[Federal Register Volume 64, Number 15 (Monday, January 25, 1999)]
[Rules and Regulations]
[Pages 3637-3650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1547]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Parts 409, 410, and 424

[HCFA-1813-FC]
RIN 0938-AH13


Medicare Program; Coverage of Ambulance Services and Vehicle and 
Staff Requirements

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Final rule with comment period.

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SUMMARY: This final rule with comment period revises and updates 
Medicare policy concerning ambulance services. It identifies 
destinations to which ambulance services are covered, establishes 
requirements for the vehicles and staff used to furnish ambulance 
services, and clarifies coverage of nonemergency ambulance services for 
Medicare beneficiaries. This rule also implements section 4531(c) of 
the Balanced Budget Act of 1997 concerning Medicare coverage for 
paramedic interecept services in rural communities.

DATES: Effective Date: These regulations are effective on February 24, 
1999. Comment Period: We will consider comments concerning Medicare 
coverage for paramedic intercept services in rural areas if we receive 
the comments at the appropriate address, as provided below, no later 
than 5 p.m. on March 26, 1999.

ADDRESSES: Mail written comments (an original and three copies) to the 
following address:

Health Care Financing Administration, Department of Health and Human 
Services, Attention: HCFA-1813-FC P.O. Box 7517, Baltimore, MD 21207-
0517.

    If you prefer, you may deliver your written comments (an original 
and three copies) to one of the following addresses:

Room 443-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW, 
Washington, DC 20201, or
Room C5-14-03, Central Building, 7500 Security Boulevard, Baltimore, MD 
21244-1850.

    Comments may also be submitted electronically to the following e-
mail address: [email protected]. For e-mail comment procedures, see 
the beginning of SUPPLEMENTARY INFORMATION. For further information on 
ordering copies of the Federal Register containing this document and on 
electronic access, see the beginning of SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Robert Niemann, (410) 786-4569 for 
issues relating to payment for Paramedic Intercept Services. Margot 
Blige, (410) 786-4642 for all other issues.

SUPPLEMENTARY INFORMATION:

E-mail, Comments, Availability of Copies, and Electronic Access

    E-mail comments must include the full name, postal address, and 
affiliation (if applicable) of the sender and must be submitted to the 
referenced address to be considered. All comments must be incorporated 
in the e-mail message because we may not be able to access attachments.
    Because of staffing and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code HCFA-1813-FC. 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 443-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).
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contact the GPO Access User Support Team by sending Internet e-mail to 
[email protected]; by faxing to (202) 512-1262; or by calling 
(202) 512-1530 between 7 a.m. and 5 p.m. Eastern time, Monday through 
Friday, except for Federal holidays.

I. Background

A. Statutory Coverage of Ambulance Services

    Under section 1861(s)(7) of the Social Security Act (the Act), 
Medicare Part B (Supplementary Medical Insurance) covers and pays for 
ambulance services, to the extent prescribed in regulations, when the 
use of other methods of transportation would be contraindicated. The 
House Ways and Means Committee and Senate Finance Committee Reports 
that accompanied the 1965 Social Security Amendments suggest that the 
Congress intended that (1) the ambulance benefit cover transportation 
services only if other means of transportation are contraindicated by 
the beneficiary's

[[Page 3638]]

medical condition, and (2) only ambulance service to local facilities 
be covered unless necessary services are not available locally, in 
which case, transportation to the nearest facility furnishing those 
services is covered (H.R. Rep. No. 213, 89th Cong., 1st Sess. 37, and 
S. Rep. No. 404, 89th Cong., 1st Sess., Pt I, 43 (1965)). The reports 
indicate that transportation may also be provided from one hospital to 
another, to the beneficiary's home, or to an extended care facility.

B. Current Medicare Regulations for Ambulance Services

    Our regulations relating to ambulance services are located at 42 
CFR Part 410, subpart B. Section 410.10(i) lists ambulance services as 
one of the covered medical and other health services under Medicare 
Part B. Ambulance services are subject to basic conditions and 
limitations set forth at Sec. 410.12 and to specific conditions and 
limitations included at Sec. 410.40.

II. Provisions of the Proposed Regulations

    On June 17, 1997, we published a proposed rule in the Federal 
Register at 62 FR 32715 that would revise and update our ambulance 
regulations at Sec. 410.40. Specifically, we proposed to provide 
coverage of ambulance services only if the supplier meets the proposed 
applicable vehicle, staff, and billing and reporting requirements and 
proposed medical necessity and origin and destination requirements. We 
also proposed to cover ambulance services in the United States at 
either the basic life support (BLS) or advanced life support (ALS) 
level of services. Under the proposed rule, we would base coverage on a 
beneficiary's medical condition as described by the International 
Classification of Diseases, 9th revision, Clinical Modification (ICD-9-
CM) diagnosis codes; these codes would be used to bill for ambulance 
services. In addition, we proposed an exception to the ALS/BLS 
distinction for certain non-Metropolitan Statistical Areas.
    We also proposed to provide for the coverage of nonemergency 
transportation, including but not limited to transportation for an end-
stage renal disease (ESRD) beneficiary, if the ambulance supplier 
obtains a written physician's order certifying that the beneficiary be 
transported in an ambulance because other means of transportation are 
contraindicated.
    Finally, we proposed to allow coverage of ambulance services for 
ESRD beneficiaries to the nearest treatment facility rather than to the 
nearest hospital-based facility.

III. The Balanced Budget Act of 1997

    On August 5, 1997, after we had issued the ambulance services 
proposed rule, the Balanced Budget Act of 1997 (the BBA), Public Law 
105-33, was enacted. Section 4531(b) of the BBA adds a new section 
1834(l) to the Act, which provides for the establishment of a fee 
schedule for payment of ambulance services effective January 1, 2000. 
In addition, section 1834(l)(1) of the Act requires that the fee 
schedule be developed through a negotiated rulemaking process. Section 
1834(l)(20(B) of the Act provides that, in establishing the fee 
schedule, the Secretary must establish definitions for ambulance 
services that link payments to the types of services furnished.
    As noted above, one of the provisions of the June 17, 1997 proposed 
rule would have defined ambulance services as either ALS or BLS 
services and linked the Medicare payment to the type of service (ALS or 
BLS) required by the beneficiary's condition. Under section 1834(l) of 
the Act, this type of service definition and resulting payment is 
required to be a part of the negotiated rulemaking. Therefore, we are 
deferring any final action on those provisions of the proposed rule. We 
will reopen the discussion of the definition of ambulance services and 
the appropriate payment as a part of the negotiated rulemaking process. 
We note, however, that our current policy, as stated in section 5116 of 
the Medicare Carriers Manual (MCM), which provides for the payment of 
two separate reasonable charge rates for ambulance services, one for 
BLS level of ambulance service and one for ALS level of service, 
remains applicable. In general, the ALS reasonable charge may be used 
as a basis for payment when an ALS level of ambulance service is 
provided. However, as stated in MCM section 5116.1, there may be 
instances when the supplier exhibits a pattern of uneconomical care 
such as repeated use of ALS ambulances in situations in which it should 
have known that the less expensive BLS ambulance was available and that 
its use would have been medically appropriate. While we allow higher 
payments for the ALS services, the carrier is responsible for 
evaluating the appropriate level of service for each claim.
    In addition to providing for a fee schedule for ambulance services, 
section 4531(c) of the BBA authorizes the Secretary to include coverage 
of ALS services provided by a paramedic intercept service provider in a 
rural area if certain conditions are met. We are implementing this 
provision in this final rule with comment period. We discuss, in 
detail, this provision and the changes to the regulations necessary to 
implement it, in section V of this preamble.

IV. Analysis of, and Responses to, Public Comments

    In response to our proposed regulation published on June 17, 1997, 
we received 2,270 comments from ambulance service suppliers, emergency 
medical service personnel, ambulance associations, health care 
providers, Medicare contractors, and private citizens. As noted above, 
because we are not proceeding in this final rule with the proposed 
provisions related to basing coverage and payment of ambulance service 
on the level of medically necessary services, we are not responding to 
the comments we received concerning that proposal, including the use of 
ICD-9-CM diagnosis codes to determine medical necessity and the 
proposed exception to this policy for ALS services furnished in areas 
that are not part of a Metropolitan Statistical Area. We not that the 
vast majority of the comments concerned the definition of services as 
ALS or BLS. The remaining comments and our responses are set forth 
below.

