74448 Federal Register / Vol. 69, No. 239 / Tuesday, December 14, 2004 / Rules and Regulations 

Under RCRA section 3006(b), EPA 

grants a State’s application for 

authorization as long as the State meets 

the criteria required by RCRA. It would 

thus be inconsistent with applicable law 

for EPA, when it reviews a State 

authorization application, to require the 

use of any particular voluntary 

consensus standard in place of another 

standard that otherwise satisfies the 

requirements of RCRA. Thus, the 

requirements of section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (15 U.S.C. 

272) do not apply. As required by 

Section 3 of Executive Order 12988 (61 

FR 4729, February 7, 1996), in issuing 

this rule, EPA has taken the necessary 

steps to eliminate drafting errors and 

ambiguity, minimize potential litigation, 

and provide a clear legal standard for 

affected conduct. EPA has complied 

with Executive Order 12630 (53 FR 

8859, March 15, 1988) by examining the 

takings implications of the rule in 

accordance with the ‘‘Attorney 

General’s Supplemental Guidelines for 

the Evaluation of Risk and Avoidance of 

Unanticipated Takings’’ issued under 

the executive order. This rule does not 

impose an information collection 

burden under the provisions of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this document and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication in the Federal Register. A 

major rule cannot take effect until 60 

days after it is published in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). This 

action will be effective February 14, 

2005.

List of Subjects in 40 CFR Part 271 

Environmental protection, 

Administrative practice and procedure, 

Confidential business information, 

Hazardous materials transportation, 

Hazardous waste, Indians lands, 

Intergovernmental relations, Penalties, 

Reporting and recordkeeping 

requirements.

Authority: This action is issued under the 

authority of sections 2002(a), 3006 and 

7004(b) of the Solid Waste Disposal Act as 

amended 42 U.S.C. 6912(a), 6926, 6974(b).

Dated: December 7, 2004. 

A. Stanley Meiburg, 

Deputy Regional Administrator, Region 4.

[FR Doc. 04–27363 Filed 12–13–04; 8:45 am] 

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300

[FRL–7844–6] 

National Oil and Hazardous 

Substances Pollution Contingency 

Plan; National Priorities List

AGENCY: Environmental Protection 

Agency.

ACTION: Direct final deletion of the York 

County Solid Waste and Refuse 

Authority Superfund Site from the 

National Priorities List. 

SUMMARY: The Environmental Protection 

Agency (EPA) Region III is publishing a 

direct final notice of deletion of the 

York County Solid Waste and Refuse 

Authority Superfund Site (Site) located 

in Hopewell Township, York County, 

Pennsylvania, from the National 

Priorities List (NPL). 

The NPL, promulgated pursuant to 

section 105 of the Comprehensive 

Environmental Response, 

Compensation, and Liability Act 

(CERCLA) of 1980, as amended, is 

appendix B of 40 CFR part 300, which 

is the National Oil and Hazardous 

Substances Pollution Contingency Plan 

(NCP). This direct final notice of 

deletion is being published by EPA with 

the concurrence of the Commonwealth 

of Pennsylvania, through the 

Pennsylvania Department of 

Environmental Protection (PADEP) 

because EPA has determined that all 

appropriate response actions under 

CERCLA have been completed and, 

therefore, further remedial action 

pursuant to CERCLA is not appropriate.

DATES: This direct final deletion will be 

effective February 14, 2005, unless EPA 

receives adverse comments by January 

13, 2005. If adverse comments are 

received, EPA will publish a timely 

withdrawal of the direct final deletion 

in the Federal Register informing the 

public that the deletion will not take 

effect.

ADDRESSES: Comments may be mailed 

to: Larry Johnson, Community 

Involvement Coordinator (3HS43), U.S. 

EPA Region III, 1650 Arch Street, 

Philadelphia, PA 19103 ((215) 814–

3239). 

Information Repositories:

Comprehensive information about the 

Site is available for viewing and copying 

at the Site Information Repositories at 

the following location: U.S. EPA Region 

III, Regional Center for Environmental 

Information (RCEI), 1650 Arch Street, 

Philadelphia, PA 19103 (phone: (215) 

814–5364, open Monday through Friday 

8 a.m. to 4:30 p.m) and the MasonDixon Public Library, Main Street, 

Stewartstown, Pennsylvania 17363.

