[Federal Register Volume 70, Number 176 (Tuesday, September 13, 2005)]
[Rules and Regulations]
[Pages 53953-53954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17915]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

Office of Inspector General

45 CFR Part 61

RIN 0906-AA46


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

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

ACTION: Correction amendment.

-----------------------------------------------------------------------

SUMMARY: This document corrects the final regulations establishing the 
Healthcare Integrity and Protection Data Bank (HIPDB), the 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. In the implementing HIPDB regulations published in 
the Federal Register on October 26, 1999 (64 FR 57740), an inadvertent 
error appeared in the regulations text concerning the definition of the 
term

[[Page 53954]]

``any other negative action or finding.'' As a result, we are 
correcting the definition of the term to assure the technical 
correctness of these regulations.

EFFECTIVE DATE: September 13, 2005.

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

SUPPLEMENTARY INFORMATION: On October 26, 1999, the HHS Office of 
Inspector General (OIG) issued final regulations (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 corrected.
    Specifically, Sec.  61.3 expanded on previous regulatory 
definitions and provided additional examples of the scope of various 
terms set forth 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 
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 proposed 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.

Proposed Correction Notice and Response to Comments

    On June 24, 2005, OIG published a proposed notice (70 FR 36554) 
setting forth the intended correction to the definition of the term 
``any other negative action or finding'' in 45 CFR 61.3, and soliciting 
public comments regarding our intent to clarify the existing definition 
of the term in accordance with the earlier final rulemaking.
    As a result of that proposed correction amendment, OIG received two 
comments. While one commenter fully supported our decision to include 
the clarifying language to ensure technical correctness of the 
regulations, a second commenter mistakenly interpreted the clarifying 
language as narrowing the regulatory exceptions and was concerned that 
the amendatory language would result in States having to report a large 
number of relatively minor corrective action plan actions that could 
unfairly prejudice the party about whom or which the report was made. 
In response to the second commenter's concern, we reiterate that a 
corrective action plan independent of an adverse licensing action is 
not reportable. Only corrective action plans submitted in conjunction 
with a specific adverse licensing action would be required to be 
reported on a single form report. (The HIPDB report form includes a 
narrative description section that is to be used by the reporting 
entity to describe the details of the action. This section of the 
report requires the reporter to provide details about why the action 
was taken, as well as other pertinent details, which may include a 
corrective action plan or other remedial steps such as citations or 
personnel actions.) This clarifying language does not result in any 
additional reporting requirements on behalf of the reporting entity.

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.


0
Accordingly, 45 CFR part 61 is 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

0
1. The authority citation for part 61 continues to read as follows:

    Authority: 42 U.S.C. 1320a-7e.


0
2. Section 61.3 is 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 or 
certification 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: September 2, 2005.
Ann C. Agnew,
Executive Secretary to the Department.
[FR Doc. 05-17915 Filed 9-12-05; 8:45 am]
BILLING CODE 4152-01-P