Unknown. Final rule

7,083 words·~32 min read·/register/2004/03/03/04-4730

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2004-03-03.xml --- 69 42 Wednesday, March 3, 2004 Contents Agency Agency for Toxic Substances and Disease Registry NOTICES Superfund program: Hazardous substances priority list (toxicological profiles), 10048-10049 04-4659 Agricultural Agricultural Marketing Service RULES Pork promotion, research, and consumer information order, 9924-9926 04-4726 Agriculture Agriculture Department See Agricultural Marketing Service See Animal and Plant Health Inspection Service See Forest Service Air Force Air Force Department NOTICES Global Positioning System:

Navstar GPS Space Segment/Navigation User Segment Interface Control Document; document identifier changes; review and comment request, 10003-10004 04-4667 Meetings: Air University Board of Visitors, 10004 04-4665 04-4666 Global Positioning System Joint Program Office; technical working group, 10004 04-4664 Scientific Advisory Board, 10004 04-4668 Alcohol Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES Agency information collection activities; proposals, submissions, and approvals, 10062-10063 04-4773 04-4774 Animal Animal and Plant Health Inspection Service PROPOSED RULES Plant-related quarantine, foreign:

Karnal bunt; wheat importation, 9976-9982 04-4723 Arts Arts and Humanities, National Foundation See National Foundation on the Arts and the Humanities Centers Centers for Disease Control and Prevention NOTICES Meetings: Disease, Disability, and Injury Prevention and Control Special Emphasis Panels, 10049 04-4680 Children Children and Families Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 10049-10050 04-4752 04-4753 Civil Civil Rights Commission NOTICES Meetings;

State advisory committees: New Mexico, 9995 04-4750 Various States, 9995 04-4751 Coast Guard Coast Guard RULES Ports and waterways safety: Paerdegat Basin, Brooklyn, NY; safety zone, 9948-9949 04-4648 PROPOSED RULES Regattas and marine parades: Cock Island Race, 9984-9986 04-4647 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration See Patent and Trademark Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 9995-9997 04-4709 04-4711 Consumer Consumer Product Safety Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, 10001-10002 04-4696 Corporation Corporation for National and Community Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 10002-10003 04-4755 Customs Customs and Border Protection Bureau NOTICES Agency information collection activities; proposals, submissions, and approvals, 10056-10057 04-4727 04-4728 Defense Defense Department See Air Force Department PROPOSED RULES Federal Acquisition Regulation (FAR):

Hazardous material safety data, 10117-10124 04-4749 Education Education Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 10005-10006 04-4674 04-4776 Grants and cooperative agreements; availability, etc.: Elementary and secondary education— Migrant Education Program, 10109-10115 04-4719 04-4720 Postsecondary education— Teacher Quality Enhancement Program, 10006-10009 04-4766 Special education and rehabilitative services— American Indians with disabilities; vocational rehabilitation services projects, 10009-10011 04-4721 Children with disabilities; personnel preparation to improve services and results, 10011-10018 04-4722 Employment Employment and Training Administration NOTICES Alien temporary employment labor certification process:

Agriculture and logging; adverse effect wage rates, meal charges, and maximum travel subsistence reimbursement, 10063-10065 04-4731 Energy Energy Department See Federal Energy Regulatory Commission EPA Environmental Protection Agency RULES Air programs; approval and promulgation; State plans for designated facilities and pollutants: Louisiana, 9949-9954 04-4622 Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Gellan gum, 9958-9963 04-4707 Yeast extract hydrolysate from saccharomyces cerevisiae, 9954-9958 04-4706 PROPOSED RULES Air programs; approval and promulgation;

State plans for designated facilities and pollutants: Louisiana, 9987-9988 04-4623 Superfund program: National oil and hazardous substances contingency plan— National priorities list update, 9988-9993 04-4624 NOTICES Agency information collection activities; proposals, submissions, and approvals, 10028-10036 04-4697 04-4705 Meetings: Pesticide programs— Enhanced Registration Service Fee Program; implementation workshop, 10036-10037 04-4813 Pesticide, food, and feed additive petitions:

Gustafson LLC, 10037-10040 04-4629 Pesticides; experimental use permits, etc.: Monsanto Co., 10040-10042 E4-454 Superfund; response and remedial actions, proposed settlements, etc.: Northwest Oil Drain Site, UT, 10042-10043 04-4699 Water supply: Public water supply supervision program— Delaware, 10043 04-4700 Executive Executive Office of the President See National Drug Control Policy Office See Presidential Documents See Trade Representative, Office of United States FAA Federal Aviation Administration RULES Airworthiness directives:

AeroSpace Technologies of Australia Pty Ltd., 9927-9930 04-4374 Airbus, 9936-9941 04-4513 Boeing, 9930-9932 04-4562 McDonnell Douglas, 9932-9935, 9941-9943 04-4560 04-4563 Class E airspace; correction, 10103 C4-4186 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 10043 04-4809 Federal Emergency Federal Emergency Management Agency NOTICES Agency information collection activities; proposals, submissions, and approvals, 10057-10058 04-4673 Federal Energy Federal Energy Regulatory Commission NOTICES Electric rate and corporate regulation filings, 10022-10024 E4-434 E4-435 Environmental statements; availability, etc.:

