Federal Register / Vol. 62, No. 159 / Monday, August 18, 1997 / Rules and Regulations 43931

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 117

[CGD09–97–014]

RIN 2115–AE47

Drawbridge Operation Regulations;

Manistee River, MI

AGENCY: Coast Guard, DOT.

ACTION: Final rule.

SUMMARY: The Coast Guard is revising

the regulation governing the operations

of the Maple Street bridge and U.S.

Route 31 bridge, miles 1.1 and 1.4,

respectively, over the Manistee River in

Manistee, MI. This revision was made at

the behest of recreational vessel owners

on Manistee River to provide for better

bridge operating hours during

navigation season.

DATES: This regulation is effective

September 17, 1997.

ADDRESSES: Documents concerning this

regulation are available for inspection

and copying at 1240 East Ninth Street,

Room 2019, Cleveland, OH 44199–2060

between 6:30 a.m. and 3 p.m., Monday

through Friday, except Federal holidays.

The telephone number is (216) 902–

6084.

FOR FURTHER INFORMATION CONTACT: Mr.

Scot M. Striffler, Project Manager,

Bridge Branch at (216) 902–6084.

SUPPLEMENTARY INFORMATION:

Regulatory History

The Coast Guard published a notice of

proposed rulemaking (NPRM) and

temporary deviation from regulations

which appeared in the Federal Register

on Thursday, May 22, 1997 (62 FR

27962 and 27990). The proposed

schedule was submitted by the city of

Manistee, MI at the request of

recreational vessel users to provide later

bridge operating hours. Under current

regulations, between May 1 and October

31 each year, the bridge is required to

open on signal for recreational vessels

between 6 a.m. and 10 p.m. The revised

regulation will require the bridge to

open on signal between the hours of 7

a.m. and 11 p.m. No comments were

received in response to either of the

notices. A public hearing was not

requested and, therefore, was not held.

The Coast Guard determined that the

revised schedule fulfills the needs of

recreational boating traffic on Manistee

River without adversely impacting

regular commercial users. Therefore, the

final rule is unchanged from the NPRM.

Regulatory Evaluation

This rule is not a significant

regulatory action under section 3(f) of

Executive Order 12866 and does not

require an assessment of potential costs

and benefits under section 6(a)(3) of that

order. It has been exempted from review

by the Office of Management and

Budget under that order. It is not

significant under the regulatory policies

and procedures of the Department of

Transportation (DOT) (44 FR 11040,

February 26, 1979).

The Coast Guard expects the

economic impact of this rule to be so

minimal that a full Regulatory

Evaluation under paragraph 10e of the

regulatory policies and procedures of

DOT is unnecessary.

Small Entities

Under the Regulatory Flexibility Act

(5 U.S.C. 601 et seq.), the Coast Guard

must consider whether this rule will

have a significant economic impact on

a substantial number of small entities.

Small entities include independently

owned and operated small businesses

that are not dominant in their field and

otherwise qualify as ‘‘small business

concerns’’ under section 3 of the Small

Business Act (15 U.S.C. 632). The

revised operating hours were requested

by the City of Manistee on behalf of

recreational boaters and the businesses

that serve them on Manistee River. This

rule was designed to enhance the

economic potential of businesses on

Manistee River while still providing for

the reasonable needs of commercial

navigation.

By virtue of the preceding, the Coast

Guard certifies under 5 U.S.C. 605(b)

that this rulemaking will not have a

significant impact on a substantial

number of small entities.

Collection of Information

This rule contains no collection of

information requirements under the

Paperwork Reduction Act (44 U.S.C.

3501 et seq.).

Federalism

The Coast Guard has analyzed this

rule under the principles and criteria

contained in Executive Order 12612 and

has determined that this rule does not

have sufficient federalism implications

to warrant the preparation of a

Federalism Assessment.

Environment

The Coast Guard considered the

environmental impact of this rule and

concluded that, under section

2.B.2.e.(32)(e) of Commandant

Instruction M16475.1B, promulgation of

operating requirements or procedures

for drawbridges is categorically

excluded from further environmental

documentation.

List of Subjects in 33 CFR Part 117

Bridges.

For reasons set out in the preamble,

part 117 of Title 33, Code of Federal

Regulations, is amended as follows:

PART 117—DRAWBRIDGE

OPERATION REGULATIONS

1. The authority citation for part 117

continues to read as follows.

Authority: 33 U.S.C. 499; 49 CFR 1.46; 33

CFR 1.05–1(g); Section 117.255 also issued

under the authority of Pub. L. 102–587, 106

Stat. 5039.

2. Section 117.637 is amended by

revising paragraph (a)(1) to read as

follows:

§ 117.637 Manistee River.

(a) * * *

(1) From May 1 through October 31,

between 7 a.m. to 11 p.m., the bridges

shall open on signal. From 11 p.m. to 7

a.m., the bridges need not open unless

notice is given at least two hours in

advance of a vessel’s time of intended

passage through the draws.

* * * * *

Dated: August 8, 1997.

J.F. McGowan,

Rear Admiral, U.S. Coast Guard, Commander,

Ninth Coast Guard District.

