Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 1997

Federal RegisterJul 2, 1996

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SUMMARY: This proposed rule discusses several policy changes affecting

Medicare payment for physician services including payment for

diagnostic services and transportation in connection with furnishing

diagnostic tests. The proposed rule also discusses comprehensive

locality changes and changes in the procedure status codes for a

variety of services.

DATES: Comments will be considered if we receive them at the

appropriate address, as provided below, no later than 5 p.m. on

September 3, 1996.

ADDRESSES: Mail written comments (1 original and 3 copies) to the

following address: Health Care Financing Administration, Department of

Health and Human Services, Attention: BPD-852-P, P.O. Box 26688,

Baltimore, MD 21207-0488.

If you prefer, you may deliver your written comments (1 original

and 3 copies) to one of the following addresses:

Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,

Washington, DC 20201, or

Room 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-852-P. 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).

For comments that relate to information collection requirements,

mail a copy of the comments to: Allison Herron Eydt, HCFA Desk Officer,

Office of Information and Regulatory Affairs, Room 10235, New Executive

Office Building, Washington, DC 20530.

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FOR FURTHER INFORMATION CONTACT: Shana Olshan, (410) 786-5714.

SUPPLEMENTARY INFORMATION: To assist readers in referencing sections

contained in this preamble, we are providing the following table of

contents. Some of the issues discussed in this preamble affect the

payment policies but do not require changes to the regulations in the

Code of Federal Regulations.

Table of Contents

I. Background

A. Legislative History

B. Published Changes to the Fee Schedule

II. Specific Proposals for Calendar Year 1997

A. Payment Area (Locality) and Corresponding Geographic Practice

Cost Index Changes

1. Background

2. Locality Study

3. Nonselected Options

4. Proposal

a. Proposed Variant of Option 1 (Option 1i, 5-Percent Threshold)

b. Proposed Option 1i, 5-Percent Threshold, with Subcounty

Payment Area Restructuring

c. Effects of Proposed Option 1i, 5-Percent Threshold, with

Subcounty FSA Restructuring

B. Special Rules for the Payment of Diagnostic Tests, Including

Diagnostic Radiologic Procedures

1. Background

2. Proposal

3. Chiropractor Exception

4. Non-Physician Practitioners

C. Transportation in Connection with Furnishing Diagnostic Tests

D. Bundled Services

1. Hot or Cold Packs

2. Dermatology Procedures

a. Bundling of Repair Codes into Excision Codes

b. Skin Lesion Destruction Codes

E. Change in Coverage Status for Screening and Obsolete

Procedures

1. Vital Capacity Testing

2. Certain Cardiovascular Procedures

F. Payments for Supervising Physicians in Teaching Settings

1. Definition of Approved Graduate Medical Education Programs

2. Evaluation and Management Services Furnished in Certain

Settings

G. Change in Global Periods for Four Percutaneous Biliary

Procedures

III. Collection of Information Requirements

IV. Response to Comments

V. Regulatory Impact Analysis

A. Regulatory Flexibility Act

B. Payment Area (Locality) and Corresponding Geographic Practice

Cost Index Changes

C. Special Rules for the Payment of Diagnostic Tests, Including

Diagnostic Radiologic Procedures

D. Transportation in Connection with Furnishing Diagnostic Tests

E. Bundled Services

1. Hot or Cold Packs

2. Dermatology Procedures

a. Bundling of Repair Codes into Excision Codes

b. Skin Lesion Destruction Codes

F. Change in Coverage Status for Screening and Obsolete

Procedures

1. Vital Capacity Testing

2. Certain Cardiovascular Procedures

G. Payments for Supervising Physicians in Teaching Settings

H. Change in Global Periods for Four Percutaneous Biliary

Procedures

I. Rural Hospital Impact Statement

Addendum A--1996 Geographic Adjustment Factors (GAFs) by Medicare

Payment Locality/Locality Part for January 1, 1996 Localities and

Proposed Option, Fee Schedule Areas (FSAs), in Descending Order of

Difference

Addendum B--Medicare Fee Schedule Areas (Localities) and 1996

Geographic

[[Page 34615]]

Adjustment Factors (GAFs), Current and Proposed Option by State and

County/County Part

In addition, because of the many organizations and terms to which

we refer by acronym in this final rule, we are listing these acronyms

and their corresponding terms in alphabetical order below:

AMA American Medical Association

CFR Code of Federal Regulations

CPT [Physicians'] Current Procedural

Terminology [4th Edition, 1996,

copyrighted by the American Medical

Association]

CY Calendar year

EKG Electrocardiogram

FSA Fee Schedule Area

FY Fiscal year

GAF Geographic adjustment factor

GPCI Geographic practice cost index

HCFA Health Care Financing Administration

HCPAC Health Care Professional Advisory

Council

HCPCS HCFA Common Procedure Coding System

HHS [Department of] Health and Human

Services

MEI Medicare Economic Index

MSA Metropolitan Statistical Area

OBRA Omnibus Budget Reconciliation Act

OMB Office of Management and Budget

PMSA Primary Metropolitan Statistical Area

RVU Relative Value Unit

TC Technical Component

I. Background

A. Legislative History

The Medicare program was established in 1965 by the addition of

title XVIII to the Social Security Act (the Act). Since January 1,

1992, Medicare pays for physician services under section 1848 of the

Act, ``Payment for Physicians' Services.'' This section contains three

major elements: (1) A fee schedule for the payment of physician

services; (2) a Medicare volume performance standard for the rates of

increase in Medicare expenditures for physician services; and (3)

limits on the amounts that nonparticipating physicians can charge

beneficiaries. The Act requires that payments under the fee schedule be

based on national uniform relative value units (RVUs) based on the

resources used in furnishing a service. Section 1848(c) of the Act

requires that national RVUs be established for physician work, practice

expense, and malpractice expense.

Section 1848(c)(2)(B)(ii)(II) of the Act provides that adjustments

in RVUs because of changes resulting from a review of those RVUs may

not cause total physician fee schedule payments to differ by more than

$20 million from what they would have been had the adjustments not been

made. If this tolerance is exceeded, we must make adjustments to the

conversion factors to preserve budget neutrality.

B. Published Changes to the Fee Schedule

We published a final rule on November 25, 1991 (56 FR 59502) to

implement section 1848 of the Act by establishing a fee schedule for

physician services furnished on or after January 1, 1992. In the

November 1991 final rule (56 FR 59511), we stated our intention to

update RVUs for new and revised codes in the American Medical

Association's (AMA's) Physicians' Current Procedural Terminology (CPT)

through an ``interim RVU'' process every year. The updates to the RVUs

and fee schedule policies follow:

November 25, 1992, as a final notice with comment period

on new and revised RVUs only (57 FR 55914).

December 2, 1993, as a final rule with comment period (58

FR 63626) to revise the refinement process used to establish physician

work RVUs and to revise payment policies for specific physician

services and supplies. (We solicited comments on new and revised RVUs

only.)

December 8, 1994, as a final rule with comment period (59

FR 63410) to revise the geographic adjustment factor (GAF) values, fee

schedule payment areas, and payment policies for specific physician

services. The final rule also discussed the process for periodic review

and adjustment of RVUs not less frequently than every 5 years as

required by section 1848(c)(2)(B)(i) of the Act.

December 8, 1995, as a final rule with comment period (60

FR 63124) to revise various policies affecting payment for physician

services including Medicare payment for physician services in teaching

settings, the RVUs for certain existing procedure codes, and to

establish interim RVUs for new and revised procedure codes. The rule

also included the final revised 1996 geographic practice cost indices.

This proposed rule would affect the regulations set forth at 42 CFR

part 405, which encompasses regulations on Federal health insurance for

the aged and disabled; part 410, which consists of regulations on

supplementary medical insurance benefits and part 415, which contains

regulations on services of physicians in provider settings, supervising

physicians in teaching settings, and residents in certain settings.

II. Specific Proposals for Calendar Year 1997

A. Payment Area (Locality) and Corresponding Geographic Practice Cost

Index Changes

1. Background

From the inception of Medicare in 1966 until 1992, Medicare

payments for physicians' services were made under the reasonable charge

system. Under the reasonable charge system, Medicare payment localities

for physicians' services were set by local Medicare carriers based on

their knowledge of local physician charging patterns. As such, payment

areas have had no consistent geographic basis. In general, localities

tended to be geographic or political subdivisions such as States,

counties, or cities, or designations such as urban and rural. Most of

the localities changed little between 1966 and 1992. There were about

240 localities, including 16 States with statewide localities, under

the reasonable charge system.

Section 1848 of the Act replaced the reasonable charge system of

paying for physician services under section 1842(b) of the Act, with

the physician fee schedule effective January 1, 1992. Section

1848(j)(2) of the Act defines a physician fee schedule payment area as

the locality existing under section 1842(b) of the Act for purposes of

computing payment amounts for physician services. Section 1848 did not,

however, delete section 1842 of the Act, which gives the Secretary the

authority to set localities. We believe the Congress enacted section

1848(j)(2) to allow us to retain existing localities to facilitate the

statutory transition to the physician fee schedule, but not to preclude

us from making locality changes if warranted. All locality changes are

now made by HCFA through the rulemaking process. Medicare carriers are

not allowed to set or revise physician fee schedule payment localities.

