PBM III QUESTION_AND_ANSWERS.xlsx
XLSX spreadsheet 28 KB Posted
- Attached to
- PHARMACY BENEFITS MANAGEMENT SERVICES (PBM) Federal contract opportunity
- Solicitation number
- 1605C3-24-R-00011
About this file
This is a Questions and Answers document for a Pharmacy Benefits Management (PBM) Services solicitation from the Department of Labor's Office of Workers' Compensation Programs (OWCP). The Q&A addresses technical clarifications about key personnel requirements, eligibility files, claims processing procedures, drug classification, and clinical requirements.
Key clarifications include: the PBM must process 1,000 Medication Use Evaluations and assist 1,500 claimants with medication adherence across all OWCP programs combined during each option period; only clinical pharmacists (not nurses) can adjudicate held/rejected/non-formulary transactions; the pricing evaluation will be based on AWP discount, rebate per brand transaction, and service fee; and the Government Acceptance Testing period must be at least 10 weeks prior to implementation. The document also clarifies requirements around processing claim reversals, handling state workers' compensation claims for Black Lung program beneficiaries, and managing prior authorizations. Questions regarding the solicitation were due by October 21, 2024, with the proposal due date to be announced in a future amendment.
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Sheet1
| Pharmacy Benefits Management Services (PBM) | ||||
| Question Title | Section Number | Question Detail | Government Response | |
| Instructions | L.7 Volume 1, Subfactor 1 | The RFP states: "An offeror’s understanding of the work will be shown through its | ||
| ability to demonstrate that it can perform the work described in Parts 1.9, 1.14, 1.15 & Part 5 of the PWS and the extent to which potential risks are identified and mitigated." Parts 1.9, 1.14, and 1.15 do not exist in the current RFP. See also the Evaluation Criteria for Subfactor 1, which also contains this error as well. Please clarify. | Corrected to 1.6.13 Key Personnel, 1.6.14 Other Personnel andD3:D9 5.18 Security. | |||
| Instructions | L.7 Volume 1, Subfactor 1 | In the list of corresponding subparts to address the RFP lists Personnel (1.6.13); however, Section 1.6.13 of the RFP corresponds to Organizational Conflict of Interest. Did the Government mean to cite 1.6.9.7, 1.6.10, and 1.6.11 instead? Please clarify. | Solcitation is corrected to reflect 1.6.13 Key Personnel and Organizational Conflict of Interest is 1.6.16. | |
| Instructions | Sections L and M | The Technical Subfactors in Section L do not match the Technical Subfactors in Section M. The numbering is off. Please update to align the Subfactors by the correct number in Section L and Section M. | Removed eligibility as it did not match sections M and L. | |
| Instructions / Page Count | L.7.c | Please confirm that cover pages, tables of contents, lists of figures/tables, and acronyms lists are exempt from page count restrictions. | Confirming that page counts excludes, covers, title pages, executive summaries, table of contents, lists of network providers, and supporting documentation. This does not include the attachments below that have their own page limitations. (Key personnel, all resumes, corporate experience, Quality control plan, start- up plan/phase out plan and security requirements) | |
| Instructions | L.7, Volune 1, Subfactor 5 | The RFP states: The offeror shall provide the experience and qualifications of all contractor personnel in support of the minimum qualifications specified at Part 1.6.13 in the PWS." Part 1.6.13 of the RFP corresponds to Organizational Conflict of Interest. Did the Government mean to cite 1.6.10 and 1.16.11 instead? See also the Evaluation Criteria for Subfactor 5, which also contains this error as well. Please clarify. | Corrected to 1.6.13 Key Personnel and 1.6.14 Other Personnel. | |
| Part 2 - Acronyms and Definitions | Part 2 | The Definition of Medication Use Evaluation in the solicitation is as follows: Medication Use Evaluation. A case review by a clinical pharmacist to identify opportunities for improving quality of care. After the review, the pharmacist prepares and shares with the prescriber a written report via electronic mail or facsimile (FAX) detailing the findings and providing recommendations, which are based on scientific evidence, pharmacoeconomic analysis, and nationally recognized clinical practice guidelines. The pharmacist then discusses the written report with the provider via a telephone call. Can the Government confirm they want the report to be faxed to the prescriber prior to the telephone call? Typically the phone call with the prescriber would precede the report. | The PBM vendor may provide the medication use evaluation report prior to or after the telephone call with the prescriber based on their preferred method. |
The definition of medication use evaluation has been updated as follows:
Medication Use Evaluation. A case review by a clinical pharmacist to identify opportunities for improving quality of care. After the review, the pharmacist prepares and shares with the prescriber a written report via electronic mail or facsimile (FAX) detailing the findings and providing recommendations, which are based on scientific evidence, pharmacoeconomic analysis, and nationally recognized clinical practice guidelines. The pharmacist should discuss the written report with the provider via a telephone call.
