doc yap - tir do - hanh phtic s6: -3045/qdbhxh ha noi...
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BAO IHEM XA 1101 VIET NAM CONG HOA XA 110I CHU NGHTA VIET NAM DOc Yap - Tir do - Hanh phtic
S6: -3045/QD-BHXH Ha Noi, ngby thang 12 nam 2017
QUYET DINH Ban hanh Quy dinh ve viec tham gia Tau thAtt thuo'c
cilia co. quan Bao hiem x5 hoi tai cac co• y to
TONG GIAM HOC BAO HIEM XA HOI VIET NAM
Can cir Luat Dau thau se) 43/2013/QH13 ngay 26 thang 11 nam 2013;
Can cir Lust Duoc se) 105/2016/QH13 ngay 06 thang 4 nam 2016;
Can cir Nghi clinh se) 63/2014/ND-CP ngay 26 thang 6 nam 2014 dm Chinh phu quy dinh chi tik thi hanh mot so dieu cua Luat Dau thau ye lua chon nha thau;
Can cir Nghi dinh s6 01/2016/ND-CP ngay 05 thang 01 nam 2016 dm Chinh phu quy dinh chi:re nang, nhiem Vu, quyen han va co cAau to chirc cilia Bao hiem xa" hOi Viet Nam;
Can cir Quye't dinh s6 08/2016/QD-TTg ngdy 26 thang 02 nam 2016 dm Thil Wang Chinh phu quy dinh vi'ec mua s'am tai san nha nuOc theo phuong thdc tap trung;
Can cir Thong to se) 09/2016/TT-BYT ngay 05 thang 5 nam 2016 cilia BO Y to Ban hanh Danh muc thu6c dau thau, Danh muc thuoc dau thau tap trung, Danh muc thuoc duoc ap dung hinh thirc dam phan gia;
, Can cir Thong tit so 10/2016/TT-BYT ngay 05 thang 5 nam 2016 dm BO Y to Ban hanh Danh muc thuoc san xuat trong nuac dap irng yeu cau ve dieu tri, gia thuoc va kha nang cung cap;
, Can ctr Thong to so 11/2016/TT-BYT ngay 11 thang 5 nam 2016 cila. BO Y quy dinh vie'c dau thau thuOc tai the co sa y to cong lap;
Theo de nghi cua Truong ban Duoc va Vat to y t6,
QUYET DINH:
Dik 1. Ban hanh kern theo Quyk dinh nay Quy dinh ve viec tham gia clan than thuoc cilia co quan Bao hiem x'a hOi tai cac co so y te.
Dik 2. Quyet dinh nay c6 hieu h.rc thi hanh tit ngay 15/12/2017. Bai 1)6 cac quy dinh khac trai v6i Quyet dinh nay.
Dieu 3. Chanh Van phOng Bao hiem xa hOi Viet Nam, Truing ban Duac va Vat to y te, Thu truing cac clan vi true thuOc Bao hiem xa hOi Viet Nam, Giam doe Trung tarn Giam dinh bao hiem y te va Thanh town da tuyen khu vuc phia Bac, Giam doe Trung tam Giam dinh bao hiem y te va Thanh toan da tuyen khu vac phia Nam, Giam dOc Bao hiem xa hoi cac tinh, thanh pho trgc thuOc Trung uang, Giam doc MID hiem xa hOi Bo Quoc phOng, Giam doe t • o hiem xa hoi Cong an nhan clan chiu trach nhiern thi hanh Quyet dinh nay./.
Noi - Nhir DiL 3; - HOi ding Quan ly BHXH Vi6t Nam; - Van phong Chinh phia; - BO Y te, BO Tai chinh, BO KO hoach va d'au tir, BO tir phap; - UBND cac tinh, thanh pho true thu6c Trung irang; - Cuc Kim soat TTHC, VPCP; - T8ng Giam di& (c18 b/c); - Cac Ph6 T8ng Giam clOc; - SO. Y t6 cac tinh, thanh phO trkrc thu6c Trung ircrng;• - Cac 1)"rih vie;n, vin co giirang 1;)'nli,,thu'Oe BO Y te; - Cue Quan y BQP, Cpc Y to Bo CA, Cue Y to Bo GTVT; - ang thong tin din tn. BHXH Vi4 Nam; - Ltru: .VT, DVT (61))4/
KT. TONG GIAM DOC PHO TONG GIAM D OC
am Luang Son
BAO HIEM XA HOI VItT NAM CONG HOA XA HOI CHU NGHIA VWT NAM D'Oc 14p - Tkr do - Hanh phac
QUY DINH Ve viec tham gia &Au thAu thu6c dm quan Bao hiem xa" hoi
tai cac s& y te (Ban hanh kern theo Quyect dinh sa: -SN5-/QD-B1IXH
ngayA5- thing 12 nom 2017 ciia Ring Giam (lac Bao Vi't Nam)
Chiro•g I
NHILING QUY DINH CHUNG
Dieu I. DOi tuvng, pham vi dieu chinh
1. Pham vi dieu chinh: Quy dinh cu the hoa viec tham gia dau thou thuOc cila co quan BHXH tai ode ca so y te theo quy dinh tai diem a khoan 3 Dieu 77 Nghi dinh so 63/2014/ND-CP ngay 26/6/2014 cila Chinh phu quy dinh chi tik thi hanh snot so dieu dia Luat Dau thou ye lira chon nha thou, khoan 4 Dieu 40 ThOng tu so 11/2016/TT-BYT ngay 11/5/2016 cila BO Y to quy dinh viec dau thou thuoc tai cac co so. y te cong lap va cac van ban huOng dan.