In the June 5, 1991 proposed rule for the physician fee schedule

(56 FR 25832), we acknowledged the lack of consistency among localities

and the significant demographic and economic changes that had occurred

since localities were originally established. We also stated that we

planned no large-scale locality changes until we evaluated the various

studies on localities being done within HCFA and by outside groups such

as the Physician Payment Review Commission and until after the

statutory transition from the reasonable charge system to the fee

schedule was completed in 1996. We

[[Page 34616]]

stated that until we decide on ultimate large-scale changes, the only

locality changes we would consider would be requests for converting

individual States with multiple localities to a single statewide

locality if ``* * * overwhelming support from the physician community

for the changes can be demonstrated.'' This position was repeated in

the November 1991 final rule on the physician fee schedule (56 FR

59514). This willingness to consider applications from physicians in a

State for conversion to a statewide locality, if overwhelming support

on the part of winning and losing physicians has been demonstrated,

reflects our belief that statewide localities generally are preferable

to the present Medicare localities because they simplify program

administration and encourage physicians to practice in rural areas by

reducing urban/rural payment differentials.

We received inquiries from a number of State medical societies

concerning conversions to a statewide payment area. Under the law,

payments vary among physician fee schedule areas only to the extent

that resource costs vary as measured by the Geographic Practice Cost

Index (GPCI). The GPCI is an index developed to measure resource cost

differences among areas in the three components of the physician fee

schedule--physician work, practice expenses, and malpractice expenses.

Area geographic adjustment factors (GAFs) are weighted composites of

the area GPCIs and are useful in comparing overall resource cost and

payment level differences among areas. (A comprehensive explanation of

the GPCIs and GAFs can be found in the June 24, 1994 proposed rule (59

FR 32756)).

We explained to the States inquiring about conversions to a

statewide payment area that these conversions involve taking a weighted

average of the existing locality GPCIs to form a new statewide GPCI.

This means that there may be ``losing'' (usually urban) areas, as well

as ``winning'' (usually rural) areas within a State if a conversion is

made. We further informed the States that a simple resolution passed by

the State medical society is not sufficient proof of overwhelming

support among both rural and urban physicians for the change. To assist

States in deciding whether to convert to a statewide payment area, we

published an informational list of projected statewide GPCIs in the

June 1991 proposed rule (56 FR 25972). A slightly revised list of

projected statewide GPCIs was published in the December 1993 final rule

(58 FR 63638). The revisions were made to ensure that any change to a

statewide payment area would be done on a budget-neutral basis. That

is, that the same amount of payments would be made within a State after

the conversion to a statewide payment area as would have been made had

the conversion not been made. A comprehensive revision of all GPCIs was

made in 1995. A list of revised projected statewide GPCIs was published

at Addendum E of the June 1994 proposed rule (59 FR 32789).

In most cases, States have been unable to generate the support of

the losing physicians for the change. However, three States--Minnesota,

Nebraska, and Oklahoma--were converted to statewide payment areas in

1992. (These conversions were announced in the November 1991 final rule

(56 FR 59514).) Two additional States--North Carolina and Ohio--were

converted to statewide payment areas in 1994. (These conversions were

announced in the December 1993 final rule (58 FR 63638).) Iowa was

converted to a statewide payment area in 1995. (This conversion was

announced in the December 1994 final rule (59 FR 63416).) There are

currently 210 payment areas under the physician fee schedule: 22 States

with single payment areas; the District of Columbia (with surrounding

Maryland and Virginia suburbs), Puerto Rico, and the Virgin Islands are

3 more single payment areas; and 28 multiple-locality States containing

185 payment areas. Table 1 summarizes existing physician fee schedule

payment areas.

Table 1.--1996 Medicare Physician Fee Schedule Payment Localities by

State and Other

------------------------------------------------------------------------

State Localities

------------------------------------------------------------------------

Single locality States:

Alaska.................................................... 1

Arkansas.................................................. 1

Colorado.................................................. 1

Delaware.................................................. 1

Hawaii/Guam............................................... 1

Iowa...................................................... 1

Minnesota................................................. 1

Montana................................................... 1

Nebraska.................................................. 1

New Hampshire............................................. 1

New Mexico................................................ 1

North Carolina............................................ 1

North Dakota.............................................. 1

Ohio...................................................... 1

Oklahoma.................................................. 1

Rhode Island.............................................. 1

South Carolina............................................ 1

South Dakota.............................................. 1

Tennessee................................................. 1

Utah...................................................... 1

Vermont................................................... 1

Wyoming................................................... 1

------------------------------------------------------------------------

22 States............................................... 22

Other:

Wash. D.C................................................. 1

Puerto Rico............................................... 1

Virgin Islands............................................ 1

------------------------------------------------------------------------

3 Other................................................. 3

Multiple locality States:

Alabama..................................................... 6

Arizona..................................................... 6

California.................................................. 28

Connecticut................................................. 4

Florida..................................................... 4

Georgia..................................................... 4

Idaho....................................................... 2

Illinois.................................................... 16

Indiana..................................................... 3

Kansas...................................................... 3

Kentucky.................................................... 3

Louisiana................................................... 8

Maine....................................................... 3

*Maryland................................................... 3

Massachusetts............................................... 2

Michigan.................................................... 2

Mississippi................................................. 2

Missouri.................................................... 7

Nevada...................................................... 4

New Jersey.................................................. 3

New York.................................................... 8

Oregon...................................................... 5

Pennsylvania................................................ 4

Texas....................................................... 32

*Virginia................................................... 4

Washington.................................................. 3

West Virginia............................................... 5

Wisconsin................................................... 11

------------------------------------------------------------------------

28 States............................................... 185

------------------------------------------------------------------------

Total 1996 Physician Fee Schedule Payment Localities=210.

*The Maryland and Virginia localities do not include the parts of

Maryland (Prince Georges and Montgomery Counties) and Virginia

(Fairfax and Arlington Counties and the city of Alexandria) included

in the Washington, D.C. locality.

2. Locality Study

There are numerous possibilities for realigning payment localities.

After considerable internal discussion, we narrowed the possibilities

to four general options. A major goal in selecting these options is to

continue to reduce the number of areas, leading to greater simplicity,

understandability, ease of administration, reduction in urban/rural

payment differences, reduction in payment differences among adjacent

areas, and stability of payment updates resulting from the periodic

GPCI revisions. Larger payment areas would mean larger data samples

thereby leading to less volatile changes in the statutory periodic GPCI

revisions. We contracted with Health Economics

[[Page 34617]]

Research, Inc. to conduct an analysis of these options. The four

general fee schedule area (FSA) options are briefly summarized as

follows:

Option 1: Use current localities as building blocks. The

22 States currently with single localities would remain statewide FSAs.

Statewide FSAs would be created in the 28 remaining States, except for

current localities whose GAF exceeds the State GAF by a specified

percentage threshold (for example, 5 percent).

Option 2: Use metropolitan areas (Metropolitan Statistical

Areas (MSAs), Primary Metropolitan Statistical Areas (PMSAs), and New

England County Metropolitan Areas) as building blocks. The 22 States

currently with single localities would remain statewide FSAs. Statewide

FSAs would be created in the 28 remaining States, except for

metropolitan areas whose GAF exceeds the State GAF by a specified

percentage threshold.

Option 3: Use metropolitan areas as building blocks. The

22 States currently with single localities would remain statewide FSAs.

Each of the 28 remaining States would be divided into 2 to 5 FSAs based

on metropolitan area population size: greater than 3 million; 1 to 3

million; .25 to 1 million; less than .25 million; nonmetropolitan.

Option 4: Use metropolitan areas as building blocks.

Designate five nationwide FSAs based on metropolitan area population

size: greater than 3 million; 1 to 3 million; .25 to 1 million; less

than .25 million; nonmetropolitan.

We also asked Health Economics Research, Inc. for any suggestions

for variations on these options that might improve them. We

specifically requested that it recommend restructuring FSAs in the 11

States that have subcounty localities. These subcounty configurations,

usually cities or zip codes, create unnecessary complexity and

administrative burden.

Health Economics Research, Inc. issued its final report to us on

November 1, 1995. The report consists of three volumes and can be

obtained by requesting the following titles from the National Technical

Information Service by calling 1-800-553-NTIS, or (703) 487-4650 in

Springfield, Virginia:

``Assessment and Redesign of Medicare Fee Schedule Areas

(Localities),'' Volume I: Text, NTIS PB96-118815.

``Assessment and Redesign of Medicare Fee Schedule Areas

(Localities),'' Volume II: Appendix Tables, NTIS PB96-118823.

``Assessment and Redesign of Medicare Fee Schedule Areas

(Localities),'' Volume III: Maps. NTIS PB96-118187.

3. Nonselected Options

While we began with four basic options, numerous variations are

possible merely depending on which threshold GAF difference is

selected. For example, Option 1 is based on the difference between the

existing FSA GAF and the State GAF. Many variants on this option are

available merely depending upon what threshold GAF difference between

the FSAs and the State is selected, for example, 1 percent, 3 percent,

5 percent, 10 percent. Likewise, Option 2 produces many variations

depending on the selected threshold GAF difference between the

metropolitan area GAF and the State GAF. The major goal of revising

FSAs is to simplify the payment areas and reduce payment differences

among geographic areas while maintaining accuracy in tracking input

price differences among areas. All options involve a certain trade-off

between simplicity and understandability and accuracy of tracking of

input prices. Many of the variations will produce a similar number of

FSAs, but some do so at the expense of producing undesirable payment

differences at boundaries or inaccuracies in tracking input prices.

After careful examination of all options and their variants, we

believe that a variant of Option 1 is clearly the best choice. Before

discussing, in depth, our reasons for selecting this option, the

following is a brief discussion of why we eliminated Options 2, 3, and

4, in order of the least promising option. A more detailed discussion

of these options with tables and maps can be found in the Health

Economics Research, Inc. report.

Option 4 is the least promising approach to constructing FSAs.

While it has the smallest number of FSAs, five nationwide, it is

unacceptably inaccurate in tracking input price differences and creates

too many large and inappropriate GAF differences across FSA boundaries.

