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Cardiac Rehabilitation Programs – Medical Policy Article
(A45888)
Contractor Information
Contractor Name
National Government Services, Inc.
Contractor Number
Number
00130
00131
00160
00180
00181
00270
00308
00332
00450
00452
00453
00454
00630
00660
00805
13101
13102
13201
13202
13282
13292
Type
FI
FI
FI
FI
FI
FI
FI
FI
FI
FI
FI
FI
Carrier
Carrier
Carrier
MAC
MAC
MAC
MAC
MAC
MAC
State(s)
IN
IL
KY
ME
MA
NH, VT
CT, DE, NY
OH
WI
MI
VA, WV
AS, CA, CNMI, GU,
HI, NV
IN
KY
NJ
CT – Part A
CT – Part B
NY – Part A
NY – Part B
NY- Part B
NY – Part B
Contractor Type
Carrier
Fiscal Intermediary
MAC – Part A
MAC – Part B
Article Information
Article ID Number
A45888
Article Type
Article
Key Article
Yes
Article Title
Cardiac Rehabilitation Programs – Medical Policy Article
AMA CPT / ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2007
American Medical Association (or such other date of publication of
CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply.
Current Dental Terminology, (CDT) (including procedure codes,
nomenclature, descriptors and other data contained therein) is
copyright by the American Dental Association.© 2002, 2004
American Dental Association. All rights reserved. Applicable
FARS/DFARS apply.
Primary Geographic Jurisdiction
Number
00130
00131
00160
00180
00181
00270
00308
00332
00450
00452
00453
00454
00630
Type
FI
FI
FI
FI
FI
FI
FI
FI
FI
FI
FI
FI
Carrier
State(s)
IN
IL
KY
ME
MA
NH, VT
CT, DE, NY
OH
WI
MI
VA, WV
AS, CA, CNMI, GU,
HI, NV
IN
00660
00805
13101
13102
13201
13202
13282
13292
Carrier
Carrier
MAC
MAC
MAC
MAC
MAC
MAC
KY
NJ
CT – Part A
CT – Part B
NY – Part A
NY – Part B
NY- Part B
NY – Part B
Original Article Effective Date
10/01/2007
Article Revision Effective Date
07/18/2008
Article Text
Language quoted from Centers for Medicare and Medicaid Services
(CMS). National Coverage Determinations (NCDs) and coverage
provisions in interpretive manuals is italicized throughout the
article.
The article clarifies CMS Publication 100-03, Medicare National
Coverage Determinations Manual, Chapter 1, Part 1, Section
20.10.
Cardiac rehabilitation programs must be comprehensive and to be
comprehensive they must include a medical evaluation, a program
to modify cardiac risk factors (e.g., nutritional counseling),
prescribed exercise, education, and counseling. (CMS Publication
100-03, Medicare National Coverage Determinations Manual,
Chapter 1, Part 1, Section 20.10) Cardiac rehabilitation programs
are designed to restore certain patients with coronary or valvular
heart disease to active and productive lives. Forms of counseling,
such as dietary counseling, psychosocial intervention, lipid
management and stress management are components of the
program, and are not separately reimbursed. Cardiac
rehabilitation, as described in the medical literature, is divided
into three phases: Phase I is the immediate in - hospital post
cardiac event phase; Phase II is the outpatient immediate post
hospitalization recuperation phase. Phase II cardiac rehabilitation,
as described by the U.S. Public Health Service, is a
comprehensive, long-term program including medical evaluation,
prescribed exercise, cardiac risk factor modification, education,
and counseling. Phase II refers to outpatient, medically
supervised programs that are typically initiated 1-3 weeks after
hospital discharge and provide appropriate electrocardiographic
monitoring; (CMS Publication 100-03, Medicare National Coverage
Determinations Manual, Chapter 1, Part 1, Section 20.10) Phase
III is the long term, maintenance phase. The program consists of
a series of supervised exercise sessions. Services provided in
connection with a cardiac rehabilitation exercise program may be
considered reasonable and necessary for up to 36 sessions.
Patients generally receive 2 to 3 sessions per week for 12 to 18
weeks. (CMS Publication 100-03, Medicare National Coverage
Determinations Manual, Chapter 1, Part 1, Section 20.10)
Phase I cardiac rehabilitation programs are covered, but not
separately payable, as they are included in the inpatient payment.
