57226 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 411 

[CMS–1810–IFC2] 

RIN–0938–AK67 

Medicare Program; Physicians’

Referrals to Health Care Entities With 

Which They Have Financial 

Relationships (Phase II); Correcting 

Amendment

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS.

ACTION: Interim final rule with comment 

period; correcting amendment. 

SUMMARY: In the March 26, 2004 issue 

of the Federal Register (69 FR 16054), 

we published an interim final rule with 

comment period that incorporated into 

regulations certain provisions of the 

physician self-referral prohibition in 

section 1877 of the Social Security Act. 

The effective date of that rule was July 

26, 2004. This correcting amendment 

corrects a technical error identified in 

the March 26, 2004 interim final rule. 

Specifically, this rule reinstates the 

physician self-referral advisory opinion 

regulations, which were inadvertently 

deleted from Part 411 in the March 26, 

2004 interim final rule.

DATES: This rule is effective July 26, 

2004. To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on November 23, 2004.

ADDRESSES: In commenting, please refer 

to file code CMS–1810–IFC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

three ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http://

www.cms.hhs.gov/regulations/

ecomments. (Attachments should be in 

Microsoft Word, WordPerfect, or Excel; 

however, we prefer Microsoft Word.) 

2. By mail. You may mail written 

comments (one original and two copies) 

to the following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–1810–

IFC2, P.O. Box 8011, Baltimore, MD 

21244–8011. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period.

3. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments (one original 

and two copies) before the close of the 

comment period to one of the following 

addresses. If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786–

7195 in advance to schedule your 

arrival with one of our staff members. 

Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201; or 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

(Because access to the interior of the 

HHH Building is not readily available to 

persons without Federal Government 

identification, commenters are 

encouraged to leave their comments in 

the CMS drop slots located in the main 

lobby of the building. A stamp-in clock 

is available for persons wishing to retain 

a proof of filing by stamping in and 

retaining an extra copy of the comments 

being filed.) 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

We are only accepting comments on 

whether to reinstate the physician selfreferral advisory opinion regulations, 

not on the substance of the regulations 

themselves. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:

Joanne Sinsheimer, (410) 786–4620.

SUPPLEMENTARY INFORMATION: 

Need for Correction 

This correction is necessary to 

reinstate the regulation text for 

§ 411.370 through § 411.389 (regarding 

the physician self-referral advisory 

opinion process), which was 

inadvertently deleted from Part 411 in 

the March 26, 2004 interim final rule. 

We note that we are updating an 

incorrect address to be used in 

submitting advisory opinions. 

Collection of Information 

The requirements in § 411.370 

through § 411.389 are subject to the 

Paperwork Reduction Act; however, 

these requirements are currently 

approved under OMB control #0938–

0714 with a current expiration date of 

October 31, 2004. Note that the 

information collection package 

containing these approved requirements 

is currently at OMB awaiting reapproval.

Waiver of Proposed Rulemaking 

We ordinarily publish a notice of 

proposed rulemaking in the Federal 

Register to provide a period for public 

comment before the provisions of a rule 

take effect. We can waive this 

procedure, however, if we find good 

cause that notice and comment 

procedure is impracticable, 

unnecessary, or contrary to the public 

interest and incorporate a statement of 

the finding and the reasons for it into 

the rule issued. 

We find it unnecessary, impracticable, 

and contrary to the public interest to 

offer an opportunity to comment on this 

rule before it becomes effective. This 

rule merely corrects the inadvertent 

removal of certain regulatory provisions 

regarding the physician self-referral 

advisory opinion process. The deleted 

advisory opinion regulations have been 

in effect since they were first published 

on January 9, 1998 in an interim final 

rule with comment period. We never 

proposed to remove or revise these 

regulations, and they were not the 

subject of the March 26, 2004 interim 

final rule. Nothing in the preamble to 

the March 26, 2004 interim final rule 

indicated any intent to remove or revise 

the advisory opinion regulations. In fact, 

the preamble referred several times to 

the existence of the advisory opinion 

process. But for the omission of an 

ellipsis at the end of the regulatory text 

for Part 411 at 69 FR 16142 of the March 

26, 2004 interim final rule, these 

regulations would not have been 

removed. Reinstatement of these 

regulations does not impose any 

additional burden on the public. 

