Medical Devices
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Implementation of the FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices, Att. A Interagency Agreement, Att. B Criteria for Catergorization of Investigational Devices, & Att. C -List #D95-2 (blue book memo) (Text Only)
Implementation of the FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices
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IDE Guidance Memorandum #95-2
This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s.
Office of Device Evaluation (HFZ-400)
Implementation of the FDA/HCFA Interagency Agreement Regarding
Reimbursement Categorization of Investigational Devices
ODE Review Staff
Purpose
The purpose of this memorandum is to establish procedures for
fulfilling FDA's responsibilities as defined in the FDA/HCFA
Interagency Agreement (IA) pertaining to the reimbursement of
investigational devices.
Background
According to the statute governing the Medicare program (Section 1862
(a)(1)(A) of the Social Securities Act), the Health Care Financing
Administration (HCFA) is permitted to reimburse for medical services
and products that are deemed "reasonable and necessary" for the
diagnosis or treatment of an illness or injury, or to improve the
functioning of a malformed body member. The Medicare program has
historically interpreted the statutory terms "reasonable and necessary"
to mean that a service or medical device must be safe and effective,
medically necessary and appropriate, and not experimental in order to
qualify for reimbursement. For Medicare coverage purposes, the term
"experimental" has been used synonymously with the term
"investigational." Therefore, with rare exception, an FDA-approved
Investigational Device Exemption (IDE) application served as an
indication that the device was not "reasonable and necessary" within
the meaning of the Medicare program. Thus, Medicare coverage was
denied for devices which were under an IDE and had not yet received
premarket notification clearance and or premarket approval.
There is increasing recognition, however, that there are devices which
are refinements of existing technologies or replications of existing
technologies made by other manufacturers. Many of these devices are
under an FDA-approved IDE as a means of gathering the scientific
information needed for FDA to establish the safety and effectiveness of
that particular device, even though there is evidence that the device
type can be safe and effective. Such devices could be viewed as
"reasonable and necessary" by Medicare and thus be reimbursed if it
were possible to identify these devices to HCFA.
On September 8, 1995, FDA and HCFA entered into an Interagency
Agreement (See Attachment A) pursuant to which FDA agreed to institute
a procedure for providing certain information to HCFA to aid in its
reimbursement decisions. The information supplied to HCFA will be used
in determining whether sufficient information exists concerning the
safety and effectiveness of the investigational device to permit
reimbursement under the Medicare program. Specifically, FDA will
inform HCFA whether the clinical evaluation of an investigational
device falls into one of two categories.
Those investigations involving innovative devices believed to be in
Class III for which "absolute risk" of the device type has not been
established (i.e., initial questions of safety and effectiveness have
not been resolved and thus FDA is unsure whether the device type can be
safe and effective) will be assigned to Category A. Devices believed
to be in Classes I or II or devices believed to be in Class III where
the incremental risk is the primary risk in question (i.e., underlying
questions of safety and effectiveness of that device type have been
resolved) will be assigned to Category B. Thus, Category B includes
those device types known to be safe and effective because, for example,
other manufacturers have obtained FDA approval/clearance for that
device type. The precise criteria to be used by FDA in assigning IDEs
to these reimbursement categories are set forth in the Interagency
Agreement.
This interagency effort is an important initiative which will
significantly impact both patient care and the development of new
medical technology. By expanding the Medicare coverage policy to
include certain investigational devices, Medicare beneficiaries will
be assured greater access to the latest advancement in medical
technology. In addition, the revision of the reimbursement policy to
include investigational devices may help to improve the quality of
clinical studies by ensuring that the Medicare patient population is
included in the investigations and thus the devices are being tested on
the appropriate patient population. Finally, it is anticipated that
this change in policy will help to facilitate patient enrollment into
clinical trials. Implementation of FDA's responsibilities as defined
in the Interagency Agreement will help attain these important goals.
Procedures
Below, the procedures to be used by ODE staff in order to fulfill FDA's
responsibilities in the Interagency Agreement are described.
