71006 Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Rules and Regulations 

TABLE 1.—WASTES EXCLUDED FROM NON-SPECIFIC SOURCES—Continued 

Facility Address Waste description 

3. Changes in Operating Conditions: GM must notify the EPA in writing if the manufacturing 

process, the chemicals used in the manufacturing process, the treatment process, or the 

chemicals used in the treatment process at JTAP significantly change. GM must handle 

wastes generated at JTAP after the process change as hazardous until it has demonstrated that the waste continues to meet the delisting levels and that no new hazardous 

constituents listed in appendix VIII of part 261 have been introduced and GM has received 

written approval from EPA. 

4. Data Submittals: GM must submit the data obtained through verification testing at JTAP or 

as required by other conditions of this rule to EPA Region 5, Waste Management Branch 

(DW–8J), 77 W. Jackson Blvd., Chicago, IL 60604. The quarterly verification data and certification of proper disposal must be submitted annually upon the anniversary of the effective date of this exclusion. GM must compile, summarize, and maintain at JTAP records of 

operating conditions and analytical data for a minimum of five years. GM must make these 

records available for inspection. All data must be accompanied by a signed copy of the 

certification statement in 40 CFR 260.22(i)(12). 

5. Reopener Language—(a) If, anytime after disposal of the delisted waste, GM possesses or 

is otherwise made aware of any data (including but not limited to leachate data or groundwater monitoring data) relevant to the delisted waste at JTAP indicating that any constituent is at a level in the leachate higher than the specified delisting level, or is in the 

groundwater at a concentration higher than the maximum allowable groundwater concentration in paragraph (e), then GM must report such data in writing to the Regional Administrator within 10 days of first possessing or being made aware of that data. 

(b) Based on the information described in paragraph (a) and any other information received 

from any source, the Regional Administrator will make a preliminary determination as to 

whether the reported information requires Agency action to protect human health or the environment. Further action may include suspending, or revoking the exclusion, or other appropriate response necessary to protect human health and the environment. 

(c) If the Regional Administrator determines that the reported information does require Agency action, the Regional Administrator will notify GM in writing of the actions the Regional 

Administrator believes are necessary to protect human health and the environment. The 

notice shall include a statement of the proposed action and a statement providing GM with 

an opportunity to present information as to why the proposed Agency action is not necessary or to suggest an alternative action. GM shall have 30 days from the date of the Regional Administrator’s notice to present the information. 

(d) If after 30 days GM presents no further information, the Regional Administrator will issue 

a final written determination describing the Agency actions that are necessary to protect 

human health or the environment. Any required action described in the Regional Administrator’s determination shall become effective immediately, unless the Regional Administrator provides otherwise. 

(e) Maximum Allowable Groundwater Concentrations (mg/L):; antimony—0.006; arsenic—

0.005; cadmium—0.005; chromium—0.1; lead—0.015; nickel—0.750; selenium—0.050; 

tin—23; zinc—11; p-Cresol—0.190; and formaldehyde—0.950. 

* * * * * * * 

[FR Doc. 05–23229 Filed 11–23–05; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 403 

[CMS–1428–F3] 

RIN–0938–AM80 

Medicare Program; Changes to the 

Hospital Inpatient Prospective 

Payment System and Fiscal Year 2005 

Rates: Fire Safety Requirements for 

Religious Non-Medical Health Care 

Institutions: Correction To Reinstate 

Requirements for Written Fire Control 

Plans and Maintenance of 

Documentation 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule; correcting 

amendment. 

SUMMARY: In the August 11, 2004 issue 

of the Federal Register (69 FR 48916), 

we published the Hospital Inpatient 

Prospective Payment System final rule. 

This correcting amendment reinstates 

paragraphs (a)(2) and (a)(3) in 42 CFR 

403.744 (Condition of participation: Life 

safety from fire), which were 

accidentally deleted by that rule. Those 

paragraphs relate to requirements for 

fire control plans and maintenance of 

documentation in religious non-medical 

health care institutions. The effective 

date was October 1, 2004. 

EFFECTIVE DATE: This correcting 

amendment is effective November 25, 

2005. 

FOR FURTHER INFORMATION CONTACT: 

Janice Graham, (410) 786–8020; Danielle 

Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Rules and Regulations 71007 

Shearer, (410) 786–6617; or Jeannie 

Miller, (410) 786–3164. 

