Questions and Answers

PADOC Pharmacy and Pharmaceutical Services

6100041263 REV 021417

Question # / RFP Page # / RFP Section Reference / Question / Answer / Addendum
1 / RFP Section III-1.D and Appendix N / RFP Section III-1.D. (Technical Submittal) seems to require a contractual relationship between the selected offeror and
Sapphire Health, LLC (“Sapphire”). Appendix N to the RFP provides: “To prevent any disruption to patient care,
Offeror must submit a Letter of Intent (LOI) outlining a plan to interface with the Sapphire EHR system. The LOI
must be included with the RFP response.” Neither the RFP nor Appendix N is clear as to when, how or by whom the
LOI with Sapphire should be negotiated and established. Please (1) confirm that all that is required in the proposal is
the LOI and not a contract with Sapphire and (2) specify when, how and by whom such an LOI is to be negotiated and
established as part of the procurement process. / Appendix N has been modified to eliminate the need for a Letter of Intent with Sapphire Health, LLC. A revised Appendix N is attached to this addendum as Attachment 1 and replaces the one posted on January 13, 2017.
Only the selected Offeror will have to contract with Sapphire Health, LLC. Refer to part II-2.A regarding transition/start-up. / 4
2 / III-2.F.4 / Offeror shall describe in detail how they will accomplish the following: Item 4. Distribute medications from a Pennsylvania Licensed Drug Wholesaler.
Initial requirements for bidders to be licensed repackagers and licensed wholesalers appear to have been removed in this RPF version, however, this requirement remains.
Was it the PADOC’s intent to continue to require licensed wholesaler status for potential bidders? / Offerors are not required to be a licensed drug wholesaler. Rather, they must obtain all medications to be dispensed from a licensed drug wholesaler. The language in Part III-2.J has been deleted and replaced with the language contained in Attachment 2 to this Addendum. / 4
3 / III-2.M / The selected Offeror must establish a file exchange including specified demographic and medication data with the PACE program for purposes of invoicing, reporting, and tracking medications billable to PACE for offenders age 65 and older.
What indicators are in the current file exchange that explicitly identify PACE program participants? How is that information relayed to the pharmacy entity?
Does the PACE program utilize a Formulary that is separate or different than the one utilized and administered by the PA DOC? / DOC updates the PACE inmate enrollment file, weekly, and sends it to PACE.PACE assigns ID numbers to new enrollees and returns the file to DOC and the vendor.
PACE has an open formulary; however, it does not pay for Over-the-Counter or medications not covered by a PACE rebate from the manufacturer. PACE still reimburses pharmacy entity for these medications and then bills those charges back to DOC. / 4
4 / APPENDIX N - Information Technology Requirements for Integration of Pharmacy Software with Electronic Health Record / Shipping information including 2-D barcodes for each medication card. All shipped medications including stock must have a 2D barcode that Sapphire can ingest from the pharmacy system.
Can a 2-D Bar Code from a current medication card be supplied as an example ( Patient / Facility Information Redacted)?
What is the specific 2D Barcode Matrix that is being utilized? Aztec Code, Code 1, or Data Matrix technology? / Appendix N has been modified to correct the barcode requirement. A revised Appendix N is attached to this addendum and replaces the one posted on January 13, 2017. / 4
5 / Section I-21.
Restriction of
Contact / Does Sapphire Health, LLC have any relationship through common ownership or otherwise with
the current pharmacy provider or any other potential offerors? In Section I-21 Restriction of
Contact, the RFP states “An Offeror who shares information contained in its proposal with other
Commonwealth personnel and/or competing Offeror personnel may be disqualified.” Does
contacting Sapphire Health, LLC violate this RFP clause? / Yes. Refer to the answer to Question 1 above and the revised Appendix N.
Pursuant to Part I-2, all questions regarding the interface with Sapphire Health, LLC will be coordinated through the Issuing Office. / 4
6 / Appendix N / How many correctional pharmacy software programs currently have interfaces working with
Sapphire Health EHR to the specifications required by APPENDIX N - Information Technology
Requirements for Integration of Pharmacy Software with Electronic Health Record? If there are
any, what is(are) the name(s) of the software program(s)? / Sapphire is currently interfaced with the CIPS Pharmacy Software Program. CIPS, provided by Kalos, Inc., is the largest provider of pharmacy dispensing software within the correctional pharmacy industry. Sapphire has been integrated with CIPS for seven years. / 4
7 / N/A / At the Pre-proposal Conference held on December 13, 2016 at SCI-Rockview, David R. Kline, the
Issuing Officer, stated that a WebEx tutorial would be presented to all bidders on Sapphire Health
EHR. Can you please provide a date and time for this webinar? / Refer to Addendum 3 posted on 1/26/17 regarding a Question and Answer session with Sapphire Health scheduled for 2/2/17 at 9:00 AM EST for all interested Offerors. / 4
8 / Section III-1. Part
E. 340B Program / Who is the contact to discuss the arrangement with Temple University and the DOC in order to
meet the 340B requirement of III-1.E 340B Program on page 14 of the RFP? / The selected Offeror will be provided contact information for Temple University Hospital upon contract award. / 4
9 / Section III-1, Part
D. Information
Technology / At the Pre-proposal Conference held on December 13, 2016 at SCI-Rockview, the Chief of Clinical
Services at PA Department of Corrections stated that Sapphire EHR is currently functioning as an
eMAR and not yet fully functional as an EHR. Since some time has passed, is the EHR referenced
in Part III, Section III-1, Part D now functioning as a full EHR? This question is relevant because
developing an interface for an EHR and an eMAR are two different tasks. Although the words
EHR and eMAR seem to be used interchangeably, the two programs are different. Not knowing
the system functionality could cause a delay in the “turnkey” requirement on the first day of the
contract start for anyone other than the incumbent. / Full implementation of the Sapphire EHR will be completed prior to the execution of a contract resulting from this RFP. / 4
10 / Appendix N / Your description of the interface requires the use of a shared database to receive and send
information.