Grouping all metropolitan areas of the same size into a single

category, regardless of geographic location, would substantially

underpay some areas while overpaying others.

For example, the following large metropolitan areas would be

substantially underpaid under Option 4 (Option 4 GAF/actual GAF is

indicated in parenthesis): San Francisco (1.024/1.141); New York City

(1.102/1.176); Nassau-Suffolk, New York (1.024/1.199); and Miami

(1.024/1.116). Conversely, the following large cites would be overpaid

under Option 4: Houston (1.102/1.030); Chicago (1.102/1.061); and

Philadelphia (1.102/1.066). In addition to these inaccuracies, Option 4

creates some severe boundary problems. For example, the Houston-

Galveston, Texas difference under Option 4 is 1.102 versus 0.937, a

nearly 20 percentage point difference, versus an actual area GAF cost

difference of 1.030 versus 1.001. Other examples may be found in the

tables and maps in the Health Economics Research, Inc. report. In

short, State-specific and metropolitan-area-specific factors, which

Option 4 ignores, appear to be important influences on input prices.

These factors are not captured by nationwide average inputs based on

population size. While New York and Houston are in the same

metropolitan area size classification of greater than 3 million, they

have less in common with each other in terms of practice costs than

they do with neighboring metropolitan areas of smaller size.

Option 3, we believe, is also unpromising. It creates the largest

number of FSAs of any option and is geographically more complex than

either Option 1 or Option 2. This option suffers from inadequate

tracking of input price variations and inappropriate differences across

boundaries, which are caused, as in Option 4, by grouping metropolitan

areas by population class. Under this option, within a State, a

metropolitan area's costliness is assumed to be dependent only on its

population. This is not always an accurate assumption. A small

metropolitan area that is a component of a major metropolitan region

(for example, a PMSA) may have much higher input prices than a small

freestanding metropolitan area surrounded by nonmetropolitan counties.

Grouping these types of metropolitan areas together can lead to

inaccurate GAFs and inappropriate differences at FSA boundaries. For

example, Houston is the only Texas metropolitan area in the highest

population category of 3 million or more, and has a GAF under Option 3

of 1.030. The contiguous Galveston PMSA is in the smallest population

class of under 250,000. Its actual GAF is 1.001, but under Option 3 it

is averaged with other small Texas metropolitan areas and is assigned a

GAF of 0.926. Option 3, thus, underpays Galveston and creates a much

larger GAF difference at the Houston-Galveston boundary than is

warranted by the actual difference in input prices. Expensive Miami and

Fort Lauderdale (with GAFs of 1.116 and 1.100) are grouped with lower-

price Orlando and Tampa-St. Petersburg (with

[[Page 34618]]

GAFs of 1.008 and 0.992) under this option.

Option 2 is more promising than Options 3 and 4, but less promising

than Option 1. While producing similar types and numbers of FSAs in

some instances, depending on the threshold used, Option 1 has some

advantages over Option 2. First, Option 1 is less disruptive because it

uses existing localities as building blocks. Second, the urban payment

localities in Option 1 tend to be smaller and more focused on high-cost

urban counties and track input price variations better than the larger

metropolitan area definitions used in Option 2. The metropolitan areas

(MSAs, PMSAs, and New England County Metropolitan Statistical Areas)

used as building blocks in this option are based on commuting patterns

and are generally much larger than the current urban localities used in

Option 1. Examples are the Washington, D.C. locality versus the

Washington, D.C. PMSA; the Dallas locality versus the Dallas PMSA; the

Chicago locality versus the Chicago PMSA; and the Houston locality

versus the Houston PMSA. Input prices in the suburban counties in these

PMSAs may be significantly lower than in the urban core and more

similar to prices in other parts of the State. This may be especially

true of some rural counties on the fringes of metropolitan areas that

are categorized as part of the metropolitan area based on commuting

patterns. For example, the Washington, D.C. PMSA includes portions of

rural West Virginia. Under Option 2, this FSA would have a GAF of

1.090, compared to the actual GAF of Washington, D.C. of 1.122, and the

actual GAF of the West Virginia counties included in the Washington,

D.C. PMSA of 0.950. Input prices in the parts of rural West Virginia

included in the Washington, D.C. PMSA have little in common with input

prices in the Washington, D.C. urban core. Also, Option 2 presents

significant problems in handling metropolitan areas that cross State

boundaries.

4. Proposal

a. Proposed Variant of Option 1 (Option 1i, 5-Percent Threshold)

Under standard Option 1, the 22 States with a single FSA would

remain statewide FSAs. Option 1 then presumes for the remaining 28

States that FSAs should be statewide for each State unless a sub-State

payment locality has sufficiently higher input prices (as measured by

its GAF) than the average input prices of its State (as measured by the

State GAF) to meet a threshold difference. If the percentage difference

between the locality's GAF and the State GAF exceeds a specified

threshold, that locality would remain a distinct FSA. Otherwise, the

locality would be merged into a residual FSA for that State. If no sub-

State locality had sufficiently higher prices than the State average to

meet the threshold difference, the State would become a single

statewide locality. For example, Alabama currently has six localities.

The GAFs range from a high of 0.957 for Locality 05, Birmingham, to a

low of 0.902 for Locality 06, rest of Alabama. The State GAF is 0.932.

Using a threshold of 5 percent, Alabama becomes a statewide locality as

the Birmingham GAF exceeds the State GAF by only 2.68 percent. Using a

threshold of 2.5 percent, Birmingham would remain a distinct FSA, while

the other five localities would become one residual FSA as none of the

other current localities exceed the State GAF by 2.5 percent.

Option 1 has several advantages over Options 2, 3, and 4. By using

the current localities as building blocks, it is the most conservative

of the options, is likely to be the least disruptive to physicians, and

imposes the least administrative burden on HCFA and the Medicare

carriers. GAFs for the largest, highest priced cities and metropolitan

areas will not change under this option. Neither will the GAFs of

current single locality States change. Many smaller cities and rural

areas are combined into residual State areas, eliminating GAF

differences among these areas and, thereby, increasing payments in

rural areas and substantially reducing the number of localities. Since

these areas usually have the smallest price input differences,

combining them reduces the number of FSAs at the smallest loss in

accuracy of input price tracking. In summation, Option 1 tends to

divide States with large variation in input prices among localities

into multiple FSAs, albeit significantly fewer than now exist in these

States, while combining localities in States with little price

variation into a single statewide locality.

However, the standard version of Option 1 has two shortcomings.

First, some mid-sized metropolitan areas in large States such as

California and Texas do not remain distinct FSAs despite their

considerably higher input prices than in the rural and small city areas

of their States with which they would be combined into a single

residual area. Second, some large metropolitan areas in small States,

such as Baltimore, Maryland, do not remain distinct FSAs. This is

because the State GAF to which all locality GAFs are compared contains

the high cost area GAFs. This makes it difficult for the mid-sized

areas in large States to exceed the State GAF, even though their own

GAFs may substantially exceed the GAF of all other localities in the

residual area to which they would be assigned under Option 1. In large

States with a wide range of GAFs, the mid-sized cities and metropolitan

areas tend to be combined with the residual rest-of-State area. Their

GAFs are sharply reduced, lessening the accuracy of input price

tracking and creating large boundary differences in GAFs between large

and mid-sized cities and at rural State boundaries that are not

reflective of true input price differences.

For example, with the current payment localities, the contiguous

California counties of Los Angeles and Ventura have 1996 GAFs of 1.103

and 1.079, respectively, a 2.4 percentage point difference. Under

Option 1, with a 2.5-percent threshold, Ventura becomes part of the

residual State area. Its GAF is reduced to 1.012, while Los Angeles's

GAF remains at 1.103, a difference of 9.1 percentage points. Other

examples of this large boundary effect, all assuming a 2.5-percent

threshold, are: San Francisco versus Marin, California (1.153/1.063

currently versus 1.153/1.012 under Option 1); Dallas versus Fort Worth,

Texas (1.006/0.977 currently versus 1.006/0.934 under Option 1). In the

case of Baltimore, its GAF of 1.032 is primarily responsible for

bringing the State GAF up to 1.016. Under Option 1, with a 2.5-percent

threshold, it becomes part of a single statewide locality (excluding

Maryland counties in the Washington, D.C. locality) with a GAF of

1.016, when in reality it is much more expensive than the rest of the

State, which has a combined GAF excluding Baltimore of 0.964.

These problems are addressed in our proposed option, Option 1i, 5-

percent threshold, a variant of Option 1. In this variant, the GAF of a

locality is compared to the average GAF of lower-price localities in

the State, rather than to the statewide average. (Like standard Option

1, the 22 States currently having single statewide localities remain

statewide localities.) If this difference exceeds a percentage

threshold, 5 percent in our proposal, the locality remains a distinct

FSA. Otherwise, it becomes part of a statewide or rest-of-State

residual FSA. Specifically, a State's localities are ranked from the

highest to the lowest GAF. The GAF of the highest-price locality is

compared to the weighted average GAF of all lower-price localities. If

the percentage difference exceeds a specified threshold,

[[Page 34619]]

the highest-price locality remains a distinct FSA. If not, the State

becomes a single statewide locality. If the highest-price locality

remains a distinct FSA, the process is repeated (iterated, hence the

designation Option 1i) for the second-highest-price locality. Its GAF

is compared to the statewide average GAF excluding the two highest-

price localities. If this difference exceeds the threshold, the second-

highest-price locality remains a distinct FSA. The logic is repeated

(iterated), moving down the ranking of localities by costliness, until

the highest-price locality does not exceed the threshold and does not

remain a distinct FSA. No further comparisons are made, and the

remaining localities become a residual rest-of-State FSA. The GAF of a

locality always is compared only to the average GAF of all lower-price

localities. This ensures that the statewide or residual State FSA has

relatively homogeneous input prices.