Delaying the effective date of this rule 

pending prior notice and an opportunity 

for public comment would be 

impracticable because it would create 

uncertainty as to the appropriate 

procedures and standards that the 

agency would apply in receiving and 

processing requests for advisory 

opinions. The absence of these 

regulations in the CFR could increase 

the burden on both the agency and the 

public. For these reasons, we find it 

unnecessary and impracticable to 

provide an opportunity to comment on 

the technical correction made by this 

rule. Moreover, it would be contrary to 

the public interest for us to require 

members of the public to draft and 

submit advisory opinion requests, and 

for us to issue advisory opinions, in the 

absence of any rules to guide the 

process. We believe that the comment 

period established by this interim final 

rule will protect the public’s interest in 

this rulemaking. Therefore, we find 

good cause to waive the opportunity to 

receive public comments on this rule 

prior to its effective date.

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57227

Retroactive Application 

We ordinarily designate an interim 

final rule to be effective at least 30 days 

from the date of publication. Under 5 

U.S.C. 553(d), a rule may have a 

retroactive effective date if the agency 

finds good cause and incorporates a 

statement of the finding and the reasons 

for it into the rule issued. Section 1871 

of the Social Security Act, as amended 

by section 903(a) of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA), 

provides that a substantive change in 

regulations may be applied retroactively 

if the Secretary determines that ‘‘failure 

to apply the change retroactively would 

be contrary to the public interest.’’

We believe that there is good cause to 

reinstate § 411.370 through § 411.389 

retroactively and that failure to reinstate 

these regulations retroactively would be 

contrary to the public interest. We have 

issued two advisory opinions since July 

26, 2004, and we are currently 

reviewing approximately 30 advisory 

opinion requests that were submitted 

under an MMA mandate related to an 

18-month moratorium on physician 

referrals to specialty hospitals in which 

they have an ownership interest. We 

need to issue all advisory opinions 

related to the moratorium well before 

the moratorium expires in June 2005. 

We believe that it would be contrary to 

the public interest for us to require 

members of the public to draft and 

submit advisory opinion requests, and 

for us to issue advisory opinions, in the 

absence of any rules to guide the 

process and to increase its efficiency. In 

addition, retroactive reinstatement of 

the rules removes any uncertainty 

regarding whether appropriate 

procedures and standards were followed 

with respect to advisory opinions issued 

after July 26, 2004.

List of Subjects in 42 CFR Part 411 

Kidney diseases, Medicare, Reporting 

and recordkeeping requirements.

■ Accordingly, 42 CFR chapter IV is 

corrected by making the following 

correcting amendments:

PART 411—EXCLUSIONS FROM 

MEDICARE AND LIMITATIONS ON 

MEDICARE PAYMENT

■ 1. The authority citation for part 411 

continues to read as follows:

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395hh).

Subpart J—Financial Relationships 

Between Physicians and Entities 

Furnishing Designated Health Services

■ 2. In Subpart J, §411.370 is added to 

read as follows.

§ 411.370 Advisory opinions relating to 

physician referrals. 

(a) Period during which CMS will 

accept requests. The provisions of 

§ 411.370 through § 411.389 apply to 

requests for advisory opinions that are 

submitted to CMS after November 3, 

1997, and before August 21, 2000, and 

to any requests submitted during any 

other time period during which CMS is 

required by law to issue the advisory 

opinions described in this subpart. 