Cowlitz County Public Utility District No. 1, WA, 10024 E4-447 Pacific Gas and Electric, 10025 E4-437 Hydroelectric applications, 10025-10028 E4-438 E4-448 Meetings: Florida Gas Transmission Co.; settlement conference, 10028 E4-446 *Applications, hearings, determinations, etc.:* ANR Pipeline Co., 10018 E4-450 Aquila, Inc., 10018-10019 E4-449 California Independent System Operator Corp., et al., 10019 E4-451 CenterPoint Energy-Mississippi River Transmission Corp., 10019 E4-443 El Paso Natural Gas Co.; correction, 10103 E4-359 Emera Energy, 10020 E4-445 Gas Transmission Northwest Corp., 10020 E4-442 North Baja Pipeline, LLC, 10020-10021 E4-441 Northwest Pipeline Corp., 10021 E4-436 Tennessee Gas Pipeline Co., 10021 E4-440 Transcontinental Gas Pipe Line Corp., 10021-10022 E4-444 FMC Federal Maritime Commission NOTICES Agreements filed; etc., 10043-10044 04-4765 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies:

Formations, acquisitions, and mergers, 10044 E4-453 FTC Federal Trade Commission RULES Hobby Protection Act: Imitation political and numismatic items, 9943-9946 04-4768 NOTICES Premerger notification waiting periods; early terminations, 10044-10048 04-4767 Food Food and Drug Administration RULES Animal drugs, feeds, and related products: Diclazuril, 9947-9948 04-4654 Penicillin G potassium in drinking water, 9946-9947 04-4653 PROPOSED RULES Human drugs: Medicare Prescription Drug, Improvement, and Modernization Act of 2003— Abbreviated new drug applications regulations; issues identification; comment request, 9982 04-4775 NOTICES Agency information collection activities; proposals, submissions, and approvals, 10050-10051 04-4655 Reports and guidance documents; availability, etc.:

Juice hazard analysis critical control hazards and controls guidance; first edition, 10051-10052 E4-452 Forest Forest Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 9994 04-4764 Meetings: Resource Advisory Committees— Trinity County, 9994-9995 04-4679 GSA General Services Administration PROPOSED RULES Federal Acquisition Regulation (FAR): Hazardous material safety data, 10117-10124 04-4749 Health Health and Human Services Department See Agency for Toxic Substances and Disease Registry See Centers for Disease Control and Prevention See Children and Families Administration See Food and Drug Administration See National Institutes of Health Homeland Homeland Security Department See Coast Guard See Customs and Border Protection Bureau See Federal Emergency Management Agency Housing Housing and Urban Development Department RULES FHA programs; introduction:

Maximum mortgage limits for multifamily housing, 10105-10107 04-4649 PROPOSED RULES Grants: Faith-based organizations; equal participation; agency policy, 10125-10129 04-4811 NOTICES Agency information collection activities; proposals, submissions, and approvals, 10058 04-4651 Interior Interior Department See Land Management Bureau See Surface Mining Reclamation and Enforcement Office NOTICES Watches and watch movements; duty-exemption allocations: Virgin Islands, 10000 04-4734 IRS Internal Revenue Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 10098-10102 04-4739 04-4759 International International Trade Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 9997 04-4708 Antidumping:

Stainless steel butt-weld pipe fittings from— Taiwan, 9997-9998 04-4732 Export trade certificates of review, 9998-10000 04-4754 Watches and watch movements; duty-exemption allocations: Virgin Islands, 10000 04-4734 Justice Justice Department See Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES Pollution control; consent judgments: Alaska General Seafoods, 10061 04-4763 Princeton Gamma-Tech, et al., 10061-10062 04-4762 Reunion Industries, Inc., 10062 04-4761 Labor Labor Department See Employment and Training Administration Land Land Management Bureau NOTICES Closure of public lands:

California, 10058-10059 04-4758 Public land orders: California, 10059 04-4757 Recreation management restrictions, etc.: Clark County, ID; temporary closure to motorized vehicles and camping, 10059-10060 04-4756 Resource management plans, etc.: Lower Snake River District's Cascade Resource Management Plan, ID; plan amendment and land exchange, 10060-10061 04-4146 NASA National Aeronautics and Space Administration RULES Acquisition regulations: Special contracting methods; performance period limitations, 9963-9964 04-4760 PROPOSED RULES Federal Acquisition Regulation (FAR):

Hazardous material safety data, 10117-10124 04-4749 National National Council on Disability NOTICES Meetings; Sunshine Act, 10065 04-4894 National Credit National Credit Union Administration RULES Credit unions: Suretyship and guaranty requirements; maximum borrowing authority; correction, 9926 04-4669 National Drug National Drug Control Policy Office NOTICES Meetings: Drug Control Research, Data, and Evaluation Advisory Committee, 10065 04-4687 National Foundation National Foundation on the Arts and the Humanities NOTICES Meetings:

Leadership Initiatives Advisory Panel, 10065-10066 04-4661 04-4662 National Highway National Highway Traffic Safety Administration RULES Motor vehicle theft prevention standard: High-theft vehicle lines for 2005 model year; listing, 9964-9969 04-4772 NOTICES Agency information collection activities; proposals, submissions, and approvals, 10096-10098 04-4770 04-4771 NIH National Institutes of Health NOTICES Agency information collection activities; proposals, submissions, and approvals, 10052-10053 04-4646 Meetings:

National Heart, Lung, and Blood Institute, 10053 04-4641 National Institute of Allergy and Infectious Diseases, 10055-10056 04-4643 04-4645 National Institute of Child Health and Human Development; correction, 10103 C4-3507 National Institute of Dental and Craniofacial Research, 10054-10055 04-4642 National Institute of Neurological Disorders and Stroke, 10053-10054 04-4637 04-4639 National Library of Medicine, 10056 04-4640 NOAA National Oceanic and Atmospheric Administration RULES Fishery conservation and management:

Caribbean, Gulf, and South Atlantic fisheries— Coastal migratory pelagic resources, 9969-9970 04-4678 Northeastern United States fisheries— Atlantic sea scallop, 9970-9975 04-4677 NOTICES Meetings: Gulf of Mexico Fishery Management Council, 10000 04-4745 Pacific Fishery Management Council, 10001 04-4746 National Science National Science Foundation NOTICES Environmental statements; availability, etc.: Antarctic activities; comment request, 10066 04-4729 Nuclear Nuclear Regulatory Commission NOTICES Reports and guidance documents; availability, etc.:

National origin discrimination as it affects limited English proficient persons; prohibition; policy guidance to Federal financial assistance recipients, 10066-10075 04-4672 National Office of National Drug Control Policy See National Drug Control Policy Office Office of U.S. Trade Office of United States Trade Representative See Trade Representative, Office of United States Patent Patent and Trademark Office PROPOSED RULES Practice and procedure: Representation of others before PTO, 9986-9987 04-4652 Personnel Personnel Management Office RULES Health benefits, Federal employees:

Health care providers; debarments and suspensions; financial sanctions, 9919-9924 04-4730 NOTICES Agency information collection activities; proposals, submissions, and approvals, 10075-10077 04-4735 04-4738 Postal Postal Rate Commission NOTICES Domestic rates, fees, and mail classifications: Experimental mail classification cases— Periodicals mailers; experimental discounts to co-palletized, dropshipped publications, etc., 10077-10079 04-4769 Presidential Presidential Documents EXECUTIVE ORDERS Community Service, Corporation for National and; policymaking criteria for programs authorized under the national service laws (EO 13331), 9911-9913 04-4884 ADMINISTRATIVE ORDERS Liberia; assistance determination (Presidential Determination No. 2004-23 of February 23, 2004), 9915 04-4854 West Bank and Gaza; availability of funds under the Migration and Refugee Assistance Act of 1962 (Presidential Determination No. 2004-24 of February 25, 2004), 9917 04-4855 SEC Securities and Exchange Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, 10079-10080 04-4713 Options Price Reporting Authority:

Consolidated Options Last Sale Reports and Quotation Information; Reporting Plan; amendments, 10080-10081 04-4717 Self-regulatory organizations; proposed rule changes: American Stock Exchange LLC, 10081-10085 04-4715 Chicago Board Options Exchange, Inc., 10085-10087 04-4663 International Securities Exchange, Inc., 10087-10089 04-4716 Philadelphia Stock Exchange, Inc., 10089-10094 04-4714 04-4718 State State Department NOTICES Art objects; importation for exhibition: Byzantium:

Faith and Power (1261-1557); correction, 10094 04-4748 Surface Surface Mining Reclamation and Enforcement Office PROPOSED RULES Permanent program and abandoned mine land reclamation plan submissions: Texas, 9983-9984 04-4636 Surface Surface Transportation Board NOTICES Railroad operation, acquisition, construction, etc.: Burlington Northern & Sante Fe Railway Co., 10098 04-4591 Toxic Toxic Substances and Disease Registry Agency See Agency for Toxic Substances and Disease Registry Trade Trade Representative, Office of United States NOTICES World Trade Organization:

European communities— Settlement proceeding regarding offsets to calculated dumping margins for instances of non-dumping, 10094-10096 04-4657 Transportation Transportation Department See Federal Aviation Administration See National Highway Traffic Safety Administration See Surface Transportation Board Treasury Treasury Department See Internal Revenue Service Separate Parts In This Issue Part II Housing and Urban Development Department, 10105-10107 04-4649 Part III Education Department, 10109-10115 04-4719 04-4720 Part IV Defense Department;

General Services Administration; National Aeronautics and Space Administration, 10117-10124 04-4749 Part V Housing and Urban Development Department, 10125-10129 04-4811 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 69 42 Wednesday, March 3, 2004 Rules and Regulations OFFICE OF PERSONNEL MANAGEMENT 5 CFR Part 890 RIN 3206-AJ42 Eligibility of Suspended Health Care Providers To Receive Payment of Federal Employees Health Benefits Program Funds;

Financial Sanctions of Health Care Providers Participating in the Federal Employees Health Benefits Program AGENCY: Office of Personnel Management. ACTION: Final rule. SUMMARY: The Office of Personnel Management

