CCEs Synopsis Questions_Responses.xlsx
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- World Trade Center Health Program Clinical Centers of Excellence (CCE) - Draft Solicitation
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- Draft_75D301-22-R-72142
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| # | Draft PWS Page # and Section Number or Related Section | Question/Comment | Response |
| 1 | Page # 44 of 57 Section 9 Deliverables/Reporting Schedule | Is it the intent of the Government that the Pharmacy Services Plan should be a separate plan deliverable? This is not listed as a separate plan in the referenced Section 4.6 and in the deliverables table within parentheses; it is listed as part of the Ops Manual.) | No, as the solicitation states, the Pharmacy Services Plan should be incorporated into the Ops Manual. |
| 2 | Page # 45 of 57 Section 9 Deliverables/Reporting Schedule | Please clarify the requirement for the Syslog-ng: audit logs. | Syslog is a log service for system logs. The requirement is for the Contractor to provide daily records via a Syslog as part of Program security audit controls (See Section 12.5). |
| 3 | Page # 55 of 57 Skills and Experience Requirements for Key Personnel | The table on this page under the Key Personnel heading lists three positions (Program Administrator, Medical Director, and Mental Health Director). However, in the section below titled Skills and Experience Requirements for Key Personnel, the position of Lifestyle Medicine Provider Champion is listed. Please clarify whether or not this last position is also a required Key Personnel position. | This has been corrected. There are 4 key personnel roles for this contract--Program Administrator, Medical Director, Mental Health Director, and the Lifestyle Medicine Provider Champion. |
| 4 | Page # 14 of 57 Section 4.1.2 | The Government states: |
The CCE contractor’s multi- and inter-disciplinary team shall include, at the minimum, mid- to high-level medical (physical and mental) and nursing professionals, licensed case managers and social workers, a health service administration manager, …
| Is the Health Service Administration Manager the equivalent to the Program Administrator or a separate position? If separate, please provide qualifications. | It could be the same person or it could be multiple people performing similar roles as a team, depending on the size of the cohort and the organizational structure of the vendor. The purpose of this section is to generally summarize Program requirements regarding the expertise and skills necessary to meet the requirements of the PWS; however, specific qualifications for individual staff members are not required outside of Key Personnel and those listed in the Minimum Vendor Qualifications and Level of Effort section. | |||
| 5 | Page # 15 of 57 Section 4.1.2.1 | The requirement for a reconciliation staffing report is required within 15 days after the end of each month in this section. However, in Section 4.1.2.1 this is a quarterly requirement. | ||
| Please clarify which is correct. | This has been corrected. The reconciled staff report is due quarterly; we have also provided a template for clarity. | |||
| 6 | Page # 16 of 57 Section 4.1.6 | Please provide the NARA-approved records control schedules required for the CCE. | The CCE is required to adhere to all applicable NARA-approved records control schedules. Those can be found here: https://www.archives.gov/records-mgmt/rcs. Generally speaking, CCE records wil fall into the records controls for CDC and NIOSH. A WTC Health Program-specific records control schedule is currently going through the NARA approval process as well and once approved, will be shared with all Program vendors. | |
| 7 | Pages # 26-27 of 57 Section 4.3.8.3.2 and 4.3.8.3.3 | These two sections are contradictory. Please clarify: Section 4.2.8.3.2 states making contact and scheduling within the first four weeks and within the first three months. Section 4.3.8.3.3 states within three days. Please clarify. | This has been corrected. New members should be contacted within the first 4 months (and at least 3 times within the first 3 months). Transfers in should be contacted to initiate services within the first 3 days, but may not need to schedule a monitoring exam at that time depending on when the member's last monitoring exam was. | |
| 8 | Related PWS Section: Section 1.2 Definitions, definition of “Adjunct Condition” | Will WTC Clinical Centers of Excellence be required to track “Adjunct Conditions” in any way? How do “Adjunct Conditions” differ from medically associated conditions which do not required certification, if at all? | ||