Phase II begins with an overall treatment plan including a
physician’s prescription for progressive exercise based on the
individual’s clinical status and physical capacity. Programs
incorporate close monitoring, individualized progressive increase
in the intensity of physical activity and patient education and
counseling to modify cardiac risk factors (e.g., encouraging
lifestyle changes, dietary modifications, and smoking cessation).
Phase II exercise programs for cardiac patients may be conducted
in specialized, freestanding, cardiac rehabilitation clinics as well as
in outpatient hospital departments.
Phase III refers to maintenance programs (e.g., continued
lifestyle changes and aerobic exercise) without physician
supervision and monitoring. Medicare does not provide coverage
for Phase III programs.
Indications:
Effective for services performed on or after March 22, 2006,
Medicare coverage of cardiac rehabilitation programs is considered
reasonable and necessary only for patients who: (1) have a
documented diagnosis of acute myocardial infarction within the
preceding 12 months; or (2) have had coronary bypass surgery;
or (3) have stable angina pectoris; or (4) have had heart valve
repair/replacement; or (5) have had percutaneous transluminal
coronary angioplasty (PTCA) or coronary stenting; or (6) have had
a heart or heart-lung transplant. (CMS Publication 100-03,
Medicare National Coverage Determinations Manual, Chapter 1,
Part 1, Section 20.10)
1. The following information is intended as a further
clarification of the nationally covered indications listed
above:
o
o
o
o
o
o
Patients who begin the program within 12 months of
an acute myocardial infarction (ICD-9-CM codes
410.00 - 410.02, 410.10 - 410.12, 410.20 - 410.22,
410.30 - 410.32, 410.40 - 410.42, 410.50 – 410.52,
410.60 - 410.62, 410.70 - 410.72, 410.80 - 410.82,
410.90 - 410.92,412, and 414.8)
Patients who are status post coronary artery bypass
(CABG) surgery (ICD-9-CM code V45.81)
Patients with stable angina pectoris (ICD-9-CM code
413.9)
Patients who have had heart valve repair/replacement
(ICD-9-CM code V15.1, V42.2 and V43.3)
Patients who have had percutaneous coronary
angioplasty (PTCA) or coronary stenting (ICD-9-CM
code V45.82)
Patients who have had a heart or heart-lung
transplant (ICD-9-CM code V42.1)
2. Cardiac rehabilitation is covered when the patient’s
condition meets the following requirement(s):
o
o
o
For myocardial infarction, the date of entry in the
program must be within 12 months of the date of the
infarction.
For CABG, in order to support the medical necessity
for cardiac rehabilitation services, the initiation of the
program should be early enough to have a restorative
effect on the recuperative process.
For angina, all patients should have a pre-entry stress
test which is positive for exercise-induced ischemia
within 6 months of starting cardiac rehabilitation. A
positive stress test in this context implies a junctional
o
o
depression of 2 mm or more with associated slowly
rising ST segment, or 1 mm horizontal or downsloping ST segment depressions. Over the years,
nuclear perfusion studies have supplanted standard
ECG treadmill tests as a means of evaluating ischemic
heart disease, especially for patients who have
abnormal rest ECGs. Therefore the "positive" stress
test also includes perfusion studies which demonstrate
ischemia.
For patients with heart valve repair or replacement,
the program should be early enough to provide a
restorative benefit.
For patients who have had a percutaneous
transluminal angioplasty (PTCA) or stent placement,
the program should be early enough to provide a
restorative benefit.
3. Facilities:
Cardiac rehabilitation programs may be provided at the
outpatient department of a hospital, a physician-directed
clinic or in a physician's office. Coverage is subject to the
following conditions:
o For the facility meeting the definition of a hospital
outpatient department or a physician-directed clinic, a
physician must be on the premises available to
perform medical duties at all times that the facility is
open, and each patient must be under the care of a
hospital or clinic physician;
o For a physician's office, the physician must be on the
premises and available for all medically appropriate
duties.
