, are never made lightly but on the basis of widely shared experiences, and not according to the cost price of the material. This aspect of things, for the health of patients, for their compliance through their particular biographies, for the optimization of costs, is in opposition to an economy strictly limited by profit. This very notion risks falling under the radar of the RIZIV, because the regulation cannot deal with such micro-decisions in the field. This is already the case with the current convention.
It seems absurd to limit the interest of RIZIV/INAMI’s portfolio of specialists to six months, thus stating that the patient with OSA beyond six months must first of all turn to a Service Company and, if necessary, to an otherwise overburdened general practitioner.
6. On the evolution of nCPAP monitoring technologies and potential equivalent developments for OAM adherence.
Contrary to the position of NAMI/RIZIV RDTSA document, these technologies bring great value to the work of « portfolio sleep physicians ». Indeed, the possibilities of monitoring by telemetry can be gathered in a specialized medical point like the Sleep Medicine Centers. This is a considerable help in detecting adherence breakdowns or long-term failures. These events provide a much more rational basis for timely reaction than annual medical visits, within the framework of the present Convention 2.
These background remarks allow us to address the points in the report that we consider questionable because they are detrimental, in particular, to the objectives of the INAMI/RIZIV.
A. Diagnosis of Obstructive Sleep Apnea and Hypopnea Syndrome (OSA).
The « portfolio sleep specialist », assisted by the general practitioner, based on polysomnography performed competitively (hospital versus home) should receive an adequate increase in remuneration (x3 for PSGhosp) and at least (x4 for PSGhome).
B. PSGhosp versus PSGhome.
Why not consider, with a sufficiently restricted hospital tariff, an accreditation as a « night hospital », similar to the already existing « day hospital »?
C. Strengthen the relationship between general practitioners and specialists.
It would be desirable for the RIZIV/INAMI to introduce an RIZIV/INAMI « portfolio » sleep specialist title for general practitioners, implying proof of adequate training.
D. Long-term follow-up of Obstructive Sleep Apnea and Hypopnea Syndrome (OSA).
This follow-up should be ensured by the « portfolio sleep specialists », with decreasing remuneration according to the time since a patient has been treated by nCPAP or OAM, probably also revisable according to the whole number of patients treated in the whole country.
E. Exclusion of the Service Companies from any patient management mission.
The Service Companies must, however, as in the past, maintain their mission of assisting physicians in the provision of high performance technologies for diagnosis and treatment, while maintaining their legitimate objective of financial profit in a context of healthy competition.
F. Investments and global services realized in the Sleep Medicine Centers.
Over the years, for at least thirty years since the introduction of an INAMI/RIZIV convention for the treatment of patients with OSA in Belgium, many hospitals in the country have invested in beds and rooms fitted out for sleep: isolated rooms respecting privacy, without additional cost; environments free of noise pollution, inopportune lights, magnetic fields interfering with recording systems, sophisticated technical means for polysomnography and above all specialized personnel for the follow-up of patients with OSA. This staff has undergone specific training, in the hospital, in national and international teaching frameworks. These means have benefited, but still insufficiently, to the diagnosis and treatment of other sleep pathologies (chronic insomnia, drug abuses, narcolepsy, parasomnia, circadian disorders, etc.). The situation in this area should not be left to chance by abandoning or greatly reducing the follow-up of OSA. On the contrary, this follow-up has to be strengthened by a rationalization of the follow-up reports.
A clear improvement of the Sleep Medicine Centers should result from a regular inventory of all sleep disorders. This would be a guarantee for the investment in health for all sleep pathologies.
On the other hand, a rationalization, for example in the form of annual reports more in line with the current technical data available (e.g., telemetric monitoring of nCPAPs) and with what is suggested in the RDTSA note, page 24 and 25. These reports would accurately reflect the benefits and expenditures recorded (« as is done within INAMI/RIZIV, for most sectors »). Interventions for long-term follow-up of OSAs would be guided by telemetric observations.