(OPM)is amending its regulations regarding administrative sanctions of health care providers participating in the Federal Employees Health Benefits Program (FEHBP). This rule clarifies the circumstances under which payments may be made from FEHBP funds to suspended providers and implements the financial sanctions provisions of section 2 of the Federal Employees Health Care Protection Act of 1998 (Pub. L. 105-266), which authorize OPM to impose civil monetary penalties and financial assessments against health care providers who commit certain types of violations against the FEHBP. In concert with the final regulations on debarment and suspension that were issued on February 3, 2003 (68 FR 5470), the financial sanctions provisions afford OPM a full range of administrative remedies to deter and rectify provider misconduct within FEHBP. The regulatory framework established by this issuance contains appropriate procedural safeguards to assure that the amounts of financial sanctions are determined through a consistent and equitable process, that the Government's financial interests are fully protected, and that financial sanctions are imposed only after an opportunity for an administrative hearing on all facts material to the basis for the sanctions. EFFECTIVE DATE: March 3, 2004. FOR FURTHER INFORMATION CONTACT: David Cope, Debarring Official, Office of the Inspector General, Office of Personnel Management, by telephone at 202-606-2851, by fax at 202-606-2153, or by e-mail at *debar@opm.gov.* SUPPLEMENTARY INFORMATION: Background OPM's final regulations on debarment and suspension of health care providers were published in the **Federal Register** on February 3, 2003 (68 FR 5470). Subsequently, during the public comment period for OPM's proposed regulations on financial sanctions of health care providers (see the following section of this preamble titled “Financial Sanctions”), an FEHBP carrier commented to our office that the wording of several sections of the debarment and suspension regulations was ambiguous and potentially subject to misinterpretation in regard to the circumstances under which payments could be made to suspended providers. The carrier's comments focused on §§ 890.1046 through 890.1050 of the regulations, which speak to certain special situations where payments to debarred providers may be permissible. Section 890.1048, regarding providers who are the sole source of health care services in their communities and section 890.1050, authorizing special exceptions to debarments for individual FEHBP enrollees, both contain specific language prohibiting payments to suspended providers in these circumstances. Sections 890.1046, 890.1047, and 890.1049, addressing services provided in emergency situations, institutional health care providers, and claims filed by enrollees who are unaware that their provider has been sanctioned, respectively, are silent regarding the permissibility of payments to suspended providers in those situations. By not specifically identifying the treatment of suspended providers in these three sections, we intended that they be governed by the overall policy stated in § 890.1030(c), that the effect of a suspension is the same as the effect of a debarment. However, we agree with the carrier's observation that the presence of language in §§ 890.1048 and 890.1050 specifically excluding suspended providers from payment under some “special” circumstances may have inadvertently created confusion among both carriers and providers as to our actual intent in situations where the regulatory wording did not specify the rights of suspended providers. Therefore, to avoid possible misinterpretations, we are revising §§ 890.1046, 890.1047, and 890.1049 by adding appropriate language to indicate that suspended providers are eligible to receive FEHBP payments in the special situations addressed by those sections. Financial Sanctions The proposed financial sanctions regulations were issued in a notice of proposed rulemaking in the February 10, 2003, **Federal Register** (68 FR 6649). During the 60-day public comment period, OPM received written comments from an industry association of health insurance plans and oral comments from an FEHBP carrier and from employees. This section of the regulatory preamble addresses all of the comments and explains OPM's rationale for incorporating certain of them in the final rule and declining to implement others. Rewording of Redundant or Ambiguous Passages Most commenters observed that some of the wording in the proposed rule was ambiguous or redundant in addressing

(1)the factors used to determine the amounts of penalties and assessments and

(2)the procedures for contesting or settling proposed financial sanctions. Upon review, we agree that several sections could be reworded to clarify the intended meaning. In particular, the proposed § 890.1064(b) appeared to be largely duplicated by § 890.1064(c) and (d), and this redundancy might have fostered some uncertainty as to the relationship between the purposes of financial sanctions and the specific factors that may determine the amount of a sanction against a given provider. In fact, the purposes of financial sanctions are to

(1)make OPM whole for any monetary losses and damages associated with a provider's violations and

(2)deter future violations by the sanctioned provider and other providers. The procedure for determining amounts in specific cases is intended to effectuate those purposes. Therefore, we have consolidated paragraphs (b), (c), and

(d)of § 890.1064 as they appeared in the proposed rule into paragraph

(b)as it appears in the final rule, thus eliminating the redundancy and emphasizing the seamless connection between overall regulatory purpose and the amounts of penalties in individual cases. As the result of this consolidation, the proposed paragraph

(e)has been redesignated as § 890.1064(c) in the final rule. Similarly, we have reworded the proposed § 890.1067(c) to clarify that

(1)the debarring official may settle or compromise proposed financial sanctions at any stage of the sanctions process prior to issuance of a final decision and