Option 1i, thus, has all of the advantages of Option 1, while

addressing the problems inherent in Option 1: unwarranted boundary

differences and large higher-price areas not being separate FSAs in

small States. In comparison to Option 1, Option 1i breaks out more

payment areas in large States containing a wide range of GAFs by

defining more mid-sized cities/areas as distinct FSAs; it more

consistently defines homogeneous residual State FSAs; and reduces

unwarranted boundary differences.

As with Option 1 and Option 2, numerous variants of Option 1i are

possible depending on the GAF threshold difference selected. We are

proposing Option 1i with a 5-percent threshold. We believe that this

option would attain the goal of simplifying the payment areas and

reducing payment differences among areas while maintaining accuracy in

tracking input prices.

A summary measure of an FSA option's accuracy in tracking input

prices is the average percentage difference between the county GAF and

the GAF of the payment locality to which that county is assigned. These

differences are weighted by total physician services RVUs in each

county so that inaccuracies in areas where more services are provided

are emphasized. A summary measure of payment differences among adjacent

geographic areas in an FSA option is the average difference of the GAFs

between unique pairs of contiguous counties, weighted by the sum of the

RVUs of the two counties. Table 2 shows these summary measures of input

price accuracy and small area payment differences for proposed Option

1i, 5-percent threshold, compared to the current localities, statewide

localities, and the extremes of a national fee schedule (the same

payment everywhere for a specific service) and separate FSAs for all

3,223 counties.

Table 2.--Payment Accuracy and Small Area Payment Difference

----------------------------------------------------------------------------------------------------------------

Average Average

county/FSA county

Fee schedule area Number of input price boundary

FSAs difference* difference*

(percent) (percent)

----------------------------------------------------------------------------------------------------------------

National................................................................. 1 6.86 0.00

States................................................................... **53 4.06 0.73

Option 1i, 5% Threshold.................................................. 87 2.09 1.78

1996 Localities.......................................................... 210 1.67 2.30

Counties................................................................. 3223 0.00 3.18

----------------------------------------------------------------------------------------------------------------

* Weighted by total physician services RVUs.

** Includes Washington D.C., Puerto Rico, and the Virgin Islands.

Note: Input price accuracy is measured by the average absolute difference (weighted by total county RVUs)

between the county GAF and the FSA GAF. Boundary differences are measured by the average absolute difference

in county GAFs between all unique, contiguous county pairs, weighted by the sum of total RVUs of the

contiguous counties.

At one extreme is a single national FSA with no geographic

adjustments. Lack of a GAF obviously does not track input prices at

all, resulting in an average payment error of 6.86 percent, but also

avoids any payment boundary differences. At the other extreme is an FSA

for each of the 3,223 counties, which perfectly tracks county input

prices, but has the largest number of, and largest average difference

across, payment boundaries. These two extremes highlight the tradeoff

between tracking input price variations and avoiding differences among

nearby areas.

The current payment localities result in an average payment error

of 1.67 percent, with an average difference across boundaries of 2.30

percent. Our proposed Option 1i, 5-percent threshold, by itself,

without the subcounty payment restructuring discussed below, would

significantly reduce the number of payment areas from 210 to 87. It

would reduce the average county boundary difference from 2.30 percent

to 1.78 percent while increasing the average county input price error

by only 0.42 percentage points from 1.67 percent to 2.09 percent.

b. Proposed Option 1i, 5-Percent Threshold, with Subcounty Payment Area

Restructuring

We further propose to refine payment areas by combining with

proposed Option 1i, 5-percent threshold, an additional restructuring of

localities in the 11 States that currently have subcounty localities.

Three of these States--California, Mississippi, and Pennsylvania--

define subcounty localities by zip code. Eight States--Arizona,

Connecticut, Kentucky, Massachusetts, Missouri, Nevada, New York, and

Oregon employ city/town limits to define localities. The use of

subcounty localities creates unnecessary complexity and administrative

burden. One of the most compelling reasons to eliminate subcounty

payment areas from payment localities is to reduce the administrative

work required to maintain zip-code-to-locality crosswalks. Many States

employ a zip-code-to-locality crosswalk when processing claims, but the

continuous creation, deactivation, and redefinition of U.S. Postal

Codes poses a significant obstacle in the maintenance of accurate

locality definitions. Town boundaries can also be ambiguous. Since

county boundaries are unambiguous and rarely change, aggregating

subcounty parts to the county level would minimize the administrative

burden of maintaining crosswalks.

[[Page 34620]]

Another reason to eliminate subcounty localities is simplicity. By

aggregating subcounty areas to the county level, a uniform fee schedule

system with no area smaller than a county can be introduced nationwide.

Furthermore, since the input price data for GPCIs, and ultimately GAF

values, are not available at a subcounty level, the subcounty areas

provide no additional accuracy in measuring practice input price

variations. More often, subcounty localities unnecessarily complicate

the calculation of GAF values by requiring laborious tracking by zip

code of the subcounty parts. The obvious method for eliminating

subcounty localities is to expand a current locality's city/town or zip

code boundaries to the surrounding county borders. In exploring this

option, we defined ``County Equivalent Localities'' based on the

following criteria:

For a current locality that includes multiple cities/towns

in noncontiguous counties, all counties with any areas in the current

locality are incorporated into the new County Equivalent Locality

definition.

Counties currently divided between two localities are

assigned to the locality where the largest portion of physician fee

schedule services (RVUs) are provided.

The County Equivalent Option may be applied to the 11 subcounty

locality States independent of our proposed basic Option 1i, indeed

independent of any other changes in payment localities. When adopted

with our basic Option 1i, 5-percent threshold, changes are made

automatically or easily in 8 of the 11 States:

Five States--Arizona, Connecticut, Kentucky, Mississippi,

and Nevada become statewide payment areas.

California currently has eight subcounty areas, all of

which are in Los Angeles County. These areas have the same GAF and

payment level and can be aggregated into a single FSA. (These eight

localities were kept separate from 1992 to 1995 to facilitate the

statutory fee schedule transition period.)

In New York, existing subcounty areas are included in the

residual rest-of-State area.

In Oregon, the current town-based ``Portland'' locality,

which includes parts of Clackamas, Multnomah, and Washington counties,

can be redefined to encompass the boundaries of these three counties.

Because of their unique circumstances, we believe the remaining

three subcounty FSA States of Massachusetts, Missouri, and Pennsylvania

require simple fundamental payment area reconfigurations.

Massachusetts--Massachusetts currently has two noncontiguous

payment areas: ``Urban'' and ``Suburban.'' Under Option 1i, 5-Percent

Threshold, Massachusetts would become a single statewide locality. The

shortcoming of both the current localities and Option 1i, 5-Percent

Threshold, is that the high cost Boston area, comprised of parts of

Suffolk, Norfolk, and Middlesex counties, is not separated from lower-

cost central and western Massachusetts. The problem is caused by the

composition of the current ``Urban Massachusetts'' locality, which

groups the Worcester, Springfield, and Pittsfield areas with the

substantially higher-cost Boston area. We, therefore, propose to change

Massachusetts to two new localities: 01--Boston Metropolitan Area

(comprised of Suffolk, Norfolk, and Middlesex counties) and 02--rest of

Massachusetts.

Missouri--Missouri currently has seven noncontiguous payment areas:

Northern Kansas City; Kansas City; St. Louis/large East Cities; St

Joseph; Rural Northwest counties; small East Cities; and rest of

Missouri. Under our proposed Option 1i, 5-Percent Threshold, Missouri

would become a statewide payment area. This result would fail to

recognize the significant price differences between the Kansas City and

St. Louis metropolitan areas and the rest of the State and would result

in significant payment area input price difference tracking

inaccuracies. To correct this problem, we propose to change Missouri to

three payment areas: 01--Kansas City Metropolitan Area (Platte, Clay,

and Jackson counties); 02--St Louis Metropolitan Area (St Louis City,

St. Louis, Jefferson, and St Charles counties); and 03--rest of

Missouri (all other counties).

Pennsylvania--Pennsylvania currently has four noncontiguous payment

localities: 01--Philadelphia/Pittsburgh medical schools; 02--large

Pennsylvania Cities; 03--smaller Pennsylvania Cities; and 04--rest of

Pennsylvania. Under proposed Option 1i, 5-Percent Threshold, areas 03

and 04 are combined into a residual rest-of-State area. The problem is

that the high cost Philadelphia area is split into two areas, parts of

01 and 02, and is not clearly distinguished from the lower-cost

Pittsburgh area and the rest of area 02. The five counties comprising

the Philadelphia MSA are the most costly in Pennsylvania and clearly

belong together in a ``Philadelphia Metropolitan Area'' locality.

Allegheny County, which contains Pittsburgh and, therefore, part of

which is grouped with part of Philadelphia in locality 01, is much less

expensive than the Philadelphia area and does not belong in the same

locality, either cost-wise or geographically. Thus, we propose that

Pennsylvania be divided into two localities: 01--Philadelphia

Metropolitan Area (Montgomery, Philadelphia, Delaware, Bucks, and

Chester counties); and 02--rest of Pennsylvania (all other counties).

c. Effects of Proposed Option 1i, 5-Percent Threshold, with Subcounty

FSA Restructuring

We believe that our proposed restructuring of Medicare payment

areas meets the major goal of simplifying payment areas and reducing

payment differences among adjacent geographic areas while maintaining

accuracy in tracking input prices among areas. It significantly reduces

the number of FSAs from 210 to 89, and increases the number of

statewide payment areas from 22 to 34, thereby simplifying program

administration. It also provides a more rational and understandable

basis for localities, reduces urban/rural payment differences, and

maintains separate payment areas for relatively high-priced large and

mid-sized cities in large States. It decreases the number of payment

areas by almost 60 percent, while at the same time reducing average

county boundary payment differences, yet reduces average county input

price accuracy by only 0.42 percent.