o The facility must have available for immediate use the
necessary cardio-pulmonary, emergency, diagnostic,
and therapeutic life-saving equipment accepted by the
medical community as medically necessary, e.g.,
oxygen, cardiopulmonary resuscitation equipment, or
defibrillator; (CMS Publication 100-03, Medicare
National Coverage Determinations Manual, Chapter 1,
Part 1, Section 20.10)
o The program must be staffed by personnel necessary
o
to conduct the program safely and effectively, who are
trained in both basic and advanced life support
techniques and in exercise therapy for coronary
disease. The program must be under the direct
supervision of a physician, as defined in 42 CFR
§410.26(a)(2) (defined through cross reference to 42
CFR §410.32(b)(3)(ii), or 42 CFR §410.27(f)). (CMS
Publication 100-03, Medicare National Coverage
Determinations Manual, Chapter 1, Part 1, Section
20.10) Direct supervision means that a physician must
be in the exercise program area and immediately
available and accessible for all emergencies. It does
not require that a physician be physically present in
the exercise room itself.
The nonphysician personnel are employees of either
the physician, hospital or clinic conducting the
program and their services are "incident-to" a
physician's professional services or under Part A
incident to provision.
Limitations:
1. Frequency and duration:
o
o
o
o
The frequency and duration of the program are
generally a total of 36 sessions, occurring 2-3 times
per week for 12-18 weeks. Sessions extending beyond
the 18 weeks will be denied as not medically
necessary, unless additional documentation of
necessity is demonstrated.
Services at a frequency of less than 2 sessions per
week will be considered not medically necessary.
Phase II is divided into Phase IIA and Phase IIB.
Phase IIA is the initial outpatient cardiac
rehabilitation, not to exceed a total of 36 sessions
occurring 2-3 times per week for 12-18 weeks.
Phase IIB consists of an additional 36 sessions,
occurring 2-3 times per week, over 12-18 weeks, and
will only be allowed if determined to be medically
necessary. Phase IIB benefits must meet additional
medical necessity criteria. Specifically, there must be
clear demonstration that the patient is benefiting from
cardiac rehabilitation and that the exit criterion
o
o
(criteria) below from phase IIA has (have) not been
met. The maximum number of allowable sessions
under Phase IIA and IIB is 72. Coverage must not
exceed a total of 72 sessions for 36 weeks. (CMS
Publication 100-03, Medicare National Coverage
Determinations Manual, Chapter 1, Part 1, Section
20.10)
Exit Criterion
 In the American Heart Association’s functional
classification, Class I, or normal function status,
begins at 7 metabolic equivalent units (METS).
Therefore, for the patients who are status post
MI, status post CABG, status post PTCA or stent,
or patients with angina, completion of 6 minutes
of exercise during a treadmill or stress imaging
test, utilizing the Bruce protocol, without
significant ischemia or dysrhythmia is a
reasonable exit criterion.
 The post heart and heart-lung transplant patient
poses a special challenge for the cardiac
rehabilitation team. Issues such as
deconditioning and cachexic deterioration may
complicate the definition of reasonable exit
criteria. Based on the study of long term
cardiopulmonary exercise performed after heart
transplant by Osade et al, a peak oxygen
consumption (VO 2) of greater than 90% of
predicted would be the exit criterion for phase
IIA. Patients whose peak VO 2 is less than 90%
of predicted may be appropriate for phase IIB.
For patients with valvuloplasty or valve replacement
benefits are available for phase IIA only. Extension of
the program beyond 36 sessions (for patients postvalve surgery) is not reasonable and necessary
because supporting data is not available.
2. Other services
Evaluation and management services (E & M),
electrocardiograms, (ECG) and other diagnostic services
may be covered on the day of cardiac rehabilitation if these
services are separate and distinct from the cardiac
rehabilitation program, and are reasonable and necessary.
Coding Guidelines:
General Guidelines for claims submitted to Carriers or
Intermediaries:
Procedure codes may be subject to National Correct Coding
Initiative (NCCI) edits or OPPS packaging edits. Refer to NCCI and
OPPS requirements prior to billing Medicare.
For services requiring a referring/ordering physician, the name
and UPIN or NPI of the referring/ordering physician must be
reported on the claim.
The diagnosis code(s) must best describe the patient's condition
for which the service was performed.
A claim submitted without a valid ICD-9-CM diagnosis code will be
returned to the provider as an incomplete claim under Section
1833(e) of the Social Security Act.
ICD-9-CM code 412 (old myocardial infarction-MI) refers to an MI
that has occurred more than 8 weeks and less than 52 weeks
prior to cardiac rehabilitation services.
