Medicaid Program; Time Limitation on Price Recalculations and Recordkeeping Requirements Under the Drug Rebate Program; Correction

AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Final rule; correction.

SUMMARY:

This document corrects the effective date of a final rule with comment period published in the Federal Register on August 29, 2003 (68 FR 51912). That rule finalizes separately, in an accelerated timeframe, two specific provisions of the September 19, 1995 proposed rule. It establishes new recordkeeping requirements for drug manufacturers under the Medicaid drug rebate program. It also sets forth a 3-year time limitation during which manufacturers must report changes to average manufacturer price and best price for purposes of reporting data to us. In addition, it announces the pressing need for codification of fundamental recordkeeping requirements. It also announces our intention to continue to work on finalizing the complete drug rebate regulation for the Medicaid drug rebate program. This document corrects the effective date.

EFFECTIVE DATE:

The effective date of the August 29, 2003 final rule (68 FR 51912) amending 42 CFR part 447 is corrected from October 1, 2003 to January 1, 2004.

FOR FURTHER INFORMATION CONTACT:

Marge Watchorn, (410) 786-4361.

SUPPLEMENTARY INFORMATION:

I. Background

On August 29, 2003, we published in the Federal Register a final rule with comment period entitled, “Medicaid Program; Time Limitation on Price Recalculations and Recordkeeping Requirements Under the Drug Rebate Program.” The rule establishes requirements for recordkeeping and time limits on price recalculations. The effective date of these requirements as stated in the August 2003 rule is October 1, 2003.

The Office of Management and Budget (OMB) declared that the August 2003 final rule is a major rule. Thus, we should have given January 1, 2004 as the effective date in accordance with 5 U.S.C. 801(a)(4). However, we erroneously incorporated an incorrect effective date of October 1, 2003. We have identified and corrected that error in the “Correction of Errors” section below.

II. Correction of Errors

In FR Doc. 03-21548 of August 29, 2003 (68 FR 51917), make the following correction:

• On page 51912, in column one, in the “Dates” section, remove “October 1, 2003” and replace it with “January 1, 2004.”

III. Waiver of Notice of Proposed Rulemaking and Delay of the Effective Date

We ordinarily publish a general notice of proposed rulemaking in the Federal Register and invite prior public comment on a proposed rule. Final rules generally have a 30-day or longer prospective effective date. However, this document merely provides a correction to the effective date of the final rule with comment published on August 29, 2003. This correction is being made based on OMB's decision that the August 2003 final rule is a major rule. Thus, we should have given January 1, 2004 as the effective date in accordance with 5 U.S.C. 801(a)(4). However, we erroneously incorporated an incorrect effective date of October 1, 2003. It would be impracticable, unnecessary and contrary to the public interest to publish a proposed rule and solicit comments since this document is technical in nature and does not impose new limits on the substantive rights of the industry or the public. Similarly, given the imminence of the effective date, it would serve no useful purpose to further delay the effective date of this technical correction. Therefore, to the extent that 5 U.S.C. 553 applies to this action, we find good cause to waive notice and comment procedures and our usual delay in the effective date.