2. Doi Wong ap dung:
a) Cac don vi, ca nhan thuOc he thOng BHXH Viet Nam dugc TOng Giam doe BHXH Viet Nam ci:r tham gia vao cac hOi dOng dau m , thou thu3c (bao gO dau thau thuoc tap trung Quoc gia, dam phan gia thuoc, dau thou mua thuoc cna cac co sO y te thuOc BO Y te va cac BO, Nganh) va giao nhiem vv.
b) Cac don vi, ca nhan thuOc BHXH tinh dugc Giam dOc,BEEXH tinh ci:r tham gia vao cac hOi &Ong dau thou thuoc (bao gOm dau thou thuoc tap trung cap dia phuang, dau thou mua thuoc cua cac ca so y te thuOc dia ban quan ke ca cac co so' y te thuOc BO, Nganh) va giao nhiem vv.
Dieu 2. nit so quy dinh vitt tat
- Quy dinh tham gia dau thou thuoc: Quy dinh tham gia dau thou thuOc cUa co quan Bao hiem xa hOi tai cac ca so. y te.
- BHXH: Bao hiem xa hOi. - BHXH tinh: BHXH tinh, thanh pith true thuOc trung ucrng. - Ban Dugc va VTYT: Ban Dugc va Vat tu y te. - BHYT: Bao hiem y te. - KCB: Kham benh, chfra benh. - KHLCNT: Ke hoach lua chon nha thou. - KQLCNT: Ket qua lira chon nha thou. - HSMT: Ho scr mOi thau. - HSYC: Ho so yeu cau.
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- HSDT: Ho so du thau. - HSDX: HO so de xuat. - HSDXKT: Ho s• 6 xuat ye k'S'T thuat. - HSDXTC: H6 so de xuat ve tai chinh. - LCNT: Ltya chon nha thau. - DTTTQG: Dau thau tap trung cap quoc gia - DTTTDP: Dau thau tap trung cap dia phuong - DPG: Dam phan gia - UBND: Uy ban nhan dan. - BDG: Thu6c biet dugc goc
, Dieu 3. Dieu kien, tieu chuan \Teri can 13Cs co' quan BHXH tham gia dau than thuoc
Dap trng cac quy dinh tai khoan 1 Dieu 16 Lula Dau thau; khoan 3 Dieu 116 Nghi dinh 63/2014/ND-CP va mot so yeu cau cu the sau:
1. Co chUng chi dao tao ve dau thau theo quy dinh.
2. Co trinh do chuyen mon la dugo s5"Tdai hoc, bac si, cir nhan kinh te, cir nhan tai chinh, cix nhan luat.
3. Co thei gian cong tac tir 3 nam tr6 len trong link vuc,chuyen mon nghiep vu quan den not dung kinh thuat gOi thau thuOc.
Dieu4. Trach nhiem va quyen han cua thanh vien co' quan BHXH tham gia cauthau thaw
1. Thut hien day du trach nhiem theo dung cac quy dinh cua Luat Dau thau so 43/2013/QH13 (Dieu 76, Dieu 78), Nghi dinh 63/2014/ND-CP, Thong to so 11/2016/TT-BYT va cac quy Binh hien hanh ye dau than thu6c.
, 2. Thixc hien cac nhiem vu thanh vien theo Quyet dinh thanh lap cila cap c6 tham quyen va sty phan cong cua Chu tich hOi dong dau thau; tham gia hop day du; chiu trach nhiem doi voi not dung tham gia trong cac hOi dong dau
• thau thuoc tai cac co s6 y
3. Co trach nhiem bao mat cac tai lieu theo quy dinh cua phap luat ve dau thau thu6c.
4. Thuc hien nghiem quy dinh ve nhirmg hanh vi bi cam trong qua trinh tham gia dau thau thuoc neu tai Dieu 89 Lula Dau thau.
5. Co quyen yeu cau h(6i dong dau than cung cap cac thong tin tai lieu lien quan den goi thau; bao km y kien khi can thiet trong bien ban cuO'c hop da hOi dOng.
Chtro'ng II
NHIEM VU CUA THANH VIEN CO QUAN BHXH THAM GIA DAU THAU THUOC
Dieu 5. Tham gia xay citing KHLCNT
1. Vic lap KHLCNT va phan chia goi thau thtxc hien theo dimg huong dan tai Dieu 4, Dieu 5, Dieu 6 va Dieu 7 ThOng to so 11/2016/TT-BYT va cac quy dinh cda phap luat ve dau thau.
2. NOi dung tham gia:
a) Th6ng nhat nguyen tac xac dinh nhu cau thuOc ve danh muc, so luting ten co so dOi chieu voi thge to sir dung nam tuft.
TruOng hop stS, lugng thu6c bin dOng lern, yeu cau sir dung d6i thu6c
Inch, co so. y to thuyet minhtinh toan so lieu cu the cho tirng nguyen nhan nhu , nang hang benh vien; thay co cau benh tat; six can thiet, tinh hop 13"/, hieu qua sir dung cUa thuoc mgi trong dieu tri.
