[Federal Register: August 24, 2007 (Volume 72, Number 164)]
[Rules and Regulations]
[Page 48562-48574]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24au07-9]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 482
[CMS-3014-IFC]
RIN 0938-AJ29
Medicare and Medicaid Programs; Hospital Conditions of
Participation: Laboratory Services
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Interim final rule with comment period.
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SUMMARY: This interim final rule with comment period requires hospitals
that transfuse blood and blood components to: Prepare and follow
written procedures for appropriate action when it is determined that
blood and blood components the hospitals received and transfused are at
increased risk for transmitting hepatitis C virus (HCV); quarantine
prior collections from a donor who is at increased risk for
transmitting HCV infection; notify transfusion recipients, as
appropriate, of the need for HCV testing and counseling; and extend the
records retention period for transfusion-related data to 10 years.
These changes are based on recommendations by the Secretary's
Advisory Committee on Blood Safety and Availability and are being
published in conjunction with the Food and Drug Administration's (FDA)
Final Rule, ``Current Good Manufacturing Practice for Blood and Blood
Components; Notification of Consignees and Transfusion Recipients
Receiving Blood and Blood Components at Increased Risk of Transmitting
HCV Infection'' (``lookback'') found elsewhere in this issue of the
Federal Register. The intent is to aid in the prevention of HCV
infection and to create opportunities for disease prevention that, in
most cases, can occur many years after recipient exposure to a donor.
DATES: Effective Date: These regulations are effective on February 20,
2008.
Comment date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on October 23, 2007.
ADDRESSES: In commenting, please refer to file code CMS-3014-IFC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of three ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on specific
issues in this regulation to http://www.cms.hhs.gov/eRulemaking. Click
on the link ``Submit electronic comments on CMS regulations with an
open comment period.'' (Attachments should be in Microsoft Word,
WordPerfect, or Excel; however, we prefer Microsoft Word.)
2. By regular mail. You may mail written comments (one original and
two copies) to the following address ONLY: Centers for Medicare &
Medicaid
[[Page 48563]]
Services, Department of Health and Human Services, Attention: CMS-3014-
IFC, P.O. Box 8014, Baltimore, MD 21244-8014.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments (one
original and two copies) to the following address ONLY: Centers for
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-3014-IFC, Mail Stop C4-26-05, 7500 Security Boulevard,
Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original and two copies) before the
close of the comment period to one of the following addresses. If you
intend to deliver your comments to the Baltimore address, please call
telephone number (410) 786-9994 in advance to schedule your arrival
with one of our staff members. Room 445-G, Hubert H. Humphrey Building,
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security
Boulevard, Baltimore, MD 21244-1850.
(Because access to the interior of the HHH Building is not readily
available to persons without Federal Government identification,
commenters are encouraged to leave their comments in the CMS drop slots
located in the main lobby of the building. A stamp-in clock is
available for persons wishing to retain a proof of filing by stamping
in and retaining an extra copy of the comments being filed.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
Submission of comments on paperwork requirements. You may submit
comments on this document's paperwork requirements by mailing your
comments to the addresses provided at the end of the ``Collection of
Information Requirements'' section in this document.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Mary Collins, (410) 786-3189. Jeannie
Miller, (410) 786-3164.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome comments from the public on all
issues set forth in this rule to assist us in fully considering issues
and developing policies. You can assist us by referencing the file code
CMS-3014-IFC and the specific ``issue identifier'' that precedes the
section on which you choose to comment.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: http://www.cms.hhs.gov/eRulemaking.
Click on the link ``Electronic Comments on
CMS Regulations'' on that Web site to view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
This Federal Register document is also available from the Federal
Register online database through GPO Access, a service of the U.S.
Government Printing Office. The Web site address is: http://www.access.gpo.gov/fr/index.html
.
I. Background
In accordance with section 1861(e) of the Social Security Act (the
Act), hospitals must meet certain conditions in order to participate in
the Medicare program. These conditions are intended to protect patient
health and safety and ensure that high-quality care is provided.
Hospitals receiving payment under Medicaid must meet the Medicare
conditions of participation.
Regulations containing the Medicare conditions of participation for
hospitals are located in the Code of Federal Regulations (CFR) at 42
CFR part 482. The condition of participation for hospital laboratory
services at Sec. 482.27(c) currently specifies the steps hospitals
must take when they become aware they have administered potentially
human immunodeficiency virus (HIV) infectious blood or blood components
to a patient. The more detailed requirements for laboratories appear in
42 CFR part 493, which sets forth requirements for all laboratories
participating in the Medicare, Medicaid, and Clinical Laboratory
Improvement Amendments (CLIA) programs.
The Centers for Medicare & Medicaid Services (CMS) and Federal
agencies that comprise the Public Health Services, including the Food
and Drug Administration (FDA), the Centers for Disease Control and
Prevention (CDC), and the National Institutes of Health (NIH), are
responsible for ensuring the safety of blood and blood components. In
the November 16, 2000 proposed rule (65 FR 69416), we used the term
``blood banks'' to refer to establishments that supply blood. However,
for consistency, we will use the FDA's term of ``a blood collecting
establishment'' (BCE) since blood suppliers include hospital blood
banks and blood donor centers. BCEs are subject to the FDA regulations
for current good manufacturing practice and additional standards for
the manufacture of blood and blood components under 21 CFR parts 211,
600, 601, 606, 610, and 640. Laboratories that provide transfusion
services are subject to CLIA requirements for quality control and
health and safety standards (42 CFR part 493, subpart K). Laboratories
in hospitals are also subject to the hospital conditions of
participation for adequacy of laboratory services (42 CFR 482.27). We
coordinate inspections of hospital-based BCEs with the FDA to minimize
duplication of effort and reduce the burden on affected facilities.
Hepatitis C virus (HCV) was first discovered and established as a
causative agent of transfusion-associated hepatitis in the late 1980s.
In October 1989, FDA's Blood Products Advisory Committee (BPAC) first
discussed steps to identify and quarantine potentially HCV infectious
blood and blood components remaining in storage and notify recipients
that they may possibly have received infectious blood or blood
products. (These steps are known as a lookback.) BPAC advised that
there was insufficient information available concerning HCV infection
to propose either product quarantine or notification of recipients
transfused with blood and blood components prepared from prior
collections from donors later determined to be at increased risk for
transmitting HCV.
In 1996, the Tenth Report of the U.S. House of Representatives
Committee on Government Reform and Oversight (H. Rpt. No. 104-746)
focused attention on the significant public health problem that HCV
infections pose for the nation. HCV infection is the most common
chronic blood-borne infection in the United States. The CDC estimates
that during the 1980s, as many as 230,000 new HCV infections occurred
each year. Since 1989, the annual number of new infections has declined
by 80 percent. The decline is in part attributed to the blood
collection establishments' implementation of a donor screening test
(HCV enzyme linked
[[Page 48564]]
immunosorbent assay (EIA) screening test) that was licensed in May
1990. In 1996, however, data from the Third National Health and
Nutritional Examination Survey conducted from 1988 to 1994 indicated
that approximately 3 million individuals in the United States were
believed to have been chronically infected with HCV and that
chronically infected persons might not be aware of their infection.
Despite progression of the disease, HCV infection is often
asymptomatic for about 20 years, but in many cases eventually causes
serious liver injury that is thought to be a leading cause of end stage
liver disease among adults in the United States. HCV is also thought to
play a significant role in the development of liver cancer. Between
8,000 and 12,000 deaths annually result from HCV-related chronic liver
disease.
HCV can be transmitted in a number of ways, including sharing of
drug use equipment among injection drug users, blood transfusion and
solid organ transplants from infectious donors, exposure to infectious
blood or body fluids in healthcare settings (for example, hemodialysis
or occupational exposure to blood), perinatal exposure of infants to
infected mothers, and possibly by unprotected sex.
In response to scientific data that show that HCV is transmissible
through blood and blood components, FDA has implemented an extensive
system of donor screening and testing procedures performed before,
during, and after a donation takes place to help prevent the
transfusion of blood and blood components that are infected with HCV.
