298/2011 Sb.



LAW



of 6 May 1999. September 2011



amending Act No. 48/1997 Coll., on public health insurance, and

amending and supplementing certain related laws, as amended

regulations, and other related laws



Parliament has passed the following Act of the United States:



PART THE FIRST



Amendment of the Act on public health insurance



Article. (I)



Act No. 48/1997 Coll., on public health insurance and amending and

certain related laws, as amended by Act No. 242/1997

Coll., Act No. 2/1998 Coll., Act No. 125/1998 Coll., Act No. 225/1999

Coll., Act No. 363/1999 Coll., Act No. 18/2000 Coll., Act No. 132/2000

Coll., Act No. 155/2000 Coll., Constitutional Court, declared under no.

167/2000 Coll., Act No. 220/2000 Coll., Act No. 258/2000 Coll., Act No.

458/2000 Coll., Act No. 176/2002 Coll., Act No. 198/2002 Coll., Act No.

285/2002 Coll., Act No. 309/2002 Coll., Act No. 320/2002 Coll., Act No.

222/2003 Coll., Act No. 274/2003 Coll., Act No. 361/2003 Coll., Act No.

424/2003 Coll., Act No. 422/2003 Coll., Act No. 461/2003 Coll., Act No.

85/2004 Coll., Act No. 359/2004 Coll., Act No. 422/2004 Coll., Act No.

436/2004 Coll., Act No. 435/2004 Coll., Act No. 127/2005 Coll., Act No.

168/2005 Coll., Act No. 251/2005 Coll., Act No. 350/2005 Coll., Act No.

361/2005 Coll., Act No. 47/2006 Coll., Act No. 109/2006 Coll., Act No.

112/2006 Coll., Act No. 115/2006 Coll., Act No. 165/2006 Coll., Act No.

189/2006 Coll., Act No. 216/2006 Coll., Act No. 248/2006 Coll., Act No.

264/2006 Coll., Act No. 340/2006 Coll., Constitutional Court,

the declared under no. 57//2007 Coll., Act No. 181/2007 Coll., Act No.

261/2007 Coll., Act No. 296/2007 Coll., Act No. 129/2008 Coll., Act No.

137/2008 Coll., Act No. 270/2008 Coll., Act No. 274/2008 Coll., Act No.

306/2008 Coll., Act No. 59/2009 Coll., Act No. 158/2009 Coll., Act No.

228/2009 Coll., Act No. 281/2009 Coll. and Act No. 362/2009 Coll., is amended

as follows:



1. In paragraph 5 (b). and point 7), the following point 8 is added:



"8. Member of the District Election Commission at the elections to the Parliament of the Czech

States, the European Parliament and local Council elections

bodies ".



2. In article 7 (2). 1 letter h) is added:



"h) occupants of service in the armed forces, with the exception of

occupations, and persons called to military exercises. "



3. Footnote 13 is repealed, including links to a comment

below the line.



4. In article 11 (1) 1 (b). and) the words "to the 1. day of the calendar quarter "

replaced by the words "towards 1. January of the following calendar year; the application form

is the insured person or his legal representative shall be obliged to submit the selected

health insurance company no later than 6 months before the requested date changes.

Application to change the health insurance company to 1. January of the calendar year

You can submit only one; any other applications will no longer be taken into account

and even if they are submitted within the time limit "and the words" in a sentence

the second or third "are replaced by the words" this provision ".



5. In article 11 (1) 1, the following point (e)) the following new subparagraph (f)), which read as follows:



"(f)) to choose the variant of the provision of health care pursuant to section 13,".



Subparagraph (f))) to (i) shall become points (g) to (j))).



6. In article 11, the dot at the end of paragraph 1 is replaced by a comma and the following

the letter k), which read as follows:



"to) on time, and the local availability of health care by

health insurance provided by health establishments

competent health insurance company. ".



7. In article 11 (1) 3 the fifth sentence, the words "in the basic and alternative service" and

the words "Basic or alternative service or" shall be deleted.



8. In section 11 (1) 3 the seventh sentence, the words "the basic alternative service

or ' are deleted.



9. In article 11, paragraph 3, the following paragraph 4 is added:



"(4) in the case of a merger by acquisition, the military health insurance with another

health insurance company under special legislation ^ 28) at which

Military health insurance expires, rights and obligations

established by this Act of military health insurance company, as well as

obligations laid down in the Ministry of defence and others to the military

health insurance company, to the acquiring health insurance. The information about the

the merger of merger of Military health insurance with another health

the insurance company, in which the Military health insurance lapse, publish

The Ministry of health in a way allowing remote access. ".



The current paragraph 4 shall become paragraph 5.



10. In section 11 (1) 5, the words "performing civilian service people"

shall be deleted.



11. In paragraph 12, at the end of the letter m), the period is replaced by a comma and the following

the letter n) are added:



"n) to pay the medical facility, or another entity, that

provide health care to an insured, the difference between the price provided by

health care and the amount of reimbursement from health insurance pursuant to section 13. ".



12. in section 13 paragraph 1 reads:



"(1) from the health insurance covers healthcare provided

insured persons in order to improve or maintain his health or

to relieve his suffering, if



and the State of health of the insured person) matches and the purpose of which is to be the

by providing and is reasonably safe for insured persons,



(b)) is in line with the current available knowledge of medical science,



(c)), there is evidence of its effectiveness for the purpose of its

provision. ".



13. in paragraph 13, the following paragraphs 4 to 9, including the footnotes

# 49:



"(4) if the health care referred to in paragraph 1 to provide more than

in one way, with all these ways to comply with the conditions

laid down in paragraph 1 and have the same therapeutic effect, shall be borne by the

that kind of health care that is consistent with the purpose and

economical spending of resources public health insurance (hereinafter

"the basic variant"). Other forms of health care according to the sentence

First, that do not meet the condition of making efficient and economic spending

resources for public health insurance (hereinafter referred to as "economically more demanding

Variant of '), are paid by the health insurance in amounts laid down for

payment of such healthcare in the basic variant.



(5) in economically more demanding variant of health care can be considered

only health care, which is marked as such in the implementation

the regulations issued under section 17. Economically more demanding variant cannot be

mark the health care that can be provided in only one way.



(6) prior to the provision of health care that can be provided both in the

the basic variant, and in economically more demanding variant, is

medical equipment required to offer insured health

care in the basic variant, and inform him of the economically more demanding

Variant, including the difference between the price economically more challenging variants

determined in accordance with price regulation and listed in the price list.

medical equipment, and the amount of reimbursement of health care in the base

Variant laid down the implementing regulation issued pursuant to § 17 and

price regulation ^ 49). Procedure referred to in the first sentence shall not apply if it is not

possible due to the health of the sick person to ask his consent and

as for the urgent operations needed to save a life or health. Price list

economically more demanding variant of health care must be published in the

medical facility in public accessible place and in the manner

allowing remote access.



(7) the Medical device is in the cases referred to in paragraph 6 required

the medical records of the insured person notice that he was offered

the provision of health care in the basic variant, and that he was informed of the

How to provide health care, even in economically challenging

Variant. Part of the record in the medical documentation is saying

the consent of the insured person with the provision of healthcare in the basic variant,

or with the provision of healthcare in economically more demanding variant,

If the insured person for such a Variant; in this case, is

part of the record in the medical documentation also consent

of the insured person to pay the amount equal to the difference between the price of the economically

more demanding and the amount of payment variants of healthcare in the base Variant.

Following the authorization given by the treating physician and signed by the insured person; If

the insured person with respect to his medical condition, cannot sign the record

shall signify its unequivocal expression of will by the attending physician and

Another witness. The record shall indicate the way in which the insured person is your will

He showed, and for health reasons preventing the signature of the insured person.



(8) medical device may not in the provision of health care

favour of the insured person, chosen by the economically more demanding

Variant.



(9) For repeated violation of the obligations referred to in paragraphs 6 to 8 of the relevant

health insurance medical facility saves the fine to 1 0000 0000

CZK. When determining the amount of the fine, taking into account the gravity of the infringement

obligations, in particular to the method of a criminal offence and its consequences and to

circumstances in which it was committed. A fine may be imposed within 1 year from


the date on which the relevant health insurance company has found a breach of duty,

but within 3 years from the date on which the infringement occurred. Fine

a health insurance company, which it imposed. A recurring grant

the fine is the reason for the termination of the contract for the provision and payment of medical

care without giving notice pursuant to § 17 para. 3. Health care

device for the breach of the obligation is not liable if he proves that

made all efforts possible to require that the infringement of the

the obligation to prevent.



49) § 2a para. 1 of law No 266/1991 Coll., on the scope of the authorities of the United

States in the field of prices, as amended. section 10 of Act No.

526/1990 Coll., as amended. ".



14. in article 15, paragraph 2. 4 introductory part of the provision, the word "paid"

the words "in the implementation of the least economically challenging."



15. in article 15, paragraph 2. 5 the first sentence, the words "containing the active substances from the

groups of active substances referred to in annex No. 2 "shall be deleted, in the third sentence of

the words "and blood preparations" shall be replaced by "blood transfusion

preparations for advanced therapy medicinal products, and tissue and cells "and in the

the last sentence, the words "and blood preparations" shall be replaced by ",

blood products, medical devices, medicinal products for

advanced therapy medicinal products, and tissue and cells ".



16. in article 15, paragraph 2. 6 (a). e), the words "or other generic under section 39b

paragraph. 4 the holder of the registration and shall in writing during the proceedings "

replaced by the words "a similar product under section 39b of paragraph 1. 4 in the reference

the group, which was registered under the law on pharmaceuticals as a biological

medicinal product or a generic medicine, and the holder of the registration in writing along

with the request ".



17. in article 15, paragraph 2. 6 at the end of paragraph (e) is replaced by a comma and dot)

the following point (f)), which read as follows:



"(f)) which the price for the final consumer, in the case of payment of the

health insurance was less than or equal to $ 50. ".



18. in article 15, paragraph 2. 6 is the final part of the provisions repealed.



19. in article 15, paragraph 6, the following new paragraphs 7 and 8 shall be added:



"(7) Therapeutic effect is the ability to induce desirable

the effect of using the medicinal product or foods for special

medical purposes in normal clinical practice. Efficient

therapeutic intervention means healthcare provided to the

prevention or treatment of diseases in order to achieve the most effective and

the safest treatment while maintaining cost effectiveness.



(8) Cost effectiveness means the determination of the ratio between the cost and the

the benefits associated with the use of the medicinal product or food for

Special medical purposes, compared with the use of another of the medicinal

medicine, foods for special medical purposes or treatment

the procedure; cost effectiveness is evaluated in comparison with such

therapeutic procedure borne out of the health insurance funds,

that is generally accepted as usual. Cost effective are such

medical treatment at comparable costs bring the same

or a higher therapeutic effect of life extension,

improve the quality of life or to improve a substantial and measurable

the criteria of the relevant diseases, or at least comparable

therapeutic effect of mean lower total cost for the system

health insurance, or at higher costs and higher

therapeutic effect of this ratio is comparable with other therapeutic

the procedures covered by the health insurance funds. Reviews

cost effectiveness is required for medicinal products or food for

Special medical purposes that are not included in the reference group

pursuant to section 39 c of paragraph 1. 1, or for which it is proposed for prescription or

indicator limit in principle contrary to therapeutically interchangeable

medicinal products or foods for special medical purposes, or

required the determination of the next higher remuneration under section 39b of paragraph 1.

11, or for which it is required an increase in the remuneration of the medicinal product

or food for special medical purposes, as opposed to basic remuneration. ".



Paragraphs 7 to 11 shall become paragraphs 9 to 13.



20. in article 15, paragraph 2. 9 (a). a), the words "the amount of payments" shall be replaced by

"the determination, modification and revocation of remuneration".



21. in article 15, paragraph 2. 9 (a). (d)), the word "of" is replaced by "determination,

change and cancellation ".



22. in paragraph 15 of the dot at the end of paragraph 9 be replaced by a comma and the following

subparagraph (f)), which read as follows:



"(f)) the basic payment reference groups.".



23. in article 15, paragraph 10 is added:



"(10) a medicine which the reimbursement from health insurance is

by decision of the Constitution subject to the use of a specialized workplace,

health insurance company pays only medical device for

the purpose of the efficient use of such medicinal products has entered into a special

the contract. Part of such a contract must be a medicinal product and

workplace health facility. ".



24. in article 15, paragraph 10, the following paragraphs 11 and 12, which

shall be added:



"(11) the medical devices referred to in section B of annex 3 of this

the law of health insurance. Medical devices

listed in section C of annex 3 of this Act from the health

insurance paid in the amount and under the conditions laid down in this annex.



(12) medical devices not listed in paragraph 11, the health

insurance pays 75% of the cost of the medical device design

at least economically challenging, depending on the extent and severity of the

disability; the price of the least economically demanding the implementation of

medical device detects the health insurance market.

From health insurance under this paragraph shall be borne by the medical

the funds prescribed for the purpose of



and) continue in the treatment process,



(b) to support the stabilisation of health) of the insured person or the significantly

improve or eliminate its deterioration, or



(c)) to compensate or mitigate the consequences of health defects including compensation or

modification of the Anatomy or of a physiological process. ".



Paragraphs 11 to 13 shall become paragraphs 13 to 15.



25. In section 16a, paragraph 2. 1 letter d) is added:



"(d)) 30 CZK for the recipe, which was to supply the first out of the Pack

paid by the prescribed medicinal products or foods for particular

medical purposes, regardless of the number of covered by medicinal products or

foods for special medical purposes and the number of prescribed packaging ".



Footnote # 27b shall be deleted.



26. in section 16a, paragraph 2. 1 (b). (f)), the number "60" is replaced by "100".



27. in section 16a, paragraph 2. 6, the words "(§ 40 paragraph 2. 3) "is replaced by" (§ 40

paragraph. 4) ".



28. In article 16a, paragraph 9 is added:



(9) the health care facility is required to control the fee referred to in

paragraph 1 by the insured person or his legal representative to choose, if

It is not an exemption from paying regulatory charge referred to in paragraph 2 or 3.

When you detect repeated and systematic breaches of this obligation is

health insurance may save this medical facility

a fine up to Czk 1 0000 0000. A fine can be imposed repeatedly. When

storing fine health insurance takes into account the seriousness of the violation, to

the degree of fault and the circumstances in which the breach of an obligation has occurred.

A fine may be imposed within 1 year from the date on which health insurance company found

violation or infringement proceedings, but within 3 years from the date on which the

to the breach or infringement occurred. The fine is the intake of health

an insurance undertaking which it imposed. ".



29. in section 16b, para. 1, the second sentence is replaced by the phrase "to the limit by the phrase

the first includes supplements on partially reimbursable medicinal products

or food for special medical purposes, containing the same Active

the substance and the same route of administration only in the amount calculated in accordance with the supplement to the

medicine or food for special medical purposes, which

a supplement to the volume of this active substance is the lowest and

which there was no identified interruption or cessation of delivery. "and

the last is deleted.



30. In § 17 paragraph 5 is added:



"(5) the Ministry of health shall lay down by decree a list of health

performance with point values and marked variations of health care according to the

section 13. ".



31. in section 17(2). 6 sentence of the fifth, the figure ' 90 ' is replaced by ' 120 '.



32. In § 17 paragraph 2. 7 the second sentence, the words "with the exception of the establishment of

care, medicinal products containing the active substances listed in annex No. 2

This Act, for which the Institute shall decide on such method of payment "

replaced by the words "providing outpatient health care, medicinal

preparations which decides to Institute such a method of payment "and at the end of

paragraph, the following sentence "in the contract can arrange health insurance

Another method of reimbursement of medicinal products in the provision of institutional care, for

which the amount and conditions of payment, has negotiated with the holder of

the registration or with the manufacturer. ".




33. In paragraph 17, the dot at the end of paragraph 8 is replaced by a comma and the following

the letter d), which read as follows:



"(d)) of the Treaty to persons that have permission to distribute medicinal

products according to the law on pharmaceuticals, medicinal products containing vaccine

substances for regular vaccination according to the composition of vaccines antigenního

substances provided for the Ministry of health according to the law on the protection of

of public health. ".



34. In section 30 paragraph 2. 2 letter a) is added:



"and the vaccination and reimbursement) of medicinal products containing vaccine

for regular vaccination according to the composition of vaccines antigenního

established by the Ministry of health according to the law on the protection of

public health ".



Footnote No. 35 is deleted.



35. In section 30 paragraph 2. 2 (a). (b) the introductory part of the provisions): "vaccination and

reimbursement of medicinal products containing vaccine in the implementation

at least economically challenging. "



36. In paragraph 32, the following paragraphs 4 and 5 are added:



"(4) a medical facility authorized to supply medicinal products shall not in

connection with the issue of medicinal product bound to medical prescription,

paid by the public health insurance, provide, offer or

promise cash or non-cash transactions, the benefits or gifts of securities or

non-material nature, even through third parties.



(5) the determination of repeated violations of the obligations referred to in paragraph 4, the

health insurance may save this medical facility

a fine up to Czk 1 0000 0000. A fine can be imposed repeatedly. When

storing fine health insurance takes into account the seriousness of the violation, to

the degree of fault and the circumstances in which the breach of an obligation has occurred.

A fine may be imposed within 1 year from the date on which health insurance company found

violation or infringement proceedings, but within 3 years from the date on which the

to the breach or infringement occurred. The fine is the intake of health

an insurance undertaking which it imposed. ".



