Transcript VISN 15 NATIONAL ACQUISITION CENTER BRIEFING

VA Drug Accountability
Conference
National Acquisition
Center
Steve Thomas
Director, National Contract Service
VA National Acquisition Center
P.O. Box 76, Bldg 37
Hines, IL 60141
(708) 786-4920
[email protected]
David Carden
Clinical Pharmacist
VA National Acquisition Center
P.O. Box 76, Bldg 37
Hines, IL 60141
(708) 786-4923
[email protected]
vaww1.va.gov/oamm/oa/nac/ncs/index.cfm
Presentation Outline
Steve Thomas
 National Contract Service Organization
 Drug Purchasing Methods Used by VA
 National Contracts
 Pharmaceutical Prime Vendor
 Pharmaceutical Repackaging Program
David Carden
 Notes from the NAC
 Veterans Health Care Act of 1992
National Contract Service
Organization
Office of the
Director
Steve Thomas
Direct Delivery
Pharmaceuticals
Medical/Surgical
CMOP
James Booth
Maria Ramirez
Ron Jenkins
Frank Zacchigna
Direct Delivery
Eric Lee
Anthony Crumpton
Pharmaceutical
Standardization
Pharmaceutical
Prime Vendor
German Arcibal
Pharmaceutical
Repackaging
Standardization
Tim Richards
Medical/Surgical
Prime Vendor
Fran DeRosa
Willie Anthony
VACANT
Drug Purchasing Methods Used by VA
 National Contract
 Federal Supply Schedule
 Blanket Purchase Agreement
 Incentive Agreement
 Open Market Purchase
Pharmaceutical National Contracts
 Standardized products
 Leveraged pricing
 Efficient delivery
 www.fbo.gov
 Point of contact: Maria Ramirez
(708) 786-4985
Pharmaceutical National Contracts
– Broad Objectives
 Lower Cost with Same Outcomes
or, better still…
 Same Cost with Better Outcomes
or, best…
 Lower Cost with Better Outcomes
Pharmaceutical National Contracts Clinically Driven Contracting
 Individual Evaluation Tools
 Efficacy
 Outcomes
 Safety
 Compliance
 VA patient needs
 Pharmacy factors
 Clinical evaluation + Price = Best Value
Pharmaceutical National Contracts –
Contracting Process
Step 1 – Pre-Procurement Request
PBM works up clinical review, meeting
announcements, representative discussions with
PBM
Step 2 – Procurement Request from PBM to NAC
Step 3 – FedBizOpps Notice
Advertises Procurement for at least 15 days
Step 4 – Issue Solicitation
Step 5 – Solicitation Closes
Step 6 – Award
Buy American Act
 FAR 25.1
 Restricts the purchase of supplies that are not
domestic end products
 Applies to order values less than $194,000
 If domestic offer is not the low offer, apply:
 An additional 6% to the low offeror’s price if the
domestic offeror is a large business concern
 An additional 12% to the low offeror’s price if the
domestic offeror is a small business concern
Trade Agreements Act
 FAR 25.4
 Waives the Buy American Act and other
discriminatory provisions for eligible products from
countries that have signed an international trade
agreement with the United States, or that meet
certain other criteria.
 Offers of eligible products receive equal
consideration with domestic offers.
 Applies to order values over $194,000 (when not setaside for small business)
Purchasing Open Market
 If item(s) are on contract, order from the contracted
source.
 If item(s) are not on contract, seek out the advice of
an acquisition professional. Why?
 If order value is $0 to $3,000:





Follow Micropurchase Procedures in FAR 13.202
Distribute orders equitably among qualified suppliers
May be awarded without soliciting competitive quotations
Use of purchase card is the preferred method
Do not split orders to keep them under $3,000
Purchasing Open Market
(continued)
 If order value is $3,001 to $25,000
 Set-aside for small business
 Non-manufacturer rule does not apply (FAR 19.5022(c)
 Buy American Act applies
 If order value is $25,001 to $100,000
 Set-aside for small business with exception in FAR 19502-2
 Non-manufacturer rule does apply
 Buy American Act applies
Purchasing Open Market
(continued)
 If order value is $100,001 to $194,000
 Set-aside for small business if there is reasonable
expectation that 2 or more small businesses will offer
products of a small business concern.
 Buy American Act applies
 NOTE: For orders between $50,000 and $194,000, the
Israeli Trade Act Applies (FAR 25.406)
 If order value is over $194,000
 Set-aside for small business if there is reasonable
expectation that 2 or more small businesses will offer
products of a small business concern.
