Attachment No. 1 Solicitation Question-Responses.docx

RFP-CMS-2010-0047

Solicitation Question-Response Document Attachment No. 1

1. H.8 – APPROVAL OF CONTRACT ACQUIRED INFORMATION TECHNOLOGY (IT)

The language in H.8 says the contracting officer’s approval is required for any IT investment.

Questions:

Does this also include IT that is not billed directly to the contract and is generally used to support the contractor’s business operations?

For example, if a contractor buys an upgrade to Microsoft Exchange that will be used by all of its employees throughout its entire business, or buys a new server for the contractor’s IT system, does the contracting officer have to approve those purchases?

These would be overhead charges. We suggest that this approval should be limited to IT investments that will become government property.

Response: Any IT investment that is purchased and/or acquired as a direct result of the contract will require prior authorization by the CO. Other IT purchases that are going to be utilized over entire business operations should be considered as an indirect cost factor.

2. H.10 - 352.239-13 ELECTRONIC INFORMATION AND TECHNOLOGY ACCESSIBILITY, Electronic and Information Technology Accessibility (OCT 2009) Paragraphs (b), (c), and (d) require the Contractor to:

(b) demonstrate compliance with established EIT accessibility standards

(c) prepare an HHS Section 508 Product Assessment Template, in accordance with its completion instructions and provide a binding statement of conformance

(d) also provide any additional detailed information necessary for determining applicable Section 508 accessibility standards conformance, as well as for documenting EIT products or services that are incidental to the project, which would constitute an exception to the 508 requirements.

Question:

Where in the Technical Volume(s) should the Contractor address the above three requirements?

Response: Wherever EIT is discussed in the Technical Proposal, a statement of Section 508 Compliance should be affirmed.

3. H.10 - 352.239-13 ELECTRONIC INFORMATION AND TECHNOLOGY ACCESSIBILITY, Electronic and Information Technology Accessibility (OCT 2009) Question: The Statement of Work/Specification/Performance Work Statement does not identify the Section 508 accessibility standards applicable to this solicitation. Would the Government please provide any applicable accessibility standards?

Response: All general Section 508 accessibility standards apply.

4. Section I – CONTRACT CLAUSES and Section L.10 52.215-20 REQUIREMENTS FOR COST OR PRICING DATA OR INFORMATION OTHER THAN COST OR PRICIND DATA (OCT 1997) Question: The clauses 52.215-10 Price Reduction for Defective Cost or Pricing Data (Oct 1997), 52.215-11 Price Reduction for Defective Cost of Pricing Data – Modifications (OCT 1997), 52.215-12 Subcontractor Cost or Pricing Data (Oct 1997) and 52.215-13 Subcontractor Cost or Pricing Data – Modifications (Oct 1997) are included in the solicitation. However, these clauses apply only when cost or pricing data “will be required.” See FAR 15.408. Here, the proposing company (and other offerors) will be exempt from providing cost or pricing data in accordance with FAR 15.403-1(b)(1). See also FAR 15.403-4 (“The contracting officer must obtain cost or pricing data only if the contracting officer concludes that none of the exceptions in 15.403-1(b) applies” (emphasis added).) Since this RFP is issued using full and open competition procedures, there is every reasonable expectation that the prices agreed upon will be based upon adequate price competition, and in accordance with FAR 15.403-1(b)(1) and (c)(1)(i),(ii) and (iii) that two or more responsible offerors, competing independently, submit priced offers that satisfy the Government’s requirements. Therefore, unless the Government already knows that it will not receive more than one responsible offer, it cannot have already determined that cost or pricing data is required, and these clauses simply do not yet apply – if ever. The price information the government will receive from multiple competitive offers will be more than adequate to determine whether the price proposed is fair and reasonable and to make a determination of cost reasonableness and realism. Cost or pricing data is simply not necessary and, pursuant to the FAR, it is inappropriate to request it.

Response: If a specific clause or provision is not applicable to the subject solicitation or resulting contract, it is self deleting.