A. Medicare Coverage of Ambulance Services--Basic Rule

    In the proposed rule, we clarified in Sec. 410.40(a) the 
circumstances under which an ambulance service is paid under Medicare 
Part B as opposed to Medicare Part A. We received one comment on this 
proposal.
    Comment: A supplier commented that the proposed regulations are 
unclear on two points. First, they do not indicate the point at which 
Part A begins to cover transportation services and whether those 
services provided before admission to the hospital are covered under 
that Part or only those provided during the patient's hospital stay. 
Second, the proposed regulations seem to indicate that if a patient's 
stay in the hospital is covered by Part A, the ambulance service 
provided before admission and at discharge would be part of the Part A 
payment and could not be billed under Part B. If this is true, the 
commenter believed that this is a change in policy that would destroy 
many Part B ambulance services and be detrimental to hospitals.
    Response: The proposed revisions to the regulations were made 
merely to clarify and restate current policy on the scope of benefits 
under Parts A and B of Medicare, not to make any change in policy. To 
explain the policy in this area, we must distinguish between

[[Page 3639]]

ambulance services, which are covered under Part B, and transportation 
services, which are covered under Part A. The movement of a beneficiary 
from his or her home, an accident scene, or any other point of origin 
to the nearest hospital, critical care access hospital (CAH) (formally 
known as a rural primary care hospital (RPCH)), or skilled nursing 
facility (SNF) that is capable of furnishing the required level and 
type of care for the beneficiary's illness or injury is covered, 
assuming medical necessity and other coverage criteria are met, only 
under Part B as an ambulance service. No Part A coverage is available 
because, at the time the beneficiary is transported, he or she is not 
an inpatient of any provider paid under Part A of the program. The 
transfer of a beneficiary from one provider to another (for example, 
from an acute care hospital to a long-term care hospital or to an SNF) 
is also not covered as a Part A provider service because, at the time 
the person is in transit, he or she is not a patient of either 
provider. This service may be covered under Part B.
    However, once a beneficiary has been admitted to a hospital, CAH,or 
SNF, it may be necessary to transport the beneficiary to another 
hospital or other site for specialized care. In this instance, the 
specialized services are furnished under arrangements made by the 
hospital, CAH, or SNF. Following that treatment, the beneficiary is 
returned to the hospital, CAH, or SNF to complete the inpatient stay. 
This movement of the beneficiary is considered ``patient 
transportation'' and is covered as an inpatient hospital or CAH service 
under Part A of the program and as an SNF service when the SNF is 
furnishing it as a covered SNF service, and Part A payment is made for 
that service. Because the service is covered and payable as a 
beneficiary transportation service under Part A, the service cannot be 
classified and paid for as an ambulance service under Part B. This is 
not a change from current policy, but has been the policy since the 
inception of the Medicare program. In order to more clearly indicate 
that ambulance services are covered under Part A when the beneficiary 
is an inpatient of a hospital or CAH, we have revised the regulations 
at Sec. 409.10 to include this service as a covered inpatient hospital 
or CAH service. We have also revised Sec. 409.20 to include it as a SNF 
covered service.
    We note that, as provided in Secs. 412.2(c)(5)(iii)(B) and 
413.40(c)(2)(iii)(B), ambulance services are specifically excluded from 
the preadmission payment window provisions applicable to hospital 
inpatient services. That is, ambulance services furnished during the 3 
days before the day of a beneficiary's admission to a hospital (or 1 
day for hospitals excluded from the prospective payment system) may be 
paid under Part B and are not considered inpatient hospital services.

B. Medical Necessity

    Under current regulations, Medicare covers transportation provided 
by an ambulance if the beneficiary must be transported by an ambulance 
because other means of transportation are contraindicated. In the June 
1997 proposed rule (62 FR 32719), we proposed that if a beneficiary is 
``bed-confined,'' other means of transportation would be presumed to be 
contraindicated. We also proposed that ``bed-confined'' would be 
defined as the inability to--
     Get up from bed without assistance;
     Ambulate; and
     Sit in a chair, including a wheelchair.

We noted that we used this term synonymously with the terms 
``bedridden'' or ``stretcher-bound.'' However, it is not synonymous 
with ``bed rest'' or ``nonambulatory.''
    In addition, nonemergency transportation would be covered only if, 
before furnishing the service, the ambulance supplier obtained a 
physician's written order certifying that the beneficiary must be 
transported in an ambulance because other means of transportation are 
contraindicated (Sec. 410.40(c)(2)). The physician's order must be 
dated no more than 60 days before the date the service is furnished. We 
received several comments on these proposed policies.
    Comment: A Medicare carrier and a national renal association 
supported the definition of bed-confined as proposed. They believed 
that the definition ensures that ambulance services will be provided 
only to those individuals with the greatest need and the most severe 
physical limitations.
    Response: We agree with the commenters. Our purpose in developing 
this definition was to identify as eligible for covered ambulance 
services only those individuals who are not able to be up and out of 
bed under any condition and cannot tolerate other methods of 
transportation.
    Comment: Three commenters stated that the definition of ``bed-
confined'' as proposed is too restrictive and that the policy 
eliminates transportation for many individuals who would ``in reality 
have no other way of obtaining medical care.''
    Response: It is important to note that the Medicare law contains no 
provisions for ``transportation,'' but rather provides for coverage of 
ambulance services. Section 1861(s)(7) of the Act allows Medicare 
coverage of ambulance services only when the use of other methods of 
transportation is contraindicated by the beneficiary's condition. The 
regulations reflect the intent expressed in the House Ways and Means 
Committee and Senate Finance Committee reports on H.R. 6675, the 1965 
Social Security Amendments (H. Rep. No. 213 at page 36 and S. Rep. No. 
404 at page 43) that ambulance transportation be covered only if ``* * 
* normal transportation would endanger the health of the patient * * 
*'' Therefore, a patient whose condition permits transport in any type 
of vehicle other than an ambulance would not qualify for ambulance 
services under Medicare Part B.
    Comment: Seven ambulance suppliers stated that all factors relating 
to the beneficiary's condition should be considered in evaluating if a 
beneficiary has met the medical necessity criteria for ambulance 
service. That is, bed-confinement should not be the sole criterion used 
in determining medical necessity because it is only one factor. The 
commenters suggested that suppliers should provide documentation on why 
the beneficiary is bed-confined.
    Response: It is always the responsibility of the ambulance supplier 
to furnish complete and accurate documentation to demonstrate that the 
ambulance service being furnished meets the medical necessity criteria. 
The fact that a definition of bed-confined has been adopted does not 
suggest that bed-confinement is the sole determinant of medical 
necessity nor does it relieve the supplier of his or her responsibility 
to submit adequate information supporting the reason for a bed-
confinement determination.
    Comment: Three ambulance suppliers disagreed that the proposed bed-
confined definition should be synonymous with ``stretcher-bound.'' They 
suggested that ``stretcher-bound'' refers to the beneficiary being 
secured to the stretcher and not specifically to the condition of the 
beneficiary. They asked that we clarify that stretcher-bound is not a 
synonym for ``bed-confined.''
    Response: We agree with the commenters and will not use the term 
``stretcher-bound'' in describing the medical condition of the 
beneficiary. We proposed a definition of ``bed-confined'' as a part of 
our proposal to use ICD-9-CM medical condition codes. The ICD-9-CM list 
set forth in the

[[Page 3640]]