37. In section 39a of paragraphs 2 to 4 shall be added:



"(2) the Institute shall determine the maximum price of the manufacturer, with the exception of the procedures referred to in

paragraphs 4 to 6, at the rate of



and the average of the prices of the manufacturer) of the medicinal product under consideration, or food

for special medical purposes of the 3 Member States of the European Union, with the

the exception of the Czech Republic, Estonia, Cyprus, Luxembourg, Malta and Germany

(hereinafter referred to as "the land of the reference basket"), which have the lowest price

the medicinal product under consideration, or foods for special medical

purposes, if the medicinal product or foodstuff under consideration for special

medical purposes on the market in at least 3 countries reference basket,



(b) the manufacturer of a medicinal product prices), or foods for special medical

the purposes contained in the written agreement closed in the public interest pursuant to section

Article 17(1). 2 health insurance with the holder of the marketing authorisation

of the medicinal product, the importer or domestic manufacturer of food for

Special medical purposes, by the importer or by the promoter of the specific

the treatment program, if the arrangement is concluded for a period of at least 1 year with

at least 3 months ' notice for all supplies of medicinal

medicine or food for special medical purposes on the Czech market

Republic, and if you cannot do this under (a)),



(c)) the producer price of the nearest therapeutically correspond to those of the medicinal

medicine or food for special medical purposes identified in countries

the reference basket or in the Czech Republic, if you can not follow the

letters and) and (b)). If the nearest therapeutically comparable pharmaceutical

product or foodstuff for special medical purposes available in Czech

Republic, then applies its lowest cost manufacturer established in the United

Republic; If in such therapeutically correspond to those of the medicinal

medicine or food for special medical purposes, the holder of the

the decision on the registration of identical to that of the medicinal product under consideration

or foods for special medical purposes, this price shall apply,

If it was established pursuant to subparagraph (a)). If you cannot do this

in a way, it is the lowest price the manufacturer identified in countries

the reference basket. When selecting the nearest therapeutically correspond

medicinal product or foods for special medical purposes

the criteria taken into account in the following order: the active substance,

pharmaceutical form, strength of the medicinal product, the size of the package.



(3) the Ministry of health shall lay down the implementing regulation



and rules for the selection) the vesting period for the conversion of foreign prices from

foreign currency,



(b)) the vesting period and the rules for price and manufacturer for

the assessment of the availability of the medicinal product or foods for special

medical purposes,



(c) maximum above) how the price of a similar product by

paragraphs 4 to 6,



d) rules to exclude foreign producer price levels identified pursuant to

paragraph 2 of the application for the fixing of maximum prices



e) tolerance in the size of the Pack in search of foreign prices

the manufacturer referred to in paragraph 2,



(f) increase the maximum) the prices in the public interest pursuant to section 17

paragraph. 2,



(g) the method of determining the maximum prices) for highly innovative medicinal

products for which the application is made on the fixing of maximum prices in the

the same amount for all strengths of the medicinal product, regardless of the content of the

the active substances,



h) rules relating to notification of the highest price at which the holder intends to

the marketing authorisation for the medicinal product, the importer or the domestic

manufacturer of foods for special medical purposes or an unauthorised

the medicinal product is used in the context of a specific treatment program

indicate a medicine or food for special medical purposes

the market for medicinal products or foods for special medical purposes,

not subject to the control of the producer price fixing maximum prices.



(4) the Institute shall determine the maximum price of a similar product as the maximum

the price of the medicinal product, which is the medicinal product under consideration

similar to, in the case that



and the determination is not required) maximum price in excess of the maximum prices

a medicinal product which is similar to that of the medicinal product under consideration

accordance with the application under section 39f of paragraph 1. 8,



(b) the applicant in the request for) the fixing of maximum prices for similar product

ask for the maximum price in the proceedings under section 39 g of paragraph 1. 9, and



(c) the remuneration does not prevent conditions) pursuant to § 15 para. 6 (a). e) or section

39 g of paragraph 1. 10. ".



38. In paragraph 39a is inserted after paragraph 4 paragraphs 5 to 7, which

shall be added:



"(5) the Institute shall calculate the maximum price of a similar product in the first

the reference group referred to in paragraph 4 and that price will be reduced by



and) 15% in the case that it is a product that was according to the law on pharmaceuticals

registered as a biological medicinal product, when it is in

the system of payments from health insurance (hereinafter referred to as "the system of payments") only

1 similar to a product which has been registered as a biological medicinal product

medicine,



(b)), 32% in the case of a product which was according to the law on pharmaceuticals

registered as a generic medicine in a situation where the system is only 1 tender

similar to a product which has not been registered as a generic medicine,



c) 15% in the case that it is a product that was not in accordance with the law on

Pharmaceuticals registered as a generic medicine, in a situation where the system of payments

only one similar to a product which has not been registered as a generic medicine.



(6) the Institute shall calculate the maximum price of a similar product in the first

the reference group, for which the conditions are not fulfilled in accordance with paragraph 4,

procedure laid down in paragraphs 2 and 5 and the maximum price shall be fixed at a level which

According to this calculation, the lowest.



(7) the maximum price of the medicinal product as provided for in accordance with paragraphs 5 and 6

You cannot increase the execution of the first following an in-depth revision pursuant to §

39 l. ".



The present paragraph 5 shall become paragraph 8.



39. In § 39a para. 8 the second sentence, the words "the prices recorded at least in 1 country

the reference basket or at the average cost of production "is replaced by

"the average of the prices of the manufacturer".



40. In section 39b para. 2 (c)):



"(c)) submitted by a party to evaluate the cost-effectiveness of and

impact on the financial resources of health insurance caused by

the use of the medicinal product or foods for special medical purposes,

the assessment of the cost of 1 and the estimated number of patients treated with

for the year, and that in those cases the setting or change of the terms and conditions of payment

or deep or shortened revision for medicinal products or food

for special medical purposes, for which the extension is requested, the conditions

payments to increase the number of patients treated, the increase of the remuneration

compared to the basic payment or other remuneration 1 increased compared to the current

State or over other medicines or food for

Special medical purposes in the reference group, ".



41. In section 39b, paragraph 4 reads:



"(4) a similar product for the purposes of this Act, a medicinal

a product that has the same active substance or active substances and the same

or similar pharmaceutical form of the medicinal product with borne, which is


in principle, therapeutically interchangeable. Additionally, similar with means

a biological medicinal product which is similar to a biological substance or

biological substances and the same pharmaceutical form or similar with borne

medicinal product, which is in principle, therapeutically interchangeable.

The first similar product means a similar product for

that is the request for the fixing of the maximum price or amount and conditions

payment of the first in the order. ".



42. In section 39b are inserted after paragraph 4, a new paragraph 5 to 9, which

shall be added:



"(5) the Institute shall determine the amount of payment under consideration of a similar product by

the amount and conditions of payment of the medicinal product, which is a medicinal product under consideration

the preparation is similar to, in the case that



and is not required to determine the amount) and the conditions of payment beyond the amount and

the terms of payment of the medicinal product, which is a medicinal product under consideration

the preparation is similar to that in accordance with section 39f of paragraph 1. 8,



(b) the applicant in the request for) fixing the amount and conditions of payment of a similar

the product requests a determination of the amount and terms of payment in the proceedings under section

39 g of paragraph 1. 9,



(c) the remuneration does not prevent conditions) pursuant to § 15 para. 6 (a). e) or section

39 g of paragraph 1. 10 and



(d) whether or not the request is made) on the fixing of maximum prices pursuant to § 39a para. 4

or 5, if the medicinal product or foodstuff for special medical

purposes shall be subject to price regulation.



(6) the Institute calculates the amount to be paid for a similar product in the first reference

the group referred to in paragraph 5 and this payment will decrease in the manner prescribed in

§ 39a para. 5.



(7) in the event that the first similar product in the reference group

does not meet the conditions referred to in paragraph 5, the Institute calculates the amount of payment

pursuant to section 39 c of paragraph 1. 8 and this further reduces the remuneration referred to in paragraph 6.



(8) the Department with legal force of the decision determining the amount and terms and conditions

the remuneration referred to in paragraph 6 or 7 shall forthwith initiate the procedure pursuant to § 39 c

paragraph. 9.



(9) to change the decision on the registration or transfer of registration of medicinal product

the medicine has no effect on a fixed maximum price or amount and conditions

payment of an authorised medicinal product if the change registration

or transfer the registration not to change, which can have a direct impact

the maximum price or the amount of, or conditions for reimbursement ".



Paragraphs 5 to 7 shall be renumbered as paragraphs 10 to 12.



43. In section 39b are inserted after paragraph 11 paragraph 12 and 13 of that

shall be added:



"(12) the amount of the reimbursement of medicinal products consisting of two or more medicinal

substances for which there is more than 1 active substance separately remunerated,

provides for the



and the sum of the payments for the usual) daily therapeutic dose of relevant

separately payable by active substances laid down pursuant to § 39 c of paragraph 1. 7,



(b)) of the highest producer price contained in the written agreement referred to in section

39A para. 2 (a). (b)), if the latter price is lower than the remuneration is calculated

According to subparagraph (a)),



(c) the amount of payment) contained in the written agreement under section 39 c of paragraph 1. 2

(a). (d)), if the payment is lower than the remuneration, calculated in accordance with subparagraphs

a) and (b)).



(13) the amount of the reimbursement of medicinal products consisting of two or more medicinal

substances for which there is only 1 active substance separately paid, shall be adopted



and as for the usual remittance) daily therapeutic dose of the appropriate

separately paid for active substances laid down pursuant to § 39 c of paragraph 1. 7,



(b)) of the highest producer price contained in the written agreement referred to in section

39A para. 2 (a). (b)), if the latter price is lower than the remuneration is calculated

According to subparagraph (a)),



(c) the amount of payment) contained in the written agreement under section 39 c of paragraph 1. 2

(a). (d)), if the payment is lower than the remuneration, calculated in accordance with subparagraphs

a) and (b)). ".



The former paragraph 12 shall become paragraph 14.



44. In section 39b, paragraph 14:



"(2) the Ministry of health shall lay down the implementing regulation



and) the rules and limits for increase or decrease of the remuneration referred to in paragraph 2

compared to the set basic remuneration having regard to the characteristics of the period

medicinal product or foods for special medical purposes in

compared to the other, in principle, therapeutically interchangeable medicinal

products or foodstuffs for special medical purposes,



(b)) the level of remuneration of a similar method of conversion of the product in accordance with paragraphs 5 to

7,



(c)) use of the procedures under section 39b to 39i for setting or changing the amount and

conditions of reimbursement of medicinal products consisting of two or more medicinal

substances,



(d)) the procedures under section 39b to 39i for setting or changing the amount and

the conditions of payment of medicines and foods for special medical

the purpose of the non-split in the form of liquid pharmaceutical forms,



e) method of determining remuneration for a highly innovative medicinal products

where an application for the determination of the remuneration in the same amount for all

force regardless of the content of the active substance,



(f) determining the conditions) rules for payment in the form of preskripčních and

restrictions and payment methods. ".



45. In section 39 c of paragraph 1. 1 at the end of the text of the first sentence, the words ",

If during the proceedings proved that in the reference group

does not belong "and in the second sentence, the words" the basic remuneration of the medicinal product

is equal to the basic pay "shall be replaced by" payment of the medicinal product

determined based on the basic remuneration ".



46. In § 39 c paragraph 2 reads as follows:



"(2) the basic remuneration in reference groups shall be



the lowest price of the manufacturer) attributable to the daily therapeutic dose

medicinal product or foods for special medical purposes

included in the reference group, found in any country of the European

the Union for medicine or food for special medical purposes

available in the Czech Republic; a medicine or food for

Special medical purposes is available on the market in the Czech Republic means

medicine or food for special medical purposes, which

share of the total sales volume, in principle, therapeutically interchangeable

medicinal products or foods for special medical purposes,

containing the same active substance, in the period amounted to at least 3%,

If this is not the first to third a similar medicine in the healing substance in order

by the time of application for the fixing of the amount and conditions of payment, or

the medicinal product in respect of which the manufacturer or pay the highest price was

concluded a written agreement; such medicinal products shall always be deemed

available on the market in the Czech Republic,



b) daily cost other therapy reduced the margin and

applied to value added tax, if a comparably efficient and cost-

effective compared with taking the medicinal product or food for

Special medical purposes under subparagraph (a)), and these facts are the Institute of

When the basic remuneration, taking into account the necessary

length of therapy medicinal product or a foodstuff for special medical

purposes and the necessary period of comparable treatment,



(c)) the highest producer price contained in the written agreement pursuant to § 39a para.

2 (a). (b)), if the latter price is lower than the remuneration, calculated in accordance with subparagraphs

a) and b), if the holder of the marketing authorisation of the medicinal product,

the importer or domestic manufacturer of foods for special medical purposes,

the importer or the submitter of a specific treatment program did not make in the

the last 2 years the administrative offense under § 39q para. 1 (b). (b)),



(d)) the remuneration included in the written agreement closed in the public interest

all health insurance companies with the holder of the marketing authorisation

of the medicinal product, the importer or domestic manufacturer of food for

Special medical purposes, if not committed in the last 2 years

the administrative offense under § 39q para. 1 (b). (c)), if the payment of the

lower than the remuneration, calculated in accordance with subparagraphs), b) and (c)), if the arrangement

closed for at least 1 year with at least 3 months ' notice for

all supplies of medicinal products or foods for special medical

the purpose of the market of the Czech Republic, and if its part of the commitment that the medicinal

product or foodstuff for special medical purposes for

the validity of this agreement available on the market in the United States, and the price for

the final consumer of such medicine or food for

Special medical purposes does not exceed the maximum possible reimbursement for the final

consumers. ".



47. In section 39 c paragraphs 4 and 5 are added:



"(4) the provisions on reference groups on the medicinal product, or

food for special medical purposes, which cannot be classified in

reference group, or group of medicinal products or food for

Special medical purposes, in principle, therapeutically interchangeable, that

cannot be assigned to any reference groups, apply mutatis mutandis.



(5) in the event that, in the determination of remuneration under section 39b-39e was not in

some of the groups of active substances referred to in annex 2 of this Act,

regardless of the therapeutic interchangeability of at least 1 medicine

fully paid, the Department shall adjust the remittance decision so that the least expensive

medicinal product from a group of medicinal products has been fully assessed

paid. ".



48. In § 39 c paragraphs 7 and 8 are added:




"(7) the basic remuneration reference groups will be established in the framework of the deep

or abbreviated revision of payments and is valid until the following revision changes

remittances. Similarly in the determination of the next higher remuneration pursuant to §

39B para. 11.



(8) unless otherwise provided by this Act, in proceedings for the setting or change of

the amount and conditions of payment to the payment made to the changes to the base

following the revision of the system used for the establishment or modification of the level of remuneration

all, in principle, therapeutically interchangeable medicinal products and food

for special medical purposes, the amount of the basic remuneration reference group

determined in accordance with paragraph 7; This does not apply if the applicant referred to in section

39f para. 2 (a). and) or (b)) was designed, the amount and conditions for reimbursement

more cost effective. "



49. In section 39 c shall be added to paragraph 9 to 11 shall be added:



"(9) in the case that was in accordance with section 39b para. 6 or 7 set

the first payment of a similar product in the reference group, which



and according to the law) was on pharmaceuticals registered as a generic medicine,

the basic payment established pursuant to paragraph 7 of 32%,



(b)) was not according to the law on medicinal products registered as a generic medicine,

the basic payment established pursuant to paragraph 7 of 15%,



(c)) was according to the law on medicinal products registered as a biological medicinal product

the product reduces the basic remuneration referred to in paragraph 7 by 15%.



(10) the reduction of the basic remuneration referred to in paragraph 9 shall be carried out according to the procedure

laid down in § 39p.



(11) the Ministry of health shall lay down the implementing regulation



and the procedure for the calculation of the lowest) producer price referred to in paragraph 2 (a).

and)



(b) the determination of the basic details of the remuneration),



(c) the vesting period for the assessment of) the availability and price of the manufacturer

under section 39b and 39 c,



(d) the rules for the assessment of the presence) of the medicinal product, or

foods for special medical purposes on the market,



e) rules for the increase and decrease of the basic remuneration in the public interest,



f) assessment criteria of medicinal products or foods for particular

medical purposes, whose therapeutic efficacy is low, they are not

giving rise to the treatment of diseases, or are used to treat non-serious

disease,



g) the method of determining the typical daily therapeutic dose



(h) the procedure for determining the base) the remuneration referred to in paragraph 5. ".



50. in paragraph 39d paragraph. 1, the words "in 1 country" shall be replaced by "in 3 countries," and

at the end of the text of the paragraph with the words "if it is not stipulated

otherwise ".



51. In paragraph 39d paragraph 2 reads as follows:



"(2) the amount and conditions of the temporary payment is fixed at 24 months and can be

fix it again, up to a further 12 months. For such other

determination of temporary payment, you must submit the results of reviews

laid down in paragraph 3, the application must be made no later than 6

months before the expiry of the period for which was the first temporary settlement

established. The second interim payment shall be determined pursuant to § 39 c of paragraph 1. 2 to 5,

the provisions of § 39 c of paragraph 1. 8 does not apply. Between the terms of payment of the highly

the innovative product is always on a specialized workplace. ".



52. In section 39d, the following paragraphs 3 to 7 shall be inserted:



"(3) The requirements for an application for a temporary payment shall apply section 39f of paragraph 1. 1,

5 to 11. The applicant is also required to demonstrate how the

shall ensure



and the interim evaluation of the therapy under consideration) highly innovative

with,



(b) impact, offers temporary payment) on the financial resources of the health

insurance,



(c) evaluate the cost-effectiveness of),



(d)) to cover costs on the rehabilitation of a patient with highly innovative

After the expiry of the period for which temporary settlement was established, until the

transferring a patient to another therapy.



(4) in proceedings for the determination of temporary payment and in proceedings relating to the determination of the amount and

conditions of payment after the expiry of the temporary payment, section 39 c of paragraph 1. 8 does not apply, and

The Institute provides for reimbursement under section 39 c of paragraph 1. 2 to 5.



(5) in the event of a breach of the undertaking referred to in paragraph 3, the Institute will not admit

considered highly innovative product second temporary cover.



