59818 Federal Register / Vol. 62, No. 214 / Wednesday, November 5, 1997 / Rules and Regulations

these situations, the total minimum number

of required lead NAMS is one.

* * * * *

6. References.

* * * * *

6. Lead Guideline Document, U.S.

Environmental Protection Agency, Research

Triangle Park, NC. EPA–452/R–93–009.

7. Air Quality Criteria for Lead. Office of

Research and Development, U.S.

Environmental Protection Agency,

Washington, DC. EPA–600/8–83–028 aF—dF,

1986, and supplements EPA–600/8–89/049F,

August 1990. (NTIS document numbers

PB87–142378 and PB91–138420.)

* * * * *

10. ‘‘Guidance for Conducting Ambient Air

Monitoring for Lead Around Point Sources,’’

Office of Air Quality Planning and Standards,

U.S. Environmental Protection Agency,

Research Triangle Park, NC EPA–454/R–92–

009, May 1997.

* * * * *

19. National Air Pollutant Emissions

Trends, 1900–1995, Office of Air Quality

Planning and Standards, U.S. Environmental

Protection Agency, Research Triangle Park,

NC. EPA–454/R96–007, October 1996,

updated annually.

* * * * *

6. Appendix E is amended by revising the

first paragraph of section 7.1, adding a

sentence at the beginning of section 7.3,

revising section 7.4, and revising reference 18

in section 13 to read as follows:

Appendix E—Probe and Monitoring

Path Siting Criteria for Ambient Air

Quality Monitoring

* * * * *

7.1 Vertical Placement. Optimal

placement of the sampler inlet for Pb

monitoring should be at breathing height

level. However, practical factors such as

prevention of vandalism, security, and safety

precautions must also be considered when

siting a Pb monitor. Given these

considerations, the sampler inlet for

microscale Pb monitors must be 2–7 meters

above ground level. The lower limit was

based on a compromise between ease of

servicing the sampler and the desire to avoid

unrepresentative conditions due to reentrainment from dusty surfaces. The upper

limit represents a compromise between the

desire to have measurements which are most

representative of population exposures and a

consideration of the practical factors noted

above.

* * * * *

7.3. Spacing from Roadways. This criteria

applies only to those Pb sites designed to

assess lead concentrations from mobile

sources. Numerous studies have shown that

ambient Pb levels near mobile sources are a

function of the traffic volume and are most

pronounced at ADT >30,000 within the first

15 meters on the downwind side of the

roadways. * * *

7.4. Spacing from trees and other

considerations. Trees can provide surfaces

for deposition or adsorption of Pb particles

and obstruct normal wind flow patterns. For

microscale and middle scale category (a) sites

there must not be any tree(s) between the

source of the Pb and the sampler. For

neighborhood scale category (b) sites, the

sampler should be at least 20 meters from the

drip line of trees. The sampler must,

however, be placed at least 10 meters from

the drip line of trees which could be

classified as an obstruction, i.e., the distance

between the tree(s) and the sampler is less

than the height that the tree protrudes above

the sampler.

* * * * *

13. References.

* * * * *

18. Air Quality Criteria for Lead. Office of

Research and Development, U.S.

Environmental Protection Agency,

Washington, DC EPA–600/8–83–028 aF–dF,

1986, and supplements EPA–600/8–89/049F,

August 1990. (NTIS document numbers

PB87–142378 and PB91–138420.)

* * * * *

7. Section 1 and section 2b of

Appendix G are revised to read as

follows:

Appendix G—Uniform Air Quality

Index and Daily Reporting

* * * * *

1. General. This appendix describes

the uniform air quality index to be used

by States in reporting the daily air

quality index required by § 58.50.

2. Definitions.

* * * * *

b. Reporting Agency means the

applicable State agency or a local air

pollution control agency designated by

the State, that will carry out the

provisions of § 58.50.

* * * * *

[FR Doc. 97–29294 Filed 11–4–97; 8:45 am]

BILLING CODE 6560–50–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 424

[BPD–875–NC]

Medicare Program; Home Health

Agency Physician Certification

Regulations

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Decision to reexamine

interpretations, with comment.

SUMMARY: This document with comment

period announces our decision to

reexamine our recent interpretations of

the Medicare regulations pertaining to

indirect compensation arrangements

between home health agencies (HHAs)

and physicians who certify or recertify

the need for home health services or

establish or review the home health

plan of care. We are withdrawing recent

interpretations regarding indirect

compensation arrangements where the

physicians are salaried employees of, or

have a contractual arrangement to

provide services for, an entity that also

owns the HHA. This will enable us to

evaluate our recent interpretations of

these regulations and related provisions

of section 1877 of the Social Security

Act to ensure consistent application of

Medicare policy among providers of

services.