proposed rule included the diagnosis code V49.8, Other Specified 
Problems Influencing Health Status. We added a definition of bed-
confined which could be used in conjunction with this code. As noted 
above, we are not including the proposed medical necessity provision 
based on ICD-9-CM codes in this final rule. However, as a result of 
comments, as well as past questions, we have specified certain criteria 
that must be met in order for ambulance services to be covered. In 
accordance with Sec. 410.40(d), nonemergency ambulance transportation 
would be covered if the beneficiary is unable to get up from bed 
without assistance.
    Comment: One ambulance supplier commented that the proposed 
definition will cause undue hardship for the beneficiary, family, 
physician, and ambulance supplier because some beneficiaries are able 
to sit in a wheelchair for brief periods of time, but cannot tolerate a 
wheelchair for the period of time required for transport. Under the 
proposed definition, ambulance transportation furnished to 
beneficiaries such as these would not be covered.
    Response: If there are circumstances associated with the 
beneficiary's condition that warrant the need for ambulance 
transportation, the documentation submitted on behalf of that 
beneficiary should reflect the condition and support the need for the 
services. That documentation will then be considered by the carrier in 
processing the claim.
    Comment: Several ambulance suppliers and a national ambulance 
association commented that the proposed definition of ``bed-confined'' 
is too narrow and that most beneficiaries who can ``technically sit in 
a chair or wheelchair momentarily'' or be ``restrained'' to a chair or 
wheelchair would not meet the definition and would therefore be denied 
ambulance services. They also expressed the belief that the definition 
should be based on the condition of the beneficiary at the time of 
transport rather than any period before or after the transport. One of 
the commenters suggested that it is not safe to transport someone in a 
wheelchair who must be restrained in order to travel. To ensure that 
the definition allows those beneficiaries who are bed-confined to 
receive ambulance benefits, commenters suggested the following 
revisions for the definition of ``bed-confined'':
     Add the phrase ``without assistance'' to the second and 
third criteria of the proposed definition.
     Add the phrase ``* * * the inability to ride in a moving 
vehicle without being restrained to that chair'' to the last criterion.
     Revise the third criterion to read ``* * * the inability 
to sit for an extended period of time in a chair or wheelchair, without 
restraint.''
     The phrase ``without assistance'' should be removed from 
the first criterion and the ``and'' be replaced with ``or'' so that if 
any one of the criteria is met, the beneficiary would be determined to 
be ``bed-confined.''
    Response: In developing the proposed definition, it was our intent 
to describe clearly individuals who are completely confined to bed and 
unable to tolerate any activity out of bed. We recognize that it is 
standard and accepted medical practice in both hospitals and nursing 
homes to take steps to ensure that beneficiaries are up and out of bed 
as often as their condition permits. Such beneficiaries are not bed-
confined. It is incumbent upon health care professionals responsible 
for the care of individual beneficiaries to determine what is safe for 
those beneficiaries. If it is determined that it is unsafe for a 
particular beneficiary to be unmonitored during transport, then the 
documentation submitted for that particular transport should support 
the need for ambulance transportation. That documentation will be 
considered by the carrier in processing the claim.
    We considered whether it would be appropriate to include a time-
frame with respect to the ``bed-confined'' definition. That is, adding 
a phrase such as `'for more than 10 minutes'' to the various criteria. 
Because of the difficulty associated with obtaining accurate 
information related to how long an individual may have been out of bed 
as well as the difficulty associated with efforts to substantiate such 
information, we determined that it would be inappropriate to employ the 
use of absolute terms if we did not intend to identify a means by which 
a time factor could be measured.
    We do not believe it is necessary to make the proposed revisions on 
the basis that the proposed definition encompasses the variations 
requested by the commenters. We will however, revise the definition to 
clarify that all three components must be met in order for the patient 
to meet the requirements of the definition of ``bed-confined''.
    Comment: A national ambulance association stated that because we 
did not define ``emergency'' and ``nonemergency'' in the proposed rule, 
ambulance suppliers will not know when physician certification is 
needed. The association does, however, support the need for physician 
certification, in 60-day intervals, for repetitive transports. They 
recommended the following definition for repetitive patients:
    ``Multiple scheduled treatments (for example, dialysis or radiation 
therapy treatments) for the same diagnosis that requires ambulance 
transportation over an extended period of time.''
    Response: The applicable definition that we use to define emergency 
services is the definition set forth in section 1861(v)(1)(K)(ii) of 
the act, which defines the term ``bona fide emergency services.'' This 
definition provides that an emergency service is one that is provided 
after the sudden onset of a medical condition manifesting itself by 
acute sysmptoms of sufficient severity such that the absence of 
immediate medical attention could reasonably be expected to result in 
placing the beneficiary's health in serious jeopardy; serious 
impairment to bodily functions; or serious dysfunction of any bodily 
organ or part. Any ambulance transportation service that does not meet 
these criteria would be a nonemergency service. This would include all 
scheduled transports (regardless of origin and destination), as well as 
transports to SNFs or to the beneficiary's residence. Medically 
necessary transports to and from dialysis facilities are scheduled and, 
therefore, are nonemergency ambulance services.
    Comment: Four ambulance suppliers commended that the physician 
certification requirement should not apply to beneficiaries who reside 
at home or in facilities where they are not directly under the care of 
a physician.
    Response: We agree that suppliers may often be unable to obtain the 
appropriate physician certificate for these patients for a unscheduled 
transport. We will revise the final regulations to provide that the 
physician certification will be required for these beneficiaries for 
scheduled, repetitive transports and scheduled, nonrepetitive 
transports because we can assume that beneficiaries who are scheduled 
for medical appointments are under a physician's care. In addition, for 
beneficiaries who reside in a facility and are under a physician's 
care, there should be little difficulty in obtaining the certificate 
for unscheduled transports. For nonemergency, unscheduled 
transportation of beneficiaries residing at home or in facilities were 
they are not under the direct care of a physician, the physician 
certification requirement will not apply.
    Comment: Several commenters, including an Emergency Medical 
Services (EMS) Director, stated that nonscheduled, nonemergency 
transports

[[Page 3641]]

should be judged on their medical necessity and therefore exempt from 
the bed-confined requirement and that, to avoid unnecessary delays, it 
would be appropriate to obtain the physician certification with 48 
hours after the ambulance service was furnished. The commenters do 
support use of a physician certification for those patients needing 
repetitive transports to receive specialized services.
    Response: After considering the arguments and observations made by 
commenters, we concluded that we should proceed with our proposal to 
require physician certification for all nonemergency transports, both 
scheduled and unscheduled, except for the revisions discussed in the 
previous response to comments concerning beneficiaries who are not 
living in a facility directly under a physician's care. Nonemergency 
ambulance service is a Medicare service furnished to a beneficiary for 
whom a physician is responsible; therefore, the physician is 
responsible for the medical necessity determination. The physician 
certification requirement will help to ensure that the claims submitted 
for ambulance services are reasonable and necessary, because other 
methods of transportation are contraindicated. We believe that this 
requirement will help to avoid Medicare payment for unnecessary 
ambulance services that are not medically necessary even though they 
may be desirable to beneficiaries. However, we agree with the 
commenters that, to avoid unnecessary delays, for unscheduled 
transports, the required documentation can be obtained within 48 hours 
after the ambulance transportation service has been furnished. That is, 
it is not necessary that the ambulance suppliers have the physician 
certification in hand prior to furnishing the service. While it is 
reasonable to expect that an ambulance supplier could obtain 
pretransport physician certification for routine, scheduled trips, it 
is less reasonable to impose such a requirement on unscheduled 
transports. Therefore, we have revised the final regulations to reflect 
this change.
    Comment: Two ambulance suppliers commented that physicians are 
unaware of the coverage requirements for ambulance services and that 
their decisions to request ambulance services may be based on ``family 
preference or the inability to safely transport the beneficiary by 
other means rather than on the medical necessity requirement imposed by 
Medicare.''
    Response: Section 1861(s)(7) of the Act allows for Medicare 
coverage of ambulance services only when the use of other methods of 
transportation is contraindicated by the beneficiary's condition. If 
the ability to safely transport the beneficiary, given the 
beneficiary's condition, is at issue, then the supplier may obtain from 
the physician the necessary documentation supporting the reason for the 
transportation. If the decision to use ambulance services is based on 
the convenience of the beneficiary, the beneficiary's family, the 
beneficiary's physician, or some other element of personal preference, 
Medicare coverage is not available.
    To facilitate awareness of the Medicare rules as they relate to the 
ambulance service benefit, ambulance suppliers may need to educate the 
physician (or the physician's staff members) when making arrangements 
for the ambulance transportation of a beneficiary. Suppliers may wish 
to furnish an explanation of applicable medical necessity requirements 
as well as requirements for physician certification and to explain that 
the certification statement should indicate that the ambulance services 
being requested by the attending physician are medically necessary.

C. Origins and Destinations

    In the proposed rule, we added a provision that allowed coverage of 
round-trip ambulance transportation for an ESRD beneficiary living at 
home to the nearest treatment facility capable of furnishing the 
necessary dialysis service regardless of whether the dialysis facility 
is located at a hospital. We currently cover the ambulance services 
only if the beneficiary is transported to a hospital-based facility for 
dialysis.
    Comment: Several commenters, including a consortium of EMS 
Directors, renal associations, and dialysis facilities, believed that 
the proposed change concerning transportation to the nearest dialysis 
facility is not in the best interest of the beneficiary and that it 
will have an impact on the continuity of beneficiary care. That is, 
beneficiaries who have been receiving dialysis at the nearest hospital-
based treatment facility may now be forced to go to another, closer 
nonhospital treatment facility. The commenters recommended that we 
allow for transport to the nearest facility where there is an 
``existing, established beneficiary care relationship'' and the 
facility has an ``available bed.''
    Response: While we were developing the proposed regulation, 
concerns were raised by representatives of the renal community that the 
current policy was detrimental to beneficiaries with ESRD because it 
forced some of them to travel great distances to a hospital for 
dialysis when the same services were available closer to their homes. 
In response to these concerns, we proposed to allow coverage of 
ambulance services to the nearest appropriate dialysis facility. This 
policy is consistent with our general ambulance policy, set forth in 
section 2120.3.F of the MCM, for emergency services which, in general, 
limits payment for otherwise covered ambulance transportation services 
to the nearest facility capable of furnishing care.
    If the closest dialysis facility is not able to perform the type of 
treatment the beneficiary requires or is unable to accommodate the 
beneficiary for another reason, for example, lack of capacity, then 
Medicare will pay for the beneficiary to be transported to the more 
distant facility. It is, of course, the prerogative of the beneficiary 
to choose the facility where he or she wishes to be treated. If the 
beneficiary decides to be transported to a facility farther away, and 
it is determined that the nearer facility was capable of providing the 
required type and level of care, Medicare payment for the ambulance 
service is limited to the amount that would have been paid to transport 
the beneficiary to the nearest appropriate dialysis facility.
    Comment: Three ambulance suppliers commented that we should 
consider paying for other forms of transportation for ESRD 
beneficiaries.
    Response: As noted above, the only transportation service covered 
by Medicare is that set forth at section 1861(s)(7) of the Act. That 
section allows Medicare coverage for ambulance services only when the 
use of other methods of transportation are contraindicated by the 
beneficiary's condition. We believe Congress made a distinction between 
``transportation by ambulance'' and ``normal transportation.'' We 
believe Congress intended, by this distinction that Medicare coverage 
be limited to ambulance services for beneficiaries who could not reach 
care any other way. Thus, a beneficiary whose condition permits 
transfer in any vehicle other than ambulance would not qualify for 
Medicare Part B payment.
    Comment: A State ambulance association and a hospital-based 
ambulance provider commented that the proposed change for ESRD 
beneficiaries will increase the number of transports and the incidence 
of fraud and abuse.
    Response: The proposed change in the policy for ESRD beneficiaries 
does not expand the coverage of transportation for these beneficiaries; 
it merely changes the allowable destinations for dialysis