The GPCIs, and, therefore, the GAFs, for the proposed new payment

areas would be budget neutral within each State. That is, an adjustment

would be made to them later in the year (to incorporate the most recent

data into the adjustments) to yield the same total physician fee

schedule payments within that State that would have been made had the

payment areas not been changed. We are anticipating the adjustments to

be minor. While some current individual payment areas will experience

slight increases in payments and some areas will experience slight

decreases in payments under our proposed FSA changes, the effects on

the overwhelming majority of areas will be minimal. Of the total

current areas in the 28 States currently having multiple FSAs, 82

percent change less than 3 percent, 93 percent change less than 4

percent, and 96 percent change less than 5 percent. Forty-three percent

of the areas will experience increases in payments, 33 percent will

experience decreases, and 24 percent will experience no change.

Addendum A, ``1996 Geographic Adjustment Factors (GAFs) by Medicare

Payment Locality/

[[Page 34621]]

Locality Part for January 1, 1996 Localities and Proposed Option, Fee

Schedule Areas (FSAs) in Descending Order of Difference'' shows the

effects for each of the current localities in multiple FSA States (as

previously mentioned, the 22 States currently having a single statewide

locality remain statewide localities) of our proposed locality

reconfiguration by comparing existing GAFs to the GAFs for the new

localities. Because our proposal eliminates subcounty areas, we are

also publishing Addendum B, ``Medicare Fee Schedule Areas (Localities)

and 1996 Geographic Adjustment Factors (GAFs), Current and Proposed

Option by State and County/County Part'' that shows, alphabetically by

State and county, the current locality and GAF and the proposed

locality and GAF for each county.

As can be seen from Addendum A, only four areas will lose more than

4 percent under our proposal: Pennsylvania area 01, Philadelphia/

Pittsburgh Medical Schools; Pennsylvania area 02, large Pennsylvania

Cities; Missouri area 01, St. Louis/large Eastern Cities; and

Massachusetts area 01, Urban Massachusetts. These are unique situations

and require explanation. As the asterisks on these areas indicate,

these losing areas are only part of an existing locality and are in

States in which we are recommending fundamental restructuring of FSAs

because of existing subcounty FSAs and the current combining of areas

with widely different input prices into a single area. In actuality,

only part of the existing area will lose. As Addendum A shows, the

remaining part of the area will win under our proposal. For example,

the largest projected loser, Pennsylvania area 01, is in reality only

the part of Pittsburgh that is currently included in area 01. The

Philadelphia portion of Pennsylvania area 01 is a projected winner

under our proposal. As mentioned earlier, while Pittsburgh is in

Allegheny County, which has considerably lower input prices than the

Philadelphia area, part of Pittsburgh is included with part of

Philadelphia in area 01. This has the effect of overpaying the

Pittsburgh part of area 01 and underpaying the Philadelphia part of

area 01. Our proposal remedies this situation by grouping Philadelphia

with similar priced counties in the Philadelphia MSA, while grouping

Pittsburgh with similar priced areas in the rest of Pennsylvania. This

also explains why Pennsylvania area 02 shows up as both one of the four

largest losers and as the largest winner. Under our proposal, the part

of area 02 comprised of larger cities outside of the Philadelphia MSA

is no longer included with the higher priced counties in the

Philadelphia MSA, but is included in the residual Pennsylvania FSA.

This lowers their GAFs, while increasing the GAFs of the higher priced

counties in the Philadelphia MSA that now become part of the

Philadelphia FSA.

The same logic holds true for Massachusetts and Missouri. The

losing parts of current Massachusetts locality 01 are the Worcester,

Springfield, and Pittsfield areas which, while having substantially

lower costs than Boston, are currently included in the same locality.

The winning part of Massachusetts locality 01 is the higher-cost Boston

metropolitan area. In Missouri, the losing parts of locality 01, St.

Louis/large East Cities, are the lower-cost Columbia, Springfield, and

Jefferson City areas that are currently included with higher-cost St.

Louis. The winning part of this locality is the St. Louis metropolitan

area. These four largest losing areas then result from our correcting

the current anomalous situation created by including low-cost and high-

cost areas in a single locality by reconfiguring the localities to more

accurately reflect input price variations.

We welcome comments on our proposed payment area changes. Our

proposal is based on the application of statistical criteria to

aggregate localities within a State that are not significantly

different as indicated by current GAFs. We would welcome alternative

rationale and criteria for exceptions to this statistically based

methodology. While we are open to considering exceptions to this

statistically based realignment, commenters suggesting variations on

our proposal should submit an analysis of why their variation is

preferable. For example, commenters suggesting that their particular

area, which would become part of a residual rest-of-state area under

our proposal, should be retained as a separate payment area should

submit data to show that their area costs exceed the costs of the other

areas in the residual payment area by the 5-percent threshold.

As mentioned earlier, the great majority of existing FSAs would

experience only very minor changes in payment levels under the proposed

new payment area configuration. We are concerned, however, about the

few areas estimated to experience the largest reductions in payments.

To lessen the impact on these areas, we propose phasing in the effect

of the proposed new payment areas over a 2-year period in States

containing a locality that is estimated to experience a decrease in

payments that exceeds a certain threshold. We selected a 2-year period

because when we implement the GPCI revisions required by law every 3

years, the law provides for a 2-year transition period. Revising

localities requires calculating GPCIs to correspond to the revised

localities.

A transition period, however, adds another element to the changes

to the physician fee schedule. For example, the law requires that the

conversion factor be updated each year. In addition, we annually add

new RVUs for new and revised services. In 1997, we will implement the

comprehensive changes in work RVUs required by law. In 1998, the law

requires us to implement new resource-based practice expense RVUs. In

1998 and 1999, we will implement new GPCIs as required by law. A

transition period for our locality changes would add one more payment

change to these other changes. Since most payment areas would

experience very minor changes, we believe that transitioning these

areas would unnecessarily add another change.

Since the purpose of the proposed phase-in is to limit the effect

on the areas estimated to experience the largest decrease in payments

because of our proposed payment area revisions, we propose that no area

be allowed to lose more than 4 percent in the first year. We selected

the 4-percent threshold because that is about one-half of the largest

estimated area payment decrease. The proposed payment area changes

would be fully effective in 1997 in all States not containing an area

whose payments are estimated to decrease by more than 4 percent under

our proposal. Under this phase-in, only two States, Pennsylvania and

Missouri, would be transitioned as they are the only States with areas

that would experience a decrease of more than 4 percent. In these

States, areas estimated to lose more than 4 percent would be assigned

1997 GPCIs whose values would limit the loss to 4 percent. Since the

proposed new payment area changes would be budget-neutral within a

State, all areas within a State would be subject to the 2-year phase-in

if the State contained an area whose payment level is estimated to

decrease by more than 4 percent. This means that areas estimated to

receive increases in payments in these States would receive only part

of the increase in 1997 as transitional 1997 GPCIs would be calculated

to maintain budget neutrality within the State. In 1998, all areas in

these transitioned States would be totally incorporated into their new

localities and be assigned the fully implemented new locality GPCIs. We

have designed this transition approach

[[Page 34622]]

to cushion the effect of the change for the localities that would be

experiencing the greatest losses. We invite comments on this transition

proposal and are open to suggestions about alternative transition

approaches.

Our proposal would leave 16 States with multiple payment areas. We

believe our proposal justifies multiple areas in these States because

of input price differences within these States. However, as stated

earlier in the background discussion on this issue, we are generally in

favor of statewide payment areas as they simplify program

administration and encourage physicians to practice in rural areas by

eliminating urban/rural payment differentials within the State.

Therefore, to continue to be responsive to the physician community,

even if our proposed payment area reconfiguration is adopted, we will

continue to consider converting any of the remaining multiple payment

area States into a single statewide payment area if overwhelming

support among physicians in both winning and losing areas can be

demonstrated. This proposed policy change does not require a change to

the regulations set forth in Sec. 414.4 (``Fee schedule areas'').

B. Special Rules for the Payment of Diagnostic Tests, Including

Diagnostic Radiologic Procedures

1. Background

The payment for diagnostic procedures, including diagnostic

radiologic procedures, under the Medicare program is made under two

statutory benefits. Section 1861(s)(1) of the Act describes physician

services as part of the medical and other health services benefit. This

paragraph describes the professional component of a diagnostic test,

which is the interpretation of the test. Under the physician fee

schedule and the Medicare carrier payment systems, these services are

coded with the CPT modifier ``26.''

Payment for taking a test is made under section 1861(s)(3) of the

Act. We have termed the taking of a test the technical component of the

test, and it is indicated under the physician fee schedule with the

``TC'' modifier.

Section 2070.1 of the Medicare Carriers Manual provides that for a

diagnostic test to be covered, the service must be related to a

patient's illness or injury (or symptom or complaint) and ordered by a

physician. This instruction was intended to relate a diagnostic test to

a patient's illness or injury, symptom, or complaint. The results of

the test were to be used to treat the patient or refer him or her for

treatment. It has come to our attention from various sources, including

carrier medical directors, that, in some cases, the intent of this

instruction has been frustrated. We have heard of instances in which a

physician is employed for the sole purpose of ordering tests. This

physician has no relationship to the beneficiary, and it is highly

likely that tests by this physician would not be medically necessary.

We believe this practice generates unnecessary diagnostic tests and

places Medicare beneficiaries at needless risk both medically and

financially. We propose to further clarify this long-standing manual

instruction requirement that tests be ordered by a physician by

specifying that the physician ordering the test must be the physician

treating the patient. This proposed policy would link the ordering of

the diagnostic test to the physician who will use the test results to

treat the patient.