[FR Doc. 97–21813 Filed 8–15–97; 8:45 am]

BILLING CODE 4910–14–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

42 CFR Parts 431, 442, 488, 489, and

498

[HSQ–139–F]

RIN 0938–AC88

Medicare and Medicaid Programs:

Effective Dates of Provider

Agreements and Supplier Approvals

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Final rule.

SUMMARY: This rule establishes uniform

criteria for determining the effective

dates of Medicare and Medicaid

provider agreements and of the approval

of Medicare suppliers when the

provider or supplier is subject to survey

and certification as a basis for

determining participation in those

programs. It also establishes appeal
43932 Federal Register / Vol. 62, No. 159 / Monday, August 18, 1997 / Rules and Regulations

rights and procedures for entities that

are dissatisfied with effective date

determinations.

DATES: Effective date: This rule is

effective September 17, 1997.

FOR FURTHER INFORMATION CONTACT:

Diane Bavaria, (410) 786–6773 or

Sandra Farragut, (410) 786–3503.

SUPPLEMENTARY INFORMATION:

A. Background

Under sections 1866 and 1902 of the

Social Security Act (the Act), providers

of services seeking to participate in

Medicare or Medicaid must enter into

an agreement with the Secretary or the

State Medicaid agency, as appropriate.

Under HCFA rules, suppliers of

Medicare services must be approved for

coverage of the services they furnish to

Medicare beneficiaries.

Generally, in order to enter into a

provider agreement or obtain approval

as a supplier, an entity must first be

surveyed by HCFA or the State survey

agency to ascertain whether it complies

with the conditions of participation,

conditions for coverage, or long-term

care requirements. However, under

section 1865 of the Act, HCFA may

‘‘deem’’ that an entity meets the Federal

requirements if that entity is accredited

by a national accrediting organization

whose program is approved by HCFA.

Medicare or Medicaid payment may

not be made for services furnished

before the effective date of the provider

agreement or supplier approval.

B. Notice of Proposed Rulemaking

On October 8, 1992, we published a

Notice of Proposed Rulemaking (at 57

FR 46362) to establish uniform criteria

for determining the effective date of

provider agreements and supplier

approvals. We received 6 letters of

comment from two States, one health

care association, the Small Business

Administration, one lawyer, and one

citizen. Those comments and our

responses to them are detailed below.

C. Discussion of Comments

1. Level of Compliance

Comment: One commenter noted that

the proposed rule was not consistent

with Federal statutes that require full

compliance for skilled nursing facilities

(SNFs) and nursing facilities (NFs) or

automatic termination within 6 months

after survey. The commenter disagreed

with our references to level A and level

B requirements, and the provision that

would permit initial certification of

SNFs and NFs that have lower level

deficiencies.

Response: As noted by the

commenter, under the Omnibus Budget

Reconciliation Act of 1987 (OBRA ’87),

we must, for SNFs and NFs, replace our

hierarchical requirement scheme

(condition level or level A, and standard

level or level B) with a scheme built on

the premise that all requirements must

be met and enforced. However, because

the final rule for implementing the

OBRA ’87 amendments had not been

published, we had to continue using the

hierarchical ‘‘level A and Level B’’

scheme in the proposed rule.

A final rule identified as HSQ–156–F,

published on November 10, 1994 (at 59

FR 56116) implemented the OBRA ’87

amendments. That rule—

• Establishes a revised enforcement

system that detects and responds to

noncompliance with any of the

requirements, as opposed to the

previous system which provided for

adverse action only when the

noncompliance was with level A

requirements;

• Establishes the concept of

‘‘substantial compliance’’ as the

criterion that SNFs and NFs must meet

in order to participate in Medicare and

Medicaid, and defines the term;

• Provides for termination of any SNF

or NF that does not achieve substantial

compliance within 6 months from the

date of survey; and

• Removes references to ‘‘level A and

level B’’ requirements.

Regarding the issue of allowing

participation by an SNF or NF that has

minor deficiencies, we believe that it is

impractical and unrealistic to require

perfect compliance. In fact, in 1992,

only 7.3 percent of all SNFs and NFs

surveyed were deficiency-free. Under

the previous enforcement system

defined by ‘‘level A’’ and ‘‘level B’’

requirements, most of the facilities that

were experiencing only minor problems

could continue to participate because

the system allowed for some

noncompliance at the lower or ‘‘B’’

level. That is no longer the case. By

vastly increasing the number of

statutory requirements that SNFs and

NFs must meet, and by requiring us to

do away with the hierarchy of

requirements, Congress made it far more

difficult for the facilities to qualify for

program participation. We do not

believe that Congress intended to write

into law a set of requirements that

would preclude almost all SNFs and

NFs from participating in Medicare and

Medicaid. Therefore, we have defined

‘‘substantial compliance’’ as a degree of

compliance such that any existing

deficiencies have not caused actual

harm and do not create the potential for

more than minimal harm to a resident.

This definition is consistent with the

statutory focus on resident outcomes as

opposed to procedural requirements

that do not always accurately measure

whether quality care is being furnished.

Although an SNF or NF that falls short

of total compliance may escape

imposition of a remedy, it still has a

duty to provide, to each resident, care

that enhances the chances of positive

outcomes and avoids negative

outcomes. If a single resident

experiences any harm, the facility has

not satisfied its statutory obligations.