Blood collecting establishments are currently testing each donation
of blood and blood components for evidence of HCV infection. Current
testing for HCV includes antibody screening, as well as direct viral
detection through the current use of nucleic acid tests (NAT). FDA
restricts the use of donations that test reactive for evidence of HCV
infection for transfusion or further manufacture. (The term
``repeatedly reactive'' has been used to indicate that the initial HCV
antibody screening test is reactive (in which case it is retested in
duplicate), and that one or both of the duplicate tests are reactive.)
FDA now refers to screening tests as ``reactive,'' instead of
``repeatedly reactive'' to accommodate the different testing algorithms
established for NAT and other screening tests. In cases where the
screening algorithm requires initial and repeat testing as part of a
single screening procedure, FDA would interpret the term ``reactive''
to mean ``repeatedly reactive.''
As a result of blood donor screening and testing procedures, the
risk of transmitting HCV infections through blood transfusion is very
low. Despite the best practices of blood establishments, however, a
person may donate blood early in the infection process when the
testable marker to HCV is not detectable by the test but HCV is
nevertheless present in the donor's blood (called a ``window'' period).
If the donor later tests reactive for evidence of HCV infection, or
when the blood collecting establishment is made aware of other reliable
test results or information indicating evidence of HCV infection,
previously collected blood and blood components would be at increased
risk for transmitting HCV. We believe that approximately 7 percent of
the estimated 3.9 million Americans ever infected with HCV were
infected as a result of transfusion of blood components before the
availability of donor screening tests or due to past use of non-viral-
inactivated plasma derivative products.
As a result of advances in identifying the presence of HCV, most
notably through screening tests based on nucleic acid amplification
technology, the window period and risk of HCV transmission from blood
continues to shrink. The preamble to FDA's proposed rule entitled
``Current Good Manufacturing Practice for Blood and Blood Components:
Notification of Consignees and Transfusion Recipients Receiving Blood
and Blood Components at Increased Risk of Transmitting HCV Infection
(lookback),'' published on November 16, 2000 (65 FR 69378), and FDA's
final rule published elsewhere in this issue of the Federal Register
provide more information on the length of the window period and discuss
various diagnostic modalities for HCV infection.
The incidence of transfusion-transmitted HCV infection has
decreased markedly since the implementation of donor screening and
testing for HCV, and viral inactivation of derivatives. Blood
establishments implemented donor screening tests after a single
antigen, enzyme linked immunosorbent assay (EIA) for antibody to HCV
(HCV EIA 1.0 screening test) was licensed in May 1990. The FDA issued a
memorandum to all registered blood establishments in November 1990,
``Testing for the Antibody to Hepatitis C Virus Encoded Antigen (Anti-
HCV),'' recommending use of approved donor screening tests for antibody
to HCV. A lookback program was not recommended at that time because:
(1) Screening tests available at the time could not distinguish between
on-going infection and recovery, thus making unclear the meaning of a
reactive test for any one individual; (2) donor screening for the
antibody to HCV did not include confirmatory testing, and most
notification would have been based on false positive donor test
results; (3) there was limited knowledge of routes of transmission for
HCV other than parenteral; and (4) no potential long-term benefits of
therapy were known.
A significantly more sensitive multiantigen screening test (HCV EIA
2.0 screening test) was licensed in March 1992. In June 1993, FDA
licensed an HCV 2.0 strip immunoblot assay (HCV RIBA 2.0), also known
as recombinant immunoblot assay (RIBA), a supplemental test for
antibody to HCV. Supplemental tests for HCV antibodies are used to
counsel and resolve the donor's status. Following the December 1993
BPAC meeting, BPAC recommended product quarantine of prior collections
from a donor who later tests repeatedly reactive for the antibody to
HCV and tests positive or indeterminate on a supplemental test;
however, BPAC only marginally endorsed consignee notification for the
purpose of transfusion recipient notification because the public health
benefit of the notification was not clear.
The Public Health Service Advisory Committee on Blood Safety and
Availability (PHS Advisory Committee) discussed improvements in the
treatment and management of HCV infection and improvements in testing
for the antibody to HCV at public meetings held on April 24, 1997 and
on August 11 and 12, 1997. The PHS Advisory Committee also discussed
the public health benefits of notifying transfusion recipients
receiving prior collections from a donor who subsequently tests
repeatedly reactive for evidence of HCV infection. Following the
Department of Health and Human Services' acceptance of recommendations
from the PHS Advisory Committee, the FDA developed guidance, published
in March 1998, regarding procedures for testing blood for HCV,
quarantining blood and blood components, and notifying patients who may
have received HCV-infected blood and blood components.
In response to comments received, the March 1998 guidance was
withdrawn and FDA issued a revised guidance dated September 1998, which
it announced in the Federal Register on October 21, 1998 (63 FR 56198),
entitled ``Guidance for Industry: Current Good Manufacturing Practice
for Blood and
[[Page 48565]]
Blood Components: (1) Quarantine and Disposition of Units From Prior
Collections From Donors With Repeatedly Reactive Screening Test for
Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and
the Notification of Consignees and Blood Recipients of Donor Test
Results for Anti-HCV'' (the September 1998 guidance). The September
1998 guidance provided recommendations to enable quarantine and
disposition of blood and blood components from prior collections from
donors with repeatedly reactive screening test results.
At public meetings on November 24, 1998 and January 28, 1999, the
PHS Advisory Committee reconsidered the issue of recipient notification
related to repeatedly reactive results on the single antigen screening
test. The PHS Advisory Committee recommended that targeted lookback
should be initiated based on a repeatedly reactive HCV EIA 1.0
screening test result on a repeat donor unless a supplemental test was
performed and the result did not indicate increased risk of HCV
infection or, in the absence of a supplemental test result, unless the
signal to cut off value of the repeatedly reactive HCV EIA 1.0
screening test was less than 2.5 or follow-up testing of the donor was
negative.
The FDA published a notice in the Federal Register on June 22, 1999
(64 FR 33309) announcing the availability of a revised draft guidance
titled ``Draft Guidance for Industry: Current Good Manufacturing
Practice for Blood and Blood Components: (1) Quarantine and Disposition
of Prior Collections from Donors with Repeatedly Reactive Screening
Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the
Notification of Consignees and Transfusion Recipients of Donor Test
Results for Antibody to HCV (Anti-HCV).'' Consistent with the
recommendations of the PHS Advisory Committee, this revised draft
guidance addressed lookback actions related to donor screening by HCV
EIA 1.0 and also recommended that the search of historical testing
records of prior donations from donors with repeatedly reactive EIA
1.0, EIA 2.0, or EIA 3.0 screening tests for HCV should extend back
indefinitely to the extent that electronic or other retrievable records
exist.
In October 2004 FDA issued a final guidance, ``Guidance for
Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples
from Donors of Whole Blood and Blood Components (Including Source
Plasma and Source Leukocytes) to Adequately and Appropriately Reduce
the Risk of Transmission of Human Immunodeficiency Virus Type 1 and
Hepatitis C Virus'' which was announced in the Federal Register on
October 28, 2004 (69 FR 62902). The guidance informed blood collecting
establishments that FDA had licensed NAT as tests to screen blood
donors for HIV-1 RNA and HCV RNA, that the licensed tests could detect
evidence of infection at a significantly earlier stage than was
possible under previously approved tests using antibody or antigen
detection technology, and that the FDA believed that these newly
licensed tests were widely available and met the criteria in 21 CFR
610.40(b) for screening tests that are necessary to reduce adequately
and appropriately the risk of transmission of communicable disease
through blood products.
II. Provisions of the Proposed Rule
In order to have consistent industry standards for potentially
infectious blood and blood components, on November 16, 2000 (65 FR
69416), we proposed to adopt as our requirements for hospitals the
procedures for HCV proposed by the FDA in that same Federal Register
(65 FR 69378). Since our proposed rule was published in conjunction
with the FDA's proposed rule, we have considered comments we received
in conjunction with the FDA. We specifically requested in the proposed
rule comments on the reasonableness of our adopting the FDA
requirements.
The FDA proposed rule for HCV lookback would require blood
establishments (in this IFC we changed the reference of ``blood
establishments'' to ``blood collecting establishments'' (BCE)) to
search historical testing records of prior donations from donors with
repeatedly reactive EIA 1.0, EIA 2.0, or EIA 3.0 screening tests for
HCV, extending back indefinitely for computerized electronic records,
and to January 1, 1988 for other retrievable records. Under the FDA
rule, a BCE would be required to notify a hospital if it supplied such
hospital with potentially HCV infectious blood.
