NAPPI CODE ALLOCATION POLICY VERSION 2.7

Transcription

1 NAPPI CODE ALLOCATION POLICY VERSION 2.7 Cpyright Ntice: Cpyright reserved by MediKredit Integrated Healthcare Slutins (Pty) Ltd 10 Kikuyu Rd, Sunninghill, Sandtn, 2157 All rights, title and interest in the infrmatin cntained in this dcument, including all cpyrights therein, are prprietary t MediKredit Integrated Healthcare Slutins (Pty) Ltd. Any use, distributin, reprductin, cpying r transmissin f this dcument, withut the prir written cnsent f MediKredit Integrated Healthcare Slutins (Pty) Ltd, is prhibited, and may in certain circumstances make the der liable fr civil law cpyright infringement and subject t criminal prsecutin. 1

2 1. BACKGROUND AND PURPOSE OF THE NAPPI CODE OBJECTIVES NON-SURGICAL PRODUCTS SURGICAL PRODUCTS RENTAL MEDICAL DEVICES AND APPLIANCES GENERAL POLICY ISSUES

3 1. BACKGROUND AND PURPOSE OF THE NAPPI CODE 1.1. NAPPI (Natinal Pharmaceutical Prduct Interface) is a glbally unique natinal cding system, wned by MediKredit Integrated Healthcare Slutins (Pty) Ltd ( MediKredit ), fr all pharmaceutical, surgical and cnsumable healthcare prducts in the RSA A NAPPI cde is a unique identifier fr a given pharmaceutical, surgical r cnsumable healthcare prduct which enables electrnic transfer f infrmatin thrughut the healthcare delivery chain. Tariff cdes, n the ther hand, are used as the standard fr electrnic infrmatin exchange fr prcedure and cnsultatin claims NAPPI cdes enable healthcare prviders t claim frm medical schemes fr the reimbursement f prducts via a unique, medical scheme-recgnised, cde. NAPPI has als been vluntarily adpted as a natinal electrnic standard n behalf f the Suth African private healthcare industry Applicatin fr a NAPPI Cde is a vluntary prcess that is initiated by the manufacturer / supplier The allcatin f a NAPPI cde by MediKredit des hwever nt serve as an endrsement r accreditatin f the prduct in questin by MediKredit, nr is it a guarantee f reimbursement f any given prduct by a medical scheme MediKredit, as custdians f the NAPPI Prduct File, publishes the allcated NAPPI cdes in the public dmain. This public dmain file cntains infrmatin n the NAPPI cde, prduct descriptin, prduct strength (where applicable), dsage frm (where applicable), catalgue number (where applicable), pack size and manufacturer / supplier MediKredit is als ne f the price file vendrs / managers in the healthcare industry. A price file typically cnsists f the NAPPI public dmain file infrmatin as well as the assciated prices Please nte that the registratin and evaluatin f pharmaceutical, surgical and cnsumable healthcare prducts are regulated by the Medicines and Related Substances Act 101 f 1965 and the regulatins theret ( the Act ), and fall within the purview f the Suth African Health Prducts Regulatry Authrity ( SAHPRA ), previusly the Medicines Cntrl Cuncil ( MCC ), and nt MediKredit. 3

4 2. OBJECTIVES 2.1. The NAPPI Cde Allcatin Plicy ( Plicy ) is designed t establish clear guidelines, business rules and plicies in the NAPPI allcatin prcess t ensure an accurate NAPPI prduct database and cnsistency in allcatin These guidelines, business rules and plicies are defined and updated where necessary in cnjunctin with the NAPPI Advisry Bard (NAB) which cnsists f healthcare industry rle-players wh may utilise ne r mre f the prduct database cmpnents The guidelines, business rules and plicies distinguish between the tw majr prduct classes i.e. Nn-surgical and Surgical prducts in terms f requirements fr NAPPI cde allcatin. 3. NON-SURGICAL PRODUCTS 3.1. The nn-surgical prducts are defined fr the purpses f the Plicy as: Ethical prducts Sectin 21 prducts Cmplementary prducts Ttal Parenteral Nutritinal Prducts (TPN) Bld prducts Nn-surgicals ther 3.2. Ethical Prducts Descriptins accrding t the Act: Legal Descriptin f Medicine The prduct must be a medicine as defined in the Medicines and Related Substances Act 101 f 1965: medicine - (a) means any substance r mixture f substances used r purprting t be suitable fr use r manufactured r sld fr use in- (i) (ii) the diagnsis, treatment, mitigatin, mdificatin r preventin f disease, abnrmal physical r mental state r the symptms theref in humans; r restring, crrecting r mdifying any smatic r psychic r rganic functin in humans; and (b) includes any veterinary medicine The fllwing are the basic categries f medicines accrding t the Act: 4

5 General Descriptins Medicines Categry A: Medicines which are intended fr use in humans and which are, withut manipulatin, ready fr administratin, including packaged preparatins where nly a vehicle is added t the effective medicine. Categry B: Medicines which can nt nrmally be administered withut further manipulatin. Categry C: Medicines intended fr veterinary use which are, withut further manipulatin, ready fr administratin, including packaged preparatins where nly a vehicle is added t the effective medicine. Categry D: Cmplementary medicines intended fr use in humans and animals, which are, withut manipulatin, ready fr administratin, including packaged preparatins where nly a vehicle is added t the effective medicine. Medicines are substances designed fr the preventin and treatment f diseases in all its relatins, especially thse nt usually requiring surgical interventin. As the Plicy des nt cater fr the allcatin f NAPPI cdes fr veterinary prducts (Categry C medicines), these are currently excluded frm the peratin f this Plicy Galenical Prducts (Categry B Medicines) Galenicals are remedies prepared accrding t an fficial frmula and cnsist f: Herbs and ther vegetable drugs, as distinguished frm mineral r chemical remedies. Crude ils and the tinctures, decctins and ther preparatins made frm them, as distinguished frm the alkalids and ther active principles. Galenical prducts are generally in pwder, liquid r cream frm and used in mixtures. Prducts include Ung Emulsificans, Zinc Oxide, Mrphine Pwder and many thers. Galenicals may als be defined as materials nt intended fr use until further manipulatin f the prduct has taken place Nutritinal Supplements and Feeds Falling int this categry are fdstuffs that are subject t registratin with SAHPRA / MCC, generally used in hspitals. Such fdstuffs are intrduced thrugh the gastrintestinal tract, rally, nas-gastric and / r sme ther means referring particularly by intravenus, subcutaneus, intramuscular, r intra-medullary injectin, t cntribute t the patient s recvery. 5