Implementation of the IA will involve two phases. In phase I, all IDE
applications that are either approved, conditionally approved, or
deemed approved (unless deemed approved and immediately withdrawn) by
September 15, 1995 will be assigned to one of the two reimbursement
categories as described in the Interagency Agreement. Phase II of the
process will begin on September 18, 1995. On this date, each
reviewing division, as a routine part of the IDE review process, will
assume responsibility for implementing the reimbursement categorization
process for all IDEs that are received on or after that date. Each of
these phases is discussed in detail below.
A. Phase I: Categorization of Approved IDEs
Using the criteria defined in the attachment of the Interagency
Agreement, the divisions will be responsible for categorizing all IDEs
which are approved ("full", conditional, or deemed) by September 15,
1995. A special training session will be conducted by ODE senior
management and the IDE staff during which guidance on the
categorization determination process will be provided to division
supervisors (branch chiefs and associate/deputy division directors).
In most instances, it will be possible to categorize the
investigational device based on data available in the IDE database;
however, in some instances, it may be necessary to refer to the actual
IDE application as well as information regarding similar marketed
devices. It is anticipated that the vast majority of devices will be
assigned to Category B (i.e., Non-experimental/Investigational). The
data on reimbursement categorization will be compiled and forwarded to
HCFA on or before November 1, 1995. Therefore, the categorization of
all IDEs approved by September 15, 1995 must be completed and forwarded
to the IDE staff no later than October 6, 1995.
The IDE staff will provide the divisions with a list of all IDE
applications which must be categorized. This will include only those
IDEs in the database which are approved. IDEs which have been
terminated will be considered exempt from this IA agreement and thus
will not be assigned to a reimbursement category. The IDE staff will
also provide ODE's reviewing divisions with a standardized form to
allow the information to be captured in a uniform fashion. IDE staff
consultation and concurrence is required for any IDE application which
is assigned to Category A (i.e., Experimental). (The boilerplate
checklist (Document H-1 on the LAN) which identifies the rationale for
this categorization determination must be signed-off by both division
management and the IDE staff. Also see Attachment B)
In order to make this information publicly available, the Division of
Small Manufacturers Assistance (DSMA) will post on its electronic
docket a list of the approved IDEs (IDE numbers only) and the
corresponding reimbursement category.
B. Phase II: IDEs Approved after September 15, 1995
On September 18, 1995, the divisions will become responsible for
determining the reimbursement categorization for those IDEs which are
approved, conditionally approved, or deemed approved (unless deemed
approved and immediately withdrawn). As previously noted, it is
anticipated that in most instances categorization will be possible on
the basis of a quick review of the division's records and the IDE
database. As discussed above, for those cases where an IDE is assigned
to Category A, the branch chief must contact the IDE staff prior to
issuing the approval letter or otherwise notifying the sponsor or HCFA
of this categorization decision. The IDE staff will review the
decision and notify the division of its concurrence.
IDE boilerplate approval letters ("full", conditional, and deemed
approved) for original IDEs and amendments will be modified as follows:
1. The reference block will be modified to include not only the IDE
number and the name of the device but also the proposed indication
for use for the device as stated in the clinical protocol and the
HCFA Reimbursement Category: A (or B).
2. HCFA will be added to the distribution list at the bottom of all
such letters. The Document Mail Center (DMC) will be responsible
for mailing copies of these approval letters to HCFA.
3. An enclosure entitled, "Procedures to Request Re-evaluation of
Categorization Decisions" must be included in the approval letters
when a Category A determination is made.
In order to create a written record of the basis for each
categorization decision, reviewers must complete the checklist provided
by the IDE staff (See Attachment B or document H-1 on the LAN). By
using this checklist, the criterion which served as the basis for the
categorization decision of the investigational device will be included
in the IDE file as the checklist must be attached to the last page of
the review memo. The categorization determination (category and reason
code) must also be recorded on the tracking sheets for all original
IDEs and amendments which are approved. (If this information is not
included on the tracking sheet, the DMC will not be able to log the IDE
out of the tracking system.) The DMC will be responsible for entering
this information into the IDE database when the IDE is logged out of
the tracking system.