5. L.9. FAR 52. 215-1 INSTRUCTIONS TO OFFERORS – COMPETITIVE ACQUSITION (JAN 2004) (Alternate I (OCT 1997), which clearly indicates the Government is expecting the solicitation to be competitive, and therefore the pricing is based upon adequate competition.

Response: If a specific clause or provision is not applicable to the subject solicitation or resulting contract, it is self deleting.

6. G.11 – INDIRECT COST RATES APPLICATION AND H.6 INDIRECT COST RATES

Question: If the Contractor has already submitted provisional and/or indirect cost rates to the cognizant Federal Audit agency, and can so advise, do provisional and/or final indirect cost rates also have to be provided to the National Institutes of Health address listed at H.6.?

Response: Offeror should so advise.

7. Solicitation Announcement posted on www.fedbizopps.gov on June 20, 2010, and K.1 52.204.8 Annual Representations and Certification (FEB 2009) (a) (1).

Question: The NAICS code is listed as 446110, however that NAICS code is for retail pharmacies and drug stores engaged in retailing prescriptions or nonprescription drugs and medicines. Can the offeror bid if they are not registered under this code, but are registered under 541611 or 7371?

Response: Yes

8. L.15 – GENERAL INSTRUCTIONS

Subparagraph (a) requires the submission of a Business and Technical Proposal for Part I and Business and Technical Proposal for Part II, and subparagraph (b) requires and original and six (6) copies of each technical and business volumes, plus the CD-ROM.

Question:

Is it the Government’s intent to have the offeror submit twenty-eight (28) separate volumes and four (4) CD-ROMs?

Response: Yes

9. L. 16 - PROPOSAL ORGANIZATION

Subparagraph 1, provides the organization of the Business Proposal.

Questions:

1. Should the offeror include only the costs for Part I in the Part I Business Proposal and only the costs for Part II in the Part II Business Proposal?

2. Where should the offeror provide the total contract costs as required under B.3 – ESTIMATED COSTS & FEE?

3. Should the Business Volume for Part I and the Business Volume for Part II include all the information required under the instructions given at L.16 a.1., as some of the information would be duplicative?

Response: The Business Proposal for each Part should be provided in separate binders. The Estimated Cost and Fee should be provided for each Part.

10. L.17 - VOLUME 1-TECHNICAL PROPOSAL INSTRUCTIONS

Subparagraph D – Chapter 4 – Project Management Plan requires a significant level of detail that may hamper the offeror’s ability to stay within the fifty (50) page limit.

Question:

Can the offeror provide a complete Work Breakdown Structure (WBS) as an appendix to the Technical Volume?

Response: Appendices are not included in the page limit.

11. L.21 ESCALATION FACTOR

Question: Can the Government please clarify the recommended escalation factors for labor rates, as FY2010 would not be applicable, and there is no recommended escalation rate for FY2015?

Response: A projected rounded rate of 2.7% for all years should be used.

SECTION M .3 TECHNICAL EVALUATION FACTORS

12. Page 84 of the RFP lists Other Factors – (1), and states the factors will be considered in the Best Value award determination.

Question:

Do the Other Factors apply to only Part I and/or Part II or both?

Response: Part I and Part II.

13. M.3 – TECHNICAL EVAUALTION FACTORS

Question: Are there significant sub factors that the Government intends to evaluate and assign a point value?

Response: No

14. M.3 – TECHNICAL EVALUATION FACTORS

Questions:

Is a point score given for price?

How will price and cost be evaluated, other than cost realism and cost reasonableness?

What weighting is given to cost?

Response: Refer to Section M.1. of the RFP. A point score is not given for price. An Offeror’s business proposal will be analyzed for a determination of cost reasonableness and realism. All evaluation factors other than cost, when combined are considered to be significantly more important than cost.

15. Attachment J-1 – STATEMENT OF WORK, Survey of Retail Prices; Payment and Utilization Rates; and Performance Rankings Questions:

Does CMS prefer the average drug acquisition cost file to be reported at the same grouping level (i.e., identical active ingredient combination, strength, dosage form, route of administration) as the Federal Upper Limit?

Response: No, each NDC shall have an ingredient cost.