Ca so y to tang cueng sir dung thuOc san xuat trong nuot dap img yeu cau dieu tri, gia thuoc, thuc hien de an "Ngtfoi Viet Nam um tien dung thuoc Viet Nam" da dugc B"O truang Bo Y to phe duyet tai Quyet dinh so 4824/QD-BYT ngay 03/12/2012; khong dua vao KHLCNT cac thuoc có nhng do/ham lugng, Bang bag che, duerng dung, clang dOng gOi, clang phOi hop it canh tranh va có gia ke hoach cao.
b) Th6ng nhat va pho'i hop thus hien viec phan chia so lugng thuoc, darn bao ca cau thuoc hop 1)'!, dam bao gia ke hoach thuoc phi], hgp khi phan chia thuoe vao cac gOi thau, nhom thu6c, nong de)/ham lugng, &Tong &mg, dang bao che cua thuoc.
c) Lap bao cao, kien nght, de xuat veri -t6 chuyen gia xay dung KHLCNT, vgi chit dau tu nhang not dung lam can cir de xay dung du thao KHLCNT con chua hap ly, chua dung the quy dinh cua phap luat, nhang not dung den den ban che su tham gia cUa nha thau va cac giai phap kik phu.c.
Dieu 6. Tham gia thAm dinh KHLCNT
1. Thue hien tham dinh KHLCNT theo quy dinh tai Dieu 8 Thong tu 11/2016/TT-BYT.
2. MOt so not dung tong tam trong tham gia tham dinh KHLCNT:
a) Kiem tra, danh gia can dr lap KHLCNT theo quy dinh tai Dieu 4 Thong -Lir 11/2016/TT-BYT.
,b) Kiem tra, danh gia thanh phan h6 so trinh duyet KHLCNT. Yeu eau ho so trinh duyet KHLCNT phai dit the nOi. dung.
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c) Kiem tra, danh gia cac not dung cUa KHLCNT, bao Ten goi thau, gia goi thau, nguon von, hinh thirc va phuang,thirc Ilia chon nha thau, thei gian bat dau to chi.rc lira chon nha that', loci hop Tong, thed gian thirc hien hop Tong theo quy dinh tai Dieu 6 Thong tu so 11/2016/TT-BYT.
d) Kiem tra, danh gia phan chia goi thau, ten g6i thau va gia goi thau:
- Viec ghi ten hoat chat, nOng dO/ham lacing, dung dung, dang bao che, don vi tinh theo dung quy dinh, khOng trong lap ve danh mac thuoc, tranh dan tad mod thau c6 dinh huOng.
- Sg hop lY ve gia ke hoach giira cac nh6m thu6c, quy doi gida cac nOng dO/ham lacing, throng thing, dang bao che; doi chieu can ctr tham khdo de xay dung gia k8 hoach cua thuOc theo huong dan tai diem c khoan 2 Dieu 6 Thong tu so 11/2016/TT-BYT.
- Ca cau hop 1Y giira cac nhom thuoc: BDG vOi thuoc generic; cac nhom thuOc generic;,thuoc ho trci trong tri thuoc can thiet trong tri; thuoc cos truyen,.thuOc dugc lieu yoi thuoc tan throe dam bao dap irng yeu cau dieu tri, hieu qua kinh te.
+ Ra soat, kiem tra, phat hien cac thuoc thuoc c6 nong dO/ham lacing, clang bao che, dung dUng, clang phoi hop it canh tranh va c6 gia ke hoach cao (da dugc cong bo) va cac loci m6i xuat hien, de nghi co so y te, to chdc dugc giao lap KHLCNT khong dua vac) KHLCNT. Truemg hop dac biet can sir dung doi veYi cac thuoc nay, de nghi don vi chiu trach nhiem xay dung KHLCNT bao cap BO Y te va chi dua \Tao KHLCNT khi dal dugc BO Y , Tong y theo huong dan tai Cong van 4837/BYT-BH ngdy 7/7/2015 .
+ Coy kien dOi cac thuOc BDG het han ban quyen ma thi tracing da c6 san thuOc generic nhom 1 thay the: de nghi co ser y te, to chic throe., giao lap KHLCNT,dieu chinh KHLCNT, 0am so lacing thuoc biet dugc goc, be) sung so luting thuoc generic nh6m 1, dam bao hieu qua sir dung thuoc, Tang thi thirc hien chitin lugc sir dung thuoc generic.
+ So sanh, dOi chieu, phat hien cac thuOc c6 gia ke hoach cao bat hop lY gifra nh6m c6 tieu chi ky thuat va tieu chuan cong nghe dugc cap phepo mirc thap han voi thuoc o nhom c6 c6 lieu chi ky thuat va tieu chuan cong ghe dugc cap phep er mi c cao han, de nghi to chic tham dinh yeu cau to chdc lap KHLCNT dieu chinh gia cho phu hop.
+ So sanh, d6i chieu, phat hien cac thuOc,c6 gia ke hoach cao bat hop IY trong cal-1g nhom thuoc, de nghi to chirc tham dinh yeu cau to cluirc lap KHLCNT dieu chinh gia cho phn hop.
e) Kiem tra, dank gia hinh tilde va phuang thirc lga chon nha thau:
chieu, kiem tra tinh hop ly, hop le cua hinh thirc lira chon nha than dugc de xuat trong KHLCNT theo quy dinh;
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Doi chieu dieu kien ap dung doi voi cac gOi thau khong de xuat hinh thirc dau thau rang rai, dau thau han che, kien nghi to chirc lap KHLCNT lam rO, va dieu chink cho phU hop.
- Doi chieu, kiem tra dieu kien ap dung phucmg thirc lira chon nha thau de xuat tai KHLCNT theo quy dinh. Kien nghi to chirc lap KHLCNT xem xet, b6 sung neu khong du dieu
f) Kiem tra, dank gia tiled gian thuc hien hop (tang:
- Doi KHLCNT do co so. KCB tu to chirc dau thau: Tai da khong qua 12 thang, ke -Ur ngay hop &Ong co hieu luc den ngay cac ben hoan thanh nghia vu theo quy dinh trong hap Eng nhu quy dinh tai khoan 7 Dieu 6 Thong tu so 11/2016/TT-BYT.