(6) the Ministry of health shall lay down the implementing regulation

the elements of the undertaking referred to in paragraph 3, the conditions under which

specialised workplaces can be a highly innovative product, and

support criteria and procedures for the assessment, whether the medicinal product is

highly innovative, with the highly innovative product should always be

designed for the treatment of highly serious illnesses.



(7) a specialized institution, which may bring a highly innovative

the product on the basis of a special contract under § 15 para. 10, is required to

to provide, at the request of transmission of data related to assessing the effectiveness and

the position of the highly innovative product in clinical practice, health

the insurance company, and in promotional marketing authorisation holder

This medicinal product. The range of the data transmitted to health

the insurance company and the marketing authorisation holder of highly innovative

of the Ministry of health shall lay down the implementing

Regulation. ".



53. section 39e including title:



"section 39e



Úhradová contest



(1) in order to ensure a fully covered by medicinal products and savings

resources health insurance Institute may enlist in a contest for the lowest

reimbursement of medicinal product (hereinafter referred to as "úhradová"), if its

the notice will ask the health insurance company. Úhradovou competition can be listed in the

the active substances and formulations, in which occur the healing

products from at least 3 marketing authorisation holders. In the reimbursement

the contest participants offer the lowest payment attributable to the usual

daily therapeutic dose and undertake to place on the market medicinal products

the corresponding request reimbursement of the competition so that their price for

the final consumer does not exceed the maximum possible reimbursement for

the final consumer.



(2) the Úhradová contest is carried out by means of the electronic auction. Electronic

the auction means the process of evaluation of the tenders, in which

the participant uses the electronic tools for the presentation of new

reduced tender values. A participant in the price competition is the holder of the

of the marketing authorisation that has fulfilled the conditions of qualification. Qualifications

shall mean verification of eligibility for fulfilment of the obligation of reimbursement of the competition.



(3) the request for invitation to tender the competition must always include



and affirmative representations of the Ministry of health) with an application on

invitation to tender competition,



(b)) the designation of the active substances and formulations, in the framework of which a notice of

reimbursement of the competition asks.



(4) Furthermore, the request typically contains



and the content of the active substance) in medicinal products, whose full

payment must be ensured, or úhradovou competitions required dose,

to be achieved by the unit of the pharmaceutical form of medicinal products

preparations or their division or times use (hereinafter referred to as

"the content"),



(b)) the minimum number of usual daily therapeutic dose in the package

medicinal products whose full remuneration must be úhradovou competitions

assured.



(5) the Institute shall notify the initiation of reimbursement of the contest within 30 days from the date of submission of the

the application in your Journal, and in a way allowing remote access.

The notification shall contain



and labelling of the active substance) and formulations, in the framework of which úhradová

competition prints,



(b) the number of the usual daily) of therapeutic doses of this active substance, and

pharmaceutical forms distributed on the Czech market for 18 months

prior to the initiation of reimbursement of the competition,



(c)) the conditions of qualification



(d)) the deadline by which it is possible to qualify to participate in the tender competition,

that is at least 15 days from the date of publication of the notice in the Gazette,



e) instruction on the course of the reimbursement of the competition,



(f) additional requirements arising from) the request referred to in paragraph 4.



(6) can qualify only the marketing authorisation holder of the medicinal

product available under section 39 c of paragraph 1. 2 (a). and) and containing the

the active substance in the dosage form in the application referred to in paragraph 3, which

for the last three years did not make the administrative offense under § 39q para. 1

(a). (d)). the condition of qualification for participation in the tender competition is further



specifications for medicinal products) the content that will be

placed on the Czech market in the case of winnings in the competition with the payment of the reimbursement

the corresponding decision in competition and a maximum reimbursement for the price for

the final consumer, not exceeding the maximum possible reimbursement for

the final consumer,



(b)) a written declaration of commitment to supply in the event of winning in the reimbursement

competition on the Czech market medicinal products referred to in point (a)) for the price for

the final consumer, not exceeding the maximum possible reimbursement for

the final consumer, and evenly over a period of 18 months from the date of

the enforcement of such a decision, and to the extent of at least half of the

the usual daily consumption of therapeutic doses in the medicinal substance, and

pharmaceutical form, distributed on the Czech market for 18 months

prior to the initiation of reimbursement of the competition.



(7) Department of the resolution decides that a person who or when prompted to

compensate for the lack of Administration did not fulfil the conditions of qualification, is not


participant. Against that order can be appealed.



(8) If a reimbursement is not participating in the competition at least 2 participants, Institute of

úhradovou contest by order of stops.



(9) the Institute participants reimbursement at least 7 days in advance of the competition shall notify the date

and the exact time of the implementation of the electronic auction. Notice under this

paragraph shall be delivered only a public decree in a manner allowing

remote access, and shall be deemed received on the tenth day after

off-hook. The notification also contains



and information on the number of participants) reimbursement of the competition,



b) opening auction value that corresponds to a valid basic pay

active substance and formulations for the usual daily therapeutic dose,



c) instruction on the course of the electronic auction,



(d)) information related to the used electronic means and other

technical information necessary for electronic communications in the context of the

electronic auctions,



(e) determining the minimum difference) for individual administration of decreasing auction

value, which corresponds to approximately 1% of the base payment for the usual daily

therapeutic dose of the drug substance and dosage form.



(10) electronic auction in the reimbursement of the contest takes place the day and time

provided by the Institute and notified the participants referred to in paragraph 9 and has only 1

bike. The Institute to issue a decision not to disclose the identity of the participants

reimbursement of the competition.



(11) electronic auction takes at least 30 minutes. Each administration, reducing

the auction value of 29. minute, extended the duration of the electronic auction

about another minute from this administration. Throughout the electronic auction is

The Institute is obliged to disclose information about the participants is currently the lowest

auction value.



(12) if the lowest auction value reached in electronic

the auction is at least 2% lower, than the opening value of the auction, the Department of

úhradovou contest by order of stops.



(13) the stopping of the reimbursement of the competition referred to in paragraphs 8 and 12, the Institute shall notify the

participants and make communication about it in their Journal and the way

allowing remote access. Against the resolution terminating the reimbursement

competition cannot be appealed.



(14) if the úhradová contest is not stopped, the Institute shall issue, within 7 days after

their electronic auction in reimbursement decisions, which

receives the lowest auction value (hereinafter referred to as "taken by the auction value").

The decision is delivered to the participants of the competition, and can be a "settlement against him

appeal. In the operative part of the decision, the Institute shall indicate the



and the list of participants) reimbursement of the competition,



(b) the designation of the party) offered the lowest auction value (hereinafter referred to as

the "winner"),



(c)) adopted the auction value



(d)) the designation of medicinal products requested content that will be put

on the Czech market with payment of the corresponding auction value received (hereinafter referred to as

"products"),



(e) the determination of the obligations of the winner) to supply medicinal products to the desired

the content, for which it was adopted the auction value at the price on the Czech market for

the final consumer, not exceeding the maximum possible reimbursement for

the final consumer, and evenly over a period of 18 months from the date of

enforceability of a judgment in the amount corresponding to at least half of the

the usual daily consumption of therapeutic doses in the medicinal substance, and

formulation of distributed on the Czech market for 18 months

prior to the initiation of reimbursement of the competition (hereinafter referred to as "the obligation of reimbursement

the competition ").



(15) in the preamble to the decision of the Institute shall, in particular,



and) list of people who meet the conditions for qualification in the reimbursement

the competition, on the grounds



(b) a summary of the course of the reimbursement) competition.



(16) following the entry into force of the decision on the reimbursement shall contest the

the result of the reimbursement of the competition notice, which shall be published within five days in a way

allowing remote access and in your Journal, and which contains the

information from the grounds of the decision in the tender competition.



(17) following the entry into force of the decision on the reimbursement Department of competition to 10

the days of initiating the procedure on changing the amount of remuneration and the conditions of medicinal products

that contain the same active ingredient and the same pharmaceutical form as the

received products. In this procedure, the Institute changed the amount of payment received

products according to accepted auction values and other medicinal products

changes the amount of payment according to 75% of the value of the auction, and received it on time

the validity of the tender competition, the violation of this obligation, or

to fulfill this commitment, the waiver. Conditions for reimbursement in this

control does not change. The parties are persons referred to in section 39f of paragraph 1. 2.

The first act in this control is the issue of the decision. The appeal against the

This decision does not have suspensory effect. The decision is enforceable on the day

enforceability of a judgment in the price competition.



(18) decision on the reimbursement shall be enforceable on the first day competition of the fifth

calendar month following the acquisition of its legal power.



(19) for the duration of the obligation of reimbursement of medicinal products, the competition

containing the active substance and the pharmaceutical form in which it was issued

the decision on reimbursement, paid in the amount provided for in paragraph 17;

enforceability of the terms and conditions of payment set out above to these medicinal products

in proceedings pursuant to § 39 g is hereby suspended.



(20) the provisions of paragraph 7 shall not prevent the initiation and conduct of the proceedings and issue

the decision to establish or change the amount and conditions of payment of medical

the products referred to in this paragraph, as well as perform an in-depth or

short review reference group, to which it belongs, including the

These medicinal products. Such a decision is enforceable on the expiry of

the period of validity of the reimbursement of the contest, is a violation of this commitment,

the obligation to observe this obligation to release, or under paragraph 25.



(21) from the date of enforcement of the decision on the reimbursement is the winner of the competition

obliged to fulfill the obligation of reimbursement of the competition. The Institute may winner

by a decision of exemption from the obligation to fulfil the obligation of reimbursement if

winner proves that there has been such and not caused by him in advance

unpredictable material change in the conditions under which you can no longer

reasonably required to fulfil the obligation of reimbursement of the competition. Such

the decision is enforceable in the first day of the calendar month following

After a month in which came into legal force. On the day of the enforcement of this

the provisions of paragraph 19 of the decision does not apply and the obligation of reimbursement

the competition is valid.



(22) in the case of an infringement of the obligation of reimbursement under section competition

39q first day of the next calendar month, with the provisions of the

paragraph 7 shall not apply and the commitment of the reimbursement of the competition will be cancelled.



(23) the next úhradovou competition can be in the same active ingredients and pharmaceutical

forms of launch soon after 10 months from the date of enforcement

the previous decision on the reimbursement. The inaugural auction value

auction value is received from the previous decision on the reimbursement.



(24) in the next contest for reimbursement listed medicines of the same

active substances and pharmaceutical forms is not the lowest auction value reached in

electronic auction of at least 2% lower than the opening auction value has

the former winner of the ability to deliver the Institute's proposal to extend the existing

the auction received value and its obligation of reimbursement for the period

the next 18 months. The proposal must be delivered to the winner's 30 calendar days after the

stop reimbursement of the competition, or at least 30 calendar days before

the expiry date of the reimbursement of the contest in the event that additional

úhradová competition has not been announced. For the submission of the proposal the provisions of the

paragraph 6 similarly. In this case the Department of his proposal without delay

will meet.



(25) in the case that after the period of validity of the tender competition the Institute of

Decides in deep or shortened revision amending the above terms and conditions

the remuneration received by the preparations so that the level of remuneration is less than the amount

the remuneration provided for in paragraph 5, the provisions of paragraphs 19 and 23,

does not apply and the commitment of the reimbursement of the competition will be cancelled. Such

the decision shall be enforceable pursuant to section 39 h of paragraph 1. 3. ".



54. In section 39f of paragraph 1. 6 (a). (c)), the word "available" is replaced by

"present", the words "production prices and prices for the final consumer"

replaced by ' producer price ' and the words '; in the case of requests to increase the

prices, if it is not a medicinal product on the market in the countries of the reference basket, can

the applicant must indicate the price of the cheapest generic medicine manufacturers "

shall be deleted.



55. In section 39f of paragraph 1. 6 (a). (e)), the words "paragraph. 6 "shall be replaced by" paragraph.

11. "



56. In section 39f of paragraph 1. 8 the first sentence, the word "generic" is replaced by

"similar medicinal product", the words "or is it" shall be replaced by the words "and with the

It "and at the end of the text of the first sentence, the words" or in

different indications ".



57. In section 39f of paragraph 1. 9, the words ", f) and (h))" shall be replaced by "and (f))".



58. In section 39 g paragraph 3 reads:



"(3) Institute of the request of the person referred to in § 39f para. 2 (a). and) or (b))

granted when the proposed maximum price is less than the maximum price

the calculated pursuant to § 39a para. 2 to 6 or less is the proposed level of remuneration


than the amount of remuneration calculated according to § 39 c and adjusted in accordance with section 39b. ".



59. In section 39 g of paragraph 1. 4 first and second sentence, the word "basic" is deleted and the

the end of the second sentence the words "(section 39b para. 7) ".



60. In section 39 g of paragraph 1. 5 is the number "30" is replaced by "15" and at the end of

paragraph, the following sentence "parties to the proceedings have the right to respond to

the supporting documents for the decision within 10 days from the date of receipt of the

their discovery of documents for decision; This time limit may Institute

the resolution extended. ".



61. In section 39 g shall be added to paragraph 8 to 11 shall be added:



"(8) the Institute collected price reference medicinal products and food

for special medical purposes and details of their availability and the presence of

shall be deemed correct if the party to the proceedings is not to the contrary.



(9) if the conditions of section 39b para. 5 and 6 and article 39f of paragraph 1. 8 and

If he fails, according to paragraph 10, the Institute shall decide within a period of 30 days from the

the initiation of proceedings. Will not issue a decision within the time limit under the first sentence, the

consider that sets the amount of and conditions for reimbursement in accordance with section 39b para. 5 and 6

or the maximum price in accordance with § 39a para. 4 and 5. Decision referred to in

the second sentence is enforceable in accordance with section 39 h of paragraph 1. 3. in proceedings under

the first sentence of the provisions of paragraphs 2, 4 and 5 shall not apply and the participants

control is given the opportunity to comment on the background to the decision referred to in

paragraph 10.



(10) the Institute proceedings pursuant to paragraph 9, where it stops within 10 days of its

begin the request for determining the amount and terms of payment does not meet the

the elements listed in section 39f of paragraph 1. 8, and at least one of the parties with

Thus, within 5 days of receipt of notice of termination detection

supporting documents for the issuance of the decision concerned give their consent. On the day following

the legal force of a resolution in the first sentence, the Institute shall initiate proceedings on the application for

determining the amount and terms of payment with the procedure laid down in paragraphs 1 to 8.



(11) the Agreement closed in the public interest under section 39 c of paragraph 1. 2 (a). (c))

or (d)), it is possible to negotiate a suspensory effect not later than the date of application

the decision establishing or changing the base remuneration. ".



62. In section 39 h of paragraph 1. 1 the second sentence shall be replaced by the phrase "medicinal product is

paid in the amount specified by the sum of the fixed payment, the maximum amount of

trade margins and value added tax (hereinafter referred to as "the highest possible

payment for the final consumer "), with a maximum of up to the amount actually

raised prices for the final consumer. "and in the third sentence, the word

"also" is deleted.



63. In section 39 h at the end of the text of paragraph 2, the words ", and to

enforceability of a decision on the fixing of maximum prices ".



64. In section 39 h of paragraph 3 is added:



"(3) If the decision in the deep or shortened revision, the decision to

determination of the maximum price or the decision on the determination of the amount and the conditions of

the remuneration, as well as their modification or cancellation of the decision on appeal

resource, or the decision on examination procedure has the power to

15. day of the calendar month, including enforceable release of the nearest

the following list under § 39n para. 1. If it has power

15. day of the calendar month, shall be enforceable by issuing the second nearest

list referred to in paragraph 1(b). paragraph 39n 1. ".



65. In section 39 h after paragraph 3 paragraphs 4 and 5 shall be added as follows:



"(4) an appeal against a decision in deep or shortened revision,

the decision on the fixing of maximum prices or decisions fixing the amount of

and conditions of remuneration, as well as their modification or cancellation, and against

the decision in the review does not have suspensory effect. If such

the decision challenged by the appeal, or decomposition, is provisionally enforceable

in accordance with paragraph 3.



(5) the effects of a decision repealing the decision referred to in paragraph 4,

occur under paragraph 3 apply mutatis mutandis. ".



66. In the heading of section 39i, the words "the decision on the determination of ' shall be deleted.



67. In section 39i paragraph 2 reads as follows:



"(2) the Institute shall without delay initiate proceedings ex officio on the change set

the amount and conditions of payment of the medicinal product or foods for special

medical purposes, which does not correspond to the basic payment established pursuant to § 39 c

paragraph. 7, or the conditions for reimbursement of unsatisfactory conditions has the remuneration

laid down in deep or shortened revision. The first sentence shall not apply to

medicines and foods for special medical purposes for which the

payment in accordance with section 39 c of paragraph 1. 8 the second sentence. The Institute will initiate proceedings ex officio

official about changing the maximum prices if after the evaluation laid down by

maximum prices according to § 39 l finds that the maximum price is

higher than the maximum price that you would Institute established under section 39a, or

If it is clear that the maximum price of a similar product determined in accordance with

§ 39a para. 4 or 5 is higher than the maximum price that you would Institute

established pursuant to § 39a para. 2. ".



68. In section 39i for paragraph 3, the following paragraph 4 is added:



"(4) the Institute shall decide on the request of the person referred to in section 39f of paragraph 1. 2 (a). and)

or (b)) on the reduction of the maximum prices according to § 39 g of paragraph 1. 9. ".



The current paragraph 4 shall become paragraph 5.



69. section 39i paragraph 5 is added:



"(5) in proceedings about changing the process according to § 39 g of paragraph 1. 1 to 8 and section 39 h

by analogy. The requirements for an application for amendment of the maximum price or changes in the amount of

and the conditions of payment shall apply section 39f of paragraph 1. 1, 5 and 11. The applicant,

seeking a reduction in payment or tightening conditions of payment, may

ask the Institute about the abandonment of the submission of the particulars referred to in section 39f

paragraph. 6. the Institute a request, unless the particulars necessary to

the assessment of interest on the availability of effective and safe medical care.