(b) Matters that qualify for advisory 

opinions and who may request one. Any 

individual or entity may request a 

written advisory opinion from CMS 

concerning whether a physician’s 

referral relating to designated health 

services (other than clinical laboratory 

services) is prohibited under section 

1877 of the Act. In the advisory opinion, 

CMS determines whether a business 

arrangement described by the parties to 

that arrangement appears to constitute a 

‘‘financial relationship’’ (as defined in 

section 1877(a)(2) of the Act) that could 

potentially restrict a physician’s 

referrals, and whether the arrangement 

or the designated health services at 

issue appear to qualify for any of the 

exceptions to the referral prohibition 

described in section 1877 of the Act. 

(1) The request must involve an 

existing arrangement or one into which 

the requestor, in good faith, specifically 

plans to enter. The planned arrangement 

may be contingent upon the party or 

parties receiving a favorable advisory 

opinion. CMS does not consider, for 

purposes of an advisory opinion, 

requests that present a general question 

of interpretation, pose a hypothetical 

situation, or involve the activities of 

third parties. 

(2) The requestor must be a party to 

the existing or proposed arrangement. 

(c) Matters not subject to advisory 

opinions. CMS does not address through 

the advisory opinion process—

(1) Whether the fair market value was, 

or will be, paid or received for any 

goods, services, or property; and 

(2) Whether an individual is a bona 

fide employee within the requirements 

of section 3121(d)(2) of the Internal 

Revenue Code of 1986. 

(d) Facts subject to advisory opinions.

CMS considers requests for advisory 

opinions that involve applying specific 

facts to the subject matter described in 

paragraph (b) of this section. Requestors 

must include in the advisory opinion 

request a complete description of the 

arrangement that the requestor is 

undertaking, or plans to undertake, as 

described in § 411.372. 

(e) Requests that will not be accepted.

CMS does not accept an advisory 

opinion request or issue an advisory 

opinion if—

(1) The request is not related to a 

named individual or entity; 

(2) CMS is aware that the same, or 

substantially the same, course of action 

is under investigation, or is or has been 

the subject of a proceeding involving the 

Department of Health and Human 

Services or another governmental 

agency; or 

(3) CMS believes that it cannot make 

an informed opinion or could only make 

an informed opinion after extensive 

investigation, clinical study, testing, or 

collateral inquiry. 

(f) Effects of an advisory opinion on 

other Governmental authority. Nothing 

in this part limits the investigatory or 

prosecutorial authority of the OIG, the 

Department of Justice, or any other 

agency of the Government. In addition, 

in connection with any request for an 

advisory opinion, CMS, the OIG, or the 

Department of Justice may conduct 

whatever independent investigation it 

believes appropriate.

■ 3. Sections 411.372 and 411.373 are 

added to subpart J to read as follows.

§ 411.372 Procedure for submitting a 

request. 

(a) Format for a request. A party or 

parties must submit a request for an 

advisory opinion to CMS in writing, 

including an original request and 2 

copies. The request must be addressed 

to: Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Office of Financial 

Management, Division of Premium 

Billing and Collections, Mail Stop C3–

09–27, Attention: Advisory Opinions, 

7500 Security Boulevard, Baltimore, MD 

21244–1850. 

(b) Information CMS requires with all 

submissions. The request must include 

the following: 

(1) The name, address, telephone 

number, and Taxpayer Identification 

Number of the requestor.

(2) The names and addresses, to the 

extent known, of all other actual and 

potential parties to the arrangement that 

is the subject of the request. 

(3) The name, title, address, and 

daytime telephone number of a contact 

person who will be available to discuss 

the request with CMS on behalf of the 

requestor. 