Advance Beneficiary Notice of Noncoverage (ABN) Modifier
Guidelines (for outpatient services):
An ABN may be used for services which are likely to be noncovered, whether for medical necessity or for other reasons.
Services not meeting medical necessity guidelines should be billed
with modifier -GA or -GZ.
The –GA modifier should be used when physicians, practitioners,
or suppliers want to indicate that they expect that Medicare will
deny a specific service as not reasonable and necessary and they
do have an ABN signed by the beneficiary on file. An ABN, Form
CMS-R-131, should be signed by the beneficiary to indicate that
he/she accepts responsibility for payment. The -GA modifier may
also be used on assigned claims when a patient refuses to sign
the ABN and the latter is properly witnessed. For claims submitted
to the Fiscal Intermediary, occurrence code 32 and the date of the
ABN is required.
The –GZ modifier should be used when physicians, practitioners,
or suppliers want to indicate that they expect that Medicare will
deny an item or service as not reasonable and necessary and they
have not had an ABN signed by the beneficiary.
If the service is statutorily non-covered, or without a benefit
category, submit the appropriate CPT/HCPCS code with the -GY
modifier.
For claims submitted to the carrier:
Claims for cardiac rehabilitation services are payable under
Medicare Part B in the following places of service:
office (11), outpatient hospital (22), independent clinic (49),
comprehensive outpatient rehabilitation facility (62), and state or
local public health clinic (71).
For claims submitted to the fiscal intermediary:
Hospital Outpatient Claims:


The hospital should report the full ICD-9-CM code for the
diagnosis shown to be chiefly responsible for the outpatient
services in FL 67. If no definitive diagnosis is made during
the outpatient evaluation, the patient’s symptom is
reported. If the patient arrives without a referring diagnosis,
symptom or complaint, the provider should report an ICD-9CM code for Persons Without Reported Diagnosis
Encountered During Examination and Investigation of
Individuals and Populations (V70-V82).
The hospital enters the full ICD-9-CM codes in FLs 67A-67Q
for up to eight other diagnoses that co-existed in addition to
the diagnosis reported in FL 67.
Bill Type Guidelines
CMS Publication 100-04, Medicare Claims Processing Manual,
Chapter 9, Section 100(B) states that no type of technical
services, such as…a technical component of a diagnostic or
screening service, is ever billed on TOBs 71x or 73x...Technical
services/components associated with professional
services/components performed by independent RHCs or FQHCs
are billed to Medicare carriers…Technical services/components
associated with professional services/components performed by
provider-based RHCs or FQHCs are billed by the base-provider on
the TOB for the base-provider and submitted to the FI.
Per CMS Publication 100-04, Medicare Claims Processing Manual,
Chapter 9, Section 100(B), only four types of services are billed
on TOBs 71X and 73X: Professional or primary services not
subject to the Medicare outpatient mental health treatment
limitation are bundled into line item(s) using revenue code 052X;
services subject to the Medicare outpatient mental health
treatment limitation are billed under revenue code 0900
(previously 0910); …telehealth originating site facility fees under
revenue code 0780 [and] FQHC supplemental payments are billed
under revenue code 0519, effective for dates of service on or after
01/01/2006.
For dates of service on or after July 1, 2006, the following
revenue codes should be used when billing for RHC or FQHC
services, other than those services subject to the Medicare
outpatient mental health treatment limitation or for the FQHC
supplement payment…: 0521, 0522, 0524, 0525, 0527 and 0528
(See CMS Publication 100-04, Medicare Claims Processing Manual,
Chapter 9, Section 100[B].)
Beginning January 1, 2008, hospitals may report more than one
unit of HCPCS codes 93797 or 93798 for a date of service if more
than one cardiac rehabilitation session lasting at least 1 hour each
is provided on the same day. In order to report more than one
session for a given date of service, each session must last a
minimum of 60 minutes. For example, if the services provided on
a given day total 1 hour and 50 minutes, then only one session
should be billed to report the cardiac rehabilitation services
provided on that day. (See Change Request (CR) 5912,
Transmittal 1417, January 2008 Update of the Hospital Outpatient
Prospective Payment System (OPPS))
Coverage Topic
Cardiac Rehabilitation Program
Coding Information
Bill Type Codes:
Contractors may specify Bill Types to help providers
identify those Bill Types typically used to report this
service. Absence of a Bill Type does not guarantee that the
article does not apply to that Bill Type. Complete absence
of all Bill Types indicates that coverage is not influenced by
Bill Type and the article should be assumed to apply
equally to all claims.
