[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,
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(phone: (202) 690-7890).
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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