[Federal Register Volume 70, Number 121 (Friday, June 24, 2005)]
[Proposed Rules]
[Pages 36554-36555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-12481]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Inspector General

45 CFR Part 61

RIN 0906-AA46


Office of the Secretary, Health Care Fraud and Abuse Data 
Collection Program: Reporting of Final Adverse Actions; Correction

AGENCY: Office of Inspector General (OIG), HHS.

ACTION: Proposed correction amendment.

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SUMMARY: This document proposes a correction to the final regulations, 
which were published in the Federal Register on October 26, 1999 (64 FR 
57740). These regulations established a national health care fraud and 
abuse data collection program for the reporting and disclosing of 
certain adverse actions taken against health care providers, suppliers 
and practitioners, and for maintaining a data base of final adverse 
actions taken against health care providers, suppliers and 
practitioners. An inadvertent error appeared in the text of the 
regulations concerning the definition of the term ``any other negative 
action or finding.'' As a result, we are proposing to correct 45 CFR 
61.3, Definitions, to assure the technical correctness of these 
regulations.

DATES: To assure consideration, public comments must be mailed and 
delivered to the address provided below by no later than 5 p.m., July 
25, 2005.

ADDRESSES: Please mail or deliver your written comments to the 
following address: Department of Health and Human Services, Office of 
Inspector General, Attention: OIG-46-CA2, 330 Independence Avenue, SW., 
Room 5246, Washington, DC 20201.

FOR FURTHER INFORMATION CONTACT: Joel Schaer, OIG Regulations Officer 
Office of External Affairs, (202) 619-0089.

SUPPLEMENTARY INFORMATION: The HHS Office of Inspector General (OIG) 
issued final regulations on October 26, 1999 (64 FR 57740) that 
established a national health care fraud and abuse data collection 
program--the Healthcare Integrity and Protection Data Bank (HIPDB)--for 
the reporting and disclosing of certain final adverse actions taken 
against health care providers, suppliers and practitioners, and for 
maintaining a data base of final adverse actions taken against health 
care providers, suppliers and practitioners. The final rule established 
a new 45 CFR part 61 to implement the requirements for reporting of 
specific data elements to, and procedures for obtaining information 
from, the HIPDB. In that final rule, an inadvertent error appeared in 
Sec.  61.3--the definitions section of the regulations--and is now 
being proposed for correction.
    Section 61.3 expanded on previous regulatory definitions and 
provided additional examples of the scope of various terms set fort in 
the statute. On page 57755 of the preamble, summarizing the various 
revisions being made to the final rule, we indicated that with respect 
to the definition for the term ``any other negative action or finding'' 
there are certain kinds of actions or findings that would not meet the 
intent of the statute and not be

[[Page 36555]]

reportable. We cited, as an example, administrative actions, such as 
limited training permits, limited licenses for telemedicine, fines or 
citations that do not restrict a practitioner's practice, or personnel 
actions for tardiness, that were not within the range of actions 
intended by the statute. As a result, we agreed to add a clarifying 
phrase to this term. The revised definition would exclude 
administrative fines or citations, corrective action plans and other 
personnel actions, unless they are (1) connected to the billing, 
provision or delivery of health care services, and (2) taken in 
conjunction with other licensure or certification actions such as 
revocation, suspension, censure, reprimand, probation, or surrender. 
However, we inadvertently omitted this clarifying language to the 
regulations text of the rule itself. Therefore, to be consistent with 
the intended clarification and the overall intent of the final 
rulemaking, we are correcting this inadvertent error in the definition 
of the term ``any other negative action or finding'' that appeared on 
page 57759 in the October 26, 1999 final regulations to include this 
additional clarifying language.
    Comments should be addressed specifically to the issue of 
clarifying the existing definition of the term in question in 
accordance with the earlier final rulemaking.

Response to Public Comments

    Comments will be available for public inspection beginning on July 
8, 2005 in Room 5518 of the Office of Inspector General at 330 
Independence Avenue, SW., Washington DC, on Monday through Friday of 
each week from 8 a.m. to 4 p.m., (202) 619-0089. Because of the number 
of comments we normally receive on regulations, we will not acknowledge 
or respond to them individually. However, we will consider all timely 
and appropriate comments when developing the final corrections 
amendment.

List of Subjects in 45 CFR Part 61

    Billing and transportation services, Durable medical equipment 
suppliers and manufacturers, Health care insurers, Health maintenance 
organizations, Health professions, Home health care agencies, 
Hospitals, Penalties, Pharmaceutical suppliers and manufacturers, 
Privacy, Reporting and recordkeeping requirements, Skilled nursing 
facilities.
    Therefore, 45 CFR part 61 is proposed to be amended by making the 
following correcting amendment:

PART 61--HEALTHCARE INTEGRITY AND PROTECTION DATA BANK FOR FINAL 
ADVERSE INFORMATION ON HEALTH CARE PROVIDERS, SUPPLIERS AND 
PRACTITIONERS

    1. The authority citation for part 61 would continue to read as 
follows:

    Authority: 42 U.S.C. 1320a-7e.
    2. Section 61.3 would be amended by republishing the introductory 
text, and by revising the definition for the term ``Any other negative 
action or finding'' to read as follows:


Sec.  61.3  Definitions.

    The following definitions apply to this part:
* * * * *
    Any other negative action or finding by a Federal or State 
licensing agency means any action or finding that under the State's law 
is publicly available information, and rendered by a licensing 
authority, including but not limited to, limitations on the scope of 
practice, liquidations, injunctions and forfeitures. This definition 
also includes final adverse actions rendered by a Federal or State 
licensing or certification authority, such as exclusions, revocations 
or suspension of license or certification that occur in conjunction 
with settlements in which no finding of liability has been made 
(although such a settlement itself is not reportable under the 
statute). This definition excludes administrative fines or citations 
and corrective action plans and other personnel actions, unless they 
are:
    (1) Connected to the delivery of health care services; and
    (2) taken in conjunction with other licensure or certification 
actions such as revocation, suspension, censure, reprimand, probation 
or surrender.
* * * * *

    Dated: June 20, 2005.
Ann Agnew,
Executive Secretary to the Department.
[FR Doc. 05-12481 Filed 6-23-05; 8:45 am]
BILLING CODE 4152-01-P