6 Nutritinal feeds are further subdivided int: Transparenteral Feeds i.e. intrduced via intravenus injectin Other Vitamins Cntrast Medium Screening Tests Vitamins are ne f a grup f rganic substances present in minute amunts in natural fdstuffs that are essential t the nrmal metablism. Insufficient amunts in the diet may cause deficiency diseases. Vitamins that are regarded as categry A medicines are thse where the vitamin cntent is abve the levels as cntained in the Schedules t the Act. Any internally administered substance that has a different pacity frm sft tissue n radigraphy r cmputed tmgraphy; used t pacify parts f the gastrintestinal tract, bld vessels, r the geniturinary tract. General NAPPI cdes are issued fr use by e.g. pharmacists fr the rendering f the service f perfrming a screening test t identify a ptential health prblem in a patient. This is used specifically where the healthcare discipline des nt have a specific tariff cde e.g. Suth African Pharmacy Cuncil s guidelines fr a pharmacist levying fees t claim fr services rendered. These NAPPI cdes are nt specific t material used e.g. Wellness screening test Health assessment In the event that a tariff cde is issued fr a screening test with a NAPPI cde, the NAPPI cde fr the specific screening test will be discntinued Business Rules fr the allcatin f NAPPI cdes Categry A medicines Manufacturer / Whlesaler / Distributr requirements The manufacturer, whlesaler r distributr f the ethical prducts must be a registered cmpany, registered clse crpratin r individual. Details f the registratin number and the cuntry f registratin must be supplied in respect f a cmpany r clse crpratin. If trading in persnal capacity, the individual s ID number / passprt number is required The NAPPI applicant needs t be the hlder f the registratin with SAHPRA / MCC as it appears n the SAHPRA / MCC registratin certificate. 6

7 Manufacturers, whlesalers r distributrs f medicines must be the hlder f a license issued by SAHPRA / MCC, as cntemplated in Sectin 22C(1)(b) f the Act, t manufacture, imprt, act as a whlesaler f, r distribute, as the case may be, any medicine. The prducts f nn-licensed manufacturers, whlesalers and distributrs d nt qualify fr NAPPI cdes. [See Sectin 22C(6) and General Regulatin 19 f the Act] Prduct requirements The prduct must be registered as a medicine in terms f the Act. Please refer t General Regulatin 22 fr registratin requirements and General Regulatin 26 regarding the certificate f registratin All ethical prducts that are subject t the Single Exit Price (SEP) legislatin require SEP apprval by the Department f Health (DOH) befre a NAPPI cde can be released int the public dmain All medicines and scheduled substances that are subject t registratin in terms f the Act will qualify fr NAPPI allcatin, excluding Categry C medicines Dcumentatin requirements include the SAHPRA / MCC registratin certificate, the apprved Package Insert and a price fr the prduct frm a registered manufacturer / whlesaler / distributr in terms f the Act. Nte fr ethical prducts subject t SEP legislatin, the NAPPI cde can nly be released int the public dmain upn SEP apprval as indicated abve Where the cst f the prduct is already included in the tariff, acrss all relevant disciplines, a NAPPI cde will nt be allcated. Anaesthetic gasses are exempted frm this rule as the current tariff guide nly caters fr a per minute billing structure. Anaesthetic gasses are scheduled substances and are subject t the Single Exit Price legislatin and hence need t be billed per millilitre. Anaesthetic gasses therefre qualify fr NAPPI cde allcatin as the current tariff cdes d nt cater fr the apprpriate billing f these prducts All scheduled raw materials require a cpy f the imprt permit as issued by SAHPRA / MCC t the imprter t accmpany the NAPPI cde applicatin as well as the technical reprt frm a lcal independent labratry verifying purity & ther chemical standards f the material All nn-scheduled raw materials shuld have pharmaceutical applicatins befre a NAPPI cde can be issued Submissin Requirements Summary- Ethical prducts SAHPRA / MCC registered prducts All submissins fr MCC registered prducts must be accmpanied by a SAHPRA / MCC registratin certificate, Package Insert and price per pack size either SEP r nn-sep. Als f imprtance is the effective date f the availability f the prduct i.e. the date that the prduct will first be available in the public dmain fr electrnic prcessing. This 7

8 may be f strategic imprtance t a manufacturer / whlesaler / distributr and therefre must be clearly indicated in the applicatin hwever fr SEP prducts, this cannt be befre the date f SEP apprval by the DOH Health supplements (including vitamins, minerals and ther health supplements) NAPPI cdes will be allcated t dietary supplements that cntain vitamins, minerals, and ther health supplements alne r in cmbinatin that are belw the scheduled levels as per Gazette N f 11 February The applicatin must be accmpanied by a price clearly indicated as Whlesale r Retail, in the event that SEP is nt applicable, and whether inclusive r exclusive f VAT. The Package Insert and cntainer label must als accmpany the applicatin. Refer t (i) abve fr health supplements that are abve the scheduled levels Galenical prducts (Categry B medicines) 3.4. Sectin 21 Prducts All submissins fr galenical prducts must be accmpanied by the frmulatin and price f the prduct- clearly indicated as Whlesale r Retail, in the event that SEP is nt applicable, and whether inclusive r exclusive f VAT. Either a Package Insert r a cpy f the cntainer label must als accmpany the applicatin Descriptins accrding t the Act: Legal Descriptin f sectin 21 Prduct In terms f sectin 21 f the Act as alluded t in Sectin 14(1), SAHPRA may authrise the sale f unregistered medicines fr certain purpses as fllws: (1) SAHPRA may in writing authrise any persn t sell during a specified perid t any specified persn r institutin a specified quantity f medicine which is nt registered. (2) Any medicine sld in pursuance f any authrisatin under paragraph 1 abve may be used fr such purpses and in such a manner and during such perid as SAHPRA may in writing determine. (3) SAHPRA may at any time by ntice in writing withdraw the authrisatin granted in terms f paragraph 1 abve if effect is nt given t any determinatin made in terms f paragraph 2 abve. Sectin 21 mandates SAHPRA t apprve the use f unregistered medicine. SAHPRA therefre, is required t address the fllwing requirements f Sectin 21: 8