SUPPLEMENTARY INFORMATION: 

Need for Corrections 

On November 30, 1999, we published 

an interim final rule with comment 

period titled ‘‘Religious Nonmedical 

Health Care Institutions and Advance 

Directives’’ (64 FR 67028) to adopt the 

1997 edition of the Life Safety Code 

(LSC) for religious non-medical health 

care institutions (RNHCIs). We adopted 

the 1997 edition of the LSC because we 

believed that it provided the highest 

available level of protection for patients, 

staff, and the public at that time. The 

regulation also permitted a RNHCI to 

meet a fire and safety code imposed by 

State law if we found that the Stateimposed code adequately protected 

patients. This interim final rule also 

added paragraphs (a)(2) and (a)(3) to the 

Life Safety from Fire Condition of 

Participation at 42 CFR 403.744. These 

paragraphs were added in order to 

ensure that RNHCIs had adequate fire 

plans in case of a fire emergency and to 

ensure that RNHCIs documented the fire 

safety inspections and approvals related 

to their State or local fire control 

agencies. 

On January 10, 2003, we issued a final 

rule titled ‘‘Fire Safety Requirements for 

Certain Health Care Facilities’’ (68 FR 

1374) amending the fire safety standards 

for RNHCIs that adopted, with certain 

exceptions, the 2000 edition of the LSC 

published by the National Fire 

Protection Association (NFPA). One of 

the exceptions to the 2000 edition of the 

LSC concerned the use of roller latches 

in health care facilities, including 

RNHCIs. In the 2003 final rule, we 

prohibited health care facilities, 

including RNHCIs, from having roller 

latches. The final rule provided a 3-year 

phase-in period to allow facilities time 

to replace their roller latches. 

On August 11, 2004, we published the 

Hospital Inpatient Prospective Payment 

System (IPPS) final rule (69 FR 48916). 

In this final rule, we clarified the phasein date of the roller latch provision, and 

accidentally deleted paragraphs (a)(2) 

and (a)(3), which stated: 

• (a)(2) The religious non-medical 

health care institution (RNHCI) must 

have written fire control plans that 

contain provisions for prompt reporting 

of fires; extinguishing fires; protection 

of patients, staff, and the public; 

evacuation; and cooperation with fire 

fighting authorities. 

• (a)(3) The RNHCI must maintain 

written evidence of regular inspection 

and approval by State or local fire 

control agencies. 

This correcting amendment reincorporates paragraphs (a)(2) and (3), 

which were inadvertently deleted from 

the regulations by the 2004 IPPS rule. 

Collection of Information Requirements 

This document does contain 

information collection requirements as 

summarized below. However, we 

believe the burden associated with these 

requirements is exempt from the 

requirements of the Paperwork 

Reduction Act of 1995 (PRA) as defined 

in 5 CFR 1320.3(b)(2) because the time, 

effort, and financial resources necessary 

to comply with the requirement would 

be incurred by persons in the normal 

course of their activities. 

Section 403.744(a)(2) states that the 

RNHCI must have written fire control 

plans that contain provisions for prompt 

reporting of fires; extinguishing fires; 

protection of patients, staff and the 

public; evacuation; and cooperation 

with fire fighting authorities. 

Section 403.744(a)(3) states that the 

RNHCI must maintain written evidence 

of regular inspection and approval by 

State or local fire control agencies. 

Waiver of Proposed Rulemaking and 

Delayed Effective Date 

We ordinarily publish a notice of 

proposed rulemaking in the Federal 

Register and invite public comment on 

the proposed rule. We also ordinarily 

provide a 30-day delay in the effective 

date of the provisions of a rule. The 

notice of proposed rulemaking includes 

a reference to the legal authority under 

which the rule is proposed, and the 

terms and substances of the proposed 

rule or a description of the subjects and 

issues involved. We can waive both the 

notice of proposed rulemaking and the 

30-day delay in effective date, however, 

if the Secretary finds good cause that a 

notice-and-comment procedure and a 

30-day delay in the effective date are 

impracticable, or contrary to the public 

interest and incorporates a statement of 

the finding and the reasons in the rule 

issued. 

We believe that proceeding with 

notice and comment procedures and 

delaying the effective date are 

impracticable, and contrary to the 

public interest. 