Given the statute’s focus on each

resident’s right to receive quality care,

and the facility’s obligation to provide

it, we could not adopt a less rigorous

standard of compliance. (The preamble

to HSQ–156–F contained a more

detailed discussion of the background

and rationale for the ‘‘substantial

compliance’’ concept.)

However, precisely because the new

standard is more stringent than its

predecessor, it follows that once an SNF

or NF achieves ‘‘substantial

compliance’’, it has demonstrated its

capacity for participation in the

programs. Thus, if the survey finds that

the facility is in ‘‘substantial

compliance’’, the provider agreement is

effective on the date the survey is

completed. If we require the SNF or NF

to submit a plan of correction for

whatever requirements it does not fully

meet, that does not delay the effective

date of the agreement. If the facility

needs a waiver, current practice remains

unchanged, and the effective date is

delayed until we receive an approvable

waiver request.

2. Appeals and Payment

Comment: One commenter expressed

the opinion that the proposed rule

would not change the basic procedures

for determining effective date, but

merely add an appeal mechanism. The

commenter understood the appeals

provisions to mean that—

• Payment to a new provider would

continue during the pendency of an

appeal; and

• If the hearing decision changed the

effective date, payments would be

effective as of the new date.

Response: We agree that the

procedures for determining effective

date remain essentially unchanged

except for the new ‘‘substantial

compliance’’ concept for SNFs and NFs.

For other providers, the rule continues

to be that the effective date is the earlier

of the date on which the provider meets

all requirements or the date on which it

meets all condition level requirements

(or conditions for coverage in the case

of suppliers) and has an acceptable plan

of correction for standard level
Federal Register / Vol. 62, No. 159 / Monday, August 18, 1997 / Rules and Regulations 43933

deficiencies or an approvable waiver

request, or both.

To preclude any confusion

concerning the determination of

effective date when it is related to a plan

of correction or waiver request, we

revised the rule to state that the effective

date of the agreement or approval is the

date that the State or HCFA receives (as

opposed to the date the facility submits)

the acceptable plan or approvable

waiver request.

The commenter is correct in

interpreting that payment would be

made, during pendency of the appeal,

for services furnished on or after the

effective date of the agreement or

approval; and would be adjusted to the

new effective date determined by the

hearing decision.

3. Effective Date When Facility Is

Accredited Before It Seeks Participation

Comment: Two commenters were

concerned about how the proposed rule

would be applied when a facility had

already been accredited by an

accrediting organization. The proposed

rule would not allow the provider to

enter into a retroactive agreement so

that it could receive payment for

services furnished after accreditation

but before it sought participation in

Medicare or Medicaid. The commenters

stated that this situation commonly

arises when a provider that has been

surveyed and found to be in compliance

with Federal requirements—

• Is participating in its own State’s

Medicaid program and provides services

to a Medicaid recipient from another

State; or

• Is not participating in Medicaid but

provides services to a Medicaid

recipient before learning of the

individual’s Medicaid status.

Response: We consider the concerns

to be justified. Accordingly, we have

revised § 431.108 (content previously

contained in § 442.13) and § 489.13 to

provide that an agreement or approval

may be made retroactive for a provider

or supplier that—

• Has been deemed to meet all

applicable Federal requirements on the

basis of accreditation by an accrediting

organization whose program had HCFA

approval at the time the organization

surveyed and accredited the provider or

supplier; and

• Meets all applicable State licensure

and Life Safety Code requirements.

Specifically, the final rule provides

that the effective date of an agreement

or approval can be made retroactive for

up to one year to encompass dates on

which the provider or supplier

furnished covered services to a

beneficiary or recipient. However, the

retroactive effective date may not be

before the earlier of—

• The date on which HCFA approves

the accrediting organization’s program;

and

• The date of accreditation.

We already have several regulations

that provide for payment in special

situations:

§ 431.52—for Medicaid services

furnished out of State.

Part 424 and §§ 440.170(e) and

482.2—for emergency care furnished by

nonparticipating hospitals.

We believe that additional flexibility

in determining effective dates of

agreements and approvals will further

ensure that all eligible providers and

suppliers receive payment. The one-year

period for retroactivity is consistent

with Medicare and Medicaid regulations

which generally require that claims be

submitted for payment within one year

from the date of service.

4. Applicability of the Rule

Comment: Two commenters

questioned whether physicians in

private practice and other noninstitutional providers of Medicaid

services would be subject to the

regulation since, according to § 440.3,

the effective date provisions apply to all

types of Medicaid providers. One of the

commenters disagreed with the

provisions governing deemed status if

they are to be applied to Medicaid

private non-institutional providers.

Response: In response to these

comments, § 431.108(a)(2) (for

Medicaid) and § 489.13(a) (for Medicare)

specify that the rules for determining

effective date apply only to providers

and suppliers that are subject to survey

and certification by HCFA or the State

survey agency, or have deemed status

on the basis of accreditation by an

accrediting organization whose program

has HCFA approval. (Section 440.3 of

the proposed rule cited § 442.13 for the

effective date rules. In this final

regulation, we have moved those rules

to the new § 431.108 of subpart C

because that is the subpart that pertains

to Medicaid provider agreements.)