FOR FURTHER INFORMATION CONTACT:

Romuald A. Roman, Remedial Project 

Manager (3HS22), U.S. EPA Region III, 

1650 Arch Street, Philadelphia, PA 

19103 (phone: (215) 814–3212; fax: 

(215) 814–3002; e-mail: 

roman.romuald@epa.gov).

SUPPLEMENTARY INFORMATION:

Table of Contents 

I. Introduction 

II. NPL Deletion Criteria 

III. Deletion Procedures 

IV. Basis for Site Deletion 

V. Deletion Action

I. Introduction 

EPA Region III is publishing this 

direct final deletion of the York County 

Solid Waste and Refuse Authority 

Superfund Site from the NPL. 

The EPA identifies sites that appear to 

present a significant risk to public 

health or the environment and 

maintains the NPL as the list of those 

sites. As described in § 300.425(e)(3) of 

the NCP, sites deleted from the NPL 

remain eligible for remedial actions if 

conditions at a deleted site warrant such 

action. 

Because EPA considers this action to 

be noncontroversial and routine, EPA is 

taking it without prior publication of a 

notice of intent to delete. This action 

will be effective February 14, 2005 

unless EPA receives adverse comments 

by January 13, 2005 on this notice or the 

parallel notice of intent to delete 

published in the Proposed Rules section 

of today’s Federal Register. If adverse 

comments are received within the 30-

day public comment period on this 

notice or the notice of intent to delete, 

EPA will publish a timely withdrawal of 

this direct final deletion before the 

effective date of the deletion and the 

deletion will not take effect. EPA will, 

as appropriate, prepare a response to 

comments and continue with the 

deletion process on the basis of the 

notice of intent to delete and the 

comments already received. There will 

be no additional opportunity to 

comment. 

Section II of this document explains 

the criteria for deleting sites from the 

NPL. Section III discusses procedures 

Federal Register / Vol. 69, No. 239 / Tuesday, December 14, 2004 / Rules and Regulations 74449

that EPA is using for this action. Section 

IV discusses the York County Solid 

Waste and Refuse Authority Superfund 

Site and demonstrates how it meets the 

deletion criteria. Section V discusses 

EPA’s action to delete the Site from the 

NPL unless adverse comments are 

received during the public comment 

period. 

II. NPL Deletion Criteria 

Section 300.425(e) of the NCP 

provides that releases may be deleted 

from the NPL where no further response 

is appropriate. In making a 

determination to delete a release from 

the NPL, EPA shall consider, in 

consultation with the State, whether any 

of the following criteria have been met: 

i. Responsible parties or other persons 

have implemented all appropriate 

response actions required; 

ii. All appropriate Fund-financed 

(Hazardous Substance Superfund 

Response Trust Fund) response under 

CERCLA has been implemented, and no 

further response action by responsible 

parties is appropriate; or 

iii. The remedial investigation has 

shown that the release poses no 

significant threat to public health or the 

environment and, therefore, the taking 

of remedial measures is not appropriate. 

Even if a site is deleted from the NPL, 

where hazardous substances, pollutants, 

or contaminants remain at the deleted 

site above levels that allow for 

unlimited use and unrestricted 

exposure, CERCLA Section 121(c), 42 

U.S.C. 9621(c), requires that a 

subsequent review of the site be 

conducted at least every five years after 

the initiation of the remedial action at 

the deleted site to ensure that the action 

remains protective of public health and 

the environment. If new information 

becomes available which indicates a 

need for further action, EPA may initiate 

remedial actions. Whenever there is a 

significant release from a site deleted 

from the NPL, the deleted site may be 

restored to the NPL without application 

of the hazard ranking system. 

III. Deletion Procedures 

The following procedures apply to 

deletion of the Site: 

(1) The EPA consulted with the 

Commonwealth of Pennsylvania on the 

deletion of the Site from the NPL prior 

to developing this direct final notice of 

deletion. 

(2) The Commonwealth of 

Pennsylvania concurred with the 

deletion of the Site from the NPL. 

(3) Concurrently with the publication 

of this direct final deletion, a notice of 

the availability of the parallel notice of 

intent to delete published today in the 

‘‘Proposed Rules’’ section of the Federal 

Register is being published in a major 

local newspaper of general circulation at 

or near the Site and is being distributed 

to the appropriate federal, state, and 

local government officials and other 

interested parties; the newspaper notice 

announces the 30-day public comment 

period concerning the notice of intent to 

delete the Site from the NPL. 

