Questions_and_Answers_-_PBM_Solicitation_1605DC-18-R-00020.pdf

Questions and Answers Submitted For

Pharmacy Benefits Management (PBM) Services

Request For Proposal (RFP)

Department of Labor (DOL) Office of Workers’ Compensation Programs (OWCP)

Solicitation Number 1605DC-18-R-00020

1. QUESTION:

Section 5.1.2 of the solicitation states:

PHASE 1 – services shall begin no later than 60 days after award. To address the opioid epidemic public health emergency, this functionality will be required within 30 days of award for approximately 3,000 individuals receiving 90 MED or higher of prescribed opioids. OWCP will identify these individuals in its full eligibility file for all beneficiaries, provided to the PBM within 5 days of award.

Question A:

It was stated, as an example, the provision of inserts/information/notices specific to individuals receiving opioids greater than 90 MED. Are there other functionalities or applications DOL wishes to implement for MED threshold such as clinical review of prior authorization?

Question B:

Besides these 3,000 individuals, is the 90 MED functionality applicable to other patients at a later time?

Reference: Solicitation Section 5.1.2, Paragraph 2, Page 23.

ANSWER:

(Question A) No other functionality is envisioned for those approximately 3,000 individuals receiving 90 MED or higher of prescribed opioids, except what is described in the requirements for all claimants at Sections 5.1 and 5.2.

(Question B) Phase 1 functionality must be available to all claimants within 60 days after award.

No special functionality is required for individuals meeting the 90 MED threshold, other than implementation by 30 days rather than 60 days.

2. QUESTION:

Section 1.1 of the solicitation states in part:

The PBM Services requirement as defined in this Performance Work Statement (PWS) represents new services. As a result, there is no Incumbent Contractor currently providing

PBM Services.

The phrase “as defined in this PWS represents…” seems to suggest that some of the services in the current PWS may be being performed by an Incumbent.

If this is the case, please identify which services (if any) are “incumbent” and which companies are performing the work.

Reference: Solicitation Section 1.1.

There are no contractors providing the PBM Services required by this solicitation. Therefore, there is no Incumbent Contractor for PBM Services.

However, the Office of Workers’ Compensation Programs (OWCP) currently receives

Contractor services for medical bill processing, which include some utilization review functionality. Information related to the Contractor and services provided are as follows:

A. Contractor Name: Conduent Federal Solutions, LLC

(formerly Xerox Federal Solutions, LLC)

B. Contract Number: DOL-OPS-16-C-0067

C. Service Description: Medical Bill Processing Services

3. QUESTION:

Is it the expectation of DOL/OWCP that the utilization of MAC would actually increase the effective discounts (versus AWP discounts that equate to a percentage below FECA) that have already been listed in the pricing CLINS?

Reference: RFP Section 5.1.2.5.2.

As per Section 5.1.2.5.2, the MAC shall be used after contract award to obtain pricing that is better than the Net Discount, where applicable.

4. QUESTION:

The Government has referenced both “Guaranteed AWP Discounts” (Section L, Page 88) as well as MAC lists/schedules (Section 5.1.2.5.2, Page 26) to be used in conjunction or lieu of the fully transparent AWP discount value.

Does this imply that the DOL/OWCP is receptive to a manipulated discount pricing model

(either in full, or partial) at the point-of-sale that deviates from the traditional FECA fee schedule discount methodology, in which all pharmacy transactions/discounts are tied directly to Medi-

Span’s daily publication of AWP values?

If so:

A. How will the DOL/OWCP ensure that all vendors pricing proposals are evaluated in an

"apples to apples" comparison; and

B. How will the DOL/OWCP ensure a fully transparent pricing model is utilized and publicized going forward?

Reference: Solicitation Section 5.1.2.5.2 and Section L.

4. Yes.

4.a.: Each Offeror shall submit a completed Schedule of Supplies/Services (Schedule B) reflecting the Net Proposed Price/Discount for basic services and any pricing for optional service

CLINs. Net Proposed Price/Discount shall be formatted as discount-below-AWP. MAC pricing will not be evaluated as part of the pricing proposal.