[[Page 3642]]

treatment. We concluded the transporting ESRD beneficiaries from their 
residence to the nearest appropriate dialysis facility to receive 
medically necessary dialysis services could result in a cost savings to 
the Medicare program through the substitution of shorter trips for 
unnecessarily long trips and, in some cases, ambulance trips to distant 
hospital-based facilities to obtain dialysis. This modification, 
coupled with the 60-day physician certification requirement for 
nonemergency, scheduled ambulance transports and the medical necessity 
determination, provides limitations that should prevent inappropriate 
coverage of ambulance services furnished to ESRD beneficiaries. 
Therefore, we anticipate that this revision to the Medicare ambulance 
services policy will not result in an increased number of transports or 
an increase in the incidence of fraud and abuse.
    Comment: Three ambulance suppliers commented that, in order to 
decrease the burden on local emergency rooms and to provide most cost-
effective service, HCFA should consider expanding the allowable 
destinations for ambulances transportation to include physician's 
offices, urgent care facilities, and freestanding radiological 
facilities. In support of this recommendation, one supplier indicated 
that the Omnibus Reconciliation Act of 1980 (Public Law 96-499) 
specifically covered ambulance transportation to freestanding 
radiological facilities.
    Response: Although we proposed to allow ESRD beneficiaries residing 
at home to receive medically necessary ambulance transportation to the 
nearest appropriate dialysis facility, even if that facility is not 
hospital-based, we are not proposing to extend ambulance coverage for 
transport to other facilities or for other populations of 
beneficiaries. In making our decision to expand the destination sites 
for ESRD beneficiaries, we considered the fact that many beneficiaries 
who are confined to home may have a broader range of needs on a routine 
basis, such as visits to the physician, for which they might wish to 
have ambulance transportation could be available. However, an expansion 
of this type would be difficult to monitor to ensure that the ambulance 
services benefit was being used only for medically necessary 
transportation where all other means of transportation were 
unacceptable. Without built-in limitations (for example, routinely 
requiring the use of physician certifications) and extensive rules for 
determining when the need for medical services justifies coverage of 
ambulance transportation, the ambulance services benefit could easily 
become a benefit for general transportation services, which would be 
inconsistent with Congressional intent and program history.
    It is also important to note that, generally, Medicare does not 
provide coverage for ambulance transportation to a physician's office, 
for example, transportation to a physician's office for a follow-up 
visit with an attending physician. There are two exceptions to this 
rule. First, under Medicare Part A, we cover ambulance transportation 
of hospital or SNF inpatients to the nearest appropriate treatment 
facility including a physician's office to obtain medically necessary 
diagnostic or therapeutic services not available at the institution 
where the beneficiary is an inpatient. This exception may be applied 
only if the services cannot reasonably be brought to the beneficiary or 
the cost of transporting the beneficiary is less than the cost of 
bringing the services to the beneficiary. Second, if while transporting 
a beneficiary to a hospital, the ambulance stops at a physician's 
office because of the beneficiary's dire need for professional 
attention, and, immediately thereafter, the ambulance continues to the 
hospital, Medicare coverage may be available.
    The House Report of the Committee on the Budget that accompanied 
Public Law 96-499 did recommend that we consider including coverage of 
round-trip ambulance transportation for beneficiaries in SNFs or 
confined to their homes to obtain medically necessary radiological 
services furnished in a nonhospital setting. However, the suggestion to 
provide coverage for round-trip ambulance transportation services to 
freestanding radiological facilities was not included in the final 
provisions of the law.

D. Requirements for Ambulance Suppliers

1. Vehicles
    We proposed that any vehicle used as an ambulance must be designed 
and equipped to respond to medical emergencies and, in nonemergency 
situations, be capable of transporting beneficiaries with acute medical 
conditions. The vehicle must also comply with all applicable State and 
local laws governing the licensing and certification of an emergency 
medical transportation vehicle. In addition, we proposed that, at a 
minimum, the ambulance must contain a stretcher, linens, emergency 
medical supplies, oxygen equipment, and other lifesaving emergency 
medical equipment and be equipped with emergency warning lights, 
sirens, and two-way telecommunications.
    Comment: Several ambulance suppliers commented that requiring 
``two-way telecommunications'' is unnecessary, cost prohibitive, and 
not practical for rural areas. One commenter suggested that the 
requirement be revised to state, ``* * * be equipped with 
telecommunications equipment as required by State or local law, to 
include, at a minimum, one two-way voice radio or wireless telephone.''
    Response: We agree that the commenter's alternative will satisfy 
our needs for safety and efficiency. We have decided, therefore, that 
we will adopt the commenter's suggestion.
    Comment: Three ambulance suppliers commented that the reference to 
``lifesaving equipment'' is vague. One commenter suggested that we 
specifically enumerate the ALS equipment required.
    Response: It is our intent to defer to State or local requirements 
where vehicle equipment and personnel certification requirements are 
concerned. In addition, a review of the proposal reflects an 
inadvertent omission of the phrase ``* * * as required by State or 
local law''; therefore, Sec. 410.41(a) will be revised accordingly.
2. Vehicle Staff
    We proposed staffing requirements at both the BLS and ALS level of 
service. As proposed, a BLS vehicle would have to be staffed by at 
least two persons, each trained to provide first aid and certified as 
an emergency medical technician-basic (EMT-B) by the State or local 
authority where the services are furnished and legally authorized to 
operate all lifesaving equipment on board the vehicle.
    An ALS vehicle would need to include at least two persons: one 
person trained to provide basic first aid at the EMT-B level and one 
person trained and certified as a paramedic or emergency medical 
technician-advance (EMT-A) who is also trained and certified to perform 
one or more ALS services. The EMT-A or paramedic would have had to be 
certified by the State in which the services are furnished and legally 
authorized to operate all lifesaving equipment on board the vehicle.
    Comment: Several ambulance suppliers commented that the proposed 
staffing requirements are contrary to existing State standards and the 
proposed requirement that a BLS ambulance be staffed with two EMTs

[[Page 3643]]

would have a detrimental effect on volunteer companies. The commenters 
recommended that we revise the staffing requirements to defer to State 
or local requirements for ambulance staffing. Many comments pointed out 
that the State EMS offices set the minimum staffing level requirements.
    Response: We agree with the commenters that it is sufficient for 
Medicare purposes if the BLS vehicle staffing meets the State and local 
laws. Based on a review of the comments, we acknowledge that a 
requirement for a minimum of two EMTs, as proposed, has the potential 
of placing considerable burden on volunteer ambulance services and may 
possibly lead to the elimination of such services, particularly in 
rural areas. We will revise the regulations accordingly.
    Comment: Three suppliers requested that we define the following 
terms: EMT-A, EMT-B, and paramedic.
    Response: Based on comments received in response to the proposed 
regulation, we acknowledge that the terms EMT-A and EMT-B are no longer 
used by the EMS industry; thus, we are deleting reference to EMT-A and 
EMT-B. We will, however, maintain our proposed requirement that if an 
ALS staff member is authorized, under State or local laws, to operate 
as an ALS crew member, then the EMT must be certified to perform one or 
more ALS services. The term ``paramedic'' is defined by State and local 
laws.
3. Billing and Reporting Requirements
    In the proposed rule, we stated that we would require ambulance 
suppliers to use the HCFA Common Procedure Coding System (HCPCS) codes 
to describe the origin and destination of ambulance trips. We also 
proposed that, at the carrier's request, a supplier would complete and 
submit an ambulance supplier form established by HCFA and provide the 
carrier with documentation of the supplier's compliance with State and 
local emergency vehicle and staff licensure and certification 
requirements. In addition, suppliers would be required to provide any 
information requested by the carrier for purposes of documenting the 
ambulance supplier's compliance with the regulations and to support 
claims processing.
    Comment: A majority of the commenters objected to the proposed 
billing and reporting requirements on the ground that they are unfunded 
mandates that are burdensome and in excess of the informational updates 
required at the State or local level. They also believe that the 
carriers should not be allowed unlimited access to records, many of 
which are protected under other Federal laws and regulations.
    Response: Current Medicare instructions (section 2120.1 of the MCM) 
require ambulance suppliers to submit a statement and other documentary 
evidence that their vehicles and personnel meet all of the requirements 
set by State or local authorities. The guideline specifies that, in 
addition to the submission of documentary evidence, the statement 
should describe the equipment and beneficiary care items with which the 
vehicles are equipped, the extent of first-aid training acquired by 
personnel staffing those vehicles and the supplier's agreement to 
notify the carrier of any changes in operation that would affect the 
coverage of the supplier's ambulance services. Our intent in proposing 
that suppliers complete a HCFA-developed Ambulance Supplier Form was to 
promote consistency in the collection of this already-required 
information as well as make it easier for suppliers by providing them 
with a preprinted form to complete.
    Current guidelines also specify that when the required information 
is not submitted or whenever there is a question about the supplier's 
compliance with the requirements, the carrier should take appropriate 
action. The appropriate action may include conducting an on-site visit 
as well as requesting additional information. We disagree with 
commenters that the proposed requirement allow unlimited access to 
protected records. This requirement formalizes, in a consistent format, 
an informational requirement that has been in effect for several years.
    Based on comments, we will revise the final regulations to clarify 
that, upon carriers' request, suppliers will be required to submit 
additional information and documentation as it relates to vehicle and 
personnel operations. That is, suppliers will not be required to 
automatically submit information and documentation for each new vehicle 
that is purchased or crew member that is hired.
    Comment: Several suppliers stated that verification of compliance 
information should be obtained from State databases and not directly 
from the ambulance supplier.
    Response: To coordinate the transfer of information between various 
State computer systems and the systems used by our Medicare contractors 
could present administrative problems for the State as well as the 
carrier. We would also need to take into consideration system 
capabilities, compatibility, and the potential cost to the State, 
carrier, HCFA, and the supplier. We are not requiring the submission of 
documentation that is inconsistent with information suppliers are 
already required to report to the State or local authority. This 
provision requires suppliers to complete the standardized Ambulance 
Supplier Form and to photocopy documentation already in their 
possession.
    Comment: One ambulance supplier commented that the Ambulance 
Supplier Form appears to contradict the information provided in the 
HCFA-855, Medicare Provider/Supplier Enrollment form. The supplier 
questioned whether the State ambulance license will be acceptable in 
lieu of vehicle and staffing information required on the HCFA-855 
application.
    Response: The HCFA-855 is required to be completed by all providers 
and suppliers who wish to enroll in the Medicare program (except for 
those who are required to enroll through the survey and certification 
process). The information being requested on that form is used to 
determine eligibility and to make proper payments under the Medicare 
program. Attachment 2 of the HCFA-855 Enrollment Application form 
indicates that, ``If you are licensed by your State as an Ambulance 
Supply Service, you are not required to submit the information on the 
supplier form Attachment 2.'' The information that Attachment 2 
requires related to vehicle descriptions for each vehicle including 
specifying the type of vehicle, license number, and the list of first-
aid, ALS equipment, if applicable, safety and other care items. Even in 
instances where a supplier does complete the Ambulance Supplier Form 
shown in the attachment, because the service is not licensed by the 
State, the company would still be required to submit to the carrier 
evidence of recertification. This is the same requirement imposed on 
suppliers who are State licensed. The enrollment form instructions 
specify that evidence of vehicle and personnel recertification must be 
submitted to the carrier on an ongoing basis and that copies of 
applicable certificates and licenses should be included. This 
instruction guideline is applicable to all ambulance service suppliers.
    In conclusion, the proposed billing and reporting requirements, 
which require submission of the Ambulance Supplier Form, are not new 
requirements. This form is the method by which suppliers will submit 
evidence of vehicle and crew recertification. The form was developed to 
provide a consistent format for the collection of verification of 
compliance