(4) A complete and specific 

description of all relevant information 

bearing on the arrangement, including—

57228 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

(i) A complete description of the 

arrangement that the requestor is 

undertaking, or plans to undertake, 

including: the purpose of the 

arrangement; the nature of each party’s 

(including each entity’s) contribution to 

the arrangement; the direct or indirect 

relationships between the parties, with 

an emphasis on the relationships 

between physicians involved in the 

arrangement (or their immediate family 

members who are involved) and any 

entities that provide designated health 

services; the types of services for which 

a physician wishes to refer, and whether 

the referrals will involve Medicare or 

Medicaid patients; 

(ii) Complete copies of all relevant 

documents or relevant portions of 

documents that affect or could affect the 

arrangement, such as personal services 

or employment contracts, leases, deeds, 

pension or insurance plans, financial 

statements, or stock certificates (or, if 

these relevant documents do not yet 

exist, a complete description, to the best 

of the requestor’s knowledge, of what 

these documents are likely to contain); 

(iii) Detailed statements of all 

collateral or oral understandings, if any; 

and 

(iv) Descriptions of any other 

arrangements or relationships that could 

affect CMS’s analysis. 

(5) Complete information on the 

identity of all entities involved either 

directly or indirectly in the 

arrangement, including their names, 

addresses, legal form, ownership 

structure, nature of the business 

(products and services) and, if relevant, 

their Medicare and Medicaid provider 

numbers. The requestor must also 

include a brief description of any other 

entities that could affect the outcome of 

the opinion, including those with which 

the requestor, the other parties, or the 

immediate family members of involved 

physicians, have any financial 

relationships (either direct or indirect, 

and as defined in section 1877(a)(2) of 

the Act and § 411.351), or in which any 

of the parties holds an ownership or 

control interest as defined in section 

1124(a)(3) of the Act. 

(6) A discussion of the specific issues 

or questions the requestor would like 

CMS to address including, if possible, a 

description of why the requestor 

believes the referral prohibition in 

section 1877 of the Act might or might 

not be triggered by the arrangement and 

which, if any, exceptions to the 

prohibition the requestor believes might 

apply. The requestor should attempt to 

designate which facts are relevant to 

each issue or question raised in the 

request and should cite the provisions 

of law under which each issue or 

question arises. 

(7) An indication of whether the 

parties involved in the request have also 

asked for or are planning to ask for an 

advisory opinion on the arrangement in 

question from the OIG under section 

1128D(b) of the Act (42 U.S.C. 1320a–

7d(b)) and whether the arrangement is 

or is not, to the best of the requestor’s 

knowledge, the subject of an 

investigation. 

(8) The certification(s) described in 

§ 411.373. The certification(s) must be 

signed by—

(i) The requestor, if the requestor is an 

individual; 

(ii) The chief executive officer, or 

comparable officer, of the requestor, if 

the requestor is a corporation; 

(iii) The managing partner of the 

requestor, if the requestor is a 

partnership; or 

(iv) A managing member, if the 

requestor is a limited liability company.

(9) A check or money order payable 

to CMS in the amount described in 

§ 411.375(a). 

(c) Additional information CMS might 

require. If the request does not contain 

all of the information required by 

paragraph (b) of this section, or, if either 

before or after accepting the request, 

CMS believes it needs more information 

in order to render an advisory opinion, 

it may request whatever additional 

information or documents it deems 

necessary. Additional information must 

be provided in writing, signed by the 

same person who signed the initial 

request (or by an individual in a 

comparable position), and be certified as 

described in § 411.373.

§ 411.373 Certification. 

(a) Every request must include the 

following signed certification: ‘‘With 

knowledge of the penalties for false 

statements provided by 18 U.S.C. 1001 

and with knowledge that this request for 

an advisory opinion is being submitted 

to the Department of Health and Human 

Services, I certify that all of the 

information provided is true and 

correct, and constitutes a complete 

description of the facts regarding which 

an advisory opinion is sought, to the 

best of my knowledge and belief.’’

(b) If the advisory opinion relates to 

a proposed arrangement, in addition to 

the certification required by paragraph 

(a) of this section, the following 

certification must be included and 

signed by the requestor: ‘‘The 

arrangement described in this request 

for an advisory opinion is one into 

which [the requestor], in good faith, 

plans to enter.’’ This statement may be 

made contingent on a favorable advisory 

opinion, in which case the requestor 

should add one of the following phrases 

to the certification: 

(1) ‘‘if CMS issues a favorable 

advisory opinion.’’