| Related PWS Section: Section 1.2 Definitions, definition of “Adjunct Condition” | Adjunct conditions--also known as ancillary conditions--are conditions that do not meet the requirements for certification under the Program, but must be treated in order to manage, ameliorate, or cure a certified WTC-related health condition or health condition medically associated with a certified WT C-related health condition (See Chapter 4 Section 2.4 “Treatment Benefit Plans” of the Administrative Manual). The CCE is required to track these conditions insofar as services provided to a member for an adjunct or ancillary condition must be medically necessary. | |||
| 9 | Related PWS section: Section 4.4.4 Lifestyle Medicine | Will lifestyle medicine services be available to all WTC Clinical Center of Excellence patients (including those receiving monitoring only), or is the provision of these (Lifestyle Medicine) services limited to those patients with a WTC-certified condition only. | Lifestyle medicine services should be limited to individuals with WTC-certified disease, for which lifestyle medicine interventions are appropriate and have evidence base for managing, ameliorating, or curing the certified condition; the proposed lifestyle medicine Program should be realistic and achievable, with scope informed by the resources available and the size of the population cohort. CCEs interested in expanding lifestyle medicine services to all members, including those receiving monitoring only, can consider submitting a proposal through the Lifestyle Medicine R21. | |
| 10 | Related PWS Section: Section 4.5 Claims Submission and Payment | Please describe the workflow for the WTC Clinical Center of Excellence review of external provider claims. | ||
| Related PWS Section: Section 4.5 Claims Submission and Payment | External provider claims are submitted directly to the Program's Health Program Support/Third Party Administrator contractor. The CCE is not required to review external provider claims except on an ad hoc basis as requested by NIOSH to review services for medical necessity (See Section 4.5.2). | |||
| 11 | Related PWS Section: Section 4.2.2 – Cost Tracking and Invoicing | Please clarify what the Contract Line Item Numbers (CLINS) will be and how many CLINs there will be | This is a synopsis posting. The solicitation will contain the CLIN structure. | |
| 12 | Related PWS Section: Section 4.2.2 – Cost Tracking and Invoicing | Will travel require a separate CLIN? | Yes. | |
| 13 | Related PWS Section: Section 4.4.2 – Utilization Management | Please clarity the notification process for members admitted for inpatient (IP) hospitalization – will this be a process where the WTC Clinical Center notifies CDC/NIOSH when a patient has been admitted for an inpatient hospitalization, rehabilitation, skilled nursing facility or any post-acute care facility? | Yes; specifically, the CCE would have to notify the Program's Health Program Support/Third Party Administrator contractor who is managing concurrent review for the Program. There is always the possibility that a hospital or other facility will directly notify the Health Program Support/Third Party Administrator contractor. | |
| 14 | Related PWS Section: Section 4.7.2 – Licensing and Insurance | Please confirm that the licensing and insurance requirement in section 4.7.2 is for internal network providers only (not external network providers). Please note that one organization may have both internal and external network providers. | Correct. Confirmation of appropriate licensing and insurance requirements for external network providers will be performed by the Program's Health Program Support/Third Party Administrator contractor. | |
| 15 | Related PWS section: Section 5.2 – Data Transfer | Will the WTC Clinical Center of Excellence be able to maintain program records at the home institution as part of data transfers? | Not sure what this question is asking. All information shall be transferred to the WTC Health Program on the required timeline, but the CCE may also retain the records, as appropriate, for purposes such as continuity of care. | |
| 16 | Related PWS section: Section 11 – HIPAA Compliance and Business Associate Agreement | Will a draft business associate agreement be provided as a follow up to pre-solicitation and/or at the time of the release of the full solicitation? It will be important for applicants to have an opportunity to review the BAA prior to the submission of a bid. | ||
| Yes, the Business Associate Agreement will be provided as one of the attachments to the full solicitation. | ||||
| 17 | Related section: Section 12.2 – Cyber Incident Reporting | Will CDC consider longer notification window for he discover of a Cyber Incident? Current PWS language states “All contractors and subcontracts shall report a suspected or confirmed breach in any medium as soon as possible and no later than 1 hours of discovery to the NIOSH Security Team and the Contracting Office” | No. However, please note that this requirement is just for a notification, and not for a full report. The full written report is not due until 3 business days after discovery. | |