An applicant who applies for a reduction in the maximum price, it may request the Institute of

the abandonment of the submission of the particulars referred to in section 39f of paragraph 1. 6 (a).

c).“.



70. In the title of § 39j, the words ' the decision on determining the "be deleted and for the

the word "cancellation" with the words "and the demise of".



71. In § 39j paragraphs 1 and 2 shall be added:



"(1) where a medicinal product or a food for special medical

the purposes are not made available on the Czech market for more than 12 months, the Institute can

to revoke a specified maximum price or amount and conditions

reimbursement at the request of the person referred to in section 39f of paragraph 1. 2 (a). and) or (b)), or from the

ex officio, and the maximum price or the cancellation of the above terms or conditions

remuneration is not contrary to the interest of the security of the availability of effective and

safe health care.



(2) the Institute may decide to revoke the above terms and conditions of payment



at the request of the person) and referred to in section 39f of paragraph 1. 2 (a). and) or (b)),



(b) at the request of the person) referred to in section 39f of paragraph 1. 2 (a). (c)), if provided for in

the amount and conditions of payment are not in accordance with this Act and the

compliance cannot be achieved by changing the maximum price or amount and conditions

payment, or



c) ex officio, if it is not a medicine or food for

Special medical purposes, suitable for use in clinical practice, and the holder of the

registration of the medicinal product or the importer or the domestic

manufacturer of foods for special medical purposes, evidence to the contrary. ".



72. In paragraph after paragraph 2 39j the following paragraph 3 is added:



"(3) the Institute may decide to revoke the above terms and conditions of payment can

the official, provided this is not contrary to the public interest, if the person on whose

the request was granted by a decision of the administrative offense under § 39q

paragraph. 1, will not ensure the fulfilment of the obligations under paragraph 39d paragraph. 3 or fails to comply with

the obligation provided for in § 39 para. 1 (b). and) or (b)) or in § 39 para.

2. the decision to cancel the payment to that person may Institute for up to 3 years

Disable submission for determination of the amount and terms of payment of the medicinal

medicine or food for special medical purposes, in connection with the

This person committed an administrative offense. ".



The former paragraph 3 shall become paragraph 4.



73. In paragraph § 39j 4, the words "or a 2" are replaced by the words "up to 3" and at the end of

paragraph, the following sentence "in proceedings for annulment provided for maximum

prices and conditions of payment, the amount shall be treated according to section 39 g of paragraph 1. 1 to 8

and section 39 h. The requirements for an application for revocation of the maximum price or

the cancellation of the above terms and conditions of payment shall apply section 39f of paragraph 1. 1 and section 39f of paragraph 1. 5

(a). a) to (c)), and (e)). ".



74. In § 39j, the following paragraphs 5 and 6 are added:



"(5) the maximum prices of proprietary medicinal products and food

for special medical purposes, for which the price is according to the decision of the

issued under the price regulation ^ 23 c) decided to cancel a regulation

the maximum price, the effective date of this decision.

The maximum price of the medicinal product or foods for special medical

the purpose of the enforceability of the decision expires on the date of the cancellation of the above terms and conditions

the remittance of this medicine or foods for special medical

purposes.



(6) the maximum price and the amount and terms of payment of the authorised

products expire on the date when the registration has been cancelled or allowed to lapse

the medicinal product or the marketing authorisation for the medicinal product

lost its validity, if it was not yet decided on the progressive download


medicinal product out of circulation; If it was possible to its gradual withdrawal from the

circulation, the amount and conditions of payment and the maximum price shall cease the expiry of

the deadline for the implementation of this download. For unregistered medicinal

the maximum price and the amount of products and conditions for reimbursement shall cease on the date of

a specific treatment program has been terminated; This does not apply, if it was with the

implementation of a specific treatment program for an identical pharmaceutical

product is reissued in a period of 6 months from the date of their

the validity of prior informed consent. ".



75. section 39 l including the title reads as follows:



"§ 39 l



A thorough revision of maximum prices or payments



(1) the Institute shall regularly evaluate at least once every 3 years, whether provided for

maximum prices do not exceed the limits laid down by law, the amount of

the basic remuneration, the amount of remittance compliance for all in principle, therapeutically

substitute medicinal products or foodstuffs for special medical

the purpose of the basic remuneration, consistency and effectiveness of the conditions laid down

reimbursement and compliance set out above and the terms of reimbursement of medicinal products and

foods for special medical purposes with this Act, and in particular

meet the expected results and the reasons, the effectiveness of the pharmacotherapy

determination of reference groups, the amount of the basic remuneration, conditions of payment,

evaluation of the clinical and cost effectiveness and comparison with the original objectives

pharmacotherapy.



(2) the Institute shall regularly evaluate the data obtained from its own activities and from the

third parties and observed situation maximum prices or reimbursement.



(3) on the basis of the information collected under paragraphs 1 and 2 of the Institute handles

the audit report, including the proposal on the adjustment of the reference groups and proceed

under paragraph 4 of the setting, modification or deletion of the maximum price or

the amount and conditions of payment of medicines and foods for special

medical purposes.



(4) a thorough revision of maximum prices or payments (hereinafter referred to as

"thorough revision") is done in the common procedure for the whole reference

a group within the period specified under section 39 g of paragraph 1. 2. In-depth review can be

self initiate and lead and to those medicinal products or

foods for special medical purposes for which it is proceeding on the

establishing, changing or cancelling the maximum price or amount and conditions

payment, or a shortened revision. ".



76. In paragraph 1 of section 39n reads as follows:



"(1) the Institute publishes on the first day of the calendar month a list that

exposes the electronic notice board. The list contains



and) for medicinal products and foods for special medical purposes

covered by the general health insurance scheme, for which the Institute shall decide on the amount and

conditions of payment, their full list along with the amount of the advertised price

the manufacturer, or the maximum set prices on the grounds, as the maximum

prices were established, with the amount and the terms of payment on the grounds, as above

and conditions for reimbursement laid down, with the highest possible remuneration for the final

consumers on the grounds, as it was calculated, and with the amount of the balance due

in the limit of pensionable service under section 16b, para. 1,



(b)) the basic payment reference groups on the grounds, as the base

the remuneration laid down, together with a full listing of medicinal products and food

for special medical purposes listed in reference groups,



(c)) the maximum prices of medicines and foods for special medical

the purposes for which the Institute shall act only on the maximum price together with a full

listing of medicines and foods for special medical purposes and with the

the rationale, as the maximum prices established. ".



77. In paragraph after paragraph 1 39n following new paragraphs 2 and 3 shall be added:



"(2) the Institute shall regularly publish in the electronic notice board to 20.

day of the calendar month, the draft list referred to in paragraph 1. To

the penultimate day of the calendar month, the list can be used to design

Express. The Institute evaluates the expression and performs the repair. On the evaluation of the

proposal to fix the list of Institute who filed a proposal, not inform.



(3) in the case of detection of defects in the amount of the maximum price or the highest possible

payment for the final consumers of the medicinal product in the list referred to in

paragraph 1 or update it promptly removes defects Institute. ".



Paragraphs 2 to 5 shall become paragraphs 4 to 7.



78. In § 39o, the words "pursuant to § 39 g up to 39 l and section 39p" shall be replaced by the words "in

deep or shortened revision, in appeal proceedings, or in the

review "and at the end of the text, the following sentence" the document is

be deemed the fifth day after posting. ".



79. § 39p, including the title reads as follows:



"§ 39p



Abridged revision of maximum prices or payments



(1) the Institute conducts the proceedings ex officio or at the request of the person referred to

in section 39f of paragraph 1. 2 (a). (c) the revision of the maximum reduced) prices or

payments (hereinafter referred to as "shortened revision") in the event that the projected savings

health insurance resources in the reference group is greater than 30

0000 0000 CZK per year, or 5 0000 0000 CZK in the case of high level of remuneration

an innovative product.



(2) if the Department finds that in some of the groups of medicinal substances

referred to in annex 2 of this Act is not even 1 medicine fully

paid, shall forthwith initiate ex officio the abridged revision of all

reference groups containing active substances referred to in the relevant

the Group of annex 2 of this Act and a decision modifies the remuneration so that

in accordance with section 39 c of paragraph 1. 5 was the least expensive medicine

belonging to this group are fully paid.



(3) the Institute shall without delay initiate the shortened revision on the basis of the written

agreement under section 39 c of paragraph 1. 2 (a). c) or (d)) in the case that

the estimated savings in health insurance funds in the reference

the group is at least 20 0000 0000 CZK per year.



(4) the Institute shall without delay initiate the shortened review in the case that there has been a



and) violation of written agreement under section 39 c of paragraph 1. 2 (a). (c))

the basic payment reference group was established in the amount of such

the written agreement, or



(b)) violation of written agreement under section 39 c of paragraph 1. 2 (a). (d))

the basic payment reference group was established by such

the written agreement.



(5) the decision in the proceedings referred to in paragraphs 1 to 4 and § 39 c of paragraph 1. 9 Department of

to 50 calendar days from the date of initiation of the proceeding. Parties to the proceedings

they are entitled to propose evidence and make other suggestions 10 calendar days

from the date of initiation of the proceeding, and this period may Institute by resolution

extended. In the management of the revision of the maximum prices or

tender, the provisions of section 39 g of paragraph 1. 5 does not apply. A shortened revision under

paragraphs 1 to 4 and pursuant to section 39 c of paragraph 1. 9 it is possible to take place only at

in principle, therapeutically interchangeable group of medicinal products and

foods for special medical purposes, in which took place the first revision

the system of payments; otherwise, the Institute shall proceed pursuant to section 39 l short

revision pursuant to § 39 c of paragraph 1. 9 shall be carried out from the base of the remuneration conversion

set out under section 39 c of paragraph 1. 7 and the conditions of payment are maintained.



(6) a shortened revision is done in the common procedure for the whole reference

the Group of. A shortened revision can be separately to initiate and lead and to those

medicinal products or foods for special medical purposes,

which is proceeding for the establishment, amendment or repeal of maximum prices

or the amount of the remuneration, terms and conditions, or depth revision. ".



80. under section 39p shall be added to § 39q, which including the title reads as follows:



"§ 39q



Administrative offences



(1) legal or natural person has committed the administrative business

offense, if the breach



and submitted pursuant to section). 6 (a). (e)),



(b) a written agreement) pursuant to § 39 c of paragraph 1. 2 (a). (c)), which was

fixed basic remuneration reference groups,



(c) a written agreement under paragraph) 39 c of paragraph 1. 2 (a). (d)), which was

fixed basic remuneration or reference groups



(d) the obligation of reimbursement) the competition under section 39e.



(2) for the administrative offence referred to in paragraph 1 shall be fined



and the $ 10 0000 0000), in the case of an administrative offence referred to in paragraph 1 (b). (b))

or (c)),



(b)) for a third of annual turnover in the context of the active substances and

the dosage form in the Czech Republic, up to 100 0000 0000 Czk in the case

on administrative offence pursuant to paragraph 1. (d)).



(3) a legal or natural person-entrepreneur for the administrative offence

does not match, if it proves that made every effort, which was

may be required to prevent a breach of duty.



(4) in determining the amount of the fine to take account of the seriousness of the administrative

offense, in particular, the way a criminal offence and its consequences, and

circumstances in which it was committed, and if it is a repeated

violation of this law.



(5) the responsibility for the administrative offence shall cease, if the administrative authority about him

has commenced proceedings in 2 years, when aware of it, but not later than 5

years from the date on which it was committed.



(6) administrative offences referred to in paragraph 1 dealt with the Institute. The fine exacted

the Customs Office. Income from fines is the State budget revenue. ".



81. In § 40 paragraph 2, the following paragraph 3 is added:



"(3) the health insurance companies are obliged to ensure their insurance policy holders




and paid for by the local availability of care). The local availability of means

reasonable distance of the place of the provision of health care relative to the location

permanent or reported barriers. Local availability

expresses the coastdown time. The local availability of emergency medical

services provided by other legislation governing the health emergency

the service. The coastdown time shall, for the purposes of this Act, means the time in

whole minutes, which corresponds to the effective availability of space transport

means the recommended speed. The recommended speed for the purposes

This Act means a speed that is appropriate to the type of land

communication and is in accordance with the law governing the operation of the road

roads. Driving time determined by the Government, by regulation,



(b) the availability of paid care) time. The time availability of the means

ensuring the provision of paid care within a period appropriate to its

the urgency of the emergency and acute medical care. The deadline for expressing

time availability planned paid care lays down government regulation. ".



Paragraphs 3 to 9 shall be renumbered as paragraphs 4 to 10.



82. In § 40 paragraph 6 is added:



"(6) health insurance lead



and a list of contracted medical facilities); This list, which

does not include the information referred to in point (a)



(b)), is required to disclose any health insurance company way

allowing remote access, (b)) for an overview of health care workers

providing paid care in each of the contracting of medical

devices in the breakdown of doctor, dentist and health professional

performing non-medical health profession under the Act on

paramedical professions who report health

the insurance company made to medical procedures according to the list of medical procedures

with point values (hereinafter referred to as the "recipient"); for this purpose,

medical devices shall be obliged to communicate to the health insurers for

the previous quarter, and at the latest within 60 days, the list of individual

holders of performances on the last day of the quarter, giving the name,

last name, title, social security number and category of the wearer power according to the

list of medical procedures with spot values. ".



83. section 41 is repealed.



84. In § 42 para. 1, after the word "insurance", the words "and accounted

health insurance company "and the word" of "is deleted.



85. In paragraph 42, at the end of paragraph 2, the following sentence including notes

footnote No. 44a is inserted: "health insurance companies for the implementation of the control

activities through access to a central repository of electronic

recipes by a special Act ^ 44a).



44a) Law No 378/2007 Coll., on pharmaceuticals and on changes of some

related laws (law on medicinal products), as amended

regulations. ".



86. In paragraph 43, the following shall be added at the end of paragraph 2, the phrase "health insurance company

upon request of the insured person is obliged to provide remote access to its

personal account. If you can to the insured person or his legal representative

written consent may be made available to this personal account as well as attending

the doctor of the insured person. ".



87. In § 44 para. 2, the words "one year" is replaced by "2 years" and

the word "three" is replaced by the figure "5".



88. under § 45a is added to § 45b, which reads as follows:



"section 45b



Health insurance company, which does not flow in accordance with § 17 para. 1, 3, 6

up to 8, § 46 para. 2 and § 52 para. 2, the Ministry of health

impose a fine of up to 10 0000 0000 CZK. The fine is the income of the State

the budget. Health insurance fund is required to pay the fine from its

operational fund. ".



89. The annex No. 1 to 3 shall be added:



"The annex No. 1 to Act No. 48/1997 Coll.



LIST OF MEDICAL PROCEDURES FROM PUBLIC HEALTH INSURANCE COMPANY

OR COVERED ONLY UNDER CERTAIN CONDITIONS



LIST OF ABBREVIATIONS AND SYMBOLS

----------- ---------------------------------------------------------------------------

Mark, Explanation

symbol

----------- ---------------------------------------------------------------------------

ODB expertise



CAT health category performance in terms of payment of health insurance

-symbols N, Z, W-see below



The performance marked in column n KAT symbol "N"-health performance significantly

nehrazený of health insurance, the exception may be the previous

to enable the audit trail for the insured's doctor, due to its

serious medical condition (or special health need)



W marked in column performance KAT symbol "W"-health výkonplně

paid from health insurance only when certain conditions or

maximum reimbursable limit frequencies, you do not need the approval of the revision

doctor



Of performance in the column marked "Z" symbol KAT-health výkonplně

paid health insurance only under certain conditions and after approval by

the review by a doctor



DG. diagnosis



sequence. No serial number power

----------- ---------------------------------------------------------------------------



----------- ---------------------------------------------------------------------------

ODB Name

----------- ---------------------------------------------------------------------------

001 General practical medicine



002 practical medicine for children and adolescents



014 Dentistry General-General dentist-dentist



015 Orthodontics



201 rehabilitation and physical medicine



401 occupational medicine



404 Dermatovenereology



504 vascular surgery



601 plastic surgery



603 of gynaecology and obstetrics



605 Oral and maxillo-facial surgery



606 Orthopedics



701 Otorhinolaryngology



705 Ophthalmology



706 Urology



808 forensic medicine



809 diagnostic radiology



903 clinical speech therapy



911 General nurse



999 Universal care-without binding on the expertise

----------- ---------------------------------------------------------------------------



List of medical procedures from public health insurance company

or covered only under certain conditions

---------------- -------------------------------------------------- -------------------------------------

Sequence. ODB Name Health Condition of payment performance KAT

No.

