[Federal Register Volume 68, Number 158 (Friday, August 15, 2003)]
[Rules and Regulations]
[Pages 48805-48813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20955]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 424

[CMS-0008-IFC]
RIN 0938-AM22


Medicare Program; Electronic Submission of Medicare Claims

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Interim final rule with comment period.

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SUMMARY: This interim final rule with comment period implements the 
statutory requirement that claims for reimbursement under the Medicare 
Program be submitted electronically as of October 16, 2003,except where 
waived. This rule identifies those circumstances for which mandatory 
submission of electronic claims to the Medicare Program is waived.

DATES: Effective date: October 16, 2003. These regulations are 
applicable for Medicare claims submitted on or after October 16, 2003.
    Comment date: Comments will be considered if we receive them at the 
appropriate address, as provided below, no later than 5 p.m. on October 
14, 2003.

ADDRESSES: In commenting, please refer to file code CMS-0008-IFC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission or e-mail. Mail written comments (one 
original and three copies) to the following address ONLY: Centers for 
Medicare & Medicaid Services, Department of Health and Human Services, 
Attention: CMS-0008-IFC, P.O. Box 8010, Baltimore, MD 21244-8010.
    Please allow sufficient time for mailed comments to be timely 
received in the event of delivery delays. If you prefer, you may 
deliver (by hand or courier) your written comments (one original and 
three copies) to one of the following addresses: Room 445-G, Hubert H. 
Humphrey (HHH) Building, 200 Independence Avenue, SW., Washington, DC 
20201, or Room C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-
8010.
    (Because access to the interior of the HHH Building is not readily 
available to persons without Federal Government identification, 
commenters are encouraged to leave their comments in the CMS drop slots 
located in the main lobby of the building. A stamp-in clock is 
available for commenters wishing to retain a proof of filing by 
stamping in and retaining an extra copy of the comments being filed.)
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed, and could be considered untimely.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Kathleen Simmons, (410) 786-6157. 
Stewart Streimer, (410) 786-9318.

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: Comments received timely will be 
available for public inspection as they are received, generally 
beginning approximately 3 weeks after publication of a document, at the 
headquarters of the Centers for Medicare & Medicaid Services, 7500 
Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of 
each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view 
public comments, contact Sharon Jones (410) 786-9994.
    Copies: Additional copies of the Federal Register containing this 
interim final rule with comment period can be made at most libraries 
designated as Federal Depository Libraries and at many other public and 
academic libraries throughout the country that receive the Federal 
Register.
    This Federal Register document is also available from the Federal 
Register online database through GPO Access, a service of the U.S. 
Government Printing Office. The Web site address is: http://www.access.gpo.gov/nara/index.html.

I. Background

    Section 3 of the Administrative Simplification Compliance Act 
(ASCA), Pub. L. 107-105, was enacted by the Congress to improve the 
administration of the Medicare Program by facilitating program 
efficiencies gained through the electronic submission of Medicare 
claims. Section 3 of ASCA amends subsection (a) of section 1862 of the 
Social Security Act (the Act) (42 U.S.C. 1395y(a)) and adds a new 
subsection (h) to section 1862 (42 U.S.C. 1395y). The amendment to 
subsection (a) requires

[[Page 48806]]