We proposed to amend the hospital conditions of participation to
require a hospital to develop agreements with outside BCEs under which
the BCE would notify the hospital if it supplied the hospital with
potentially HCV infectious blood and blood components. We proposed to
establish a lookback, similar to that now in effect for HIV, requiring
hospitals, when notified by BCEs, to quarantine prior collections from
a donor who later tested repeatedly reactive for evidence of HCV
infection, and to notify transfusion recipients of the prior
collections, based on further testing of the donor, as appropriate.
We proposed to remove current paragraph (a) in the existing Sec.
482.27 and re-designate paragraphs (b) and (c) as (a) and (b),
respectively. In addition, we proposed adding a definition of
``potentially HCV infected blood and blood components'' as previous
collections from a donor--(1) Who tested repeatedly reactive for
evidence of HCV infection on a single antigen screening test with a
signal to cut off value equal to or greater than 2.5 for at least two
of the three EIA tests, or when the signal to cut off value for such
donor could not be calculated, with no record of further testing; (2)
who tested repeatedly reactive for evidence of HCV infection and
positive on a multiantigen supplemental test licensed at an earlier or
later date by FDA; (3) who tested repeatedly reactive for evidence of
HCV infection and indeterminate on a supplemental test for HCV, unless
an indeterminate RIBA 3.0 supplemental test result was obtained or a
negative EIA 3.0 or negative RIBA 3.0 test result was subsequently
obtained; (4) who tested repeatedly reactive for evidence of HCV
infection on a multiantigen screening test with no record of further
testing; or (5) who tested repeatedly reactive for evidence of HCV
infection on a single antigen screening test and repeatedly reactive on
a subsequent multiantigen screening test, unless a negative
supplemental test result or an indeterminate RIBA 3.0 supplemental test
result was obtained. (See proposed Sec. 482.27(b)(2).)
Our regulations currently require a hospital that regularly uses
the services of an outside BCE to have an agreement with the BCE that
requires the establishment to notify the hospital if the establishment
has supplied the hospital with potentially HIV infected blood. We
proposed to amend that provision to also require notification in the
case of potentially HCV infected blood. (See proposed Sec.
482.27(b)(3).) In addition, we proposed to revise our regulations to
include HCV-relevant testing required by FDA. (See proposed Sec.
482.27(b)(3)(ii).)
We also proposed conforming changes to the HIV requirement at Sec.
482.27(b)(3)(i) by removing the word ``promptly'' and instead require
that a blood bank notify a hospital of potentially infected blood
within 3 calendar days after testing. Also, hospitals would have been
required to make at least three attempts to notify the patient, or to
notify the attending physician who ordered the blood or blood
components.
[[Page 48566]]
We proposed additional conforming changes that would have required
a hospital's agreement with a BCE to require the BCE to notify the
hospital within 3 calendar days of testing if blood tested repeatedly
reactive for HCV antibodies. This change provides further clarity of
the notification requirement.
The FDA proposed a change to the maximum time permitted for a BCE
to notify hospitals of the results of the further testing, from 30 to
45 days, in order to create consistency between the HIV and HCV
lookback provisions. Although FDA has stated that further testing for
HIV and HCV could be completed within 30 days, additional time was
needed to notify hospitals following completion of the further testing.
We proposed the appropriate changes to Sec. 482.27(b)(3)(ii) to
include the change from 30 to 45 days in the agreement a hospital had
with a BCE.
In Sec. 482.27(c)(3)(i) and (ii) regarding follow-up testing, we
proposed deleting the words in Sec. 482.27(b)(1)(ii) to reflect that
the additional follow-up testing was an FDA requirement and not a
recommendation.
As a new provision, we proposed that hospitals be required to
include in agreements with BCEs a provision requiring the BCE to notify
the hospital of lookback results under FDA's proposed 21 CFR
610.48(h)(3)(i) and (h)(3)(ii), and (i)(3)(i) and (i)(3)(ii). FDA
proposed that hospitals perform a lookback of blood or blood components
collected from a donor extending back indefinitely for computerized
electronic records and to January 1, 1988 for other retrievable
records, or to the date 12 months before the donor's most recent
negative multiantigen screening test for the antibody to HCV, whichever
is the later date.
We also proposed to revise our regulations to apply the provisions
regarding the quarantine of potentially HIV infectious blood and blood
components currently set forth at Sec. 482.27(c)(3) to potentially HCV
infected blood and blood components. (See proposed Sec. 482.27(b)(4).)
In addition, we proposed requiring hospitals to destroy or re-label
previous collections of blood or blood components held in quarantine if
the results of the testing were indeterminate. We proposed that
hospitals re-label previous collections of blood or blood components
held in quarantine if the results of the testing were indeterminate, in
accordance with the FDA regulations at 21 CFR 606.121 and the HCV
Lookback Guidance Documents.
We proposed a change to Sec. 482.27(b)(4) by adding a
parenthetical phrase ``(either internal or under an agreement).'' We
proposed this change to clarify that a blood collecting establishment
has a responsibility to notify the hospital of HIV or HCV screening
results even when located at a hospital site.
Hospitals are currently required to maintain clinical records on
all patients for 5 years. We proposed adding a new provision requiring
hospitals to maintain adequate records of the source and disposition of
all units of blood and blood components for at least 10 years after the
date of disposition. The FDA also proposed to increase record retention
requirements for blood establishments from 5 years to 10 years.
Hospitals would be required to increase the record retention period
yearly until 10 years of records from the date of disposition had
accrued. (For example, the first year after the effective date of this
regulation, hospitals would have had 6 years of records, the second
year after the effective date, 7 years, and so on until 10 years had
been reached.) Hospitals would then have been able and expected to
maintain 10 years of patient records. (See proposed Sec.
482.27(b)(5).) We believed this would be necessary to increase
opportunities for disease prevention or treatment years after a
recipient had been exposed to a donor later determined to be at risk of
transmitting the disease through transfusion. We proposed, as is
currently required at Sec. 482.24(b)(2), that hospitals maintain the
clinical records in such a manner that would permit prompt retrieval.
We also had proposed that hospitals ensure that medical records would
be transferred to another hospital or other entity if the former
hospital ceased operation for any reason. (See proposed Sec.
482.27(b)(5)(iii).)
The FDA had proposed changes in its requirement for patient
notification to allow transfusion services to make three attempts to
either notify patients directly or notify the attending physician or
the physician who ordered the blood. We proposed that hospitals follow
the same notification procedures with regard to potentially HIV and HCV
infectious blood and blood components. For consistency, we also
proposed that the HIV lookback requirements be changed to conform to
the requirements for HCV lookback.
We had proposed adding a new paragraph (c) requiring hospitals to
comply with FDA regulations pertaining to the appropriate testing and
quarantining of infectious blood and blood components and to the
notification and counseling of recipients who may receive any
infectious blood and blood components that are identified after the
publication of this rule.
Note that our Medicaid regulations at Sec. 441.17 (``Laboratory
services'') provide that the State plan must pay for laboratory
services furnished by a hospital-based laboratory meeting the
requirements for Medicare participation set forth in Sec. 482.27.
Therefore, the provisions of this interim final rule with comment
period will also affect the Medicaid program. That is, in order for the
laboratory services furnished by a hospital-based laboratory under
Medicaid to be covered under the State plan, the hospital will have to
meet the new requirements set forth in this rule.
III. Analysis of and Responses to Public Comments
While we are not issuing a new proposed rule as would otherwise be
required under section 1871(a)(3)(B) of the Act, we are considering
comments we received on the proposed rule published on November 16,
2000 in this interim final rule with comment period. See section VI
below for a more detailed discussion of our decision to publish this
matter as an interim final rule with comment period.
Six types of organizations, including blood banks, blood centers,
the blood industry trade association, and hospitals, submitted comments
raising several issues with the proposed rule. The main concerns were
with the proposed requirement to make three attempts to notify affected
transfusion recipients and the requirement to notify the deceased's
relative of possible HCV infection.
Both CMS and the FDA received comments related to the complex and
prescriptive language in their respective proposed rules. As we stated
in section II of this rule, we also reviewed the comments and responses
that the FDA received, and we have coordinated our responses with the
FDA.
Comment: One commenter disagreed with adding specific language
about the test method in the interim final rule with comment period,
stating that the methodology could be obsolete in a few years.