(4) The EPA placed copies of 

documents supporting the deletion in 

the Site information repositories 

identified above. 

(5) If adverse comments are received 

within the 30-day public comment 

period on this notice or the companion 

notice of intent to delete also published 

in today’s Federal Register, EPA will 

publish a timely withdrawal of this 

direct final notice of deletion before its 

effective date and will prepare a 

response to comments and continue 

with the deletion process on the basis of 

the notice of intent to delete and the 

comments already received. 

Deletion of a Site from the NPL does 

not itself create, alter, or revoke any 

individual’s rights or obligations. 

Deletion of a site from the NPL does not 

in any way alter EPA’s right to take 

enforcement actions, as appropriate. 

The NPL is designed primarily for 

informational purposes and to assist 

EPA management. Section 300.425(e)(3) 

of the NCP states that the deletion of a 

site from the NPL does not preclude 

eligibility for future response actions, 

should future conditions warrant such 

actions. 

IV. Basis For Site Deletion 

The following information provides 

EPA’s rationale for deleting the Site 

from the NPL: 

A. Site Location 

The York County Solid Waste and 

Refuse Authority Superfund Site (Site) 

is located in Hopewell Township, York 

County, Pennsylvania, approximately 

two miles northwest of the center of 

Stewartstown Borough, Pennsylvania. 

The Site consists of a 135-acre inactive 

municipal landfill containing three 

unlined cells and a plume of 

contamination emanating from these 

cells. Adjacent to the former landfill is 

a currently operating, permitted landfill 

of approximately 45 acres that is not 

part of the NPL Site. 

B. Site History 

The York County Solid Waste and 

Refuse Authority (YCSWRA) was 

established in 1971 and commenced 

landfill operations at the Site by 1974. 

The landfill operated between 1974 and 

1985 and received approximately 400 

tons of waste daily. The landfill ceased 

operation in 1985 and was closed in 

accordance with a closure plan 

approved by the Pennsylvania 

Department of Environmental Resources 

(PADER, now the Pennsylvania 

Department of Environmental Protection 

or PADEP). 

An investigation conducted by 

PADER between 1982 and 1984 revealed 

that volatile organic compounds (VOCs) 

were migrating from the landfill and 

contaminating adjacent residential 

wells. In 1984, YSCWRA entered into an 

Agreement for Amicable Action and 

Consent Decree with PADER (1984 

PADER Agreement) which required 

YCSWRA to, among other things, 

construct a lined landfill, implement a 

ground water treatment and monitoring 

program for the Site, and provide 

potable water to the residents whose 

water was contaminated by the Site. In 

1984 and 1985, YCSWRA installed 

additional ground water monitoring 

wells, constructed and started operating 

the adjacent lined landfill, and 

constructed and started operating the 

ground water contamination 

containment/extraction and treatment 

system for the Site. The treatment 

system currently in operation consists of 

seventeen pumping wells and three air 

stripping treatment towers. Effluent 

from the air stripping towers is 

discharged to two National Pollutant 

Discharge Elimination System (NPDES) 

permitted outfalls on streams adjacent 

to the former landfill. Additionally, 

YCSWRA currently supplies and 

maintains a point-of-entry carbon filter 

treatment system for eight residents and 

provides bottled drinking water to two 

residents whose domestic wells do not 

appear to have been impacted by the 

Site. 

EPA completed a Preliminary 

Assessment/Site Investigation (PA/SI) 

for the Site in July 1984. The PA/SI 

confirmed the earlier findings that 

ground water beneath and beyond the 

landfill was contaminated with VOCs 

and that contamination had migrated to 

adjacent wells. EPA proposed the Site 

for inclusion on the National Priorities 

List (NPL) in April 1985. The Site was 

finalized on the NPL on July 22, 1987.

In December 1987, PADER and the 

YCSWRA entered into a Consent Order 

and Agreement requiring YCSWRA to 

perform a Remedial Investigation and 

Feasability Study (RI/FS) at the Site to 

ascertain the nature and extent of 

contamination and evaluate cleanup 

actions. The RI/FS was started in 1988 

and was finalized in 1994. The Risk 

Assessment (RA) completed during the 

RI/FS identified ground water 

contamination beneath and beyond the 

74450 Federal Register / Vol. 69, No. 239 / Tuesday, December 14, 2004 / Rules and Regulations 

boundaries of the Site as posing an 

unacceptable level of risk. 