9 Authrise sales Specify the perid f sale Specify the purchaser r institutin Specify the quantity f medicine Determine the purpse fr the use f such medicine Determine the manner f use Determine the perid f use Withdrawal f the authrity t sell r use General Descriptin f a Sectin 21 Prduct A sectin 21 prduct is a drug which des nt have registratin in Suth Africa with SAHPRA, but which has been granted limited apprval t be sld in a specific quantity, ver a specific time perid and t a specific persn r institutin Business Rules fr allcatin f NAPPI cdes- Sectin 21 Prducts In rder t cater fr requests frm the industry fr sme frm f differentiatin between the varius Ethical Sectin 21 prducts, MediKredit has made prvisin fr the creatin f individual NAPPI cdes fr the varius Sectin 21 prducts currently being utilised with SAHPRA / MCC apprval in Suth Africa Manufacturer / Whlesaler / Distributr requirements - Sectin 21 Prducts The manufacturer, whlesaler r distributr must be a registered cmpany, registered clse crpratin r individual. Details f the registratin number and the cuntry f registratin must be supplied in respect f a cmpany r clse crpratin. If trading in persnal capacity, the individual s ID number / passprt number is required. The NAPPI applicant must be the highest authrity in the supply chain fr the prduct in questin within the brders f Suth Africa. If the prduct is imprted frm verseas, the immediate imprter f the prduct shuld be the applicant and subsequent wner f the NAPPI cde and nt the whlesalers and/r distributrs that are buying frm such imprter. If mre than ne entity has a license t imprt directly frm the manufacturer/supplier verseas each such entity will be entitled t a NAPPI cde fr its prduct. Manufacturers, whlesalers r distributrs f medicines must be the hlder f a license issued by SAHPRA / MCC, as cntemplated in Sectin 22C(1)(b) f the Act, t manufacture, imprt, act as a whlesaler f, r distribute, as the case may be, any medicine. The prducts f nn-licensed manufacturers, whlesalers and distributrs d nt qualify fr NAPPI cdes. [See Sectin 22C(6) and General Regulatin 19 f the Act in this regard]. All requests will nly be cnsidered if submitted by the persn whse prduct has been granted the Sectin 21 apprval. 9

10 Prduct requirements Sectin 21 Prducts NAPPI cdes will nly be allcated t Sectin 21 drugs that have a valid Sectin 21 apprval at the time f applicatin f the NAPPI cde. The Sectin 21 Nn-specific NAPPI cde (702508) which is currently available will cntinue t be available in the public dmain fr thse manufacturers and medical schemes that wish t cntinue t utilise this cde. The pricing f the unique sectin 21 NAPPI cde will be inflated by 15% f the prducts actual price at the time f applicatin. This wuld thus cater fr currency fluctuatins that may ccur with these prducts as they are imprted. Shuld the price f the Sectin 21 prduct increase by mre than 15% and exceed the NAPPI reference price, the nus is n the supplier f the prduct t infrm Medikredit t update the price t prevent shrt payments. The term (Sectin 21) will be added at the end f the prduct descriptin t identify the prduct as such. Shuld a prduct be discntinued internatinally and n lnger be brught int Suth Africa, the imprter f that particular prduct shuld infrm MediKredit s that the applicable Sectin 21 NAPPI cde can be discntinued in the public dmain files. Where the Sectin 21 prduct becmes registered and the Single Exit Price (SEP) apprved by the Department f Health (DOH), the term (Sectin 21) will be remved frm the descriptin and the price will be adjusted t the apprved SEP i.e. the same NAPPI cde will cntinue t be used after registratin Submissin Requirements Summary- Sectin 21 prducts Each applicatin has t be submitted by the prduct manufacturer imprting the prduct int the cuntry and wh hlds the Sectin 21 apprval. A NAPPI cde will nly be allcated if a Sectin 21 apprval letter frm SAHPRA / MCC is supplied as evidence. This dcument must be valid at the time f applicatin. (Als see under Prduct requirements.) Every applicatin fr a new Individual Sectin 21 NAPPI cde has t be accmpanied by a Registered Package Insert frm the cuntry it is being imprted frm. If the Package Insert is nt available in English, a translated versin shuld be supplied. 10

11 3.5. Cmplementary Medicines (Categry D medicines) Descriptins accrding t the Act: Legal descriptin f cmplementary medicine Accrding t the Gvernment Gazette N f 15 Nvember 2013 the definitin f a cmplementary medicine is as fllws: cmplementary medicine means any substance r mixture f substances that- (a) (b) (c) riginates frm plants, minerals r animals; is used r intended t be used fr, r manufactured r sld fr use in assisting the innate healing pwer f a human being r animal t mitigate, mdify, alleviate r prevent illness r the symptms theref r abnrmal physical r mental state; and is used in accrdance with the practice f the prfessins regulated under the Allied Health Prfessins Act, 1982 (Act N. 63 f 1982) Business Rules - Cmplementary Medicines Manufacturer / Whlesaler / Distributr requirements - Cmplementary Medicines The manufacturer, whlesaler r distributr must be a registered cmpany, registered clse crpratin r individual. Details f the registratin number and the cuntry f registratin must be supplied in respect f a cmpany r clse crpratin. If trading in persnal capacity, the individual s ID number / passprt number is required. The NAPPI applicant must be the highest authrity in the supply chain fr the prduct in questin within the brders f Suth Africa: If the prduct is manufactured within the brders f Suth Africa, the manufacturer shuld be the applicant and subsequent wner f the NAPPI cde and nt the whlesalers and/r distributrs that are buying frm such manufacturer. If the prduct is imprted frm verseas, the immediate imprter f the prduct shuld be the applicant and subsequent wner f the NAPPI cde and nt the whlesalers and/r distributrs that are buying frm such imprter. If mre than ne entity has a license t imprt directly frm the manufacturer/supplier verseas each such entity will be entitled t a NAPPI cde fr its prduct. 11

12 Prduct requirements - Cmplementary Medicines Applicatins fr cmplementary medicines must be accmpanied by the relevant SAHPRA / MCC registratin certificate, where applicable. Cmplementary medicines falling int categry D that became available after 15 Nvember 2013 are subject t registratin with SAHPRA / MCC and require a SAHPRA / MCC registratin certificate. Cmplementary medicines falling int categry D that were available prir t 15 Nvember 2013 wuld require registratin in accrdance with the timelines indicated in the Rad Map fr Registratin f Cmplementary Medicines as published by SAHPRA / MCC. Where a registratin certificate is required, it must accmpany the NAPPI applicatin. A stamped MBR20.8 is required fr prducts available prir t 15 Nvember 2013 that are nt subject t call-up as indicated abve. Currently health supplements are nt part f cmplementary medicines as per the regulatins published n 15 Nvember 2013 hwever draft regulatins have been published t include health supplements int the definitin f cmplementary medicines. Until such time that health supplements are included in the cmplementary medicines regulatins, NAPPI cde will be allcated withut any regulatry requirements. Additinally, the applicatin must be accmpanied by a price, clearly indicated as Whlesale r Retail, in the event that SEP is nt applicable, and whether inclusive r exclusive f VAT. A Package Insert and a cpy f the cntainer label must als accmpany the applicatin Ttal Parenteral Nutritinal Prducts (TPN) Descriptins: Legal Descriptin Clear guidance and instructins given fr the creatin and cmpunding f patient specific TPN in pharmacies under rules and 2.20 f the Rules relating t Gd Pharmacy Practice published in terms f sectin 35A(b)(ii) f the Pharmacy Act 53 f General Descriptins Ttal parenteral nutritin (TPN), is the practice f feeding a persn intravenusly, when nutritinal supprt by the gastrintestinal tract is impssible r inadequate. It is nrmally used fllwing surgery, when feeding by muth r using the gut is nt pssible, when a persn's digestive system cannt absrb nutrients due t chrnic disease, r, 12

13 alternatively, if a persn's nutrient requirement cannt be met by enteral feeding (tube feeding) and supplementatin. Fdstuffs as a categry makes prvisin fr distinctin between: Parenteral feeds (Ethical Fdstuffs) vs. General Fdstuffs (See sectin 1.6 f this Plicy titled Nn Surgicals ther ) Based n the nature f the prduct as well as SAHPRA / MCC exemptin status, ttal parenteral nutritinal prducts (TPNs) is regarded as a separate categry which des nt require the limited audit prcess by SAHPRA / MCC fr cmplementary medicines. The main reasn fr this is because all individual cmpnents f TPNs are registered with SAHPRA / MCC and have individual NAPPI cdes. Distinctin is further made between: Standard (All cmpnents registered with SAHPRA / MCC and underg the same registratin prcess as fr Ethical prducts in terms f this Plicy. N unregistered cmpnents can be added, in which case it wuld be at a patient specific level.) Patient Specific TPN (Made up in hspitals r by registered manufacturing sites n a patient specific basis using the gd manufacturing prcedures as utlined in rules and 2.20 f the Rules relating t Gd Pharmacy Practice published in terms f sectin 35A(b)(ii) f the Pharmacy Act 53 f 1974.) Business Rules fr Allcatin f NAPPI cdes- TPN Prducts Manufacturer Requirements- TPN Prducts The manufacturer, whlesaler r distributr f Standard TPN must be a registered cmpany, registered clse crpratin r individual. Details f the registratin number and the cuntry f registratin must be supplied in respect f a cmpany r clse crpratin. If trading in persnal capacity, the individual s ID number / passprt number is required. The Standard TPN NAPPI applicant must be the highest authrity in the supply chain fr the prduct in questin within the brders f Suth Africa: If the prduct is manufactured within the brder f Suth Africa the manufacturer shuld be the applicant and subsequent wner f the NAPPI cde, and nt the whlesalers and/r distributrs that are buying frm such manufacturer If the prduct is imprted frm verseas the immediate imprter f the prduct shuld be the applicant and subsequent wner f the NAPPI cde and nt the whlesalers and/r distributrs that are buying frm such imprter. If mre than ne entity has a license t imprt directly frm the manufacturer/supplier 13

14 verseas each such entity will be entitled t a NAPPI cde fr its prduct Manufacturers, whlesalers r distributrs f medicines must be the hlder f a license issued by SAHPRA / MCC, as cntemplated in Sectin 22C(1)(b) f the Act, t manufacture, imprt, act as a whlesaler f, r distribute, as the case may be, any medicine. The prducts f nn-licensed manufacturers, whlesalers and distributrs d nt qualify fr NAPPI cdes. [See Sectin 22C(6) and General Regulatin 19 f the Act in this regard]. The cntents f a standard TPN KIT cannt be multi-surced and is cnfined t ethical cmpnents frm a single manufacturer Prduct Requirements All cmpnents f a standard TPN must be registered as a medicine in terms f Sectin 14 (1) f the Act which prvides as fllws: Save as prvided in this sectin r sectins 21 and 22A, n persn shall sell any medicine, medical device r IVD which is subject t registratin by virtue f a declaratin published in terms f subsectin (2) unless it is registered. Please als see General Regulatin 22 fr registratin requirements and General Regulatin 26 regarding the certificate f registratin. All medicines and scheduled substances that are subject t registratin in terms f the Act will qualify fr NAPPI allcatin, excluding Categry C medicines which are classified as Medicines intended fr veterinary use which are, withut further manipulatin, ready fr administratin, including packaged preparatins where nly vehicle is added t the effective medicine. [Please see General Regulatin 25(1)(c) in this regard]. All ethical prducts require SAHPRA / MCC registratin and shuld adhere t gd manufacturing principles as prescribed by SAHPRA / MCC. Befre MediKredit can allcate a NAPPI cde, MediKredit requires the SAHPRA / MCC registratin certificate, apprved Package Insert and a price fr the prduct frm a registered Manufacturer / Supplier in terms f the Act. All scheduled raw materials require a cpy f the imprt permit as issued by SAHPRA / MCC t the imprter t accmpany the NAPPI cde applicatin as well as the technical reprt frm a lcal independent labratry verifying purity & ther chemical standards f the material. All nn-scheduled raw materials shuld have ethical applicatins befre a NAPPI cde can be issued. All standard TPNs t be treated as KITs where individual registered cmpnents are used as KIT cntents: 14