 Trade Agreements Act applies
Pharmaceutical National
Contracts – Products
 Pharmaceuticals
 Medical gases
 Dietary supplements
 IV solutions
 Influenza vaccine
Prime Vendor
 Wide variety of product coverage
 One stop shopping
 Flexible delivery to multiple sites
 Electronic ordering and price look-up
 Inventory and space reduction
 Fill rates greater than 97%
Pharmaceutical Prime Vendor
Program
 Awarded to McKesson Corporation on December 31,
2003
 Potential 8 Year Contract (2 year contract with three,
2 year options)
 Negative distribution fees
 Point of contact: German Arcibal
(708) 786-7663
Pharmaceutical Repackaging Initiative
 NAC coordinates bulk order shipments to PrePak
 PrePak repackages product in government
labeled bottles
 Facilities order from PrePak
 7 Drugs Currently Covered by the Program –
Alprazolam, Furosemide, Ibuprofen, Isosorbide
Dinitrate, Omeprazole, Spironolactone &
Temazepam
 Point of Contact: Fran DeRosa (708) 786-5921
Notes from the NAC
 Notes From The NAC
March 26, 2010
Attached are this week's Top 10+ Report, an Open Market Report, a Prepak Fax in order form, a Wyeth
Product Status Report a Merck Vaccine Status Report and a copy of the FDA Unapproved Drug Initiative
Link I forgot last week.
FSS QUESTIONS…The Federal Supply Schedule management now has a “Help Desk” for any questions you may
have about products that may have dropped off contract or need to be on contract. [email protected] or
708-786-7737. Please copy me on e-mails so I can follow up and maybe suggest alternatives and let other centers
with the same problem know.
Many Big Shortages Continue…Since the end of last year there has continued to be ongoing shortages of many
drug products. Ciprofloxin regular release tablets is one drug that is experiencing shortages due to the Apotex and
Ranbaxy problems with the FDA; the other generics and the brand have been either unavailable or on very low
allocation. Only in the past few weeks have products from Teva,Watson and a few smaller companies been
available open market along with the contract brand but all of these are still subject to allocation. Doxazosin and
Prazosin generics are still not available in most cases and the brands are allocated. The newer problem is
Flunisolide Nasal where the brand was discontinued and the generic used most by the VA had raw material
shortages. The other generic has not been able to keep up and conversion of patients to Fluticasone has created
a shortage and allocation of that product. This little review does not even cover half the drugs that have been in
short supply. The only good news is that where many of the products since January have had no expected return
date, many are now listed as “April”. Some say “early April” and some say “late April” but we now have some hope.
Let’s just hope that in April the expected return date does not change to June or July, that would make a painful
summer.
Notes from the NAC
 The Attachments
 Top 10+ Report
 Open Market Report
 Prepak Fax in Order Form
 Wyeth Product Status Report
 Merck Vaccine Status Report
 Others as needed
Notes from the NAC
Top 10 + Report
Econo # Description
Generic Name
NDC
1381342 FLUNISOL N/SOL 0.025%
APX25ML@
FLUNISOLIDE
605050824 APOTEX CORPORATION
00
@
This company is reporting production delays
with NO return date. There is a shortage of
raw material. The brand to this product has
been discontinued so little is available as an
alternative.
2736726 FLUNISOL N/SPR 0.025%
B&L25ML@
FLUNISOLIDE
242080344 BAUSCH & LOMB PHARM
25
@
Due to the shortage of the product above the
demand for this product has it in production
delays with allocation. B&L is ramping up to
produce more but it is not available yet.
2794386 IPRATRO INH SOL .02% NEPH IPRATROPIUM BROMIDE
30
004879801 NEPHRON
30
PHARMACEUTICALS
This is listed with production delays with
return in Mid March. The 25s are available in
most areas. There are also some other FSS
products, check McKesson Connect.
3231610 SIMVASTAT TAB 80MG
45
1778554 SIMVASTAT TAB 80MG
90
1777366 SIMVASTAT TAB 80MG
30
1771252 SIMVASTAT TAB 10MG
90
246580214 BLU PHARMACEUTICALS
45
LLC
246580214 BLU PHARMACEUTICALS
90
LLC
246580214 BLU PHARMACEUTICALS
30
LLC
246580211 BLU PHARMACEUTICALS
90
LLC
These are samples of some out products
others may be allocated.
BLU cannot keep up with the current demand
so some sizes have
been on and off. A number of sizes shipped
the middle of last week.
They have told McKesson they will continue
to be on and off and have not given a back to
normal date.