(2) ‘‘if CMS and the OIG issue 

favorable advisory opinions.’’

■ 4. Section 411.375 is added to subpart 

J to read as follows.

§ 411.375 Fees for the cost of advisory 

opinions. 

(a) Initial payment. Parties must 

include with each request for an 

advisory opinion submitted through 

December 31, 1998, a check or money 

order payable to CMS for $250. For 

requests submitted after this date, 

parties must include a check or money 

order in this amount, unless CMS has 

revised the amount of the initial fee in 

a program issuance, in which case, the 

requestor must include the revised 

amount. This initial payment is 

nonrefundable. 

(b) How costs are calculated. Before 

issuing the advisory opinion, CMS 

calculates the costs the Department has 

incurred in responding to the request. 

The calculation includes the costs of 

salaries, benefits, and overhead for 

analysts, attorneys, and others who have 

worked on the request, as well as 

administrative and supervisory support 

for these individuals. 

(c) Agreement to pay all costs. (1) By 

submitting the request for an advisory 

opinion, the requestor agrees, except as 

indicated in paragraph (c)(3) of this 

section, to pay all costs the Department 

incurs in responding to the request for 

an advisory opinion. 

(2) In its request for an advisory 

opinion, the requestor may designate a 

triggering dollar amount. If CMS 

estimates that the costs of processing the 

advisory opinion request have reached 

or are likely to exceed the designated 

triggering dollar amount, CMS notifies 

the requestor. 

(3) If CMS notifies the requestor that 

the actual or estimated cost of 

processing the request has reached or is 

likely to exceed the triggering dollar 

amount, CMS stops processing the 

request until the requestor makes a 

written request for CMS to continue. If 

CMS is delayed in processing the 

request for an advisory opinion because 

of this procedure, the time within which 

CMS must issue an advisory opinion is 

suspended until the requestor asks CMS 

to continue working on the request. 

(4) If the requestor chooses not to pay 

for CMS to complete an advisory 

opinion, or withdraws the request, the 

requestor is still obligated to pay for all 

costs CMS has identified as costs it 

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57229

incurred in processing the request for an 

advisory opinion, up to that point. 

(5) If the costs CMS has incurred in 

responding to the request are greater 

than the amount the requestor has paid, 

CMS, before issuing the advisory 

opinion, notifies the requestor of any 

additional amount that is due. CMS 

does not issue an advisory opinion until 

the requestor has paid the full amount 

that is owed. Once the requestor has 

paid CMS the total amount due for the 

costs of processing the request, CMS 

issues the advisory opinion. The time 

period CMS has for issuing advisory 

opinions is suspended from the time 

CMS notifies the requestor of the 

amount owed until the time CMS 

receives full payment. 

(d) Fees for outside experts. (1) In 

addition to the fees identified in this 

section, the requestor also must pay any 

required fees for expert opinions, if any, 

from outside sources, as described in 

§ 411.377. 

(2) The time period for issuing an 

advisory opinion is suspended from the 

time that CMS notifies the requestor that 

it needs an outside expert opinion until 

the time CMS receives that opinion.

■ 5. Sections 411.377 through 411.380 

are added to subpart J to read as follows.

§ 411.377 Expert opinions from outside 

sources. 

(a) CMS may request expert advice 

from qualified sources if CMS believes 

that the advice is necessary to respond 

to a request for an advisory opinion. For 

example, CMS may require the use of 

accountants or business experts to 

assess the structure of a complex 

business arrangement or to ascertain a 

physician’s or immediate family 

member’s financial relationship with 

entities that provide designated health 

services. 