15 Standard Kit principles t be applied e.g. Price fr a standard TPN can never be mre than the price f the cmpnents within the KIT. Scheduling status f the KIT will be determined by the scheduling status f the individual cmpnents. Because cmpnent scheduling is dependent n the cmpnent cncentratin in the TPN the highest schedule f the cmpnents will be used as per instructin frm the manufacturer. A dsage frm cde fr TPN KITS is listed as TPN t distinguish frm ther KITS. Cmpnents f a TPN KIT will be limited t ethical cmpnents fr which there is an existing NAPPI cde that was assigned as per the nrmal Plicy. Patient Specific TPNs t be treated as Sectin 21 items and Sectin 21 TPN NAPPI cde used t distinguish TPNs frm ther Sectin 21 nn-specific items. In rder t distinguish a TPN Sectin 21 item frm ther Sectin 21 NAPPI cdes a new Sectin 21 TPN Nn-Specific NAPPI cde was created. The details f the TPN Nn-specific NAPPI cde are as fllws: NAPPI Cde: Descriptin: TPN Nn-Specific Maximum Price: R2, (Retail VAT Incl.) In view f the abve Plicy change all existing NAPPI cdes fr patient-specific TPNs have been discntinued as the Sectin 21 TPN NAPPI cde shuld be used fr all f these items in future Submissin Requirements Summary- TPN prducts All submissins fr Standard TPN prducts need t list all cmpnents f the prduct and all cmpnents need t be SAHPRA / MCC registered. The submissin must be accmpanied as indicated in the sectin catering fr Prduct Requirements - by a SAHPRA / MCC registratin certificate, Package Insert and prices fr the individual cmpnents. The price f the cmplete TPN Kit cannt be greater than the price f all the active cmpnents. Als f imprtance is the effective date f the availability f the prduct i.e. the date that the prduct will first be available in the public dmain fr electrnic prcessing. This may be f strategic imprtance t a manufacturer and therefre must be clearly indicated in the applicatin. 15

16 3.7. Bld Prducts Descriptin: Prducts prcessed frm whle human bld r prtins theref Business Rules - Bld prducts Manufacturer Requirements - Bld prducts The manufacturer, whlesaler r distributr must be a registered cmpany, registered clse crpratin r individual. Details f the registratin number and the cuntry f registratin must be supplied in respect f a cmpany r clse crpratin. If trading in persnal capacity, the individual s ID number / passprt number is required. Bld prducts are nt required t be registered by SAHPRA / MCC and therefre d nt have registratin numbers. Hwever, fr bld prducts t be allcated a NAPPI cde the prduct must be prduced by a Bld Transfusin Service which is: Licensed t perate in accrdance with the Regulatins: Bld and Bld Prducts, which are issued in terms f the Natinal Health Act N. 61 f 2003 (these Regulatins were published under Gvernment Ntice R179 in Gvernment Gazette f 2 March 2012). Fully accredited by the Suth African Natinal Accreditatin Services (SANAS), r an equivalent bdy, in terms f the SANAS Requirements fr Accreditatin f Bld Transfusin Services. The NAPPI applicant must be the highest authrity in the supply chain fr the prduct in questin within the brders f Suth Africa: If the prduct is manufactured within the brders f Suth Africa, the manufacturer shuld be the applicant and subsequent wner f the NAPPI cde and nt the whlesalers and/r distributrs that are buying frm such manufacturer. If the prduct is imprted frm verseas the immediate imprter f the prduct shuld be the applicant and subsequent wner f the NAPPI cde and nt the whlesalers and/r distributrs that are buying frm such imprter. If mre than ne entity has a license t imprt directly frm the manufacturer/supplier verseas each such entity will be entitled t a NAPPI cde fr its prduct Prduct Requirements - Bld prducts The prduct must be prduced in accrdance with the Standards fr Practice f Bld Transfusin in Suth Africa as determined by the Minister f Health pursuant t Regulatin 13 the Regulatins: Bld and Bld Prducts, which are issued in terms f the Natinal Health Act N. 61 f 2003 (these Regulatins were published under Gvernment Ntice R179 in Gvernment Gazette f 2 March 2012). 16