the Medicare Program, subject to subsection (h), to deny payment under 
Part A or Part B for services ``for which a claim is submitted other 
than in an electronic form specified by the Secretary.'' Subsection (h) 
provides that the Secretary shall waive such denial in two types of 
cases and may also waive such denial ``in such unusual cases as the 
Secretary finds appropriate.''
    Section 3 of ASCA operates in the context of the Administrative 
Simplification provisions of the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA), Pub. L. 104-191. Those provisions 
require the Secretary to adopt, among other standards, standards for 
financial and administrative transactions for the health care industry, 
including the health care claim transaction (see section 1173(a) of the 
Act). In 2000, the Secretary of Health and Human Services (HHS) adopted 
standards for eight electronic transactions, including the Health Care 
Claim or Equivalent Encounter Information transaction, 65 FR 50312 
(August 17, 2000). These rules, which are codified at 45 CFR part 162, 
subparts A and I through R, are generally known as the Transactions 
Rule.
    The HIPAA standards apply to health plans, health care 
clearinghouses, and certain health care providers; collectively, these 
entities are known as ``covered entities.'' Covered entities are 
required to comply not only with the Transactions Rule, but also with 
the other HIPAA Administrative Simplification rules--the Privacy Rule, 
the Employer Identifier Rule, and the Security Rule--when the 
respective applicable compliance dates for those rules occur.
    Compliance with the standards for the electronic transactions 
covered by the Transactions Rule was required for all covered entities 
other than small health plans by October 16, 2002; compliance by small 
health plans is required by October 16, 2003. However, section 2 of 
ASCA extended the October 16, 2002 compliance deadline to October 16, 
2003 for covered entities that submitted a compliance plan by October 
15, 2002. Covered entities that were not small health plans and that 
did not timely submit a compliance plan under ASCA were required to 
comply with the Transactions Rule by October 16, 2002. Regardless, no 
later than October 16, 2003, all covered entities must be in compliance 
with the Transactions Rule.
    By statute, the Medicare Program is a health plan under HIPAA (see 
section 1171(5)(D) of the Act). It is, therefore, a covered entity. 
Health care providers are covered entities if they transmit health 
information in electronic form in connection with a transaction for 
which the Secretary has adopted a standard (covered transaction) (see 
45 CFR 160.102). Under the Transactions Rule, if a covered entity 
electronically conducts a covered transaction with another covered 
entity, it must conduct it as a standard transaction (see 45 CFR 
162.923(a)).
    Approximately 86.1 percent of claims submitted to the Medicare 
Program are submitted electronically, which means that approximately 
139 million claims are submitted on paper per year (fiscal year (FY) 
2002). Section 3 of ASCA requires Medicare providers to submit claims 
electronically by October 16, 2003, unless one of the specified grounds 
for waiver applies. Section 3 of ASCA, thus, in general has the effect 
of requiring Medicare providers that are not already covered entities 
to conduct a covered transaction (the health care claim transaction) 
electronically and, thereby, become covered entities. In submitting 
claims electronically, the providers will be required to comply with 
the applicable HIPAA standard for the health care claim transaction, by 
virtue of the Transactions Rule. Thus, section 3 of ASCA promotes the 
submission of standard transactions and will further the goal of 
improved health care delivery by reducing the administrative burden and 
paperwork associated with Medicare claims submission.
    Although 86.1 percent of Medicare claims are submitted 
electronically, the volume of Medicare claims submitted in paper form 
is substantial, and moving from paper to electronic submission has the 
potential for significant savings and efficiencies for Medicare 
physicians, practitioners, facilities, suppliers, and other health care 
providers, as well as for the Medicare program itself. Although these 
Medicare physicians, practitioners, facilities, suppliers, and other 
health care providers would incur a cost to comply with the mandatory 
electronic billing requirement, we believe their savings will offset 
the cost. Further, the use of the HIPAA electronic claim standard could 
result in additional savings should these entities begin electronically 
billing other payers. However, the statute recognizes that certain 
circumstances may preclude or make less attractive converting from a 
paper to an electronic environment. ASCA, thus, identifies exceptions 
to the mandatory submission of electronic Medicare claims. These 
exceptions are interpreted and provided for by this interim final rule 
with comment period.
    We considered whether the amendment to section 1862(a) in section 3 
of ASCA could be interpreted to apply to payments made by Medicare + 
Choice (M+C) organizations to providers for services provided to 
Medicare beneficiaries. The question was raised by the provision in 
section 4 of ASCA which expressly adds Medicare Part C, found in Part C 
of Title XVIII, to the definition of Medicare ``health plans'' found in 
section 1171(5)(D).
    The plain language of section 1862(a), however, provides that 
``payment may not be made under Part A or Part B'' for a number of 
activities. The Congress could have amended this provision, just as it 
amended section 1171(5), if it had wanted to prohibit M+C organizations 
from paying for claims for services given to M+C enrollees by the M+C 
organization's participating providers. The fact that it did not so 
amend this provision indicates that it did not intend to apply the ASCA 
payment prohibition to the M+C organizations. The Congress's intent to 
apply the broader definition of ``health plan'' in section 4 of ASCA 
solely to the Administrative Simplifications provisions of HIPAA and 
not to the electronic submission requirement for Medicare claims is 
further suggested by in the title of section 4 of ASCA: ``Clarification 
with Respect to Applicability of Administrative Simplification 
Requirement to M+C Organizations.''
    The M+C organizations, as health plans for the purposes of HIPAA 
Administrative Simplification, are required to come into compliance 
with the requirements of the HIPAA Transactions Rule no later than 
October 16, 2003. We understand that all M+C organizations properly 
filed ASCA compliance plans prior to October 16, 2002. They, therefore, 
obtained extensions and have a compliance date of October 16, 2003.
    An M+C organization that pays a non-compliant electronic claim 
after October 16, 2003, would accordingly be out of compliance with the 
HIPAA Transactions Rule requirements, but would not violate the 
provisions of section 1862(a)(22) or the requirements of this 
regulation. This regulation applies only to providers, practitioners 
and suppliers who submit claims under Part A or Part B of Medicare. It 
does not apply to the submission of claims by providers to M+C 
organizations. Moreover, the waiver provisions for small providers, 
practitioners and suppliers established by section 3 of ASCA and this 
regulation do not extend to claims submitted by such providers to any 
health plans other than Medicare.

[[Page 48807]]

II. Provisions of the Interim Final Rule With Comment Period

    Section 3 of ASCA established the requirements and exceptions under 
the Medicare Program for the mandatory submission of claims submitted 
in electronic form. 45 CFR 162.1101(a) defines a health care claim as 
the transmission of ``A request to obtain payment, and the necessary 
accompanying information from a health care provider to a health plan, 
for health care.'' 45 CFR 160.103 defines electronic media as--

    (1) Electronic storage media including memory devices in 
computers (hard drives) and any such removable/transportable digital 
memory medium, such as magnetic tape or disk, optical disk, or 
digital memory card; or (2) Transmission media used to exchange 
information already in electronic storage media. Transmission media 
include, for example, the internet (wide-open), extranet (using 
internet technology to l ink a business with information accessible 
only to collaborating parties), leased lines, dial-up lines, private 
networks, and the physical movement of removable/transportable 
electronic storage media. Certain transmissions, including of paper, 
via facsimile, and of voice, via telephone, are not considered to be 
transmissions via electronic media, because the information being 
exchanged did not exist in electronic form before the transmission.

    In this interim final Rule with comment period, we integrate the 
definitions of ``electronic media'' and ``claims submitted in 
electronic form'' into the newly defined term, ``electronic claim.'' 
Furthermore, for brevity, and to reflect common use, the term 
``electronic claim(s)'' is considered to be synonymous with and is 
being used in lieu of the term ``claims submitted in electronic form'' 
in this Rule.

A. Definitions Used for Electronic Claim Submission

    In Sec.  424.32(d)(1), we are adding a definition section to define 
terms used in paragraph (d). We define the following terms: claim; 
electronic claim; direct data entry; electronic media; initial Medicare 
claim; physician, practitioner, facility or supplier; provider of 
services; and small provider or small supplier. We define ``claim'' to 
mean the transaction defined at 45 CFR 162.1101(a), which is the 
regulatory definition of `` health care claim'' in the Transactions 
Rule. We specify the definition of ``electronic claim'' to mean a claim 
that is submitted via electronic media. We specify that the definitions 
of ``direct data entry'' and ``electronic media'' are defined as those 
terms are defined in 45 CFR 162.103, and 160.103, respectively.
    In Sec.  424.32(d)(1)(iv), we define an ``initial Medicare claim'' 
as a claim submitted to Medicare for payment under Part A or Part B of 
the Medicare Program for the first time for processing, including 
claims sent to Medicare for the first time for secondary payment 
purposes. Initial Medicare claim excludes any adjustment or appeal of a 
previously submitted claim.
    We specify in Sec.  424.32(d)(1)(vi) that a ``Physician, 
practitioner, facility, or supplier'' is a Medicare provider other than 
a provider of services. In Sec.  424.32(d)(1)(vii), we define a 
``Provider of services'' as a provider of services as defined in 
section 1861(u) of the Act. We define in Sec.  424.32(d)(1)(viii), a 
``Small provider or small supplier'' as a provider of services with 
fewer than 25 full-time equivalent employees; or a physician, 
practitioner, facility, or supplier (other than provider of services) 
with fewer than 10 full-time equivalent employees.