---------------- -------------------------------------------------- -------------------------------------

1. Health educational activities N 001



2.002 Disabled educational activity N



3.014 Sealing fissures-tooth N



4.014 Koferdam-one jaw N



5.014 alveolár bone Trephination N



6.014 Augmentation, guided tissue N

regeneration and implantation in dentistry



7.014 Makeshift bridge made in N



8. Fix the fixed compensation in 014 surgery N



9. The expert consultation on the 015 orthodontic N

request patient



10. Reconstruction and 504. iliaca int. and other feats of N

for vascular impotence



11.603 Rekanalizace the fallopian tube after the previous N

sterilization



12.701 Indirect laryngoscopy with instillation of drug to N

the larynx



13. The implantation of penile prostheses 706 N



14.706 cock-kavernosometrie N



15.706 Kavernosografie N



16. the types of preventive examinations-903 N

detect in the field



17.001 workplace Savings carried out by W performance will be paid if the

race doctor is essential to determine the

epidemiologickésituace on

workplace



18.014 Injectable anesthesia W performance will be paid except

intraligamentární anesthesia



19.014 comprehensive examination Performance will be paid client W only when

the takeover of the insured person to the care

upon registration of the insured person



20.014 Review oral hygiene-prophylaxis W Paid dvakrátročně



21.014, the removal of tartar-W Paid once a year

prophylactic



22.014 Local fluoridation with drying W Paid when the product

with aminofluoridem without carrier



23.014 Fill permanent teeth (regardless of the number of Watts Paid only when you use

faces, including the reconstruction of the nedózovaného amalgam in)

the scope of the entire set of teeth, when you

use samopolymerujícího

composite only range

the canine teeth, including



24.014 Composite fill the permanent tooth (without Watts Paid for children up to the age

regardless of the number of faces, including 18 years in the range of the canines, including

reconstruction and completion of the corner.

plastic)



25.014 endodontic treatment W Paid when you use

the registered material

method of the central pin



26.014 Transitional splint without preparation-per tooth W Paid when you use

self-polymerizing


composite resin



27.014 Temporary splint with the preparací-per tooth W Paid when you use

composite resin self-polymerizing

composite resin



28. Determination of the fixed 201 W Paid once during treatment

a rehabilitation plan based on

past rehabilitation Conference



29.401 Investigation in the workplace of the insured person from Watts power will be paid only

risk of professional examination for indication of imminent,

suspected or actual damage

Professional disability



30.601 Reshaping and tightening odstálého ears W Full payment to 10 years of age

a child over 10 years of health

the insurance company will not refund the



31.701 agravaci tests and simulation of W in the case of proven simulation nehrazen



32.705 Applications contact lenses W performance will be paid after cataract surgery



33.808 Consultation findings the Court doctor W performance will be paid, if it is

at the request of the treating physician

necessary to explain the findings

a particular case



34. A comprehensive assessment of health 911 W Performance will be paid only on

the status of an insured person in his environment recommendations

a doctor at the takeover of the insured person

the doctor indicated

temporary or long-term

nursing care in the home



35. the insured person's control at 911 Targeted domestic W performance will be paid after

environment previous indication

a medical practitioner, that

can be single or

expressing the specific

the frequency of visits for certain

period



36.911 Nursing intervention is simple in W performance will be paid after

Home previous indication

a medical practitioner, that

can be single or

expressing the specific

the frequency of visits for certain

period



37.911 Comprehensive care ošetřovatelsky W performance will be paid after

challenging or immovable of the insured person in the previous indication

the domestic environment of the medical practitioner, that

can be single or

expressing the specific

the frequency of visits for certain

period



38.999 Psychotherapy support-performed W performance will be paid only on

doctor nepsychiatrem of one of the insured person once

a year in a single scope after

detailed registration of the documentation



39.999 to interview the doctor with the family will be paid on Performance W

one insured person aged

to 15 years more than twice

Once a year for adult

a year after a detailed registration

in the documentation



40.999 Educational interview doctor with a sick or W Paid only when health

family indicate in writing a reasoned

in the documentation astvrzené

signature edukovaného or

his legal representative



41.999 Consultation specialist W Performance paid only if it is on

the request of a medical practitioner



42.404 Epilation á 30 minutes of performance will be paid only for

DG. E00-E07 (disorders of the thyroid

gland, hormonal disorders),

E10-E14 (diabetes mellitus),

E20-E35 (diencefalohypofyzární

disorders)



43.601 correction of congenital anomalies of the auricle and the small of

(bone growths)



44.601 Xanthelasma of



45.601 Operation ptózy face-top, bottom of the



46.601 Operation ptózy face-total (smas of

lifting)



47.601 Operations hard and soft nose for Z

functional disorder



48.601-soft nose Rinoplastika from



49. Rinoplastika-601 sedlovitý nose (L-graft, from

including collection)



50.601 Rinofyma from



51. gigantomastie Operation of 601



52.601 Ablation with preserving the areola of the breast



53.601 reconstruction of areomamilárního from

complex



54.601 Capsulotomy implant from housing



55.601 breast implant removal from

kapsulektomií



56. The implantation of tissue Expander and 601 of



57.605 chin augmentation bone, cartilage, or from

the prosthetic



60.605 Subperiosteal implant-one jaw of the



61. the Chin Correction of 605



62.606 Osteotomy of the hip



63.606, shortening of the long bones Extending from the



64.701 of Septoplasty



65. Laser iridotomy 705 of the performance is hrazenpři

the implementation of most of the 1 St

three times, the next time you perform a

the payment order must consent

medical



66.705 Dermatoplastika one eyelid, or from

blepharochalasis-exize from one eyelid

+ fat removal and fold



67.705 Laser coagulation of the retina of the performance is hrazenpři

the implementation of most of the 1 St

five times, the next time you perform a

the payment order must consent

medical



68.705 plastic surgery of the skin of the eyelid of the Rotary

the caudate lobe or offset



69. thermotherapy Transurethral prostate of 706



70.706 cock-intrakavernózní injection of

Vasoactive substances



71. the vas deferens-706 Ligature vazektomie from



72.999 patient care Equipment outside of the

medical equipment

---------------- -------------------------------------------------- -------------------------------------



Annex 2 to the Act No. 48/1997 Coll.



LIST OF GROUPS OF ACTIVE SUBSTANCES



-------- --------------------------------------------------------------------------------- ---------

The number of the name of a group of substances

Group

-------- --------------------------------------------------------------------------------- ---------

1 adsobční anatacida and protivředová of the drug from a group of H2 blockers, oral administration



2 protivředová of the drug from a group of Proton pump inhibitors and other protivředová drugs



3 anti-spasmodics, oral administration



4 anti-spasmodics, other application path



5 anticholinergics and antispasmodics in combination with analgesics



6 agents, antiflatulencia, oral administration



7 the application agents, other



8 antiemetics, oral administration



9 antiemetics, other application path



10 hepatika and hepatoprotektiva and other drugs acting on the bile ducts, or liver



11 laxatives and other drugs for the cleansing of the bowel



12 antidiarhoika, anti-infective and anti-inflammatory drugs in the gastrointestinal tract,

oral administration of



13 antidiarhoika, anti-infective and anti-inflammatory drugs in the gastrointestinal tract,

the other path of the application



14 lowered, including the enzyme



15 short-acting insuliny



16 insuliny intermediate acting



17 insuliny-combination



18 oral agents from a group of biguanides and glitazonů



19 oral agents from a group of sulphonylurea and meglitinidů, or other antidiabetic drugs



20 vitamin A or D, including combinations, oral administration



21 vitamin A or D, including combinations of them, the other the application paths



22, oral administration of calcium salts



23 the combination of oral administration of calcium salts



24 calcium salts, other application path



25-salt, potassium oral



26 salt of potassium, other application path



27 salt of magnesium and other mineral products, oral administration



28 salts of magnesium, the other the application paths



29 treatment to long-term substitution therapy with inherited metabolic disorders



30 antithrombotika of vitamin K antagonist



31 antithrombotika of a group of heparin and antithrombinu III



32 antithrombotika of a group of low molecular weight heparins



33 inhibitors Excl. heparin



34 of fibrinolytic enzymes



35 antifibrinolytics, oral administration



36 antifibrinolytics, other application path



37 vitamin K and other hemostatics



38 the coagulation factors (coagulation factor VIII)



39 the coagulation factors (coagulation factor IX)




40 other clotting factors



41 iron salts, oral administration



42 iron salts in combination with folic acid and other combinations, oral administration



43 iron salts, other application path



44 vitamin B12, folic acid and other antianemika



45 erythropoietin and other drugs of the blood and blood-forming organs



46 substituents plasma and plasma proteins (albumin)



47 substituents plasma and plasma proteins (other)



48 total parenteral nutrition



49 by solutions has the solution



50 others by solutions for peritoneal dialysis and hemodialysis



51 additives for intravenozním solutions



52 other drugs used in diseases of the krvetvorného system



53 cardiac glycosides



54 class I and III antiarrhythmics, oral administration



55 antiarrhythmics, the other the application paths



56 adrenergic and dopaminergic agents and other cardiac preparations



57 vasodilator substance for heart disease, oral administration for chronic treatment



58 vasodilator substance for heart disease, oral administration for acute treatment



59 prostaglandins and other cardiac preparations



60 antihypertensives-antiadrenergic agents and agents acting on the smooth muscles

arterioles, including combinations with diuretics, perorání administration



61 antihypertensive and other application path



62 diuretics lower diuretickým effect



63 diuretics with high effect, oral administration



64 diuretics with high effect, the other the application paths



potassium-sparing diuretics, 65



66 peripheral vasodilators, oral administration



67 peripheral vasodilators and vasoprotektiva, the other the application paths



68 vasoprotektiva and venofarmaka



69 non-selective beta blockers, oral administration



70 selective beta blockers and a combination of alpha and beta activity, perorání administration



71 beta blockers, the other the application paths



72 vápníkového channel blockers from the Group dihydropyridinů, perorání administration



73 other calcium channel blockers, perorání administration



74 calcium channel blockers, the other the application paths



75 ACEI



76 drugs affecting the renin-angiotensin system, with the exception of the ACE-inhibitors



Statin lipid lowering medicines of the Group of 77



lipid lowering medicines from a group of 78 Fibrates and other groups



79 other drugs used in diseases of the cardiovascular system



80 antifungals for topical use



81 emolliencia and protectives



82 of the drug for the treatment of wounds and ulcers



83 antipsoriatics



84 antibiotics for external use



85 antibiotics and chemotherapeutics for external use and antivirals



86 moderately effective and weak effective corticosteroid for topical use and their

the combination of the



87 very strong and potent corticosteroid for topical administration and jejichkombinace



88 corticosteroids in other combinations



89 antiseptics and desinficiencia



90 active substances against acne and other dermatological medicinal substances



91 other drugs used in diseases of the skin



92 gynecological chemotherapy and antifungals for topical use



93 gynecological antiinfectives and antiseptics for topical use



94 of the drug rising tone of the uterus



95-lowering drugs tone of the uterus



96 prolactin inhibitors



97 male sex hormones



98 female sex hormones of estrogen, oral administration group



99 female sex hormones of estrogen, the other group the application paths



100 female hormones from a group of progestins



the combination of the female reproductive hormone 101



102 gonadotropins and other ovulation stimulants



103 other sex hormones, androgens and modulators



104 other urologicals, including spasmolytik



105 drugs used in benign prostatic hyperplasii



106 the other drugs used in diseases of the urogenital system



front lobe of the pituitary hormones 107 and their analogues



the rear lobe of the pituitary gland 108 hormones and their analogues



109 the hypothalamus hormones and their analogues



110 total use of corticosteroids, oral administration



111 total use of corticosteroids, other application path



112 thyroid hormones and following therapy



113 of antithyroid drugs



114 glucagon and homeostatika calcium and other hormonal drugs



115 tetracycline and amfenikolová antibiotics



116 Penicillins with a wide spectrum of oral administration



117 Penicillins with a wide spectrum of other application path



118 Penicillins sensitive to betalaktamáze, oral administration



119 Penicillins sensitive to betalaktamáze, the other the application paths



120 betalaktamáze, and resistant to Penicillins, combinations of Penicillins, including inhibitors

betalactamases, oral administration



121 cephalosporins and other indicated antibiotics, oral administration



122 different lactam antibiotics and cephalosporins, other application path



123 sulfonamides and trimethoprim



124 macrolide antibiotics and their combination with antibacterial drugs



125 linkosamidová antibiotics



126 aminoglycoside antibiotics



127 quinolone chemotherapeutics



128 other antibiotics or chemotherapy, including urinary chemotherapeutic agents



129 imidazolová chemotherapy for total use and other antibacterial agents



130 antimycotics for systemic use



131 other antimycobacterial agents



132 systemic antivirals for the treatment of herpes, infections and cytomegalovirových

some of the other viral infections



133 antiretroviral therapy



134 animal immunoglobulins against the stafylokokovým infections



135 animal immunoglobulins against diphtheria



136 animal immunoglobulins against snake venom



137 animal immunoglobulins against botulism



138 animal immunoglobulins against gas gangrene



139 animal immunoglobulins against rabies



140 immunoglobulins, normal human, for extravascular application



141 immunoglobulins, normal human, for intravascular application



142 human tetanus immunoglobulin



143 human immunoglobulins against the hepatitis



144 human immunoglobulins against rabies



145 other human specific immunoglobulins



146 tetanus vaccine



147 other bacterial vaccines



148 of vaccine against tuberculosis



149 rabies vaccine



150 influenza vaccine



151 the vaccine against pneumococcal infections



152 other vaccines and immunoglobulins and other antiinfectives for systemic

application



153 other medicines from a group of antibiotics, chemotherapy, imunoglobulinůnebo

vaccines



alkylating antineoplastic agents from a group of 154 agents, oral administration



alkylating antineoplastic agents from a group of 155 of the substances, the other the application paths



156-folic acid analogues antimetabolites, oral administration



157-folic acid analogues antimetabolites, other application path



158 antimetabolites-purine and pyrimidine analogs, oral administration



159 antimetabolites-purine analogues, the other the application paths



160 antimetabolites-pyrimidine analogues, the other the application paths



161 of the vinca alkaloids and analogues



162 podofylotoxinu derivatives, oral administration



163 podofylotoxinu derivatives, the other the application paths



164 taxanes



165 anthracyclines and their derivatives



166 other cytotoxic antibiotics



167 Platinum antineoplastic agents



168 other antineoplastic agents, oral administration



169 other antineoplastic agents in addition to Platinum, the other the application paths



170 with a cytostatic effect of endocrine



171 male hormone antagonists and related substances used in Oncology



172 antagonists of female hormones and related substances used in Oncology



173 inhibitors of steroid hormones that are used in Oncology



174 immunostimulatory and immunomodulatory drugs including the interferon



175 ostání immunostimulatory and immunomodulatory drugs



176 immunosuppressive drugs, oral administration



177 immunosuppressive drugs other paths of the application and the other antineoplastic agents



178 nonsteroidal anti-inflammatory drugs, oral administration



179 non-steroidal anti-inflammatory drug, ostání the application paths



180 specific anti-inflammatory drugs and other drugs used in diseases of the musculoskeletal system



181 locally applied nonsteroidal anti-inflammatory drugs



182 muscle relaxants, parenteral administration



183 anti-gout agents



184 Drugs acting on bone mineralisation



drugs for the treatment of hypercalcemia 185/osteolysis of the malignant disease



186 other drugs used in diseases of the musculoskeletal system



187 local anesthetics



188 analgesics-anodyna, morphine and its derivatives from a group of strong opioid

analgesics, oral administration



189 analgesics-anodyna, analogues of morphine, oral administration



190 analgesics-opioids, anodyna, the other the application paths



191 analgesics-antipyretics



192 antimigraine preparations



193 antiepileptics from a group of barbiturates



194 hydantoinátů from the group, antiepileptics, oxazolidinů, and sukcinimidů



195 antiepileptics from a group of benzodiazepines and karboxamidů



196 antiepileptics from the Group derivatives of fatty acids



197 other antiepileptics



198 anticholinergic antiparkinsonian



199 dopaminergic antiparkinsonian levodopa from the Group and their derivatives




200 antiparkinsonian in other groups



201 antiparkinsonian acting on MAO or COMT



202 Neuroleptics-sedative, oral administration



203 Neuroleptics-incisivní, oral administration



204 atypical neuroleptics, oral administration



205 lithium



206 antipsychotic drugs, Neuroleptics, the other the application paths-nedepotní products



207 antipsychotic drugs, Neuroleptics, the other the application paths-depot preparations



208 anxiolytics, oral administration



209 anxiolytics and hypnotics, other application path



210 antidepressants non-selectively inhibits the reuptake of Monoamines, oral administration



211 antidepressants selectively inhibits the reuptake of Monoamines, oral administration



212 antidepressants acting on possess monoamine oxidase inhibitory and other antidepressants,

oral administration of



213 antidepressants, other application path



214 stimulants and nootropics and medicines intended for the treatment of dementia



215 parasympatomimetika of cholinesterase inhibitors, group, oral



216 parasympatomimetika, the other the application paths



217 used in the treatment of Vertigo



218 other drugs used in diseases of the central nervous system, parenteral administration



219 antimalarial drugs



220 anthelmintic and antiektoparazitika and other medicines from a group of drugs used

for parasitic diseases



221 nasal corticosteroids including hypoallergenic



222 inhaled sympathomimetics including combinations



223 inhaled corticosteroids and anticholinergics



224 other inhalant anti-asthmatics



225 anti-asthmatics, oral administration



226 anti-asthmatics, other application path



In addition to the combination of 227 expectorants, oral administration



In addition, 228 expectorants other application path



229 cough from a group of opioid derivatives



230 other cough suppressant.