| Part 5 - Pharmacy Networks | 5.2.6 | This requirement states: The contractor must have the ability to retroactively process pharmacy bills at the full pass-through price, for example, between the case filing date and case acceptance date. What is meant by "between the case filing date and case acceptance date”? How would the contractor know? Is this date range provided electronically? |
| The case filing date is when the case was provided by the responsible party to the government. The case acceptance date is when the case was formally accepted by the government. |
The PBM vendor would know the difference in dates by using the government's eligibility files. Data fields exist on the governments eligibility files to inform the PBM vendor when the case filing date is and when the case acceptance date is. The date range is provided electronically through these files.
| Part 5 - Processing Claims for Payment | 5.5.5 | The requirement says: The contractor must bill for prescriptions using the 11-digit NDC. The contractor must not pay for an NDC unless it is listed on the FDA NSDE file – even if it is listed in a drug compendium such as Medi-Span or First Databank. Please explain in greater detail the concern OWCP is trying to address regarding the NDC and the FDA NDSE list. |
| The FDA’s Comprehensive National Drug Code (NDC) Structured Product Labeling Data Elements file (NSDE) is used as a source of NDC information for the Medicare Part D Formulary Reference File and prescription drug event (PDE) editing. OWCP plans to align more of its pharmacy processing standards with Medicare and other federal payers and plans to utilize the NSDE as a starting point when processing prescription drug claims. |
The NSDE file can be found at: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm240580.htm
| Part 5 - Processing Claims for Payment | 5.5.7 | The requriement states: The contractor must employ ICD codes in accordance with OWCP regulations and procedures. Does OWCP utilize ICD9/ICD10/ICD11? Or a mix of all? | OWCP utilizes both International Classification of Diseases, Ninth Revision and Tenth Revision (ICD-9 and ICD-10) for accepted conditions, and will utilize the International Classification of Diseases, Eleventh Revision (ICD-11) in the future. |
| Part 5 - Processing Claims for Payment | 5.5.10 | From the PWS: Claims for reimbursement received from claimants on Form OWCP-915 must be converted into electronic format to detail necessary claim elements. After conversion into electronic format, claimant claims must undergo all edits and meet formulary requirements before payment. Form OWCP-915 does not appear to include all of the data elements required for processing (including applying edits and formulary). Will submissions on this form consistently include NDC, quantity, dose, days supply, prescriber? | Requirement 5.5.10 has been revised to read: Claims for reimbursement received from claimants on Form OWCP-915 must be converted into electronic format to detail necessary claim elements. After conversion into electronic format, claimant claims must undergo certain edits and meet certain formulary requirements before payment. |
PBM vendors should review Form OWCP-915 to understand what is submitted on the form. The Form OWCP-915 is located here: https://www.dol.gov/sites/dolgov/files/owcp/dfec/regs/compliance/owcp-915.pdf
| Part 5 - Processing Claims for Payment | 5.5.12 | The soliciation states: The contractor must develop procedures for processing so-called “split claims” where a claimant submits both medical and pharmacy bills on a single Form OWCP-915 to the contractor’s mailroom. The contractor must adjudicate the pharmacy bill and coordinate with the OWCP medical bill processor for adjudication of the medical bill. Can the Government please confirm who pays the claimant? | If the PBM vendor receives a request for a claimant reimbursement, the PBM vendor will only be responsible for including the transaction on the payment file. The government will issue the payment to the claimant. |
| Part 5 - Processing Claims For Payment | 5.5.14 | The solicitation says: The contractor must develop procedures for pricing drugs associated with unlisted J-codes on bills received by the OWCP medical bill processor. The OWCP medical bill processor will be responsible for paying these bills. Is the Government simply requiring the contractor to recommend a price for the unlisted J-code for the medical bill processor? Will there be an NDC present? | Yes, there will be an NDC present. The PBM vendor will be expected to apply edits and formulary requirements to determine if the transaction is payable. If it is payable, the PBM vendor is responsible for pricing the medication and providing the information back to the OWCP medical bill processor who will provide payment. |
| Part 5 - Processing Claims for Payment | 5.5.20 | The PWS says: The contractor must develop a process to accept and process reversal of bills adjudicated by the previous contractor’s system and to provide information pertaining to those reversals to the appropriate OWCP compensation programs for collection. Please clarify how this requirement will process with the new contractor. | The PBM vendor must work with the OWCP to develop the exact process for each program. A possible process might involve: |
1. The pharmacy submits a reversal for a prescription that was processed by a previous PBM vendor.
2. The PBM vendor identifies the reversal from a pharmacy linked to a historical transaction (provided by DOL) from the previous PBM vendor.