B. Submission of Electronic Claims Required

    Electronic submission of Medicare claims is required for initial 
Medicare claims, including initial claims with paper attachments, 
submitted for processing by the Medicare fiscal intermediary (FI) or 
carrier that serves the physician, practitioner, facility, supplier, or 
other health care provider. No other transactions, including changes, 
adjustments, or appeals to the initial claim, are required to be 
submitted electronically.
    In Sec.  424.32(d)(2), we specify that except for claims to which 
Sec.  424.32(d)(3) applies, an initial Medicare claim under Part A and/
or Part B may be paid only if submitted as an electronic claim for 
processing by the Medicare FI or carrier that serves the physician, 
practitioner, facility, supplier, or provider of services. This 
requirement does not apply to any other transactions, including 
adjustment or appeal of the initial Medicare claim.

C. Exceptions to Requirement To Submit Electronic Claims

    The regulation set forth at 45 CFR 162.923 states that ``Except as 
otherwise provided in this part, if a covered entity conducts with 
another covered entity (or within the same covered entity), using 
electronic media, a transaction for which the Secretary has adopted a 
standard under this part, the covered entity must conduct the 
transaction as a standard transaction.'' HIPAA does not require that a 
health care plan be able to accept claims via every type of electronic 
media, only that claims received via such media comply with the 
standard format and content requirements of HIPAA (www.wpc-edi.com/HIPAA). Only electronic media accepted by Medicare, and as defined in 
the Medicare Carrier and Intermediary Manuals and Program Memoranda 
issued by CMS, are affected by this requirement of ASCA. At present, 
Medicare does not accept claims via the internet, an extranet or, in 
many cases, via removable/transportable storage media. This rule does 
not change this Medicare policy. Advance notice of any future plans for 
expansion or contraction in the electronic media accepted for 
submission of Medicare claims would be published in Medicare program 
instructions and via routine contractor notification and instructional 
media.
    Claims submitted via a direct data entry screen maintained for 
Medicare, and as permitted by 45 CFR 162.923, are considered to be 
electronic claims for purposes of this requirement. Claims transmitted 
to a Medicare contractor using the free or low cost claims software 
issued by Medicare fee-for-service plans are also electronic claims for 
purposes of this requirement.
    The ASCA provides for exceptions to the mandatory electronic 
submission of Medicare claims. Under the ASCA, the Secretary of Health 
and Human Services will waive the application of the electronic claim 
requirement for specific cases. This interim final rule with comment 
period provides more explicit requirements to implement the statutory 
mandate that we specify in the regulations at Sec.  424.32(d). 
Specifically, in Sec.  424.32(d)(3), we specify the exceptions when 
electronic submission of initial Medicare claims can be waived. In 
Sec.  424.32(d)(3)(i), we specify that electronic submission will be 
waived when: (a) there is no method available for the submission of an 
electronic claim. We cannot reasonably expect Medicare beneficiaries to 
submit electronic claims. (Even though, the statute requires, with very 
few exceptions, that providers of health care bill Medicare on behalf 
of a beneficiary (sections 1814(a) and 1848(g)(4) of the Act) some 
beneficiaries will still submit claims to Medicare. However, those 
relatively few beneficiaries who submit claims are not likely to 
possess the capability to submit a HIPAA compliant claim). Further, 
there is no method available in those situations in which the standard 
adopted by the Secretary at 45 CFR 162.1102 does not support all of the 
information necessary for payment of the claim. At this time, we have 
identified three situations which fall into this category, in addition 
to beneficiary claims: (1) Roster billing of

[[Page 48808]]

vaccinations covered by the Medicare Program (In order to promote an 
increase in the flu vaccinations for Medicare beneficiaries, since 1993 
Medicare allowed mass immunizers to bill the program using a single 
claim form with an attached list of beneficiaries to which a flu 
vaccine was administered. Generally, mass immunizers bill 
electronically, but in a non-standard format. This roster billing 
simplified provider billing but is not available in electronic form 
under the HIPAA Transaction Rule); (2) claims for payment under 
Medicare demonstration projects (Medicare demonstration projects often 
allow for unusual situations not normally handled by the standard 
transactions.); and (3) claims where more than one plan is responsible 
for payment prior to Medicare. The standard electronic formats do not 
currently have a clear method for the reporting of per service payments 
made by more than one primary payer. Efforts are being made to resolve 
this deficiency. These claims can continue to be submitted to Medicare 
on paper, but once a solution is reached we will notify the public, and 
providers will then be required to submit these claims electronically. 
Specific program guidance will be issued to Medicare providers 
concerning submission of these claims on paper effective October 16, 
2003. We will also issue specific guidance or regulations, as 
necessary, informing covered entities if this or another exception no 
longer applies. (b) In 424.32(d)(3)(ii), we provide that electronic 
submission will be waived when the entity submitting the claim is a 
small provider or small supplier. The statute is quite specific as to 
the size requirements and the rule simply incorporates the statutory 
requirements.