On December 29, 1994, EPA issued a 

Record of Decision (ROD) selecting 

remedial action for implementation at 

the Site. The selected remedy consisted 

of the following components: 

1. Continued operation of the 

currently existing ground water 

extraction and air stripper treatment 

system at the landfill; 

2. Continued operation and 

maintenance of the point of entry 

ground water carbon filter treatment 

systems and/or provision of bottled 

water for affected private wells as 

necessary; 

3. Continued maintenance of the 

landfill’s soil and vegetated cap and the 

passive gas venting system currently in 

place at the landfill; 

4. Continued sampling of ground 

water and treated water to ensure that 

treatment components are effective and 

ground water remediation is progressing 

toward required cleanup levels; 

5. Implementation of a monitoring 

program to assess the effectiveness of 

the ground water treatment system and 

its impact on down-gradient surface 

water and wetland habitat; 

6. Implementation of a monitoring 

program to assess the impact of the 

treated effluent discharge on the 

environmental quality of surface waters 

and sediments in the streams where the 

outfalls are located; 

7. Deed restrictions to prohibit the 

installation of new on-Site wells in 

areas of contamination that do not meet 

applicable or relevant and appropriate 

requirements (ARARs), which 

restrictions can be withdrawn when 

ARARs are achieved; and 

8. Deed restrictions to prohibit the 

excavation or disturbance of the soil cap 

which results in exposing the fill 

materials. 

In 1997, the YCSWRA entered into a 

Consent Order (1997 Consent Order) 

with EPA which required YCSWRA to 

implement a removal action consisting 

of certain actions selected by EPA in the 

ROD. The 1997 Consent Order did not 

expressly require that YCSWRA 

continue implementation of the pump 

and treat, maintenance, and sampling 

activities called for in the 1984 PADER 

Agreement; rather, the 1997 Consent 

Order required that YCSWRA describe 

to EPA, on a monthly basis, all actions 

undertaken at the Site to comply with 

that 1984 PADER Agreement. Since 

1997, YCSWRA has complied with the 

1997 Consent Order by, among other 

things, identifying all actions taken at 

the Site pursuant to the 1984 PADER 

Agreement, performed monitoring to 

assess the effectiveness of the actions 

taken pursuant to the 1984 PADER 

Agreement on down gradient surface 

water and wetland habitat and the 

impact of the treated effluent discharge 

on the environmental quality of surface 

waters where outfalls are located, 

implemented deed restrictions to 

prohibit the extraction of groundwater 

from the Site for drinking water and 

other residential uses; and implemented 

deed restrictions to prohibit all 

extraction or disturbance of the soil cap 

which may result in the exposure of fill 

material (except for certain limited 

exceptions). Deed restrictions were 

developed and placed in the deed to the 

Site by filing the restrictions with the 

Recorder of Deeds. The deed restrictions 

prohibit the use of ground water at the 

Site and prohibit unauthorized 

excavation or disturbance of the soil 

cap. The continued need for deed 

restrictions will be reevaluated during 

the Five-Year Reviews which will be 

conducted for the Site. 

On September 27, 2004 EPA issued an 

Explanation of Significant Differences 

(ESD) which announced a significant, 

but not fundamental, change to the 

remedial action selected in the ROD. 

The ESD eliminated the items numbered 

1–4 in the list above from the 

components of the remedial action. EPA 

made this change because (a) the 1984 

PADER Agreement requires that 

YCSWRA conduct these actions under 

PADEP’s oversight, (b) based on 

YCSWRA’s past performance under the 

1984 PADEP Agreement, EPA expects 

that YCSWRA will continue to conduct 

these actions under PADEP’s oversight, 

and (c) YCSWRA is required, under the 

1997 Consent Order with EPA, to report 

to EPA all actions taken to comply with 

the 1984 PADEP Agreement on a 

monthly basis. The ESD explained that 

EPA will continue to monitor 

YCSWRA’s performance of these actions 

that are required by the 1984 PADEP 

Agreement through the monthly reports 

received pursuant to the 1997 Consent 

Order. 

C. Characterization of Risk 

An assessment of the risk associated 

with the Site was conducted during the 

Remedial Investigation to characterize 

the current and potential threats to 

human health and the environment 

based on reasonable maximum 

exposures to contaminants in the 

ground water, soil, migration of 

contaminants to surface water, 

sediments, and exposure to the air. The 

Risk Assessment (RA) identified ground 

water contamination beneath and 

beyond the boundaries of the Site as 

posing an unacceptable level of risk. 