BLU
SIMVASTATIN
BLU
SIMVASTATIN
BLU
SIMVASTATIN
BLU
SIMVASTATIN
Vendor Name
Comments
Notes from the NAC
Top 10+ Report Stock Status
CMOP
Econo
Sell Description
1238690
ACCU-CHEK COMF CV GLU T/STR 50
1695477
ACETAM TAB 325MG
1696129
ACETAM TAB 500MG
1953181
8144
8148
8149
8165
HINES
CHARLESTON
MURFREESBOR
O
DALLAS
On
Hand
On
Order
On
Hand
On
Order
On
Hand
On
Order
On
Hand
On
Order
19663
0
289
0
10559
1152
1604
0
MARL 100
3502
12912
277
4128
27
0
0
4080
MARL 100
1208
11267
0
7400
142
0
0
6000
ALBUTEROL INH 0.083% UDNEPH 25
7588
5016
1448
0
478
360
717
360
2434801
ALBUTEROL INH SGL 0.083%NEPH30
1076
972
2237
0
787
720
791
360
1417542
ALENDRONAT TAB 70MG UU COB 4@
164
0
1274
0
448
0
941
0
1271386
AMLODIPINE TAB 10MG COB
87
0
8032
0
568
0
2103
0
1271220
AMLODIPINE TB 5MG COB
547
0
0
0
90@
90
N/C
N/C
Notes from the NAC
Open Market Report
Econo
NDC Num
Vendor Name
3251048 93067005
TEVA
PHARMACEUTICALS
1421338 31722022505 CAMBER
PHARMACEUTICALS I@
Open
Sell Description
Market $
Notes
GEMFIBR TAB 600MG TEV 500@ $83,530.62 There continues to be a shortage of the
GEMFIBR TAB 600MG CAMB
500@
$48,438.85
contract Gemfibrizol and these two items
are all that is available. Major just added it
to FSS 4/1/2010 so ask McKesson to stock
the Major items on contract.
$40,326.34
This is one of those generics that is being
reviewed by the FDA. There is a brand
available that is FDA approved and on FSS.
1749852 143120110
WEST WARD
PHARMACEUTICALS
COLCHICIN TAB 0.6MG WEST
1000
1254846 781105310
SANDOZ
BUPROPIO TAB 75MG SAN 1000@ $29,576.16
I am not sure why anybody bought this.
There seems to be plenty of the National
Contract item available everywhere I look.
Please do not reorder…ask McKesson to
stock the Golden State contract item.
2716033 407222317
GE HEALTHCARE
GE Healthcare products that are not on FSS
1227107 407222323
GE HEALTHCARE
VISIPAQUE 320MG POLYB 100ML $28,133.00
10
VISIPAQUE 320MG POLYB 500ML $17,584.64
10
@
are made in China. McKesson should have a
corresponding product available on FSS. If
they do not stock it ask them to.
Notes from the NAC
 Other Attachments
 Prepak Fax in Order Form
 Wyeth Product Status Report
 Merck Vaccine Status Report
 Others… Notices from companies, Holiday hours for
ordering and pages that may help clarify one of the
“Notes”.
Veterans Health Care Act of 1992
Public Law 102-585 Section 603
• Only covers brand name (NDA) prescription products
and biological products.
• For these “covered” drugs, companies must follow
the rules under the Public Law and their product is
given a Federal Ceiling Price (FCP).
• Generic products (ANDA), OTC (non-prescription)
and certain brands that were grandfathered out of
the law in 1992 are not subject to the law.
Veterans Health Care Act of 1992
Public Law 102-585 Section 603
• Companies are required to submit their NFAMP
(Non Federal Average Manufacturer’s Price) for each
new drug (NDC).
• The companies are given temporary FCPs during the first
90 days of sales but basically once the NFAMP is
determined they have a permanent FCP.
FCP = 76% of the NFAMP
(The VA gets about a 24% discount)
Veterans Health Care Act of 1992
Public Law 102-585 Section 603
• “Covered” drugs must be on FSS.
• The Big4 price must be equal to or lower than the
FCP.
• Some companies have “dual” pricing. That means
their product has a Big 4 FCP price but can have a
FSS negotiated price for all “OGAs” other
government agencies.
• Companies can have National Contracts, BPAs
(Blanket Purchase Agreements) or TPRs (Temporary
Price reductions) but the price must be lower than
the FCP for Big 4 customers.
Veterans Health Care Act of 1992
Public Law 102-585 Section 603
• Each year in November companies must supply their
•
•
•
•
current NFAMP.
The previous calculation is done and compared to
the current FSS price plus the increase in the CPI-U
as of October.
The lower of the two is the new FCP.
Every 5th year, the FCP goes back to the original
calculation, not lower of the two. (2009)
In some cases, where a company raises prices too
fast, they can cause an additional discount which
causes a negative FCP. The company then gets a
penny price for a year.
THANK YOU