[[Page 3644]]

information currently required by Medicare instructional guidelines.

V. Paramedic Intercept Provisions of the BBA

    Paramedic intercept services are ALS services delivered by 
paramedics who operate separately from the agency that provides the 
ambulance transport. This type of service is most often provided for an 
emergency ambulance transport in which a local volunteer ambulance that 
can provide only BLS-level service is dispatched to transport a 
beneficiary. If the beneficiary needs ALS services, such as EKG 
monitoring, chest decompression, or IV therapy, another agency, 
typically a hospital or proprietary emergency medical service, 
dispatches a paramedic to meet the BLS ambulance at the scene or en 
route to the hospital. The ALS paramedics then provide their services 
to the beneficiary.
    This tiered approach to life-saving may be cost effective in many 
areas because most volunteer ambulances do not charge for their 
service, and one paramedic service can cover many communities. Under 
current policy, Medicare payment may be made for these services only 
when the claim is submitted by the ambulance provider (that is, the 
actual transporting ambulance unit). Payment cannot be made directly to 
the intercept service supplier because there is no benefit category in 
the Medicare statute for the intercept service itself. With the limited 
exception provided in section 4531(c) of the BBA (discussed below), the 
only statutory basis for covering these services is under section 
1861(s)(7) of the Act, as an integral part of the ambulance 
transportation benefit. In a jurisdiction that prohibits volunteer 
ambulances from billing Medicare and other health insurance, the 
intercept service cannot be paid for treating a Medicare beneficiary 
and is forced to bill the beneficiary for the intercept service.
    Section 4531(c) of the BBA provided that the Secretary could 
include limited coverage of these intercept services provided in a 
rural area; that is, payment may be made directly to the agency 
providing the paramedic service. However, the services could be covered 
only if they are provided under contract with one or more volunteer 
ambulance services and they are medically necessary based on the 
condition of the beneficiary receiving the ambulance service. In 
addition, the volunteer ambulance service involved must meet all of the 
following requirements:
     Be certified as qualified to provide ambulance services 
for purposes of this provision.
     Provide only BLS services at the time of the intercept.
     Be prohibited by State law from billing for any service. 
Finally, the entity providing the ALS paramedic intercept service must 
meet the following requirements:
     Be certified as qualified to provide the services under 
the Medicare program.
     Bill all Recipients who receive ALS paramedic intercept 
services from the entity, regardless of whether or not those recipients 
are Medicare Beneficiaries.
    We are revising Sec. 410.40 to include these provisions. We are 
defining rural area in the same way it is defined for purposes of the 
Medicare hospital inpatient prospective payment system under section 
1886(d)(2)(D) of the Act and in regulations at Sec. 412.62(f). A rural 
area is any area outside of a Metropolitan Statistical Area (MSA) or 
New England County Metropolitan Area (NECMA) as defined by the Office 
of Management and Budget. (Please see Tables 4A and 4B in the final 
rule in the July 31, 1998 Federal Register entitled, Health Care 
Financing Administration, Medicare Program; Changes to the Hospital 
Inpatient Prospective Payment Systems and Fiscal Year 1999 Rates; Final 
Rule.)
    Although it provided the Secretary with the authority to cover ALS 
paramedic intercept services under certain conditions, section 4531(c) 
of the BBA did not specify what the payment should be for those 
services. We considered three different methods of payment for these 
services.
    First, we considered paying the full ALS payment rate. We discussed 
the issued with several ambulance companies that furnish paramedic 
intercept services, that believe that the total cost of providing these 
services is virtually the same as that of providing the full ALS 
ambulance service. In addition, because these services are furnished in 
rural areas, there is a low utilization rate that raises their cost per 
service. That is, the paramedic intercept service has the same fixed 
costs as ambulance company (i.e., flycar vehicle, life saving 
equipment, labor and overhead) but these costs are spread over only 2 
or 3 calls per day, whereas the typical ALS ambulance company has 30 to 
40 calls per day.
    A second option would be to pay for intercept services based on the 
difference between the ALS ambulance service rate and the BLS ambulance 
service rate. This would Place a value on the intercept service 
consistent with the fact that the full ALS service is comprised of two 
components: the intercept service and a transport service. The 
transport would be valued at the BLS rate and the intercept service 
would be valued as the difference between the ALS rate and the BLS 
rate.
    Finally, we could pay the average salary of a paramedic multiplied 
by the average amount of time involved for an intercept service. While 
this option would cover the costs associated with the paramedic's 
services during an intercept, it would not recognize other costs such 
as standby time, the vehicle used by the paramedics, medical equipment 
carried on that vehicle, and other overhead expenses.
    After examining these options, we believe the best option would be 
the second option; that is, pay the difference between the ALS payment 
rate and the BLS payment rate. If we were to pay the full ALS rate, we 
would be recognizing the intercept service as virtually equivalent to 
the full ALS ambulance service. However, the ALS ambulance service is 
actually equivalent to a paramedic intercept service plus a transport 
service. We do not believe that it is appropriate to price a component 
of the ALS service at the same rate as the total ALS service. However, 
to pay only the costs of the paramedics' services does not recognize 
the additional costs associated with furnishing the BLS service.
    We believe the second option balances considerations for access to 
care and consistency with current ambulance payment policy. We would be 
providing the intercept company with a reasonable payment while not 
providing the same amount of payment that we would to an ambulance 
company that provides both the transport and the paramedic service. If 
we pay the difference between the ALS and BLS rates to the intercept 
company, we would be acknowledging the BLS rate that would have been 
paid to the volunteer company had it been permitted to bill the program 
for the transport.

VI. Provisions of the Final Regulations

    Other than the changes made to implement section 4531(c) of the 
BBA, those provisions of this final rule that differ from the proposed 
rule are as follows:
     We are revising Secs. 409.10 and 409.20 to clarify that 
ambulance services are covered under Medicare Part A as hospital, CAH, 
and SNF inpatient services.
     We have revised the medical necessity requirements in 
Sec. 410.40(d) to specify when a beneficiary can be determined to be 
bed-confined and,

[[Page 3645]]

thus, potentially eligible for ambulance services.
     We have revised the physician certification requirements 
for nonemergency, unscheduled ambulance services in Sec. 410.40(d). In 
cases where a beneficiary requires a nonemergency, unscheduled 
ambulance transport, the written physician certificate can be obtained 
48 hours after the ambulance transportation has been furnished. We are 
also revising the regulations to provide that in situations where 
nonemergency, unscheduled ambulance transportation is required for 
beneficiaries residing at home (private residence) or in facilities 
where they are not under the direct care of a physician, the physician 
certification will not be required.
     We have revised the provision in Sec. 410.41(a) that 
identifies the minimum equipment required on a vehicle used as an 
ambulance, to require that a vehicle used as an ambulance must be 
equipped with telecommunication equipment as required by State or local 
law, to include, at a minimum, one two-way voice radio or wireless 
telephone.
     We have revised Sec. 410.41(b), which established minimum 
vehicle staffing requirements for both the BLS and ALS level of 
service. For BLS vehicles, we require that, at a minimum, the staff 
must meet staffing requirements established by State or local 
authorities. For ALS vehicles, we have revised this provision to delete 
reference to EMT-A and EMT-B designations.