Response: We agree with the commenter that including specific
testing methods in this interim final rule with comment period is too
restrictive. We have changed the regulation at Sec. 482.27(b)(2) to
reference 21 CFR 610.47, which describes blood and blood components
subject to HCV lookback.
Comment: Several commenters disagreed with our proposal to require
a hospital to notify a patient's legal
[[Page 48567]]
guardian or relative of possible HCV exposure after a patient had
already died (of any cause). They noted that there are no clear
indications of risk to household contacts of patients with HCV. They
request that Sec. 482.27(b)(10) be deleted.
Response: We agree with respect to HCV. As previously discussed in
both the FDA and CMS's rules, direct percutaneous exposure to infected
blood, particularly in the setting of drug abuse, accounts for the
majority of HCV infections acquired in the United States. Secondary
transmission of HCV to sexual partners, care providers, or others with
close contact is very unlikely. The proposed rule implies that
notification efforts should be continued for HCV transmissions if the
recipient is deceased. We will clarify that if the patient is deceased,
the requirement to notify the legal guardian or relative of possible
exposure applies only to HIV infection and not HCV infection. We have
changed Sec. 482.27(b)(10) to reflect the clarification.
Comment: One commenter stated that since the FDA requires that all
blood donors and donated transfusions are screened, the risks of
transmission through blood transfusions are currently very low. The
commenter stated that there does not appear to be a need to increase
the regulatory burden on hospitals because the problem of HCV
transmission in hospitals by blood transfusion and tissue transplant
has been effectively solved. The commenter stated that the proposed
regulation should be withdrawn.
Response: We understand that due to advanced screening techniques
and the fact that hospitals are currently following the FDA's industry
guidelines on HCV testing and quarantining of blood and blood
components that test reactive for evidence of HCV infection, the risk
of transmitting HCV through blood transfusions or administration has
been greatly reduced. In addition to reducing the risk of current and
future HCV transmission, this rule will ensure that hospitals
appropriately notify those Americans who may have been infected with
HCV as a result of transfusion of blood components before the broad
availability of donor screening tests in 1990. It is important that
these individuals are notified of the need for HCV testing and
counseling. HCV infection is usually asymptomatic for about 20 years,
but may cause serious liver injury that is thought to be a leading
cause of end stage liver disease among adults in the United States. HCV
is also thought to play a role in the development of liver cancer.
Between 8,000 and 12,000 deaths annually result from HCV-related
chronic liver disease.
This interim final rule with comment period also increases the
medical record retention period from 5 to 10 years. The FDA has
recommended that the records retention period be increased because
advances in medical diagnosis and therapy have created opportunities
for disease prevention or treatment many years after recipient exposure
to a donor later determined to be at increased risk of transfusion
transmitted disease.
Comment: One commenter stated that the burden of 16 hours for a
hospital to develop the required procedures and establish the contract
with the BCE is underestimated. They also stated that the estimated
cost of $52,653,004 for recipient notification is very low.
Response: As stated in the proposed rule, we currently require
hospitals that receive blood from an outside BCE to have an agreement
with the BCE that governs the procurement, transfer, and availability
of blood and blood components for HIV. We do not envision that
hospitals need a separate or different agreement for HCV. Hospitals
will only need to modify their current agreement to include potentially
HCV infected blood and blood components. Also, hospitals currently have
procedures in place to conduct HIV lookback activities. We think that
16 hours, as stated in the proposed rule, will provide adequate time to
incorporate similar procedures for conducting HCV lookback activities.
We agree with the commenter regarding the cost for recipient
notification. Based on the recent Bureau of Labor Statistics estimates,
we have increased the cost for recipient notification. We have
increased the hourly wage for a staff medical technologist performing
the review from $25.67 to $33.84. Each hospital will incur a one-time
cost of $541.44, or about $2.7 million for the entire industry to
develop HCV lookback procedures. Thus, the total one-time cost to
hospitals for conducting the historical (retrospective) lookback
efforts is estimated to be $41.6 million ($2.7 million to develop
procedures and $38.9 million for recipient notification). The
calculations are based on the latest data available related to
hospitals and number of recipients that may need notification. There
are approximately 4,980 Medicare- and Medicaid-participating hospitals,
excluding 1,041 hospitals that operate blood collection centers,
because they are counted among the collection establishments. The CDC
estimated in 2000 that 212,000 recipients may need to be notified due
to the historical review.
Comment: One commenter stated that there is no reason for blood
records to be kept for 10 years, stating that there is no reason for
such records to be kept on a different basis than any other medical
records. Having special rules for this narrow class of records will
only lead to confusion. Several commenters agreed with requiring
hospitals to maintain adequate records of the source and disposition of
all units of blood and blood components for at least 10 years from the
date of disposition, but recommended that the retention period be
phased in.
Response: We maintain that increasing the record retention period
from 5 to 10 years will increase opportunities for disease prevention
or treatment years after a recipient has been exposed to a donor that
is later determined to be at risk of transmitting a disease through
transfusion. In addition, advanced technology has improved the
hospital's ability to maintain, store, and retrieve records.
The record retention period will be phased in as described above in
Section II, ``Provisions of the Proposed Regulation.'' Hospitals will
be required to increase the record retention period yearly until 10
years of records from the date of disposition have accrued.
Comment: Several commenters agree that the hospital should directly
notify the patient, the attending physician, or the physician who
ordered the blood and blood component of HCV infection. However, they
disagree with requiring, at a minimum, three attempts to notify the
patient. They stated that only one notification attempt should be made
using a traceable method such as certified mail or return receipt. A
returned letter should be proof that notification was attempted and was
unsuccessful, and that further attempts would be unsuccessful as well.
However, one commenter disagrees with requiring just one notification
attempt by certified mail. The commenter stated that there are
individuals who will not claim a certified letter.
Response: We agree that some individuals are reluctant to take
possession of a certified letter. We have clarified in the interim
final rule with comment period at 482.27(b)(6)(i) and (b)(7) that the
hospital must make reasonable attempts to perform the notification
within 12 weeks after being notified by the BCE that it has received
potentially HIV or HCV infectious blood and blood components. The
hospital will be required to notify the recipient, recipient's
physician of record, or a legal representative or relative if the
recipient is a minor or adjudged incompetent by a State court.
[[Page 48568]]
Comment: Several commenters stated that it is important for both
CMS' and FDA's requirements for HCV and HIV lookbacks to be identical
in order to ensure that the targeted lookbacks are carried out in a
uniform manner throughout the United States.
Response: We appreciate the comments supporting a unified targeted
lookback effort. It is important to have consistent industry standards
for maintaining the safety of the nation's blood supply. As previously
stated, we have collaborated with the FDA in developing and responding
to the comments received on the proposed rule.
Comment: A commenter stated that the time-frame for non-
computerized retrievable records should be from January 1, 1988 instead
of January 1, 1998.
Response: After the effective date of this rule, whenever a
hospital or other BCE receives a blood donation that tests infectious
for HCV, it must perform a lookback as far back as the period described
above (that is, 1988 or to the extent of electronic records), to
determine if that donor had previously given blood. If the donor's most
recent previous donation (before the current infectious donation)
tested non-reactive (that is, uninfected), or tested reactive on a
viral detection test (for instance, the nucleic acid test) but non-
reactive on the associated antibody screening test on that previous
occasion, the hospital and/or BCE must review the record for the 12
months previous to the earlier donation test, to determine if there
were any donations during that 12-month period, and to determine if
those blood products are still available for use. If so, all such blood
products still available for consignment/use 12 months and less before
that previous donation must be quarantined retested, and the consignees
of the blood products notified.
IV. Provisions of the Interim Final Rule With Comment Period
For the most part, this interim final rule with comment period
incorporates the provisions of the November, 2000 proposed rule. As
discussed in section III, ``Analysis of and Responses to Public
Comments,'' we have made minor changes to the proposed rule at Sec.
482.27(b)(2), (6), (7), and (10). We have added Sec. 482.27(b)(11) to
establish a cut-off date for retrospective HCV lookback.
In Sec. 482.27(b)(2), we removed language that we determined,
based on public comment, to be too restrictive. That language was
replaced with a reference to FDA's regulations in 21 CFR 610.47.
In Sec. 482.27(b)(3)(i) through (iii), we made changes to the
regulation citations to conform to the FDA rule.
