[Federal Register: June 27, 2008 (Volume 73, Number 125)]
[Rules and Regulations]
[Page 36469-36471]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jn08-18]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 482
[CMS-3014-F]
RIN 0938-AJ29
Medicare and Medicaid Programs; Hospital Conditions of
Participation: Laboratory Services
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: This final rule finalizes the hospital conditions of
participation requirements for hospitals that transfuse blood and blood
components. It requires hospitals 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. 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: The interim final rule amending 42 CFR part 482
published August 24, 2007 at 72 FR 48562 and effective on February 20,
2008, is adopted as final June 27, 2008.
FOR FURTHER INFORMATION CONTACT: Mary Collins, (410) 786-3189. Marcia
Newton, (410) 786-5265.
SUPPLEMENTARY INFORMATION:
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 (CoPs).
The CoPs for hospital laboratory services currently specifies the
steps hospitals must take when they become aware they have administered
potentially human immunodeficiency virus infectious blood or blood
components to a patient. All laboratories must be CLIA-certified to
participate in Medicare and Medicaid. 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.
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.
On November 16, 2000, we published in the Federal Register a
proposed rule (65 FR 69416). In that proposed rule, we discussed in
detail the steps that had been taken since the late 1980's to avoid the
transmission of HCV infection and to create opportunities for disease
prevention that, in most cases, can occur many years after recipient
exposure to a donor.
On August 24, 2007, we published an interim final rule with comment
period in the Federal Register (72 FR 48562). The interim final rule
with comment period incorporated the provisions of the November 16,
2000 proposed rule, responses to public comments, and changes to
further conform our regulation to FDA's final rule that was also
published on August 24, 2007. For a detailed discussion of this
information, we refer the reader to the August 24, 2007 interim final
rule (72 FR 48562 through 48565).
II. Provisions of the Interim Final Rule With Comment Period
In order to have consistent industry standards for potentially
infectious blood and blood components, on August 24, 2007, we published
in the Federal Register an interim final rule with comment period (72
FR 48562) entitled, ``Medicare and Medicaid Programs; Hospital
Conditions of Participation: Laboratory Services''. The provisions of
the interim final rule were effective on February 20, 2008. The interim
final rule with comment period addressed the comments CMS received
regarding the proposed rule that was published on November 16, 2000 (65
FR 69416). Since our proposed rule was published in conjunction with
the FDA's rule, we coordinated our responses with the FDA's responses
in its ``lookback'' rule (72 FR 48766) 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
[[Page 36470]]
Infection'' (``lookback''). In the interim final rule with comment
period, we implemented the following provisions--
Changed the reference of ``blood establishments'' to
``blood collecting establishments'' (BCE). Under this requirement, a
BCE must notify a hospital if it supplies such hospital with
potentially HCV infectious blood.
Amended the hospital conditions of participation to
require hospitals 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.
Required 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.
Required blood banks to notify a hospital of potentially
infected blood within 3 calendar days after testing. We also require
hospitals to make at least three attempts to notify the patient, or to
notify the attending physician who ordered the blood or blood
components.
Required hospitals to destroy and re-label previous
collection of blood or blood components held in quarantine if the
results of the testing were indeterminate.
Required 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.
III. Analysis of and Responses to Public Comments and Provisions of the
Final Regulation
We did not receive any public comments on the August 24, 2007
interim final rule with comment period. Therefore, the provisions of
this final rule are identical to the provisions of the August 24, 2007
interim final rule with comment period (72 FR 48562).
IV. 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 solicited public comment on each of these issues for the
following sections of this document that contain information collection
requirements.
Condition of Participation: Laboratory Services (Sec. 482.27)
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 aforementioned information collection requirements
referenced are subject to the Paperwork Reduction Act, the associated
burden is captured and discussed in the Food and Drug Administration's
(FDA) 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'' (72 FR 48766).
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.
In the interim final rule with comment period, we assigned 1 token
hour of burden to these requirements; however, we are no longer
assessing 1 token burden hour for the information collection
requirements because, as stated earlier, the burden associated with the
information collection requirements contained in this final rule was
addressed in the FDA's final rule (72 FR 48766). The burden associated
with the FDA's final rule was approved under OMB control number 0910-
0610 with an October 31, 2010, expiration date.
We have submitted a copy of this final rule to OMB for its review
of the information collection requirements. These requirements are not
effective until they have been approved by OMB.
[[Page 36471]]
V. Regulatory Impact Analysis
A. Overall Impact
We have examined the impacts of this final rule 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), Executive Order 13132 on Federalism
and the Congressional Review Act (5 U.S.C. 804(2)).
In the August 24, 2007 interim final rule with comment period, we
presented a full regulatory impact analysis that discussed the costs
and benefits of the rule. The provisions of the interim final rule with
comment period became effective on February 20, 2008. For a full
description of the regulatory impact analysis, we refer the reader to
the August 24, 2007 interim final rule (see 72 FR 48570 through 48574).
We did not receive any comments on the August 24, 2007 interim final
rule with comment period; and therefore, we have not made any changes
to the regulatory impact analysis in this final rule. This rule merely
finalizes, without change, the interim final rule, which is already in
effect. Therefore, we have determined that this final rule has no
economic impact.
Executive Order 12866 (as amended) 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 must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).
The August 24, 2007 interim final rule with comment period estimated a
one-time cost of $41.6 million and an annual cost of $1.7 million.
Because the estimated cost falls below the threshold for a major rule,
we have determined that this final 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
the Secretary has determined that this final 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'') and
has fewer than 100 beds. As stated above, the Secretary has determined
that this final rule will not have a significant impact on a
substantial number of small rural hospitals.
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 impose spending costs on State, local,
or tribal governments in the aggregate, or by private sector in any 1
year of $100 million in 1995 dollars, updated annually for inflation.
That threshold level is currently approximately $130 million. We
believe this final rule will not be an economically significant rule as
described in the Executive Order, or a significant action as defined in
the Unfunded Mandates Reform Act. Aggregate impacts and expenditures
imposed by this final rule, will not reach $130 million for State,
local, or tribal governments in the aggregate, or by the private
sector.
We did not receive any comments on the August 24, 2007 interim
final rule with comment period, and as previously stated above, we have
not made any changes to the impact analysis in this final rule. As
summarized, the impacts in the interim rule with comment period
presented an overall one-time cost of $41.6 million and an annual cost
of $1.7 million. The one-time cost of $41.6 million consists of $2.7
million for the development of HCV lookback procedures and $38.9
million for the historical record review (retrospective lookback
effort). The annual cost of $1.7 million consists of $1.4 million for
record retention (retain records for 10 years) and $0.3 million for
prospective reviews.
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. 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 final rule also requires hospitals to have in their agreements
with BCEs, that BCEs notify hospitals after performing their own FDA-
mandated lookback.
In accordance with the provisions of Executive Order 12866, this
final rule was not 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
The interim final rule with comment period amending 42 CFR Part 482,
which was published on August 24, 2007, in the Federal Register at 72
FR 48562 through 48574, is adopted as a final rule.
(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: April 25, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: May 22, 2008.
Michael O. Leavitt,
Secretary.
[FR Doc. E8-13279 Filed 6-26-08; 8:45 am]
BILLING CODE 4120-01-P