(2)such settlements or compromises do not have to be predicated on a provider's filing a contest of the proposed sanctions or making a formal settlement offer. Several commenters noted that the phrase “intention to contest” in § 890.1068(a) was ambiguous as to the nature of the contact from a provider that would be sufficient to initiate OPM contest procedures. We have rewritten this section in the final rule to make it clear that, in filing a contest, the provider must adhere to the instructions given by the notice of proposed sanctions issued by OPM. If a provider does not file a contest within the timeframe stated in the notice, in a manner that complies with the procedures specified by the notice, OPM may implement the proposed sanctions immediately and without further procedures. However, OPM does not intend to use this provision to deny the opportunity to contest on the grounds of minor “technical” deviations from the instructions in the notice of proposed sanctions. Providers will receive the benefit of any reasonable doubt regarding their adherence to the requirements for filing a contest. Some commenters also observed that the proposed §§ 890.1070 and 890.1071 were partially redundant and unclear regarding OPM's procedures for conducting and deciding contests. Upon review, we agree that a revision of these sections is warranted. Accordingly, we have consolidated the proposed §§ 890.1070 and 890.1071 into a single § 890.1070 in the final rule. This section sets forth in sequential order the process that the debarring official must apply to deciding contests of proposed financial sanctions and identifies the critical decision points at each stage of this process. To account for the consolidation, we have renumbered proposed §§ 890.1072 and 890.1073 as §§ 890.1071 and 890.1072, respectively, in the final rule. Impact of Financial Sanctions on FEHBP Carriers The association of insurance carriers suggested that the scope of the proposed rule be expanded to provide a mechanism for crediting collected amounts of financial sanctions, deposited in the Employees Health Benefits Fund, to reimburse FEHBP plans for any losses and costs they incur as a result of the provider misconduct on which the financial sanctions are based. In support of this suggestion, the association noted that FEHBP plans may expend substantial amounts when investigating provider violations, and that there is no formula for “compensating plans for [such] losses.” However, FEHBP carriers are reimbursed from the Employees Health Benefits Fund for allowable costs incurred in administering their responsibilities under their FEHBP contracts. The nature and extent of such reimbursement is addressed within the regulatory framework of the Federal Employees Health Benefits Acquisition Regulations, and is subject to annual negotiation between OPM and the carrier. In contrast, the FEHBP sanctions statute is designed solely as an enforcement measure aimed at untrustworthy health care providers, and offers no basis or authority for regulating costs and/or reimbursement policies. Therefore, we have not accepted the carrier association's suggestions. Regulatory Flexibility Act I certify that this proposed regulation will not have a significant economic impact on a substantial number of small entities, because the financial sanctions are limited to the portion of health care providers' activities involving transactions with the Federal Employees Health Benefits Program. Executive Order 12866, Regulatory Review This rule has been reviewed by the Office of Management and Budget in accordance with Executive Order 12866. List of Subjects in 5 CFR Part 890 Administrative practice and procedure, Government employees, Health facilities, Health insurance, Health professions. Office of Personnel Management. Kay Coles James, Director. Accordingly, OPM is amending part 890 of title 5, Code of Federal Regulations as follows: PART 890—FEDERAL EMPLOYEES HEALTH BENEFITS PROGRAM 1. The authority citation for part 890 continues to read as follows: Authority: 5 U.S.C. 8913; § 890.803 also issued under 50 U.S.C. 403(p), 22 U.S.C. 4069c and 4069c-1; subpart L also issued under sec. 599c of Pub. L. 101-513, 104 Stat. 2064, as amended; § 890.102 also issued under sections 11202(f), 11232(e), 11246(b) and

(c)of Pub. L. 105-33, 111 Stat 251; and section 721 of Pub. L. 105-261, 112 Stat. 2061. 2. In subpart J, § 890.1046 is revised to read as follows: § 890.1046 Effect of debarment or suspension on payments for services furnished in emergency situations. A debarred or suspended health care provider may receive FEHBP funds paid for items or services furnished on an emergency basis if the FEHBP carrier serving the covered individual determines that:

(a)The provider's treatment was essential to the health and safety of the covered individual; and

(b)No other source of equivalent treatment was reasonably available. 3. In subpart J, § 890.1047 is revised to read as follows: § 890.1047 Special rules for institutional providers.

(a)*Covered individual admitted before debarment or suspension.* If a covered person is admitted as an inpatient before the effective date of an institutional provider's debarment or suspension, that provider may continue to receive payment of FEHBP funds for inpatient institutional services until the covered person is released or transferred, unless the debarring or suspending official terminates payments under paragraph

(b)of this section.

(b)*Health and safety of covered individuals.* If the debarring or suspending official determines that the health and safety of covered persons would be at risk if they remain in a debarred or suspended institution, OPM may terminate FEHBP payments at any time.

(c)*Notice of payment limitations.* If OPM limits any payment under paragraph

(b)of this section, it must immediately send written notice of its action to the institutional provider.

(d)*Finality of debarring or suspending official's decision.* The debarring or suspending official's decision to limit or deny payments under paragraph

(b)of this section is not subject to administrative review or reconsideration. 4. In subpart J, § 890.1049 is revised to read as follows: § 890.1049 Claims for non-emergency items or services furnished by a debarred or suspended provider.

(a)*Covered individual unaware of debarment or suspension.* FEHBP funds may be paid for items or services furnished by a debarred or suspended provider if, at the time the items or services were furnished, the covered individual did not know, and could not reasonably be expected to have known, that the provider was debarred or suspended. This provision is intended solely to protect the interests of FEHBP-covered persons who obtain services from a debarred or suspended provider in good faith and without knowledge that the provider has been sanctioned. It does not authorize debarred or suspended providers to submit claims for payment to FEHBP carriers.