17 Where multi-surced bld is used t prduce an ethical prduct, that prduct wuld be treated as a medicine as defined in the Act and wuld need t cmply with the requirements as set ut in the relevant sectin f this Plicy t qualify fr NAPPI allcatin Submissin Requirements Summary- Bld prducts The applicant must be a registered Bld Transfusin Service Nn-Surgicals: Other (any nn-surgical nt regarded as an ethical prduct r cmplementary medicine r cvered under the Sectin 21 rules) Fdstuffs, csmetics r disinfectants that are nt subject t registratin in terms f the Act with SAHPRA / MCC as an ethical, r as a cmplementary medicine, will nt qualify fr NAPPI allcatin. Included under these categries are the fllwing: Fdstuffs defined in the Fdstuffs, Csmetics and Disinfectants Act N. 54 f 1972 as: any article r substance (except a medicine as defined in the Medicines and Related Substances Act, 1965 (Act N. 101 f 1965)) rdinarily eaten r drunk by a persn r purprting t be suitable, r manufactured r sld, fr human cnsumptin, and includes any part r ingredient f any such article r substance, r any substance used r intended r destined t be used as a part r ingredient f any such article r substance Csmetics defined in the Fdstuffs, Csmetics and Disinfectants Act N. 54 f 1972 as: any article, preparatin r substance (except a medicine as defined in the Medicines and Related Substances Act, 1965 (Act N. 101 f 1965)) intended t be rubbed, pured, sprinkled r sprayed n r therwise applied t the human bdy, including the epidermis, hair, teeth, mucus membranes f the ral cavity, lips and external genital rgans, fr purpses f cleansing, perfuming, crrecting bdy durs, cnditining, beautifying, prtecting, prmting attractiveness r imprving r altering the appearance, and includes any part r ingredient f any such article r substance Disinfectants defined in the Fdstuffs, Csmetics and Disinfectants Act N. 54 f 1972 as: any article r substance used r applied r intended t be used r applied as a germicide, preservative r antiseptic, r as a dedrant r cleansing material which is nt a csmetic NAPPI Cdes fr Nn-surgical Prducts nt claiming t be medicines The NAB recgnised that there were nn-surgical prducts that were nt medicines and nt subject t registratin in terms f the Act with SAHPRA / MCC as an ethical, r as a cmplementary medicine, but were eligible fr reimbursement by medical schemes. 17

18 In rder t facilitate reimbursement f these prducts, the NAB decided t allw allcatin f NAPPI cdes t specific categries f nn-surgical prducts that were nt medicines The fllwing categries f prducts are eligible fr nn-surgical NAPPI cdes withut any medicine registratin requirements: Infant frmulas Milk substitutes Derma csmetics Sunscreen Germicides and antiseptics fr hme use n the skin Oral rehydratin Saline nasal preparatins Artificial tears/lubricating eye drps Lubricating gel (persnal use) Ear drps nt cntaining any medicines Distilled/purified water Any new categry t be added t the abve list wuld need t be apprved by the NAB. 4. SURGICAL PRODUCTS 4.1. Descriptins Legal Descriptin The prduct must be a medical device as defined in the Act: medical device means any instrument, apparatus, implement, machine, appliance, implant, reagent fr invitr use, sftware, material r ther similar r related article, including Grup III and IV Hazardus Substances cntemplated in the Hazardus Substances Act, 1973 (Act N. 15 f 1973)- (a) intended by the manufacturer t be used, alne r in cmbinatin, fr humans r animals, fr ne r mre f the fllwing- (i) (ii) (iii) (iv) (v) (vi) diagnsis, preventin, mnitring, treatment r alleviatin f disease; diagnsis, mnitring, treatment, alleviatin f r cmpensatin fr an injury; investigatin, replacement, mdificatin r supprt f the anatmy r f a physilgical prcess; supprting r sustaining life; cntrl f cnceptin; disinfectin f medical devices; r 18

19 (vii) prviding infrmatin fr medical r diagnstic purpses by means f in vitr examinatin f specimens derived frm the human bdy; and (b) which des nt achieve its primary intended actin by pharmaclgical, immunlgical r metablic means, in r n the human r animal bdy, but which may be assisted in its intended functin by such means General descriptin Dispsable and/r limited-life reusable prducts (fractinal) that can be classified as medical devices in terms f the Act, used in prcedures with reference t a particular patient. Currently the fllwing categries exist: Dispsable single use = quantity 1 (ne); Reusable limited-life = quantity 2 99 uses; Multiple use Capital Equipment = 100 & mre uses (N NAPPI cde will be allcated). Please nte that where a prduct is limited-life reusable and certain dispsable cmpnents may frm time t time have t be replaced after a use, these prducts wuld be allcated a number f uses f 1 with a distinctin t ther limited-life reusable cmpnents Business Rules Surgical Prducts Manufacturer Requirements Surgical Prducts The manufacturer, whlesaler r distributr must be a registered cmpany, registered clse crpratin r individual in the brders f Suth Africa. Details f the registratin number and the cuntry f registratin must be supplied in respect f a cmpany r clse crpratin. If trading in persnal capacity, the individual s ID number / passprt number is required The NAPPI applicant must be the highest authrity in the supply chain fr the prduct in questin within the brders f Suth Africa: If the prduct is manufactured within the brders f Suth Africa the manufacturer shuld be the applicant and subsequent wner f the NAPPI cde and nt the whlesalers and/r distributrs that are buying frm such manufacturer unless the whlesalers and/r distributrs have a different list price t the manufacturer in which case they wuld require their wn unique NAPPI cde/s. If the prduct is imprted frm verseas the immediate imprter f the prduct shuld be the applicant and subsequent wner f the NAPPI cde and nt the whlesalers and/r distributrs that are buying frm such imprter, unless such whlesalers and/r distributrs have a different list price t the imprter, in which case they wuld require their wn unique NAPPI cde/s. If mre than ne entity has a license t imprt directly frm the manufacturer/supplier verseas r mre than ne supplier exists verseas frm which many Suth African suppliers are licensed t imprt, each such entity will be entitled t a NAPPI cde fr its prduct. 19