D. Unusual Circumstances

    The Secretary may waive the electronic submission requirement in 
certain situations as the Secretary finds appropriate. In Sec.  
424.32(d)(4), we specify three circumstances that will provide for an 
exception to exist in the following situations: (1) The submission of 
dental claims (This exception is being included because, under HIPAA, 
dentists are required to submit electronic transactions to other payers 
in a format different from that generally used in the Medicare Program. 
Since Medicare does not generally cover dental services, this exception 
is added to minimize the burden on dentists who may, at times, need to 
bill the Program.); (2) A service interruption in the mode of 
submitting the electronic claim that is outside of the control of the 
entity submitting the claim, for the period of the interruption (This 
exception will apply only if the physician, practitioner, facility, 
supplier, or other health care provider has no telephone or other 
communication service. If telephone service exists but is unavailable 
for a period of time (for example, because of inclement whether or due 
to telephone company technical breakdowns), paper claims will be 
accepted during the period of disrupted telephone service.); and (3) On 
demonstration, satisfactory to the Secretary, of other extraordinary 
circumstances precluding submission of electronic claims.
    Entities will not generally need to make a special request to 
determine whether an exception applies that would make them eligible 
for a mandatory waiver under Sec.  424.32(d)(3) or a discretionary 
waiver under Sec.  424.32(d)(4). A special request must be submitted to 
a Medicare FI or carrier when an entity does not meet the mandated or 
discretionary waiver criteria being established but believes there are 
other extraordinary circumstances that preclude their submission of 
electronic claims. We will issue program guidance to Medicare FIs and 
carriers to enable them to handle, on a case-by-case basis, requests 
for relief in extraordinary circumstances.

E. Enforcement

    ASCA's amendment to section 1862(a) of the Act prescribes that ``no 
payment may be made under Part A or Part B of the Medicare Program for 
any expenses incurred for items or services'' for which a claim is 
submitted in a non-electronic form. Consequently, absent an applicable 
exception, paper claims submitted to Medicare will not be paid.
    The Secretary may audit entities that bill Medicare non-
electronically. Entities determined to be in violation of the statute 
or this rule may be subject to claim denials, overpayment recoveries, 
and applicable interest on overpayments.

F. Effective Date

    In Sec.  424.32(d)(6), we specify the effective date for these 
amendments will be for claims submitted on or after October 16, 2003. 
This effective date is specified in section 3(b) of ASCA.

III. 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 revise this final rule, we will 
respond to the major comments in the preamble to that document.

IV. Waiver of Proposed Rulemaking

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register and invite public comment on the proposed rule. The 
notice of proposed rulemaking includes a reference to the legal 
authority, under which the rule is proposed, and the terms and 
substances of the proposed rule or a description of the subjects and 
issues involved. This procedure can be waived, however, if an agency 
finds good cause that a notice-and-comment procedure is impracticable, 
unnecessary, or contrary to the public interest and incorporates a 
statement of the finding and its reasons in the rule issued.
    We find that it would be contrary to the public interest to 
undertake prior notice and comment procedures before implementing this 
interim final rule with comment period. The ASCA evidences the 
Congress' intent to increase electronic claims submission to the 
Medicare Program through mandatory electronic billing requirements and 
to tie the mandatory Medicare electronic billing requirement's October 
16, 2003 effective date to the compliance date for national 
implementation of the electronic transactions standards required under 
the Administrative Simplification provisions of HIPAA (see 45 CFR parts 
160 and 162). However, the ASCA also provides that not all Medicare 
health care providers must engage in electronic billing and identifies, 
in general terms, those circumstances under which health care providers 
will be exempt from the requirements.
    The implementation of the HIPAA standards by health care providers 
requires detailed planning, budgeting, implementation, and testing in 
order for those covered entities to be ready to submit HIPAA 
transactions by the October 16, 2003 compliance date. Since section 3 
of ASCA mandates electronic billing for Medicare providers, these 
entities must come into compliance with the HIPAA requirements on the 
same date and, in turn, they must plan appropriately like those covered 
entities that were already planning to be electronic billers. It is 
imperative that the affected Medicare billers have sufficient time to 
ascertain whether they must transition to electronic billing as a 
result of section 3 of ASCA and, if so, begin the implementation 
process for the HIPAA transaction standards. This interim final rule 
with comment period allows those

[[Page 48809]]

Medicare paper billers to fully understand their obligations under ASCA 
and, in turn, begin preparing for HIPAA implementation, if required to 
do so. We believe any delay in implementing this rule, effective 
October 16, 2003, would hinder Medicare providers' ability to meet the 
October 16, 2003 HIPAA compliance date or determine that they did not 
have to file electronically with Medicare and so incur unnecessary 
costs.
    Thus, we find, for good cause, that providing notice and 
opportunity to comment under 5 U.S.C. 553(b) would be impracticable and 
contrary to the public interest. We are providing a 60-day public 
comment period.
    This rule is effective October 16, 2003, as required by section 
3(b) of the ASCA.

V. Collection of Information Requirements

    Under the Paperwork Reduction Act (PRA) of 1995, we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the PRA of 1995 requires that 
we solicit comment on the following issues:
    [sbull] The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
    [sbull] The accuracy of our estimate of the information collection 
burden.
    [sbull] The quality, utility, and clarity of the information to be 
collected.
    [sbull] Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    Therefore, we are soliciting public comments on each of these 
issues for the information collection requirements discussed below.
    The information collection requirements and associated burdens in 
Sec.  424.32 are subject to the PRA. The burden of submitting the 
information required is addressed under OMB approval number:

    0938-0866, HIPAA Standards for Coding Electronic Transactions, with 
a one-time burden of 34,000,000 hours. The current approval expires 5/
31/05.
    0938-0279, Medicare Uniform Institutional Provider Bill, with an 
annual burden of 1,666,208 (form CMS-1450). The current approval 
expires 12/31/05.
    0938-0042, Request for Medicare Payment--Ambulance, with an annual 
burden of 390,418 hours (form CMS-1491). The current approval expires 
3/31/04.
    0938-0008, Common Claim form, instructions, and supporting 
regulations at Sec. Sec.  414.40, 424.32, and 414.40, with an annual 
burden of 44,189,007 (form CMS-1500). The current approval expires 3/
31/06.
    Approximately 205,409 providers and suppliers will be affected by 
this rule and will have to change the format for the claims they submit 
(the information collected does not change). They will incur some 
costs, either that of switching to clearinghouses, which will not 
affect the time it takes to submit the information for a claim, but 
will cost them $.30 per claim, or that of purchasing computer 
equipment, which we estimate at $500 to $1,000.
    For our rule published to implement the electronic transactions in 
general, we estimated that it would take an average of ten hours per 
entity to switch over to the mandated standard transaction. (The switch 
could be from paper to electronic or from another electronic format to 
the standard format.)
    For purposes of this discussion, we are estimating that 37.5 
percent of the affected providers and suppliers (that is, those not 
meeting one of the exceptions) already own computers and will not incur 
capital costs. We are also estimating that 50 percent of the affected 
providers and suppliers will start using a clearinghouse or billing 
service, which will not impose any capital costs subject to the PRA. 
The remaining 12.5 percent (25,676) will buy computers at an average of 
$750, for a total capital cost of $19.3 million.
    On the other hand, the providers and suppliers who own or who will 
buy a computer will require less time to submit claims. Form CMS-1450 
takes approximately 9 minutes to submit in hard copy and .5 minutes to 
submit electronically; form CMS-1500 takes 15 minutes and 1 minute, 
respectively; form CMS-1491 takes 10 minutes and 1 minute, 
respectively.
    If the 50 percent of the entities that will bill us directly are 
responsible for 25 percent of the paper bills (we assume that half of 
the bills are submitted by entities that will be excepted from the 
requirements, and that 25 percent will be submitted through an 
intermediate party), they will save 7,651,089 million hours for form 
1500, 58,850 hours for form 1491, and 129,196 hours for form 1450. 
Mailing costs will be reduced by approximately $.40 per claim on 
average and the cost of the forms by $.03 for the form 1450 and form 
1500 (the third form is furnished by CMS). We welcome comments on this 
aspect of the collection.
    We are submitting a copy of the revision to Sec.  424.32 to OMB for 
its review of the information collection requirements. The revision is 
not effective until OMB has approved it. If you comment on any of these 
information collection and record keeping requirements, please mail 
copies directly to the following: Office of Strategic Operations and 
Regulatory Affairs, Centers for Medicare and Medicaid Services, 7500 
Security Boulevard, Attn: PRA Reports Clearance Officer, Baltimore, MD 
21244, Attn: Julie Brown, CMS-0008-IFC, and Office of Information and 
Regulatory Affairs, Office of Management and Budget, Room 10235, New 
Executive Office Building, Washington, DC 20503, Attn: Brenda Aguilar, 
Desk Officer, CMS-0008-IFC.

VI. Regulatory Impact Analysis

A. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 (September 1993, Regulatory Planning and Review), the 
Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354), 
section 1102(b) of the Social Security Act, the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
    For the purpose of this analysis, CMS uses a pre-statute baseline; 
therefore, all costs and benefits identified in this impact analysis 
are attributed to this rulemaking. Nevertheless, the ASCA mandates most 
aspects of this rulemaking. In particular, the ASCA requires Medicare 
providers to submit claims electronically and stipulates exceptions 
that will and may be granted. However, CMS did have discretion in 
setting the conditions for exceptions, and believes that these 
exceptions reduce the burden relative to the burden that may have been 
imposed by ASCA without this enabling regulation.
    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, distributive impacts, and equity). A regulatory impact 
analysis (RIA) must be prepared for major rules with economically 
significant effects ($100 million or more in any 1 year). This is not a 
major rule. While additional costs will be imposed on those entities 
that do not meet any of the exception requirements and which must 
purchase the capability to

[[Page 48810]]

bill Medicare electronically, we estimate the impact to be less than 
$100 million. Our estimates of the cost impact are based on the 
following analysis. (Note: The primary sources of data contained herein 
are the Medicare Program's ``Contractor Reporting of Operational 
Workload Data'' (CROWD), the ``2002 CMS Statistics'' Handbook), and the 
Year 2000 ``Statistics of U.S. Business'' issued by the U.S. Census 
Bureau.
    The Administrative Simplification provisions under HIPAA establish 
the standards for electronic data transmission when transactions are 
conducted electronically, but they do not require physicians, 
practitioners, facilities, suppliers, and other health care providers 
to transmit claims and other transactions electronically. ASCA, 
however, does require Medicare physicians, practitioners, facilities, 
suppliers, and other health care providers (except those for which this 
rule provides for an exception) to submit claims electronically to 
Medicare. Consequently, Medicare claims must be submitted in the HIPAA-
prescribed electronic format. Thus, this rule will only have an impact 
on that group of entities that now submit paper claims to the Medicare 
Program and who do not fall into one of the excepted groups.
    Approximately 139 million paper claims were submitted to Medicare 
in FY 2002. This represents about 13.9 percent of all claims processed. 
Broken down between paper claims submitted to FIs and carriers, the 
number of paper claims in FY 2002 was 3.4 million and 136 million, 
respectively (source of data is CROWD).
    Over the past 4 years, Medicare's electronic media claims rate 
(EMC) has slowly grown at an average of 0.3 percent per year for FIs 
and 0.9 percent per year for carriers (source of data is CROWD). We do 
not expect a change in this trend for the immediate future. Therefore, 
we assume that similar changes will continue for, at least, FY 2003 and 
FY 2004, the first year of implementation of mandatory Medicare EMC. 
Using workload growth projections from the CMS FY 2004 budget 
submission to the Congress, we estimate the FY 2004 volume of paper 
claims impacted by the ASCA, factoring out Medicare's continuing trend 
of higher EMC rates, will be 2.5 million for Medicare FIs and 133.7 
million for carriers. Please note that these volumes could be even 
smaller in FY 2004 due to the simultaneous implementation of HIPAA. 
However, the impact of HIPAA, coupled with Medicare's EMC trends, 
cannot be quantified, though the impact would only further reduce the 
cost/savings impact of ASCA and further support that a RIA is not 
needed.
    We do not know at this time how many providers will be excepted 
from the ASCA requirements, but projections have been made based upon 
the percentage of health care providers reported in the Census Bureau's 
``Year 2000 Statistics of U.S. Businesses,'' which includes data on the 
number of health care providers by type with fewer than 20 employees 
and the numbers of physician, practitioner, and supplier entities with 
fewer than 10 employees. The Census figures do not differentiate 
between part-time and full-time employees, and would be expected to 
result in inflated numbers on the whole when applied to Medicare, but 
that is acceptable for impact assessment purposes. The Census did not 
have a category for fewer than 25 employees; fewer than 20 employees 
was their closest statistic. Overall, the Census data would still be 
reliable indicators of the anticipated worse case scenario of the 
maximum number of Medicare providers, physicians, practitioners, and 
suppliers likely to be impacted by this regulation. The percentages of 
small providers, physicians, practitioners, and suppliers based on 
employment numbers for the universe of all U.S. providers, physicians, 
practitioners, and suppliers should be comparable to the percentage of 
the subset of those providers that bill the Medicare program.
    The Census figures did not include each of the same provider, 
physician, practitioner, and supplier breakouts as tracked by 
Medicare's statistics, but the Census figures did include the largest 
provider, physician, practitioner, and supplier types. The Census 
figures included 90 percent of all Medicare providers, physicians, 
practitioners, and suppliers by type. The provider types track 
differently by CMS and the Census Bureau include regional referral 
centers, Christian Science Sanitoria, rural health clinics, critical 
access facilities, and hospices. The ``2002 CMS Statistics'' directory 
and the 2000 Census data health care establishment totals reported the 
following:

----------------------------------------------------------------------------------------------------------------
                                                                                   Percentage of
                                                                     Number of    providers with   Likely number
                          Provider type                              providers     less than 20      excepted
                                                                                     employees
----------------------------------------------------------------------------------------------------------------
Hospitals.......................................................           6,031            10.6             639
Home Health Agencies............................................           7,099            69.2           4,913
ESRD Facilities.................................................           3,991            16.6             663
Skilled Nursing Facilities......................................          14,841            25.7           3,814
                                                                 -----------------
    Totals......................................................          31,962            31.4          10,029


----------------------------------------------------------------------------------------------------------------
                                                                                   Percentage of
                                                                     Number of    providers with   Likely number
           Type of physician, practitioner or supplier               providers     less than 10      excepted
                                                                                     employees
----------------------------------------------------------------------------------------------------------------
Clinical Labs...................................................         168,333            41.4          69,690
Ambulatory Surgical Centers.....................................           3,147            34.9           1,098
Physicians......................................................         567,412            70.6         400,593
All Other Practitioners.........................................         297,967            71.8         213,940
                                                                 -----------------
    Totals......................................................       1,036,859            66.1         685,321
----------------------------------------------------------------------------------------------------------------

    As there was a 10 percent difference between the Census provider, 
physician, practitioner, and supplier types and the Medicare provider 
types, dues to differences in type collection, the numbers impacted 
would need to be increased by 10 percent to account for the difference. 
Increased by 10 percent, approximately 11,032 (31.4 percent) of

[[Page 48811]]

all Medicare providers, and 753,853 (66.1 percent) of all Medicare 
physicians, practitioners and suppliers could qualify for an exception 
of the electronic claim filing requirement based on provider size, 
leaving approximately 24,126 providers and 386,692 physicians, 
practitioners, and suppliers (a total of 410,818 potentially affected 
by the ASCA Medicare requirement nationally).
    Approximately 98 percent of providers, and 83 percent or 
physicians, practitioners, and suppliers already submit claims to 
Medicare electronically though, and are expected to continue doing so, 
so the total impacted must be further reduced to determine the 
approximate number of current paper claim submitters that would likely 
be affected. It is reasonable to assume that the majority of the paper 
claims received by Medicare are submitted by smaller providers, 
physicians, practitioners, and suppliers. As a result, it would not be 
accurate to reduce the number of affected providers by the full 98 
percent of 83 percent. In the absence of reliable statistics to project 
the current source of all paper claims however, the number of providers 
potentially affected by the mandatory Medicare electronic claim 
requirement will be conservatively estimated at a maximum of 50 percent 
of the entities that would not qualify for a waiver. This leaves 12,063 
providers and 193,346 physicians, practitioners, and suppliers (a total 
of 205,409) that would need to begin submitting claims to Medicare 
electronically.
    Statistics collected for PRA clearance of the Medicare paper claim 
forms and referenced in the ``Collection of Information Requirements'' 
section of this preamble indicate that in the absence of a mandatory 
electronic claim requirement effective for FY 2004, 2.5 million paper 
claims are expected to be sent to Medicare intermediaries and 133.7 
million paper claims are to be sent to Medicare carriers.
    Today, many Medicare providers use billing agents or clearinghouses 
to bill the Medicare program. Many providers, physicians, 
practitioners, and suppliers that currently submit paper claims have 
indicated anecdotally that they use paper as they would rather avoid 
the ``hassle'' of dealing with the multiple electronic claim formats 
currently required by payers, and the need to have staff keep abreast 
of the updates to those formats. HIPAA will largely eliminate format 
differences among payers, but there will continue to be differences 
concerning use of certain ``situational'' segments and data elements in 
the formats. It is reasonable to assume that up to half (205,409 x 50 
percent = 102,704) of those entities that do not submit claims to 
Medicare electronically today would prefer to contract with third party 
to deal with such differences on their behalf.
    A small sampling of Medicare contractors indicated an average cost 
of $0.30 per claim for billing agent and clearinghouse services. The 
total cost to physicians, practitioners, facilities, suppliers, and 
other health care providers to use a billing agent or clearinghouse 
should not be more than $7,055,895 (that is, $.30 x {the sum of 2.5 
million paper claims sent to intermediaries as estimated previously for 
FY 2004 multiplied by the 68.6 percent of providers that would not meet 
the exception criteria plus 133.7 million paper claims estimated to be 
sent to carriers multiplied by the 33.9 percent of physicians, 
practitioners, and suppliers that would not meet the exception 
criteria{time} , reduced by 50 percent to account for the assumption 
that 50 percent of the firms will contract with the third party claims 
processors).
    Finally, in regard to the balance of 102,704 (205,409 x 50 percent) 
providers, physicians, practitioners, and suppliers that would not be 
expected to meet the criteria to submit paper claims, we conservatively 
estimate that approximately 75 percent of these already own personal 
computers that are used to prepare the paper claim forms they currently 
submitted to Medicare. Very few hand-written or manually typed claims 
are submitted to Medicare. Although many paper claim submitters have 
not used personal computers for electronic billing, they have used them 
for claim preparation, patient scheduling and other aspects of their 
practice.
    We estimate that at a maximum, the remaining total of 25,676 (25 
percent of 102,704) providers, physicians, practitioners, and suppliers 
will obtain personal computers to allow them to submit their claims 
directly to Medicare electronically. A recent review of ads in Sunday 
newspapers indicated that personal computers sufficient to meet the 
mandatory electronic claim requirement could be obtained for between 
$500 to $1,000 for hardware (personal computer, monitor, printer, and 
modem). Billing software is available free or at low cost (less than 
$25 for shipping and handling) from Medicare. At the average rate of 
$750, it would cost $19.3 million to purchase 25,676 personal computer 
systems. More expensive equipment and peripherals could be used, but 
would not be necessary for basic compliance. Therefore, the total 
maximum cost should be no higher than $26.4 million ($7.1 million for 
users of clearinghouses or billing services, and $19.3 million for 
those that obtain personal computers).
    Following the HIPAA savings calculation used in the Transaction 
Rule, but projected to FY 2004 to account for inflation, a savings of 
$615 per provider could result in a total provider savings of 
approximately $15.8 million (that is, 25,676 times $615).
    We note that pages 50353 through 50359 of the August 17, 2000 
transaction final rule for HIPAA used a 10-year time frame to capture 
the full extent of costs and savings that could be attributed to the 
use of the transactions adopted under HIPAA. Data from the 2000 edition 
of Faulkner and Gray's ``Health Data Directory,'' from a Workgroup for 
Electronic Data Interchange study report, and from the Department of 
Labor was used in those calculations to determine total claims in the 
health care industry, costs to use the transactions electronically, 
savings expected to be realized, the historical growth rate for claims 
overall as well as electronic claims, the percentage of electronic 
health care claims nationally in 2000, and the anticipated inflation 
rate for the 10-year period.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and government agencies. 
According to the Small Business Administration's (SBA's) data, 
approximately 95 percent of offices of physicians are considered small 
businesses (see the Small Business Administration's final rule titled 
``Small Business Size Standards, Health Care,'' published in the 
Federal Register on November 17, 2000, 65 FR 69432). Most 
practitioners, facilities, suppliers, and other providers are small 
entities either because of nonprofit status or because of having 
revenues of $6 million to $29 million or less in any 1 year. For 
purposes of the RFA, all physicians, practitioners, facilities, 
suppliers, and other health care providers that serve Medicare 
beneficiaries are considered to be small entities. However, as stated 
earlier, this rule in and of itself does not impose a regulatory 
burden. The ASCA mandates most aspects of this rule, in particular, the 
ASCA requires Medicare providers to submit claims electronically and 
stipulates exceptions that will and may be granted. We did have 
discretion; however, in setting conditions for exceptions, and believe 
these exceptions reduce the burden relative to the burden that may have 
been imposed by ASCA without this enabling regulation.