- Doi vai KHLCNT do dia phuong to chirc (tau thau tap trung cap dia phuang, hoac dugc dau thau tap trung cap quoc gia: Toi da khOng qua 36 thang, ke tir ngay hop dong co hieu luc den ngay cac ben hoan thanh nghia vu theo quy dinh trong hop &Ong ntar quy dinh tai diem a, diem b Khoan 1 Dieu 3 Thong tu so 11/2016/TT-BYT.
- Trueyng hop co sa KCB t r t6 chirc dau thau thuoc bang hinh thirc dau thau khac, ,trong khi relief ket qua dau thau thuoc bang hinh thirc dau thau rang raj, dau thau han che, co so KCB du kien tiled gian, xay dung s8 Wong thu6c can mua pita harp, khong de tinh trang thieu thuoc sir dung trong ca so KCB.
Dieu 7. Tham gia xay dung HSMT, HSYC
1. Thixc hien theo quy dinh tai Dieu 18 Thong tu so 11/2016/TT-BYT, ThOng tu. so 31/2016/TT-BYT.
, a) Vic lap HSMT, HSYC mua thuoc phai can cir vao KHLCNT dugc cap có tham quyen phe duyet.
,b) Doi thuoc thuoc Danh muc thuac, sari xuat trong nu& dap img yeu cau ve dieu tri, gia thuoc va kha. nang cung cap do BO Y t8 cong bo thuoc tieu chi k5Tthu'at cua nhom thuoc nao thi trong HSMT, HSYC phai quy dinh nha thau khong dugc chao thuoc nhap khau thuoc nhom do.
2. Ni dung than gia:
a) Tham gia xay dung HSMT, HSYC phu. hop voi phuong thirc LCNT, hinh thirc LCNT va not dung yeu cau tai KHLCNT dugc phe duyet dimg ML HSMT theo quy dinh. Cu the:
- Dau thau rang rai, dau than han che:
+ Phuang thirc lua chon nha thau mat giai down mat tdi ha so:
GOi thau thuoc BDG, gOi thau thuoc generic, goi than thuoc ca truyen (trix vi thuoc co truyen), thuoc dugc Ap dung Mau HSMT tai Phu luc 3 kern ThOng tu so 11/2016/TT-BYT;
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Goi thau dugc lieu, vi thuOc co truyen: Ap dung Mau 1 kem Thong tu so 31/2016/TT-BYT.
+ Phuong thirc lira chon nha thau mot giai doan hai tui hO so:
Goi thAu thuOc BDG, g6i than thuOc generic, goi thau thuOc ca truyen (trir vi thuoc co trUyen), thuOc dugc lieu: Ap dung Mg.0 HSMT tai Phu luc 4 kern Thong tu so 11/2016/TT-BYT;
G6i thau dugc lieu, vi thuOc co truyen: Ap dung ML 2 kern Thong tu so 3 1/2016/TT-BYT.
- Chi dinh thau thong thuong, chap hang canh tranh thong thueng, mua sam truc tiep: Xay dung HSYC theo phuong thirc mot giai doan mot tUi ho so.
- Chi dinh thau rut gon, chao hang canh tranh rut gon: Khong phal xay dung HSMT, HSYC.
b) Tham gia xay dung phuong phap danh gia HSDT, HSDX darn bao phU hop voi phuong thdc LCNT, hinh thirc LCNT tai KHI,CNT dugc phe
, - Phuong thirc mot giai doan mot ho so: Ap dung phuong phap gia
thap nhat hoac phuong phap gia danh gia.
Phuong thirc mot giai doan hai tUi he) so: Tay thuOc vao tinh chat, yeu cau k5r" thuat cua goi thau thuoc de xem xet ap dung phuang, phap gia thap nhat hoc phuong phap gia danh gia hoc phuong phap danh gia tong hop.
c) Tham gia xay dung tieu chuan danh gia HSDT, HSDX ve nang luc \fa kinh nghiem; ve l<ST thuat; ve gia d'Oi voi phuong thirc lua chon nha thau mot giai doan mot tdi ho so; tieu chuan danh gia chi tiet ye tai chinh doi veri phuong thtrc lua chon nha thau mot giai doan hai tui ho so theo quy dinh.
, Dam bao muc tieu lua chon dugc nha thau du nang luc cung cap thuOc chat luting voi gia hop ly, 'thong dua cac dieu kien nham han the su tham gia cua nha thau.
d) Tham gia xay dung pham vi cung cap thuOc: Doi chieu KHLCNT dirge phe duyet.
e) Lap bao cao, kien nghi, de xuat voci To chuyen gia xay dung HSMT, HSYC dieu chinh nhang not dung cila du thao HSMT, HSYC chua &mg cac quy dinh, dan den han che su tham gia cua nha thau (neu c6).
Dieu 8. Tham gia thAm dinh HSMT, HSYC
1. Thug hien theo quy dinh tai Dieu 19 ThOng tu so 11/2016/TT-BYT; Thong tu so 19/2015/TT-BKHDT.
2. NOi dung tham gia:
a) Do'i chiL, hem tra, danh gia HSMT, HSYC, dam bao phU hop vgi phuong thirc LCNT, hinh thtirc LCNT tai KHLCNT dal dugc phe duyet.