231 non-sedating antihistamines



232 sedating antihistamines for oral administration



233 antihistamines, other application path



234 other drugs used in diseases of the respiratory system



235 ophthalmologicals-antibiotics, chemotherapeutics and antiseptics



Our 236-antivirals



237 ophthalmologicals-corticosteroids



238 ophthalmologicals-nonsteroidal anti-inflammatory drugs



239 antiglaukomatika of a group of sympathomimetics and parasympatomimetik



240 antiglaukomatika from the Group of beta blockers



241 other antiglaukomatika



242 mydriatika and cykloplegika



243 dekongescenty and antialergika



244 local anaesthetics and other ophthalmologicals



245 other drugs used in diseases of the sensory organs



246 therapeutic extracts standardized allergens oral administration



247 therapeutic extracts standardized allergens other paths of the application



248 basic antidotes and Phage lysates



249 antidotes used organophosphates poisoning



250 antidotes used in some heavy metals poisoning



251 antidotes used in cyanide poisoning



252 antidotes used in the treatment of chemotherapy, oral administration



253 antidotes used in the treatment of chemotherapy, the other the application paths



254 the secretion of pituitary gland hormones tests, diagnosis of renal function and thyroid function



255 a tuberculin test



256 tests for allergic diseases



257 other drugs for diagnostic and therapeutic purposes, oral administration



258 other drugs for diagnostic and therapeutic purposes, the other the application paths



259 nutrition for inherited disorders of metabolism



260 ketoanaloga and special amino acids



261 polymeric nutrition standard



262 oligopeptidická nutrition



263 solvents and irrigation solutions and other drugs from the Group varií



264 nefrotropní hyperosmolar radiopaque water-soluble substance



265 water-soluble nefrotropní nízkoosmolární X-RAY contrast media



266 water-soluble hepatotropní and vodonerozpustné X-RAY contrast media



267 radiopaque preparations containing barium sulfate



268 by contrast and contrast agents for Ultrasound



269 individually prepared radiopharmaceutical for diagnosis



270 individually prepared radiopharmaceutical therapy



271 individually prepared medicines from drug dermatologik groups (with the exception of the kosmetik)



272 individually prepared medicines from a group of ophthalmic and otologik



273 individually prepared medicines from a group of analgesics-anodyn (opioids)



274 individually prepared medicines from the Group gynekologik



275 individually prepared medicines from the pharmaceutical group of the digestive system



276 individually prepared medicines from a group of otorhinolaryngologik and antiastmatik



277 of packed products



278 trombocytární preparations



279 preparations of plasma



280 leukocyte preparations

-------- --------------------------------------------------------------------------------- ---------



Annex No. 3 to Act No. 48/1997 Coll.



THE LIST OF MEDICAL DEVICES



SECTION AND



List of abbreviations and symbols



In the list of medical devices which are not fully from the resources

health insurance and in the list of medical devices covered by

health insurance funds in the provision of out-patient

health services have used abbreviations and symbols the following meaning:



and) group

1 bandages, plasters

2 AIDS for incontinence

3 Ostomy AIDS

4 orthopaedic prosthetic devices mass produced

5 orthopaedic prosthetic devices individually made

6 compression stockings and girdles

7 disability including trolleys accessories

8 hearing aid accessories

9 glasses and optical AIDS

10 AIDS respiratory and inhalation

11 tools for diabetics

12 compensatory aids for the disabled

13 on unspecified equipment

14 compensatory aids for the visually impaired

15 compensatory aids for the hearing impaired

16 orthopedic shoes

17 tools for laryngektomované,



(b)) the abbreviation

PVC (polyvinyl chloride),



(c) specialisation and marking abbreviations) special focus sites

ALG Allergology and Clinical Immunology

CHI surgery

DER dermatovenereology

DIA of diabetology and endocrinology

FON foniatrie

GER Geriatrics

J16 surgeries with the activity of angiologickou

NEU Neurology

ONK Oncology and Hematology

OP on rthopedický technician

OPH ophthalmology

ENT Otolaryngology

ORT orthopedics

PED paediatrics, practical medicine for children and adolescents

PRL general practical medicine

REH, rehabilitation and physical medicine

S3 owning Company ENT doctor certificate entitling it to regulation and the issue of hearing aids covered by public health insurance resources

S5 of the special arrangements for the approval of the headquarters, the review by a doctor

TRN Pneumology and phthisiology

TVL sports medicine

URN in urology and Nephrology



SECTION B



The list of medical devices which are not fully public health

insurance in the provision of out-patient health services



-------------------- -------------------------------------------- ----------------------------

Item Group name of the species (kind of) medical device Note



-------------------- -------------------------------------------- ----------------------------

1 1 patches with the exception of hypoalergických

patches



2 1 patch for corns



plena 3 2 PVC



4 2 pads PVC



5 4 shoe tennis



6 4 brace sports



stroller accessories-7 7 worktop



8 7 of the pram accessories-storage basket



9 7 the stroller accessories-raincoat



10 7 accessories to the cart-job board



11 7 accessories to the trolley-raincoat



12 7 electric trolleys accessories

-control for escorts



13 11 test strips to determine the

cholesterol



14 12 chodítkům accessories that are above the

beyond their function



15 13 eye dropper



16 13 Rod eye



17 13 breast pump



18 13 finger technical rubber



19 13 bed health



20 13 intrauterine device



21 13 pillow including coating



22 16 neortopedické insoles



23 repair medical devices in addition to the

wheelchairs and strollers and individually manufactured

Orthopedic and prosthetic products and repair

jacks and positioning beds

-------------------- -------------------------------------------- ----------------------------



SECTION C



The list of medical devices covered by public health

insurance in the provision of out-patient health services

--------------------- ------------------------------ ----------------------------------- --------------------------------

Item Group name of the species (kind of) the restriction of the limitations of the above remuneration

--------------------- ------------------------------ ----------------------------------- --------------------------------

1 1 gauze hydrophilic coated up to size 10 x 10 cm 100% for up to 8 Eur

and the size of the Pack of 2 PCs




2 1 cover no more than the size of the gel of 10 x 10 cm 100% up to $ 150

based on the approval of the revision per 1 piece

doctor



Hypo-allergenic patch 3 1 for children under 18 years of age and not more than 30 CZK

patients with Ostomy, and

diabetics



elastic bandage 4 1 up to size 14 cm x 5 m 100% up to $ 50



5 1 bandage sterile hydrophilic maximum dimension of 12 cm x 5 m 100% up to £ 15



flexible hose wrap 6 1 up to 30 Eur



7 1 coil only on prescription wipes DIA, a maximum of 70 CZK

1 pack of 1 000 pieces per year



cellulose wadding 100 8 1 g up to 10 Eur



9 1 100 g cotton wool dressing stacked up to 20 Eur



cotton wool dressing sterile 10 1 25 g up to 10 Eur



11 2 absorption means for min. 90 DC, max. 150 PCs per month, up to 1 400 Czk

severe incontinence-nehrazeno patients in the constitutional

panty diaper care and in specialist hospitals



12 2 absorption means for min. 90 DC, max. 150 PCs up to 550 Eur

incontinent-inserts for a month, nehrazeno patients

light incontinence in residential care and in professional

hospitals



13 2 absorbent means for min. 90 DC, max. 150 PCs up to 900 Czk

medium incontinence-a month nehrazeno patients

shaped nappies in care and in professional

hospitals



14 2 absorbent fixation devices max. 24 PCs per month, up to $ 190 nehrazeno

for moderate and severe patients in institutional care and in

incontinence specialist hospitals



15 2 condoms urine of prices for the end

consumer at least

economically challenging variants

up to 900 Czk



16 2 bags of urine collection of prices for the end

consumer at least

economically challenging variants

up to 500 €



17 2 clamp incontinence for max. 2 PCs 100% per year

man



18 3 caps only after approval of the revision Ostomy 100%

doctor, max. 60 PCs per month up to 3 100 Czk



19 3 washers colostomy and max. 10 PCs per month, 100% up to $ 1 100

Ileostomy



20 3 washers urostomy max. 15 PCs per month 100% for up to 1 500 Czk



21 3 means cleaning only after approval of the revision Ostomy of prices for the end

doctor of the consumer at least

economically challenging variants

not more than 1 500 Eur per month



22 3 protective Ostomy resources equal to the price for the final

consumer at least

economically challenging variants

within a maximum of 2 760 CZK per year



two-piece systems, 23 3 max. 60 PCs per month, 100% up to $ 1 600

the closed colostomy-bags



24 3 two-piece systems max. 30 PCs per month, 100% for up to 1 350 Czk

Ileostomy drain-bags



one-piece systems, 25 3 max. 60 PCs per month, 100% for up to 2 600 Czk

the closed colostomy-bags



one-piece systems 26 3 max. 30 PCs per month, 100% for up to 1 950 Eur

Ileostomy drain-bags



urostomy two-piece systems 27 3 max. 30 PCs per month, 100% up to $ 200

-bags



urostomy systems 28 3 max. 30 PCs per month, 100% up to $ 200

one-piece-bags



29 3 retaining straps and a max. 2 packs of 100% per year

resources for stomiky



30 3 plugs only upon approval of the review Ostomy 100% for up to 1 200 Czk

doctor, max. 60 PCs per month



epitéza breast 31 4 max. 1 DC in 2 years, only to a maximum of 1 800 Czk to

the basis of the prescription of CHI, ONK, PRL



32 4 series-produced orthosis based only on the prescription of ORT, 100%

OP, REH, CHI, NEU, TVL,

Max. 1 PCs per year



33 4 shoe one of not more than 100% per year, 8 PCs



34 4 Jockstrap max. 2 PCs 100% per year up to 130 Eur



35 5 epitéza breast individually based only on the approval of 100%

zhotovovaná review by a doctor, max. 1 PCs

in 2 years



36 5 brace individually based only on the prescription of the OP, 100%

zhotovovaná ORT, REH, CHI, NEU and approval

the review by a doctor



37 5 upper and lower dentures based only on the prescription of the OP, 100%

the basic design of the extremities REH, ORT, max. 1 DC in 2 years



38 5 modular prosthesis for upper and only on the prescription of the OP, REH, ORT 100%

the lower limbs that are the review and approval of a doctor

constructed of modular max. 1 DC in 2 years

preparations and reports, including

tensile dentures upper

the limbs



39 5 myoelektrické prosthesis, based only on the prescription of the OP, 100%

the loss of both upper limbs, REH, ORT, and approval review

or unilateral amputation with doctor S5, max. DC in 5 years

functional disabilities second (in the case of disability of both

upper limb in extremities 1 pair for 5 years)



40 6 compression elastic only on the basis of prescribing PRL, 100% up to $ 410

stockings leg II. K. T CHI, INT, DER, J16, max. 2 pairs

per year



41 6 compression elastic only under prescription, 100% of the maximum of the CHI to 448 Czk

stockings leg III. K. T INT, DER, J16, max. 2 pairs per year



42 6 compression elastic only under prescription, 100% of the maximum of the CHI to 675 Eur

stockings leg IV. K. T INT, DER, J16, max. 2 pairs per year



43 6 compression elastic only on the basis of prescribing PRL, 100% up to $ 517

stockings polostehenní II. CHI, INT, DER, J16, max. 2 pairs

K. T per year



44 6 compression elastic only under prescription, 100% of the maximum of the CHI to 565 Eur

stockings polostehenní III. Int, DER, J16, max. 2 pairs per year

K. T



45 6 compression elastic only under prescription, 100% of the maximum of the CHI to 879 Eur

stockings polostehenní IV. Int, DER, J16, max. 2 pairs per year

K. T



46 6 compression elastic only on the basis of prescribing PRL, 100% up to $ 566

stockings thigh II. K. T CHI, INT, DER, J16, max. 2 pairs

per year



47 6 compression elastic only under prescription, 100% of the maximum of the CHI to 620 €

stockings thigh III. K. T INT, DER, J16, max. 2 pairs per year



48 6 compression elastic only under prescription, 100% of the maximum of the CHI to 1 013 Czk

stockings thigh IV. K. T INT, DER, J16, max. 2 pairs per year



49 6 compression elastic only on the basis of prescribing PRL, 100% up to £ 345

stockings thigh with CHI, INT, DER, J16, max. 2 pairs

at the waist (II). K. T per year



50 6 compression elastic only under prescription, 100% of the maximum of the CHI to 372 Czk

stockings thigh with INT, DER, J16, max. 2 pairs

sewn at the waist (III). K. T per year



51 6 compression elastic only under prescription, 100% of the maximum of the CHI to 400 Czk

stockings thigh with INT, DER, J16, max. 2 pairs per year

sewn at the waist (IV). K. T



52 6 compression elastic only on prescribing PRL, CHI, not more than 100%-$ 950

pantyhose INT, DER, J16, approves the revisions

women's II. K. T. the doctor, max. 2 PCs per year



53 6 compression elastic only on the prescription of CHI, INT, 100% up to $ 1,000

pantyhose DER, J16, approves the revisions

women's III. K. T. the doctor, max. 2 PCs per year



54 6 compression elastic only on the prescription of CHI, INT, 100% up to $ 1,000

pantyhose DER, J16, approves the revisions

women's IV. K. T. the doctor, max. 2 PCs per year



55 6 compression elastic only on the prescription of CHI, INT, 100% up to $ 950

pantyhose DER, J16, approves the revisions

maternity (II). K. T. the doctor, max. 1 PCs per year



56 6 compression elastic only on the prescription of CHI, INT, 100% for up to 1 300 Czk

pantyhose DER, J16, approves the revisions


maternity III. and (IV). K. T. the doctor, max. 1 PCs per year



57 6 compression elastic only on prescribing PRL, CHI, not more than 100%-$ 950

pantyhose INT, DER, J16, approves the revisions

men's II. K. T. the doctor, max. 2 PCs per year



58 6 compression elastic only on the prescription of CHI, INT, 100% up to $ 1,000

pantyhose DER, J16, approves the revisions

men's III. and (IV). K. T. the doctor, max. 2 PCs per year



59 6 arm shoe assy II. K. only on the prescription of a CHI, INT, 100% up to $ 1,000

T. DER, J16, approves the revisions

the doctor, max. 2 PCs per year



60 6 arm shoe assy (III). and only on the prescription of CHI, INT, 100% up to 300 €

IV. A. T. DER, J16, max. 2 PCs per year



61 6 compression elastic only on the prescription of CHI, INT, 100%

stockings and girdles, J16, DER approves revision

individually made by the doctor, max. 2 PCs per year



ankle and knee 62 6 piece part only on the prescription of CHI, ORT, up to 100% of the 130 Czk

II. and III. K. T. Rev PRL, DER, J16, max.

2 PCs per year



63 6 aid for donning only on the basis of the PRL, CHI, INT, 100% up to £ 242

compressive elastic DER, J16, max. 1 PCs per year

stockings



64 7 health based on the prescription of a stroller REH, ORT to 21% for up to 100 000 CZK

NEU and approval review a doctor

Max. 1 SC in 3 years



65 7 stroller health-based on the prescription of REH, ORT, a maximum of 100% of 5 000 CZK

Accessories approval and review by a doctor in NEU

Max. 1 SC in 3 years



truck repair mechanical, 66 7 only on the basis of the approval of 90%

electric and a stroller review a doctor

health



67 7 leather gloves for wheelchair users max. 2 pairs per year up to $ 300



68 7 cart electric-only on prescription, 100% REH

Accessories ORT, NEU, INT and approval

the review by a doctor, max. 1 PCs

in 5 years



69 7 truck mechanical based only on prescription, 100% maximum REH to 12 000 CZK

ORT, NEU, INT and approval

the review by a doctor, max. 1 PCs

in 5 years



70 7 truck mechanical-based only on prescription, 100% REH

Accessories ORT, NEU, INT and approval

the review by a doctor, max. 1 PCs

in 5 years



71 7 cart with electric drive only on prescription, the 100% maximum REH to 136 000 CZK

to operate normally in the ORT, NEU, INT and approval

the exterior of the review doctor S5, Max. 1 PCs

in 5 years



72 7 cart with electric drive only on prescription, the 100% maximum REH to 120 EUR

the standard for light traffic ORT, NEU, INT and approval

usually in the Interior of a revision doctor S5, Max. 1 PCs

in 5 years



73 7 cart special subject only on the basis of the prescription, 100% maximum REH to 55 EUR

the peace and the severity of the ORT, NEU and approval review

disability by a doctor, max. 1 DC in 5 years



74 8 hearing aid suspension for medium based only on the prescription of FON, not more than 100% of 5 300 Czk

severe hearing loss, loss of children from 0 to 7 years, max. 2 PCs

from 30 dB to 60 dB SRT in 5 years



75 8 hearing aid suspension for heavy based only on the prescription of FON, not more than 100% of 5 800 Eur

and very severe children from 0 to 7 years, max. 2 PCs

conductive hearing loss, loss of over 5 years

60 dB SRT, remnants of the hearing,

deafness



76 8 hearing aid on bone conduction, based only on the prescription of FON, 11% for up to 100 000 CZK

eyeglass, Pocket-children from 0 to 7 years, max. 1 PCs

in 5 years, approves the revisions

doctor



77 8 hearing aid for an airy, based only on the prescription of FON, not more than 100% of 5 300 Czk

leadership for moderate ENT S3, children from 7 to 18 years of age,

conductive hearing loss, the loss from the max. 2 DC in 5 years

30 dB to 60 dB SRT



78 8 hearing aid for an airy, based only on the prescription of FON, not more than 100% of 5 800 Eur

the management, for heavy and very ENT S3, children from 7 to 18 years of age,

severe hearing loss above the max. 2 DC in 5 years

60 dB SRT, remnants of the hearing,

deafness



79 8 hearing aid spectacle on bone based only on the prescription of FON, not more than 100% 6 800 €

keeping children from 7 to 18 years, Max. 1 PCs

in 5 years, approves the revisions

doctor



80 8 hearing aid for an airy, based only on the prescription of FON, not more than 2 700 Czk

leadership for moderate ENT S3, from 18 years max. 1 PCs

conductive hearing loss, loss of in 5 years

40 dB to 59 dB SRT



81 8 hearing aid for an airy, based only on the prescription of FON, not more than 100% to CZK 3 900

the management, for severe ENT S3, from 18 years, max. 1pcs

conductive hearing loss, loss of in 5 years

60 dB to 79 dB SRT



82 8 hearing aid for an airy, based only on the prescription of FON, not more than 5 100 100% Eur

leadership for a very severe ENT S3, from 18 years, max. 1pcs

conductive hearing loss, loss of in 5 years

80 dB SRT, the remnants of hearing,

deafness



83 8 hearing aid spectacle on bone based only on the prescription of FON, not more than 100% 6 800 €

leadership ENT S3, from 18 years, max. 1pcs

in 5 years, approves the revisions

doctor



84 8 batteries to the SoundBridge converts based only on the prescription of FON, not more than 100% 80 CZK

ENT S3, max. 1 in 5 years



85 8 optician adapter to only on the basis of 100% of the prescription of the FON, within a maximum of 90 CZK

most SoundBridge converts ENT S3, max. 1 DC in 5 years



86 8 ear fitting individual based only on the prescription of FON, not more than 100%-$ 350

ENT S3, under 18 years old, max. 1pcs

for 1 year



87 8 ear fitting individual based only on the prescription of FON, not more than 100%-$ 350

ENT S3, from 18 years, max. 1pcs

in 5 years



88 9 ear fitting factory based only on the prescription of FON, not more than 100% 20 CZK

ENT S3, max. 1 DC in 5 years



89 9 eye glasses only on prescription, 100% of the maximum of PBC to 300 Czk

children up to 6 years max. 3 PCs a year from

6 years max. 3 PCs per year, to od6

15 years max. 1 piece a year, two

glasses when the refractive defect +-3

Into the distance, DPTR



90 9 eye glasses only on prescription, up to 150 OPH Czk

from 15 years and above, max. 1 ksza

3 years, two glasses during

Refractive defect DPTR to +-3

a distance



91 9 lens eyewear spherical, based only on the prescription of OPH, 100%

tórická children under 6 years without changing the correction

entitled max. 3 PCs per year, from

6 to 15 years max. 1 piece a year, from

15 years of age and max. 1 SC in 3 years



92 9 lens eyewear lenticular only on prescription OPH, children up to 100%

6 years without changing the correction of max.