a. Most CIPS versions don’t use this model. Is a shared database required?
b. CIPS typical model would be to have Sapphire run a file drop of HL7 messages
where Sapphire would be given SFTP access to our server and drop orders, as well
as pick-up response files from CIPS as we fill the scripts. Would you allow
Sapphire to work in that manner? / Refer to requirements set forth in Appendix N. / 6
11 / Appendix N / A recently answered question stated that CIPS Correctional Pharmacy Software was written as the
program with which you interface. However, Appendix N states, “Barcode must identify the
Medispan GPI of the medication on the card for proper administration screening.” CIPS contains
data tied to the fill ID and would not be what Sapphire is expecting. Can you control how you
handle different barcodes? / Sapphire can process a variety of barcode, however the end resultant data must be representative of unique item identification which also must be tied to a known GPI and supporting data. This information is used to validate that proper medication is being administered to the patient. Alternative barcode options would need to be further explained before a determination could be made if they comply with the requirements to identify the GPI. / 6
12 / Appendix N / Referring to the above statement that CIPS Correctional Pharmacy Software is the program for
which you have a Sapphire interface. The updated Appendix N states “The preferred interface
message format is HL7.” Does your CIPS Correctional Pharmacy Software use HL7 to interface with Sapphire? / Refer to requirements set forth in Appendix N. / 6
13 / Appendix N / Is there a cost associated with using the interface, e.g., per claim, per order, per refill? / Refer to Part III-1.D / 6
14 / Appendix N / What monthly and/or quarterly costs are tied to the interface? / There are no financial obligations, routine or otherwise, to Sapphire Health for the Offeror. / 6
15 / Appendix N / Do the above costs, in questions 4 and 5, remain the same over the course of the contract? / Yes. / 6
16 / Appendix N / Does the processing fee to the state include profiles? / Yes / 6
17 / Appendix N / What is our cost to Sapphire for the programming of the interface? / The selected Offeror may incur technical costs associated with making any necessary modifications to their pharmacy system to accommodate the interface with the Sapphire E.H.R. per the requirements. If Sapphire is required to make custom programing changes to the Sapphire system for features not currently supported under the existing interface to accommodate the Offeror’s interface, Sapphire will charge a hourly rate for custom programing. / 6
18 / Appendix N / In Question and Answers for PADOC Pharmacy and Pharmaceutical Services, Question #6, the
answer received stated that Sapphire has an interface with the CIPS Pharmacy Software Program.
Is Sapphire’s interface with CIPS through an HL7 interface? Can you tell us if Sapphire has been
integrated with the CIPS Standard version in addition to the incumbent’s own proprietary version
of CIPS for the past 7 years? The answer to this question is most important because the largest
provider of pharmacy dispensing software within the correctional pharmacy industry, CIPS, uses
the standard version for ease of interfacing with any EHR. Stating that there is a CIPS interface for
Sapphire, when it was built and programmed for a proprietary version of CIPS, is misleading
because that interface doesn’t work with the standard CIPS version. Can you please clarify
Sapphire’s interface experience with CIPS’standard HL7? / Refer to requirements set forth in Appendix N. / 6
19 / Appendix J / Cost Proposal Appendix J: There is a discrepancy between the number of prescriptions to base pricing on in the Cost Proposal Appendix J (lists total number of prescriptions as 946,331) and Appendix D amount of medical orders by Institution (lists total number of prescriptions as 1,065,359). Should Appendix J be modified to reflect actual orders placed/received during the utilization period of 9-1-15 to 8-31-16 provided in Appendix D? / Appendix D – Medication Orders by Institution is a historical report of ALL prescriptions ordered for the period indicated. Appendix J – Cost Submittal is a subset of medications for pricing evaluation purposes. / 6
20 / Appendix D / Appendix D: Please clarify whether the number of Stock medication orders and OTC medication orders are included in the total prescription orders or if they are in addition to the total prescription orders listed in column 4. / Yes. They are included in the total prescription column. / 6
21 / III-1.D / What is the current published price from SapphireHealth, LLC for a bi-directional interface for a pharmacy information system to Sapphire EHR? / See response to question #17. Sapphire charges per hour for custom programing. / 6
22 / III-1.D / Will the pharmacy information system be supplying ADT in addition to script information, or will Sapphire EHR have a separate ADT feed? / No. The pharmacy system will not supply ADT to Sapphire. Sapphire EHR receives routine ADT feed from the DOC. If the Offeror requires an ADT feed separately, this must be arranged through the DOC. / 6
23 / Appendix S / Please provide the number of Pharmacy Medication Events (Errors) with detail the current vendor has made and the amount of the chargeback to vendor (credit to PADOC) over the past two (2) fiscal quarters based on the Contract Performance Standards outlined in Appendix S. / None. / 6