(b)*Notice sent by carrier.* When paying a claim under the authority of paragraph

(a)of this section, an FEHBP carrier must send a written notice to the covered individual, stating:

(1)That the provider is debarred or suspended and is prohibited from receiving payment of FEHBP funds for items or services furnished after the effective date of the debarment or suspension;

(2)That claims may not be paid for items or services furnished by the debarred or suspended provider after the covered individual is informed of the debarment or suspension;

(3)That the current claim is being paid as a legally-authorized exception to the effect of the debarment or suspension in order to protect covered individuals who obtain items or services without knowledge of their provider's debarment or suspension;

(4)That FEHBP carriers are required to deny payment of any claim for items or services rendered by a debarred or suspended provider 15 days or longer after the date of the notice described in paragraph

(b)of this section, unless the covered individual had no knowledge of the provider's debarment or suspension when the items or services were rendered;

(5)The minimum period remaining in the provider's debarment or suspension; and

(6)That FEHBP funds cannot otherwise be paid to the provider until OPM terminates the debarment or suspension. 5. In subpart J, §§ 890.1060 through 890.1072 are added to read as follows: Subpart J—Administrative Sanctions Imposed Against Health Care Providers Civil Monetary Penalties and Financial Assessments Sec. 890.1060 Purpose and scope of civil monetary penalties and assessments. 890.1061 Bases for penalties and assessments. 890.1062 Deciding whether to impose penalties and assessments. 890.1063 Maximum amounts of penalties and assessments. 890.1064 Determining the amounts of penalties and assessments to be imposed on a provider. 890.1065 Deciding whether to suspend or debar a provider in a case that also involves penalties and assessments. 890.1066 Notice of proposed penalties and assessments. 890.1067 Provider contests of proposed penalties and assessments. 890.1068 Effect of not contesting proposed penalties and assessments. 890.1069 Information the debarring official must consider in deciding a provider's contest of proposed penalties and assessments. 890.1070 Deciding contests of proposed penalties and assessments. 890.1071 Further appeal rights after final decision to impose penalties and assessments. 890.1072 Collecting penalties and assessments. Civil Monetary Penalties and Financial Assessments § 890.1060 Purpose and scope of civil monetary penalties and assessments.

(a)*Civil monetary penalty.* A civil monetary penalty is an amount that OPM may impose on a health care provider who commits one of the violations listed in § 890.1061. Penalties are intended to protect the integrity of FEHBP by deterring repeat violations by the same provider and by reducing the likelihood of future violations by other providers.

(b)*Assessment.* An assessment is an amount that OPM may impose on a provider, calculated by reference to the claims involved in the underlying violations. Assessments are intended to recognize monetary losses, costs, and damages sustained by OPM as the result of a provider's violations.

(c)*Definitions.* In §§ 890.1060 through 890.1072: *Penalty* means civil monetary penalty; and *Penalties and assessments* may connote the singular or plural forms of either of those terms, and may represent either the conjunctive or disjunctive sense.

(d)*Relationship to debarment and suspension.* In addition to imposing penalties and assessments, OPM may concurrently debar or suspend a provider from participating in the FEHBP on the basis of the same violations.

(e)*Relationship to other penalties provided by law.* The penalties, assessments, debarment, and suspension imposed by OPM are in addition to any other penalties that may be prescribed by law or regulation administered by an agency of the Federal Government or any State. § 890.1061 Bases for penalties and assessments.

(a)*Improper claims.* OPM may impose penalties and assessments on a provider if a claim presented by that provider for payment from FEHBP funds meets the criteria set forth in 5 U.S.C. 8902a(d)(1).

(b)*False or misleading statements.* OPM may impose penalties and assessments on a provider who makes a false statement or misrepresentation as set forth in 5 U.S.C. 8902a(d)(2).

(c)*Failing to provide claims-related information.* OPM may impose penalties and assessments on a provider who knowingly fails to provide claims-related information as otherwise required by law. § 890.1062 Deciding whether to impose penalties and assessments.

(a)*Authority of debarring official.* The debarring official has discretionary authority to impose penalties and assessments in accordance with 5 U.S.C. 8902a and this subpart.

(b)*Factors to be considered.* In deciding whether to impose penalties and assessments against a provider that has committed one of the violations identified in § 890.1061, OPM must consider:

(1)The number and frequency of the provider's violations;

(2)The period of time over which the violations were committed;

(3)The provider's culpability for the specific conduct underlying the violations;

(4)The nature of any claims involved in the violations and the circumstances under which the claims were presented to FEHBP carriers;

(5)The provider's history of prior offenses or improper conduct, including any actions that could have constituted a basis for a suspension, debarment, penalty, or assessment by any Federal or State agency, whether or not any sanction was actually imposed;

(6)The monetary amount of any damages, losses, and costs, as described in § 890.1064(c), attributable to the provider's violations; and

(7)Such other factors as justice may require.

(c)* Additional factors when penalty or assessment is based on provisions of § 890.1061(b) or (c). * In the case of violations involving false or misleading statements or the failure to provide claims-related information, OPM must also consider:

(1)The nature and circumstances of the provider's failure to properly report information; and

(2)The materiality and significance of the false statements or misrepresentations the provider made or caused to be made, or the information that the provider knowingly did not report. § 890.1063 Maximum amounts of penalties and assessments. OPM may impose penalties and assessments in amounts not to exceed those set forth in U.S.C. 8902a(d). § 890.1064 Determining the amounts of penalties and assessments to be imposed on a provider.

(a)*Authority of debarring official.* The debarring official has discretionary authority to set the amounts of penalties and assessments in accordance with law and this subpart.