2. Proposal

We propose that for diagnostic tests, including diagnostic

radiologic procedures, to be covered, they must be ordered by the

physician who treats the beneficiary. The physician who treats the

beneficiary is the physician responsible for the treatment of the

patient and who orders the test or radiologic procedure to use the

results in the management of the beneficiary's specific medical

problem(s). (Physicians can order tests while they are consulting for

another physician.) We believe this requirement is fundamental for

coverage and payment of diagnostic tests and, therefore, are including

it in the regulations at Sec. 410.32 (``Diagnostic X-ray tests,

diagnostic laboratory tests, and other diagnostic tests: Conditions'').

3. Chiropractor Exception

A physician who orders the x-ray that is used by a chiropractor to

demonstrate the subluxation of the spine in a beneficiary who is

receiving manual manipulation treatments would be exempted from this

rule. Because no payment can be made for a diagnostic test ordered by a

chiropractor under Sec. 410.22(b)(2), we propose to allow payment for

the x-ray when ordered by a physician who will not be treating the

patient for subluxation of the spine. Otherwise, beneficiaries would

always have to pay out-of-pocket for these x-rays, which would

frustrate their use of the chiropractic benefit.

4. Non-Physician Practitioners

Certain non-physician practitioners who provide services that would

be physician services if furnished by a physician under a specific

enumerated benefit in the statute would be considered as the physician

treating the beneficiary for the purpose of this section. Non-physician

practitioners who meet this definition are physician assistants

(section 1861(s)(2)(K)(i) of the Act); and nurse practitioners and

clinical nurse specialists (sections 1861(s)(2)(K)(ii) and

1861(s)(2)(K)(iii) of the Act), operating within the scope of their

State licenses.

C. Transportation in Connection with Furnishing Diagnostic Tests

Section 1861(s)(3) of the Act establishes coverage for diagnostic

x-rays furnished in a place of residence used as the patient's home if

the performance of the tests meets health and safety conditions

established by the Secretary. This provision is the basis for payment

of x-ray services furnished by approved portable suppliers to

beneficiaries in their homes and in nursing facilities.

Although the Congress did not explicitly so state, we determined

that, because of the increased costs in transporting the x-ray

equipment to the beneficiary, the Congress intended that we pay an

additional amount for transportation expenses. Therefore, we

established HCFA Common Procedure Coding System (HCPCS) codes R0070 and

R0075 (for single-patient and multiple-patient trips, respectively) to

pay approved portable x-ray suppliers a transportation ``component''

when they furnish the services listed in section 2070.4.C of the

Medicare Carriers Manual.

We later added the taking of an electrocardiogram (EKG) tracing to

the list of services approved suppliers of portable x-ray services may

furnish (section 2070.4.F of the Medicare Carriers Manual) and

established HCPCS code R0076 to pay for the transportation of EKG

equipment. In the December 1995 final rule (60 FR 63149), we published

our revised policy of precluding separate payment for the

transportation of diagnostic equipment except under certain

circumstances. These circumstances include standard EKG procedures

furnished by an approved supplier of portable x-ray services or by an

independent physiological laboratory (section 2070.1.G of the Medicare

Carriers Manual) under HCPCS code R0076 in connection with the

provision of CPT codes 93000 (Electrocardiogram, complete) or 93005

(Electrocardiogram, tracing).

After further review of this policy, we have decided that the

exceptions are inconsistent with the law and legislative

[[Page 34623]]

history regarding the payment for transportation of EKG equipment.

Section 1861(s)(3) discusses only the coverage of x-rays furnished in a

beneficiary's place of residence. Because there is no mention in the

statute about the coverage of EKGs furnished in a beneficiary's place

of residence, we are returning to our original interpretation of the

law.

We propose allowing separate payment only for the transportation of

x-ray equipment furnished by approved suppliers of portable x-ray

services. As a result, we would not allow separate payment for the

transportation of EKG equipment furnished by any supplier. Therefore,

we propose to eliminate HCPCS code R0076. Payment for CPT codes 93000

and 93005 will not change, nor will the coverage of these services

change. This proposed policy change is not explicitly addressed in our

regulations.

D. Bundled Services

1. Hot or Cold Packs

The application of hot or cold packs to one or more areas is billed

using CPT code 97010. These modalities (that is, physical agents

applied to produce therapeutic change to biologic tissue) are primarily

used in conjunction with therapeutic procedures to provide analgesia,

relieve muscle spasm, or reduce inflammation and edema. Generally, hot

packs are used for subacute or chronic conditions, while cold packs are

used for acute and chronic conditions.

The results of a comprehensive analysis of Medicare claims data

indicate that CPT code 97010 is being used extensively with a wide

variety of services such as office visits and physical medicine and

rehabilitative services. Therefore, we are proposing to bundle payment

for CPT code 97010 into the payment for all other services including,

but not limited to, those with which it historically has been billed

with the greatest frequency (such as office visits and physical

therapy).

We believe that our proposal to bundle payment and, thus, to

preclude separate payment for the application of hot and cold packs is

justified for three reasons:

As a therapy, hot and cold packs are easily self-

administered. Generally, we do not cover procedures that are basically

self-administered; hot and cold packs, by their nature, do not require

the level of professional involvement as do the other physical medicine

and rehabilitation modalities.

Although we acknowledge that professional judgment is

involved in the use of hot and cold packs, much less judgment is

demanded for them than for other modalities. These packs are commonly

used in the home, and, thus, require a minimal level of professional

attention.

The application of hot and cold packs is usually a

precursor to other interventions and, as such, is appropriately used in

combination with other procedures. Our data analysis supports this

conclusion because the majority of claims for CPT code 97010 occurred

in conjunction with claims for other services performed on the same

day.

We propose to change the status indicator for CPT code 97010 to

``B'' to indicate that the service is covered under Medicare but

payment for it is bundled into the payment for other services. Separate

payment for CPT code 97010 would not be permitted under this proposed

change. This change would be implemented in a budget neutral manner

across all other procedures. Because the RVUs for this procedure would

be redistributed across all physician fee schedule services, there

would be no measurable impact. This proposed policy change is not

explicitly addressed in our regulations.

2. Dermatology Procedures

a. Bundling of Repair Codes into Excision Codes

Currently, the RVUs for the dermatology excision codes (CPT codes

11400 through 11446 and 11600 through 11646) include services described

by the simple repair codes (CPT codes 12001 through 12018). The

dermatologist can bill separately for the intermediate or complex

repair (closure) codes (CPT codes 12031 through 12057 and 13100 through

13152, respectively) in addition to the excision codes. We do not allow

separate billing for closure for any other surgical procedure. The

closure is included in the comprehensive procedure. We believe that

applying the same standard to dermatologists is appropriate.

Therefore, we propose to cease paying separately for the repair

codes when billed in conjunction with the excision codes. We are

proposing to bundle the RVUs for the intermediate and complex repair

codes (CPT codes 12031 through 12057 and CPT codes 13100 through 13152,

respectively) into both the benign and malignant skin lesion excision

codes (CPT codes 11400 through 11446 and 11600 through 11646,

respectively). Under our proposal, we would redistribute the RVUs for

the repair codes across CPT codes 11400 through 11446 and 11600 through

11646. We would base the number of RVUs for redistribution on the

frequency with which the repair codes are billed with the excision

codes.

We are not proposing to assign these repair codes a ``B'' status

indicator because we acknowledge that these codes are not used

exclusively with excision services. Instead, we would implement this

proposed policy change through our correct coding initiative. This

proposed change would standardize our policy for payment for wound

closure. This proposed policy change is not explicitly addressed in our

regulations.

b. Skin Lesion Destruction Codes

There are several CPT codes that describe the destruction of

various benign or premalignant lesions. Within this group of codes, the

reporting methods vary. Sometimes the code describes the destruction of

a single lesion but requires reporting multiple codes for the

destruction of several lesions; other times it describes destruction of

as many as 15 lesions. Thus, it is sometimes not clear how many codes

to report. The codes are specific to particular areas of the body or

particular types of lesions. Because these categories are not mutually

exclusive, the coding system provides the opportunity to report the

destruction of a given lesion in more than one way. Finally, this

complicated coding structure has produced anomalies in work relative

values. We propose to simplify the reporting of and payment for the

destruction of benign or premalignant skin lesions.

We propose to assign a ``G'' status indicator to CPT codes 11050

through 11052, 11200 and 11201, 17000 through 17105, 17110, and 17200

and 17201 to indicate that these CPT codes are not valid for Medicare

purposes and that there is another code to use for the reporting of and

payment for these services.

To report the destruction of benign and premalignant skin lesions,

we propose to create two HCPCS codes. The first code would describe the

destruction of up to and including 15 lesions. The second code would

describe destruction of each additional 10 lesions. To assign RVUs to

these codes, we propose to take a weighted average of the RVUs assigned

to CPT codes 11050 through 11052, 11200 and 11201, 17000 through 17105,

17110, and 17200 and 17201 based on the billing frequencies and the

code descriptors. This proposed policy change is not explicitly

addressed in our regulations.

[[Page 34624]]

E. Change in Coverage Status for Screening and Obsolete Procedures

1. Vital Capacity Testing

CPT code 94150 (Vital capacity, total) is a screening measure. It

is typically performed on patients who are asymptomatic. Because these

tests are performed on patients who do not have symptoms of breathing

problems, they represent preventive services that are, by statute, not

covered by Medicare. Some Medicare carriers do not cover this code at

present. However, we inadvertently failed to identify CPT code 94150 as

noncovered by Medicare on a national basis. Therefore, we propose

changing the status indicator for CPT code 94150 from ``A'' to ``N'' to

represent its noncovered status. This policy change is not specifically

addressed in our regulations. It would be reflected in the Medicare

physician fee schedule database and in Addendum B (Relative Value Units

and Related Information) of the physician fee schedule final rule,

which will be published later this year.