[[Page 48812]]

Individuals and States are not considered small entities. Therefore, no 
regulatory relief options are considered. A rule has a significant 
economic impact if it exceeds 3-5 percent of its total costs or 
revenues according to criterion set by the SBA. The statute exempts 
many small firms from this rulemaking, affording considerable relief to 
small entities. At most, small firms that are not exempt will incur an 
average of either $69 per firm ($7.1 million/102,704 firms) to contract 
out their claims filing, or purchase computer equipment at an average 
net cost of $135 per firm ($750 cost-$615 savings.) Therefore, we 
expect the impact of this rulemaking to fall well below the SBA 
threshold.
    In addition, section 1102(b) of the Act requires us 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 604 of the RFA. 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 100 beds. As indicated above, this 
rule could have an impact on those small rural hospitals that bill 
Medicare and that do not meet one of the exceptions. However, we do not 
believe the impact is significant since the cost of compliance is 
relatively small ($500 to $1,000) and small rural hospitals may be able 
to qualify for the small provider exception. Therefore, no regulatory 
impact analysis is required as the impact on small rural hospitals is 
not significant.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule that may result in an expenditure in any 1 year by 
State, local, or tribal governments, in the aggregate, or by the 
private sector, of $110 million. This interim final rule with comment 
period will not have an impact on State, local, or tribal governments 
or on the private sector. Instead, the primary impact on State, local, 
or tribal governments, or the private sector will be that entities that 
must begin billing Medicare electronically as a result of the ASCA are 
likely to use that capability to also bill other payers (such as State, 
local, or tribal governments and the private sector).
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a final rule that imposes 
substantial direct requirement costs on State and local governments, 
preempts State law, or otherwise has federalism implications. This 
interim final rule with comment period will not have a substantial 
effect on State or local governments for the reasons noted above.