13x Hospital-outpatient (HHA-A also) (under OPPS 13X must be
used for ASC claims submitted for OPPS payment -- eff.
7/00)
85x Special facility or ASC surgery-rural primary care hospital
(eff 10/94)
Revenue Codes:
Contractors may specify Revenue Codes to help providers
identify those Revenue Codes typically used to report this
service. In most instances Revenue Codes are purely
advisory; unless specified in the article services reported
under other Revenue Codes are equally subject to this
coverage determination. Complete absence of all Revenue
Codes indicates that coverage is not influenced by Revenue
Code and the article should be assumed to apply equally to
all Revenue Codes.
Revenue codes only apply to providers who bill these services to
the fiscal intermediary. Revenue codes do not apply to physicians,
other professionals and suppliers who bill these services to the
carrier.
Please note that not all revenue codes apply to every type of bill
code. Providers are encouraged to refer to the FISS revenue code
file for allowable bill types. Similarly, not all revenue codes apply to
each CPT/HCPCS code. Providers are encouraged to refer to the
FISS HCPCS file for allowable revenue codes.
Revenue codes 096X, 097X and 098X are to be used only by
Critical Access Hospitals (CAHs) choosing the optional payment
method (also called Option 2 or Method 2) and only for services
performed by physicians or practitioners who have reassigned their
billing rights. When a CAH has selected the optional payment
method, physicians or other practitioners providing professional
services at the CAH may elect to bill their carrier or assign their
billing rights to the CAH. When professional services are reassigned
to the CAH, the CAH must bill the FI using revenue codes 096X,
097X or 098X.
0482
Cardiology-stress test
0943
Other therapeutic services-cardiac rehabilitation
0960
Professional fees-general classification
0969
Professional fees-other
0982
Professional fees-outpatient services
0983
Professional fees-clinic
CPT/HCPCS Codes
93797
Cardiac rehab
93798
Cardiac rehab/monitor
ICD-9 Codes that are Covered
ICD-9-CM code 414.8 should be reported for patients with a history
of a myocardial infarction from eight weeks to twelve months from
the date of the myocardial infarction.
ICD-9-CM code V15.1 should be reported for patients who have
undergone heart valve repair.
410.00 ACUTE MYOCARDIAL INFARCTION OF ANTEROLATERAL
WALL EPISODE OF CARE UNSPECIFIED
410.01 ACUTE MYOCARDIAL INFARCTION OF ANTEROLATERAL
WALL INITIAL EPISODE OF CARE
410.02 ACUTE MYOCARDIAL INFARCTION OF ANTEROLATERAL
WALL SUBSEQUENT EPISODE OF CARE
410.10 ACUTE MYOCARDIAL INFARCTION OF OTHER ANTERIOR
WALL EPISODE OF CARE UNSPECIFIED
410.11 ACUTE MYOCARDIAL INFARCTION OF OTHER ANTERIOR
WALL INITIAL EPISODE OF CARE
410.12 ACUTE MYOCARDIAL INFARCTION OF OTHER ANTERIOR
WALL SUBSEQUENT EPISODE OF CARE
410.20 ACUTE MYOCARDIAL INFARCTION OF INFEROLATERAL
WALL EPISODE OF CARE UNSPECIFIED
410.21 ACUTE MYOCARDIAL INFARCTION OF INFEROLATERAL
WALL INITIAL EPISODE OF CARE
410.22 ACUTE MYOCARDIAL INFARCTION OF INFEROLATERAL
WALL SUBSEQUENT EPISODE OF CARE
410.30 ACUTE MYOCARDIAL INFARCTION OF INFEROPOSTERIOR
WALL EPISODE OF CARE UNSPECIFIED
410.31 ACUTE MYOCARDIAL INFARCTION OF INFEROPOSTERIOR