20 Prduct Requirements All prducts that can be linked t a tariff cde wuld qualify fr allcatin f a NAPPI, subject t the cnditins set ut belw Where the cst f the prduct is already included in the tariff cde fr a prcedure, acrss all relevant disciplines, a NAPPI cde will nt be allcated Surgical prducts that may therwise nt qualify fr NAPPI allcatin, hwever it has been agreed between the medical schemes in questin and a specific prvider r prvider grup that such prduct/s will be reimbursed. NAPPI allcatin under these circumstances will nly take place upn written instructins frm the medical scheme invlved and subject t the cnditins prescribed by the said medical scheme A surgical prduct that has an active ingredient r medicinal cmpnent, which is subject t registratin in terms f the Act, and has SAHPRA / MCC registratin, will be allcated an Ethical NAPPI cde. Shuld the medicinal cmpnent f the surgical prduct nt have SAHPRA / MCC registratin, it will be allcated a Surgical NAPPI cde. In general, this includes prducts where the active/medicinal cmpnent will have a systemic effect. Examples f such prducts include heparin catheters and drug eluting stents Diagnstic preparatins are laded as surgical prducts and n ingredient capturing is required Nt all medical devices will autmatically qualify fr NAPPI cde allcatin based n the high cst f certain devices. Decisins with regards t specific high cst devices will be driven by NAB and the medical schemes individual mtivatinal criteria fr reimbursement f said prducts e.g. C-pap machines The fllwing prducts wuld nt be eligible fr NAPPI cde allcatin ntwithstanding certain tariff structures and/r applicable medical scheme/prvider agreements: All capital equipment; Certain multiple use items. Due t the frequency f use these items are treated as capital equipment fr purpses f NAPPI cde allcatin. See abve. Cnsumables that are nt specifically linked t the treatment f a patient r a prcedure Chargeable Indicatr: Nn-chargeable prducts were histrically laded n the database despite the fact that the prduct was nt recverable frm a medical scheme as part f a patient s hspital accunt. Hwever, with the enfrcement f N NAPPI N Payment principle by the medical schemes in the industry, this practice will n lnger be applied. Nnchargeable items will n lnger be added r maintained n the database and n newly applied NAPPI cdes will require this flag. 20

21 Multi-cmpnent Surgical Prducts: These were previusly referred t as Kits, Packs and Trays. Where the same multi-cmpnent surgical prduct is packed lcally fr a particular dctr and can be sld t ther dctrs, then nly ne NAPPI cde will be applied fr. Reusable r multi use surgical prducts shuld nt be included in multi-cmpnent surgical prducts. The ttal Rand sum f the multi-cmpnent surgical prduct shuld nt be mre than the sum f the individual chargeable cmpnents. Multi-cmpnent surgical prducts may cntain Single Exit Price (SEP) prducts, hwever, the price f the multi-cmpnent prduct must be greater than r equal t the sum f the SEP prduct/s cntained therein. The accuntability wuld be n the supplier f such prducts t ensure cmpliance t SEP regulatins. Multi-cmpnent Surgical Prduct Variatin 1 Any surgical prduct that is sld as a unit cntaining mre than ne individually wrapped cmpnent, all f which are critical t a prcedure and which can be used r supplied individually bth lcally and/r internatinally. It is mandatry that the individual cmpnents as well as the multi-cmpnent surgical prduct have their wn NAPPI Cdes e.g. Laparscpic Kits. Effective 1 July 2009, n NAPPI cde will be allcated t this prduct categry unless each cmpnent has its wn NAPPI cde. Multi-cmpnent Surgical Prduct Variatin 2 A nce-ff use surgical prduct that is sld as a unit cntaining mre than ne cmpnent where every cmpnent is essential t the prcedure. The individual cmpnents may r may nt have NAPPI cdes but cmpnents will be detailed in the frmat defined. Nthing shuld be reused as nce pened it is rendered nn-sterile e.g. Catheter Tray cntaining 5ml Water fr Injectin. Multi-cmpnent Surgical Prduct Variatin 3 A surgical prduct that is sld as a single unit cntaining mre than ne cmpnent which tgether make up a functinal unit. The individual cmpnents are integral t ne anther and cannt have their wn NAPPI cdes since they can never be used r supplied individually / separately t ne anther as stand-alne items bth lcally and/r internatinally i.e. n part f the prduct can be excluded, brken dwn, sld r used as an individual item. N stand alne spare parts / pieces exist fr this item either. Fr variatin 1 and 2 abve, n NAPPI cde will be allcated unless all the cmpnents are detailed in the frmat defined. 21

22 Ranges: Pack sizes: The abve variatins will be differentiated n the NAPPI public dmain file in the Dsage Frm field as fllws: MC1 - Multi-cmpnent Surgical Prduct Variatin 1 MC2 - Multi-cmpnent Surgical Prduct Variatin 2 MC3 - Multi-cmpnent Surgical Prduct Variatin 3 The abve dsage frm will nly apply t new NAPPI cdes allcated as f 1 July 2009 and nt retrspectively t existing NAPPI cdes. Range cdes describe prducts in mre detail with regards t size, clr, flavr and ther physical attributes distinguishing prducts within the same NAPPI cde and with the same price frm ne anther. Similar prducts with the same price will be listed under ne NAPPI cde but can be separately identified by the range indicatr. Prducts within a range are uniquely identified thrugh their wn catalgue numbers. As f 19 Nvember 2007, the NAB ruled that n further range NAPPI cdes will be allcated and that all new requests fr NAPPI cdes fr surgical prducts with ranges, will be dealt with by allcating a unique NAPPI cde fr each surgical prduct within the range. The NAB agreed t quarterly implementatins t cnvert all active Range NAPPI cdes t unique NAPPI cdes cmmencing 1 February Details f the Range Implementatin will be published in NAPPI Circulars which can be fund n the MediKredit website. The pack size is laded as the smallest dispensable quantity and nt accrding t pack f rdering, e.g. ECG paper bx f 200 sheets t be laded as 200 and nt 1 as it is charged per sheet by the hspitals. All pack sizes available n a supplier s price list will have a unique NAPPI suffix cde fr which a price will be maintained. Since hspitals are unable t bill fractins, where the pack size fr a surgical NAPPI cde is a fractin, the unit f measure must be changed s that the cnverted pack size in the new unit f measure is n lnger a fractin e.g. 22.5m t be captured as 2250cm Limited life re-usable prducts: Shuld the prduct nt state the usage f the prduct, the allcatin f the NAPPI cde cannt be finalised. It is ne f the mandatry fields in the NAPPI applicatin frm. Limited life re-usable r fractinal items are laded with the number f times that the prduct may be re-used as endrsed by the manufacturer/distributr. See abve. 22