2. Certain Cardiovascular Procedures

In the absence of a national Medicare policy on the following CPT

codes, we currently allow our Medicare carriers discretion in deciding

whether to allow coverage for these procedures:

------------------------------------------------------------------------

CPT code Descriptor

------------------------------------------------------------------------

93201 Phonocardiogram with or without ECG lead; with

supervision during recording with interpretation

and report (when equipment is supplied by the

physician).

93202 Phonocardiogram * * *; tracing only, without

interpretation and report (eg, when equipment is

supplied by the hospital, clinic).

93204 Phonocardiogram * * *; interpretation and report.

93205 Phonocardiogram with ECG lead, with indirect

carotid artery and/or jugular vein tracing, and/

or apex cardiogram; with interpretation and

report).

93208 Phonocardiogram * * *; tracing only, without

interpretation and report.

93209 Phonocardiogram * * *; interpretation and report

only.

93210 Phonocardiogram intracardiac.

93220 Vectorcardiogram (VCG), with or without ECG; with

interpretation and report.

93221 Vectorcardiogram * * *; tracing only, without

interpretation and report.

93222 Vectorcardiogram * * *; interpretation and report

only.

------------------------------------------------------------------------

As a result of our request for comments on the 5-year review of

physician work RVUs in the December 1994 final rule (59 FR 63453), the

American College of Cardiology commented that these 10

phonocardiography and vectorcardiography diagnostic tests are outmoded

and of little clinical value. Our review of Medicare claims data for

these tests supports this contention because the volume of claims for

these tests has declined significantly in recent years. Only 17,925

claims were submitted in calendar year 1994 for all 10 tests.

Based on the American College of Cardiology's recommendation, our

review of our recent claims history, and our consultation with other

medical specialty groups, we propose to discontinue coverage for these

10 diagnostic tests. The status indicators for these 10 procedures

would be changed from ``A'' to ``N'' to reflect their noncovered

status. This proposed policy change is not explicitly addressed in our

regulations.

F. Payments for Supervising Physicians in Teaching Settings

1. Definition of Approved Graduate Medical Education Programs

Since publication of the December 1995 final rule, we have received

questions about the difference in the definition of an approved

residency program for purposes of the teaching physician rules under

Sec. 415.152 (``Definitions'') and the definition used in the direct

medical education rules under Sec. 413.86(b) (``Direct graduate medical

education payments''). To be consistent, we propose to modify

Sec. 415.152 to match the definition of an approved graduate medical

education program in Sec. 413.86(b). We would add a reference to

programs that are recognized as an ``approved medical residency

program'' under Sec. 413.86(b). By making this change, the regulations

text would reflect a common definition of approved graduate medical

education programs for Medicare Part A and Part B. This is a technical

change and would have no effect on the implementation of our revised

policy regarding the payment for supervising physicians in teaching

settings that is effective July 1, 1996.

2. Evaluation and Management Services Furnished in Certain Settings

In the December 1995 final rule (60 FR 63135), we revised our

policy regarding the payment for supervising physicians in teaching

settings. We eliminated the attending physician criteria but clarified

the physician presence requirement for services billed to the Medicare

carrier. As part of our revised policy, we created a limited exception

for residency programs that are fundamentally incompatible with a

physical presence requirement. The exception to the physician presence

requirement is for certain evaluation and management services (CPT

codes 99201, 99202, 99203, 99211, 99212, and 99213) furnished in

certain ambulatory care centers within the context of certain types of

residency training programs. The exception is set forth in Sec. 415.174

(``Exception: Evaluation and management services furnished in certain

centers'').

As the exception currently reads, one of the criteria is that ``The

range of services furnished by residents in the center includes * * *

Comprehensive care not limited by organ system, diagnosis, or gender.''

(Sec. 415.174(a)(4)(iii)). It has come to our attention that many

obstetric and gynecological residency programs have been restructured

over the years to have a greater primary care focus. Some of these

programs that otherwise qualify for an exception might be denied

payment if the gender limitation were strictly applied.

Contrary to suggestions in correspondence we received after

publication of the final rule, it was not our intention to prevent

obstetric and gynecological residency programs or other residency

programs focusing on women's health care from qualifying for the

exception solely because of the patient's gender. Thus, we propose to

make a technical change to the regulations text to delete the reference

to gender in Sec. 415.174(a)(4)(iii) and change the text to

``Comprehensive care not limited by organ system or diagnosis.'' Of

course, such programs must satisfy the otherwise applicable criteria to

qualify for an exception.

[[Page 34625]]

G. Change in Global Periods for Four Percutaneous Biliary Procedures

The Society of Cardiovascular and Interventional Radiology advised

us that a 90-day global period is inappropriate for four percutaneous

biliary procedures. The four procedures are CPT codes 47490

(percutaneous cholecystectomy), 47510 (introduction of percutaneous

transhepatic catheter for biliary drainage), 47511 (introduction of

percutaneous transhepatic stent for internal and external biliary

drainage), and 47630 (biliary duct stone extraction, percutaneous via

T-tube tract, basket, or snare (for example, Burhenne technique)). The

Society believes that these four procedures should have a ``0-day''

global period. We agree with the Society's arguments that a 90-day

global period is contrary to the widespread practice conventions of

percutaneous biliary intervention and is inconsistent with other

similar interventions in the biliary tract and urinary tract.

We believe that the global periods for these four codes should be

changed. Therefore, we are proposing to change the global periods for

these services from 90 days to 0 days. To make this change, we would

reduce the work RVUs assigned to these procedures to reflect the lack

of postsurgical work in the shortened global period. We propose to

reduce the work RVUs for CPT codes 47490, 47510, 47511, and 47630 by 17

percent if we change the global periods. The 17 percent figure was

taken from the original data developed by the Harvard School of Public

Health Resource-Based Relative Value Study as the measure of the

postsurgical work associated with these codes. This proposed policy

change is not explicitly addressed in our regulations.

III. Collection of Information Requirements

This document does not impose information collection and

recordkeeping requirements. Consequently, it need not be reviewed by

the Office of Management and Budget under the authority of the

Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

IV. 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 preamble, and, if we proceed with a subsequent

document, we will respond to the comments in the preamble to that

document.

V. Regulatory Impact Analysis

A. Regulatory Flexibility Act

Consistent with the Regulatory Flexibility Act (5 U.S.C. 601

through 612), we prepare a regulatory flexibility analysis unless the

Secretary certifies that a rule would not have a significant economic

impact on a substantial number of small entities. For purposes of the

Regulatory Flexibility Act, all physicians are considered to be small

entities.

We anticipate that virtually all of the approximately 500,000

physicians who furnish covered services to Medicare beneficiaries would

be affected by one or more provisions of this rule. In addition,

physicians who are paid by private insurers for non-Medicare services

would be affected to the extent that they are paid by private insurers

that choose to use the proposed RVUs.

This proposed rule is expected to have varying effects on the

distribution of Medicare physician payments and services. With few

exceptions, we expect that the impact would be limited. Although the

proposed rule would not have a significant economic impact on a

substantial number of small entities, we are preparing a voluntary

regulatory flexibility analysis.

Section 1848(c)(2)(B) of the Act requires that adjustments in a

year may not cause the amount of expenditures for the year to differ by

more than $20 million from the amount of expenditures that would have

been made if these adjustments had not been made. If this threshold is

exceeded, we would make adjustments to the conversion factors to

preserve budget neutrality. The proposals discussed in sections B

through H below would have no impact on total Medicare expenditures

because the effects of these changes would be neutralized in the

calculation of the conversion factors for 1997.

B. Payment Area (Locality) and Corresponding Geographic Practice Cost

Index Changes

As mentioned earlier, our proposal would reduce existing urban/

rural payment differences. Overall, urban areas would experience an

average decrease in payments of -0.14 percent, while rural areas will

experience an increase in payments of 1 percent. We analyzed the

effects of these changes on physicians by specialty. The changes are

quite small and follow the expected pattern. We estimate that overall,

physicians in family practice and general practice will experience

modest increases of about 0.3 percent in payments, while most medical

and surgical specialties will experience negligible decreases of about

-0.1 to -0.2 percent. This pattern results from the tendency of

specialists to be disproportionately concentrated in urban areas, which

are estimated to experience a slight decrease in payments under our

proposal.

The impact on beneficiaries is likewise minor. We examined the

impact by beneficiary age, gender, race, and income level. Roughly 20

percent of beneficiaries reside in areas in which payments decrease by

less than 5 percent, roughly 50 percent live in areas that experience

no change in payments, roughly 25 percent live in areas where payments

will increase by less than 5 percent, and about 2 percent live in areas

where payments would rise by 5 to 10 percent.

The distribution of beneficiaries by age and gender and of

Caucasian beneficiaries are nearly identical to this overall

distribution. Minority beneficiaries are more heavily concentrated in

areas that experience no change in payments; a lower proportion of

minority beneficiaries live in both areas experiencing a loss and areas

experiencing a gain than do Caucasian beneficiaries. For example, 14.4

percent of minority beneficiaries live in an area experiencing a loss

compared to 21 percent of all beneficiaries who live in these areas.

Beneficiaries living below poverty level are less likely than all

beneficiaries to be living in an area experiencing a payment decrease

under our proposal, 16 percent compared to 21 percent. It does not

appear that vulnerable Medicare groups--minorities, the very old, or

the poor--would suffer decreases in access resulting from our proposal.