The Office of Systems and Management has modified the IDE database to
capture the reimbursement category and reason code assigned to each
approved IDE. Such modifications will permit both searching of the IDE
database and the generation of reports based on this criteria.
C. Changes in IDE Status
In the event that the approval of an IDE application is withdrawn, it
is imperative that HCFA be apprised of this fact as soon as possible.
Therefore, if after consultation with the IDE staff, the decision is
made to withdraw approval of the IDE application, the reviewing
division will be responsible for FAXing a copy of the final order which
withdraws approval of the IDE to HCFA at the same time that the
sponsor is notified of the withdrawal of approval. (See IDE
boilerplate letter G-30A for the name of the HCFA contact person and
FAX number to which this information should be forwarded.) HCFA should
not be notified of proposed withdrawal letters as these may not lead to
the final order.
D. Confidentiality of Categorization Determination
As provided for under 21 CFR 812.38(a), all information pertaining to
an IDE, regardless of its status, is confidential. This includes the
categorization determination. Thus, except for the information which
DSMA will post on its electronic docket, information regarding the
reimbursement categorization decision should only be released to the
sponsor of the IDE and to HCFA. Therefore, the divisions should refer
inquiries (particularly those from physicians, patients, and insurance
carriers) pertaining to the HCFA reimbursement policy to Sharon Hippler
at: HCFA, 7500 Security Boulevard, C4-04-05, Baltimore, MD 21244 or
(410) 786-4633.
E. Sponsor Inquiries and Requests for Re-evaluation of Categorization
Decisions
The division may discuss the basis for the reimbursement categorization
with the study sponsor. A request for re-evaluation of the
reimbursement determination must be submitted in writing to FDA as an
IDE supplement. Upon receipt of this request, the reviewing division
will reconsider the original decision and issue a letter setting forth
the basis of its final decision. The appropriate boilerplate letter
(H-2 on the LAN) should be used when responding to such requests, and
IDE Staff concurrence must be obtained before the letter is issued.
After this point, the sponsor must refer any subsequent inquiries
regarding the categorization decision to HCFA as FDA's determination
may be only one of several factors considered when the reimbursement
decision is made and HCFA is the final arbiter of all reimbursement
decisions.
F. Updating of the Categorization Decisions
If the circumstances which led to the original categorization
determination change (e.g., a PMA is approved for a device similar to
one under investigation), the reviewing division will be responsible
for reconsidering the categorization designation for all IDEs which may
have been affected by this change. Any resulting modifications must be
immediately reported to the IDE Staff. The IDE Staff will be
responsible for reporting these changes in the categorization
designation to both HCFA and the sponsor of the IDE (See boilerplate H-
3 on the LAN).
Effective Date
This memorandum is effective immediately.
Philip J. Phillips
IDE Memorandum - #D95-2
Attachment A - Page 1
Interagency Agreement
Between the Health Care Financing Administration (HCFA) and the
Food and Drug Administration (FDA) regarding Medicare coverage of
certain investigational medical devices.
I. Purpose
To establish a process by which FDA will assist HCFA to place
IDE devices into categories based on the level of risk the
device presents to patients. This categorization will be
used by HCFA as part of its determination of which devices
meet the requirements for Medicare coverage under section
1862(a)(1)(A) of the Social Security Act (the, "reasonable
and necessary" clause). To be covered under Medicare, the
device must be reasonable and necessary for the diagnosis or
treatment of an illness or injury, or to improve the
functioning of a malformed body member.
II. Authority
The legal authority to enter into this Agreement is provided
in sections 1874 and 1862(a)(1)(A) of the Social Security Act
and sections 520(g) and 701(a) of the Federal Food, Drug and
Cosmetic Act.
III. Background
In his National Performance Review, Vice President Gore
directed the health agencies of the Department of Health and
Human Services (HHS) to review their policies and processes
to determine which requirements could be reduced or
eliminated without lowering health and safety standards. In
accordance with this directive, FDA reviewed its current
regulatory approval processes and HCFA reviewed its Medicare
coverage policies for medical devices that have not received
full FDA approval.
