Appendix D- Review Types 02-13-23.xlsx
XLSX spreadsheet 13 KB Posted
- Solicitation number
- 75FCMC23R0006
About this file
This document contains definitions for various types of coverage review support tasks that could be performed under a federal contract. The contract opportunity outlined is solicitation number 75FCMC23R0006 from the Department of Health and Human Services Centers for Medicare and Medicaid Services. It would allow the Coverage and Analysis Group to establish external contractor support to complete up to 30 needed environmental scans in a timely manner over the period of performance to support policymaking priorities. The document defines different review types including environmental scans, literature reviews, technology assessments, and clinical outcome reviews. It specifies factors such as the expected number of clinical hours, total hours, timing or frequency of each type of task. Relevant details are provided around requirements for same-specialty physician input and formal reporting length.
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Task Order
| Type | Definition | Publications | Time | Timing | Number | Clinical | Hours | Total |
| Mature Environmental Scan [Support National Coverage Analyses] | Write background section. Research CMS coverage history. Conduct systematic literature review. Create standardized tables. Complete risk of bias and applicability assessments. Comment on strengths and weaknesses of reviewed studies. Conduct commercial payer survey. A same-specialty physician specialist should incorporate clinical context, particularly in the background section and in incorporating perspective around the clinical importance of the outcomes achieved. | 20 < 50 | 4 weeks | Ad Hoc | 5 | Yes | 20 | 100 |
| Mature Environmental Scan with Evidence Synthesis [Support NCD reconsideration] | Write background section. Research CMS coverage history. Review existing NCD. Conduct refreshed systematic literature review. Confirm completion and publication of approved CED studies. Risk of bias, applicability, and evidence GRADE assessments. Written summary of the evidence and standardized tables. Conduct commercial payer survey. A same-specialty physician specialist should incorporate clinical context, particularly in the background section and in incorporating perspective around the clinical importance of the outcomes achieved. The commentary should put the technology in the context of the current standard of care. | 20 < 50 | 8 weeks | Ad Hoc | 2 | Yes | 40 | 80 |
| New Technology Add-on Payment (NTAP) Reviews [Support CMS Medical Officer reviews] | Abstract and distill applicant-submitted materials and FDA materials into NTAP review template. Review submitted publications. Conduct supplmental literature search. Create summary text and standardized tables. Assess risk of bias and applicability of individual studies. | < 20 | 2 weeks | October (Batched) | 5 | No | 0 | 0 |
| Evidence Previews [Support CMS preliminary review of emerging technologies] | Write background section. Abstract SSED document. Verify current FDA labelling. Research CMS coverage history. Review publications submitted by applicant and perform supplemental literature review. Assess risk of bias and applicability of individual studies. Create summary text and standardized tables. Includes single, limited revision for material inaccuracies. A same-specialty physician specialist should incorporate clinical context, particularly in the background section and in incorporating perspective around the clinical importance of the outcomes achieved. | < 20 | 3 weeks | Ad Hoc | 5 | Yes | 20 | 100 |
| Emerging Environmental Scan with Evidence Synthesis [Support NCD reconsiderations] | Write background section. Research CMS coverage history. Review existing NCD. Conduct refreshed systematic literature review. Confirm completion and publication of approved CED studies. Risk of bias, applicability, and evidence GRADE assessments. Written summary of the evidence and standardized tables. Conduct commercial payer survey. A same-specialty physician specialist should incorporate clinical context, particularly in the background section and in incorporating perspective around the clinical importance of the outcomes achieved. The commentary should put the technology in the context of the current standard of care. | < 20 | 6 weeks | Ad Hoc | 1 | Yes | 40 | 40 |
| Focused Literature Reviews / Ad hoc supplemental searches [Support ongoing National Coverage Analysis development] | Focused supplemental literature review to address specific aspects of already-completed systematic literature review. Examples include: assess evidence of access or care delivery disparities; focused review of outcomes of interest and clinically meaningful differences; evidence of volume-outcome relationship. The review includes summary text that is publication-ready and may be directly incorporated into a National Coveage Analysis. | < 20 | 2 weeks | Ad Hoc | 3 | No | 0 | 0 |
| Policy Reviews [Support CSG in review of ad-hoc policy topics] | Write background section. Conduct systematic or targeted literature review as appropriate to the question. Summarize evidence of healthcare disparities, if applicable. | < 50 | 4 weeks | Ad Hoc | 3 | Yes | 40 | 120 |
| Clinical Outcome Reviews [Support development of focused MEDCAC panels] | Write background section. Conduct focused review of outcomes of interest and clinically meaningful differences for clinical topics identified by CAG. Create summary text and standardized tables. Formal report, generally not exceeding 25 pages. | < 50 | 8 weeks | Ad Hoc | 4 | Yes | 20 | 80 |
| Technology Assessment / Policy Assessment [Support ad-hoc review of clinical topics] | Write background section. Research CMS coverage history. Conduct systematic literature review with evidence synthesis. Formal report, generally not exceeding 25 pages. Policy Assessment: Focused research project on topic of interest, with formal report , generally not exceeding 25 pages. A same-specialty physician specialist should incorporate clinical context, particularly in the background section and in incorporating perspective around the clinical importance of the outcomes achieved. The commentary should put the technology in the context of the current standard of care. | < 50 | 8 weeks | Ad Hoc | 2 | Yes | 160 | 320 |
| 30 | 840 |
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