(b)*Factors considered in determining amounts of penalties and assessments.* In determining the amounts of penalties and assessments to impose on a provider, the debarring official must consider:

(1)The Government's interests in being fully compensated for all damages, losses, and costs associated with the provider's violations, including:

(i)Amounts wrongfully paid from FEHBP funds as the result of the provider's violations and interest on those amounts, at rates determined by the Department of the Treasury;

(ii)All costs incurred by OPM in investigating a provider's sanctionable misconduct; and

(iii)All costs incurred in OPM's administrative review of the case, including every phase of the administrative sanctions processes described by this subpart;

(2)The Government's interests in deterring future misconduct by health care providers;

(3)The provider's personal financial situation, or, in the case of an entity, the entity's financial situation;

(4)All of the factors set forth in § 890.1062(b) and (c); and

(5)The presence of aggravating or less serious circumstances, as described in paragraphs (c)(1) through (c)(7) of this section.

(c)*Aggravated and less serious circumstances.* The presence of aggravating circumstances may cause OPM to impose penalties and assessments at a higher level within the authorized range, while less serious violations may warrant sanctions of relatively lower amounts. Paragraphs (c)(1) through (c)(7) of this section provide examples of aggravated and less serious violations. These examples are illustrative only, and are not intended to represent an exhaustive list of all possible types of violations.

(1)The existence of many separate violations, or of violations committed over an extended period of time, constitutes an aggravating circumstance. OPM may consider conduct involving a small number of violations, committed either infrequently or within a brief period of time, to be less serious.

(2)Violations for which a provider had direct knowledge of the material facts (for example, submitting claims that the provider knew to contain false, inaccurate, or misleading information), or for which the provider did not cooperate with OPM's or an FEHBP carrier's investigations, constitute aggravating circumstances. OPM may consider violations where the provider did not have direct knowledge of the material facts, or in which the provider cooperated with post-violation investigative efforts, to be less serious.

(3)Violations resulting in substantial damages, losses, and costs to OPM, the FEHBP, or FEHBP-covered persons constitute aggravating circumstances. Violations producing a small or negligible overall financial impact may be considered to be less serious.

(4)A pattern of conduct reflecting numerous improper claims, high-dollar false claims, or improper claims involving several types of items or services constitutes aggravating circumstances. OPM may consider a small number of improper claims for relatively low dollar amounts to be less serious.

(5)Every violation involving any harm, or the risk of harm, to the health and safety of an FEHBP enrollee, must be considered an aggravating circumstance.

(6)Any prior violation described in § 890.1062(b)(5) constitutes an aggravating circumstance. OPM may consider repeated or multiple prior violations to represent an especially serious form of aggravating circumstances.

(7)OPM may consider other circumstances or actions to be aggravating or less serious within the context of an individual case, as the interests of justice require. § 890.1065 Deciding whether to suspend or debar a provider in a case that also involves penalties and assessments. In a case where both penalties and assessments and debarment are proposed concurrently,OPM must decide the proposed debarment under the same criteria and procedures as if it had been proposed separately from penalties and assessments. § 890.1066 Notice of proposed penalties and assessments.

(a)*Written notice.* OPM must inform a provider of proposed penalties and assessments by written notice, sent via certified mail with return receipt requested, to the provider's last known street or post office address. OPM may, at its discretion, use an express service that furnishes a verification of delivery instead of postal mail.

(b)*Statutory limitations period.* OPM must send the notice to the provider within 6 years of the date on which the claim underlying the proposed penalties and assessments was presented to an FEHBP carrier. If the proposed penalties and assessments do not involve a claim presented for payment, OPM must send the notice within 6 years of the date of the actions on which the proposed penalties and assessments are based.

(c)*Contents of the notice.* OPM's notice must contain, at a minimum:

(1)The statement that OPM proposes to impose penalties and/or assessments against the provider;

(2)Identification of the actions, conduct, and claims that comprise the basis for the proposed penalties and assessments;

(3)The amount of the proposed penalties and assessments, and an explanation of how OPM determined those amounts;

(4)The statutory and regulatory bases for the proposed penalties and assessments; and

(5)Instructions for responding to the notice, including specific explanations regarding:

(i)The provider's right to contest the imposition and/or amounts of penalties and assessments before they are formally imposed; and

(ii)OPM's right, if the provider does not contest the proposed penalties and assessments within 30 days of the date he receives the notice, to implement them immediately without further administrative appeal or recourse.

(d)*Proposing debarment in the same notice.* OPM may propose a provider's debarment in the same notice that also proposes penalties and assessments. In this case, the notice must also provide the elements of information required to appear in a notice of proposed debarment under § 890.1006(b).

(e)*Procedures if the notice cannot be delivered.* OPM must apply the provisions of § 890.1006(f) if the notice of proposed penalties and assessments cannot be delivered as originally addressed.

(f)*Sending notice by electronic means.* [Reserved] § 890.1067 Provider contests of proposed penalties and assessments.

(a)*Contesting proposed sanctions.* A provider may formally contest the proposed penalties and assessments by sending a written notice to the debarring official within 30 days after receiving the notice described in § 890.1066. The debarring official must apply the administrative procedures set forth in §§ 890.1069 and 890.1070 to decide the contest.