The RA was used to evaluate the need 

for remedial action and to determine the 

levels to which site related 

contaminants would need to be treated 

to ensure the protection of human 

health and the environment. Current 

land use in the vicinity of the Site is 

residential and agricultural and is 

expected to remain as such in the 

future. Ground water beneath the Site is 

classified as a source of drinking water 

and contaminants from the Site have 

migrated towards private drinking water 

wells through the ground water flow 

system. Residents who obtain water 

from private wells which have an inplace point of entry (POE) carbon filter 

treatment systems filter treatment 

system. The supply, maintenance and 

proper disposal of the filters is 

conduced by YCSWRA and is required 

by the 1984 PADER Agreement. 

Currently there is a 31⁄2–13 foot 

vegetated soil cover over the former 

landfill. As a result no risk to human 

health or the environment is currently 

present nor should any future risk occur 

as long as the cap integrity is 

maintained. 

D. Future Activity 

Operation and Maintenance 

The YCSWRA maintains a permanent 

office at the landfill and performs 

regularly scheduled monitoring and 

response activities which include 

monitoring NPDES discharges, flow 

rates from remediation wells, depth-towater in remediation wells, water 

quality in remediation and monitoring 

wells, water quality in residential wells, 

and groundwater flow; maintaining 

residential filters; and maintaining the 

cap and vegetative cover. Pumping and 

treating, which is being completed 

under the 1984 PADER Agreement, has 

been successful in containing 

contaminated ground water and in 

providing a potable water supply to 

residents with impacted wells. Pumping 

and treating will be continued until the 

maximum contaminant levels (MCLs) 

for each contaminant of concern or 

background, which ever is more 

stringent, is achieved and maintained 

throughout the entire plume of 

contamination for a period of 12 

consecutive quarters. Residential 

filtration units will continue to be 

maintained for those residences whose 

wells are affected.

Five-Year Reviews 

The NCP requires that if EPA selects 

remedial action that results in any 

hazardous substances remaining at a site 

above levels that allow for unlimited 

use and unrestricted exposure, EPA 

must conduct a review of such remedial 

Federal Register / Vol. 69, No. 239 / Tuesday, December 14, 2004 / Rules and Regulations 74451

1Eligible beneficiaries may enroll in the Medicare 

drug discount card program beginning no later than 

6 months after the date of enactment of MMA and 

ending December 31, 2005. After December 31, 

2005, beneficiaries enrolled in the program may 

continue to use their drug discount card during a 

short transition period beginning January 1, 2006 

and ending upon the effective date of a beneficiary’s 

outpatient drug coverage under Medicare Part D, 

but no later than the last day of the initial open 

enrollment period under Part D.

action no less often than every five years 

following initiation of that remedial 

action to ensure that human health and 

the environment are being protected. 

EPA has determined as a matter of 

policy that such reviews will also be 

conducted if a removal action leaves 

hazardous substances on site above 

levels that allow for unlimited use and 

unrestricted exposure and no remedial 

action has taken or will take place. 

Since ground water contamination 

remains at the Site above levels that 

allow for unlimited use and unrestricted 

exposure, EPA will use the five-year 

review process to ensure protection of 

human health and the environment. 

EPA completed the first five-year review 

of the Site on September 30, 2002. In 

that five-year review, EPA determined 

that the immediate threats have been 

addressed and the actions taken have 

been protective of human health and the 

environment. EPA plans to complete the 

next five year review prior to September 

30, 2009. 

E. Community Involvement 

Public participation activities have 

been satisfied as required in CERCLA 

Section 113(k), 42 U.S.C. 9613(k), and 

CERCLA Section 117, 42 U.S.C 9617. 

Documents in the deletion docket which 

EPA relied on for recommendation of 

the deletion from the NPL are available 

to the public in the information 

repositories. 

V. Deletion Action 

The EPA, with the concurrence of the 

Commonwealth of Pennsylvania, has 

determined that all appropriate 

responses under CERCLA have been 

completed, and that no further response 

actions, under CERCLA, other than 

O&M of the existing treatment system 

which will be completed under the 1984 

PADER Agreement and five-year 

reviews, are necessary. Therefore, EPA 

is deleting the Site from the NPL. 