3. The PBM vendor saves the original transaction data and reversal in a separate file (excel) and provides this file to OWCP for debt collection.
4. The PBM vendor may mark the transaction as being reversed in their database.
5. OWCP will collect the reversal debt. OWCP does not require the PBM vendor to take any steps to collect payments for debt resulting from the reversal.
| Part 5- Processing Claims for Payment | 5.5.23 | In this requirement the Eligibility Files and the daily updates must be validated using the appropriate compensation program business rules prior to being uploaded into the contractor’s system. Invalid records must be identified and returned to the appropriate compensation program case management system for correction and resubmission. Please define what "returned" means in this context. | Invalid eligibility records may not load correctly into the contractor's database because of either missing or invalid data. This must be identified in an error file that would be sent back to the programs for correction of these records (ie. Returned). | ||
| Part 5 - Processing Claims for Payment | 5.5.24 | This requirement states: The contractor must develop a specification document for each compensation program articulating the business rules related to eligibility and apply those business rules when adjudicating claims. The contractor’s system must support all claimant status indicators, prior authorizations based on fixed criteria, and, where authorized by compensation program policy, prior authorizations that fall outside the fixed criteria. Prior authorizations that fall outside the fixed criteria will be transmitted in daily updates of eligibility data. Please clarify this requirement - particulary when it states "Prior authorizations that fall outside the fixed criteria will be transmitted in daily updates of eligibility data." | The sentence of requirement 5.5.24, "Prior authorizations that fall outside the fixed criteria will be transmitted in daily updates of eligibility data." has been deleted. DOL anticipates the PBM vendor will manage prior authorizations and the fixed criteria of each prior authorization, such as NDC, GPI, dosage, quantity, days’ supply and duration of the prior authorization. | ||
| Part 5 - Processing Claims for Payment | 5.5.27 | For BLACK LUNG Claimants. Claims submitted by BLACK LUNG claimants receiving state workers’ compensation pharmacy benefits must be submitted through the state program. The contractor must develop a process for handling claims from claimants with state pharmacy benefits that are submitted to the contractor without having been submitted to and denied by the state program. The contractor’s process must be approved by the BLACK LUNG program. If a claimant has submitted a claim to a state program, the state program has denied coverage for that claim, and that claim is then submitted to the contractor, the contractor must process the claim. The vendor must work with the program to develop a process for claimants that received a denial letter from the state. How will the contractor know if a claimant is eligible for service (if denied by the state)? | The current process allows the claimant to submit the State's denial letter to the contractor's mail room. This will indicate to OWCP that the medication was denied by the state and the federal black lung program can attempt processing the prescription as the secondary payer. OWCP is interested in alternative ways to improve this secondary payer process instead of a mailed letter by the claimant. For example, various NCPDP payer segments could be explored for use at the point of sale such as 308-C8 (Other Coverage Code), 431-DV (Other Payer Amount Paid), 340-7C (Other Payer ID), 339-6C (Other Payer ID Qualifier), 991-MH (Other Payer Processor Control Number), 356-NU (Other Payer Cardholder ID), 992-MJ (Other Payer Group ID). | ||
| Part 5 - Fee Schedule | 5.6.4 | The solicitation states: The contractor must display the cost basis of the full pass-through price on the pharmacy data file, any reports, and on portals visible to the Government. Can the Government please provide clarity into the definition of "cost basis"? | See NCPDP Standard (423-DN) - Basis of Cost Determination. Code indicating the method by which Ingredient Cost Submitted (409-D9) was calculated. The cost basis will be the OWCP Pharmacy Fee Schedule, the pharmacy's usual and customary (U&C) rate, the generic maximum allowable cost (MAC), the guaranteed AWP discount negotiated under this contract, or any other price the contractor pays the pharmacy. | ||
| Part 5 - Drug Classification Table | 5.6.6.2 | The market classification of all biosimilar/biologic medications (regardless of interchangability) more closely aligns with brand discounts. Will the Government consider re-classifying biosimilar medications as brand in the table? | Yes. All products approved through a BLA will be based on Medi-span's multi-source code. Multi-source codes of M, O, or N will be brand, and a multi-source code of Y will be generic for these products. See revised requirement at Section C 5.6.6.2 Drug Classification Table. | ||