The notice and comment procedures 

and delay in the effective date are 

impracticable because delaying 

implementation of these provisions 

would hinder our ability to provide 

continuous safety standards for RNHCI 

patients. These requirements were 

established in order to protect the 

patients, facility staff, and the public, 

and they continue to be necessary in 

order to ensure that RNHCIs provide 

safe care. 

Proceeding with notice and comment 

rulemaking and delaying the effective 

date would delay the restoration of 

these two paragraphs. During this delay, 

fire safety could be compromised 

because providers would not be 

required to maintain their written fire 

control plans or document their 

inspection and approval by State or 

local fire control agencies, two 

requirements that are key to ensuring 

patient safety. In addition, our ability to 

ensure compliance with § 403.738 

would be impeded if facilities did not 

maintain documentation of their 

compliance with State or local 

inspections and approval processes, as 

required by applicable State or local 

laws, regulations, and codes. 

Publishing a proposed rule and 

delaying the effective date are contrary 

to the public interest because of the 

imminent danger to life posed by failing 

to enforce the requirements of 

§ 403.744(a)(2) and (a)(3). One of the 

major responsibilities of a RNHCI is to 

provide an environment for their 

patients, staff, and the public that 

includes safety measures as outlined in 

its fire safety plan. These requirements 

re-enforce the importance of continually 

providing and maintaining a safe 

environment for RNHCI patients. 

Therefore, we find good cause to 

waive the notice of proposed 

rulemaking and delayed effective date 

and to issue this correcting amendment. 

Corrections to Regulations Text 

List of Subjects in 42 CFR Part 403 

Grant programs-health, Health 

insurance, Hospitals, Intergovernmental 

relations, Medicare, Reporting and 

recordkeeping requirements. 

■ Accordingly, 42 CFR chapter IV is 

corrected by making the following 

correcting amendments: 

PART 403—SPECIAL PROGRAMS AND 

PROJECTS 

■ 1. The authority citations for part 403 

continues to read as follows: 

Authority: 42 U.S.C. 1395b–3 and Secs. 

1102 and 1871 of the Social Security Act (42 

U.S.C. 1302 and 1395hh). 

■ 2. Section 403.744 is corrected by 

adding paragraphs (a)(2) and (a)(3) to 

read as follows: 

§ 403.744 Condition of participation: Life 

safety from fire. 

(a) * * * 

(2) The RNHCI must have written fire 

control plans that contain provisions for 

prompt reporting of fires; extinguishing 

71008 Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Rules and Regulations 

fires; protection of patients, staff, and 

the public; evacuation; and cooperation 

with fire fighting authorities. 

(3) The RNHCI must maintain written 

evidence of regular inspection and 

approval by State or local fire control 

agencies. 

* * * * * 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program) 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: November 21, 2005. 

Ann C. Agnew, 

Executive Secretary to the Department. 

[FR Doc. 05–23289 Filed 11–23–05; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 424 

[CMS–0008–F] 

RIN 0938–AM22 

Medicare Program; Electronic 

Submission of Medicare Claims 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule. 

SUMMARY: This final rule adopts as final, 

and makes amendments to, the interim 

final rule published on August 15, 2003. 

That interim final rule implemented the 

statutory requirement that claims for 

reimbursement under the Medicare 

Program be submitted electronically as 

of October 16, 2003, except where 

waived. These regulations identify those 

circumstances for which mandatory 

submission of electronic claims to the 

Medicare Program is waived. 

DATES: Effective date: These regulations 

are effective on December 27, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Kathleen Simmons, (410) 786–6157. 

Stewart Streimer, (410) 786–9318. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 3 of the Administrative 

Simplification Compliance Act (ASCA), 

Pub. L. 107–105, was enacted by the 

Congress to improve the administration 

of the Medicare Program by facilitating 

program efficiencies gained through the 

electronic submission of Medicare 

claims. Section 3 of ASCA amends 

subsection (a) of section 1862 of the 

Social Security Act (the Act) (42 U.S.C. 

1395y(a)) and adds a new subsection (h) 

to section 1862 (42 U.S.C. 1395y). The 

amendment to subsection (a) requires 

the Medicare Program, subject to 

subsection (h), to deny payment under 

Part A or Part B for any expenses for 

items or services ‘‘for which a claim is 

submitted other than in an electronic 

form specified by the Secretary.’’