Because EPA considers this action to 

be noncontroversial and routine, EPA is 

taking it without prior publication of a 

notice of intent to delete. This action 

will be effective February 14, 2005 

unless EPA receives adverse comments 

by January 13, 2005 on a parallel notice 

of intent to delete published in the 

Proposed Rule section of today’s 

Federal Register. If adverse comments 

are received within the 30-day public 

comment period on the proposal, EPA 

will publish a timely withdrawal of this 

direct final notice of deletion before the 

effective date of the deletion and the 

deletion will not take effect. EPA will 

prepare a response to comments and 

continue with the deletion process on 

the basis of the notice of intent to delete 

and the comments already received. 

There will be no additional opportunity 

to comment.

List of Subjects in 40 CFR Part 300 

Environmental protection, Air 

pollution control, Chemicals, Hazardous 

substances, Hazardous waste, 

Intergovernmental relations, Penalties, 

Reporting and recordkeeping 

requirements, Superfund, Water 

pollution control, Water supply.

Dated: October 26, 2004. 

Richard J. Kampf, 

Acting Regional Administrator, Region III.

■ For the reasons set out in this 

document, 40 CFR part 300 is amended 

as follows:

PART 300—[AMENDED]

■ 1. The authority citation for part 300 

continues to read as follows:

Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 

9601–9657; E.O. 12777, 56 FR 54757, 3 CFR., 

1991 Comp., p.351; E.O. 12580, 52 FR 2923, 

3 CFR., 1987 Comp., p. 193.

Appendix B—[Amended]

■ 2. Table 1 of Appendix B to part 300 

is amended by removing the site name 

‘‘York County Solid Waste and Refuse 

Authority, Hopewell Township, PA.’’

[FR Doc. 04–27168 Filed 12–13–04; 8:45 am] 

BILLING CODE 6560–50–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

42 CFR Part 1003 

RIN 0991–AB30 

Medicare and State Health Care 

Programs; Fraud and Abuse: OIG Civil 

Money Penalties Under the Medicare 

Prescription Drug Discount Card 

Program

AGENCY: Office of Inspector General 

(OIG), HHS.

ACTION: Final rule.

SUMMARY: In accordance with section 

1860D–31 of the Social Security Act, 

this rule finalizes OIG’s new authority 

for imposing civil money penalties 

(CMPs) against endorsed sponsors under 

the Medicare prescription drug discount 

card program that knowingly engage in 

false or misleading marketing practices; 

overcharge program enrollees; or misuse 

transitional assistance funds.

DATES: The interim rule amending 42 

CFR part 1003 became effective on June 

18, 2004.

FOR FURTHER INFORMATION CONTACT: Joel 

Schaer, Office of External Affairs, (202) 

619–0089.

SUPPLEMENTARY INFORMATION: 

I. Background 

A. OIG Civil Money Penalties 

In 1981, Congress enacted the civil 

money penalty statute, section 1128A of 

the Social Security Act (the Act) (42 

U.S.C. 1320a–7a), as one of several 

administrative remedies to combat 

increases in fraud and abuse. The civil 

money penalty (CMP) law authorized 

the HHS Secretary and the Inspector 

General to impose CMPs and program 

exclusions on individuals and entities 

whose wrongdoing caused injury to 

HHS programs or their beneficiaries. 

Since 1981, the CMP provisions have 

been expanded to apply by reference to 

numerous types of fraudulent and 

abusive activities. 

B. The Medicare Prescription Drug, 

Improvement, and Modernization Act 

Section 101 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act (MMA) of 2003, as 

enacted by Public Law 108–173 and 

codified in section 1860D–31 of the Act, 

provides for a voluntary prescription 

drug discount card program for 

Medicare beneficiaries entitled to 

benefits, or enrolled, under Part A or 

enrolled under Part B, excluding 

beneficiaries entitled to medical 

assistance for outpatient prescription 

drugs under Medicaid, including 

section 1115 waiver demonstrations. 

Eligible beneficiaries may access 

negotiated prices on prescription drugs 

by enrolling in drug discount card 

programs offered by Medicare-endorsed 

sponsors.1 The Medicare drug discount 

card program is intended to serve as a 

transitional program providing 

immediate assistance to Medicare 

beneficiaries with prescription drug 

costs during calendar years 2004 and 

2005 while preparations are made for 

implementation of the Medicare drug 

benefit under Medicare Part D in 2006.

The implementing regulations 

establishing the requirements for the 

MMA program were published in the 

Federal Register as an interim final rule 

with comment period by the Centers for