Organ of the
GD Society for Dermopharmacy
GKV-Modernisierungsgesetz (GMG) (GKV-Modernization Act)
Consequences on prices and refundabilty of dermatics
Joachim Kresken, Viersen
The "Gesetz zur Modernisierung der gesetzlichen Krankenversicherung" (Act for the Modernization of the Legal Health Insurance ), in brief "GKV-Modernisierungsgesetz (GMG)" (GKV-Modernization Act), includes 472 pages and became effective on 1 January 2004. According to the intention of the Bundesministerium für Gesundheit und Soziale Sicherung (BMGS) (Federal Ministry for Health and Social Security) it is to bring about a higher degree of co-determination for patients, increased quality in health care as well as improved efficiency and competition. A series of measures have been introduced in the pharmaceutical sector by implementing this act which are to lead to a reduction of expenses for medicinal products of the GKV without a loss of quality. These measures include a reorganization of the pricing for prescription drugs as well as the discontinuation of the fundability for non-prescription products.
Till the taking effect of the GMG, the price formation for prescription and ethical drugs was effected according to a standardized procedure: Pharmaceutical wholesalers and pharmacies raised in general proportional charges on the sales price of the producer. The extent of the charges resulted from the degressively graded Arzneimittelpreisverordnung (AmPreisV) (Price Regulation for Pharmaceuticals). According to this regulation, the gross profit at both trade levels was exclusively depending on the price of the drug and did not consider the consulting service rendered by the pharmacy when dispensing the drug.
New Price Formation With Prescription Drugs
With coming into force of the GMG, the AMPreisV (AMPriceV) for prescription drugs has been subject to fundamental modification. At the level of the pharmaceutical wholesale trade, the proportional extra charge on the producers' sales price has been approximately halved. Thus the average margin of the wholesale trade on prescription drugs amounts at present only to 6,5 percent. According to information by the Bundesverband des pharmazeutischen Großhandels, PHAGRO (Federal Association of the Pharmaceutical Wholesale Trade) this shortened margin does no longer concede any range for reductions as they had been previously accorded to pharmacists. The legislator has thus implemented his manifested objective to eliminate reductions formerly usual in the system of the sale of pharmaceuticals in favor of the GKV.
At present the pharmacy adds an extra charge of generally only three percent to the reduced wholesale sales price - compared with 30 to 68 percent - as well as a fixed charge of 8,10 Euro and the sales tax. The latter is still at 16 percent and has not been reduced to half of the turnover tax rate - as often requested in the preliminary stages of the GMG adoption. By means of the fixed supplement introduced, the consulting service of the pharmacy when dispensing pharmaceuticals is to be compensated which had not been taken into account in the earlier price formation system.
This reorganization of the pharmacy supplement - also known under the name of 'combi-model - applies to all prescription ready-to-use drugs - no matter whether they have been prescribed to the debit of a compulsory health insurance fund, a different cost unit or privately. The pharmacy has granted the compulsory health insurances a reduction of two Euro on the calculated final price of the pharmaceutical. Ethical ready-to-use drugs which are not subject to an obligatory prescription as well as all formulated drugs are exempted from the 'combi-model'.
However, these prices are not calculated following the new 'combi-model' for prescription drugs, but further on according to the old AMPreisV (AMPriceV) as described above. As far as no price change has been effected on the part of the manufacturer by 1 January 2004, the GKV-invoice prices are therefore identical to the prices binding until 31 December 2003. In accordance to survey results, the majority of the pharmacies will continue charging these prices to self-pay patients und private patients.
TTable 1: Pharmacy Sales Prices of Different Prescription Dermatics
(selection; price quotations as to Lauer-Taxe (Lauer-charge)
Consequences of New Price Formation
With the introduction of the 'combi-model' the prices of all prescription ready-to-use drugs have changed with the effective date 1 January 2004. Expensive pharmaceuticals whose pharmacy sales prices were above 29 Euro until 31 December 2003, have become up to several hundred Euros less expensive through the reorganization. Contrariwise products the prices of which were previously in the one-digit scope raised by several hundred percent. Conditional on the fixed supplement of 8,10 Euro, pharmacy sales prices of below ten Euro are virtually no longer feasible. When considering the prices of different dermatics as example this connection becomes clear (table 1).
This situation signifies for the practicing physician that his former prescription mean will change without any influence on his part. Whereas for example the prescription mean of internal specialists and oncologists who prescribe numerous expensive prescription drugs will decrease, most dermatologists without being able to make them responsible will probably determine a considerable increase of their prescription mean.