In Sec. 482.27(b)(6) and (7), we changed the proposed requirement
that the hospital make three attempts to notify the patient or
physician of record that potentially infectious blood was transfused to
the patient. Instead, we are requiring the hospital to make reasonable
attempts to notify the recipient or the physician of record. We
emphasize that a hospital should continue attempting its notification
efforts until it is clear that further attempts would not be
successful.
In Sec. 482.27(b)(10), we have revised the language to clarify
that if a patient is deceased, the requirement to notify a legal
guardian or relative of possible exposure applies only to HIV infection
and not to HCV infection.
We have made changes to the interim final rule with comment period
in Sec. 482.27(b)(11) to conform with the FDA's rule at Sec. 610.48
whereby a cut-off date has been established for the retrospective
lookback. As such, we have established a cut-off date in this rule for
the retrospective (historical) HCV lookback. The requirement under
Sec. 482.27(b) will remain in effect for 8 years after the date of
publication in the Federal Register.
We clarified the regulation at Sec. 482.27(c) by stating that the
lookback activities discussed in this section are related only to new
blood safety issues that are identified after the publication of this
rule. Hospitals should comply with the FDA regulations pertaining to
the appropriate testing and quarantining of infectious blood and blood
components, and to the notification and counseling of recipients who
may receive any infectious blood and blood components.
V. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
VI. Waiver of Proposed Rulemaking
Section 1871(a)(3) of the Act (as added by section 902 of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA)) provides that, effective December 8, 2003, the Secretary, in
consultation with the Director of the Office of Management and Budget
(OMB), shall establish and publish a regular timeline for the
publication of Medicare final regulations based on the previous
publication of a proposed regulation or an interim final regulation.
Section 1871(a)(3)(B) of the Act further provides that such timelines
may vary among different regulations, but shall not be longer than 3
years except under exceptional circumstances. As noted above, CMS
published a proposed rule regarding Hepatitis C Virus and blood
collecting establishments on November 16, 2000. On December 30, 2004,
we published a notice in the Federal Register implementing section
1871(a)(3) of the Act (68 FR 78442). In that notice, we interpreted the
effect of that section as generally rendering legally inoperative
Medicare proposed rules that were over 3 years old on the MMA's
effective date. Therefore, since 3 years had already elapsed since
publication of the November, 2000 NPRM on December 8, 2003, we believe
that the 2000 NPRM became legally ineffective as of that date.
Accordingly, even though we sought and received extensive comments on
this interim final rule with comment period in response to the 2000
proposed rule, we are not publishing this rule as a final rule.
Under such circumstances, we ordinarily would publish a new
proposed rule in the Federal Register and invite public comment on the
proposed rule. The proposed rule would include a reference to the legal
authority under which the rule was proposed, and the terms and
substance of the proposed rule or a description of the subjects and
issues involved. This procedure can be waived, however, if an agency
finds good cause that a notice and comment procedure is impracticable,
unnecessary, or contrary to the public interest, and incorporates a
statement of the finding and its reasons in the rule issued.
We are waiving publishing a proposed rule, and instead publishing
this rule as an interim final rule with comment period. We are
specifically going forward because of the importance of keeping this
document coordinated with the FDA's lookback rule covering blood
establishments, and the present danger to lives and health of
individuals that arise from unknown contaminants in the nation's blood
supply. Section 1871(a)(3) of the Act does not prohibit us from issuing
an interim final rule with comment period based on the expired proposed
rule, as long as we issue a final rule no later than 3 years after the
interim final rule's publication
[[Page 48569]]
date (or publish in the Federal Register a notice extending the
period).
The FDA's final rule and CMS's interim final rule on blood safety
are very closely related and dependent upon each other. However, the
FDA is not restricted by this section of the MMA (which applies only to
Medicare rules) and therefore is also issuing its final rule in this
issue of the Federal Register. We believe that it would not be in the
best interest of the public for the FDA to publish a final rule
requiring blood establishments to notify hospitals of infectious blood
and blood products and CMS not to require hospitals to perform the
necessary lookback activities of notifying transfusion recipients of
the need for HCV testing and counseling.
For the FDA's rule to be effective practically, it is therefore
necessary that we issue a companion interim final rule with comment
period that covers transfusion services and further supports the
notification of recipients of blood and blood components that are at
increased risk of infection and transmission of HCV.
Therefore, we find good cause to waive the publication of a
proposed rule and to issue this interim final rule with comment period.
We are providing a 60-day public comment period.
VII. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 30-day notice in the Federal Register and solicit public
comment when 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
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying 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.
We are soliciting public comment on each of these issues for the
following sections of this document that contain information collection
requirements (ICRs):
Section 482.27 Condition of Participation: Laboratory Services
Section 482.27(b)(3) requires a hospital that regularly uses the
services of an outside BCE to establish and maintain a written
agreement with the BCE that governs the procurement, transfer, and
availability of blood and blood components. This section also requires
the BCE to notify the hospital within 3 calendar days after the date on
which the donor tested reactive for evidence of HCV infection or after
the date on which the blood establishment was made aware of other test
results indicating evidence of HCV infection, as outlined in (b)(3)(i)
through (iii).
Section 482.27(b)(5) requires a hospital to maintain, in a manner
that permits prompt retrieval, adequate records of the source and
disposition of all units of blood and blood components for at least 10
years from the date of disposition. In addition, this section requires
a hospital to maintain a fully funded and documented plan that will
allow the hospital to transfer these records to another hospital or
other entity if such hospital ceases operation for any reason.
Section 482.27(b)(6) requires a hospital that has administered
potentially HIV or HCV infectious blood or blood components (either
directly through its own BCE or under an agreement), or released the
blood or blood components to another entity or individual, to make
reasonable attempts to notify the patient, or to notify the attending
physician or the physician who ordered the blood or blood component and
ask the physician to notify the patient, that potentially HIV or HCV
infectious blood or blood components were transfused to the patient.
Time frame and notification requirements are outlined in Sec.
482.27(b)(6), (b)(7), and (b)(8).
Section 482.27(b)(9) requires a hospital to maintain policies and
procedures for notification and documentation that conform to Federal,
State, and local laws, including requirements for the confidentiality
of medical records.
Section 482.27(b)(10) requires a physician or hospital, if the
patient has been adjudged incompetent by a State court, to notify a
legal representative designated in accordance with State law. If the
patient is competent, but State law permits a legal representative or
relative to receive the information on the patient's behalf, the
physician or hospital must notify the patient or his or her legal
representative or relative. If the patient is deceased, the physician
or hospital must continue the notification process for HIV infection
and inform the deceased patient's legal representative or relative. If
the patient is a minor, the legal guardian must be notified.
While all of the information collection requirements referenced
above are subject to the Paperwork Reduction Act, the burden associated
with these requirements is captured and discussed in the FDA's final
regulation titled ``Current Good Manufacturing Practice for Blood and
Blood Components: Notification of Consignees and Transfusion Recipients
Receiving Blood and Blood Components at Increased Risk of Transmitting
HCV Infection'' published elsewhere in today's Federal Register.
Therefore, we are assigning 1 token hour of burden to these
requirements.
The FDA's rule assigns a one-time burden of 16 hours for hospitals
to develop procedures to conduct lookback activities. We also require
hospitals that currently receive blood from an outside BCE to have an
agreement with the BCE that governs the procurement, transfer, and
availability of blood and blood components for HIV. Our rule requires
hospitals to modify their current agreements to include HCV. Although
the FDA does not require hospitals to have an agreement with a BCE, we
believe that the time necessary to perform this task will be minimal
and is already captured in the 16 hours allotted in the FDA rule.
We received a comment that the burden of 16 hours for a hospital to
develop the required procedures and establish the contract with the BCE
is underestimated. This interim final rule with comment period will
require a hospital to make minor modifications to the current agreement
they have with the BCE for HIV. Therefore, we disagree with the comment
that the 16 hours is not adequate to develop procedures to conduct
lookback activities and modify their agreement with the BCE.
We have submitted a copy of this interim final rule with comment
period to OMB for its review of the information collection
requirements. These requirements are not effective until they have been
approved by OMB. A notice will be published in the Federal Register
when we receive approval.