VII. Collection of Information Requirements

    Under the Paperwork Reduction Act 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 Paperwork Reduction Act 
requires that we solicit comment on the following issues:
     Whether the information collection is necessary and useful 
to carry out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.

Section 410.40  Coverage of Ambulance Services

    The information collection requirements in Sec. 410.40 require the 
ambulance supplier to obtain written certification from the 
beneficiary's attending physician certifying that the medical necessity 
requirements of paragraph (d)(1) of this section are met, before 
furnishing non-emergency, scheduled ambulance services. The physician's 
order must be dated no earlier than 60 days before the date the service 
is furnished. And, for nonemergency, unscheduled ambulance services for 
a resident of a facility who is under the care of a physician, the 
ambulance supplier must obtain the written certification, within 48 
hours after the transport, from the beneficiary's attending physician 
certifying that the medical necessity requirements of paragraph (d)(1) 
of this section are met.
    The requirement for the physician's certification does not require 
a particular form or format and can be simply a written statement to 
describe the beneficiary's condition that supports the need for 
ambulance services. Some suppliers have developed their own physician 
certification forms. We estimate that a physician's certification could 
take, on average, 10 minutes of the physician's time per beneficiary 
and, in cases involving repetitive transports, one certificate could be 
used by the supplier for a 60-day period. The following chart shows the 
potential paperwork burden that may be imposed on physicians by this 
final rule.

                                    Estimated Paperwork Burden on Physicians
----------------------------------------------------------------------------------------------------------------
                                            Estimated annual
                                           number of ambulance                          Estimated total annual
                                           trips per supplier     Estimated average    burden for all physicians
               CFR Section                  (9,000 suppliers)    time in minutes to   combined  (9,000  x  3,000
                                                requiring           complete each      certificates per supplier
                                              certification     statement  (Minutes)    x  10 minutes)  (Hours)
                                               statements
----------------------------------------------------------------------------------------------------------------
410.40(d)(2) & (3)(i)...................                 3,000                    10                   4,500,000
----------------------------------------------------------------------------------------------------------------

    In addition, suppliers will be required to retain all physician 
certifications on file and make the certifications available upon 
request by the Medicare carrier or intermediary. The burden associated 
with this requirement is the time required for the supplier to retain 
the physician certification. We estimate that this could take, on 
average, 2 minutes to file each physician certification. Given that we 
estimate 3,000 certifications per year, the total burden associated 
with these requirements is 6,000 minutes or 100 annual hours, per 
supplier. The total burden imposed by the requirements of this section 
are 4,500,000 hours for all physicians and (9,000  x  100 hours record 
keeping) 900,000 hours for suppliers. This paperwork burden requirement 
will impact all physicians. We estimate that there are 500,000 
physicians. Total burden hours imposed on physicians times $15 (the 
estimated hourly cost for an administrative employee to complete the 
form, less the attending physician's signature) equals an additional 
cost of $67.5 million for physicians and a cost of $9 million for 
ambulance suppliers.

Section 410.41  Requirements for ambulance suppliers

    This section requires an ambulance supplier to bill for ambulance 
services using HCFA-designated procedure codes to describe origin and 
destination and indicate on the claims form that the physician 
certification is on file and available for review upon request by the 
Medicare carrier or intermediary. The burden associated with this 
requirement is captured during the completion of the HCFA 1500/1491 
common claim file form, approved under OMB number 0938-0008. Therefore, 
we are assigning one token-hour of burden for this requirement.
    This section also requires, upon a carrier's request, an ambulance 
supplier to complete and return the attached Ambulance Supplier Form 
and to submit documentation of emergency vehicle and staff licensure 
and certification requirements in keeping with State and local laws to 
the Medicare carrier.
    This requires completion of the Ambulance Supplier Form, 
photocopying documentation already required by State or local laws and 
in

[[Page 3646]]

the possession of the supplier, and sending those copies, along with 
the completed form to the carrier. We will require ambulance suppliers 
to complete the Ambulance Supplier Form on an annual basis or in 
keeping with licensure or certification requirements established by 
State or local laws. It is our understanding that an overwhelming 
number of States require ambulance supplier licensure or certification 
renewal on an annual basis.
    Our decision no to state a specific time frame, for example 
requiring annual submission of the documentation, in which ambulance 
suppliers will be required to submit the form took into consideration 
the potential burden on those suppliers operating in areas with renewal 
requirements other than on an annual basis. It is estimated that the 
time to complete this form is no more than 32 minutes.
    The following chart shows the potential paperwork burden that may 
be imposed on ambulance suppliers by this final rule.

               Estimated Annual Supplier Reporting Burden
------------------------------------------------------------------------
                                 Estimated      Estimated     Estimated
                                   no. of    average burden     annual
         CFR Sections            ambulance    per response      burden
                                 suppliers      (Minutes)      (Hours)
------------------------------------------------------------------------
410.41(c)(2) ambulance
 supplier form and
 documentation................        9,000              32        4,530
------------------------------------------------------------------------

    We have submitted a copy of this final rule to OMB for its review 
of the information collection requirements in Secs. 410.40 and 410.41. 
The information collection requirements are not effective until they 
have been approved by OMB. A notice will be published in the Federal 
Register when approval is obtained.
    If you comment on these information collection and record keeping 
requirements, or the attached form, please mail copies directly to the 
following:

Health Care Financing Administration, Office of Information Services, 
Security and Standards Group, Division of HCFA Enterprise Standards, 
Room C2-26-17, 7500 Security Boulevard, Baltimore, MD 21244-1850, Attn: 
John Burke, HCFA-1813-FC, or
Office of Information and Regulatory Affairs, Office of Management and 
Budget, Room 10235, New Executive Office Building, Washington, DC 
20503, Attn: Allison Herron Eydt, HCFA Desk Officer

VIII. Regulatory Impact Statement

    Consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
through 612), we prepare a regulatory flexibility analysis unless the 
Secretary certifies that a rule will not have a significant economic 
impact on a substantial number of small entities. For purposes of the 
RFA, all suppliers of ambulance services are considered to be small 
entities. Individuals, carriers, and States are not considered to be 
``small entities.''
    In addition, 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 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 50 beds.
    As illustrated below, the impact of this regulation does not meet 
the criteria under Executive Order 12866 to require a regulatory impact 
analysis; however, the following information, together with information 
provided elsewhere in this preamble, constitutes a voluntary analysis 
and meets the requirements of the RFA.
    First, this final rule was initiated partly because of the concern 
over the rapid increase in the cost to the Medicare program for 
furnishing ambulance services to beneficiaries. This rapid increase in 
expenditures can be attributed to a variety of causes that include the 
following:
     High costs for equipment, supplies, and trained personnel 
incurred by all ambulance suppliers are passed on to the public.
     Provision of nonemergency, scheduled ambulance services to 
ESRD beneficiaries for treatment or therapy to hospital-based 
facilities that may be farther away from the beneficiary's home than 
nonhospital-based facilities offering the same service. These 
transports cost the Medicare program more because of the higher mileage 
charges.
     Erroneous Medicare payment of claims for ambulance 
services from suppliers using nonemergency vehicles that transport 
beneficiaries whose medical condition is such that transportation in an 
ambulance is unnecessary.
    Second, we believe the policies contained in this rule will result 
in the consequences outlined below:
     The requirement that ambulance services be furnished in a 
vehicle equipped and staffed to respond to a medical emergency or an 
acute care situation will improve the overall quality of services 
furnished to beneficiaries and eliminate payment for transportation 
services that are furnished in a vehicle not equipped or staffed to 
provide ambulance services. This particular aspect of the final rule 
may cause some suppliers to have to upgrade their vehicles, equipment 
or staff training and certification so that the vehicles meet the 
definition of an ambulance. There may be some, however, who may not be 
able to upgrade their vehicles or staff. We do not know how many 
suppliers this requirement would affect; however, because we believe 
the entities that may be affected by this final rule primarily provide 
transportation services, such as wheelchair van transportation, we do 
not believe the number to be substantial.
     The requirement for physicians to certify the need for 
scheduled and certain unscheduled, nonemergency ambulance services for 
beneficiaries to receive therapy or treatment will ensure that those 
beneficiaries receiving the ambulance services actually require that 
level of transport.

--This requirement will affect all physicians. We estimate that there 
are 500,000 physicians. Total burden hours imposed on physicians times 
$15 (the estimated hourly cost for an administrative employee to 
complete the form, less the attending physician's signature) equals an 
additional cost of $67.5 million for physicians and a cost of $9 
million for ambulance suppliers.
--The physician certification provision also affects the suppliers:

     The physician certification provision requires, in 
situations

[[Page 3647]]

involving scheduled, nonemergency transportation, suppliers to obtain, 
from the beneficiary's attending physician, a written physician's order 
certifying the need for ambulance transportation. The certification is 
renewable every 60 days. Many suppliers currently provide carriers with 
similar documentation to certify medical necessity when transporting 
beneficiaries with ESRD. In cases where a beneficiary requires a 
nonemergency, unscheduled ambulance transport, the supplier must 
obtain, from the beneficiary's attending physician, the physician's 
written certificate 48 hours after the ambulance transportation has 
been furnished.
     The billing and reporting provision set forth in 
Sec. 410.41(c)(2) requires ambulance suppliers to verify compliance 
with State or local licensure and certification requirements. This 
provision does not require the submission of information that is 
inconsistent with information suppliers provide to State or local 
authorities. Suppliers are already required to complete the 
standardized HCFA-Ambulance Supplier Form and submit the appropriate 
documentary evidence. This provision will require the photocopying of 
documentary evidence in the possession of the supplier.