B. Anticipated Effects

1. Effects on Beneficiaries, Physicians, Practitioners, Facilities, 
Suppliers, and Other Health Care Providers
    The anticipated effects on Medicare's beneficiaries will be that 
additional attention and services may be provided by their health care 
physician because, for example, electronic billing should reduce 
administrative paperwork. (This assertion has been made by the medical 
community in numerous forums over the years, though documentation to 
this effect is not available.)
    The anticipated effects on the entities required to bill 
electronically will reduce or eliminate paper in their administrative 
operations, realizing increased efficiencies and indeterminable 
savings. These savings may be increased by the fact that the 
Administrative Simplification provisions of HIPAA mandate a standard 
transaction for electronic claim submissions, and this will facilitate 
electronic claims submissions to all health care payers. At this time, 
we do not have additional data to estimate those savings to Medicare 
physicians, practitioners, facilities, suppliers, and other healthcare 
providers. As previously stated, there will be a cost incurred by those 
entities that cannot satisfy one of the exceptions and would be 
required to bill Medicare in electronic form.
2. Effects on the Medicare and Medicaid Programs
    Implementation of this interim final rule with comment period will 
result in a savings to the Medicare program. If the FY 2004 projected 
paper claims submissions of 136.2 million (HHS FY 2004 Budget 
submission to the Congress and estimated electronic media claims rate), 
are reduced by half and we assume a savings of $1.40 per claim as a 
result, the program could realize administrative savings of over $95 
million per year. (Note: The $1.40 per claim savings is the CMS 
estimate of savings based upon a 1990 Industrial Engineering Study, 
contracted by CMS (then HCFA). The study documented that FI paper 
claims cost about $3.30 more to process than electronic claims and, 
similarly, carrier paper claims cost about $1.00 more to process than 
electronic claims. Weighing these differences by the 2004 workloads and 
combining them yields the $1.40 estimated per claim savings.)
    We might expect similar types of savings for the States, which 
administer the Medicaid Program. That is, Medicare providers who become 
electronic billers due to ASCA may decide to begin billing Medicaid 
electronically as well. However, this would depend on which of the 
affected Medicare physicians, practitioners, facilities, suppliers, and 
other healthcare providers also bill Medicaid. Again, the fact that the 
Administrative Simplification provisions of HIPAA mandate a standard 
transaction for electronic claim submissions will facilitate electronic 
claims submissions to all health care payers.

C. Alternatives Considered

    Section 3 of ASCA requires electronic claims submission by those 
who bill Medicare. There is little room for us to consider 
alternatives, though we expect that public comment may focus upon 
further definition regarding the mandatory waivers or regarding those 
``unusual cases'' for which the Secretary may waive the mandatory 
electronic claims submission requirement.

D. Conclusion

    As described above, this interim final rule with comment period 
establishes the requirements for implementing the statutory provisions 
under section 3 of the ASCA. The law requires, with few exceptions, 
that physicians, practitioners, facilities, suppliers, and other health 
care providers that bill Medicare must do so electronically. Coupled 
with the electronic standard transaction requirements under HIPAA, this 
rule facilitates greater administrative efficiencies for the Medicare 
program as well as for those that bill Medicare. There will be a cost 
incurred for those entities that are unable to meet one of the 
statutory exceptions, but we expect these initial costs to be offset by 
increased efficiencies and ongoing lower costs attributable to Medicare 
claims processing.
    In accordance with the provisions of Executive Order 12866, the 
Office of Management and Budget reviewed this regulation.

List of Subjects in 42 CFR Part 424

    Emergency medical services, Health facilities, Health professions, 
Medicare, Reporting and recordkeeping requirements.

0
For the reasons set forth in the preamble, CMS proposes to amend 42 CFR 
chapter VI part 424 as set forth below:

[[Page 48813]]

PART 424--CONDITIONS FOR MEDICARE PAYMENT

0
1. The authority citation for part 424 continues to read as follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


0
2. In Sec.  424.32, add a new paragraph (d) to read as follows:


Sec.  424.32  Basic requirements for all claims.

* * * * *
    (d) Submission of electronic claims.
    (1) Definitions. For purposes of this paragraph, the following 
terms have the following meanings:
    (i) Claim means a transaction defined at 45 CFR 162.1101(a).
    (ii) Electronic claim means a claim that is submitted via 
electronic media. A claim submitted via direct data entry is considered 
to be an electronic claim.
    (iii) Direct data entry is defined at 45 CFR 162.103.
    (iv) Electronic media is defined at 45 CFR 160.103.
    (v) Initial Medicare claim means a claim submitted to Medicare for 
payment under Part A or Part B of the Medicare Program under title 
XVIII of the Act for the first time for processing, including claims 
sent to Medicare for the first time for secondary payment purposes. 
Initial Medicare claim excludes any adjustment or appeal of a 
previously submitted claim, and claims submitted for payment under Part 
C of the Medicare program under Title XVIII of the Act.
    (vi) Physician, practitioner, facility, or supplier is a Medicare 
provider other than a provider of services.
    (vii) Provider of services means a provider of services as defined 
in section 1861(u) of the Act.
    (viii) Small provider of services or small supplier means--
    (A) A provider of services with fewer than 25 full-time equivalent 
employees; or
    (B) A physician, practitioner, facility, or supplier with fewer 
than 10 full-time equivalent employees.
    (2) Submission of electronic claims required. Except for claims to 
which paragraph (d)(3) or (d)(4) of this section applies, an initial 
Medicare claim may be paid only if submitted as an electronic claim for 
processing by the Medicare fiscal intermediary or carrier that serves 
the physician, practitioner, facility, supplier, or provider of 
services. This requirement does not apply to any other transactions, 
including adjustment or appeal of the initial Medicare claim.
    (3) Exceptions to requirement to submit electronic claims. The 
requirement of paragraph (d)(2) of this section is waived for any 
initial Medicare claim when--
    (i) There is no method available for the submission of an 
electronic claim. This exception includes claims submitted by Medicare 
beneficiaries and situations in which the standard adopted by the 
Secretary at 45 FR 162.1102 does not support all of the information 
necessary for payment of the claim. The Secretary may identify 
situations coming within this exception in guidance.
    (ii) The entity submitting the claim is a small provider or small 
supplier.
    (4) Unusual circumstances. The Secretary may waive the requirement 
of paragraph (d)(2) of this section in such unusual circumstances as 
the Secretary finds appropriate. Unusual circumstances are deemed to 
exist in the following situations:
    (i) The submission of dental claims.
    (ii) There is a service interruption in the mode of submitting the 
electronic claim that is outside the control of the entity submitting 
the claim, for the period of the interruption.
    (iii) On demonstration, satisfactory to the Secretary, of other 
extraordinary circumstances precluding submission of electronic claims.
    (5) Effective date. This paragraph (d) is effective October 16, 
2003, and applies to claims submitted on or after October 16, 2003.

(Catalog of Federal Domestic Assistance Program No. 93.774, 
Medicare--Supplementary Medical Insurance Program)

    Dated: April 22, 2003.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
    Approved: August 12, 2003.
Tommy G. Thompson,
Secretary.
[FR Doc. 03-20955 Filed 8-14-03; 8:45 am]
BILLING CODE 4120-01-P