If you comment on any of these information collection and record
keeping requirements, please mail copies directly to the following:
Centers for Medicare and Medicaid Services, Office of Strategic
Operations and Regulatory Affairs, Regulations Development Group, Attn:
Melissa Musotto, CMS-3014-IFC, Room C4-26-05, 7500 Security Boulevard,
Baltimore, MD 21244-1850; and Office of
[[Page 48570]]
Information and Regulatory Affairs, Office of Management and Budget,
Room 10235, New Executive Office Building, Washington, DC 20503, Attn:
Carolyn Lovett, CMS Desk Officer, CMS-3014-IFC,
carolyn_lovett@omb.eop.gov. Fax (202) 395-6974.
VIII. Regulatory Impact Analysis
A. Overall Impact
We have examined the impacts of this interim final rule with
comment period as required by Executive Order 12866 (September 1993,
Regulatory Planning and Review), the Regulatory Flexibility Act (RFA)
(September 16, 1980, Pub. L. 96-354), section 1102(b) of the Social
Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4),
and Executive Order 13132.
Executive Order 12866 (as amended by Executive Order 13258, which
merely reassigns responsibility of duties) directs agencies to assess
all costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more annually).
Because the projected cost of this rule falls below the threshold for a
major rule, we have determined that this rule is not a major rule.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and small governmental
jurisdictions. Most hospitals and most other providers and suppliers
are small entities, either by nonprofit status or by having revenues of
less than $31.5 million in any 1 year. For purposes of the RFA, a
majority of hospitals are considered small entities due to their non-
profit status. The agency has examined the impact on small entities and
has determined that this rule will not have a significant economic
impact on a substantial number of small entities. Individuals and
States are not included in the definition of a small entity.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area (superseded by ``core-based statistical areas''
(CBSAs)) and has fewer than 100 beds. Because of the lack of
information to characterize the number and volume of affected blood and
blood components in small rural hospitals, we have prepared an analysis
that is consistent with section 604 of the RFA.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. That threshold
level is currently approximately $122 million. We believe that this
interim final rule with comment period is not an economically
significant rule as described in the Executive Order, or a significant
action as defined in the Unfunded Mandates Reform Act. Aggregate
impacts of the rule, and aggregate expenditures caused by the rule will
not reach $120 million for either the public or the private sector. As
discussed in the following paragraphs, because of the lack of
information to characterize the number and volumes of affected blood
and blood components in hospitals that might qualify as small entities,
the impact on small entities is uncertain.
It is clear that a number of hospitals that provide blood
transfusions will be affected by the implementation of this interim
final rule with comment period and that a substantial number of those
entities will be required to make changes in their operations. For
these reasons, we have prepared the following analysis. This analysis,
in combination with the rest of the preamble, is consistent with the
analysis set forth by the RFA.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. We have determined that the rule does not contain
policies that have substantial direct effects on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. Accordingly, we have concluded that the rule does not
contain policies that have federalism implications as defined in the
Executive Order 13132 and, consequently, a federalism summary impact
statement is not required.
B. Anticipated Effects
1. Effects on Hospitals
This interim final rule with comment period requires hospitals that
transfuse blood and blood components to (1) prepare and follow written
procedures for appropriate action when it is determined that blood and
blood components the hospitals received and transfused are at increased
risk for transmitting HCV; (2) quarantine prior collections in
inventory from a donor who is at increased risk for transmitting HCV
infection; (3) notify transfusion recipients (and, where required,
legal representatives or relatives), as appropriate, of the need for
HCV testing and counseling; and (4) extend the records retention period
to 10 years.
This interim final rule with comment period will affect hospitals
that transfuse blood and blood components. There are approximately
4,980 Medicare- and Medicaid-participating hospitals, excluding 1,041
hospitals that operate blood collection centers, because they are
counted among the collection establishments. The CDC estimated in 2000
that 212,000 recipients may need to be notified due to the historical
review.
Fixed Cost--Standard Operating Procedures and Record Review. This
interim final rule with comment period is expected to generate one-time
costs and some additional annual costs for hospitals. One-time costs
include the development of procedures and policies for recipient
notification and the agreement a hospital should have if it uses the
services of an outside BCE. We assume that these tasks will involve a
review of current procedures and policies (for example, for HIV
lookback) and the adaptation or modification of current procedures and
policies to address the provisions of this rule. We estimate, in
consultation with the FDA, that the tasks will require an average of 16
hours per facility.
In the proposed rule, we estimated, based on the 1997 Bureau of
Labor Statistics (BLS) estimates, that the total hourly compensation
for a staff medical technologist is $25.67. We have revised the
estimates to increase the hourly compensation to $33.84 to reflect the
most recent BLS data. Each hospital will incur a one-time cost of
$541.44 ($33.84 x 16 hours = $541.44). The total cost is about $2.7
million ($541.44 x 4980 establishments = $2,696,371.) (See the table in
this section.) The proposed rule would have required hospitals to make
at least three attempts to notify the
[[Page 48571]]
transfusion recipient. Several commenters expressed concern that it
would be unnecessary to continue notification attempts if the hospital
had proof that notification was attempted and was unsuccessful and that
further attempts would most likely be unsuccessful. Therefore, we have
changed the prescriptive language about the number of attempts.
However, hospitals must make a reasonable attempt to contact any
affected transfusion recipient within a maximum of 12 weeks from the
time they receive from the blood establishment the results of a donor's
supplemental positive test for HCV.
We did not receive comments on the initial estimate that it would
cost $165 to comply with all of the lookback provisions for each
affected component. However, based on a recent report the FDA received
from Los Angeles County, a vendor was paid $118 per patient to abstract
health records, locate and notify transfusion recipients, and to give
pretest counseling. Therefore, the FDA has revised the cost for
lookback activities. The FDA estimates that the product quarantine
accounts for about 40 percent of the unit cost (that is, $66), and the
recipient notification accounts for the other 60 percent of the unit
cost (that is, $99). [EB2] Without other data from both the prospective
and retrospective lookbacks, the FDA continues to use the $66 as the
cost of product quarantine, but increased the cost of recipient
notification from $99 to $118 based on the experience of Los Angeles
County.
Prospective HCV lookback. The FDA estimates (based on prevalence
levels reported by the American Red Cross for 2000) about 2,400
discrete components could trigger recipient notification (780 donations
from HCV-infected donors x 3.1 components per donation). The CDC survey
found that on average about 85 percent of the at-risk components sent
to hospitals were transfused. For the analysis of the proposed rule,
FDA assumed that no patient would receive more than one affected
component. This assumption suggests that hospitals will quarantine
about 2,400 components and attempt about 2,050 recipient notifications
(780 HCV positive donors x 3.1 components per donor x 85 percent
transfused). Because CMS inspected hospitals account for about 65
percent to 75 percent of the number of transfusions, the annual costs
for consignees to conduct the prospective lookback actions range from
$260,000 to $300,000 (65 percent by CMS-inspected establishments x
2,400 components annually triggering recipient notification x $66 per
component quarantine plus 2050 components annually triggering recipient
notification x $118 per recipient notification to 75 percent by CMS-
inspected establishments x 2,400 components annually triggering
quarantine x $66 per component quarantine plus 2,050 components
annually triggering recipient notification x $118 per recipient
notification. (See the table in this section. The numbers in the table
are rounded).
Retrospective HCV lookback. For notifications resulting from donors
tested before February 20, 2008 under 21 CFR 610.48(c), the hospital
must complete the notification effort within 1 year from the time it
receives notification from the blood establishment. The recipient
notification provided by the hospital must include a basic explanation
to the recipient, referral for counseling and further testing, and
documentation of the notification or attempts to notify the attending
physician or recipient. The estimated one-time cost of recipient
notification associated with the review of historical testing records
is $41.6 million. This is based on the FDA estimate of blood components
of about 212,000 recipients identified for notification produced from
donations, and the average cost of $184 ($66 + $118) for staff time per
component for recipient notification. Thus, the total one-time cost to
hospitals for conducting the historical (retrospective) lookback effort
is estimated to be $38.9 million for recipient notification). (See the
table in this section.)
This interim final rule with comment period requires hospitals to
increase the time they keep records from 5 to 10 years. Although we did
not include the annual cost of keeping records for a longer period of
time in the analysis for the proposed rule, we are including the cost
in this interim final rule with comment period. The FDA has estimated
in its final rule that it may take 40 hours for a computer programmer
to perform routine maintenance of these additional records. At a wage
of $34 per hour, including benefits, a hospital would spend an
additional $1,360 annually to conform to this provision of the rule.