23 4.3. Submissin Requirements Summary- Surgical prducts Befre a NAPPI cde can be allcated t a surgical applicant, the number f uses needs t be indicated if it is a limited use prduct. Single use/dispsable prducts wuld need t be indicated n the applicatin frm as 1 uses All applicatins must be accmpanied by the crrect surgical classificatin f that prduct. Training n the classificatin f surgical prducts is prvided by MediKredit and needs t be dne befre a new supplier can classify their prducts All submissins must be accmpanied by a price - clearly indicated as Whlesale r Retail and whether inclusive r exclusive f VAT. The price prvided must be the price f the medical device alne and must exclude any discunts r prfessinal fees. 5. RENTAL MEDICAL DEVICES AND APPLIANCES 5.1. Any categry f rental medical devices r appliances must be apprved by the NAB befre being added t this Plicy, unless it has been agreed between the medical schemes in questin and a specific prvider r prvider grup that such rental prduct/s will be reimbursed. NAPPI allcatin under these circumstances will nly take place upn written instructins frm the medical scheme invlved and subject t the cnditins prescribed by the said medical scheme The descriptin f all NAPPI cdes fr rental medical devices and appliances must begin with Rental Only ne NAPPI cde can be issued per prduct as per the standard NAPPI Cde Allcatin Plicy. Multiple NAPPI cdes will nt be issued t accmmdate variable pricing including variable pricing fr Designated Service Prvider (DSP) arrangements Distributr Requirements The NAPPI applicant must be a registered cmpany, registered clse crpratin r individual. Details f the registratin number and the cuntry f registratin must be supplied in respect f a cmpany r clse crpratin. If trading in persnal capacity, the individual s ID number / passprt number is required The NAPPI applicant must be registered with the Bard f Healthcare Funders (BHF) and be in pssessin f a BHF practice number Prduct Requirements Only rental medical devices r appliances apprved by the NAB will be cnsidered fr NAPPI allcatin under this Plicy Oxygen is excluded frm this Plicy as it is a scheduled substance and as such is cvered under the NAPPI Cde Allcatin Plicy fr Nn-surgical Prducts. The NAPPI cde and assciated price fr rental medical devices and appliances must nt include xygen. 23

24 The price linked t the NAPPI cde fr rental must be based n a mnthly rental tariff If the cst f the rental f the medical device r appliance is included in a tariff that is applicable t discipline cde 90, the rental medical device r appliance will nt be allcated a NAPPI cde The fllwing rental medical devices r appliances are eligible fr NAPPI cdes: Oxygen cylinders (empty) Prtable xygen cylinders (empty) Regulatrs Cnserving devices (demand valve) Cncentratrs Gauges Pulse ximeters Any cmbinatin f the abve prvided as a kit (the rental cst f the kit cannt exceed the sum f the rental cst f the individual cmpnents) Nebulisers (excludes all dispsable cmpnents as these need t be purchased) Equipment used fr sleep apnea (e.g. CPAP machines) Wheelchairs Insulin pumps All dispsable medical devices and appliances are excluded frm this Plicy e.g. nasal cannulae and masks, etc. These wuld be purchased and wuld be allcated NAPPI cdes in accrdance with the NAPPI Cde Allcatin Plicy fr Surgical Prducts. The cst f these prducts als cannt be included in the rental csts f any f the cmbinatin kits The price assciated t the rental NAPPI t be based n a daily rate since the minimum rental perid culd be less than a mnth r week r part theref. If a prvider was t claim fr ne mnth then they must submit the number f days e.g. 30, The NAPPI pack size t be based n the listed rental perids as per the suppliers price list (expressed in days). 6. GENERAL POLICY ISSUES 6.1. NAPPI cdes fr prducts unique t freign cuntries NAPPI cdes will be allcated t prducts that are nt registered in Suth Africa but are unique t a freign cuntry n cnditin that such prducts: are laded as an exclusin within Suth Africa (e.g. exclusin categry 33 fr Namibian prducts), and will have an indicatin f the cuntry f rigin after the prduct name, e.g. Azee (Namibian nly) Current NAPPI plicy is nly fr allcatin f unique pharmaceutical NAPPI cdes t Namibia fr reimbursement by Suth African Medical Schemes. 24

25 6.2. NAPPI cdes fr prducts which have differential pricing between Suth Africa and Namibia MediKredit des nt allcate a separate NAPPI cde t prducts supplied t bth Suth Africa and Namibia with different pricing Parallel Imprted prducts Sectin 15C(b) f the Act allws a Supplier frm Suth Africa t parallel imprt Ethical prducts frm verseas if, amngst ther regulatins: they can prvide this prduct cheaper than the Suth African Manufacturer / Distributr, and the riginal prduct is still under patent in RSA The imprter must apply fr SAHPRA / MCC registratin f the imprted prduct As part f the NAPPI applicatin, the parallel imprter must issue a cpy f the permit issued by the Minister f Health (in rder t prve legality f prduct) as well as the SAHPRA /MCC registratin certificate This permit is nly valid fr 24 mnths (tw years) These prducts, the current prduct and the parallel imprted prduct, shuld be exactly the same (Prduct name, quality standards, ingredients, strength, etc.) except that the Supplier may be different in cases where cuntry specific subsidiary cmpanies perate as different legal entities with different branding etc A new NAPPI cde will be allcated t the parallel imprted prduct The wrds (PIM) will be laded as part f each prduct descriptin. This is the abbreviatin fr Parallel Imprted Prduct and is included n the label f each distributin packet, e.g. Panad (PIM) The price f the parallel imprted prduct will be verified, and if it is fund t be higher than the price f riginal prduct, the NAPPI cde will be withheld until further investigatins can be cncluded Stent and Delivery Balln System NAPPI allcatin Applicable t bth drug eluting stents as well as surgical stents (Bareback Stents) Frm 01 January 2007, nly single NAPPI cdes t be supplied by MediKredit fr any new applicatin fr the entire device All existing NAPPI cdes fr the delivery balln t be terminated effective 01 January 2007 and added int the existing nn-chargeable discntinued prduct flder n the public dmain frm this date Medical schemes wh apply separate Prsthetic Limits must take cgnisance f this change in NAPPI allcatin plicy in their Benefit design fr Market dynamics may change again in the future which may dictate a need fr individual NAPPI cdes t be allcated fr the delivery device, but this will be referred t NAB fr review shuld the need arise. 25