Subsection (h) provides that the 

Secretary shall waive such denial in two 

types of cases and may also waive such 

denial ‘‘in such unusual cases as the 

Secretary finds appropriate.’’

Section 3 of ASCA operates in the 

context of the Administrative 

Simplification provisions of the Health 

Insurance Portability and 

Accountability Act of 1996 (HIPAA), 

Pub. L. 104–191. Those provisions 

require the Secretary to adopt, among 

other standards, standards for financial 

and administrative transactions for the 

health care industry, including health 

claims transactions (see section 1173(a) 

of the Act). In the August 17, 2000 

Federal Register (65 FR 50311), the 

Secretary of Health and Human Services 

(the Secretary) published a final rule 

(generally known as the Transactions 

Rule) that adopted standards for eight 

electronic transactions. The transactions 

standards adopted by that final rule, as 

subsequently modified by final rule 

published on February 20, 2003 (68 FR 

8381), are codified at 45 CFR part 162, 

subparts A and I through R. 

The HIPAA standards apply to health 

plans, health care clearinghouses, and 

certain health care providers; 

collectively, these entities are known as 

‘‘covered entities.’’ An additional 

category of covered entities—

prescription drug card sponsors—was 

added by the Medicare Prescription 

Drug, Improvement, and Modernization 

Act of 2003 (MMA), Pub. L. 108–173. 

Covered entities are required to comply 

not only with the standards established 

by the Transactions Rule, but also with 

those established via other HIPAA 

Administrative Simplification rules—

such as the Privacy Rule, the Employer 

Identifier Rule, the Security Rule, and 

the National Provider Identifier Rule—

by the respective applicable compliance 

dates specified in those rules. 

Compliance with the standards for the 

electronic transactions established by 

the Transactions Rule was required for 

all covered entities other than small 

health plans by October 16, 2002; 

compliance by small health plans was 

required by October 16, 2003. However, 

section 2 of ASCA extended the October 

16, 2002 compliance deadline to 

October 16, 2003 for covered entities 

that were not small health plans and 

that submitted a compliance plan by 

October 15, 2002. In accordance with 45 

CFR 162.900(c), covered entities that 

were not small health plans and that did 

not timely submit a compliance plan 

under ASCA were required to comply 

by October 16, 2002. Thus, all covered 

entities, regardless of type, were 

required to be in compliance no later 

than October 16, 2003. 

Since a significant number of covered 

entities had expressed strong concern 

over the health care industry’s state of 

readiness to conduct fully compliant 

HIPAA transactions and we wanted to 

promote compliance while ensuring that 

cash flow and health care operations 

would not be unnecessarily disrupted, 

the Department of Health and Human 

Services (HHS) issued guidance on the 

approach CMS would take to enforce 

the HIPAA electronic transactions and 

code sets provisions. In accordance with 

the July 24, 2003 guidance, the 

Secretary explained that we would 

focus on voluntary compliance, use a 

complaint-driven approach, and would 

not impose penalties on covered entities 

that deployed temporary contingency 

plans, if they made reasonable and 

diligent efforts to become compliant 

and, in the case of health plans, 

facilitated the compliance of their 

trading partners. 

By statute, the Medicare Program is a 

health plan under HIPAA (see section 

1171(5)(D) of the Act). It is, therefore, a 

covered entity. In 45 CFR 160.102(a)(3), 

we specify that, in accordance with 

section 1172(a)(3) of the Act, health care 

providers are covered entities if they 

transmit health information in 

electronic form in connection with a 

transaction for which the Secretary has 

adopted a standard (covered 

transaction). In 45 CFR 162.923(a), we 

specify that if a covered entity 

electronically conducts a covered 

transaction with another covered entity, 

it must conduct it as a standard 

transaction. 

Approximately 86.1 percent of claims 

submitted to the Medicare Program are 

submitted electronically, which means 

that approximately 139 million claims 

are submitted on paper per year (fiscal 

year (FY) 2002). Section 3 of ASCA 

required Medicare providers to submit 

Medicare claims electronically by 

October 16, 2003, unless one of the 

specified grounds for waiver applies. As 

the October 16, 2003 deadline 

approached, we made the decision to 

implement our own contingency plan 

after reviewing statistics showing that 

an unacceptably low number of 

Medicare providers would likely be 

capable of submitting compliant claims