Is the intent that a single list of national average drug acquisition costs will be published on the CMS website every month, and the additional separate national average drug acquisition cost files for chain, retail community, and specialty pharmacy types are not intended for publication at this time?

Response: This is yet to be determined.

Please discuss CMS’ plan for encouraging or mandating pharmacy participation in this survey initiative, particularly regarding the involvement of pharmacy interest groups?

Response: CMS plans a transparent implementation that will encourage the input of the interest groups and the States. Shortly after award, we plan to initiate this process.

16. G.12 – SERVICE OF CONSULTANTS

Questions:

What is CMS definition of consultant versus subcontractor? There is no definition in the FAR (see FAR 2.101 – Definitions) of a consultant.

As long as contractor satisfies the requirements in Section G.12, does the contractor also need to provide all the items as indicated in the RFP, Section L.18, page 72 and 73, Item 3 Subcontracts (as appropriate)?

The contractor is planning to use consultants for ad-hoc hourly support and we are not sure where to draw the line for what is stated in Section G.12 and what is requested in Section L.18, page 72 and 73.

Response: Consultant agreements with supporting price information should be submitted.

17. L.18 – Volume 2 BUSINESS PROPOSAL INSTRUCTIONS, 3 a., b., and c.

Questions:

Can the offeror utilize a subcontractor with an existing GSA schedule, and will the Contracting Officer authorize the offeror to do so?

If utilizing a subcontractor with an existing GSA schedule, what information under L.18, 3.a., b., and c. should be provided in the proposal?

Response: Yes. Pricing information in accordance with the GSA schedule should be submitted.

18. Section H.8 – Approval of Contract Acquired Information Technology

Requirement of Contracting Officer’s written approval for technical specifications

Questions:

1. Will CMS provide datacenter guidelines to ensure the contractor’s datacenter meets CMS requirements?

Response: The Contractor will not use CMS’ datacenter.

1. Will CMS provide its infrastructure/architecture requirements, and all other documents related to providing a solution to meet the technical standards defined by CMS to ensure compatibility?

Response: No, CMS datacenter will not be involved.

19. Section H.12 – CMS Information Security

Adherence to governing CMS IT policies

Question:

1. The website link identified in the RFP, http://www.cms.hhs.gov/informationsecurity is not operative. Will CMS provide the information systems security policies and guidelines?

Response: The website link listed above is operable.

20. Section H.12 – Information Security Compliance with CMS IS Program requirements Question:

1. Will CMS make available CMS IS policies, standards, procedures, and guidelines and CMS security requirements?

Response: All IS policies, standards, procedures and guidelines are available on the website above.

21. Section L.17, Part I, A – Statement of Problem and Technical Approach Choice of database management system Questions:

1. Is there a specific: database management system, report creation tool, and job scheduler that should be used by the contractor in the proposed technical solution?

Response: No

1. Since based on CMS standards, ERWin is the database design tool of choice, is its use mandated by this RFP? Similarly, Java is CMS language of choice for application development; is its use also mandated by this RFP?

Response: Contractor will use its own database.

1. Are there Office of Information Services / Enterprise Data Group (OIS/EDG) standards, e.g., for database design, that the contractor will be required to meet?

Response: No, Contractor will be required to design, use and maintain its own database.

1. Does CMS already have a bus architecture in place that the survey and any data it produces will have to accommodate?

Response: No, there is nothing to accommodate.

22. Section C.1, – Statement of Work

Questions:

1. Will the contractor be treated as a “Medicare Contractor” as that term is defined under Section 1893 of the Social Security Act, as modified by Section 935(f) of Medicare Prescription Drug, Improvement, and Modernization Act of 2003?

Response: No

1. Will the contractor be entitled to indemnification under the Public Health Service Act?

Response: No

23. Substantive Survey Requirements

Statement of Work, Section II, Parts I and II Requirements – Nature of the Survey Surveyor’s Capacity to Require Provision of Information Questions:

1. Pharmacies will be under no obligation to respond to a contractor unless they are recipients of federal health care payments and are required to do so by CMS.