Offerors should discuss their approach to Section 5.1.2.5.2 requirements in Volume I of their proposal. The proposed technical approach to utilizing MAC over the standard AWP discount will be evaluated as part of the technical proposal.

4.b.: The Government intends to utilize compliance and oversight analyses to ensure claims submitted are in compliance with the agreed-upon pricing model.

5. QUESTION:

The Government requests that we price the Optional Services CLINS using Quantity defined as twelve (12), and Unit defined as Months.

This suggests we should price these CLINS with a per month unit price. However, this does not seem to fit CLIN 0002—Specialty Pharmacy, which would be typically priced on a discount model.

Additionally, it appears that there is not enough information in the Performance Work Statement

(PWS) to set the parameters (number of patients, depth of service levels, etc.) of how to price

CLINS 0003 and 0004 on a per month basis.

Please provide more information to allow Vendors to properly price these CLINS.

Reference: Solicitation Section L (VOLUME III– PRICE/DISCOUNT).

Schedule B is amended to reflect a revised approach to pricing optional service CLINS. The

Optional Service CLIN for Specialty Pharmacy is now formatted as discount-below-AWP for brand name retail, generic retail, brand name mail order or 90-day supply, and generic mail order or 90-day supply. The Optional Service CLINS for Patient Compliance Program and for Disease

Management Program are formatted as “per case” units for a volume of 2,000 cases for each

CLIN. The cases will be selected by OWCP from among those with > # MED level, > # prescriptions per month, > # diagnoses, > # prescribers, and/or > $# in monthly drug spend, where “#” are variables to be determined by OWCP.

6. QUESTION:

Please confirm whether DOL/OWCP’s evaluation of Offerors’ Price/Discount (i.e., Factor III) will be based exclusively on the Net Discount off of AWP proposed in Schedule B.

Reference: Solicitation M.

DOL will evaluate price proposals based on the CLIN prices/discounts in each Offeror’s completed Schedule B, including all option periods and optional service CLINS.

7. QUESTION:

Why did the Government include the document titled “Attachment 4 - Updated Pharmacy

Transaction Data Including NDC and NPI”?

The Government included the document titled “Attachment 4 - Updated Pharmacy Transaction

Data Including NDC and NPI” to provide the Offerors a historical look at claims and thus allow them to provide more accurate pricing for services. The updated attachment includes NDC and

NPI codes for the data set previously shared in Amendment 0002.

8. QUESTION:

How, if at all, does the Government expect Offerors to use “Attachment 4 - Updated Pharmacy

Transaction Data Including NDC and NPI” in their revised proposals?

Offerors may use Attachment 4 at their own discretion.

9. QUESTION:

Is the Government actively working with a Third-Party Consultant on this solicitation in any way, weather to formulate questions, review proposals, establish evaluation criteria, and/or conduct market intel/feedback on Offerors, etc.?

If so, would the Government consider providing information on the Third-Party Consultant?

We want to ensure that there are no conflicts of interest with any potential third-parties engaged by the Government in this solicitation.

There are no third party consultants involved in this solicitation. This solicitation is based on requirements established by the Government from market research performed by the

Government. Proposals will be evaluated by Government employees using criteria developed by the Government.

10. QUESTION:

Reference: PART 1 GENERAL INFORMATION, Specific Tasks, Paragraph(s): 1.6.7.2.1, Page(s): 12. The RFP states: 1.6.7.2.1 The contractor shall ensure conformance to the most recent DOL implementation of Federal information security guidelines, currently defined as:

The Freedom of Information Act, as amended (5 USC 522), which provides for the disclosure of information maintained by Federal agencies to the public, while allowing limited protection for privacy.

The Privacy Act of 1974, as amended (5 USC 522a), including the Computer

Matching and Privacy Act of 1988 (Public Law 100-503)

The Federal Information Security Modernization Act of 2014 (FISMA), 44 USC §

3551 et seq.

OMB Circular A-130, Management of Federal Information Resources, which provides instructions to Federal agencies on how to comply with the fair information practices and security requirements for operating automated information systems.

OMB Memorandum M-07-16, Safeguarding Against the Breach of Personally

Identifiable Information, May 22, 2007.