As concerns pharmacies, the impression may arise at cursory consideration of the overall correlation that they are among the winners of the GMG in view of the - at times - several hundred percent increase in sales prices for so far very low-priced generics. However, if one offsets these price increases induced by the legislator with the regression of the gross profit of the expensive pharmaceuticals and the discontinuation of the previous wholesale discount, the reorganization will in all likelihood lead to noticeable losses in income for most pharmacies.
Limitations of Refundability
In connection with the coming into force of the GMG, also a legal and health politic questionable connection of prescription obligation and refundability has been introduced. In principle, non-prescription pharmaceuticals are now - independent from their therapeutic effect - no longer reimbursable by the compulsory health insurance funds. Exceptions from this rule only apply to prescriptions for children till the completed age of 12, adolescents with development disorders till the completed age of 18 years as well as the treatment of severe diseases for which non-prescription pharmaceuticals are considered to be the therapy standard.
Table 2: Price Comparison Between a Formulated and an Industrially Produced Ten-percent Urea Cream (example)
Which definite diseases will be counted among the last-mentioned exception is not known so far. The recently formed, so-called "Gemeinsame Bundesausschuss" (Joint Federal Committee) to which as a whole 21 representatives of physicians and health insurances belong will present an appropriate list until 31 March 2004. However, according to the present evaluation of the situation it cannot be expected that this list will comprise dermatological diseases. This is why at the present time it has to be emanated from the fact that non-prescription dermatics may definitely be no longer prescribed to the debit of the GKV starting 1 April 2004.
Further Prescribing of
The question poses to the practicing dermatologist on how to react on the abolition of the refundability of non-prescription pharmaceuticals. As to the specialized journal DERMAforum reports (issue 12/2003) - in the view of the BMGS - every contractual physician is further on obliged to prescribe in principle appropriately, sufficiently and economically.
This means that also non-prescription pharmaceuticals are to be further applied in case they are medicinally necessary, appropriate and sufficient for the treatment of a skin disease. A medicinally not justifiable switching to a more expensive prescription pharmaceutical by the physician can be interpreted as offence against the precept of an economical prescription and taken up in the frame of cost effectiveness analyses.
Against this background it is recommended to continue prescribing non-prescription pharmaceuticals in the future, not to perform however, the prescription on a panel prescription but on a different prescription form. For this purpose the so-called "green prescription" is suited. Such a prescription form which is similarly composed as the pink form of the panel prescription has for example been established by the Apothekerverband Nordrhein (Pharmacist Association North Rhine) in coordination with the KV Nordrhein (KV North Rhine) (Figure).
When making use of this prescription form, the physician signalizes the patient that he considers the prescription in question as medically necessary and would have performed it on a panel prescription before coming into force of the GMG. The patient will accept this way of proceedings by the physician in particular if the price of the preparation prescribed is in the range of five to ten Euro and thus at the level of the new legal extra payment for prescription pharmaceuticals.
Effects on the Dermatological Prescription
The same rules apply to prescription drugs concerning their refundability by the compulsory health insurance funds as for ready-to-use drugs. This means that as of 1 April 2004 at the latest - apart from the exceptions described above - only prescription drugs may be prescribed to the debit of the GKV. Prescriptions which are not available on prescription only but medicinally indicated should therefore in the future as comparable ready-to-use drugs no longer be prescribed on panel prescription but preferably on the green prescription form as explained above.
A prescription is always then available on prescription only if it contains at least one prescription substance. A current register of all prescriptive substances is contained in the annex of the decree concerning prescription drugs (last amendment on 23 June 2003). This register can be consulted if required in the corpus juris available in each pharmacy. Among the substances which are relatively often applied in dermatological prescriptions the following ones are not subject to the prescription obligation at topical application:
Ammonium bitumino sulfonate
Hydrocortisone and hydrocortisone acetate are exempted for topical use at adults and children until the completed sixth year in concentrations of up to 0,25 percent and in packaging sizes of up to 50 grams from the prescription obligation.
The pricing of dermatological prescriptions is further on effected according to the old AMPreisV (AMPriceV). Nevertheless the prices of all dermatological prescriptions have increased by 2,24 Euro starting 1 January 2004 as at the same time of the amendment of the AMPreisV the labor prices for the preparation of products for external application have been increased to presently five Euro. As the example in table 2 shows, the price advantages frequently asserted in the field of non-prescription dermatics which often serve as argument for cost effectiveness in comparison to comparable ready-to-use drugs have decreased respectively are no longer existent.
Dr. Joachim Kresken
Tönisvorster Straße 27
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