The Medicare program has historically interpreted the
statutory terms "reasonable and necessary" to mean that a
service or medical device must be safe and effective,
medically necessary and appropriate, and not experimental in
order to qualify for reimbursement. For Medicare coverage
purposes, the term experimental has been used synonymously
with the term investigational. Therefore, an approved
Investigational Device Exemption (IDE) application served as
an indication that the device was not "reasonable and
necessary" within the meaning of the Medicare program. Under
this policy, Medicare coverage was denied for devices that
require, but have yet to receive, 510(k) clearance and those
that have received an IDE but have not received PreMarket
Approval (PMA).
There is increasing recognition that there are devices which
are refinements of existing technologies or replications of
existing technologies by other manufacturers. Many of these
devices are placed within the IDE category as a means of
gathering the scientific information necessary for FDA to
establish the safety and effectiveness of the particular
device, even though there is scientific evidence that the
type of device can be safe and effective. Arguably, these
devices could be viewed as "reasonable and necessary" by
Medicare and recognized for payment if it were possible to
identify them in the FDA's process.
Accordingly, FDA and HCFA are developing a revised policy to
meet the needs of Medicare beneficiaries. The purpose of
this effort is to determine if it is feasible to expand.
Medicare coverage to include certain medical devices that
have not yet received FDA marketing approval/clearance
without compromising the safety of medical care provided to
Medicare beneficiaries. The intent is to devise ways to:
· assure Medicare beneficiaries greater access to advances
in proven medical technology;
· encourage clinical researchers to conduct high quality
studies; and,
· clarify Medicare coverage of reasonable and necessary
medical services during clinical trials for
investigational devices.
IV. Scope of Work and Responsibilities
The Health Care Financing Administration, in conjunction with
the Food and Drug Administration, will develop a process to
differentiate between novel, first-of-a-kind medical devices
and newer generations of proven technologies. New Medicare
policies will be established in accordance with the
requirements for Federal rule-making under section 553 of the
Administrative Procedure Act.
This Interagency Agreement (IA) supports this process under
which HCFA will establish a stratified policy for Medicare
coverage of certain IDE devices under FDA review. For
purposes of assisting HCFA in determining Medicare coverage,
the FDA will place all IDEs it approves in one of two
categories:
· Category A - Experimental- innovative devices believed
to be in class III for which "absolute risk" of the
device type has not been established (i.e., initial
questions of safety and effectiveness have not been
resolved). That is, FDA is unsure whether the device
type can be safe and effective.
· Category B - Non-experimental/Investigational - device
types believed to be in classes I or II or device types
believed to be in class III where the incremental risk
is the primary risk in question (i.e., underlying
questions of safety and effectiveness of that device
type have been resolved), or it is known that the device
type can be safe and effective because, for
example, other manufacturers have obtained FDA approval
for that device type.1
In order to properly categorize device investigations, HCFA
and FDA have agreed to employ criteria outlined in the
Attachment. As experience is gained in making
categorizations, the criteria may be updated.
For purposes of determining Medicare coverage, medical
devices classified under this system as "Category B: Non-
experimental/Investigational," could be viewed as "reasonable
and necessary" if they also meet all other Medicare coverage
requirements. In some cases, HCFA may also wish to conduct a
separate assessment of the device to determine medical
necessity and appropriateness specifically with respect to
Medicare beneficiaries.
In support of this basic agreement HCFA and FDA agree to the
following:
· FDA will assign each FDA-approved IDE to one of the two
categories listed in the Attachment and notify HCFA of
its categorization no less than each calendar quarter,
either by electronic means or written communication.
· Medicare coverage of devices under "investigation" is
predicated, in part, upon their status with FDA. In
the event a sponsor loses its category B categorization
or violates relevant IDE requirements necessitating
FDA's withdrawal of approval of the IDE, FDA will
immediately notify HCFA in order that HCFA may
reevaluate the coverage status of the device under
Medicare. HCFA will establish specific procedures for
the withdrawal of Medicare coverage. These procedures
will be described in Medicare regulations.