G. Evaluation of the particular services of the Sleep Medicine Centers.
Some expenses are commonly performed by these centers, but never billed to the INAMI/RIZIV, because they are not included in the current nomenclature, even though they correspond to good clinical practice: MSLTs (daytime Iterative Napping Test), CSF hypocretin assays, either required for reimbursements for Oxybate or Pitolisant treatment (narcolepsy), actimetries (for circadian sleep disorders or hypersomnias); MWTs, or aptitude or performance tests, required for driver’s license.
The RIZIV/INAMI would thus introduce a more adequate measure of the impacts of these sleep medicine centers.
H. Strengthening the role of the general practitioner.
This reinforcement of the links is expected and desired by the « portfolio sleep specialists », but there is no question of keeping these colleagues in ignorance of the field of sleep medicine. Contrary to an assertion repeated in the RDTSA report, neither the history (anamnesis) nor the questionnaires (which ones?) make it possible to establish a diagnosis of OSA with sufficient sensitivity and especially specificity. The clinical examination can be convincing when the patient is asleep, during a nap. Apart from this rather rare situation, the level of certainty of the general practitioner can be supported on the basis of a true screening test that he/she can easily master with a « four channel, type III ASDA » recorder, provided that a measurement of the periodic movements of the limbs is added, because there is progress since the 1994 classification. These periodic movements of the limbs regularly give rise to an element of confusion with the diagnosis of sleep apnea. The detection of periodic movements of the limbs can also help in the complete treatment when they accompany OSA (with or without restless legs syndrome) may provide a valuable aid for the treatment of OSA itself. This type of device is no more complex than an ECG. The “portfolio sleep specialist” could help them in the choice of the material, they who had to start their own screening poorly by home recordings of oximeter or cardiac Holter…
Nota bene :
Many of the statements and figures put forward in the report seem to us open to challenge:
Anamnesis-signals, screening questionnaire, clinical examination as means of suspecting obstructive sleep apnea and hypopnea syndrome (OSA).
What are the signals: Fatigue? Excessive daytime sleepiness? High blood pressure? Obesity ? Diabetes ? Retrognathia ? Mouth breathing?
What questionnaires are we talking about? The STOP-BANG? The Berlin questionnaire? These are complex questionnaires, of delicate use or only useful in certain environments (pre-operation, anesthesia). What are the specificity and sensitivity values of these questionnaires: rather low.
90% of recordings at home, for « simple » cases versus 10% for recordings in hospital, i.e. for « complicated » cases of morbidity. But which ones?
General practitioner plus pediatrician up to 16 or 18 years of age? General practitioner alone, beyond that? Why does the GP have to be accompanied by a paediatrician when he can make this decision alone in adults?
How to count apneas under 16 years old? 5 seconds, 10 seconds, what is the number of apneas per hour?
The objective of the RIZIV/INAMI to raise the percentage of OAM to 25% of the total treatments is curious. What will happen if this objective is not reached? What about the medical indication of treatment?
Unnecessary multidisciplinary consultations?
In reality, they already take place and are not part of the RIZIV/INAMI remuneration. They allow, among other things, to judge the interest of alternative treatments, by maxillo-mandibular surgery, by physiotherapy, speech therapy etc.
What is the value of self-titration by autoPPCn. How long ?
1 This reflection by SleepOnline Schelde Maas Moselle is inspired by 1) reading of the discussion note on the Reform of the Diagnosis and Treatment of Sleep Apnea (RDTSA), 2) discussions that took place on 3 occasions within the Board of our Association, 3) results of a survey on the treatment of OSA, its screening and reimbursement methods, among the affiliated Sleep Medicine Centers, 4) the KCE 330 report, 5) the reading of the National Medical-Mutual Agreement 2022-2023 (in particular 2. 4.2.2. page 6 and 3.2.2. page 10.
2 This monitoring does not rely on sophisticated technology, apart from telemetry itself. It involves the insertion of a pneumotachograph or equivalent, together with an electronic reader and transmitter, on the circuit of the device. All this could be standardized, at the national level and independent of the industry, with a minimal investment by the RIZIV/INAMI, which would thus have privileged access to these data. The same reasoning could be applied to OAM.