5. Regulatory Impact Statement

Comment: One commenter noted that

the impact statement in the proposed

rule did not explain why the Secretary

certified that the rule would not have a

significant impact on a substantial

number of small entities. The

commenter requested that the final rule

include a comprehensive regulatory

impact analysis.

Response: A regulatory impact

analysis is required when a rule would

have a significant impact. It has been

determined that the effect of this rule on

small entities is negligible because, in

practice, we have for the most part

determined effective dates of provider

agreements and supplier approvals

using the policies and procedures that

were not until now incorporated in the

regulations. Therefore, since the

procedures for determining effective

dates generally do not change, the

impact on providers and suppliers is

inconsequential and thus forms the

basis for certifying that this rule will not

have a significant economic impact.

Since there is no significant impact, a

regulatory impact analysis is not

required.

Although this rule makes only

minimal changes in the way effective

dates are determined, it does add an

appeals mechanism. We do not

anticipate a significant increase in the

number of requests for hearings for two

reasons:

First, the current Federal regulations

provide appeal rights for a prospective

provider or supplier who is denied

participation in the Medicare program.

(State regulations may provide a similar

appeals mechanism for Medicaid

denials.) A determination to deny a

prospective provider’s or prospective

supplier’s request for participation in

Medicare is usually based on the

entity’s lack of compliance with our

requirements for participation. Effective

date hearings would, for the most part,

focus on the same noncompliance

issues. Appeals from effective date

determinations will probably arise when

an entity disagrees with the date that

HCFA or the State determines that

noncompliance was corrected. We do

not anticipate that entities will appeal

both an initial denial and a subsequent

effective date determination.

Second, the right to appeal an

effective date determination, while not

previously codified, had already been

confirmed by court decisions. Since the

effective date of participation is usually

determined only once, at the time of the

initial survey (the exception being ICFs/

MR which have time-limited

agreements), and since entities are

already appealing these decisions, we

do not anticipate that codification of the

appeal rights will cause any great

increase in the number of hearing

requests.

Further, we have no reason to

anticipate that publication of this rule

will cause an increase in the number of

small entities that request agreements or

approvals for participation in Medicare,

or Medicaid, or both. Neither do we

have any basis for estimating how many

prospective providers or suppliers will
43934 Federal Register / Vol. 62, No. 159 / Monday, August 18, 1997 / Rules and Regulations

make such requests after this rule is

published.

6. Part Title

Comment: One commenter suggested

that we change the title of part 442 from

‘‘Standards for Payment to Nursing

Facilities and Intermediate Care

Facilities for the Mentally Retarded’’ to

‘‘Standards for Payment to Nursing

Facilities and Intermediate Care

Facilities for Persons with Mental

Retardation’’.

Response: We agree that it would be

preferable to have a title that recognizes

the person first and the disability

second, as opposed to referring directly

to the disability. However, section

1905(d) of the statute identifies these

institutions as ‘‘intermediate care

facilities for the mentally retarded’’. We

believe that retention of that language is

the best way to preclude any possible

misunderstanding.

7. Miscellaneous Comments

Comment: We received favorable

comments on two provisions of the

proposed rule—

• Having the State survey agency

recommend the effective date when it

has conducted the survey.

• Precluding appeals based on the

contention that a survey should have

been conducted earlier than it was.

Response: We appreciate the

commenter’s support and believe that

these two provisions will contribute to

smooth implementation of the rules.

D. Provisions of the Final Rule

In summary, this final rule—

• Makes clear that the rules for

determination of the effective date of a

provider agreement or supplier approval

apply to all providers and suppliers that

are subject to survey and certification by

HCFA, or the State survey agency, or

have deemed status on the basis of

accreditation;

• Provides that the State agency that

conducts the survey makes

recommendations concerning the

effective date;

• Reflects statutory changes under

which the basis for determining

effective date for SNFs and NFs is

different from the basis used in

connection with other providers and

with suppliers;

• Sets forth the circumstances under

which effective dates may be made

retroactive;

• Makes existing Medicare appeals

procedures available, and requires

Medicaid agencies to make their

existing appeals procedures available,

for effective date determinations.

• Specifies that, for laboratories,

Medicaid agreements and Medicare

approvals are effective only while the

laboratory has in effect a valid CLIA

certificate issued under part 493 of the

HCFA rules, and only for the specialty

and subspecialty tests it is authorized to

perform; and

• Sets forth the effective date rules

that apply to Medicare provider

agreements with community mental

health centers (CMHCs) and Federally

qualified health centers (FQHCs). The

effective date rule for Medicaid

agreements with FQHCs will be issued

as part of a separate regulation. (CMHCs

do not participate in the Medicaid

program.)

We are also taking advantage of this

opportunity to clarify policy on

termination of provider agreements, as

set forth in § 489.53. Specifically, this

final rule amends that section to revise

the paragraph (b) heading and restore

language that was inadvertently

changed by HSQ–156–F, Survey,

Certification, and Enforcement for

Skilled Nursing Facilities and Nursing

Facilities (59 FR 56116 of November 10,

1994).