3 PCs per year, ranging from 6 to 15 years max.

1 piece a year, from 15 years and above max.

1 SC in 3 years, nad +-10

DPTR, up to 3 years for afakie



93 9 lens eyewear vysokoindexová only on the basis of 100% prescription OPH,

children under 6 years without changing the correction

entitled max. 3 PCs per year, to od6

15 years max. 1 piece a year, from

15 years of age and max. 1 SC in 3 years,

myopia over-10 DPTR, disorders

the Central field of vision,

approves a revision doctor



94 9 lens bifocal glasses, based only on the prescription of OPH, 100%

Franklin, zatavovaná, children under 6 years without changing the correction

vybrušovaná, silicate, plastic entitled max. 2 PCs per year, to od6

18 years old max. 1 PCs per year,

annually, strabismus, afakie,

from 18 years of nehrazeno



95 9 lens eyewear prismatická only on the basis of 100% prescription OPH,


children under 6 years without changing the correction

entitled max. 3 PCs per year, from

6 to 15 years max. 1 PCs per year,

from 15 years max. 1 SC in 3 years,

When you doplopii, strabismus



96 9 lens glasses plastic only on the prescription of OPH, children up to 100%

6 years without changing the correction shall be entitled

Max. 2 PCs per year, ranging from 6 to 15 years

Max. 1 piece a year, from 15 years max.

1 SC in 3 years, nad +-10DPTR,

up to 15 years over +-3 DPTR



97 9 lens glasses with absorption based only on the prescription of OPH, 100%

a layer of children under 6 years without changing the correction

entitled max. 3 PCs per year, from

6 to 15 years max. 1 piece a year, from

15 years max. 1 SC in 3 years,

afakie, pseudoafakie, disease and

defects accompanied by světloplachostí



98 9 lens eyewear hyperokulární only on the basis of 100% prescription OPH,

children under 18 years of age without changing the correction

entitled max. 2 PCs per year, A18 years

Max. 1 SC in 3 years, approves the

review a doctor



soft contact lens 99 9 based on the prescription of OPH, children 100%

(hydrophilic) to 15 years without changing the correction

entitled max. 2 PCs a year, from 18 years old

Max. 1 piece a year, afakie over

+-10 DPT, astigmatism

irregularis, anisometropie

3.0 DPT and more



100 9 lens hard contact only on the basis of 100% prescription OPH,

including plynopropustných children up to 15 years without changing the correction

entitlement to the max. 1 PCs per year,

from 15 years max. 1 DC in 2 years,

Keratoconus, astigmatism

irregularis, up to 15 years

anisometropie 3.0 DPT and more



101 9 lens contact only on the basis of 100% prescription OPH,

stenopeutická, color, serious diseases of the cornea

therapeutic approves a revision doctor



102 9 Occluder gel, based only on the prescription of OPH 100%

náplasťový, plastic



103 9 dalekohledový system remotely based only on the prescription of OPH within a maximum of 8 000 CZK

even at the close, with accessories max. 1 DC in 7 years, approves the

review a doctor



104 9 asferická Magnifier magnifying based only on the prescription of not more than 1 500 Czk OPH

4 x + max. 1 DC in 5 years



Zoom to 105 9 spherical expanding only based on the prescription of a maximum of 100 Czk OPH

4 x max. 1 DC in 5 years



106 9 prosthesis eye glass prescription only on the basis of 100% up to OPH 800 Czk



107 9 acrylic eye prosthesis based only on the prescription of 100% up to OPH 2 000 CZK

individually made and approval review by a doctor

Max. 1 SC in 3 years



108 10 applicators aerosol based only on the prescription of a THORN, a maximum of 500 Czk

ALG products, ENT, PED, in pacientůod

18 years old only after approval by the

the review by a doctor



109 10 inhaler compressor based only on the prescription of a THORN, a maximum of 100% of 3 500 Czk

ALG, ENT and approval review

doctor, max. 1 DC in 10 years



110 10 inhaler ultrasonic based only on the prescription of a THORN, to not more than 100% to CZK 4 500

ALG, ENT and approval review

doctor, max. 1 DC in 10 years



111 10 oxygen concentrator based only on the prescription of TRN 100%

the review and approval of a doctor, S5



112 10 resources for application only on the basis of prescription according to the maximum 300 Czk

powder inhaled drug restrictions, preksripčního

forms of medicines max. 1 DC in 2 years



CPAP device 113 10 based only on the prescription of a THORN, the price for the final

NEU and approval review the consumer at least

doctor S5 economically challenging variants

up to 40 000 CZK



114 10 appliance BPAP based only on the prescription of a THORN, the price for the final

NEU and approval review the consumer at least

doctor S5 economically challenging variants

a maximum of 60 000 CZK



115 10 spirometer personal based only on the prescription of a THORN, up to 300 Eur

ALG and the approval of the review a doctor



116 11 applicator insulin-based only on the prescription of the DIA, the price for the final

insulin Pen max. 1 SC in 3 years the consumer at least

economically challenging variants

up to 500 €



117 11 applicator insulin to based only on the prescription of DIA, to not more than 100% of the 1 200 Czk

application syringe max. 1 SC in 3 years



118 11 applicator collect blood only on the basis of 100% of the prescription, the DIA up to 250 Czk

by using the lancet max. 1 DC in 5 years



119 11-meter for diabetics based only on the prescription of DIA of prices for the end

the review and approval of the intenzifikovaným treated by a doctor, at least the consumer

the insulin regimen (3 doses max. 1 DC in 10 years economically challenging variants

daily or insulin pump), not more than 1 000 CZK

for unstable diabetics with 2

doses of insulin per day



120 11 needles to injection syringes Only based on the prescription of a 100% on up to DIA 120 CZK per

the application of insulin 100 PCs



121 11 needles to the insulin pens based only on the prescription of the DIA, the price for the final

Max. 200 PCs per year of the consumer at least

economically challenging variants

up to 530 Czk



122 11 complete the application Only on the basis of 100% of the maximum prescription DIA to 370 per 100

(syringe with fixed 100 PCs

needle)



123 11 lancets for blood sampling based only on the prescription of DIA, to not more than 100% to CZK 300

Max. 100 PCs per year



124 11 diagnostic strips on Only on the basis of 100% of the prescription of the DIA, within a maximum of 5 600 Czk

determination of glucose by max. 400 PCs per year.

+----------------------------------+-------------------------------+

Only on the basis of 100% of the maximum prescription DIA up to 14 000 CZK

the review and approval of a doctor

If the insured person review

doctor the competent health

insurance approved and blood glucose meter,

Max. 1 000 pieces per year



125 11 insulin pump based only on the prescription of DIA of prices for the end

the review and approval of a doctor, the S5 at least consumer

Max. 1 piece or set of 2 for economically challenging variants

4 years to not more than 106 000 CZK



126 11 sets infusní to insulin based only on the prescription of 100% up to DIA. 160 CZK per

station 1 set



127 11 syringe for injection to the application only on the basis of 100% of the maximum prescription DIA to 230 €

insulin 100 PCs



128 12 crutches max. 1 pair every 2 years 100% up to 400 €



crutch forearm 129 12 max. 1 pair or 1 PC for 2 years 100% up to € 300

1 PCs



130 12 Walker based only on prescription, 100% maximum REH to 7 000 CZK

NEU, OP and approval review

doctor, max. 1 DC in 5 years



131 12 stick max. 1 DC for 3 years 100% for up to 130 Eur



132 12 bed positioning only on the basis of the prescription, the 100% maximum REH to 30 000 Eur

the electrical set up and approval of the ORT, NEU review

doctor, S5, max. 1 ks za10 years



Chair of the 133 12 based on the prescription of REH, 100%, not more than 4 000 CZK

NEU, PRL, GER, max. 1 SC in

5 years



134 12 TOILET attachment based on the prescription of REH, ORT, not more than 2 100% USD

NEU, PRL, GER, max. 1 SC in

3 years



135 12 seat in the tub and the shower on the basis of the prescription, ORT, REH, 100% up to $ 200

NEU, PRL, GER, max. 1 PCs

in 5 years




136 12 device positioning based on the prescription of REH, ORT, up to 100% of the 60 000 CZK

NEU and approval review

doctor, max. 1 DC in 10 years



137 12 accessories to positioning based on the prescription, ORT, REH, within a maximum of 10 000 CZK

the review and approval of the device NEU

doctor, max. 1 DC in 10 years



138 12 lifter mechanical, based on the prescription of REH, 100% of ORT, a maximum of 25 000 CZK

Electric, hydraulic and approval review doctor NEU



139 12 bed positioning only on the basis of the prescription, the 100% maximum REH to 15 000 CZK

the mechanical setting of ORT, NEU and approval review

doctor, max. 1 DC in 10 years



140 13 wig only on prescription, up to 1 ONK USD

DER, INT, max. 1 PCs per year



141 13 pad Anti-decubitus based only on the prescription of REH, 100%

ORT, NEU and approval review

doctor, max. 1 SC in 3 years



142 13 helmet protection based on the prescription of REH, NEU, a maximum of 100% of 2 500 Czk

Dogs and approval review

doctor, max. 1 DC in 2 years



143 14 stick white Braille based only on the prescription of OPH, 100%

PRL, max. 3 PCs per year



144 14 compensatory aids for only on the basis of the prescription, 100% of the maximum of PBC to 2 000 Czk

the blind review and approval of the PRL doctor



145 15 amp induction set based only on the prescription of a 100% on up to FON 1 000 CZK

S3, S3 ENT, max. 1 DC in 7 years



146 15 compensatory aids for only on the basis of 100% of the maximum prescription FON to 2 000 Czk

the hearing-impaired, S3, S3 and approval review ENT

doctor



147 16 orthopedic shoes for children based on the prescription of REH, ORT, up to 100% of the 2 000 CZK

individual OP and the approval of the review a doctor

Max. 3 pairs per year



148 16 orthopedic shoes for children based on the prescription of REH, ORT, not more than 1 000 CZK

series-produced OP and the approval of the review a doctor

Max. 3 pairs per year



149 16 orthopedic shoes, based only on the prescription of REH, 50%

individually made-ORT, OP, max. 1 pair every 2 years

simple



150 16 orthopedic shoes, based only on the prescription of REH, 90%

individually made-ORT, OP, max. 1 pair every 2 years

more complex and very complex



151 16 shoes for diabetics based only on the prescription of the DIA to not more than 1 000 CZK

the review and approval of a doctor

Max. 1 pair every 2 years



152 16 insoles, orthopedic, based only on the prescription of REH, up to 100 Eur

individual ORT, OP, max. 1 pair per year



153 16 insoles, orthopedic, based only on the prescription of REH, up to 300 Eur

personalized children's ORT, OP, max. 2 pairs per year



154 16 special insoles, orthopedic, based only on the prescription of REH, 80%

ORT, OP, max. 2 pairs per year



155 17-cannula only, on the basis of a prescription, 100% of the maximum of ENT to 3 500 Czk

noble metal FON, approves a revision doctor

children under the age of 18 max. 3 PCs per year



156 17-cannula only, on the basis of a prescription, 100% of the maximum of ENT to 2 000

noble metal FON, from 18 years max. 2 DC on

5 years



157 17-cannula only on prescription, 100% of the maximum of ENT to 2 000 Czk

silicone, PVC FON, approves the revision doctor,

Max. 2 PCs per year



158 17 accessories for tube based on the prescription of ENT, FON, not more than 100% of the 2 000 CZK

tracheostomické max. 1 x per year



159 17 elektrolaryng on the basis of 100% of the prescription of the FON, within a maximum of 20 000 CZK

Max. 1 DC in 10 years, S5,

approves a revision doctor



160 17 battery to elektrolaryngu only on the basis of 100% of the prescription of the FON, up to 700 Eur

elektrolaryngu prescription of FON, max. 1 ksza

2 years, approves reviznílékař ".

--------------------- ------------------------------ ----------------------------------- --------------------------------



Article. (II)



Transitional provisions



1. The legal relations arising from the written agreement contained in

the public interest pursuant to 48/1997 Coll., in the version in force before the date of application

the effectiveness of this law, the health insurance company and holder of the

registration, the manufacturer or importer does not apply to section 39 c of paragraph 1. 2 (a). (c))

Act No. 48/1997 Coll., in the version in force from the date of entry into force of this

the law.



2. the amount of compensation provided for by the decision of the State of the medicinal product

Institute for drug control (hereinafter referred to as "the Institute") in accordance with Act No. 48/1997

Coll., in the version in force from the date of entry into force of this Act,

considers the level of remuneration of the medicinal product as laid down by law No.

48/1997 Coll., in the version in force until the date of entry into force of this Act,

reduced by the maximum amount of trade margins and on the applied tax

the added value. The amount of the basic remuneration reference group established

the Institute's decision pursuant to Act No. 48/1997 Coll., in the version in force from

the effective date of this Act, is deemed to be the amount of the basic remuneration

established by decision of the Institute by Act No. 48/1997 Coll., as amended by

effective from 1 January 2006. January 2008 to the date of entry into force of this Act,

reduced by the maximum amount of trade margins and on the applied tax

the added value. If the basic remuneration established according to the second sentence,

then the Institute lays down the procedure under section 39 c of paragraph 1. 2 to 5 of law No.

48/1997 Coll., in the version in force from the date of entry into force of this Act.



3. the Department within 60 days from the date of entry into force of this Act shall initiate procedures

to reject reimbursement for medicinal products and foods for particular

medical purposes that are written on the basis of Act No. 261/2007 Coll.

stabilization of public budgets, in the list referred to in paragraph 1(b). paragraph 39n 1 of the law

No. 48/1997 Coll., in the version in force until the date of entry into force of this Act,

and are marked with the symbol B, H, K, T, and U, in order to verify the conditions of the

laid down by section 15 para. 6 of Act No. 48/1997 Coll., in the version in force from the date of

entry into force of this Act. If the Department finds that the reasons for maintaining

the remuneration paid to the management stops and shall forthwith initiate the procedure for the change of the amount and

the terms of payment. In the case of refusal of payment remains the maximum price

medicinal product or foods for special medical purposes in

the validity of.



4. the Institute within 60 days from the date of entry into force of this Act shall initiate procedures

to reject reimbursement for medicinal products and foods for particular

medical purposes, incorporating medicinal substances within the scope of

the annex to Decree No 385/2007 Coll., on the establishment of the list of medicinal substances

for additional support or treatment, in the version in force until the date of

entry into force of this Act, for the purpose of verification of the conditions laid down in §

15 paragraph 1. 6 (a). and Act No. 48)/1997 Coll., in the version in force from the date of

entry into force of this Act. If the control has been demonstrated that the

This is not about medicines to support or additional treatment, Institute of

control stops.



5. the proceedings initiated pursuant to Act No. 48/1997 Coll., in the version in force until the date of

entry into force of this Act, the procedure shall be completed according to the existing

legislation; It does not apply to section 39 g of paragraph 1. 3 and 8, section 39 h of paragraph 1. 2 and 3,

§ 39n and 39o Act No. 48/1997 Coll., in the version in force from the date of acquisition

the effectiveness of this Act.



6. the Institute to 120 days from the date of entry into force of this Act, it shall initiate the

the procedure for the reduction of the maximum prices on medicines and food for

Special medical purposes on the date of entry into force of this Act

exceeded the limitations referred to in § 39a para. 2 of Act No. 48/1997 Coll., on

the version in force from the date of entry into force of this Act.



7. the proceedings initiated pursuant to section 39i and 39 l of Act No. 48/1997 Coll., as amended by

effective until the date of entry into force of this law, the Institute by resolution stops,

If



and assumptions are true) to begin the shortened revision under section 39p

Act No. 48/1997 Coll., in the version in force from the date of entry into force of this

of the Act, and



(b)) if within a period of 30 days from the date of entry into force of this Act

a decision in the case. The day following the legal force

the resolution in the first sentence, the Institute will initiate proceedings under § 39p of the law No.

48/1997 Coll., in the version in force from the date of entry into force of this Act.



8. If the proceedings referred to in point 8, stopped, set out above, remittance of medicinal


medicines and foods for special medical purposes shall be construed as

the highest possible remuneration for the final consumer in accordance with section 39 h of paragraph 1. 1

Act No. 48/1997 Coll., in the version in force from the date of entry into force of this

the law.



9. The appeal against the decision in deep or shortened revision,

the decision on the fixing of maximum prices or decisions fixing the amount of

and conditions of remuneration, as well as their modification or cancellation, and against

the decision in the review issued before the date of entry into force of

This Act have suspensory effect. This decision shall be enforceable

According to the existing legislation.