WALL INITIAL EPISODE OF CARE
410.32 ACUTE MYOCARDIAL INFARCTION OF INFEROPOSTERIOR
WALL SUBSEQUENT EPISODE OF CARE
410.40 ACUTE MYOCARDIAL INFARCTION OF OTHER INFERIOR
WALL EPISODE OF CARE UNSPECIFIED
410.41 ACUTE MYOCARDIAL INFARCTION OF OTHER INFERIOR
WALL INITIAL EPISODE OF CARE
410.42 ACUTE MYOCARDIAL INFARCTION OF OTHER INFERIOR
WALL SUBSEQUENT EPISODE OF CARE
410.50 ACUTE MYOCARDIAL INFARCTION OF OTHER LATERAL
WALL EPISODE OF CARE UNSPECIFIED
410.51 ACUTE MYOCARDIAL INFARCTION OF OTHER LATERAL
WALL INITIAL EPISODE OF CARE
410.52 ACUTE MYOCARDIAL INFARCTION OF OTHER LATERAL
WALL SUBSEQUENT EPISODE OF CARE
410.60 TRUE POSTERIOR WALL INFARCTION EPISODE OF CARE
UNSPECIFIED
410.61 TRUE POSTERIOR WALL INFARCTION INITIAL EPISODE
OF CARE
410.62 TRUE POSTERIOR WALL INFARCTION SUBSEQUENT
EPISODE OF CARE
410.70 SUBENDOCARDIAL INFARCTION EPISODE OF CARE
UNSPECIFIED
410.71 SUBENDOCARDIAL INFARCTION INITIAL EPISODE OF
CARE
410.72 SUBENDOCARDIAL INFARCTION SUBSEQUENT EPISODE
OF CARE
410.80 ACUTE MYOCARDIAL INFARCTION OF OTHER SPECIFIED
SITES EPISODE OF CARE UNSPECIFIED
410.81 ACUTE MYOCARDIAL INFARCTION OF OTHER SPECIFIED
SITES INITIAL EPISODE OF CARE
410.82 ACUTE MYOCARDIAL INFARCTION OF OTHER SPECIFIED
SITES SUBSEQUENT EPISODE OF CARE
410.90 ACUTE MYOCARDIAL INFARCTION OF UNSPECIFIED SITE
EPISODE OF CARE UNSPECIFIED
410.91 ACUTE MYOCARDIAL INFARCTION OF UNSPECIFIED SITE
INITIAL EPISODE OF CARE
410.92 ACUTE MYOCARDIAL INFARCTION OF UNSPECIFIED SITE
SUBSEQUENT EPISODE OF CARE
412
OLD MYOCARDIAL INFARCTION
413.9
OTHER AND UNSPECIFIED ANGINA PECTORIS
414.8
OTHER SPECIFIED FORMS OF CHRONIC ISCHEMIC HEART
DISEASE
V15.1
PERSONAL HISTORY OF SURGERY TO HEART AND GREAT
VESSELS PRESENTING HAZARDS TO HEALTH
V42.1
HEART REPLACED BY TRANSPLANT
V42.2
HEART VALVE REPLACED BY TRANSPLANT
V43.3
HEART VALVE REPLACED BY OTHER MEANS
V45.81 POSTSURGICAL AORTOCORONARY BYPASS STATUS
V45.82 PERCUTANEOUS TRANSLUMINAL CORONARY
ANGIOPLASTY STATUS
ICD-9 Codes that are Not Covered
Not applicable.
Other Information
Other Comments
These instructions apply within states outside the primary
geographic jurisdiction with facilities that have nominated National
Government Services to process their claims.
Revision History Explanation
Article published July 2008. This article was revised to add the
Jurisdiction 13 (J-13) MAC contractor numbers.
This revised article is effective for all National Government
Services jurisdictions on July 18, 2008 with these
exceptions: for Connecticut – Part B the article is effective
on August 1, 2008; for Upstate New York – Part B, the
article is effective on September 1, 2008; and for New York
and Connecticut – Part A, the article is effective on
November 14, 2008. For New York – Part A (contract
00308), the content of this article is currently in effect but
the article will be transferred to the J-13 contract number
13201 on November 14, 2008.
Article published Febuary 2008: Source of revision internal/external: Added exit criterion to Limitations, #1. Added
intermediary guidelines based on CR 5912.
This article was revised on November 1, 2007 to include the
language from CMS Publication 100-03, Medicare National
Coverage Determinations Manual, Chapter 1, Part 1, Section
20.10.
Article published October 2007.