| 2013 (old version) |
2014 (new version) |
Type of Change |
Reason for Change |
Burden Change |
| Data Fields - CMS-367a |
Quarterly Pricing Data Fields - CMS-367a |
Rev |
To clarify which data fields are being described on the 367a |
No |
| Data Fields - CMS-367b |
Monthly Pricing Data Fields - CMS-367b |
Rev |
To clarify which data fields are being described on the 367b |
No |
| Blank |
5i Threshold |
Rev |
In accordance with the Affordable Care Act, the 5i Threshold data definition and valid values are being added. |
1 hour per labeler per month |
| Data Fields - CMS-367c |
Drug Product Data Fields - CMS-367c |
Rev |
To clarify which data fields are being described on the 367c |
No |
| DESI Indicator |
COD Status and FDA Application Number/OTC Monograph Number |
Rev |
The data definition and valid values for the DESI Indicator are being replaced with the data definition and valid values for the new Covered Outpatient Drug Status field and the associated FDA Application Number/OTC Monograph Number field. |
One-time burden of 5 hours per labeler |
| Blank |
5i Drug Indicator and 5i Route of Administration |
Rev |
In accordance with the Affordable Care Act, the data definitions and valid values for the 5i Drug Indicator and 5i Route of Administration fields are being added. |
One-time burden of 2.5 hours per labeler |
| Blank |
ACA Baseline AMP |
Rev |
In accordance with the Affordable Care Act, the data definition and valid values for the voluntary ACA Baseline AMP are being added. |
Negligible because not every labeler will report it, nor will it be reported for every drug |
| Blank |
Reactivation Date |
Rev |
To ensure more accurate product data reporting and allow labelers to report a date on which a terminated NDC is reintroduced to the market, the data definition for the voluntary Reactivation Date field is being added for purposes of online reporting. |
Negligible because not every labeler will report it, nor will it be reported for every drug |
| Edits & Alerts |
Edits & Alerts |
Rev |
Various systems-generated edit and alert messages are being revised and/or added to reflect current business rules. Labelers may receive these messages in response to file transfer data submissions. |
No |