10. the procedure for price competition under section 39e of Act No. 48/1997 Coll., as amended by

effective until the date of entry into force of this Act, the date of acquisition of the executor

the effectiveness of this law, the Institute by order of stops. Liabilities from price

competition completed under section 39e of Act No. 48/1997 Coll., in the version in force in

the effective date of this Act, apply under Act No. 48/1997 Coll.,

in the version in force until the date of entry into force of this Act, if the

based on the result of this price competition set the basic remuneration

reference group.



11. the Institute to 15. January 2012 will launch proceedings on the cancellation of the payment of the medicinal

products and foods for special medical purposes, of which the price for

the final consumer is less than or equal to $ 50.



PART TWO



Amendment of the Act on general health insurance



Article. (III)



Act No. 592/1992 Coll., on premiums for general health insurance, in

amended by Act No. 10/1993 Coll., Act No. 15/1993 Coll., Act No. 166/1993

Coll., Act No. 333/1993 Coll., Act No. 42/1994 Coll., Act No. 241/1994

Coll., Act No. 58/1995 Coll., Act No. 145/1996 Coll., Act No. 48/1997

Coll., Act No. 125/1998 Coll., Act No. 29/2000 Coll., Act No. 118/2000

Coll., Act No. 258/2000 Coll., Act No. 492/2000 Coll., Act No. 137/2001

Coll., Act No. 48/2002 Coll., Act No. 176/2002 Coll., Act No. 309/2002

Coll., Act No. 424/2003 Coll., Act No. 437/2003 Coll., Act No. 461/2003

Coll., Act No. 53/2004 Coll., Act No. 435/2004 Coll., Act No. 123/2005

Coll., Act No. 381/2005 Coll., Act No. 413/2005 Coll., Act No. 545/2005

Coll., Act No. 62/2006 Coll., Act No. 115/2006 Coll., Act No. 189/2006

Coll., Act No. 216/2006 Coll., Act No. 262/2006 Coll., Act No. 261/2007

Coll., Act No. 296/2007 Coll., Act No. 306/2008 Coll., Act No. 227/2009

Coll., Act No. 281/2009 Coll., Act No. 285/2009 Coll., Act No. 362/2009

Coll. and Act No. 73/2010 Coll., shall be amended as follows:



1. In section 8 paragraph 4 is added:



"(4) the health insurance fund at the request of the self-employed

relatively reducing the amounts of advances on premiums, if the income of the

people from self-employment is after deduction of expenses

incurred to achieve and maintain, providing income that falls in

average of 1 calendar month for the period from 1. January of the calendar year in

end of the calendar month preceding submission of the application, but at least

in the period of 3 consecutive calendar months, at least one

one third lower than income attributable to an average of 1 calendar month in

the previous year, in which at least part of the month has been exercised

self-employed economic activity. The reduction can be performed for a maximum of up to

end of the calendar month preceding the calendar month in which the

was or should have been filed pursuant to section 24 of the overview paragraph. 2. ".



2. In article 12 paragraph 2. 1, the words "to 20. the date "shall be replaced by the words" to 25. of the day ".



3. in § 14 para. 1 and § 16 para. 1, the word ' five ' is replaced by the digit

"10".



4. In article 16(1). 2 the word ' five ' is replaced by the figure "10".



5. In section 20 (2). 3 the first sentence after the word "gender", the words "after the

deduction of part of the costs to the insured person under section 21a of the costly para. 3 "and on the

the end of text in a paragraph, the following sentence "the account administrator is entitled to information

referred to in the sentence of the fifth request in another term, if it decides so

the supervisory authority; in this case, health insurance companies are required to

provide information within 30 calendar days from the date of their

request. ".



6. in article 21, paragraph 1, the following paragraph 2 is added:



"(2) the number of insured persons, for which the State pays the premiums, communicated to the

the relevant health insurance account manager, referred to in paragraph 1 sentence

First, are the basis for the payment of premiums by the State. The account administrator shall notify the

the total number of insured persons according to the first sentence, the Ministry of finance to 12.

day of the calendar month. ".



Paragraphs 2 to 5 shall become paragraphs 3 to 6.



7. in section 21a para. 2 the term "victim's" shall be replaced by

"patnáctinásobku".



8. In section 21a para. 6, after the word "care", the words "referred to in paragraph

3. "



9. in section 21a para. 10, the words "within 3 months after" shall be replaced by the words "in

deadline for the submission of annual reports "and at the end of the text

paragraph, the following sentence "the account administrator is entitled to the information referred to in

the first sentence should even on a different date, decides if the supervisory authority;

in this case, health insurance companies are obliged to submit data in

within 30 calendar days from the date of their request. ".



10. in section 26 para. 2, the words "one year" is replaced by "2 years".



11. In section 27 is at the end of paragraph 1, the following sentence "in the case of a merger

by merging with other Military health insurance health insurance

under special legislation ^ 24), in which the Military Health

insurance company ceases to exist, the rights and obligations provided for in this

by law, Military health insurance company on acquiring a health

the insurance company. ".



12. in section 27, paragraph 3 reads:



"(3) the health insurance fund referred to in paragraph 1 provides data on

changes in the registry, the number of insured persons, which is the payer

State insurance, to 12. day of the month other health

insurance companies set up under a special law ^ 28). ".



13. in paragraph 27, paragraph 4 shall be deleted.



The present paragraph 5 shall become paragraph 4.



Article. (IV)



Transitional provisions



1. If the right to prescribe and enforce the insurance was due before the date of

entry into force of this Act, the procedure shall be in accordance with section 16 of the Act.

593/1992 Coll., in the version in force until the date of entry into force of this Act.



2. the administrator of the special account of the general health insurance when

the calculation of cost indexes under section 20 (2). 3, costly care and

cost of the insured person under section 21a, para. 2, percentage under section

21A, para. 5 and the amount of the advance payments under section 21a, para. 6 of law No.

593/1992 Coll., in the version in force until the date of entry into force of this Act,

It's for the year 2012, in 2011, the values specified in § 21a para. 2 of the Act

No. 592/1992 Coll., in the version in force from the date of entry into force of this

the law.



3. the administrator of the special account of the general health insurance when

the calculation of cost indexes, costly care, cost of the insured person,

the percentage and amount of advance payments shall proceed in 2011, as

If he were to § 21a para. 2 Act No. 586/1992 Coll., in the version in force from

the effective date of this Act, effective in the year 2010.



PART THREE



Amendment of the Act on general health insurance company in the Czech Republic



Article. In



Act No. 551/1991 Coll., on the Czech General health insurance company

Republic, as amended by Act No. 586/1992 Coll., Act No. 10/1993 Coll.

Act No. 60/1995 Coll., Act No. 145/1996 Coll., Act No. 48/1997 Coll.,

Act No. 305/1997 Coll., Act No. 93/1998 Coll., Act No. 125/1998 Coll.,

Act No. 69/2000 Coll., Act No. 132/2000 Coll., Act No. 220/2000 Coll.

Act No. 48/2002 Coll., Act No. 422/2003 Coll., Act No. 461/2003 Coll.,

Act No. 435/2004 Coll., Act No. 115/2006 Coll., Act No. 261/2007 Coll.

Act No. 296/2007 Coll. and Act No. 362/2009 Coll., is amended as follows:



1. In article 12 paragraph 2. 1 the words "district" and "regional" shall be replaced by

"regional", and the words "territorial departments" are replaced by the words "client

workplace ".



2. In article 12 paragraph 2. 2 the term "regional" is replaced by "regional"

and the words "territorial departments" are replaced by the words "client

workplaces ".



3. in § 14 para. 2 the term "regional" is replaced by "regional".



4. in article 15, paragraph 4, the following paragraph 5 is added:



"(5) the Director of an insurance undertaking shall without undue delay notify the

The Management Board, that there was any of the facts referred to in

paragraph 4, which prevent the performance of the duties of the Director of the insurance company because of a

a conflict of interest. ".



Paragraphs 5 and 6 shall be renumbered 6 to 7.



5. In article 18, paragraph 4, the following paragraph 5 is added:



"(5) the duties of a member of the authority of the Insurance ends



and the date of expiry of term of Office)



(b)),



(c)) date of receipt of written statement of resignation to the President of

the competent authority of the assurance undertaking or



(d)) the death or declaration of death date. ".



Paragraphs 5 to 7 shall be renumbered 6 to 8.



6. in article 18, paragraph 6 shall be deleted.



Paragraphs 7 and 8 shall be renumbered as paragraphs 6 and 7.



7. in section 24 c with the word "regional" is replaced by the word "regional", and the words


"territorial departments" are replaced by the words "client departments".



Article. (VI)



Transitional provisions



1. To ensure the quality and availability of health care, the functioning of the system

health and its stability within the financial system options

public health insurance converts to 1. January 2012 at a special

account of the general health insurance scheme, set up by law No.

594/1992. General health insurance company of the United States of

the basic insurance fund an amount equal to one third of the

the amount recorded in general health insurance company of the United States

on this account as of December 31. December 2010.



2. the funds referred to in point 1 shall form part of the first

redistribution in 2012. If the general health insurance company of the United

States fail to comply with the obligation laid down in paragraph 1 to a maximum of 5. January

2012, the Ministry of health to proceed on the initiative of the supervisory

authority pursuant to § 21 para. 4 second sentence of the Act No. 586/1992 Coll., as amended by

effective before the date of entry into force of this Act.



PART FOUR



Amendment of the Act on departmental, industry, corporate, and other health

the insurance companies



Article. (VII)



Act No. 280/1992 Coll., on departmental, industry, corporate, and other

health insurance undertakings, as amended by Act No. 10/1993 Coll., Act No.

15/1993 Coll., Act No. 60/1995 Coll., Act No. 145/1996 Coll., Act No.

48/1997 Coll., Act No. 93/1998 Coll., Act No. 125/1998 Coll., Act No.

225/1999 Coll., Act No. 220/2000 Coll., Act No. 48/2002 Coll., Act No.

420/2003 Coll., Act No. 435/2004 Coll., Act No. 115/2006 Coll., Act No.

267/2006 Coll., Act No. 261/2007 Coll., Act No. 296/2007 Coll., Act No.

351/2009 Coll. and Act No. 362/2009 Coll., is amended as follows:



1. In section 6 paragraph 3 reads:



"(3) Merge with the general health insurance company of the United States

shall notify the insurer immediately to the Ministry of employment zrušovaná

the health sector. Merge employee insurance requires a permit.

This permit is issued by the Ministry of health after consultation of the

The Ministry of finance. With applications for authorisation shall be submitted by the employee

the new health insurance plan insurance. Employee insurance companies are

required to demonstrate that they meet the conditions required for the granting of

authorization to perform comprehensive health insurance, with the exception of

conditions referred to in paragraph 4a; ".



2. In article 6, paragraphs 4 and 5 shall be deleted.



Paragraphs 6 to 9 shall be renumbered as paragraphs 4 to 7.



3. In section 6 (1). 5, the words "paragraphs 4 or 5" shall be replaced by "paragraph

3. "



4. In article 6 (1). 7, the words "paragraphs 8 (a). a) "is replaced by

"paragraph 6(a). and) ".



5. In article 7 (2). 7, the words "§ 6 para. 9 "shall be replaced by the words" § 6 para. 7. "



6. In paragraph 9a(1). 6, the word "defunct" is deleted and at the end of paragraph text

shall be added the words ", which was canceled with the liquidation under section 6 (1).

6. "



7. in section 9a, the following paragraph 9 is added:



"(9) the Director employee insurance company shall without undue delay

report to the Board, that one of the listed

in paragraph 5, which prevent the performance of the duties of the Director of employee

the insurance company because of a conflict of interest. ".



8. In section 10, paragraph 1. 2, letter g) the following point (h)), which read as follows:



"(h)) on the proposal for an application for authorization to merge employee

insurance companies ".



Letter h) is referred to as the letter i).



9. in section 10, paragraph 1. 3 and § 10 (1). 5 (b). (b)), after the words "the members elected"

the words "from the ranks of the insured persons of the employee insurance company".



10. In section 10, paragraph 1. 4 the second sentence, the words "f) and (g))" shall be replaced by "f) up to

(h)) ".



11. in section 10, paragraph 1. 7 the third sentence, the word "defunct" is deleted and at the end of

the text of the paragraph with the words ", which was canceled with the liquidation

According to § 6 paragraph 1. 6. "



12. in section 10, paragraph 9 shall be deleted.



Paragraphs 10 to 13 shall become paragraphs 9 to 12.



13. in section 10, the following paragraph 13, which read as follows:



"(13), the duties of a member of the authority of the employment insurance ends



and the date of expiry of term of Office)



(b)),



(c)) date of receipt of written statement of resignation to the President of

the competent authority of employee insurance,



(d)) the date on which he became a member of the, which is the body elected by employers and

insurance by the insured person to the insured employee, other health

the insurance undertaking, or



(e) the date of the death or declaration) for the dead. ".



14. in § 22a para. 2 the words "§ 6 para. 8 (a). a) "are replaced by the words" §

6 (1). 6 (a). and) ".



15. section 25 reads:



"§ 25



In the case of a merger by acquisition, the military health insurance with another

health insurance, in which the Military health insurance company ceases to exist,

rights and obligations provided for in this law, Military

health insurance, as well as the obligations laid down by the Ministry of defence

and other individuals to military health insurance company, to the acquiring

a health insurance company. ".



Article. (VIII)



Transitional provisions



1. the health insurance of Ministry of Interior of the Czech Republic and the military

health insurance are required to bring their statutes in accordance with the

Act No. 280/1992 Coll., in the version in force from the date of entry into force of

This law, and to submit them for approval to the Ministry of health

within 3 months from the date of entry into force of this Act.



2. To ensure the quality and availability of health care, the functioning of the system

health and its stability within the financial system options

public health insurance transferred to 1. January 2012 at a special

General health insurance account established under Act No. 592/1992

SB.



and, industry-wide, departmental) corporate and other health insurance companies from

the basic insurance fund an amount equal to one third of the

the amount you recorded the appropriate health insurance on this account to

31 December 2010,



b) hedge fund an amount equal to 95% of the funds

This Fund to record 31. December 2010.



3. the funds referred to in point 2 shall become part of the first

redistribution in 2012. If your health insurance company

fail to comply with the obligation laid down in paragraph 2 (a). and) within a maximum of 5. January

2012, the Ministry of health to proceed on the initiative of the supervisory

authority pursuant to § 21 para. 4 second sentence of the Act No. 586/1992 Coll., as amended by

effective before the date of entry into force of this Act.



PART FIVE



Amendment of the Act on the protection of public health



Article. (IX)



Act No. 258/2000 Coll., on the protection of public health and amendment to certain

related laws, as amended by Act No. 254/2001 Coll., Act No.

273/2001 Coll., Act No. 13/2002 Coll., Act No. 76/2002 Coll., Act No.

86/2002 Coll., Act No. 120/2002 Coll., Act No. 320/2002 Coll., Act No.

274/2003 Coll., Act No. 356/2003 Coll., Act No. 361/2003 Coll., Act No.

167/2004 Coll., the Act No. 326/2004 Coll., Act No. 561/2004 Coll., Act No.

125/2005 Coll., Act No. 251/2005 Coll., Act No. 381/2005 Coll., Act No.

392/2005 Coll., Act No 444/2005 Coll., Act No. 59/2006 Coll., Act No.

74/2006 Coll., Act No. 186/2006 Coll., Act No. 189/2006 Coll., Act No.

222/2006 Coll., Act No. 262/2006 Coll., Act No. 342/2006 Coll., Act No.

110/2007 Coll., Act No. 296/2007 Coll., Act No. 378/2007 Coll., Act No.

124/2008 Coll., Act No. 130/2008 Coll., Act No. 274/2008 Coll., Act No.

41/2009 Coll., Act No. 227/2009 Coll., Act No. 281/2009 Coll., Act No.

301/2009 Coll. and Act No. 151/2010 Coll., shall be amended as follows:



1. In article 47, paragraph 1 reads:



"(1) for the regular, special and extraordinary may vaccination

medical devices use only vaccine by antigenního

the composition of vaccines provided by the Ministry of health according to the

§ 80 para. 1 (b). e). This does not apply in the case of regular vaccinations and

natural person requests that he perform a different registered vaccine

substance. ".



2. In article 47, paragraph 2 shall be deleted.



The former paragraph 3 shall become paragraph 2.



3. section 49 reads as follows:



"§ 49



(1) is to be paid from the State budget of the vaccine for the specific and

emergency vaccination.



(2) from the State budget is further borne by the vaccine for the regular

vaccination of individuals who are not insured under the Act

adjusting public health insurance. ".



4. In paragraph 51, the existing text shall become paragraph 1 and the following

paragraph 2, which reads as follows:



"(2) the health insurance fund shall communicate to the Ministry of

health care the number of vaccinated insured persons broken down according to a vaccination

the calendar set by the implementing regulation, and 30.

April of the calendar year for the previous calendar year. ".



5. In § 80 para. 1 letter e) is added:



"(e)) shall be based on the recommendation of the Commission, set up by the National immunization

as an advisory body to the Ministry of health, the antigenic composition of

vaccines for regular, special and emergency vaccination, and

publish is in the form of the communication in the statute book, and always to 28. February

the calendar year ".



6. In article 80, paragraph 8 shall be deleted.



The former paragraph 9, renumbered 8.



PART SIX



Amendment of the law on the army of the Czech Republic



Article. X



In the Act No. 15/1993 Coll., on the army of the United States and about the changes and


certain related laws, as amended by law No 224/1999

Coll., is part of the second deleted.



PART SEVEN



The EFFECTIVENESS of the



Article. XI



This Act shall take effect on the first day of the second calendar month

following the date of its publication, with the exception of article. I, points 25, 33, 34 and

article. (IX), which shall take effect on 1 January 2000. January 2012.



Němcová in r.



Klaus r.



Nečas in r.