(b)*Contesting debarments and financial sanctions concurrently.* If OPM proposes debarment and penalties and assessments in the same notice, the provider may contest both the debarment and the financial sanctions in the same proceeding. If the provider pursues a combined contest, the requirements set forth in §§ 890.1022 through 890.1024, as well as this section, apply.

(c)*Settling or compromising proposed sanctions.* The debarring official may settle or compromise proposed sanctions at any time before issuing a final decision under § 890.1070. § 890.1068 Effect of not contesting proposed penalties and assessments.

(a)*Proposed sanctions may be implemented immediately.* In the absence of a timely response by a provider as required in the notice described in § 890.1066, the debarring official may issue a final decision implementing the proposed financial sanctions immediately, without further procedures.

(b)*Debarring official sends notice after implementing sanctions.* Immediately upon issuing a final decision under paragraph (a), the debarring official must send the provider written notice, via certified return receipt mail or express delivery service, stating:

(1)The amount of penalties and assessments imposed;

(2)The date on which they were imposed; and

(3)The means by which the provider may pay the penalties and assessments.

(c)*No appeal rights.* A provider may not pursue a further administrative or judicial appeal of the debarring official's final decision implementing any sanctions if a timely contest was not filed in response to OPM's notice under § 890.1066. § 890.1069 Information the debarring official must consider in deciding a provider's contest of proposed penalties and assessments.

(a)*Documentary material and written arguments.* As part of a provider's contest, the provider must furnish a written statement of reasons why the proposed penalties and assessments should not be imposed and/or why the amounts proposed are excessive.

(b)*Mandatory disclosures.* In addition to any other information submitted during the contest, the provider must inform the debarring official in writing of:

(1)Any existing, proposed, or prior exclusion, debarment, penalty, assessment, or other sanction that was imposed by a Federal, State, or local government agency, including any administrative agreement that purports to affect only a single agency; and

(2)Any current or prior criminal or civil legal proceeding that was based on the same facts as the penalties and assessments proposed by OPM.

(c)*In-person appearance.* A provider may request a personal appearance (in person, by telephone conference, or through a representative) to provide testimony and oral arguments to the debarring official. § 890.1070 Deciding contests of proposed penalties and assessments.

(a)*Debarring official reviews entire administrative record.* After the provider submits the information and evidence authorized or required by § 890.1069, the debarring official shall review the entire official record to determine if the contest can be decided without additional administrative proceedings, or if an evidentiary hearing is required to resolve disputed material facts.

(b)*Previously determined facts.* Any facts relating to the basis for the proposed penalties and assessments that were determined in prior due process proceedings are binding on the debarring official in deciding the contest. “Prior due process proceedings” are those set forth in § 890.1025(a)(1) through (4).

(c)*Deciding the contest without further proceedings.* To decide the contest without further administrative proceedings, the debarring official must determine that:

(1)The preponderance of the evidence in the administrative record as a whole demonstrates that the provider committed a sanctionable violation described in § 890.1061; and

(2)The evidentiary record contains no *bona fide* dispute of any fact material to the proposed financial sanction. A “material fact” is a fact essential to determining whether a provider committed a sanctionable violation for which penalties and assessments may be imposed.

(d)*Final decision without further proceedings.* If the debarring official determines that paragraphs (c)(1) and (c)(2) of this section both apply, a final decision may be issued, imposing financial sanctions in amounts not exceeding those proposed in the notice to the provider described in § 890.1066.

(e)*Insufficient evidence.* If the debarring official determines that a preponderance of the evidence does not demonstrate that the provider committed a sanctionable violation described in § 890.1061, the notice of proposed sanctions described in § 890.1066 must be withdrawn.

(f)*Disputed material facts.* If the debarring official determines that the administrative record contains a *bona fide* dispute about any fact material to the proposed sanction, he must refer the case for a fact-finding hearing to resolve the disputed fact or facts. The provisions of § 890.1027(b) and (c), 890.1028, and 890.1029(a) and

(b)will govern such a hearing.

(g)*Final decision after fact-finding hearing.* After receiving the report of the fact-finding hearing, the debarring official must apply the provisions of paragraphs (c), (d), and

(e)of this section to reach a final decision on the provider's contest. § 890.1071 Further appeal rights after final decision to impose penalties and assessments. If the debarring official's final decision imposes any penalties and assessments, the affected provider may appeal it to the appropriate United States district court under the provisions of 5 U.S.C. 8902a(h)(2). § 890.1072 Collecting penalties and assessments.

(a)*Agreed-upon payment schedule.* At the time OPM imposes penalties and assessments, or the amounts are settled or compromised, the provider must be afforded the opportunity to arrange an agreed-upon payment schedule.

(b)*No agreed-upon payment schedule.* In the absence of an agreed-upon payment schedule, OPM must collect penalties and assessments under its regular procedures for resolving debts owed to the Employees Health Benefits Fund.

(c)*Offsets.* As part of its debt collection efforts, OPM may request other Federal agencies to offset the penalties and assessments against amounts that the agencies may owe to the provider, including Federal income tax refunds.

(d)*Civil lawsuit.* If necessary to obtain payment of penalties and assessments, the United States may file a civil lawsuit as set forth in 5 U.S.C. 8902(i).

(e)*Crediting payments.* OPM must deposit payments of penalties and assessments into the Employees Health Benefits Fund. [FR Doc. 04-4730 Filed 3-2-04; 8:45 am]

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