--The provision permitting ESRD beneficiaries to be transported to the 
nonhospital-based facilities nearest their home will be more 
convenient, since they will no longer have to be transported to 
hospital-based facilities that may be farther away. In addition, for 
those beneficiaries this is a more cost-effective policy since 
regularly transporting beneficiaries farther from their homes is more 
costly.

     For the first time, Medicare payment may be made for 
paramedic intercept services that meet the conditions for coverage. 
Currently, when these services have been provided to a Medicare 
beneficiary, the ALS paramedic intercept company has been free to bill 
the beneficiary for the full charge of the intercept service because it 
was not a covered service. Now that the service is covered, Medicare 
payment will be made to the intercept company, and the beneficiary will 
be responsible for only the applicable deductible and coinsurance. This 
will benefit both the company and the beneficiary.
    The only State that we are aware of in which the conditions 
described in section 4531(c) of the BBA exist is New York. After 
consultations with the ambulance industry in New York, and examination 
of the Medicare program data, we estimate the volume of services that 
will be covered under this provision in a year will be between 2,000 
and 4,000. A payment allowance of $150.00 per service (the difference 
between the average allowance for ALS and the average allowance for BLS 
in New York) yields a negligible cost. Because the Medicare Part B 
coinsurance and deductible provisions apply, the program payment will 
be between $240,000 and $480,000. The remainder of the cost will be the 
responsibility of beneficiaries.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any final rule with comment period that may result in an annual 
expenditure by State, local or tribal government, in the aggregate, or 
by the private sector of $100 million. The final rule with comment 
period will not have an effect on the governments mentioned, and 
private sector costs will be less than the $100 million threshold. The 
physician certification provision requires, in situations involving 
scheduled, nonemergency transportation, suppliers to obtain, from the 
beneficiary's attending physician, a written physician's order 
certifying the need for ambulance transportation. The certification is 
renewable every 60 days. Many suppliers currently provide carriers with 
similar documentation to certify medical necessity when transporting 
beneficiaries with ESRD. In cases where a beneficiary requires a 
nonemergency, unscheduled ambulance transport, the supplier must 
obtain, from the beneficiary's attending physician, the physician's 
written certificate 48 hours after the ambulance transportation has 
been furnished.
    The billing and reporting provision set forth in Sec. 410.41(c)(2) 
requires ambulance suppliers to verify compliance with State or local 
licensure and certification requirements. This provision does not 
require the submission of information that is inconsistent with 
information suppliers provide to State or local authorities. Suppliers 
are already required to complete the standardized HCFA-Ambulance 
Supplier Form and submit the appropriate documentary evidence. This 
provision will require the photocopying of documentary evidence in the 
possession of the supplier.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

IX. Other Required Information

A. Waiver of Notice of Proposed Rulemaking

    This final rule contains a provision relating to ambulance services 
that was not included in the proposed rule published on June 17, 1997. 
That provision, the limited Medicare coverage of paramedic intercept 
services in rural areas, was authorized by section 4531(c) of the BBA. 
We ordinarily publish a notice of proposed rulemaking in the Federal 
Register to provide a period for public comment before the provisions 
of the final rule take effect. However, we may waive that procedure if 
we find good cause that prior notice and comment are impracticable, 
unnecessary, or contrary to the public interest.
    As explained in detail in section V of this preamble, section 
4531(c) of the BBA authorizes us to provide coverage of paramedic 
intercept services under very limited conditions, which are 
specifically stated in the law. Because of the specificity of the law, 
we have little discretion in the manner in which we implement this 
extension of the ambulance benefit.
    This provision was not included in the proposed rule because 
publication of the proposed rule predated enactment of the BBA. 
Nonetheless, we have received many letters requesting that we implement 
the provision as soon as possible. As discussed above, this change will 
allow suppliers of paramedic intercept services that meet the statutory 
requirements to receive payment for those services. Because those 
suppliers are now prohibited from billing Medicare for their services, 
Medicare beneficiaries are responsible for paying the full charge for 
the services. We believe that it is appropriate to implement this 
change as soon as possible to reduce the burden on Medicare 
beneficiaries who must pay for these services out-of-pocket. Thus, we 
find that, in this case, prior notice and comment would be 
impracticable and unnecessary, therefore, we find good cause to waive 
proposed rulemaking for the revisions set forth at Sec. 410.40(c) and 
to issue these regulations as final. However, we are providing a 60-day 
period for public comment, as indicated at the beginning of this rule, 
on these changes.

B. 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. Comments on the

[[Page 3648]]

paramedic intercept provision will be considered if we receive them by 
the date specified in the DATES section of this preamble. We will not 
consider comments concerning the provisions of this final rule that 
were published in the June 17, 1997 proposed rule, whether those 
provisions are presented in this final rule as unchanged or have been 
revised based on public comment.

List of Subjects

42 CFR Part 409

    Health facilities, Medicare.

42 CFR Part 410

    Health facilities, Health professions, Kidney diseases, 
Laboratories, Medicare, Rural areas, X-rays.

42 CFR Part 424

    Emergency medical services, Health facilities, Health professions, 
Medicare.
    42 CFR Chapter IV is amended as set forth below:

Part 409--HOSPITAL INSURANCE BENEFITS

    A. Part 409 is amended as set forth below:
    1. The authority citation for part 409 continues to read as 
follows:

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


Sec. 409.10  [Amended]

    2. In Sec. 409.10, the following amendments are made:
    a. In paragraphs (a)(1) through (a)(5), the semicolon at the end of 
each paragraph is removed, and a period is added in its place.
    b. In paragraph (a)(6), the words ``services; and'' are removed, 
and ``services.'' is added in their place.
    c. A new paragraph (a)(8) is added to read as follows:


Sec. 409.10  Included services.

    (a) * * *
    (8) Transportation services, including transport by ambulance.
* * * * *


Sec. 409.20  [Amended]

    3. In Sec. 409.20, the following amendments are made:
    a. In paragraph (a), the period at the end of the introductory text 
is removed, and a colon is added in its place.
    b. In paragraph (a)(1) through (a)(5), the semicolon at the end of 
each paragraph is removed, and a period is added in its place.
    c. In paragraph (a)(6), ``; and'' is removed, and a period is added 
in its place.
    d. A new paragraph (a)(8) is added to read as follows:


Sec. 409.20  Coverage of services.

    (a) * * *
    (8) Transportation services, including transport by ambulance.
* * * * *

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

    B. 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).

    2. Section 410.40 is revised to read as follows:


Sec. 410.40  Coverage of ambulance services.

    (a). Basic rules. Medicare Part B covers ambulance services if the 
following conditions are met:
    (1) The supplier meets the applicable vehicle, staff, and billing 
and reporting requirements of Sec. 410.41 and the service meets the 
medical necessity and origin and destination requirements of paragraphs 
(d) and (e) of this section.
    (2) Medicare Part A payment is not made directly or indirectly for 
the services.
    (b) Levels of services. Medicare covers ambulance services within 
the United States at the following levels of services:
    (1) Basic life support (BLS) services.
    (2) Advanced life support (ALS) services.
    (3) Paramedic ALS intercept services described in paragraph (c) of 
this section.
    (c) Paramedic ALS intercept services. Paramedic ALS intercept 
services must meet the following requirements:
    (1) Be furnished in a rural area (as defined in Sec. 412.62(f) of 
this chapter).
    (2) Be furnished under contract with one or more volunteer 
ambulance services that meet the following conditions:
    (i) Are certified to furnish ambulance services as required under 
Sec. 410.41.
    (ii) Furnish services only at the BLS level.
    (iii) Be prohibited by State law from billing for any service.
    (3) Be furnished by a paramedic ALS intercept supplier that meets 
the following conditions:
    (i) Is certified to furnish ALS services as required in 
Sec. 410.41(b)(2).
    (ii) Bills all the recipients who receive ALS intercept services 
fro the entity, regardless of whether or not those recipients are 
Medicare beneficiaries.
    (d) Medical necessity requirements--(1) General rule. Medicare 
covers ambulance services only if they are furnished to a beneficiary 
whose medical condition is such that other means of transportation 
would be contraindicated. For nonemergency ambulance transportation, 
the following criteria must be met to ensure that ambulance 
transportation is medically necessary:
    (i) The beneficiary is unable to get up from bed without 
assistance.
    (ii) The beneficiary is unable to ambulate.
    (iii) The beneficiary is unable to sit in a chair or wheelchair.
    (2) Special rule for nonemergency, scheduled ambulance services. 
Medicare covers nonemergency, scheduled ambulance services if the 
ambulance supplier, before furnishing the service to the beneficiary, 
obtains a written order from the beneficiary's attending physician 
certifying that the medical necessity requirements of paragraph (d)(1) 
of this section are met. the physician's order must be dated no earlier 
than 60 days before the date the service is furnished.
    (3) Special rule for nonemergency, unscheduled ambulance services. 
Medicare covers nonemergency, unscheduled ambulance services under the 
following circumstances:
    (i) For a resident of a facility who is under the care of a 
physician if the ambulance supplier obtains a written order from the 
beneficiary's attending physician, within 48 hours after the transport, 
certifying that the medical necessity requirements of paragraph (d)(1) 
of this section are met.
    (ii) For a beneficiary residing at home or in a facility who is not 
under the direct care of a physician. A physician certification is not 
required.
    (e) Origin and destination requirements. Medicare covers the 
following ambulance transportation:
    (1) From any point of origin to the nearest hospital, CAH, or SNF 
that is capable of furnishing the required level and type of care for 
the beneficiary's illness or injury. The hospital or CAH must have 
available the type of physician or physician specialist needed to treat 
the beneficiary's condition.
    (2) From a hospital, CAH, or SNF to the beneficiary's home.
    (3) From a SNF to the nearest supplier of medically necessary 
services not available at the SNF where the beneficiary is a resident, 
including the return trip.
    (4) For a beneficiary who is receiving renal dialysis for treatment 
of ESRD, from the beneficiary's home to the

[[Page 3649]]

nearest facility that furnishes renal dialysis, including the return 
trip.
    (f) Specific limits on coverage of ambulance services outside the 
United States. If services are furnished outside the United States, 
Medicare Part B covers ambulance transportation to a foreign hospital 
only in conjunction with the beneficiary's admission for medically 
necessary inpatient services as specified in subpart H of part 424 of 
this chapter.
    3. A new Sec. 410.41 is added to read as follows:


Sec. 410.41  Requirements for ambulance suppliers.