The 1994 final rule, in revising

§ 489.53, inadvertently expanded an

exception by making the 2-day notice

applicable to ‘‘a provider or supplier’’,

instead of only to a skilled nursing

facility (SNF). This rule revises

§ 489.53(c)(2) to restore the previous

language: ‘‘For an SNF with deficiencies

that pose immediate jeopardy to the

health or safety of its residents, HCFA

gives notice at least 2 days before the

effective date of termination of the

provider agreement.’’ (The correctly

limited rule for nursing facilities is set

forth in § 488.402(f)(3) of the HCFA

rules.)

We would also correct a technical

error—the retention of ‘‘; and’’ at the

end of § 489.11(c)(2) when paragraph

(c)(3) of that section was removed.

Collection of Information Requirements

This rule contains no new

information collection requirements

subject to review by the Office of

Management and Budget under the

Paperwork Reduction Act.

Regulatory Impact Statement

Consistent with the Regulatory

Flexibility Act (RFA) and section

1102(b) of the Social Security Act, we

prepare a regulatory impact analysis for

each rule, unless we can certify that the

rule will not have a significant

economic impact on a substantial

number of small entities, or a significant

impact on the operation of a substantial

number of small rural hospitals.

The RFA defines small entity as a

small business, a nonprofit enterprise,

or a governmental jurisdiction (such as

a county, city, or township) with a

population of less than 50,000. We also

consider all providers and suppliers of

services to be small entities. For

purposes of section 1102(b) of the Act,

we define small rural hospital as a

hospital that has fewer than 50 beds,

and is not located in a metropolitan

statistical area.

This rule makes minimal changes in

the procedures for determining the

effective date of a provider agreement or

a supplier approval, and makes existing

appeals procedures available to entities

that are dissatisfied with any effective

date determination. It has been

determined that the effect of these

changes on small entities is negligible

because, in practice, we have for the

most part determined effective dates of

agreements and approvals using the

policies and procedures that had not

until now been incorporated in our

regulations. The important aspect of this

rule is that it is essentially a matter of

codification, of inclusion of those

practices in the CFR.

In addition, we do not anticipate that

codification of the right to appeal

effective date determinations will lead

to a significant increase in the number

of hearing requests for several reasons.

First, current Federal regulations

provide appeal rights for a prospective

provider or supplier who is denied

participation in the Medicare program.

(State regulations may provide a similar

appeals mechanism for Medicaid

denials). Denial of participation is

usually based on the prospective

provider’s or prospective supplier’s lack

of compliance with our requirements.

Effective date hearings would, for the

most part, focus on the same

noncompliance issues. Appeals from

effective date determinations will

probably arise when the entity disagrees

with the date that HCFA or the State

determines that the noncompliance was

corrected. We do not believe that

entities will appeal both an initial

denial and a subsequent effective date

determination.

Second, the right to appeal an

effective date determination, while not

previously codified, had been confirmed

by court decisions. Since entities are

currently appealing these decisions, and

since the effective date of participation

is usually determined only once, at the

time of the initial survey (the exception

being ICFs/MR which have time-limited

agreements) we do not anticipate a large

increase in the number of hearing

requests.

It is clear that, since the procedures

for determining and appealing effective

date determinations generally will not
Federal Register / Vol. 62, No. 159 / Monday, August 18, 1997 / Rules and Regulations 43935

change as a result of publishing this

rule, the criteria for requiring a

regulatory impact analysis are not met.

Accordingly, we have not prepared a

regulatory impact analysis because we

have determined and the Secretary

certifies that this rule will not have a

significant economic impact on a

substantial number of small entities or

a significant impact on the operation of

a substantial number of small rural

hospitals.

We have no reason to anticipate that

this rule will cause an increase in the

number of small entities that request

agreements or approvals for

participation in Medicare or Medicaid

or both. Neither do we have any basis

for estimating how many will make

such requests after the effective date of

this rule.

We have reviewed this rule and

determined that, under the provisions of

Public Law 104–121, it is not a major

rule.

In accordance with the provisions of

Executive Order 12866, this final rule

was reviewed by the Office of

Management and Budget.

List of Subjects

42 CFR Part 431

Grant programs—health, Health

facilities, Reporting and recordkeeping

requirements.

42 CFR Part 442

Grant programs—health, Health

facilities, Health professions, Health

records, Medicaid, Nursing homes,

Nutrition, Reporting and recordkeeping

requirements, Safety.

42 CFR Part 488

Health facilities, Survey and

certification, Forms and guidelines.

42 CFR Part 489

Health facilities, Medicare.

42 CFR Part 498

Administrative practice and

procedure, Appeals, Medicare,

Practitioners, providers, and suppliers.

42 CFR Chapter IV is amended as set

forth below.

PART 431—STATE ORGANIZATION

AND GENERAL ADMINISTRATION

A. Part 431 is amended as set forth

below.

1. The authority citation for part 431

continues to read as follows:

Authority: Section 1102 of the Social

Security Act (42 U.S.C. 1302).

2. Subpart C is amended to add new

§ 431.108 to read as follows:

§ 431.108 Effective date of provider

agreements.

(a) Applicability—(1) General rule.