· FDA-approved IDE study protocols for each clinical study
will require that devices be available in a
circumscribed number of sites for an approved number of
patients. HCFA will provide Medicare coverage and
payments in accordance with these limitations and other"
protocol requirements (i.e., services provided by
certain health care practitioners).
· FDA will assign each IDE an identification code or
number which will enable HCFA to establish special
claims processing procedures for Medicare claims
associated with the clinical trial. FDA will complete
this process for existing IDEs by November 1, 1995.
· FDA will require that the sponsor/manufacturer and
clinical-investigators adhere to,pertinent regulations,
including obtaining informed consent for all patients
participating in the clinical trial.
· FDA will establish a process for the reconsideration of
the categorization of IDE devices. As part of this
process, FDA will analyze all information submitted by a
party in support of a request for reconsideration. HCFA
will establish-a process to review requests for
reconsideration that are denied by FDA. FDA will
provide necessary technical and expert support relating
to FDA's categorization of devices to HCFA during the
review process. FDA will provide information to HCFA to
substantiate its decision on the categorization of each
medical device under review.
· Reimbursement under the Medicare program for a device
under an approved IDE will be limited to what Medicare
would have paid for a comparable approved device.
_______________________
Note: Under the Food, Drug, and Cosmetic Act, devices are
categorized into three classes. Class I devices are the least
regulated devices. These are devices that FDA has determined need
to be subject only to general controls, such as good manufacturing
practice regulations. Class II devices are those which, in
addition to general controls, require special controls, such as
performance standards or post-market surveillance, to assure
safety and effectiveness. Class III devices are - those which
cannot be classified into Class I or Class II because insufficient
information exists to determine that either special or general
controls would provide reasonable assurance of safety and
effectiveness. Class III devices require Pre-Market Approval
(PMA).
V. Period of Agreement
This agreement takes effect upon the signatures of the two
parties. The policy will be effective when final regulations
are published in the Federal Register, expected to be on or
about November 1, 1995. The agreement will continue in
effect for an indefinite period.
VI. Modification/Cancellation Provisions
This Interagency Agreement (IA) may be modified at any time
by mutual agreement of the patties. It may be canceled if
both parties so agree in connection with a review, or if a
Federal statute is enacted that materially affects the IA.
In the event there is a cancellation of the IA, that
cancellation will not be effective for at least 6 months.
VII. Confidentiality of IDE Information
FDA will provide HCFA access to all information in the IDE
application for making Medicare coverage and payment
determinations, insuring protection against program fraud and
abuse, and claims processing. All IDE applications will
remain on FDA premises. However, relevant portions of these
applications may be duplicated by HCFA, as necessary, for
purposes of Medicare coverage determinations.
To the extent that such information is in the possession and
control of HCFA, it is subject to the disclosure and
withholding rules established by Federal statutes and
regulations. Applicable Federal statutes include, but are
not limited to, the Freedom of Information Act (5 U.S.C.
552), the Privacy Act (5 U.S.C. 552a), the Social Security
Act (42 U.S.C. 1306a), and the Trade Secrets Act (18 U.S.C
1905). Under this agreement, FDA will have a role in
ensuring that its data release standards are met, either by
reviewing any materials and paperwork to be released by HCFA,
or through some other forms of oversight. Moreover, HCFA has
no present intention of disclosing, or authorizing
the disclosure of, individual/patient or proprietary
information.
VIII. Points of Contact
HCFA: Thomas Ault, Director
Bureau of Policy Development
FDA: D. Bruce Burlington, M.D.
Director, Center for Devices
and Radiological Health
IX. Signatures of Acceptance
8/29/95 __________/S/__________________________
Date Bruce C. Vladeck, Administrator
Health Care Financing Administration
9/8/95 __________/S/_______________________
Date David A. Kessler, M.D.