(b) If CMS determines that it needs to 

obtain expert advice in order to issue a 

requested advisory opinion, CMS 

notifies the requestor of that fact and 

provides the identity of the appropriate 

expert and an estimate of the costs of 

the expert advice. As indicated in 

§ 411.375(d), the requestor must pay the 

estimated cost of the expert advice. 

(c) Once CMS has received payment 

for the estimated cost of the expert 

advice, CMS arranges for the expert to 

provide a prompt review of the issue or 

issues in question. CMS considers any 

additional expenses for the expert 

advice, beyond the estimated amount, as 

part of the costs CMS has incurred in 

responding to the request, and the 

responsibility of the requestor, as 

described in § 411.375(c).

§ 411.378 Withdrawing a request. 

The party requesting an advisory 

opinion may withdraw the request 

before CMS issues a formal advisory 

opinion. This party must submit the 

withdrawal in writing to the same 

address as the request, as indicated in 

§ 411.372(a). Even if the party 

withdraws the request, the party must 

pay the costs the Department has 

expended in processing the request, as 

discussed in § 411.375. CMS reserves 

the right to keep any request for an 

advisory opinion and any 

accompanying documents and 

information, and to use them for any 

governmental purposes permitted by 

law.

§ 411.379 When CMS accepts a request. 

(a) Upon receiving a request for an 

advisory opinion, CMS promptly makes 

an initial determination of whether the 

request includes all of the information 

it will need to process the request. 

(b) Within 15 working days of 

receiving the request, CMS—

(1) Formally accepts the request for an 

advisory opinion; 

(2) Notifies the requestor about the 

additional information it needs; or 

(3) Declines to formally accept the 

request.

(c) If the requestor provides the 

additional information CMS has 

requested, or otherwise resubmits the 

request, CMS processes the 

resubmission in accordance with 

paragraphs (a) and (b) of this section as 

if it were an initial request for an 

advisory opinion. 

(d) Upon accepting the request, CMS 

notifies the requestor by regular U.S. 

mail of the date that CMS formally 

accepted the request. 

(e) The 90-day period that CMS has to 

issue an advisory opinion set forth in 

§ 411.380(c) does not begin until CMS 

has formally accepted the request for an 

advisory opinion.

§ 411.380 When CMS issues a formal 

advisory opinion. 

(a) CMS considers an advisory 

opinion to be issued once it has 

received payment and once the opinion 

has been dated, numbered, and signed 

by an authorized CMS official. 

(b) An advisory opinion contains a 

description of the material facts known 

to CMS that relate to the arrangement 

that is the subject of the advisory 

opinion, and states CMS’s opinion about 

the subject matter of the request based 

on those facts. If necessary, CMS 

includes in the advisory opinion 

material facts that could be considered 

confidential information or trade secrets 

within the meaning of 18 U.S.C. 1095. 

(c)(1) CMS issues an advisory 

opinion, in accordance with the 

provisions of this part, within 90 days 

after it has formally accepted the request 

for an advisory opinion, or, for requests 

that CMS determines, in its discretion, 

involve complex legal issues or highly 

complicated fact patterns, within a 

reasonable time period. 

(2) If the 90th day falls on a Saturday, 

Sunday, or Federal holiday, the time 

period ends at the close of the first 

business day following the weekend or 

holiday; 

(3) The 90-day period is suspended 

from the time CMS’

(i) Notifies the requestor that the costs 

have reached or are likely to exceed the 

triggering amount as described in 

§ 411.375(c)(2) until CMS receives 

written notice from the requestor to 

continue processing the request; 

(ii) Requests additional information 

from the requestor until CMS receives 

the additional information; 

(iii) Notifies the requestor of the full 

amount due until CMS receives 

payment of this amount; and 

(iv) Notifies the requestor of the need 

for expert advice until CMS receives the 

expert advice. 

(d) After CMS has notified the 

requestor of the full amount owed and 

has received full payment of that 

amount, CMS issues the advisory 

opinion and promptly mails it to the 

requestor by regular first class U.S. mail.