| Part 5 - Drug Classification Table | 5.6.6.2 | To underwrite more accurately, can the Government please provide its definitions for the following: Private Label Topicals; Combination Products; and | Co-Packaged Products? | Definitions for private label topicals and combination products have been added to Section C, Part 2 - Acronyms and Definitions. The term co-packaged products has been removed as it is a form of a combination product. | |
| Part 5 - Drug Classification Table | 5.6.7 | This requirement states: The Government may audit transactions at any time to determine whether the correct brand name/generic classification were made. During an audit, the Government may determine that certain charges by the contractor resulted in overpayments due to incorrect brand name/generic classification. The contractor must refund overpayments and make changes to its system to prevent further misclassification of the drug(s) in question. | |||
| As a result of an audit, is it also the Government’s intention to make the contractor whole for underpayments due to any misclassification of brand and generic? | The government will only be identifying overpayments. If the PBM vendor identifies underpayments, the PBM vendor may reverse the underpayment transaction and rebill the transaction according to the full pass-through price. | ||||
| Part 5 - Claimant Portal | 5.10.1 | The solicitation states: The contractor must provide a government-approved, interactive web portal with information regarding the contractor, available retail and mail-order pharmacy services, the DME program, and diagnostic and testing services. Users must be able to request MBIC and check claimant specific drug coverage. The web portal must allow claimants to submit specific questions to the contractor. User questions must be responded to within 24 hours, or if research is required, within 48 hours. The claimant web portal must link to the ECOMP. What types of questions would claimants be able to submit via the portal? If clinical questions, would the contactor need to have a pharmacist or nurse assigned to answer? | The claimants could submit any type of question regarding their pharmacy, DME, or diagnostic benefits. If the question is clinical in nature, a member of the PBM's clinical team should be responding. | ||
| Part 5 - Authorizations | 5.10.4 | The PWS states: The contractor must ensure that the system supports ad hoc and mass claimant authorization updates, as directed by authorized compensation program staff. All claimant authorization updates must be acknowledged and validated. Confirmation must be sent to the requesting compensation program upon completion. Updates to claimant authorizations--whether ad hoc or mass updates—are considered routine maintenance functions. Can OWCP provide more details about mass claimant authorization updates (specifically, format/methodology; e.g. API, via the portal, file exchange, etc.)? | Upon implementation, we anticipate a transfer of active prior authorizations from the current PBM vendors to the new PBM vendor via file exchange. This will be an excel file that will contain claimant information, drug information, and authorization time periods. See contract requirement 5.5.25. |
We anticipate the PBM will apply a mass authorization to all legacy prescriptions during option year 1, also known as a 12-month grandfathered period. Any prescriptions for claimants with a corresponding date of service in the six months prior to implementation for their accepted work injury, are considered legacy prescriptions. The PBM must identify legacy prescriptions through historical data and apply authorizations to those prescriptions and cases during option year 1.
There may be other situations that may require mass authorization updates to cases by the compensation programs in an excel file format throughout the contract period.
Part 5 - PBM Drug Utilization Review 5.12.17 The solicitation requires the contractor’s clinical pharmacists must adjudicate all held, rejected, non-formulary, PA-related, and LMN-related transactions in accordance with compensation program policy. Claimant medical records in compensation program record systems will be available for use by the contractor’s clinicians as needed. Transactions requiring an exception to policy must be approved in advance by the OWCP. All coverage decisions must be tracked and reported to the OWCP through the claimant, prescriber, and staff web portals. Could the contractor’s registered nurses also adjudicate these transactions? If not, what clinical services does the Government see nurses providing? Only clinical pharmacists must adjudicate all held, rejected, non-formulary, PA-related, and LMN-related transactions. Licensed Practical Nurses (LPN) nor Registered Nurses (RN) can adjudicate these transactions.
Clinical operations that do not require approval/denial of medications could utilize registered nurses (RN).
Part 5 - PBM Drug Utilization Review 5.12.18 The solicitation says: The contractor must develop an appeals process for denied transactions. The appeals process must be approved by the OWCP. Does the contractor need to be able to decision appeals or just have a process for notifying OWCP of these denied transactions? Requirement 5.12.18 has been revised to: The contractor must develop an escalation process for denied transaction inquires. The escalation process must be approved by the OWCP.