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b) Doi chieu, kiem tra phuong phap danh gia HSDT, HSDX;.
c) Doi chieu, kiem tra tieu chuan danh gia HSDT, HSDX
- Tieu chuan danh gia ye nang luc va kinh nghiem (nang• luc tai chinh, kinh nghiem thuc hien hgp &rig cung cap ,thuoc twang tu), dam bac, lira chon dugc nha than có nang luc cung cap thuoc chat luting veri gia phU hgp, tranh han the su tham gia cua nha. thau.
- Tieu chuan danh gia ve ICY thuat:
Kiem tra phat hien cac truang hap bat hap 1)"7, dan den han the sir than gia cua nha thau.
- Tieu chuan danh gia ve gia trong chuong III cua HSMT theo phuong thirc mot giai doan mot titi he) so, trueng hop chon tip dung phuong phap gia danh gia; tieu chuan danh gia chi tiet ve tai chinh trong Chuang III cua HSMT theo phuong thtrc mot giai doan hai tui ho so, tru&ng hop chon tip dung phuong phap gia danh gia hoc phuong phap ket hgp Oita ky thuat va
DOi chieu, kiem tra, danh gia cong thirc de dam bao lira chon dugc thuo'c chat lugng gia pha hap.
d) Kiem tra, danh gia pham vi cung cap thu6c tai HSMT, HSYC.
e) Lap bao cao, kien nghi, de xu'at \Teri To tharn dinh yeu cau TO xay dung HSMT, HSYC dieu chinh nhang not dung cua HSMT_ HSYC china dUng cac
quy dinh, dan den han the six tham gia cua nha thau (neu co).
Dieu 9. Tham gia danh gia HSDT, HSDX
1. Thuc hien theo quy dinh cua Lust Dau thau so 43/2013/QH13; Nghi dinh so 63/2014/ND-CP; Thong tu so 11/2016/TT-BYT (Dieu 22, Dieu 23) va HSMT, HSYC; Thong to so 23/2015/TT-BKHDT.
a) Danh gia HSDT, HSDX theo tang phan trong moi goi thau;
b) DOi chieu val tieu chuan danh gia HSDT, HSDX tai -mau HSMT trong Phu luc 03 hoc Phu luc 04 ban hanh kern theo Thong tu so 11/2016/TT-BYT va phai ghi cu the trong HSMT, HSYC. Trach nhiem dive hien tru dai trong LCNT theo quy dinh tai cac Dieu 3, 4, 5 va 6 Nghi dinh so 63/2014/ND-CP.
c) Quy trinh danh gia HSDT, HSDX: Tay thuOc vao phuong thirc lira chon nha thau dal dugc cap co than' quyen phe duyet, cu the:
+ Phuang thirc mot giai doan mot tin 116 so: Thuc hien theo quy dinh tai cac Dieu 15, 16, 17 va 18 Nghi dinh so 63/2014/ND-CP;
+ Phuong thirc mot giai doan hai tai hO so: Thuc hien theo quy dinh tai cac Dieu 27, 28, 29 va 30 Nghi dinh so 63/2014/ND-CP.
2. NOi dung tham gia:
a) Danh gia tinh hgp le cua HSDT (Phuong thirc mot giai doan mot tui ho
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so); cilaHSDXKT, HSDXTC (Phuang tithe mot giai doan hai tni ho so):
- D6i voi danh gia tinh hop le cita don du ,thau: Luu 3'7 kiem tra, danh gia tinh hop le cfla cliff 1(57, nguei trong don du thau; tiled gian thuc hien gOi than, tiled gian thuc hien hop gong dap frng yeu cau cfla HSMT, HSYC; gia du- thaughi trong don du. thau.
- Danh gia tinh hop le cilia bao dam du. thau: Luu y kiem tra, danh gia gia tri va thei gian hieu luc, ten dm ben mei than (don vi thu hugng) dap Ung yeu cau neu tai HSMT, HSYC; tinh phap 13'T cua bao dam du thau.
- Danh gia tiled gian hieu luc cua HSDT, HSDXKT, HSDXTC: Phai dap dng yeu can cua HSMT, HSYC.
b) Danh gia ve nang luc va kinh nghiem.
c) Danh gia ve Ic57- thuat: theo Bang tieu chuan danh gia ve ky thuat (tai Phdn 4, Phu luc 3 hoac Phu lye 4 Thong tu. so 11/2016/TT-BY7);
- Kiem tra, dei chieu cac thong tin nha thau khai tai Mau so 5. Bie'u gici du thau (Phu lye 3) tru&ng,hop ciciu thelu theo phuang thUr mot giai doan mot so), hoac tai Mju so 11. Bieu mdu du thau (Phu luc 4), trzthng hop d`ciu,thau theo phuang thiir mot giai doan hai ho sa), )(de Binh tinh hop le cua thuoc tham du thau, thuoc du dieu kien than vao gOi thau, nhom thuoc phu hop theo quy dinh tai Bang pham vi cung cap, tien do cung cap va yeu cau ye k-y thuat cda thu6c tai HSMT, HSYC va theo quy dinh tai Dieu 5 Thong tu. so 1 1/20 1 6/TT-BYT.
+ Tinh hop 1e thu6c du thau: Luud6i voi truong hop mat hang thuoc du thau có so clang 147 luu hanh hoac giay phep nhap khau het han hieu luc hoac het tiled han gia han hieu luc cda so clang 1c3"7 tuft the(i diem dung thau.