Commissioner of Food and Drugs
Food and Drug Administration
Attachment
CRITERIA FOR CATEGORIZATION OF
INVESTIGATIONAL DEVICES
Category A: Experimental
1. Class III devices of a type for which no marketing
application has been approved through the premarket approval
(PMA) process for any indication for use. (For preamendments
Class III devices, refer to the criteria under Category B);
or
2. Class III devices that would otherwise be in Category B but
have undergone significant modification for a new indication
or use.
Category B: Non-experimental/Investigational
1. Devices, regardless of the classification, under
investigation to establish substantial equivalence to a
predicate device, i.e., to establish substantial equivalence
to a previously/currently legally marketed device: or
2. Class III devices whose technological characteristics and
indications for use are comparable to a PMA-approved device;
or
3. Class III devices with technological advances compared to a
PMA approved device, i.e., a device with technological
changes that represent advances to a device that has already
received pre-market approval (generational changes); or
4. Class III devices that are comparable to a PMA-approved
device but are under investigation for a new indication for
use. For purposes of studying the new indication, no
significant modifications to the device were required; or
5. Pre-amendments Class III devices that become the subject of
an IDE after FDA requires premarket approval, i.e., no PMA
was submitted or the PMA was denied; or
6. Non-significant risk device investigations for which FDA
required the submission of an IDE.
Note: Some investigational devices may exhibit unique
characteristics or raise safety concerns that make additional
consideration necessary. For these devices, HCFA and FDA will
agree on the additional criteria to be used. FDA will then use
this criteria to assign the device(s) to a category. As
experience is gained in the categorization process, this
attachment may be modified.
IDE Memorandum - #D95-2
Attachment B - Page 1
CRITERIA FOR CATEGORIZATION OF
INVESTIGATIONAL DEVICES
Category A: Experimental
_______ 1) Class III devices of a type for which no marketing
application has been approved through the premarket approval
(PMA) process for any indication for use. (For pre-
amendments Class III devices, refer to the criteria under
Category B); or
_______ 2) Class III devices that would otherwise be in Category B but
have undergone significant modification for a new indication
for use.
Category B: Non-experimental/Investigational
_______ 1) Devices, regardless of the classification, under
investigation to establish substantial equivalence to a
predicate device, i.e., to establish substantial equivalence
to a previously/currently legally marketed device; or
_______ 2) Class III devices whose technological characteristics and
indications for use are comparable to a PMA-approved device;
or
_______ 3) Class III devices with technological advances compared to a
PMA-approved device, i.e., a device with technological
changes that represent advances to a device that has already
received pre-market approval (generational changes); or
_______ 4) Class III devices that are comparable to a PMA-approved
device which are under investigation for a new indication for
use. For purposes of studying the new indication, no
significant modifications to the device were required; or
_______ 5) Pre-amendments Class III devices that become the subject of
an IDE after FDA requires premarket approval, i.e., no PMA
was submitted or the PMA was denied; or
_______ 6) Non-significant risk device investigations for which FDA
required the submission of an IDE.