■ 6. Section 411.382 is added to subpart 

J to read as follows.

§ 411.382 CMS’s right to rescind advisory 

opinions. 

Any advice CMS gives in an opinion 

does not prejudice its right to reconsider 

the questions involved in the opinion 

and, if it determines that it is in the 

public interest, to rescind or revoke the 

opinion. CMS provides notice to the 

requestor of its decision to rescind or 

revoke the opinion so that the requestor 

and the parties involved in the 

requestor’s arrangement may 

discontinue any course of action they 

have taken in accordance with the 

advisory opinion. CMS does not 

proceed against the requestor with 

respect to any action the requestor and 

the involved parties have taken in good 

faith reliance upon CMS’s advice under 

this part, provided—

(a) The requestor presented to CMS a 

full, complete and accurate description 

of all the relevant facts; and 

(b) The parties promptly discontinue 

the action upon receiving notice that 

CMS had rescinded or revoked its 

approval, or discontinue the action 

within a reasonable ‘‘wind down’’

period, as determined by CMS.

57230 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

■ 7. Section 411.384 is added to subpart 

J to read as follows.

§ 411.384 Disclosing advisory opinions 

and supporting information. 

(a) Advisory opinions that CMS issues 

and releases in accordance with the 

procedures set forth in this subpart are 

available to the public. 

(b) Promptly after CMS issues an 

advisory opinion and releases it to the 

requestor, CMS makes available a copy 

of the advisory opinion for public 

inspection during its normal hours of 

operation and on the DHHS/CMS Web 

site. 

(c) Any predecisional document, or 

part of such predecisional document, 

that is prepared by CMS, the 

Department of Justice, or any other 

Department or agency of the United 

States in connection with an advisory 

opinion request under the procedures 

set forth in this part is exempt from 

disclosure under 5 U.S.C. 552, and will 

not be made publicly available. 

(d) Documents submitted by the 

requestor to CMS in connection with a 

request for an advisory opinion are 

available to the public to the extent they 

are required to be made available by 5 

U.S.C. 552, through procedures set forth 

in 45 CFR part 5. 

(e) Nothing in this section limits 

CMS’s obligation, under applicable 

laws, to publicly disclose the identity of 

the requesting party or parties, and the 

nature of the action CMS has taken in 

response to the request.

■ 8. Sections 411.386 through 411.389 

are added to subpart J to read as follows.

§ 411.386 CMS’s advisory opinions as 

exclusive. 

The procedures described in this 

subpart constitute the only method by 

which any individuals or entities can 

obtain a binding advisory opinion on 

the subject of a physician’s referrals, as 

described in § 411.370. CMS has not and 

does not issue a binding advisory 

opinion on the subject matter in 

§ 411.370, in either oral or written form, 

except through written opinions it 

issues in accordance with this subpart.

§ 411.387 Parties affected by advisory 

opinions. 

An advisory opinion issued by CMS 

does not apply in any way to any 

individual or entity that does not join in 

the request for the opinion. Individuals 

or entities other than the requestor(s) 

may not rely on an advisory opinion.

§ 411.388 When advisory opinions are not 

admissible evidence. 

The failure of a party to seek or to 

receive an advisory opinion may not be 

introduced into evidence to prove that 

the party either intended or did not 

intend to violate the provisions of 

sections 1128, 1128A or 1128B of the 

Act.

§ 411.389 Range of the advisory opinion. 

(a) An advisory opinion states only 

CMS’s opinion regarding the subject 

matter of the request. If the subject of an 

advisory opinion is an arrangement that 

must be approved by or is regulated by 

any other agency, CMS’s advisory 

opinion cannot be read to indicate 

CMS’s views on the legal or factual 

issues that may be raised before that 

agency. 

