05-12481. 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.

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, [phone].

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 § 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 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., [phone]. 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:

§ 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.