10. Will CMS impose a requirement that pharmacies participating in the Medicaid or Medicare programs are required to respond to the contractor’s survey/

Response: No, pharmacies should be asked to volunteer their services to complete surveys. However, the contractor may wish to offer a stipend for the pharmacies’ time.

10. Will CMS provide the contractor with a comprehensive list of pharmacies participating in the Medicaid or Medicare programs?

Response: No, the contractor must use its own resources to identify pharmacies.

1. To comply with HHSAR 352.201-70 PAPERWORK REDUCTION ACT, will the pharmacies surveyed be required to submit the survey results electronically?

Response: For ease of administration, an electronic vehicle is preferred.

Mechanism for Ensuring Information Produced in Survey is Accurate Question:

1. Will CMS impose an attestation or affirmation requirement on the reporting pharmacies, e.g., “The knowing provision of false information on this survey instrument may subject the submitter to legal liability and may result in the imposition of sanctions including termination from federal health insurance programs.” In the absence of such a requirement, what mechanism will CMS employ to ensure the accuracy of the information submitted?

Response: There will be no attestation or affirmation requirement. The reporting pharmacies information collected will have to be statistically sound and subject to audit by the contractor.

Definition of Terms Questions:

1. Will CMS define the terms “drug prices [for]…Cash paying customers, Customers with third party insurance, Medicaid customers” (Part I Requirements) and “ingredient cost” (Part II Requirements) or leave that definition to the surveyor? Are the resulting values of the survey to be the mean or median price/cost or will that decision be left to the surveyor?

Response: Drug prices mean drug prices paid by the cash paying customer or the total amount allowed by third party payers and Medicaid customers including dispensing fees and copays. The resulting values will be the median.

1. What is the definition of “all covered outpatient drugs” (Part I and II Requirements)? Is this term to be understood as “covered by a state Medicaid program”? If so, since coverage can vary from state to state, will CMS provide a comprehensive list of the products to be included in the survey?

Response: Covered outpatient drugs are drugs identified and published on the CMS Medicaid Drug Rebate File (MDR) which is a comprehensive list.

1. What is the definition of “retail Community pharmacies” “chain pharmacies”, and specialty pharmacies” (Part II Requirements)?

Response: CMS does not plan to further define retail community pharmacies, chain pharmacies or specialty pharmacies at this point and relies on the contractor to make a reasonable assumption for the identification of pharmacies in each category for purposes of its submission.

1. Is a “cash paying customer” (Part I Requirements) an individual with no insurance benefits of any kind?

Response: Yes

Scope of the Survey Question:

1. The SOW requires a survey of “Retail Community Pharmacy” consumer prices and costs. This reference would exclude non-pharmacy entities that also submit pharmacy claims to state Medicaid programs, such as home health care agencies, long-term care facilities and clinics, with the result that prices and costs for, e.g., injectable products would not likely be included in the survey. Is this CMS’s intent?

Response: Yes Requirement of FDA Approval for Surveyed Drugs Question:

1. Does CMS intend that the contractor will include within the survey prices for all products or for only those products for which a valid FDA approval can be identified, e.g., should the contractor report prices/costs for unapproved formulations of colchicine?

Response: The contractor need only address those products that appear on the MDR file.

Structure and Content of the Data to be Reported Question:

1. What does CMS intend the contractor to report as values for new products or for any products when there is inadequate information to support a reported price? If there is no available purchase or sale information for a product for an extended period of time, how long does CMS intend that the contractor continue to publish the last reported price?

Response: A threshold of the number of entities and the length of the period of time a published price is to be reported is yet to be determined.

Comparative Analysis and State Ranking Question:

1. The SOW refers to a report relating to “top 50 prescribed drugs” (Part I, A, Task 4). Is the report intended to capture literally the quantity of products prescribed as opposed to the quantity dispensed (if those figures are not equivalent)? Additionally, since over the counter products can be prescribed, is the report intended to capture both Rx and OTC products, or only the former?

Response: The top 50 drugs are single source drugs. The list is to be developed by the contractor.

24. Question:

Is there a list or example of the type of drugs that are being tracked?

Response: Covered outpatient drugs identified and published on the CMS Medicaid Drug Rebate File (MDR) which is a comprehensive list.