DATES: Effective Date: This document is

effective on December 5, 1997.

Comment Date: Written comments

will be considered if we receive them at

the appropriate address, as provided

below, no later than 5:00 p.m. on

January 5, 1998.

ADDRESSES: Mail written comments (an

original and three copies) to the

following address: Health Care

Financing Administration, Department

of Health and Human Services,

Attention: BPD–875–NC, P.O. Box 7517,

Baltimore, MD 21244–0517.

If you prefer, you may deliver your

written comments (an original and three

copies) to one of the following

addresses:

Room 309–G, Hubert H. Humphrey

Building, 200 Independence Avenue,

SW, Washington, DC 20201 or

C5–09–26, 7500 Security Boulevard,

Baltimore, MD 21244–1850.

Because of staffing and resource

limitations, we cannot accept comments

by facsimile (FAX) transmission. In

commenting, please refer to file code

BPD–875–NC. Comments received

timely will be available for public

inspection as they are received,

generally beginning approximately 3

weeks after publication of a document,

in Room 309–G of the Department’s

offices at 200 Independence Avenue,

SW, Washington, DC, on Monday

through Friday of each week from 8:30

a.m. to 5 p.m. (phone: (202) 690–7890).

Copies: To order copies of the Federal

Register containing this document, send

your request to: New Orders,

Superintendent of Documents, P.O. Box

371954, Pittsburgh, PA 15250–7954.

Specify the date of the issue requested

and enclose a check or money order

payable to the Superintendent of

Documents, or enclose your Visa or

Master Card number and expiration

date. Credit card orders can also placed

by calling the order desk at (202) 512–

1800 or by faxing to (202) 512–2250.

The cost of each copy is $8.00. As an

alternative, you can view and

photocopy the Federal Register

document at most libraries designated
Federal Register / Vol. 62, No. 214 / Wednesday, November 5, 1997 / Rules and Regulations 59819

as Federal Depository Libraries and at

many other public and academic

libraries throughout the country that

receive the Federal Register.

FOR FURTHER INFORMATION CONTACT:

Jennifer Carter, (410) 786–4615.

SUPPLEMENTARY INFORMATION:

I. Background

Section 903 of the Omnibus

Reconciliation Act of 1980 amended

sections 1814(a) and 1835(a) of the

Social Security Act (the Act) to prohibit

the certification of need for home

healthy services under Medicare, and

the establishment and review of a home

health plan of care for those services, by

a physician who has a significant

interest in, or a significant contractual

or significant financial relationship

with, the HHA that provides those

services. These amendments were

incorporated into the regulations at 42

CFR 405.1633(d) (which was

redesignated as § 424.22(d)), by an

interim final rule with comment period

that was published in the Federal

Register on October 26, 1982 (47 FR

47388), and was made effective on

November 26, 1992.

On June 30, 1986, we published a

final rule in the Federal Register (51 FR

23541) that confirmed the provisions of

the October 1982 rule, and clarified that

under the term, ‘‘significant interest or

a significant financial or contractual

relationship’’ with the HHA, we

intended to include salaried

employment. This clarification was

made effective on August 29, 1986.

The only exceptions to the home

health regulations were uncompensated

officers or directors of an HHA, HHAs

operated by Federal, State, or local

governmental authority, and sole

community HHAs. The home health

physician certification restrictions of

sections 1814(a) and 1835(a) of the Act

and § 424.22(d) of the regulations have

not been revised or updated since 1986.

On December 19, 1989, section 6204

of the Omnibus Budget Reconciliation

Act of 1989 added section 1877,

‘‘Limitation on Certain Physician

Referrals,’’ to the Act. In general, section

1877 of the Act prohibits a physician

who has a financial relationship with an

entity that furnishes clinical laboratory

services (or a physician with an

immediate family member who had

such a relationship) from making

referrals to the entity for clinical

laboratory services for which Medicare

may otherwise pay.

On August 10, 1993, section 13562 of

the Omnibus Budget Reconciliation Act

of 1993 (OBRA ’93) revised section 1877

of the Act to cover 10 additional

designated health services, including

home health services, beginning with

referrals made after December 31, 1994.

The statute was also revised to provide

for certain exceptions to the prohibition,

including a bona fide employment

exception subject to certain conditions.