However, according to the AABB (formerly knows as the American
Association of Blood Banks), 80 percent of the establishments that
transfuse blood are accredited by the AABB and already comply with
their standards, including retaining records for 10 years. Taking AABB
compliance into account, this analysis includes additional compliance
costs for 20 percent of the transfusion facilities at a total annual
cost of $1.4 million ($34.00 per hour x 40 hours x 4,980 hospitals x 20
percent). The following table shows the estimated compliance cost of
this interim final rule. We believe that hospitals will incur up to
$1.7 million in annual compliance costs for the prospective lookback
provisions and to retain records for 10 years, and up to $42 million in
one-time costs for SOPs and the retrospective lookback based on
historical review of records. The annualized costs of this interim
final rule over 10 years at 3 and 7 percent interest rates will be $6.5
and $7.6 million.
Summary of the Estimated Cost of This Interim Final Rule With Comment Period
----------------------------------------------------------------------------------------------------------------
Annualized costs (millions of
Number One-time cost Annual cost dollars)
Type of cost affected (millions of (millions of -------------------------------
dollars) dollars) 3 percent 7 percent
----------------------------------------------------------------------------------------------------------------
Development of HCV lookback *4,980 $2.7 .............. $0.3 $0.4
Procedures.....................
Prospective Review.............. 4,980 .............. 0.3 0.3 $0.3
Historical Review (Retrospective 4,980 $38.9 .............. $4.6 $5.5
lookback)......................
Record Retention Retain records 4,980 .............. 1.4 1.4 $1.4
for 10 years...................
-------------------------------------------------------------------------------
Total....................... .............. $41.6 $1.7 $6.5 $7.6
----------------------------------------------------------------------------------------------------------------
* Numbers are rounded. (Excluding 1,041 hospitals that operate blood collection centers, because they are
counted among the collection establishments).
* The annualized cost is for a 10 year period.
[[Page 48572]]
2. Effects on Beneficiaries
Timely notification of HCV infection benefits beneficiaries, both
directly and indirectly, in several important ways. First, although
factors predicting the severity of liver disease due to HCV have not
been well defined, recent data indicate that increased alcohol intake
is associated with more severe liver disease. According to CDC, even
moderate amounts of alcohol in patients with chronic HCV might
exacerbate liver disease. Consequently, an HCV-infected patient
identified by the lookback program could minimize liver damage
associated with alcohol consumption by restricting his or her intake.
It is also important to note that identified infected patients will
benefit from counseling and treatment with available therapies. Studies
of patient characteristics and responsiveness to therapy indicate that
when treatment is initiated early in an infection, the best and most
cost effective outcomes are achieved. That is, best results are
achieved if treatment is initiated earlier in the disease, when
patients are younger and have not yet developed cirrhosis. For example,
Bennett et al. showed that the years of life gained and cost
effectiveness of interferon-alpha 2b treatment decreased as the age of
the patient increased from 3.1 years at $500 per year of life (YLE) for
20-year-old patients to 22 days at $62,000 per YLE for 70-year-old
patients. The dollar amounts of $500 and $62,000 represent the cost
effectiveness of the treatment when it is given at an earlier age.
Finally, infected patients will be informed that they must not
donate blood. The lookback program will, therefore, help to ensure the
safety and continued availability of the national blood supply.
3. Effects on Medicare and Medicaid Programs
This interim final rule with comment period will generate a one-
time cost to develop procedures for recipient notification. We estimate
this cost to be $2.7 million. Finally, the total one-time cost for the
development of HCV lookback procedures and for recipient notification
associated with the review of historical testing records is estimated
to be $41.6 million ($2.7 + $38.9). These one-time costs would likely
be distributed among health programs as follows: Medicare, 33.3
percent; private health insurance, 30.5 percent; Federal Medicaid, 9.8
percent; State Medicaid, 5.8 percent; other private funds, 7.9 percent;
other Federal funds, 6.9 percent; and other State and local funds, 5.7
percent. The total Federal distribution would be 50 percent; that is,
33.3 percent for Medicare, 9.8 percent for Medicaid, and 6.9 percent
for other Federal sources. The degree to which the Federal programs
fund these amounts will vary: Medicaid providers may be able to pass on
costs through the States depending on the method of payment the State
Medicaid program has adopted, while Medicare payments could be limited
because of the hospital outpatient prospective payment system and
increase only in accordance with specific rules regarding coverage of
HCV testing for patients who have been exposed to HCV-infected blood,
including those identified through the FDA lookback process.
It is important to note that, although this interim final rule with
comment period presents the costs that would be imposed on all payers
of hospital services, including the Medicare and Medicaid programs, it
merely conforms to the FDA's final rule and has no additional economic
impact. We have simply restated the analysis performed in the FDA
companion rule; both rules present the same total costs to hospitals.
C. Alternatives Considered
The PHS Advisory Committee discussed improvements in the treatment
and management of HCV infection and improvements in testing for the HCV
antibody at public meetings held in April and August 1997. The PHS
Advisory Committee recommended that blood establishments and hospitals
notify previous recipients of blood components from donors who tested
positive for HCV upon a subsequent donation.
Following the Department of Health and Human Services' acceptance
of recommendations from the PHS Advisory Committee, FDA developed
industry guidance for testing blood for HCV, quarantining blood and
blood components, and notifying patients who may have received HCV-
infected blood and blood components. We explored the possibility of
using a program memorandum to notify hospitals that they must follow
FDA guidance. We believe, however, that in order to protect the health
and safety of beneficiaries, we should publish an enforceable
regulation that will enable us to ensure compliance through the survey
process.
The FDA, in its final rule published elsewhere in this issue of the
Federal Register, provides a lengthy discussion and cost-benefit
analysis regarding a targeted lookback program compared to a general
lookback program for HCV. Therefore, the following discussion considers
some key elements of successful lookback efforts, describes certain
challenges identified in lookback programs already in operation, and
reviews the value of targeted recipient notification and treatment
efforts.
The lookback provisions of this interim final rule with comment
period can be characterized as a targeted lookback program, meaning
that the notification of infection risk is limited to, or targeted at,
individuals identified as recipients of blood from donors subsequently
found to test positive for HCV. This program is distinct from general
lookback programs, which are aimed at all patients who received blood
before the onset of screening and which include the recommendation that
the patients be tested for evidence of infection. General and targeted
lookback programs may be complementary. General lookback can be
conducted in a variety of ways, including use of the broadcast media,
education, and letter campaigns addressed to physicians or patients. By
contrast, targeted lookback can only be performed successfully if the
transfusion service is aware that the donor subsequently tested
positive, if donor and product disposition records are available to
link blood components with the identified donors, and if the physician
or hospital knows the recipient's current whereabouts. Hospitals would
locate recipient records for all transfused units from an affected
donor and would have current recipient or physician address information
available so that the hospitals could deliver notifications. Ideally,
the recipient would be located, and would respond to the notification
for testing and treatment, if appropriate.
Despite the difficulties of implementing targeted lookback, it is
considered a valuable means of reaching patients at high risk for HCV.
For example, a comparison of Canadian efforts in targeted lookback with
general lookback through physician and public education found that a
large number of patients and families were unaware that the patient had
ever received a transfusion while in the hospital. These recipients
would not have been reached through the general lookback effort.
Timely notification is important because studies of patient
characteristics and responsiveness to therapy indicate that the best
results are achieved if patients receive treatment when they are
younger and have not yet developed cirrhosis. The primary treatment for
chronic hepatitis C is combination therapy with standard or pegylated
interferon alpha and ribavirin. Of those patients who undergo
combination treatment, a reported 40 to
[[Page 48573]]
50 percent show a sustained response (SR) after 12 months of therapy.
However, interferon alpha produces a wide array of adverse side
effects, and some patients experience a relapse after therapy. Still,
the benefits for patients identified for treatment through HCV lookback
are likely to continue to increase as improved therapies are developed.
FDA has recently approved the use of this combination therapy for HCV
patients who suffer a relapse after initial therapy with interferon
alone.