OMB Memorandum M-06-19, Reporting Incidents Involving Personally Identifiable

Information and Incorporating the Cost for Security in Agency Information

Technology Investments, July 12, 2006.

OMB Memorandum M-06-16, Protection of Sensitive Agency Information, June 23, 2006.

OMB Memorandum M-06-15, Safeguarding Personally Identifiable Information, May 22, 2006.

FIPS PUB 199, Standards for Security Categorization of Federal Information and

Information Systems: http://csrc.nist.gov/publications/fips/fips199/FIPS-PUB-199-final.pdf

FIPS PUB 200, Minimum Security Requirements for Federal Information Systems:

http://csrc.nist.gov/publications/fips/fips200/FIPS-200-final-march.pdf

NIST Special Publication (SP) 800-53, Rev. 4, Security and Privacy Controls for

Federal Information Systems and Organizations:

https://csrc.nist.gov/publications/detail/sp/800-53/rev-4/final

US DOL Computer Security Handbook (DOL’s implementation of NIST SP 800-

53). (Reference Attachment 25 - Computer Security Handbook 5.0)

DLMS – 9 – Chapter 1200, DOL Safeguarding Sensitive Data Including Personally

Identifiable Information (Reference Attachment 26 - Department of Labor Manual

Series (DLMS) 9 Chapter 1200)

Please confirm what stage of implementation conformance must be achieved to these requirements.

Conformance shall be achieved for Phase 3 (180 days).

11. QUESTION

Reference: PART 1 GENERAL INFORMATION, Specific Tasks, Paragraph(s): 1.6.7.4.2, Page(s): 13- 14. The RFP states: 1.6.7.4.2 In addition to the security guidelines listed above, the contractor shall adhere to DOL and Federal security standards as they apply for “moderate” systems (defined by FIPS PUB 199). At a minimum, the contractor shall ensure compliance with the following certification and accreditation standards and guideline documents:

NIST SP 800-18 Guide for Developing Security Plans for Information Technology

Systems

NIST SP 800-30, Rev 1, Risk Management Guide for Information Technology

Systems

NIST SP 800-37, Rev 1, Guide for Applying the Risk Management Framework to

Federal Information Systems: A Security Lifecycle Approach

DLMS 9 – Chapter 400, IT Security

NIST SP 800-63-3, Digital Identity Guidelines as found at http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-63-3.pdf

Please confirm what stage of implementation conformance must be achieved to these requirements.

Conformance shall be achieved for Phase 3 (180 days).

12. QUESTION:

Reference: PHASE 1, Specific Tasks, Paragraph(s): PHASE 1 PHARMACY BENEFITS

MANAGEMENT, Page: 23. The RFP states: services shall begin no later than 60 days after award. To address the opioid epidemic public health emergency, this functionality will be required within 30 days of award for approximately 3,000 individuals receiving 90 MED or higher of prescribed opioids. OWCP will identify these individuals in its full eligibility file for all beneficiaries, provided to the PBM within 5 days of award.

In order to meet the tight timelines, [vendor] recommends using our standard file formats.

Custom file formats require additional logic and mapping changes to support inbound and outbound protocols.

ANSWER:

All potential Offerors were previously provided the established claimant eligibility file format that is, and will be, utilized by the Government for this contract. For those files exchanged with the Government, the Offerors’ file formats shall conform to the layout provided by the

Government.

13. QUESTION

Reference: Phase 3, Specific Tasks, Paragraph(s): Footnote, Page(s): 30. The RFP states: It is noted that DOL must issue an Authority to Operate (ATO) for the contractor’s web portal. As reference, NIST 800-53 Rev. 4 encompasses the vast majority of required controls for moderate systems, although not all, and is the standard used to assess any system for granting ATO. The totality of IT security guidelines, which support and clarify NIST 800-53 Rev.4, are provided in

Part 6 of this document. OWCP has held initial discussions with the DOL Office of the Chief

Information Officer to ensure a pathway for timely ATO and implementation that includes working sessions immediately following award.

Can you issue an ATO based on NIST 800-171 compliance if this is our current security stance or is NIST 800-53 Rev. 4 the only compliant option?

NIST 800-53 Rev. 4 is the only compliant option.