+ Dieu kien cua thu6c du. thau:, Thgc hien viec tra dm, d6i chieu co so. san xuat, dia. chi san xuat, dang bao che/duong dung dia thuoc voi ten co so san xuat, dia chi, pham vi rchimg nhan thuoc dat tieu‘chuan PIC/S — GMP va EU :- GMP; xem xet ngay cap, ngdy het han, co quan cap tai danh sach co. so. san xuat thu6c dat tieu chuan PIC/S — GMP va EU — GMP do Cue Quan 13'7 Dugc Viet Nam c6ng 1)6 tren trang thong tin dien tfr cua Cuc Quan 1)"/ Dugc.
- Thu6c hop le va du dieu,kien du than vao goi thau, nhom thu6c hap theo quy dinh thi moi dugc tiep tuc danh gia ye ky thuat theo quy dinh tai HSMT, HSYC.
d) Danh gia ve gia, danh gia chi tit ve tai chink:
Thuc hien danh gia ve gia, danh gia chi tiet ve tai chinh theo tieu chuan danh gia quy dinh tai HSDT, HSDX.
,Sau khi lua chon dugc danh sach xep hang nha thau, tiep tuc dei chieu gia du thau cilia mat hang thuoc do nha thau tham du voi gia ke hoach neu tai
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HSMT, vai gia ke khai, ke khai lai con hieu 1-krc cua mat hang thuOc (theo quy dinh tai HSMT).
Dieu 10. Tham gia thAm dinh KQLCNT
1. Thvc hien theo quy dinh tai Dieu 106 ciia Nghi dinh so 63/2014/ND-CP; Dieu 25 cua Thong tu so 11/2016/TT-BYT; Thong tu so 19/2015/TT-BKHDT.
2. NOi dung tham gia:
a) ,D6i. chieu kiem tra xuat trung thau: mOi thuOc chi Ave xuat trimg thau 01 thuoc chat yeu cau ye 1(5/- thuat, chat Luting quy dinh trong HSMT, HSYC va c6 gia dux thau sau sira lOi va hieu chinh sai Lech, trir di gia tri giam gia (neu co) thap nhat dOi vori phirang phap gia thap nhat; c6 gia danh gia thap nhat doi yeti, phuang phap gia danh gia; c6 diem tong hop cao nhat dOi voi phuang phap ket hop gida k thuat va gia trong nhom thuoc do.
b) DOi chieu kiem tra, dam bac, gia trung than cua tixng thuOc khong dugc cao han gia ke hoach da dugc'phe duyet va khOng vugt gia ban buon ke khai, ke khai lai con hieu luc cua thuoc do (trix trung hap quy dinh tai khoan 1 Dieu 35 ThOng tu so 11/2016/TT-BYT).
c) Uu tien tap trung tham dinh dOi,voi cac thuOc c6 tri cao ho'ac,c6 so luting lorn trong ket qua lira chon nha thau, ra soat phat hien cac thuoc de xuat trung thau c6 gia cao bat hop coy kien de xuat vii TO tham dinh xem xet dieu chinh tru&c khi bac) cao de nghi phe duyet KQLCNT;
Dieu 11. Tham gia dieu tiet viec thiyc hien thOa thu4n khung ctia cac co' s& KCB dOi gOi J)TTTDP, DTTTQG, DPG.
1. Thixc hien theo quy dinh tai khoan 4 Dieu 31, khoan 9 Dieu 32, khoan 9 Dieu 33 va khoan 9 Dieu 34 Th'Ong tu so 11/2016/TT-BYT.
2. NOi dung tham gia:
a) Phi hop v6i Dan vi mua s'a.m TTDP, S& Y to de dieu tik thuOc tai cac co so KCB BHYT ten dia ban hgplf, hieu qua theo quy dinh.
b) Khong dieu chinh tang so luting sir dung cac thuOc c6 gia cao bat hop ly trong ket qua clau thau thuoc con hieu
Chtr•ng III
TO CIICC THIX HIEN TAI BHXH TINH
Dieu 12. Thanh rap TO tham gia &Au th'au thuOc cita BHXH firth
Giam dOc BHXH tinh quyet dinh thank lap TO tham gia dau thau thuOc , (TO dau thau) tham gia vao qua trinh LCNT cung cap thuoc tai cac co s&
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KCBBHYT tren dia ban va theo phan cap cila TOng Giam dOc BHXH Viet Nam (dOi voi ca s& KCB do BO nganh quan 13'7).
TO tru&ng To dau than la Giam dac 131-1)(H tinh hoac Ph6 Giarri doe BHXH tinh dugc giao phu trach cong tac dau thau thuoc, VTYT.
SO luting thanh vien cila TO dL thau can cur so luting HOi dOng dL thau thuoc tai dia phuong (DTTTDP, dau thau rieng le cilia ca s& KCB BHYT), kha nang ena can bO va dieu kien cu. the, BHXH tinh de quyet dinh dam bao yeu cau va hieu qua tham gia cong tac dau thau cua BHXH tinh;
Thanh vien TO dau thau hoat dOng kiem nhiem.
Dieu 13. Trach nhiem cua TO trtthng TO dAu thAu:
Can cu so luting thanh vien cua To dau thau, de nghi cua So' Y te, Dan vi mua sam tap trung hoac cila the ca s& KCB, de xuat Giam doe cir - thanh vien tham gia vao cac Hoi &Ong DTTTDP va cua timg ca KCB BHYT;
Xay dung va chi dao thtrc hien Quy the lam viec cua To dau thau;
Dinh kS7 hop TO dL thau thuoc nghe bao cao ket qua, giai quyet cac kien nghi cac thanh vier' theo tham quyen hoac bao cao Giam doe BHXH tinh de xem xet giai quyet theo quy dinh.