Except as provided in paragraph (a)(2)

of this section, this section applies to

Medicaid provider agreements with

entities that, as a basis for participation

in Medicaid—

(i) Are subject to survey and

certification by HCFA or the State

survey agency; or

(ii) Are deemed to meet Federal

requirements on the basis of

accreditation by an accrediting

organization whose program has HCFA

approval at the time of accreditation

survey and accreditation decision.

(2) Exception. A Medicaid provider

agreement with a laboratory is effective

only while the laboratory has in effect

a valid CLIA certificate issued under

part 493 of this chapter, and only for the

specialty and subspecialty tests it is

authorized to perform.

(b) All requirements are met on the

date of survey. The agreement is

effective on the date the onsite survey

(including the Life Safety Code survey

if applicable) is completed, if on that

date the provider meets—

(1) All applicable Federal

requirements as set forth in this chapter;

and

(2) Any other requirements imposed

by the State for participation in the

Medicaid program. (If the provider has

a time-limited agreement, the new

agreement is effective on the day

following expiration of the current

agreement.)

(c) All requirements are not met on

the date of survey. If on the date the

survey is completed the provider fails to

meet any of the requirements specified

in paragraph (b) of this section, the

following rules apply:

(1) An NF provider agreement is

effective on the date on which—

(i) The NF is found to be in

substantial compliance as defined in

§ 488.301 of this chapter; and

(ii) HCFA or the State survey agency

receives from the NF, if applicable, an

approvable waiver request.

(2) For an agreement with any other

provider, the effective date is the earlier

of the following:

(i) The date on which the provider

meets all requirements.

(ii) The date on which a provider is

found to meet all conditions of

participation but has lower level

deficiencies, and HCFA or the State

survey agency receives from the

provider an acceptable plan of

correction for the lower level

deficiencies, or an approvable waiver

request, or both. (The date of receipt is

the effective date of the agreement,

regardless of when HCFA approves the

plan of correction or waiver request, or

both.)

(d) Accredited provider requests

participation in the Medicaid

program.—(1) General rule. If a provider

is currently accredited by a national

accrediting organization whose program

had HCFA approval at the time of

accreditation survey and accreditation

decision, and on the basis of

accreditation, HCFA has deemed the

provider to meet Federal requirements,

the effective date depends on whether

the provider is subject to requirements

in addition to those included in the

accrediting organization’s approved

program.

(i) Provider subject to additional

requirements. For a provider that is

subject to additional requirements,

Federal or State, or both, the effective

date is the date on which the provider

meets all requirements, including the

additional requirements.

(ii) Provider not subject to additional

requirements. For a provider that is not

subject to additional requirements, the

effective date is the date of the

provider’s initial request for

participation if on that date the provider

met all Federal requirements.

(2) Special rule: Retroactive effective

date. If the provider meets the

requirements of paragraphs (d)(1) and

(d)(1)(i) or (d)(1)(ii) of this section, the

effective date may be retroactive for up

to one year, to encompass dates on

which the provider furnished, to a

Medicaid recipient, covered services for

which it has not been paid.

3. Section 431.151(a) is amended to

republish the introductory text and add

a paragraph (a)(3), to read as follows:

§ 431.151 Scope and applicability.

(a) General rules. This subpart sets

forth the appeals procedures that a State

must make available as follows:

* * * * *

(3) To an NF or ICF/MR that is

dissatisfied with a determination as to

the effective date of its provider

agreement.

* * * * *

4. Section 431.153 is amended to

republish the introductory text of

paragraph (b) and add a paragraph

(b)(5), to read as follows:

§ 431.153 Evidentiary hearing.

* * * * *

(b) Limit on grounds for appeal. The

following are not subject to appeal:

* * * * *

(5) A State survey agency’s decision

as to when to conduct an initial survey

of a prospective provider.

* * * * *
43936 Federal Register / Vol. 62, No. 159 / Monday, August 18, 1997 / Rules and Regulations

§ 431.610 [Amended]

5. In § 431.610, the following changes

are made:

a. In paragraph (e)(1), ‘‘if’’ is removed

and ‘‘whether’’ is inserted in its place.

b. In paragraph (e)(2), the period is

removed and ‘‘; and’’ is added in its

place.

c. A new paragraph (e)(3) is added, to

read as set forth below:

§ 431.610 Relations with standard-setting

and survey agencies.

* * * * *

(e) Designation of survey agency.

* * *

(3) The agency designated in

paragraph (e)(1) of this section makes

recommendations regarding the

effective dates of provider agreements,

as determined under § 431.108.

* * * * *

PART 442—STANDARDS FOR

PAYMENT TO NURSING FACILITIES

AND INTERMEDIATE CARE

FACILITIES FOR THE MENTALLY

RETARDED

B. Part 442 is amended as set forth

below.

1. The heading for part 442 is revised

to read as set forth above.

2. The authority citation for part 442

continues to read as follows:

Authority: Section 1102 of the Social

Security Act (42 U.S.C. 1302).

3. Section 442.13 is revised to read as

follows:

§ 442.13 Effective date of provider

agreement.

The effective date of a provider

agreement with an NF or ICF/MR is

determined in accordance with the rules

set forth in § 431.108.

PART 488—SURVEY, CERTIFICATION,

AND ENFORCEMENT PROCEDURES

C. Part 488 is amended as set forth

below.