(b) An advisory opinion that CMS 

issues under this part does not bind or 

obligate any agency other than the 

Department. It does not affect the 

requestor’s, or anyone else’s, obligations 

to any other agency, or under any 

statutory or regulatory provision other 

than that which is the specific subject 

matter of the advisory opinion.

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program)

Dated: September 15, 2004. 

Ann Agnew, 

Executive Secretary to the Department.

[FR Doc. 04–21206 Filed 9–23–04; 8:45 am] 

BILLING CODE 4120–01–P

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 1 

[OMD Docket No. 02–339; FCC 04–72] 

Implementation of the Debt Collection 

Improvement Act of 1996 and Adoption 

of Rules Governing Applications or 

Requests for Benefits by Delinquent 

Debtors

AGENCY: Federal Communications 

Commission.

ACTION: Final rule; correction.

SUMMARY: This document contains a 

correction to the final rule, which was 

published in the Federal Register at 69 

FR 27843 on May 17, 2004. The final 

rule related to the Debt Collection 

Improvement Act of 1996 (DCIA).

DATES: Effective on October 1, 2004.

FOR FURTHER INFORMATION CONTACT:

Regina W. Dorsey, Special Assistant to 

the Chief Financial Officer, at 1–202–

418–1993, or by e-mail at 

Regina.Dorsey@fcc.gov, or Laurence H. 

Schecker, Office of General Counsel, 

Administrative Law Division, at 1–202–

418–1720, or by e-mail at 

Laurence.Schecker@fcc.gov.

SUPPLEMENTARY INFORMATION: In FR Doc 

04–10661, in the Federal Register of 

Monday, May 17, 2004, the following 

corrections are made.

§ 1.1116 [Corrected]

■ 1. On page 27847, in the third column, 

in § 1.1116, the reference to 

‘‘§ 1.1109(b)’’ is corrected to read 

‘‘§ 1.1109(d)’’.

■ 2. On page 27850, in the third column, 

§ 1.1910 is corrected to read as follows:

§ 1.1910 Effect of insufficient fee 

payments, delinquent debts, or debarment. 

(a)(1) An application (including a 

petition for reconsideration or any 

application for review of a fee 

determination) or request for 

authorization subject to the FCC 

Registration Number (FRN) requirement 

set forth in subpart W of this chapter 

will be examined to determine if the 

applicant has paid the appropriate 

application fee, appropriate regulatory 

fees, is delinquent in its debts owed the 

Commission, or is debarred from 

receiving Federal benefits (see, e.g., 31 

CFR 285.13; 47 CFR part 1, subpart P). 

(2) Fee payments, delinquent debt, 

and debarment will be examined based 

on the entity’s taxpayer identifying 

number (TIN), supplied when the entity 

acquired or was assigned an FRN. See 

47 CFR 1.8002(b)(1). 

(b)(1) Applications by any entity 

found not to have paid the proper 

application or regulatory fee will be 

handled pursuant to the rules set forth 

in 47 CFR part 1, subpart G. 

(2) Action will be withheld on 

applications, including on a petition for 

reconsideration or any application for 

review of a fee determination, or 

requests for authorization by any entity 

found to be delinquent in its debt to the 

Commission (see § 1.1901(j)), unless 

otherwise provided for in this 

regulation, e.g., 47 CFR 1.1928 

(employee petition for a hearing). The 

entity will be informed that action will 

be withheld on the application until full 

payment or arrangement to pay any nontax delinquent debt owed to the 

Commission is made and/or that the 

application may be dismissed. See the 

provisisons of §§ 1.1108, 1.1109, 1.1116 

and 1.1118. Any Commission action 

taken prior to the payment of delinquent 

non-tax debt owed to the Commission is 

contingent and subject to recission. 

Failure to make payment on any 

delinquent debt is subject to collection 

of the debt, including interest thereon, 

any associated penalties, and the full 

cost of collection to the Federal 

government pursuant to the provisions 

of the Debt Collection Improvement Act, 

31 U.S.C. 3717.