Additionally, referrals are defined in

part to include the request or

establishment of a plan of care by a

physician which includes the provision

of a plan of care by a physician which

includes the provision of a designated

health service. On August 14, 1995, we

published a final rule with comment in

the Federal Register (60 FR 41914) to

implement the amendments of OBRA

’93 that apply to referrals for clinical

laboratory services and which were

effective retroactively to January 1,

1992. In this final rule we indicated our

intention to rely on the language and

interpretations of the final rule when

reviewing referrals in appropriate cases

for the 10 designated health services.

Appropriate cases were defined as those

in which our interpretation of the

statute clearly applied equally to

clinical laboratory services and other

designated health services. We are

currently developing a proposed rule to

implement the provisions of section

1877 of the Act which were effective

January 1, 1995, and relate to the

additional designated health services.

It is our intention to reconcile the

statutory prohibitions in sections

1814(a) and 1835(a) of the Act

concerning physician certification of

home health services with the related

section 1877 prohibitions as part of the

proposed regulations implementing the

OBR ’93 changes to section 1877. This

proposed regulation is in the final stages

of development and should be

published in the very near future.

In the meantime, we have received

numerous inquiries about the

applicability of the current home health

prohibitions at § 424.22 regarding

hospital-employed physicians certifying

and recertifying the need for home

health services provided by the

hospital-owned HHA. We recently

released an interpretation of

§ 424.22(d)(3)(ii) and indirect

compensation in the case where a

physician is employed by the hospital

that also owns the HHA. In that

interpretation of § 424.22, we stated that

hospital-employed physicians are

prohibited from certifying or

recertifying the need for home health

services for the hospital-owned HHA.

Furthermore, we stated that if the HHA

is separately incorporated and not

included on the hospital’s cost report,

the hospital-employed physicians are

permitted to certify or recertify the need

for home health services for the

hospital-owned HHA. We also released

an interpretation that indicated that

payment of compensation to a physician

by the HHA’s parent or related

organization would very likely be

considered to be paid by the HHA.

As we begin to reconcile the home

health prohibitions with the section

1877 prohibitions, we have concluded

that our recent interpretations of this

regulation have brought about

unintended consequences affecting rural

areas, integrated delivery systems, and

current medical practice and may be

inconsistent with the provisions of

section 1877. Therefore, we are going to

address ‘‘indirect compensation’’ and

the relationship between the HHA

regulations and the section 1877

provisions in the separate proposed rule

that is in the final stages of development

and should be published in the very

near future. We will address the scope

of an indirect compensation

arrangement where the physicians are

salaried employees of, or have a

contractual arrangement to provide

services for, the entity that owns the

HHA in that proposed regulation. In the

meantime, we withdraw these recent

interpretations concerning indirect

compensation under § 424.22(d).

II. Purpose of This Notice

We have decided to reexamine

appropriate provisions of section 1877

of the Act and the home health

regulations as they pertain to indirect

compensation arrangements between

physicians and home health agencies.

We are concerned with the situation in

which the physician receives

compensation from the same entity that

also owns the home health agency.

Pending that evaluation, we have

decided to withdraw recent

interpretations of § 424.22(d)(3)(ii) as it

applies to certification and

recertification or establishment and

review of plans of care by physicians

who are salaried employees of, or have

a contractual arrangement to provide

services for, an entity that also owns the

HHA. Instead, we will address the issue

of indirect compensation, applicable to

the health services specified in section

1877 of the Act, in the proposed rule

that is in the final stages of development

and should be published in the Federal

Register in the very near future. In the

meantime, we withdraw these recent

interpretations concerning indirect

compensation under 424.22(d).

We remain concerned about

inappropriate physician certification for

home health services. However, we are

also concerned about the effect that the

recent interpretations of the home
59820 Federal Register / Vol. 62, No. 214 / Wednesday, November 5, 1997 / Rules and Regulations

health regulation at § 424.22(d)(3)(ii), as

it applies to indirect salaried

employment or contractual

arrangements, may have on rural areas

where the hospital or other entity is so

pervasive a presence in the community

that, in addition to owning the home

health agency, it also employs the

majority of the physicians.

We have asked the Medicare fiscal

intermediaries to cooperate with the

Office of Inspector General to look into

the referral patterns of hospitals that

own facilities providing ancillary

services, including home health

services.

III. Other Required Information

A. Executive Order 12866 Review

In accordance with provisions of

Executive Order 12866, this notice with

comment period was received by the

Office of Management and Budget.

B. Collection of Information

Requirements

This notice with comment period

does not impose information collection

and recordkeeping requirements.

Consequently, it need not be reviewed

by the Office of Management and

Budget for purposes of the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501

et seq.).

C. Response to Comments

Because of the large number of items

of correspondence we normally receive

on Federal Register documents

published for comment, we are not able

to acknowledge or respond to them

individually. We will consider all

comments we receive by the date and

time specified in the DATES section of

this notice, and, if we proceed with a

subsequent document, we will respond

to the comments in that document.