1. The authority citation for part 488

continues to read as follows:

Authority: Secs. 1102 and 1871 of the

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

1395hh).

2. Section 488.11 is revised to read as

follows:

§ 488.11 State survey agency functions.

State and local agencies that have

agreements under section 1864(a) of the

Act perform the following functions:

(a) Survey and make

recommendations regarding the issues

listed in § 488.10.

(b) Conduct validation surveys of

accredited facilities as provided in

§ 488.7.

(c) Perform other surveys and carry

out other appropriate activities and

certify their findings to HCFA.

(d) Make recommendations regarding

the effective dates of provider

agreements and supplier approvals in

accordance with § 489.13 of this

chapter.

PART 489—PROVIDER AGREEMENTS

AND SUPPLIER APPROVAL

D. Part 489 is amended as set forth

below.

1. The authority citation for part 489

continues to read as follows:

Authority: Secs. 1102, and 1871 of the

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

1395hh).

2. In § 489.1, a new paragraph (d) is

added, to read as follows:

§ 489.1 Statutory basis.

* * * * *

(d) Although section 1866 of the Act

speaks only to providers and provider

agreements, the effective date rules in

this part are made applicable also to the

approval of suppliers that meet the

requirements specified in § 489.13.

3. § 489.13 is revised to read as

follows:

§ 489.13 Effective date of agreement or

approval.

(a) Applicability—(1) General rule.

Except as provided in paragraph (a)(2)

of this section, this section applies to

Medicare provider agreements with, and

supplier approval of, entities that, as a

basis for participation in Medicare—

(i) Are subject to survey and

certification by HCFA or the State

survey agency; or

(ii) Are deemed to meet Federal

requirements on the basis of

accreditation by an accrediting

organization whose program has HCFA

approval at the time of accreditation

survey and accreditation decision.

(2) Exceptions. (i) For an agreement

with a community mental health center

(CMHC) or a Federally qualified health

center (FQHC), the effective date is the

date on which HCFA accepts a signed

agreement which assures that the CMHC

or FQHC meets all Federal

requirements.

(ii) A Medicare supplier approval of a

laboratory is effective only while the

laboratory has in effect a valid CLIA

certificate issued under part 493 of this

chapter, and only for the specialty and

subspecialty tests it is authorized to

perform.

(b) All Federal requirements are met

on the date of survey. The agreement or

approval is effective on the date the

survey (including the Life Safety Code

survey, if applicable) is completed, if on

that date the provider or supplier meets

all applicable Federal requirements as

set forth in this chapter. (If the

agreement or approval is time-limited,

the new agreement or approval is

effective on the day following expiration

of the current agreement or approval.)

(c) All Federal requirements are not

met on the date of survey. If on the date

the survey is completed the provider or

supplier fails to meet any of the

requirements specified in paragraph (b)

of this section, the following rules

apply:

(1) For an agreement with an SNF, the

effective date is the date on which—

(i) The SNF is in substantial

compliance (as defined in § 488.301 of

this chapter) with the requirements for

participation; and

(ii) HCFA or the State survey agency

receives from the SNF, if applicable, an

approvable waiver request.

(2) For an agreement with, or an

approval of, any other provider or

supplier, (except those specified in

paragraph (a)(2) of this section), the

effective date is the earlier of the

following:

(i) The date on which the provider or

supplier meets all requirements.

(ii) The date on which a provider or

supplier is found to meet all conditions

of participation or coverage, but has

lower level deficiencies, and HCFA or

the State survey agency receives an

acceptable plan of correction for the

lower level deficiencies, or an

approvable waiver request, or both. (The

date of receipt is the effective date

regardless of when HCFA approves the

plan of correction or the waiver request,

or both.)

(d) Accredited provider or supplier

requests participation in the Medicare

program—(1) General rule. If the

provider or supplier is currently

accredited by a national accrediting

organization whose program had HCFA

approval at the time of accreditation

survey and accreditation decision, and

on the basis of accreditation, HCFA has

deemed the provider or supplier to meet

Federal requirements, the effective date

depends on whether the provider or

supplier is subject to requirements in

addition to those included in the

accrediting organization’s approved

program.

(i) Provider or supplier subject to

additional requirements. If the provider

or supplier is subject to additional

requirements, the effective date of the

agreement or approval is the date on

which the provider or supplier meets all

requirements, including the additional

requirements.
Federal Register / Vol. 62, No. 159 / Monday, August 18, 1997 / Rules and Regulations 43937

(ii) Provider or supplier not subject to

additional requirements. For a provider

or supplier that is not subject to

additional requirements, the effective

date is the date of the provider’s or

supplier’s initial request for

participation if on that date the provider

or supplier met all Federal

requirements.

(2) Special rule: Retroactive effective

date. If a provider or supplier meets the

requirements of paragraphs (d)(1) and

(d)(1)(i) or (d)(1)(ii) of this section, the

effective date may be retroactive for up

to one year to encompass dates on

which the provider or supplier

furnished, to a Medicare beneficiary,

covered services for which it has not

been paid.

