[Federal Register Volume 73, Number 125 (Friday, June 27, 2008)]
[Rules and Regulations]
[Pages 36469-36471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-13279]


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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