Federal Register: September 13, 2005 (Volume 70, Number 176)
DOCID: FR Doc 05-17915
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Inspector General Office, Health and Human Services Department
NOTICE: RULES
ACTION: Health care programs; fraud and abuse:
DOCUMENT ACTION: Correction amendment.
SUBJECT CATEGORY:
Office of Inspector General
EFFECTIVE DATES: September 13, 2005.
DOCUMENT 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.
SUMMARY:
Health Insurance Portability and Accountability Act—; Data collection program; final adverse actions reporting; correction,
DOCUMENT BODY 2:
45 CFR Part 61
RIN 0906AA46
Health Care Fraud and Abuse Data Collection Program: Reporting of
Final Adverse Actions; Correction
SUPPLEMENTAL 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 programthe 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. 61.3the definitions section of the regulationsand 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.
Accordingly, 45 CFR part 61 is amended by making the following correcting amendment:
PART 61HEALTHCARE INTEGRITY AND PROTECTION DATA BANK FOR FINAL
ADVERSE INFORMATION ON HEALTH CARE PROVIDERS, SUPPLIERS AND PRACTITIONERS
1. The authority citation for part 61 continues to read as follows:
Authority: 42 U.S.C. 1320a7e.
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. 0517915 Filed 91205; 8:45 am]
BILLING CODE 415201P
FOR FURTHER INFORMATION CONTACT
Joel Schaer, OIG Regulations Officer, Office of External Affairs, (202) 6190089.