| 18 | Related Section: Key Personnel | Please clarify which specific personnel are key personnel. It is our understanding that Key Personnel includes the Medical Director, Mental Health Director and Administrator Only. | ||
| Please see response to Question 3. | ||||
| 19 | Related Section: Key Personnel | Will CDC require that non-Key personnel that are required for the program can be appointed by the WTC Clinical Center of Excellence without approval from the WTC Health Program? Are there any additional requirements for non-Key Personnel that are required within the PWS? | Correct, non-key personnel do not require specific approval from the WTC Health Program. Minimum vendor qualifications and level of effort are provided with the PWS. | |
| 20 | Related Section: Key Personnel | Can the WTC Clinical Center of Excellence propose a team of lifestyle medicine champions rather than one single champion? | Yes | |
| 21 | Related section: Minimum Vendor Requirements and Level of Effort | Is it essential that all of the personnel in the category of “minimum staff requirements” be named in the proposal, or can they be named at the time that the contract commences? Will changes to these personnel require CDC/NIOSH approval, or can the WTC Clinical Center Key Personnel make these changes independently? | They can be named at a later date and do not require CDC/NIOSH approval. The purpose of this section is to generally summarize Program requirements regarding the expertise and skills necessary to meet the requirements of the PWS. However, if personnel changes also result in rate changes, or if the staffing plan is updated to change the staffing mix, the Program should approve the change via a change request. | |
| 22 | Related section: Minimum Vendor Requirements and Level of Effort | Can additional information be provided for the job description of the pharmacist? Specifically, what types of notifications will the pharmacist be expected to make/respond to NIOSH and what duties does the WTC Health Program expect the pharmacist to perform? | The pharmacist is responsible for representing the CCE's pharmacy interests at various WTC Health Program meetings, and to ensure that the CCE's pharmacy services plan is being implemented appropriately. Key duties include: comprehensive medication review, medication reconciliation, member education/counseling, member liaison for prescription questions/issues with processing, and collaborative drug therapy protocols. In addition, pharmacists will also play a vital role in quality assurance including pharmacy claims audits, controlled substances, cancer formulary QA ,etc. Generally, the pharmacist will oversee member utilization of pharmacy benefits, and other duties as listed in Section 4.6. | |
| 23 | Related PWS Section: Section 4.2.2– Cost Tracking and Invoicing | The Draft PWS Section 4.2.2– Cost Tracking and Invoicing states that “Invoices shall also include a list of internal CCE providers submitting claims for reimbursement under Federal Employees Compensation Act (FECA) for the same time frame, the claim number submitted, and if the provider is billed to this contract, the labor percentage of effort billed to this contract.” – please clarify | ||
| • | What claim detail is requested | |||
| • | Which claim number is requested | |||
| • | Should re-processed claims be included | This section has been updated to reflect the intention of the request, which is to ensure that providers who are billed to this contract and perform fee-for-service work have a clear breakdown of labor percentage between the two payment methods during the same invoicing period. | ||
| 24 | Related PWS Section: Section 4.6 Pharmacy Services | Will the pharmacy benefit coordinator provide regular education and training on the pharmacy systems for staff and new hires? Will the Clinical Center of Excellence be able to assign which users have access to various systems including read only access? | The CCE shall ensure that its staff its sufficiently trained on pharmacy systems; this includes participating in trainings as provided by the Pharmacy Benefits Manager contractor and/or the Program, but the CCE should be prepared to provide additional trainings and support internally as needed. Specific access management requests will be managed in coordination with the Pharmacy Benefits Manager and/or the Program. | |