C. Special Rules for the Payment of Diagnostic Tests, Including

Diagnostic Radiologic Procedures

Our proposal would require that, to be covered under Medicare,

diagnostic tests, including diagnostic radiologic procedures, must be

ordered by the physician who treats a beneficiary or furnishes a

consultation to the physician who treats the beneficiary. We would

allow an exception for x-rays that demonstrate subluxation of the spine

that are ordered for a chiropractor. Under Sec. 410.22(b)(2), no

payment can be made to a chiropractor who orders diagnostic tests. We

propose to allow payment for these x-rays when ordered by a physician

who will not be treating the patient for subluxation of the spine.

[[Page 34626]]

Non-physician practitioners functioning within the specific benefit

would be considered the physician treating the beneficiary for the

purpose of the proposal. Putting this requirement in regulations

(Sec. 410.31 ``Diagnostic x-ray tests, diagnostic laboratory tests, and

other diagnostic tests: Conditions'') would codify our current manual

instruction. This proposed policy may result in some program savings

due to the denial of payment for tests that may not be medically

necessary because they were ordered by a physician who was not treating

the beneficiary. However, we do not have sufficient data to furnish any

reliable estimates of savings.

D. Transportation in Connection with Furnishing Diagnostic Tests

We propose to eliminate payment for the transportation of EKG

equipment (HCPCS code R0076) by all billers. In 1994, the last year for

which we have complete data, we allowed 260,686 services and paid

$9,192,434. Therefore, were it not for our budget-neutrality

adjustment, we estimate that this proposal would result in

approximately a $9.2 million reduction in Medicare payments.

E. Bundled Services

1. Hot or Cold Packs

We propose to change the status indicator for CPT code 97010

(Application of a modality to one or more areas; hot or cold packs) to

``B'' to indicate that the service is covered under Medicare but

payment for it is bundled into payment for other services. Separate

payment for CPT code 97010 will not be permitted under this proposed

change. The annual expenditures for CPT code 97010 under our current

policy are approximately $41.2 million. Because the RVUs for this

procedure will be redistributed across all physician fee schedule

services in a budget neutral manner, there will be no measurable impact

from this proposal.

2. Dermatology Procedures

a. Bundling of Repair Codes into Excision Codes We propose to cease

paying separately for CPT codes 12031 through 12057 and 13100 through

13152 (intermediate and complex repair codes, respectively) if these

codes are billed in conjunction with CPT codes 11400 through 11446 and

11600 through 11646 (dermatology excision codes for benign and

malignant lesions, respectively). Because we would redistribute the

RVUs for the repair codes across the excision codes, there would be

little budgetary effect from this proposal.

b. Skin Lesion Destruction Codes

We propose to change the way Medicare pays for the destruction of

benign or premalignant skin lesions. Currently there are several CPT

codes that describe a variety of ways of reporting the destruction of

skin lesions. We propose to assign a ``G'' status code to CPT codes

11050 through 11052, 11200 and 11201, 17000 through 17105, 17110, and

17200 and 17201 and create two HCPCS codes to report the destruction of

skin lesions. Because we will use a weighted average of the current

RVUs assigned to the CPT codes that describe the destruction of benign

or premalignant skin lesions in valuing the two proposed codes, this

proposal would have no significant impact on Medicare expenditures.

F. Change of Coverage Status for Screening and Obsolete Procedures

1. Vital Capacity Testing

We propose changing the coverage status for vital capacity tests

(CPT code 94150) from ``active'' to ``noncovered.'' These vital

capacity tests are screening services. With limited exceptions, section

1862(a)(1)(A) of the Act precludes Medicare coverage for screening

procedures. This code is infrequently billed; in 1994 only 101,150

services were paid for CPT code 94150 for a total Medicare expenditure

of $1,077,600. We do not believe that the change in coverage status

would have a significant impact on Medicare expenditures. We would also

budget neutralize the $1 million across all fee schedule services.

2. Certain Cardiovascular Procedures

We propose changing the coverage status for certain cardiovascular

procedures (CPT codes 93201, 93202, 93204, 93205, 93208, 93209, 93210,

93220, 93221, and 93222) to noncovered. Because there has been a

decline in the billing of these services in recent years and in 1994,

we only allowed a total of 17,925 services with $690,326 in allowed

charges for all 10 diagnostic tests, we do not believe that the change

in coverage status would have a significant impact on Medicare

expenditures.

G. Payments for Supervising Physicians in Teaching Settings

This proposed rule would make a technical change to Sec. 415.152

(``Definitions'') to make the definition of an approved graduate

medical education program consistent with the definition in

Sec. 413.86(b) (``Direct graduate medical education payments'').

Because this is only a technical change to standardize almost identical

definitions, it would have no budgetary impact on Medicare

expenditures.

We propose a technical change to remove the word ``gender'' from

Sec. 415.174(a)(4)(iii) (``Exception: Evaluation and management

services furnished in certain centers''). We did not include the

reference to gender with the intention of excluding obstetric and

gynecological or other women's care residency programs solely because

of patient gender. This technical change would make clear that the

exception criteria would not be applied in such a manner. Because this

technical change merely clarifies our intent with respect to a policy

that has not yet been implemented, there would be no budgetary effect.

H. Change in Global Period for Four Percutaneous Biliary Procedures

To implement our proposal to change the global periods for four

percutaneous biliary procedures (CPT codes 47490, 47510, 47511, and

47630) from 90 days to 0 days, we are proposing to reduce the work RVUs

for these procedures by 17 percent. These work RVUs will be

redistributed across all services; therefore, there is no significant

impact.

I. Rural Hospital Impact Statement

Section 1102(b) of the Act requires the Secretary to prepare a

regulatory impact analysis if a rule may have a significant impact on

the operations of a substantial number of small rural hospitals. This

analysis must conform to the provisions of section 603 of the

Regulatory Flexibility Act. For purposes of section 1102(b) of the Act,

we define a small rural hospital as a hospital that is located outside

of a Metropolitan Statistical Area and has fewer than 50 beds.

This proposed rule would have little direct effect on payments to

rural hospitals since this rule would change only payments made to

physicians and certain other practitioners under Part B of the Medicare

program and would

[[Page 34627]]

make no change in payments to hospitals under Part A. We do not believe

the changes would have a major, indirect effect on rural hospitals.

Therefore, we are not preparing an analysis for section 1102(b) of

the Act since we have determined, and the Secretary certifies, that

this rule would not have a significant impact on the operations of a

substantial number of small rural hospitals.

In accordance with the provisions of Executive Order 12866, this

proposed rule was reviewed by OMB.

List of Subjects

42 CFR Part 410

Health facilities, Health professions, Kidney diseases,

Laboratories, Medicare, Rural areas, X-rays.

42 CFR Part 415

Health facilities, Health professions, Medicare, and Reporting and

recordkeeping requirements.

42 CFR chapter IV would be amended as set forth below:

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

A. Part 410 is amended as set forth below:

1. The authority citation for part 410 continues to read as

follows:

Authority: Secs. 1102 and 1871 of the Social Security Act (42

U.S.C. 1302 and 1395hh), unless otherwise indicated.

2. In Sec. 410.32 paragraphs (a) and (b) are redesignated as

paragraphs (b) and (c), respectively, and a new paragraph (a) is added

to read as follows:

Sec. 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and

other diagnostic tests: Conditions.

(a) Ordering diagnostic tests. All diagnostic x-ray tests,

diagnostic laboratory tests, and other diagnostic tests must be ordered

by the physician who treats the beneficiary, that is, the physician who

is actively furnishing a consultation or treating a beneficiary for a

specific medical problem(s) and uses the results in the management of

the beneficiary's specific medical problem(s). Physicians who order the

x-ray used by a chiropractor to demonstrate the subluxation of the

spine in a beneficiary who is receiving manual manipulation treatments

are exempted from this requirement. Non-physician practitioners

(physician assistants, nurse practitioners, and clinical nurse

specialists) who provide services that would be physician services if

furnished by a physician and who are operating within the scope of

their statutory benefit are considered the physician treating the

beneficiary for the purpose of this section.

* * * * *

PART 415--SERVICES FURNISHED BY PHYSICIANS IN PROVIDERS,

SUPERVISING PHYSICIANS IN TEACHING SETTINGS, AND RESIDENTS IN

CERTAIN SETTINGS

B. Part 415 is amended as set forth below:

1. The authority citation for part 415 continues to read as

follows:

Authority: Secs. 1102 and 1871 of the Social Security Act (42

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

2. In Sec. 415.152 the introductory text is republished, and the

definition of ``approved graduate medical education (GME) program'' is

revised to read as follows:

Sec. 415.152 Definitions.

As used in this subpart--

Approved graduate medical education (GME) program means one of the

following:

(1) A residency program approved by the Accreditation Council for

Graduate Medical Education of the American Medical Association, by the

Committee on Hospitals of the Bureau of Professional Education of the

American Osteopathic Association, by the Council on Dental Education of

the American Dental Association, or by the Council on Podiatric

Medicine Education of the American Podiatric Medical Association.

(2) A program otherwise recognized as an ``approved medical

residency program'' under Sec. 413.86(b) of this chapter.

* * * * *

Sec. 415.174 [Amended]

3. In Sec. 415.174, in paragraph (a)(4)(iii), the phrase ``system,

diagnosis, or gender'' is removed, and the phrase ``system or

diagnosis'' is added in its place.

(Catalog of Federal Domestic Assistance Program No. 93.774,

Medicare--Supplementary Medical Insurance Program)

Dated: June 21, 1996.

Bruce C. Vladeck,

Administrator, Health Care Financing Administration.

Dated: June 21, 1996.

Donna E. Shalala,

Secretary.

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[FR Doc. 96-16744 Filed 6-27-96; 9:43 am]

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