(Authority: Secs. 1102, 1814(a), 1835(a),

1871, and 1877 of the Social Security Act (42

U.S.C. 1302, 1395f(a), 1395(a), 1395hh, and

1395nn))

(Catalog of Federal Domestic Assistance

Program No. 93.773 Medicare—Hospitals

Insurance Program; and Program No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: October 17, 1997.

Nancy-Ann Min DeParle,

Deputy Administrator, Health Care Financing

Administration.

Dated: October 23, 1997.

Donna E. Shalala,

Secretary.

[FR Doc. 97–29071 Filed 11–4–97; 8:45 am]

BILLING CODE 4120–01–M

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

43 CFR Part 1860

[WO–350–1220–00–24 1A]

RIN 1004–AC–88

Patent Preparation and Issuance

AGENCY: Bureau of Land Management,

Interior.

ACTION: Final rulemaking.

SUMMARY: This final rule amends part

1860 of Title 43 of the Code of Federal

Regulations (CFR) to completely remove

subpart 1862, which contains internal

instructions on preparing and issuing

patents. The Bureau of Land

Management (BLM) plans to place these

procedures in an existing BLM Manual/

Handbook, a more appropriate location

than the CFR. The public will have

access to the material.

EFFECTIVE DATE: December 5, 1997.

FOR FURTHER INFORMATION CONTACT:

Vanessa Engle, Lands and Realty Group,

Bureau of Land Management, 1849 C

Street, N.W., Washington, DC 20240;

Telephone (202) 452–7776 (Commercial

or FTS).

SUPPLEMENTARY INFORMATION:

I. Background

II. Response to Comments

III. Discussion of Final Rule

IV. Procedural Matters

I. Background

The existing regulation at 43 CFR part

1862 has no requirements with which

the public must comply. Instead, it

contains internal instructions on

preparing and issuing patents, which

properly should be in manuals and

handbooks. For this reason, BLM

published a Notice of Proposed

Rulemaking in the August 16, 1996,

Federal Register (61 FR 42579), to

advise the public of its plans to

completely remove subpart 1862 from

43 CFR and place the material in the

BLM Manual/Handbook. We invited

public comments for 30 days and

received comments from a mining

association. We have considered the

association’s comments in preparing the

final rule.

II. Response to Comments

The commenter opposed the proposed

rule because it neither indicated where

in BLM’s policy manuals and

handbooks the regulation would reside

nor whether the instructions would

remain the same or change.

Changes to the proposed rule, based

on this comment, are not necessary.

BLM will not make any substantive

alterations to the instructions but will

update them before they are placed in

the existing BLM Manual/Handbook,

which currently is being updated to

ensure continuity of the subpart 1862

instructions. Under the heading of

subpart 1862, the manual/handbook

will go into considerable detail on the

requirements for preparing and issuing

patents. In addition to the information

previously contained in subpart 1862,

the manual will include sections on

different types of patents, specific

language to be included in patents,

directions on how to correctly format

and number patents and other

particulars. BLM will not remove any of

the requirements previously found in 43

CFR part 1862.

III. Discussion of Final Rule

This final rule completely removes

Subpart 1862 of Title 43 CFR, which

provides internal instructions on

preparing and issuing patents. BLM is

issuing the rule without change from the

August 16, 1996, Notice of Proposed

Rulemaking. This action meets one of

the objectives of President Clinton’s

Government-wide regulatory reform

initiative—to eliminate unnecessary

regulations from the CFR.

IV. Procedural Matters

National Environmental Policy Act of

1969

BLM has prepared an environmental

assessment (EA), and has found that the

final rule would not constitute a major

Federal action significantly affecting the

quality of the human environment

under section 102(2)(C) of the National

Environmental Policy Act of 1969

(NEPA), 42 U.S.C. 432(2)(C). BLM has

placed the EA and the Finding of No

Significant Impact (FONSI) on file in the

BLM Administrative Record, 1620 L

Street, NW, Room 401, Washington, DC,

during regular business hours, 7:45 a.m.

to 4:15 p.m. Monday through Friday.

Paperwork Reduction Act

This final rule does not contain

information collection requirements that

the Office of Management and Budget

must approve under the Paperwork

Reduction Act, 44 U.S.C. 3501.

Regulatory Flexibility Act

BLM has determined that the final

rule, which merely removes

unnecessary regulations, will not have a

significant economic impact on a

substantial number of small entities

within the meaning of the Regulatory

Flexibility Act (5 U.S.C. 601 et seq.)