24 / III-2.H.6 / Part III-2.H.6 CQI: #6 of this section refers to acceptance of error rate for filling of medication orders of no more than .05 percent per month at each SCI and aggregate statewide. This conflicts with Appendix S Performance Standards #5 which allows no more than 3 Pharmacy Medication Events (Errors) per quarter. Based on your stated medication orders in Appendix D, Appendix S would only allow for .000817 percent per month error rate for filling of medication orders. Since these two figures conflict one another, please clarify the acceptance of error rate for filling of medication orders is correct as listed in III-2.H.6 as .05 percent is more in line with industry standards and modify the number of allowable medication events in Appendix S to reflect the correct percentage listed in the RFP. / Describe and provide a sample of your medication event tracking analysis tool including screenshots or hyperlinks as appropriate. Offerors shall provide an overview of you medication event monitoring process to include electronic tracking, reporting and trending of Dispensing and Administration Events. This event report will be sent to the BHCS on a monthly basis. The PADOC will not accept an error rate for filling medication orders of more than 3 per quarter statewide.See Appendix S. / 6
25 / III-1.J.2 / Part III-1.J.2 Qualifications: Please clarify whether the meaning of “aggregate average annual claims volume of at least three million” is referring to PBM claims. / This includes al pharmacy claims. / 6
26 / Addendum 4
Official Questions and Answers
Question 2 / Question #2 of Addendum 4 was answered, “Offerors are not required to be a licensed drug wholesaler. Rather, they must obtain all medications to be dispensed from a licensed drug wholesaler. The language in Part III-2.J has been deleted and replaced with the language contained in Attachment 2 to this Addendum.”
The Federal Register (64 FR 67720 at 67748) indicates that a pharmacy cannot distribute more than 5% of its gross sales as stock without being registered as a wholesaler or using the services of a wholesaler to distribute wholesale quantities of stock medications. Although some pharmacies have a smaller customer base than others, a fair assumption is that the percentage of stock dispensed by potential Offerors to this RFP would be similar. Therefore, most if not all pharmacies working in the correctional industry provide at least 5% of their overall correctional sales as stock. Such pharmacies need to comply with the federal 5% rule regarding stock distribution as well as the Pennsylvania Wholesaler Act.
(1) Will you require bidders to comply with this regulation by amending the RFP to require Offerors to disclose in their written proposal the percentage of overall gross sales their pharmacy dispenses as stock?
(2) Will you require the Offeror to provide, at the time of proposal submittal, written documentation or a copy of their wholesaler license to show whether they are licensed as a wholesaler or they use the services of a licensed wholesaler for stock distribution?
(3) Will an Offeror’s failure to provide proof of compliance with federal regulations, specifically the aforementioned requirement, deem a pharmacy bidder non-responsive and therefore ineligible for an award?
(4) If the answer to part (3) ( immediately preceding) is “no,” what process will DGS follow prior to awarding a contract to ensure compliance with federal and state laws regarding stock distribution so that the DGS does not award a contract to a vendor, only for the DGS to later discover that the vendor is unable to comply, which would place the PADOC and DGS at risk for possible fines and/or disciplinary actions upon inspection? / (1) The selected Offeror, in the performance of all of the requirements of any contract resulting from this RFP, must comply with all applicable federal, state, and local laws and regulations as set forth in Part III-1.J(1). By submitting a proposal in response to this RFP, Offerors represent to the Commonwealth that they, and any subcontracts to be used in performance of the Contract, are compliant with the applicable federal, state, and local laws and regulations. See Part I-24.A. If at any point during the contract term, a change in status or scope requires a change in licensure/registration status in order to remain compliant with all applicable federal, state, and local laws and regulations, it is the responsibility of the selected Offeror to ensure that the new requirements are met immediately and must notify the PADOC within 10 calendar days of such a required change.
(2) See response to Question 1(1), above.
(3) See response to Question 1(1), above.
(4) See response to Question 1(1), above. / 6
27 / Addendum 4
Official Questions and Answers
Question 2 / Question #2 included, “Initial requirements for bidders to be licensed repackagers and licensed wholesalers appear to have been removed in this RPF [sic] version, however, this requirement remains.” However, Answer #2 does not appear to respond to this comment.
As PADOC facilities currently receive legend stock in cost-effective blister cards, a pharmacy or a wholesaler cannot simply put those medications in a blister card and label them as stock and still be in full regulatory compliance with 21 USC 352. A company must be an FDA-registered repackager or use the services of an FDA-registered repackager to legally repackage stock medications into blister cards or into any other packaging that results in a change to the original manufacturer’s packaging.