CMS-10517.FINAL - Supporting Statement Part B

Supporting Statement – Part B

Collections of Information Employing Statistical Methods

1. Describe (including a numerical estimate) the potential respondent universe and any sam­pling or other respondent selection method to be used. Data on the number of entities (e.g., establishments, State and local government units, households, or persons) in the universe covered by the collection and in the corre­sponding sample are to be provided in tabular form for the universe as a whole and for each of the strata in the proposed sample. Indicate expected response rates for the collection as a whole. If the collection had been conducted previously, include the actual response rate achieved during the last collection.

The potential respondent universe is to be all Medicare Part D plan sponsor contracts—or, a total of 1,550 users (775 contracts multiplied by two users per contract). Two users will be given access per each Part D plan sponsor contract. In the pilot phase of PLATO^TM’s data collection, eight plan sponsors have agreed to participate. During this pilot phase, two users per each Part D plan sponsor contract will be given access to PLATO^TM, and all users will be able to review and enter data on a voluntary basis.

2. Describe the procedures for the collection of information including:

- Statistical methodology for stratification and sample selection,

- Estimation procedure,

- Degree of accuracy needed for the pur­pose described in the justification,

- Unusual problems requiring specialized sampling procedures, and

- Any use of periodic (less frequent than annual) data collection cycles to reduce burden.

Advanced analytics process is used to predict potentially fraudulent pharmacies and providers using National Prescription Drug Event (PDE) records to which Medicare Part D plan sponsors do not have access but only have access to the PDE records within their own Medicare Part D networks. Part D plan sponsors are currently not able to view actions taken by all Part D plan sponsors across the United States against Part D providers who have been flagged for Medicare Part D fraud, waste, and abuse. PLATO™ will give them the benefit of seeing all actions taken by Part D plan sponsors and will allow them to follow and investigate the flagged Part D providers. Using PLATO™ will further give them an advantage in terms of accessing national summary data.

3. Describe methods to maximize response rates and to deal with issues of non-response. The accuracy and reliability of information collected must be shown to be adequate for intended uses. For collections based on sam­pling, a special justification must be provid­ed for any collection that will not yield 'reliable' data that can be generalized to the uni­verse studied.

The Centers for Medicare & Medicaid Services’ (CMS) contractor (the NBI MEDIC) is developing a marketing video and an instructional video of PLATO™ to encourage additional Medicare Part D plan sponsors to participate as well as to use the tool. Part D plan sponsors will see how quick and simple the tool is to use, as well as see the advantages of having the tool for their use.

4. Describe any tests of procedures or methods to be undertaken. Testing is encouraged as an effective means of refining collections of information to minimize burden and improve utility. Tests must be approved if they call for answers to identical questions from 10 or more respondents. A proposed test or set of tests may be submitted for approval separate­ly or in combination with the main collection of information.

PLATO™ is moving toward the testing phase by allowing access to nine Medicare Part D plan sponsors at maximum. This testing and feedback will allow us to develop a more user-friendly tool as well as to collect and deliver the data in the most efficient way possible.

5. Provide the name and telephone number of individuals consulted on statistical aspects of the design and the name of the agency unit, contractor(s), grantee(s), or other person(s) who will actually collect and/or analyze the information for the agency.

Holly Pu

Chief Statistician

Health Integrity

9240 Centreville Road,

Easton, MD, 21601

410-770-3058

puh@healthintegrity.org

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