4. Section 489.53 is amended to revise

the heading of paragraph (b) and

paragraphs (c)(1) and (c)(2) to read as

follows:

§ 489.53 Termination by HCFA.

* * * * *

(b) Termination of agreements with

certain hospitals. * * *

(c) Notice of termination—(1) Timing:

Basic rule. Except as provided in

paragraph (c)(2) of this section, HCFA

gives the provider notice of termination

at least 15 days before the effective date

of termination of the provider

agreement.

(2) Timing exceptions: Immediate

jeopardy situations—(i) Hospital with

emergency department. If HCFA finds

that a hospital with an emergency

department is in violation of § 489.24,

paragraphs (a) through (e), and HCFA

determines that the violation poses

immediate jeopardy to the health or

safety of individuals who present

themselves to the hospital for

emergency services, HCFA—

(A) Gives the hospital a preliminary

notice indicating that its provider

agreement will be terminated in 23 days

if it does not correct the identified

deficiencies or refute the finding; and

(B) Gives a final notice of termination,

and concurrent notice to the public, at

least 2 , but not more than 4, days before

the effective date of termination of the

provider agreement.

(ii) Skilled nursing facilities (SNFs).

For an SNF with deficiencies that pose

immediate jeopardy to the health or

safety of residents, HCFA gives notice at

least 2 days before the effective date of

termination of the provider agreement.

* * * * *

PART 498—APPEALS PROCEDURES

FOR DETERMINATIONS THAT AFFECT

PARTICIPATION IN THE MEDICARE

PROGRAM AND FOR

DETERMINATIONS THAT AFFECT THE

PARTICIPATION OF CERTAIN ICFs/MR

AND CERTAIN NFs IN THE MEDICAID

PROGRAM

E. Part 498 is amended as set forth

below.

1. The authority citation for part 498

continues to read as follows:

Authority: Secs. 1102, and 1871 of the

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

1395hh).

2. Section 498.3 is amended to revise

paragraph (a), republish the

introductory text of paragraph (b) and

add a paragraph (b)(14), revise the

introductory text of paragraph (d) and

add new paragraphs (d)(14) and (d)(15),

to read as follows:

§ 498.3 Scope and applicability.

(a) Scope. This part sets forth

procedures for reviewing initial

determinations that HCFA makes with

respect to the matters specified in

paragraph (b) of this section, and that

the OIG makes with respect to the

matters specified in paragraph (c) of this

section. It also specifies, in paragraph

(d) of this section, administrative

actions that are not subject to appeal

under this part.

(b) Initial determinations by HCFA.

HCFA makes initial determinations with

respect to the following matters:

* * * * *

(14) The effective date of a Medicare

provider agreement or supplier

approval.

* * * * *

(d) Administrative actions that are not

initial determinations. Administrative

actions that are not initial determination

(and therefore not subject to appeal

under this part) include but are not

limited to the following:

* * * * *

(14) The choice of alternative sanction

or remedy to be imposed on a provider

or supplier.

(15) A decision by the State survey

agency as to when to conduct an initial

survey of a prospective provider or

supplier.

* * * * *

F. Technical correction.

§ 489.1 [Amended]

In § 489.11(c), the following changes

are made:

a. At the end of paragraph (c)(1), the

word ‘‘and’’ is added.

b. At the end of paragraph (c)(2), ‘‘;

and’’ is removed and a period is

inserted in its place.

(Catalog of Federal Domestic Assistance

Program No. 93.773, Medicare—Hospital

Insurance; Program No. 93.774, Medicare—

Supplementary Medical Insurance; and

Program No. 93.778, Medical Assistance.)

Dated: September 20, 1996.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

Dated: December 27, 1996.

Donna E. Shalala,

Secretary.

[FR Doc. 97–21731 Filed 8–15–97; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric

Administration

50 CFR Parts 222 and 227

[Docket No. 960730210–7193–02; I.D.

050294D]

RIN 0648–XX65

Endangered and Threatened Species:

Listing of Several Evolutionary

Significant Units (ESUs) of West Coast

Steelhead

AGENCY: National Marine Fisheries

Service (NMFS), National Oceanic and

Atmospheric Administration (NOAA),

Commerce.

ACTION: Final rule.

SUMMARY: On August 9, 1996, NMFS

completed a comprehensive status

review of west coast steelhead

(Oncorhynchus mykiss, or O. mykiss)

populations in Washington, Oregon,

Idaho, and California, and identified 15

Evolutionarily Significant Units (ESUs)

within this range. NMFS is now issuing

a final rule to list two ESUs as

endangered and three ESUs as

threatened under the Endangered

Species Act (ESA). The endangered

steelhead ESUs are located in California

(Southern California) and Washington

(Upper Columbia River). The threatened

steelhead ESUs are located in California

(Central California Coast and SouthCentral California Coast) and Idaho,

Washington, and Oregon (Snake River

Basin). For the endangered ESUs,

section 9(a) prohibitions will be

effective 60 days from the publication of

this final rule. For the threatened ESUs,

NMFS will issue shortly protective

regulations under section 4(d) of the

ESA, which will apply section 9(a)

prohibitions with certain exceptions.

NMFS has examined the relationship

between hatchery and natural

populations of steelhead in these ESUs,

and has assessed whether any hatchery