Nghien cdu tham muu v6i Giam d'Oc BHXH tinh phi hop v6i Giam dOc So Y te de nghi Chu tich UBND tinh xemxet quyet dinh be) sung Danh routthuOc DTTTDP; tham gia giam sat, dieu,tiet viec cung Ung thuoc tai cac co. so' KCB BHYT theo thoa. thuan khung va ke hoach da dugc phe duyet doi v6i the thuOc DTTTQG, DTTTDP theo quy Binh va hugng an cila BHXH Viet Nam.
Dieu 14. Trach nhiem cua Giam dOc BHXH tinh
1. Lanh dao, chi dao toan dien, dam bao hieu qua cong tac dau thau thuOc va theo dung quy dinh;
2. Chiu trach nhiem TOng Giam d'Oc BHXH Viet .Nam ve viec to chirc tham gia dL thau thuoc tai cac co. s& KCB BHYT tren dia ban va theo phan cap cna BHXH Viet Nam.
3. Bao cab ve BHXH Viet Nam:
- Quyet dinh thanh lap TO d'L thau thuOc cda BHXH tinh;
- Phan cong thanh vier' tham gia \Tao timg HOi Eng dL than (kern theo email, so dien thoai di dOng cua cac thanh vien);
- Bao cao danh gia ket qua tham gia cOa To dL thau thuOc tai tUng HOi (long va tong hop ket qua chung cUa dia phuang, cac kh6 khan vuong mac, ten tai, kien nghi can kik phuc ngay trong kS7 dau thau vita qua cung nhu trong kS7 dau thau tiep theo gui So' Y te, UBND tinh va BHXH Viet Nam
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Chtrung IV
TO CH-CC THI1C HIEN TAT BHXH VIET NAM
Dieu 15. Tham gia qua trinh Iva chop nha thAu cung cap thuOc tai cac nganh.
Ban Dugc va VTYT chu tri, phihop vOi cac don vi lien quan (nLi co) de xuat danh sach can 1)0 tham gia cac hOi clOng clau thau thu3c: DTTTQG, DPG; tham gia to tham dinh KHLCNT cung cap thuoc cua cac co ser y te do BO Y te, hocdo cac bO, nganh thanh lap, giri Vu TO chirc can IDO;
- Vu To chirc can Ix) trinh TOng Giam dOc xem xet, phe duyet;
Dieu 16. Trach nhiem cua cac dun vi tru'c thui;lc BHXH Viet Nam.
1. Ban Dugc va VTYT:
a) Huong an BI-DCH cac tinh tham gia dau than thuOc theo quy dinh.
b) Dinh kST cung cap thong tin 1,Ts gia thuOc triang thau, gia thuOc trung thau trung binh theo quy dinh;
c) Chia tri, phOi hop voi cac clop vi lien quan de ciao tao, tap huan can IDO co quan BHXH tham gia dau thau thuoc.
d) De nghi BO Y te va cac BO lien quan giai quyet cac vuOng mac trong qua trinh tham gia clau than thuoc tai cac co. y te.
2. Cac don vi lien quan theo chirc nang nhiem vu dugc giao co trach nhiem , chdc thirc hien quy clinh nay.
Dieu 17. Dieu khcian tham chieu
Cac not dung trai \Teri quy dinh nay dugc bai bo;
the, sila doi, bo sung thi thvc hien theo van ban thay the, sin. &I, 136 sung./ Truerng ,hop cac van ban dugc an chiL trong,Quy dinh nay dugc
KT. TONG GIAM DOC PHO TONG GIAM DOC
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Ph u T. liainhinuC'cac van ban QPPL ye dau thAu thuoc, thOng tin, CM lieu tra cuiu O' lung trong tham gia dau thau cun.g frng thinfic
(Kern theo uy dinh tham thju thuO'c cua co. quan Bao hiem xc7 hoi tai cac co. y banVnh theo Quy dinh ja.. 3045 /QD-BHXH ngay,16-- thong 12 nam 2017
'''`'.=,,cUauTtikng Clain c1.4c Bao hi-Zyn xa 11.6i Viet Nam)
1. Van ban quy pham phap luat, bao gOm:
a) Luat Dau thau s6 43/2013/QH13 ngay 26 thang 11 nam 2013;
b) Luat Dugc s6 105/2016/QH13 ngay 06 thang 4 nam 2016;
c) Ng1-4 dinh so 63/2014/ND-CP ngay 26 thang 6 nam 2014 cua Chinh phi quy dinh chi tiet thi hanh mot so dieu cua Luat Dau thau ve LCNT (Nghi Binh 63/2014/ND-CP);
d) Quyet dinh s6 08/2016/QD-TTg ngdy 26 thang 02 nam 2016 cua Thu Mang Chinh phit quy dinh viec mua sam tai san nha nude theo phuang thirc tap trung;
d). Thong tu s6 09/2016/TT-BYT ngay s 5/5/2016 dm BO Y t.6 Ban hanh Danh muc thuoc dau thau, Danh muc thuoc dau thau tap trung, Danh muc thuoc dugc ap dung hinh thirc darn phan gia (Thong tu. 09/2016/TT-BYT);
e), Thong tu so 10/2016/TT-BYT ngdy 5/5/2016 dm BO Y to Ban hanh Danh muc thuoc san xuat trong nude dap irng yeti cau ve dieu tri, gia thuoc va kha nang cung cap (Thong tu 10/2016/TT-BYT);
f) Thong tu s6 11/2016/TT-BYT ngay 11/5/2016 cua BO Y to Quy dinh viec Tau thau thu6c tai cac ca sa y to cong lap (Thong tu 11/2016/TT-BYT);
g) Th6ng tu s6 31/2016/TT-BYT ngay 10/8/2016 dia. BO Y t6 Quy dinh chi tiet
inau h6 sa rngi thau mua sam dugc lieu NIA vi thu6c c6 truyen tai ca so. y to (Thong tu
31/2016/TT-BYT);
h) Thong tu. so 11/2015/TT-BKHDT ngay 27/10/2015 cua BO Ke hoach va Dau
tu quy dinh chi tiet lap 116 sa y8u cau de)i vai chi dinh thau, chao hang canh tranh
(Thong tu s6 11/2015/TT-BKHDT);
i) Thong tu s6 19/2015/TT-BKHDT ngay 27/11/2015 cua BO Ke hoach va Dau
tu quy dinh chi tiet lap bac, cao tham dinh trong qua trinh t6 chnc lira chon nha thau
(ThOng tu 19/2015/TT-BKHDT)
j) Thong tu so 23/2015/TT-BKHDT ngay 21/12/2015 dm BO Ke hoach va. Dau
tu quy dinh chi tiet lap bao cao danh gia 116 sa du thau (Thong tu se) 23/2015/TT-
BKHDT);
k) Thong tu se) 50/2011/TTLT-BYT-BTC-BCT ngay 30/12/2011 cua lien tich BO Y te, BO Tai chinh va BO Cong Thuang hung dan thuc hien quail 1.)", nha ntrac ve gia thu6c dung cho ngtrOi. (Thong tu 50/2011/TTLT).