    (a) Vehicle. A vehicle used as an ambulance must meet the following 
requirements:
    (1) Be specially designed to respond to medical emergencies or 
provide acute medical care to transport the sick and injured and comply 
with all State and local laws governing an emergency transportation 
vehicle.
    (2) Be equipped with emergency warning lights and sirens, as 
required by State or local laws
    (3) Be equipped with telecommunications equipment as required by 
State or local law to include, at a minimum, one two-way voice radio or 
wireless telephone.
    (4) Be equipped with a stretcher, linens, emergency medical 
supplies, oxygen equipment, and other lifesaving emergency medical 
equipment as required by State or local laws.
    (b) Vehicle staff--(1) BLS vehicles.  A vehicle furnishing 
ambulance services must be staffed by at least two people, one of whom 
must meet the following requirements:
    (i) Be certified as an emergency medical technician by the State or 
local authority where the services are furnished.
    (ii) Be legally authorized to operate all lifesaving and life-
sustaining equipment on board the vehicle.
    (2) ALS vehicles. In addition to meeting the vehicle staff 
requirements of paragraph (b)(1) of this section, one of the two staff 
members must be certified as a paramedic or an emergency medical 
technician, by the State or local authority where the services are 
being furnished, to perform one or more ALS services.
    (c) Billing and reporting requirements. An ambulance supplier must 
comply with the following requirements:
    (1) Bill for ambulance services using HCFA-designated procedure 
codes to describe origin and destination and indicate on claims form 
that the physician certification is on file.
    (2) Upon a carrier's request, complete and return the ambulance 
supplier form designated by HCFA and provide the Medicare carrier with 
documentation of compliance with emergency vehicle and staff licensure 
and certification requirements in accordance with State and local laws.
    (3) Upon a carrier's request, provide additional information and 
documentation as required.

PART 424--CONDITIONS FOR MEDICARE PAYMENT

    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).


Sec. 424.124  [Amended]

    In Sec. 424.124, paragraph (c)(2) is amended by removing the 
reference to ``Sec. 410.140'' and adding in its place the reference to 
``Sec. 410.41''.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: December 10, 1998.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.

    Dated: January 13, 1999.
Donna E. Shalala,
Secretary.

    Note: Addendum 1 and Addendum 2 will not appear in the Code of 
Federal Regulations.

Addendum 1

    NOTE TO: (INSERT NAME OF MEDICARE SUPPLIER)

FROM: (INSERT NAME OF MEDICARE CARRIER)
SUBJECT: Completion of Attached Ambulance Supplier Form

    The attached form must be completed by you whenever your State 
and Local laws require that you update the licensure of your 
vehicles and/or staff. We are also requiring that this form be 
completed at the carrier's discretion so that the latest 
documentation will be on file with the carrier to make appropriate 
claims payment determinations.
    The form is self explanatory and, therefore, there are no 
program instructions for its completion. We do not expect that it 
will take longer than 30 minutes to answer the questions and will 
require only another minute or two to copy and attach the 
photocopies supporting the response to some of the questions.
    If you have any questions about completing this form please 
contact us at (fill in the telephone number and or address of the 
carrier).

Addendum 2--Ambulance Supplier Form

1. Corporate/Business Name of Ambulance Company:-----------------------
----------------------------------------------------------------------
Trade Name of Ambulance Company:---------------------------------------
----------------------------------------------------------------------

(Exactly as it appears on the vehicle(s))

2. Medicare Provider Number:-------------------------------------------
Federal Tax Identification Number:-------------------------------------

3. License Number(s):--------------------------------------------------
(A copy of the current license/certificate must be submitted with 
this form. The effective date and expiration must be stated on the 
license/certificate. Program payment will be based these dates.)

4. Physical Address of Ambulance Company Headquarters:-----------------
----------------------------------------------------------------------
Mailing Address (If different):----------------------------------------
----------------------------------------------------------------------
(Post Office Boxes and Drop Boxes are not acceptable as a physical 
business address.)

    Physical address locations of any substations, other than 
Headquarters, where vehicles are garaged (if applicable):

a.---------------------------------------------------------------------
----------------------------------------------------------------------
b.---------------------------------------------------------------------
----------------------------------------------------------------------
(Attach additional sheets if necessary)

What geographic area(s) do you serve?----------------------------------
----------------------------------------------------------------------
5. Business Telephone Number(s): (____)--------------------------------

Fax Machine Number(s): (____)------------------------------------------

(List telephone numbers for all locations. The business telephone 
number(s) must be a number where patients or customers can reach you 
or register complaints.)

Name of Daily Contact Person:------------------------------------------
----------------------------------------------------------------------
(Please print name, title, and provide a telephone number, if 
different from the business telephone number.)

6. Owner's Name(s) and Social Security Number(s):----------------------
----------------------------------------------------------------------
(Identify all individuals and their Social Security Numbers or 
entities who have ownership or controlling interest in this company. 
Attach additional sheets if necessary.)

    7. Indicate the number of vehicles providing each type of 
service. Provide a copy of the license/certification documentation 
from the State or local regulatory agency for each vehicle:

____ Advanced Life Support
____ Advanced Life Support (Paramedic Intercept Squad Unit)
____ Advanced Life Support (Mobile Intensive Care Unit)
____ Basic Life Support
____ Air Ambulance

    Identify all vehicles in your fleet by providing the following 
information:

(Attach additional sheets if necessary)
Year      Make      Model    VIN#

----------------------------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------


[[Page 3650]]

-----------------------------------------------------------------------
    8. List the name of each crew member and their individual 
training (e.g., CPR, first aid, ACLS, etc.) A copy of their 
certificate(s) of training must be attached. (Attach additional 
sheets if necessary.)

Name:------------------------------------------------------------------
Training:--------------------------------------------------------------

Name:------------------------------------------------------------------
Training:--------------------------------------------------------------

9. Name of Medical Director:-------------------------------------------
----------------------------------------------------------------------

Medical License Number of Medical Director:----------------------------
Telephone Number: (____)-----------------------------------------------

    10. Has your company or any owner ever been excluded from 
participation in the Medicare or Medicaid program?

    Yes ______    No______
    If yes, under what corporate/business name(s), trade name(s) and 
owner(s), did the exclusion occur?

----------------------------------------------------------------------
----------------------------------------------------------------------

List prior Medicare Identification Number(s):--------------------------
----------------------------------------------------------------------

    Provide name(s) and location(s) of prior Carrier(s):
----------------------------------------------------------------------

(If service was provided under the Medicaid program, list the prior 
Medicaid Identification Number and the State where the service was 
provided.)

    11. You agree to notify this office of any change in operation, 
ownership, or revocation of licensure. It is also understood that 
representatives from the Health Care Financing Administration (HCFA) 
and HCFA Medicare contractors may make on-site inspections at any 
time.
    By signing, I agree to the above statement and verify that I 
have reviewed all of the information contained herein, or submitted 
separately in support of this verification of compliance form, and 
verify that the information is accurate and complete.

Name and Title (please print):-----------------------------------------
----------------------------------------------------------------------
Address:---------------------------------------------------------------
----------------------------------------------------------------------

Signature:-------------------------------------------------------------
Date:------------------------------------------------------------------

    According to the Paperwork Reduction Act of 1995, no persons are 
required to respond to a collection of information unless it 
displays a valid OMB control number. The valid OMB number for this 
information collection is 0938-xxxx. The time required to complete 
this information collection is estimated to average xx hours (or 
minutes) per response, including the time to review instructions, 
search existing data resources, gather the data needed, and complete 
and review the information collection. If you have any comments 
concerning the accuracy of the time estimate(s) or suggestions for 
improving this form, please write to: HCFA, 7500 Security Boulevard, 
Baltimore, Maryland 21244-1850, Mail Stop N2-14-26 and to the Office 
of the Information and Regulatory Affairs, Office of Management and 
Budget, Washington, D.C. 20503.

[FR Doc. 99-1547 Filed 1-20-99; 4:15 pm]
BILLING CODE 4120-03-M