| 25 | Related PWS Section: Section 4.6 Pharmacy Services | It is our understanding that CDC/NIOSH along with the Pharmacy Benefit Manager will determine which medications can fill through the WTCHP pharmacy benefit. Please confirm that this structure will be in place, and if so, what is expected of the CCE contractor as it relates to providing “oversight of members utilization of pharmacy benefits” and “ensuring medication are prescribed in accordance with the Program’s formulary requirements.” | The CCE contractor will continue to manage prescriber blocks related to the WTC Health Program pharmacy benefit. Although the CCE will no longer be directly responsibe for approving and denying medication prior authorizations, there will still be quality assurance checks in place. | |
| 26 | Related PWS Section: Section 4.6 Pharmacy Services | It is our understanding that CDC/NIOSH and the PBM will approve prior authorization for WTCHP medication. Please clarify if this is the process. If so, what is expected from the CCE contractor or “documenting medical necessity for prescriptions.” | That is correct. Prior authorization approval/denial will now be managed by the PBM and the WTC Health Program's Pharmacy Benefits Unit (PBU). When prompted to complete a PA, CCEs will document medical necessity based on the established PA criteria. If the medication is non-formulary or does not have specific PA criteria, the CCE will provide documentation of medical necessity using the Program's general PA form. The same process applies to external providers. | |
| 27 | Related PWS Section: Section 4.6 Pharmacy Services | It is our understanding that the CCE will have limited access to taking action in the future PBM system (Express Scripts). Please clarify how the CCE is to engage in prescribing oversight if there will be limited intervention by and interactions between the CCE personnel and the system. Specifically, we are not clear about how the following tasks can be carried out with limited access to the PBM systems: |
“7. Optimizing Member benefits and cost-effectiveness by ensuring medications are prescribed in accordance with the Programs formulary requirements.
8. Documenting medical necessity for prescriptions.
| 9. Implementing processes and other safeguards to ensure that all prior authorization submissions or decisions are made by a practicing clinician with appropriate knowledge of the medication being prescribed, the Member’s certified condition, and their treatment plan.” | CCEs will have limited acess to taking action on medications prescribed by external providers. For internal providers, prescribers will manage PAs, preferably using ePA. Real-time prescription benefits (RFTP), if turned on, will assist with determining a medication's placement on the formulary and cost-effectiveness. Medical necessity for presciptions will continue to be provided by providers when completing PAs either via ePA, phone or fax. | |||
| 28 | Related PWS Section: Section 4.6 Pharmacy Services | Will the Pharmacy Benefit Manager/CDC/NIOSH provide updates to WTC patients/members on coverage changes as has been past practice for the program? | Yes | |
| 29 | Related PWS Section: Section 4.6 Pharmacy Services | Will there be written materials from PBM contractor that will provide details/education in how to submit prior authorizations so that when prescriptions are written they ensured to be in line with program expectations? | The CCEs have received trainings on the use of electronic prior authorizations (ePA) and instructions on how PAs will be processed in the Program under the new PBM, ESI. Medications that have specific criteria will be auto-populated in the ePA system. ePA is preferred; however, the CCEs have the option of submitting PAs via phone or fax. | |
| 30 | Related section: Minimum Vendor Requirements and Level of Effort | Can the WTC Clinical Center propose an alternative to the pharmacist role should they have a clinician that can perform the same duties required for the pharmacist role? | Yes, a pharmacy technician would also be allowable (particularly for CCEs who have a smaller cohort), and the Minimum Vendor Requirements have been updated accordingly. | |
| 31 | Related section: Section 4.3.4 – Transfers | Please clarify that the contractor must contact the member 3 business days (not 3 calendar days) from CCE assignment upon receipt of an incoming transfer. Text referenced below: | ||
| “The CCE Contractor will process all incoming and outgoing transfers in accordance with the WTC Health Program Member Transfer Policy (Attachment 5). Upon member transfer to a different CCE, the contractor must contact the member within 3 days of CCE assignment.” | In line with the transfer policy and semi-annual audit report requirements, the contractor is expected to contact the member within 3 calendar days from CCE assignment. Language has been updated in the PWS to reflect this requirement. | |||
| 32 | Will a specific budget template be required? Is so, please provide the budget template. | Yes, a template has been provided (Attachment J.22) which is the format that should be used when putting together the cost proposal. | ||
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