As discussed in section I of this document, the BPAC and PHS
Advisory Committee have met a number of times to discuss HCV testing
and other issues related to HCV lookback. The PHS Advisory Committee
made recommendations after considering alternative procedures to notify
transfusion recipients. Alternative approaches for lookback are
available but are not considered fully effective. Because of the
importance of a safe national blood supply and because our mission is
to protect the public health, we accepted the recommendations of the
PHS Advisory Committee and did not select an alternative approach.
D. Conclusion
In addition to the prospective HIV lookback that hospitals are
currently required to perform, hospitals are also required to conduct a
lookback of transfusion recipients of potentially HCV-infected blood.
This interim final rule with comment period also requires hospitals to
have in their agreements with BCEs that BCEs notify hospitals after
performing their own FDA-mandated lookback. Therefore, we have prepared
an analysis consistent with the analysis set forth by the RFA. We
solicited public comments on the extent that these provisions will
significantly economically affect any of the entities.
We have reviewed this interim final rule with comment period under
the threshold criteria of Executive Order 13132, Federalism. We have
determined that it will not significantly affect the rights, roles, and
responsibilities of States.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects in 42 CFR Part 482
Grant programs--health, Hospitals, Medicaid, Medicare, Reporting
and recordkeeping requirements.
0
For the reasons set forth in the preamble 42 CFR part 482 is amended as
set forth below:
PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS
0
1. The authority citation for part 482 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
0
2. Amend Sec. 482.27 by--
0
A. Removing the designation of paragraph (a).
0
B. Redesignating paragraphs (b) and (c) as paragraphs (a) and (b),
respectively.
0
C. Revising re-designated paragraph (b).
0
D. Adding paragraph (c).
The revisions and additions read as follows:
Sec. 482.27 Condition of participation: Laboratory services.
* * * * *
(b) Standard: Potentially infectious blood and blood components--
(1) Potentially human immunodeficiency virus (HIV) infectious blood and
blood components. Potentially HIV infectious blood and blood components
are prior collections from a donor--
(i) Who tested negative at the time of donation but tests reactive
for evidence of HIV infection on a later donation;
(ii) Who tests positive on the supplemental (additional, more
specific) test or other follow-up testing required by FDA; and
(iii) For whom the timing of seroconversion cannot be precisely
estimated.
(2) Potentially hepatitis C virus (HCV) infectious blood and blood
components. Potentially HCV infectious blood and blood components are
the blood and blood components identified in 21 CFR 610.47.
(3) Services furnished by an outside blood collecting
establishment. If a hospital regularly uses the services of an outside
blood collecting establishment, it must have an agreement with the
blood collecting establishment that governs the procurement, transfer,
and availability of blood and blood components. The agreement must
require that the blood collecting establishment notify the hospital--
(i) Within 3 calendar days if the blood collecting establishment
supplied blood and blood components collected from a donor who tested
negative at the time of donation but tests reactive for evidence of HIV
or HCV infection on a later donation or who is determined to be at
increased risk for transmitting HIV or HCV infection;
(ii) Within 45 days of the test, of the results of the supplemental
(additional, more specific) test for HIV or HCV, as relevant, or other
follow-up testing required by FDA; and
(iii) Within 3 calendar days after the blood collecting
establishment supplied blood and blood components collected from an
infectious donor, whenever records are available, as set forth at 21
CFR 610.48(b)(3).
(4) Quarantine and disposition of blood and blood components
pending completion of testing. If the blood collecting establishment
(either internal or under an agreement) notifies the hospital of the
reactive HIV or HCV screening test results, the hospital must determine
the disposition of the blood or blood product and quarantine all blood
and blood components from previous donations in inventory.
(i) If the blood collecting establishment notifies the hospital
that the result of the supplemental (additional, more specific) test or
other follow-up testing required by FDA is negative, absent other
informative test results, the hospital may release the blood and blood
components from quarantine.
(ii) If the blood collecting establishment notifies the hospital
that the result of the supplemental, (additional, more specific) test
or other follow-up testing required by FDA is positive, the hospital
must--
(A) Dispose of the blood and blood components; and
(B) Notify the transfusion recipients as set forth in paragraph
(b)(6) of this section.
(iii) If the blood collecting establishment notifies the hospital
that the result of the supplemental, (additional, more specific) test
or other follow-up testing required by FDA is indeterminate, the
hospital must destroy or label prior collections of blood or blood
components held in quarantine as set forth at 21 CFR 610.46(b)(2),
610.47(b)(2), and 610.48(c)(2).
(5) Recordkeeping by the hospital. The hospital must maintain--
(i) Records of the source and disposition of all units of blood and
blood components for at least 10 years from the date of disposition in
a manner that permits prompt retrieval; and
(ii) A fully funded plan to transfer these records to another
hospital or other entity if such hospital ceases operation for any
reason.
(6) Patient notification. If the hospital has administered
potentially HIV or HCV infectious blood or blood components (either
directly through its own blood collecting establishment or under an
agreement) or released such blood or blood components to another entity
or individual, the hospital must take the following actions:
[[Page 48574]]
(i) Make reasonable attempts to notify the patient, or to notify
the attending physician or the physician who ordered the blood or blood
component and ask the physician to notify the patient, or other
individual as permitted under paragraph (b)(10) of this section, that
potentially HIV or HCV infectious blood or blood components were
transfused to the patient and that there may be a need for HIV or HCV
testing and counseling.
(ii) If the physician is unavailable or declines to make the
notification, make reasonable attempts to give this notification to the
patient, legal guardian, or relative.
(iii) Document in the patient's medical record the notification or
attempts to give the required notification.
(7) Timeframe for notification--(i) For donors tested on or after
February 20, 2008. For notifications resulting from donors tested on or
after February 20, 2008 as set forth at 21 CFR 610.46 and 21 CFR 610.47
the notification effort begins when the blood collecting establishment
notifies the hospital that it received potentially HIV or HCV
infectious blood and blood components. The hospital must make
reasonable attempts to give notification over a period of 12 weeks
unless--
(A) The patient is located and notified; or
(B) The hospital is unable to locate the patient and documents in
the patient's medical record the extenuating circumstances beyond the
hospital's control that caused the notification timeframe to exceed 12
weeks.
(ii) For donors tested before February 20, 2008. For notifications
resulting from donors tested before February 20, 2008 as set forth at
21 CFR 610.48(b) and (c), the notification effort begins when the blood
collecting establishment notifies the hospital that it received
potentially HCV infectious blood and blood components. The hospital
must make reasonable attempts to give notification and must complete
the actions within 1 year of the date on which the hospital received
notification from the outside blood collecting establishment.
(8) Content of notification. The notification must include the
following information:
(i) A basic explanation of the need for HIV or HCV testing and
counseling;
(ii) Enough oral or written information so that an informed
decision can be made about whether to obtain HIV or HCV testing and
counseling; and
(iii) A list of programs or places where the person can obtain HIV
or HCV testing and counseling, including any requirements or
restrictions the program may impose.
(9) Policies and procedures. The hospital must establish policies
and procedures for notification and documentation that conform to
Federal, State, and local laws, including requirements for the
confidentiality of medical records and other patient information.
(10) Notification to legal representative or relative. If the
patient has been adjudged incompetent by a State court, the physician
or hospital must notify a legal representative designated in accordance
with State law. If the patient is competent, but State law permits a
legal representative or relative to receive the information on the
patient's behalf, the physician or hospital must notify the patient or
his or her legal representative or relative. For possible HIV
infectious transfusion recipients that are deceased, the physician or
hospital must inform the deceased patient's legal representative or
relative. If the patient is a minor, the parents or legal guardian must
be notified.
(11) Applicability. HCV notification requirements resulting from
donors tested before February 20, 2008 as set forth at 21 CFR 610.48
will expire on August 24, 2015.
(c) General blood safety issues. For lookback activities only
related to new blood safety issues that are identified after August 24,
2007, hospitals must comply with FDA regulations as they pertain to
blood safety issues in the following areas:
(1) Appropriate testing and quarantining of infectious blood and
blood components.
(2) Notification and counseling of recipients that may have
received infectious blood and blood components.
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program)
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: July 22, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
Approved: December 18, 2006.
Michael O. Leavitt,
Secretary.
Editorial Note: This document was received at the Office of the
Federal Register on August 17, 2007.
[FR Doc. E7-16647 Filed 8-23-07; 8:45 am]
BILLING CODE 4120-01-P