________________________________________
Branch Chief (date)
For Category A determinations only:
________________________________________
IDE Staff concurrence (date)
Below is a list of the HCFA Reimbursements Categorization Determinations for FDA-Approved IDE's: G780049 B 2 G780054 B 2 G790001 B 2 G790011 B 6 G790012 B 2 G790016 B 1 G790018 B 2 G790022 B 2 G790023 B 2 G790030 B 2 G790033 B 1 G800001 B 2 G800002 B 2 G800004 B 2 G800007 B 1 G800017 B 5 G800020 B 1 G800022 B 2 G800024 B 2 G800035 B 3 G800046 B 1 G800049 B 2 G800055 B 2 G800074 B 2 G800075 B 1 G800077 B 2 G800083 B 4 G800124 B 2 G800129 B 3 G800138 B 2 G800143 B 4 G810003 B 2 G810022 B 2 G810028 B 2 G810065 B 2 G810067 B 4 G810068 B 2 G810076 B 2 G810080 B 1 G810081 B 1 G810083 B 2 G810086 B 1 G810089 B 2 G810102 B 1 G810109 B 2 G810113 B 1 G810115 B 3 G810122 B 2 G810123 B 2 G810127 B 2 G810128 B 2 G810129 B 1 G810134 B 1 G810138 B 2 G810139 B 1 G810149 B 2 G810161 B 2 G810168 B 1 G810171 B 2 G810172 B 2 G810173 B 2 G810178 B 2 G810192 B 2 G810203 B 2 G810216 B 2 G810218 B 2 G820012 B 2 G820019 B 2 G820033 B 1 G820036 B 2 G820046 B 2 G820050 B 2 G820054 B 2 G820057 B 2 G820061 B 3 G820073 B 1 G820076 B 2 G820080 B 1 G820082 B 2 G820094 B 4 G820096 B 2 G820098 B 2 G820115 B 2 G820138 B 2 G820149 B 2 G820157 B 2 G820165 B 2 G820903 B 1 G820904 B 1 G830017 B 4 G830027 B 2 G830044 B 2 G830048 B 2 G830073 B 4 G830092 B 4 G830120 B 2 G830127 B 2 G830134 B 1 G830145 B 2 G830153 B 1 G830154 B 4 G830167 B 2 G830174 B 2 G830187 B 2 G830901 B 1 G830903 B 1 G830907 B 2 G840008 B 1 G840018 B 1 G840028 B 3 G840032 B 1 G840036 B 2 G840069 B 1 G840080 B 2 G840098 B 2 G840099 B 1 G840129 B 1 G840135 B 2 G840137 B 6 G840140 B 2 G840150 B 1 G840174 B 2 G840189 B 2 G840196 B 2 G840201 B 2 G840208 A 1 G850010 B 2 G850012 B 1 G850017 B 1 G850030 B 2 G850040 B 2 G850045 B 1 G850049 B 2 G850071 B 2 G850072 B 1 G850097 B 2 G850098 B 2 G850101 B 3 G850103 B 4 G850117 B 3 G850120 B 2 G850121 B 2 G850134 B 2 G850139 B 2 G850142 B 1 G850158 B 4 G850162 B 2 G850174 B 2 G850187 B 2 G850188 B 3 G850202 B 2 G850206 B 2 G850217 B 2 G850231 B 2 G850233 B 4 G850239 B 2 G860001 B 1 G860010 B 2 G860019 B 4 G860021 B 1 G860026 B 2 G860030 B 4 G860044 B 2 G860055 B 2 G860060 B 2 G860065 B 3 G860066 B 2 G860067 B 2 G860070 B 3 G860075 B 2 G860077 B 2 G860084 B 1 G860086 B 2 G860102 B 1 G860114 B 2 G860116 B 1 G860117 B 2 G860118 B 1 G860132 B 2 G860138 B 2 G860140 B 4 G860141 B 4 G860147 B 4 G860156 B 2 G860157 B 1 G860165 B 4 G860168 B 2 G860169 B 2 G860170 B 2 G860172 B 2 G860176 B 1 G860182 B 2 G860184 B 4 G860186 B 2 G860189 B 1 G860194 B 2 G860199 B 2 G860200 B 2 G860201 B 1 G860210 B 1 G860225 B 2 G860230 B 4 G870010 B 4 G870013 B 1 G870017 B 1 G870019 B 3 G870030 B 2 G870031 A 1 G870035 B 2 G870036 B 2 G870037 B 2 G870038 B 6 G870040 B 3 G870046 B 2 G870048 B 4 G870049 B 1 G870052 B 1 G870053 B 2 G870055 B 6 G870056 B 6 G870058 B 1 G870060 B 1 G870061 B 6 G870067 B 2 G870069 B 4 G870080 B 2 G870082 B 2 G870091 B 1 G870101 B 4 G870104 B 2 G870109 B 2 G870112 B 1 G870114 B 2 G870120 B 2 G870122 B 6 G870123 B 2 G870129 B 2 G870134 B 6 G870136 B 2 G870142 B 4 G870144 B 4 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