1) Thong tu se) 40/2014/TT-BYT ngay 17/11/2014 cua BO Y t6 Ban hanh va hugng dan thirc hien danh muc thu6c tan dugc thuOc pham vi thanh toan cua guy bao hi6m y to (Thong to 40/2014/TT-BYT).
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m) Th'Ong tu. so 36/2015/TT-BYT ngay 29/10/2015 dm BO Y te sung met so dieu cilia Thong tu so 40/2014/TT-BYT ngay 17 thang 11 na.'m 2014 ban hanh va huang dan.thixc hien danh muc thuoc tan dugc thuOc pham vi thanh toan cua guy bao hiem y te.
n) Thong tu so 05/2015/TT-BYT ngay 17/3/2015,c-6a BO Y to ban hanh danh mu.c thuoc gong y, thuoc dugc lieu va vi thuoc y hoc co truyen thuec pham vi thanh toan cua quy bao hiem y to (Thong tu so 05/2015/TT-BYT).
2. Cac danh muc thu6c do BO Y te ban hanh va cong khai tren trang thOng tin dien tix dm BO Y te:
a) Danh sach nuac tham gia EMA, ICH, PIC/s; danh sach ca s& san xuat thu8c dat tieu chuan EU-GMP,,PIC/s-GMP;, danh sach co' so. san xuat thuoc dat tieu chuan WHO-GMP,dugc BO Y te Viet Nam cap giay chi:mg nhan; danh sach cac co. so. co hoat Ong che. bien dugc lieu dirge BO Y te Viet Nam kiem tra;
b) Danh muc thu8c biet dugc g6c, tuong ducrng (lieu tri, thu6c co tai lieu chirng minh tuong duang sinh hoc; Danh muc thuoc san xuat tai co. so. san xuat thuoc dat tieu chuan WHO-GMP do BO Y te. Viet Nam cap giay chirng nhan va dugc co ,quan quan
coly tham quyen cua. ntrac tham gia ICH cap phep hru hanh; Danh muc thuoc san xuat tai Viet Nam dap irng yeu.cau ye dieu tri, gia thu8c va kha nang cung cap;
c) Danh muc thu6c dugc cap so dang ky hoc gidy phep nhap khau; 10 trinh chuyen,giao cong nghe thuoc gia cong tai Viet Nam; danh m & uc cac thuoc va ca s san xuat, nha, cung cap c6 vi pham ye chat luong hoac cac quy Binh ye dau thau va cung rng thuoc; din lieu ve gia thuoc ke khai/ke khai lai; gia thuoc trung thau tai cac ca so y te; danh muc thuoc dugc san xuat tin nguyen lieu (hoat chat) dugc san xuat tai cac nuoc tham gia ICH va Australia, nguyen lieu (hoat chat) dugc cap giay chirng nhan CEP; danh sach cac doanh nghiep di to chirc chuoi nha thuoc GPP, danh sach cac doanh nghiep co to chirc trung tam phan ph6i thuoc;
d) Danh muc va gia dugc lieu tang thau;
d) Danh muc thu6c phai dau thau; danh muc thu8c dau than tap trung cap qu8c gia, cap dia phuang; danh muc thuoc dugc ap dung hinh thirc damphangia;
, 3. Ke't qua dau than thuoc cac co y to bang hinh thirc dau thau rOng rai, ket qua dau thau thuoc tap trung cap qu8c gia, cap dia phtrang, ket qua darn phan gia thuoc; ket qua gia thuoc trung thau trung binh dugc cong khai ten trang thong tin dien tit dm BO Y te va BHXH Viet Na.m.
4. Bao cao phan tich tinh hinh gia thu6c, lira chon thu8c cna co. s& y te, tinh hinh sir dung quy kham, china benh bao hiem y te cua ca so y te, tinh hinh sir dung quy , bao hiem y tai dia phuang; cac bat cap, ton tai trong dau thau thuoc, gia thuoc, lira chon thuoc cua cac co s(c y te tren dia ban.
5. Cac cong van huong dan dm BO Y te, cna BHXH Viet Nam ye dau thau thu8c, ve cac Itru )"ftrong qua trinh tham gia dau thdu thu6c.
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