CMS-10931_Supporting Statement - Part B_(CMS-1834-P)

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 universe is 100% of hospitals paid under the Outpatient Prospective Payment System (OPPS). There will be no sampling of this universe. There are approximately 3,500 hospitals that are currently paid under the OPPS. CMS will ask each hospital that was paid under the OPPS to respond to a survey. We expect all hospitals paid under the OPPS to respond to the survey.

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.

CMS is surveying the complete universe of hospitals paid under the OPPS for the survey period. Stratification and sampling will not be used. We expect to survey these hospitals every four (4) years. We believe that this frequency will appropriately balance the burden imposed on hospitals of completing the survey with ensuring that we capture the required data to inform payment rates as required under section 1833(t)(14)(D)(I)(ii) of the Act. However, this frequency is subject to revision based on the initial survey’s results and other factors as appropriate. We expect all hospitals paid under the OPPS to respond to the survey.

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.

As noted above, we are not proposing to use sampling for this survey. We intend for all hospitals paid under the OPPS to respond. To increase the response rate, CMS will announce the plan to collect data in notice and rulemaking for calendar year (CY) 2026 in the CY 2026 OPPS and Ambulatory Surgical Center (ASC) payment system proposed and final rules. Additionally, CMS will announce the plan to collect data through the Medicare Learning Network® (MLN) and Medicare Administrative Contractors (MACs). CMS will provide onboarding and training to hospitals for the Fee for Service Data Collection System (FFSDCS). As an additional means of increasing the response rate, CMS will provide hospitals with 3 months to respond to the survey to ensure that they have ample time to provide responses. If a hospital does not respond to the survey, CMS will not assume a response from the hospital and will mark the hospital down as a “non-respondent.”

CMS is considering how to account for a non-responding hospital’s drug acquisition costs and how those costs might be reflected in future payment rates. For example, since a failure on the part of a hospital to respond to the survey could suggest that the hospital has minimal acquisition costs, or has lower acquisition costs than an otherwise similar hospital that responds to the survey and so is withholding its response strategically, we might, if the data so suggests, determine that groups of hospitals who do not respond to the survey have lower acquisition costs for SCODs than their otherwise similar counterparts under section 1833(t)(14)(A)(iii)(I) of the Act. In such instances, we would consider various appropriate ways, taking into account the hospital acquisition cost survey data, to determine the average acquisition cost. One method we might consider, depending on the cost survey data, could be to use the lowest acquisition cost reported among otherwise similar responding hospitals as a proxy for the acquisition costs for hospitals that do not respond to the survey. We might also consider supplemental data sources to inform our determination of average acquisition costs for hospitals for whom we lack cost acquisition survey data. For example, we might consider using, as available, pricing from the Federal Supply Schedule (FSS); 340B ceiling price; Average Sales Price plus 6 percent, 0 percent or another percentage; or other recognized drug pricing for payment of hospitals that do not respond to the survey. We could also consider a hospital’s non-response to the survey when determining how to package drug costs for particular hospital groups.

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.

CMS will not perform a test. There is no sampling or stratification to test for this survey. Therefore, this is not applicable since CMS is not using a sampling methodology.

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.

There is no sampling or stratification to test for this survey. There was no consultation of statistical aspects of design. This survey is authorized by law and is being asked of 100 percent of the respondent universe. Accordingly, special survey design is not applicable. We believe we will have a sufficient response rate and we will continue to consult with the CMS Office of the Actuary on how the response rate will affect how we use the results.

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