January 27, 1999
Hon. Nancy-Ann Min DeParle
Administrator
Health Care Financing Administration
U.S. Department of Health & Human Services
Room 3009-G, Hubert Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201
Dear Administrator DeParle:
It has recently come to the attention of the Office of Advocacy that two errors are present in the above-captioned letter that was sent to your agency. A copy of our original November 2, 1998 letter is attached for your convenience.
First, on page two of the letter, the last paragraph reads, " HCFA has again issued its rule in final form with no opportunity for prior public notice and comment, and with no 30-day interim period prior to the rule’s effective date." This statement should read, "HCFA has again issued its rule in final form with no meaningful opportunity for prior public notice and comment."
This change does not effect the substantive message of the original letter. No proposed rule was published in this case because it was deemed unnecessary and against the public interest by HCFA. For reasons previously stated in Advocacy’s November 2 letter, our office does not believe that bypassing the proposed rule stage was necessary or in the public interest. Although a brief comment period was in fact provided prior to the rule’s effective date, the implementation date was the same as the date set for the close of the comment period. Hence, the Office of Advocacy remains concerned that the comment period did not provide a meaningful opportunity for HCFA to consider and analyze comments.
Second, on page three of the November 2 letter, the last paragraph reads, " HCFA acknowledged that the final rule would have a significant economic impact on a substantial number of small entities pursuant to the Regulatory Flexibility Act." This statement should read, "HCFA indicated that the final rule would not have a significant economic impact on a substantial number of small entities pursuant to the Regulatory Flexibility Act."
Again, this change does not effect the substantive message of the original letter. The Office of Advocacy believes that the rule would have a significant impact. As such, an analysis of the impact should have been prepared pursuant to the requirements of the RFA. Indeed, a certification by HCFA of "no impact" is equally, if not more troublesome than acknowledging an impact with no analysis of less burdensome alternatives. The impact of the inherent reasonableness provisions could be quite devastating for suppliers targeted for a reduction in payments without an opportunity for public comment.
Finally, on the issue of competitive bidding, the Office of Advocacy has been involved with OMB and representatives of HCFA and the industry to find ways to reduce the burden associated with the competitive bidding process and the associated paperwork requirements. The Office of Advocacy is pleased that some revisions have been made that will reduce burden and clarify confusing requirements. However, Advocacy remains concerned that the forms/paperwork requirements were not available for public comment through the Federal Register. Although some members of the industry were represented, we fear that the smallest medical equipment suppliers that may not be associated with a large trade association will not have had the opportunity to comment on the paperwork burden.
We regret any inconvenience these errors may have caused you or your staff. Please do not hesitate to contact our office if you have any questions, 202-205-6532.
Sincerely,
Jere W. Glover
Chief Counsel for Advocacy
Shawne Carter McGibbon
Asst. Chief Counsel for Advocacy
cc: Suey Howe, Senate Small Business Committee
William J. Long, HCFA