The PBM vendor will be required to review, and decision escalated denied transaction inquiries from pharmacies, claimants, and prescribers.
| Part 5 - Medication Use Evaluation | 5.12.20.3 | The solicitation states: The contractor must complete 1000 MUE during each option period of the contract. The contractor must create job aids and develop procedures for its clinical staff to complete MUE. The job aids and procedures must be approved by the OWCP. Can the Government confirm it must complete 1,000 MUE per program or 1,000 MUE total for all programs combined? | The PBM vendor will be responsible for completing 1,000 MUE cases for all OWCP programs combined during each option period. |
| Part 5 - Claimant Adherence | 5.12.20.5 | Part of this requirement says the contractor must assist at least 1,500 claimants during each option period of the contract to improve their adherence to their prescription medication regimen. Is the Government requiring 1,500 claimants via the claimant adherence program per program or 1,500 claimants total for all programs combined? | The PBM vendor will be responsible for completing 1,500 claimant medication adherence reviews for all OWCP programs combined during each option period. |
| Part 5 - Testing | 5.16.3 | The requirement states: The contractor must develop a schedule for all testing activities as part of the test plan. The schedule must identify timeframes for the System Integration Testing (SIT), volume and performance testing, parallel testing, and Government Acceptance Testing (GAT). The schedule must include timelines for correction and re-test of any identified defects or missed requirements that were discovered during GAT. The contractor must provide a GAT period of no less than ten weeks. This period will begin after all system integration testing, to including all approved test cases showing no failed tests. Is the statement “The contractor must provide a GAT period of no less than ten weeks” related to implementation criteria, ongoing criteria, or both? | Prior to implementation, the government must be allowed enough time (minimum 10 weeks) to test and re-test (in the case of defects and re-work) the system, which includes but not limited to, formularies, edits, portals, and authorizations before these are approved for production. |
After implementation, any system updates do not need 10 weeks of GAT testing.
| Mandatory Criteria Go/No Go Requirements Part C Rebate Reports | Section L-Instruction to Offerors | This requirement states: The Respondent must provide a full year (CY2023) of rebates (as defined in section C) it has received by NDC number in Microsoft Excel. This will inform OWCP of the total rebates the Respondent has received when considering the respondents proposed locked rebate value. Is the Government asking for PBMs results for the NDCs provided in the data files (A19 J.7 - J.9)? How is this going to be used to evaluate PBMs since rebate values fluctuate? | This report will be removed from the go/no go requirements. |
| Discounts.Rebates.Fee Tab | A.19-J.4 PBM Discount/ Rebate/Fee Workbook - | Since the Government is requesting pass through pricing, how does OWCP want to pricing sheet to be completed when pharmacies have different contracted rates across the network? PBMs that own their network (as oppposed to leasing) have stronger buying power with pharmacies and reimburse them at directly contracted rates. However, this means there are different contract rates across the network. For exmple, an NDC at one pharmacy will have different rate than the same NDC at another pharmacy depending on the contract rate the PBM has with both pharmacies. |
| In order to evaluate PBMs in an apples to apples way, ensure a transparent way to audit transactions, and allow predictability into future spend, we recommend requiring a traditional pricing structure which is the PBM pricing methodology currently in place for the FECA program. A pass-through methodology will provide challenges in evaluating PBM proposals accurately, auditing actual results, and managing to what was commmited to in the RFP. Both pricing structures can provide OWCP with same value but managing them is significantly different. | PBM offerors should provide their best possible AWP discount, rebate per brand transaction, and service fee considering all transactions from all pharmacies to have the most competitive total evaluated price. The AWP discount negotiated with this contract is one of the “lesser-than” pricing options of the full pass-through price. The price evaluation will be on the AWP discount, rebate per brand transaction, and service fee not other price options detailed in the “lesser-than” pricing structure of the PWS. | |||
| Discounts.Rebates.Fee Tab | A.19-J.4 PBM Discount/ Rebate/Fee Workbook | Based on the requirements of the solicitation, the service fee paid to the PBM is separate from the dispense fee associated with pharmacy reimbursement in pharmacy contracts. Where should the dispense fee be added in the pricing sheet? Also, how should this be handled when the pharmacy contract dispense fee varies contract to contract? | The dispensing fee is not included in the price evaluation for this procurement. Do not include dispensing fees in the PBM DISCOUNT REBATE FEES WORKBOOK. The price evaluation and the PBM DISCOUNT REBATE FEES WORKBOOK only includes the AWP discount, rebate, and service fee. During contract administration, payments will be determined by the full pass-through pricing structure (See section 1.6.9.1 PBM Billing/Costs). DOL will pay the lowest possible pass-through price and that lowest total price could include a dispensing fee. The dispensing fee is not separate of the lowest possible pass-through price it is inclusive of the pass-through price. Examples of pricing transactions at the lowest price of the full pass-through price have been added to section 1.6.9.1 PBM Billing/Costs. |
File details come from the government source that posted it. Updated .