Basic Benefit: Evidence-Based Dossier Submission Process

Evidence–Based Dossier Submission Process

Upon taking office in January 2011, Governor Andrew M. Cuomo established the Medicaid Redesign Team (MRT) by executive order. The MRT brought together experts and stakeholders from throughout the State to work cooperatively to reform the Medicaid system and reduce costs.

In Phase II of the redesign process, ten work groups were established to address more complex issues and monitor the implementation of key recommendations from Phase I, the initial redesign efforts. One of those work groups, the Basic Benefit Review Work Group, recommended the Department of Health establish an evidence–based benefit submission process for use by individuals/entities proposing a new Medicaid benefit for the Department´s consideration. The Department agreed with the recommendation and established this evidence–based dossier submission process, a process individuals/entities can use to submit evidence regarding the health benefits, harms and costs of benefits and services they request be considered for inclusion in Medicaid´s covered benefits.

Evidence–Based Policy Review

The Department is committed to ensuring that Medicaid members have access to clinically effective, cost effective and efficiently delivered services. To that end, the Department established a systematic process for making decisions about Medicaid benefits using the best available research evidence. The Evidence-Based Dossier Process is a way for those proposing a new Medicaid benefit for the Department´s consideration to provide the Department with the best available research evidence to support the proposed benefit.

Dossier Submission Process

Through the Dossier Submission Process, an individual/entity may submit a proposed benefit with supporting evidence for the Department´s consideration.

The Department then reviews a submission and evaluates available evidence to determine whether the proposed service will be added as a Medicaid covered benefit. This dossier submission process will help the State better understand the body of clinical research evidence related to the service under review and whether coverage of the service represents significant value to New York´s Medicaid program.

An individual or entity proposing a service should note the following requirements: proposed services must be FDA approved when required, supported by evidence of safety and effectiveness, and represented by Current Procedural Terminology (CPT), Healthcare Common Procedure Coding System (HCPCS), or International Classification of Diseases (ICD) 10 codes. Dossiers should be comprehensive, and include the most current research available.

After the Department reviews a dossier submission, it will offer a 30-day period to the general public in which additional sources of evidence may be submitted to the Department for consideration prior to the Department making a final coverage determination. A single document listing the proposed benefit and sources of evidence already received will be posted on the website. For 30 days from the date the document is posted to the website, the Department will accept additional sources of evidence that meet the standards and criteria of sources outlined in the dossier forms below. A completed Quality Appraisal Checklist must accompany each additional source of evidence submitted. The Department of Health, at its discretion, may review additional sources of evidence and consult with external reviewers to assist in evaluating dossier submissions prior to making a final coverage determination.

Prioritization of the selection of topics for review is at the discretion of the Department of Health. Submission of a dossier does not guarantee service coverage. The Department, in its discretion, may extend this process to any benefits matters for which it desires additional information.

To submit a dossier, please download and complete the Dossier Submission Form. If dossier submissions are incomplete, they will not be reviewed and the submitter will be notified. All dossier submissions should include the PICO framework (Population, Intervention, Comparator, Outcome) and make specific references to all potential patient harms.

Please send six (6) hard copies and four (4) electronic copies (on USB devices) to:

  • Department of Health
    Office of Health Insurance Programs
    99 Washington Ave.
    One Commerce Plaza – 720
    Albany, NY 12210
    ATTN: Dossier Review Unit

If you have questions concerning the Dossier process, please contact the Department of Health at dossier@health.ny.gov or (518) 473–2160.

Coverage Determinations

Dossiers that have been submitted to and reviewed by the Department are listed below. Please note that additional sources of evidence and Quality Appraisal Checklists must be submitted within 30 days from the date the topic is posted to the page (column 2) and meet the standards and criteria outlined in the dossier forms (e.g., systematic review; randomized control trial; observational study; expert panel/professional guideline; single expert/case report; etc.) Please submit an electronic copy of each additional source of evidence, its Quality Appraisal Checklist and a completed cover sheet to dossier@health.ny.gov. In addition, please submit a hard copy of each additional source of evidence, its Quality Appraisal Checklist and a completed cover sheet to the mailing address listed above. The Department will contact submitters to acknowledge receipt of initial dossier and additional sources of evidence submissions. Once the Department has completed its review, it will make a final coverage determination. Final coverage determinations will be listed below.

Topic: Date Posted
for 30–day period		 Evidence Sources
Received		 Final Coverage
Determination
Topical Oxygen Wound Therapy (TOWT) June 17, 2014 – July 16, 2014 Evidence Coverage Update 7/1/2017
Solesta for Fecal Incontinence November 3, 2014 – December 2, 2014 Evidence  
Implantable Infusion Pumps for Non–Cancer Pain February 12, 2016 – March 13, 2016 Evidence  
Definitive Drug Testing (LC–MS/MS) March 7, 2016 – April 6, 2016 Evidence  
BELVIQ® April 18, 2016 – May 18, 2016 Evidence  
Digital Breast Tomosynthesis April 18, 2016 – May 18, 2016 Evidence  
Synvisc and SynviscOne® May 15, 2017 – June 14, 2017 Evidence Coverage Update 9/11/2017
Real–Time Continuous Glucose Monitors May 15, 2017 – June 14, 2017 Evidence  
Continuous Glucose Monitoring (CGM) Systems for Diabetes Management July 18, 2018 – August 17, 2018 Evidence