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

AGENCY:

Office of Inspector General (OIG), HHS.

ACTION:

Final rule; correction amendment.

SUMMARY:

This document contains 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 “health plan.” As a result, we are making a correction to 45 CFR 61.3, Definitions, to assure the technical correctness of these regulations.

EFFECTIVE DATE:

November 24, 2000.

FOR FURTHER INFORMATION CONTACT:

Joel Schaer, OIG Regulations Officer, (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 § 61.3—the definitions section of the regulations—and is now being corrected.

Section 61.3 expanded on previous regulatory definitions and provided additional examples of the scope of various terms set fort in the statute. In the preamble of the final rule, we reiterated that the statutory intent of the definition for the term “health plan” was not meant to be exclusive or exhaustive, and interpreted congressional use of the word “includes” in the statutory definition of this term as an indication that additional entities may be recognized as “health plans” if they meet the basic definition of providing health benefits. The preamble of the final rule stated that the statutory language indicated that Congress intended that guarantors of payment for health care items and services—including “self insured employers” who are often the subjects of health care fraud—have access to HIPDB information. As a result, in order to make the term more inclusive, we indicated our intention of modifying the fourth element defining this term to include, but not be limited to, a plan, program, agreement or other mechanism established, maintained or made available by a self insured employer or group of self insured employers. This clarifying language, however, was not properly reflected in the regulatory text that appeared in the October 26, 1999 final regulations.

To be consistent with the intent of the final rule's preamble, we are correcting the inadvertent error that appeared in § 61.3 that failed to accurately reflect the definition of the term “health plan.”

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 corrected 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 continues to read as follows:

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

2. Section 61.3 is amended by republishing the introductory text, and by revising the definition for the term Health plan to read as follows: