National Vaccine Injury Compensation Program: Calculation of Average Cost of a Health Insurance Policy, 33420-33423 [E6-8992]
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Federal Register / Vol. 71, No. 111 / Friday, June 9, 2006 / Proposed Rules
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
42 CFR Part 100
RIN 0905–AA68
National Vaccine Injury Compensation
Program: Calculation of Average Cost
of a Health Insurance Policy
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notice of proposed rulemaking.
AGENCY:
SUMMARY: Subtitle 2 of Title XXI of the
Public Health Service Act, as enacted by
the National Childhood Vaccine Injury
Act of 1986, as amended (the Act),
governs the National Vaccine Injury
Compensation Program (VICP). The
VICP, administered by the Secretary of
Health and Human Services (the
Secretary), provides that a proceeding
for compensation for a vaccine-related
injury or death shall be initiated by
service upon the Secretary, and the
filing of a petition with the United
States Court of Federal Claims (the
Court). In some cases, the injured
individual may receive compensation
for future lost earnings, less appropriate
taxes and the ‘‘average cost of a health
insurance policy, as determined by the
Secretary.’’ The Secretary now proposes
a new method of calculating the average
cost of a health insurance policy.
DATES: Comments must be submitted by
August 8, 2006. Subject to consideration
of the comments submitted, the
Secretary intends to publish final
regulations.
You may submit comments,
identified by the Regulatory Information
Number (RIN) 0905–AD25, by any of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• E-mail: gevans@hrsa.gov. Include
RIN 0905–AD25 in the subject line of
the message.
• Mail: Geoffrey Evans, M.D.,
Director, Division of Vaccine Injury
Compensation, Healthcare Systems
Bureau, Health Resources and Services
Administration (HRSA), Room 11C–26,
Parklawn Building, 5600 Fishers Lane,
Rockville, Maryland 20857.
Instructions: All submissions received
must include the agency name and RIN
for this rulemaking. All comments
received will be available for public
inspection and copying without charge,
including any personal information
provided, at Parklawn Building, 5600
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ADDRESSES:
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Fishers Lane Room 11C–26, Rockville,
Maryland 20857, weekdays (Federal
holidays excepted) between the hours of
8:30 a.m. and 5 p.m.
FOR FURTHER INFORMATION CONTACT:
Geoffrey Evans, M.D. at the mail or email address above or by telephone at
(301) 443–6593.
SUPPLEMENTARY INFORMATION: Under the
Act, an individual may file a petition
with the Court for compensation for a
vaccine-related injury or death. The
Secretary is named by the Act as the
Respondent in these proceedings and
carries out other functions under the
Act. The Secretary’s authorities under
the VICP established by the Act have
been delegated to the HRSA.
The elements of compensation that
may be awarded to a successful
petitioner are set out in Section 2115 of
the Public Health Service (PHS) Act, 42
U.S.C. 300aa–15. Subsection (a)(3)(B)
specifically provides for compensation
for lost earnings for a person who has
sustained a vaccine-related injury before
attaining the age of 18, and whose
earning capacity is or has been impaired
sufficiently to anticipate that such
person is likely to suffer impaired
earning capacity at age 18 and beyond.
The injured person would be eligible to
receive compensation for lost earnings,
after the age of 18, which are calculated
on the basis of the average gross weekly
earnings of workers in the private, nonfarm sector, less appropriate taxes and
the ‘‘* * * average cost of a health
insurance policy, as determined by the
Secretary.’’ The wage data are taken
from the Employment and Earnings
survey done by the Department of
Labor, Bureau of Labor Statistics (BLS).
(Subsection (a)(3)(A) specifically
provides for payment of actual and
anticipated lost earnings for individuals
injured after reaching age 18 and does
not include deductions for taxes and the
cost of health insurance.)
The Department of Health and Human
Services (HHS) is proposing to revise
the current methodology for calculating
the average cost of a health insurance
policy, which is an amount deducted
from the award of compensation in
certain cases. Due to the availability of
an improved data source, the current
methodology should be changed
because the proposed methodology will
yield a more accurate calculation of the
average cost of a health insurance
policy.
Currently, the methodology uses a
baseline of $141.00, which was the
average monthly premium cost for
individuals covered under employment
related group insurance in 1990
according to the 1990 Employer Health
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Benefits survey conducted by the Health
Insurance Association of America
(HIAA). This baseline of $141.00 has
been increased by the increase in the
medical care component of the
Consumer Price Index (CPI)—All Urban
Consumers, U.S. City Average, which is
published by the BLS, plus a 2 percent
per year increase. The medical care
component of the CPI has been used
because it was the only Federal
Government survey available at the time
which reflected average changes in the
costs of health insurance. The two
percent is added to account for
technological advances in and higher
utilization of health care. From time to
time, the Secretary has published
notices in the Federal Register with
updated amounts which reflect the
average monthly cost of a health
insurance policy, as calculated above.
The medical care component of the
CPI consists of the changes in the costs
of medical care (e.g. non-prescription
drugs and medical supplies), not just
changes in the cost of health insurance.
Furthermore, it only tracks the changes
in the costs of health insurance, not the
actual cost of a health insurance policy.
Therefore, the Secretary is proposing a
new methodology to calculate the
average cost of a health insurance
policy. The proposed methodology uses
the Medical Expenditure Panel Survey–
Insurance Component (MEPS–IC) data
to periodically determine the baseline
for calculating the average cost of a
health insurance policy because it is the
only national annual survey solely
estimating health insurance costs among
various populations that is conducted
by a Federal Government agency. The
MEPS–IC is conducted annually by the
Agency for Healthcare Research and
Quality (AHRQ), an agency within HHS.
The MEPS–IC began in 1997 with data
collected for calendar year 1996. It has
the largest sample size of the national
surveys used to estimate health
insurance costs. The number of
respondents ranges from 30,000 to
40,000 annually. For more information
about MEPS–IC, call the Project
Director, Center for Cost and Financing
Studies, Medical Expenditure Panel
Survey, Agency for Healthcare Research
and Quality, 540 Gaither Road,
Rockville, Maryland 20850; telephone
(301) 427–1406, e-mail:
mepspd@ahrq.gov, or visit the MEPS
Web site at: https://www.ahrq.gov/data/
mepsix.htm.
The Secretary proposes to obtain a
new baseline periodically (generally on
an annual basis) from the average total
single premium per enrolled employee
at private-sector establishments that
offer health insurance, as reported by
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the most recent MEPS–IC data. Because
MEPS–IC data are collected
retrospectively, there is a time lag
between when the data are collected
and when they are reported. Currently,
this is a 2-year time lag. Therefore, the
Secretary proposes increasing or
decreasing the most recent MEPS–IC
baseline by the annual percentage
change(s) in the average monthly
premium costs for covered single
workers from the most recent Kaiser
Family Foundation and Health Research
and Educational Trust (KFF/HRET)
annual survey, ‘‘Employer Health
Benefits’’ or other authoritative sources
that may be more accurate or
appropriate in the future. If another
authoritative source is used, the
Secretary will publish a notice in the
Federal Register announcing this
change.
Since 1999, the KFF/HRET,
independent non-profit organizations,
have conducted the ‘‘Employer Health
Benefits’’ survey. This survey collects
prospective data from about 3,000
randomly selected public and private
employers on the cost of health
insurance benefits per employee per
employer and combines the data for
public and private employers. Data are
collected based on the anticipated cost
of a health insurance policy, not
necessarily the actual cost because the
data are collected prospectively. For
more information about this survey,
visit the KFF/HRET Web site at https://
www.kff.org/insurance/index.cfm.
Using the KFF/HRET percentage
change(s) to modify the baseline number
would make the calculation of the
average cost of a health insurance policy
current, and would produce an accurate
deduction from the compensation
award. We note that the KFF/HRET
survey data are reported the same year
in which they are collected, and tend to
have comparable annual percentage
increases or decreases to the subsequent
MEPS–IC data for the same years as
detailed in the table in the Economic
and Regulatory Impact Section of this
NPRM. The annual percentage change
as reported by the KFF/HRET survey
provides a more accurate modifier than
the addition of the medical care
component of the CPI plus 2 percent, as
has been used under the current
regulation because the medical care
component of the CPI consists of the
changes in the costs of medical care (e.g.
non-prescription drugs, medical
supplies, health insurance), not the
actual cost of a health insurance policy.
Given the current 2-year time lag, the
calculation for 2005 would be as
follows. In August 2005, MEPS–IC
published the annual 2003 average total
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single premium per enrolled employee
at private-sector establishments that
provide health insurance. The figure
published was $3,481. This figure is
divided by 12 months to determine the
cost per month of $290.08 which is the
proposed new baseline figure for 2003.
The Secretary proposes that the baseline
of $290.08 be increased or decreased by
the percentage change reported by the
most recent KFF/HRET survey. The
percentage increase from 2003–2004
was 11.2 percent. By adding this
percentage increase, the calculated
average monthly cost of a health
insurance policy in 2004 is $322.57. The
KFF/HRET reported increase from
2004–2005 was 9.2 percent. By adding
this percentage increase to the
calculated $322.57 for 2004, the
calculated average monthly cost of a
health insurance policy in 2005 would
be $352.25. Under the current
methodology, the calculated average
monthly cost of a health insurance
policy would be $374.82. If the revised
calculation of the new baseline is
published in the Federal Register in
final form using this new methodology,
the Secretary will include in the Final
Rule the latest calculation of the average
cost of a health insurance policy using
the new methodology.
Since the KFF/HRET survey is
published annually, the Department
will periodically (generally on an
annual basis) recalculate the average
cost of a health insurance policy by
obtaining a new baseline from the latest
MEPS–IC data and updating this
baseline using the percentage change(s)
reported by the most recent data from
KFF/HRET or other authoritative source
that may be more accurate or
appropriate in the future. The updated
calculation will be published as a notice
in the Federal Register and filed with
the Court.
This proposed methodology will
result in a more accurate reflection of
the actual average cost of a health
insurance policy as compared to the
figure reached under the current
methodology. Because the amount of
compensation for lost wages is reduced
by this figure for some petitioners
receiving compensation under the VICP,
such petitioners will receive a more
accurate amount of compensation if the
proposed methodology is adopted.
The reduction in the compensation is
done once and that is at the time the
award is made. It is based on the
average cost of a health insurance policy
at that point in time. No further
reductions are made because of
increases in the cost of a health
insurance policy.
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This proposed methodology will only
apply to the determination of lost wages
after the effective date of the Final Rule.
Awards already made before this date
will not be recalculated.
Economic and Regulatory Impact
Regulatory Flexibility Act and Executive
Order 12866
Executive Order 12866 directs
agencies to assess all costs and benefits
of available regulatory alternatives and,
when rulemaking is necessary, to select
regulatory approaches that provide the
greatest net benefits (including potential
economic, environmental, public health,
safety distributive and equity effects). In
addition, under the Regulatory
Flexibility Act of 1980 (RFA), if a rule
has a significant economic effect on a
substantial number of small entities, the
Secretary must specifically consider the
economic effect of a rule on small
entities and analyze regulatory options
that could lessen the impact of the rule.
Executive Order 12866 requires that all
regulations reflect consideration of
alternatives, of costs, of benefits, of
incentives, of equity, and of available
information.
Regulations must meet certain
standards, such as avoiding an
unnecessary burden. Regulations that
are ‘‘significant’’ because of cost,
adverse effects on the economy,
inconsistency with other agency actions,
effects on the budget, or novel legal or
policy issues, require special analysis.
In the Secretary’s view, the amendment
proposed in this notice would require
minimal resources to implement, if any.
Therefore, in accordance with the RFA,
and the Small Business Regulatory
Enforcement Fairness Act of 1996,
which amended the RFA, the Secretary
certifies that the amendment proposed
by this rule will not affect any entities
defined as small under this Act and will
not have a significant impact on a
substantial number of small entities.
The change proposed here does not
meet the criteria for a major rule as
defined by Executive Order 12866 and
would have no major effect on the
economy or Federal expenditures. The
Secretary has determined that the
proposed rule is not a ‘‘major rule’’’
within the meaning of the statute
providing for Congressional Review of
Agency Rulemaking, 5 U.S.C. 801. The
Secretary conducted a cost analysis of
the current versus the proposed
methodology. The difference in using
the current vs. proposed methodologies
was calculated for a single claim. This
difference was multiplied by the annual
average percent of claims compensated
that include this calculation (20
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percent). The proposed methodology is
estimated to increase the annual total
amount of awards by $50,000.
Therefore, the additional cost to the
Federal government will be about
$50,000 per year.
The table below compares the average
cost of a health insurance policy using
KFF/HRET
only
Year
2000
2001
2002
2003
2004
2005
MEPS–IC only, KFF/HRET only and the
proposed methodology.
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
MEPS–IC
only
$202
221
255
282
308
335
Proposed
methodology
1$206.44
$221.22
240.77
265.75
290.08
N/A
N/A
2 232.46
3 276.98
4 309.61
5 336.59
6 352.25
N/A—Not available due to 2-year lag in reporting data.
1 1998 MEPS–IC increased by 1999 and 2000 percent changes from KFF/HRET.
2 1999 MEPS–IC increased by 2000 and 2001 percent changes from KFF/HRET.
3 2000 MEPS–IC increased by 2001and 2002 percent changes from KFF/HRET.
4 2001 MEPS–IC increased by 2002 and 2003 percent changes from KFF/HRET.
5 2002 MEPS–IC increased by 2003 and 2004 percent changes from KFF/HRET.
6 2003 MEPS–IC increased by 2004 and 2005 percent changes from KFF/HRET.
The table below shows a comparison
of the average cost of a health insurance
policy using the current and proposed
methodologies, and the percent change
between these methodologies.
Current
methodology
Year
2000
2001
2002
2003
2004
2005
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
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Unfunded Mandates Reform Act of 1995
The Secretary has determined that the
amendment proposed in this notice
would not have effects on State, local,
and tribal governments and on the
private sector such as to require
consultation under the Unfunded
Mandates Reform Act of 1995.
Federalism Impact Statement
The Secretary has also reviewed this
proposed rule in accordance with
Executive Order 13132 regarding
federalism, and has determined that it
does not have ‘‘federalism
implications.’’ The proposed rule would
not ‘‘have substantial direct effects on
the States, or on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government.’’
Impact on Family Well-Being
This proposed rule will not adversely
affect the following elements of family
well-being: family safety, family
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stability, marital commitment; parental
rights in the education, nurture and
supervision of their children; family
functioning, disposable income or
poverty; or the behavior and personal
responsibility of youth, as determined
under section 654(c) of the Treasury and
General Government Appropriations
Act of 1999.
Impact of the New Rule
If the amendment proposed in this
notice is adopted, § 100.2 will be
revised to incorporate a new
methodology for calculating the average
cost of a health insurance policy. As
explained in this notice, we expect this
new methodology to result in a more
accurate reflection of the actual average
cost of a health insurance policy as
compared to the figure reached under
the methodology that is currently used
which resulted in a number that was too
high in the past.
Proposed
methodology
$276.28
294.24
313.78
332.60
353.81
374.82
Percent
change
(current vs.
proposed)
$206.44
232.46
276.98
309.61
336.59
352.25
¥25
¥21
¥12
¥7
¥5
¥6
Dated: May 25, 2006.
Elizabeth M. Duke,
Administrator, HRSA.
Approved: February 28, 2006.
Michael O. Leavitt,
Secretary.
For the reasons stated above, HHS
proposes to amend part 100 of 42 CFR
as follows:
PART 100—VACCINE INJURY
COMPENSATION
1. The authority section for 42 CFR
part 100 is revised to read as follows:
Authority: Secs. 312 and 313 of Pub. L. 99–
660, 100 Stat. 3779–3782 (42 U.S.C. 300aa–
1 note); sec. 2114(c) and (e) of the PHS Act
(42 U.S.C. 300aa–14(c) and (e)); sec.
2115(a)(3)(B) of the PHS Act (42 U.S.C.
300aa–15(a)(3)(B)); sec. 904(b) of Pub. L. 105–
34, 111 Stat. 873; sec. 1503 of Pub. L. 105–
277, 112 Stat. 2681–741; and sec. 523(a) of
Pub. L. 106–170, 113 Stat. 1927–1928.
Paperwork Reduction Act of 1980
This proposed rule has no
information collection requirements.
2. Section 100.2 is revised to read as
follows:
List of Subjects
Biologics, Compensation, Health
insurance, Immunizations.
For purposes of determining the
amount of compensation under the
VICP, section 2115(a)(3)(B) of the PHS
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§ 100.2
policy.
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Average cost of a health insurance
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Federal Register / Vol. 71, No. 111 / Friday, June 9, 2006 / Proposed Rules
Act, 42 U.S.C. 300aa–15(a)(3)(B),
provides that certain individuals are
entitled to receive an amount reflecting
lost earnings, less certain deductions.
One of the deductions is the average
cost of a health insurance policy, as
determined by the Secretary. The
Secretary has determined that the
average cost of a health insurance policy
is $352.25 for 2005. This figure is
calculated periodically (generally on an
annual basis) using the most recent
Medical Expenditure Panel SurveyInsurance Component (MEPS–IC) data
available as the baseline for the average
monthly cost of a health insurance
policy. This baseline is adjusted by the
annual percentage increase/decrease
obtained from the most recent annual
Kaiser Family Foundation and Health
Research and Educational Trust (KFF/
HRET) Employer Health Benefits survey
or other authoritative source that may be
more accurate or appropriate in the
future. The revised amount will be
effective upon its delivery by the
Secretary to the United States Court of
Federal Claims, and the amount will be
published as a notice in the Federal
Register periodically (generally on an
annual basis).
[FR Doc. E6–8992 Filed 6–8–06; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 622
[Docket No. 060525140–6140–01; I.D.
051106B]
RIN 0648–AT75
Fisheries of the Caribbean, Gulf of
Mexico, and South Atlantic; SnapperGrouper Fishery Off the Southern
Atlantic States; Amendment 13C
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Proposed rule; request for
comments.
AGENCY:
NMFS issues this proposed
rule to implement Amendment 13C to
the Fishery Management Plan for the
Snapper-Grouper Fishery of the South
Atlantic Region (FMP), as prepared and
submitted by the South Atlantic Fishery
Management Council (Council).
Amendment 13C proposes management
measures to end overfishing of snowy
grouper, golden tilefish, vermilion
snapper, and black sea bass and
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SUMMARY:
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measures to allow moderate increases in
recreational and commercial harvest of
red porgy consistent with the rebuilding
program for that stock.
For the commercial fisheries, this
proposed rule would establish
restrictive quotas for snowy grouper,
golden tilefish, vermilion snapper, and
black sea bass and, after the quotas are
met, prohibit all purchase and sale of
the applicable species and restrict all
harvest and possession to the applicable
bag limit; establish restrictive trip limits
for snowy grouper and golden tilefish;
require at least 2–inch (5.1–cm) mesh in
the back panel of black sea bass pots;
require black sea bass pots to be
removed from the water after the quota
is reached; change the fishing year for
black sea bass; increase the trip limit for
red porgy; establish a red porgy quota
that would allow a moderate increase in
harvest; and, after the red porgy quota
is reached, prohibit all purchase and
sale and restrict all harvest and
possession to the bag limit.
For the recreational fisheries, this
proposed rule would reduce the bag
limits for snowy grouper, golden
tilefish, and black sea bass; increase the
minimum size limit for vermilion
snapper and black sea bass; change the
fishing year for black sea bass; and
increase the bag limit for red porgy.
The intended effects of this proposed
rule are to eliminate or phase out
overfishing of snowy grouper, golden
tilefish, vermilion snapper, and black
sea bass; and increase red porgy harvest
consistent with an updated stock
assessment and rebuilding plan to
achieve optimum yield.
DATES: Written comments on this
proposed rule must be received no later
than 5 p.m., eastern time, on July 24,
2006.
You may submit comments
on the proposed rule by any of the
following methods:
• E-mail: 0648–
AT75.Proposed@noaa.gov. Include in
the subject line of the e-mail comment
the following document identifier:
0648–AT75.
• Federal e-Rulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: John McGovern, Southeast
Regional Office, NMFS, 263 13th
Avenue South, St. Petersburg, FL 33701.
• Fax: 727–824–5308; Attention: John
McGovern.
Copies of Amendment 13C may be
obtained from the South Atlantic
Fishery Management Council, One
Southpark Circle, Suite 306, Charleston,
SC 29407–4699; phone: 843–571–4366
or 866–SAFMC–10 (toll free); fax: 843–
ADDRESSES:
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33423
769–4520; e-mail: safmc@safmc.net.
Amendment 13C includes a Final
Environmental Impact Statement (FEIS),
a Biological Assessment, an Initial
Regulatory Flexibility Analysis (IRFA), a
Regulatory Impact Review, and a Social
Impact Assessment/Fishery Impact
Statement.
Comments regarding the burden-hour
estimates or other aspects of the
collection-of-information requirements
contained in this proposed rule may be
submitted in writing to Jason Rueter at
the Southeast Regional Office address
above and to David Rostker, Office of
Management and Budget (OMB), by email at DavidlRostker@omb.eop.gov, or
by fax to 202–395–7285.
FOR FURTHER INFORMATION CONTACT: John
McGovern, telephone: 727–824–5305;
fax: 727–824–5308; e-mail:
John.McGovern@noaa.gov.
The
snapper-grouper fishery off the southern
Atlantic states is managed under the
FMP. The FMP was prepared by the
Council and is implemented under the
authority of the Magnuson-Stevens
Fishery Conservation and Management
Act (Magnuson-Stevens Act) by
regulations at 50 CFR part 622. NMFS
issues this proposed rule to implement
Amendment 13C to the FMP.
SUPPLEMENTARY INFORMATION:
Background
Recent stock assessments indicate that
snowy grouper, golden tilefish,
vermilion snapper, and black sea bass
are experiencing overfishing.
Overfishing means that the current rate
of fishing mortality jeopardizes the
capacity of the fishery for a species to
produce its maximum sustainable yield
on a continuing basis. Reductions in
catch are needed to end overfishing.
Red porgy, however, are no longer
experiencing overfishing, and the stock
is rebuilding. Accordingly, catch can be
increased to meet the annual allowable
biological catch established in the
rebuilding program for this species.
Provisions of This Proposed Rule
(Note that all poundages in this
proposed rule are expressed in terms of
gutted weight.)
Snowy Grouper
In the commercial fishery for snowy
grouper, this proposed rule would:
Reduce, over a 3-year period, the
commercial quota from 344,508 lb
(156,266 kg), gutted weight, to 84,000 lb
(38,102 kg), gutted weight. The quota
would be reduced from 344,508 lb
(156,266 kg) to 151,000 lb (68,492 kg)
for year 1; to 118,000 lb (53,524 kg) for
year 2; and to 84,000 lb (38,102 kg) for
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]]>Agencies
[Federal Register Volume 71, Number 111 (Friday, June 9, 2006)]
[Proposed Rules]
[Pages 33420-33423]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-8992]
[[Page 33420]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
42 CFR Part 100
RIN 0905-AA68
National Vaccine Injury Compensation Program: Calculation of
Average Cost of a Health Insurance Policy
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: Subtitle 2 of Title XXI of the Public Health Service Act, as
enacted by the National Childhood Vaccine Injury Act of 1986, as
amended (the Act), governs the National Vaccine Injury Compensation
Program (VICP). The VICP, administered by the Secretary of Health and
Human Services (the Secretary), provides that a proceeding for
compensation for a vaccine-related injury or death shall be initiated
by service upon the Secretary, and the filing of a petition with the
United States Court of Federal Claims (the Court). In some cases, the
injured individual may receive compensation for future lost earnings,
less appropriate taxes and the ``average cost of a health insurance
policy, as determined by the Secretary.'' The Secretary now proposes a
new method of calculating the average cost of a health insurance
policy.
DATES: Comments must be submitted by August 8, 2006. Subject to
consideration of the comments submitted, the Secretary intends to
publish final regulations.
ADDRESSES: You may submit comments, identified by the Regulatory
Information Number (RIN) 0905-AD25, by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
E-mail: gevans@hrsa.gov. Include RIN 0905-AD25 in the
subject line of the message.
Mail: Geoffrey Evans, M.D., Director, Division of Vaccine
Injury Compensation, Healthcare Systems Bureau, Health Resources and
Services Administration (HRSA), Room 11C-26, Parklawn Building, 5600
Fishers Lane, Rockville, Maryland 20857.
Instructions: All submissions received must include the agency name
and RIN for this rulemaking. All comments received will be available
for public inspection and copying without charge, including any
personal information provided, at Parklawn Building, 5600 Fishers Lane
Room 11C-26, Rockville, Maryland 20857, weekdays (Federal holidays
excepted) between the hours of 8:30 a.m. and 5 p.m.
FOR FURTHER INFORMATION CONTACT: Geoffrey Evans, M.D. at the mail or e-
mail address above or by telephone at (301) 443-6593.
SUPPLEMENTARY INFORMATION: Under the Act, an individual may file a
petition with the Court for compensation for a vaccine-related injury
or death. The Secretary is named by the Act as the Respondent in these
proceedings and carries out other functions under the Act. The
Secretary's authorities under the VICP established by the Act have been
delegated to the HRSA.
The elements of compensation that may be awarded to a successful
petitioner are set out in Section 2115 of the Public Health Service
(PHS) Act, 42 U.S.C. 300aa-15. Subsection (a)(3)(B) specifically
provides for compensation for lost earnings for a person who has
sustained a vaccine-related injury before attaining the age of 18, and
whose earning capacity is or has been impaired sufficiently to
anticipate that such person is likely to suffer impaired earning
capacity at age 18 and beyond. The injured person would be eligible to
receive compensation for lost earnings, after the age of 18, which are
calculated on the basis of the average gross weekly earnings of workers
in the private, non-farm sector, less appropriate taxes and the ``* * *
average cost of a health insurance policy, as determined by the
Secretary.'' The wage data are taken from the Employment and Earnings
survey done by the Department of Labor, Bureau of Labor Statistics
(BLS). (Subsection (a)(3)(A) specifically provides for payment of
actual and anticipated lost earnings for individuals injured after
reaching age 18 and does not include deductions for taxes and the cost
of health insurance.)
The Department of Health and Human Services (HHS) is proposing to
revise the current methodology for calculating the average cost of a
health insurance policy, which is an amount deducted from the award of
compensation in certain cases. Due to the availability of an improved
data source, the current methodology should be changed because the
proposed methodology will yield a more accurate calculation of the
average cost of a health insurance policy.
Currently, the methodology uses a baseline of $141.00, which was
the average monthly premium cost for individuals covered under
employment related group insurance in 1990 according to the 1990
Employer Health Benefits survey conducted by the Health Insurance
Association of America (HIAA). This baseline of $141.00 has been
increased by the increase in the medical care component of the Consumer
Price Index (CPI)--All Urban Consumers, U.S. City Average, which is
published by the BLS, plus a 2 percent per year increase. The medical
care component of the CPI has been used because it was the only Federal
Government survey available at the time which reflected average changes
in the costs of health insurance. The two percent is added to account
for technological advances in and higher utilization of health care.
From time to time, the Secretary has published notices in the Federal
Register with updated amounts which reflect the average monthly cost of
a health insurance policy, as calculated above.
The medical care component of the CPI consists of the changes in
the costs of medical care (e.g. non-prescription drugs and medical
supplies), not just changes in the cost of health insurance.
Furthermore, it only tracks the changes in the costs of health
insurance, not the actual cost of a health insurance policy. Therefore,
the Secretary is proposing a new methodology to calculate the average
cost of a health insurance policy. The proposed methodology uses the
Medical Expenditure Panel Survey-Insurance Component (MEPS-IC) data to
periodically determine the baseline for calculating the average cost of
a health insurance policy because it is the only national annual survey
solely estimating health insurance costs among various populations that
is conducted by a Federal Government agency. The MEPS-IC is conducted
annually by the Agency for Healthcare Research and Quality (AHRQ), an
agency within HHS. The MEPS-IC began in 1997 with data collected for
calendar year 1996. It has the largest sample size of the national
surveys used to estimate health insurance costs. The number of
respondents ranges from 30,000 to 40,000 annually. For more information
about MEPS-IC, call the Project Director, Center for Cost and Financing
Studies, Medical Expenditure Panel Survey, Agency for Healthcare
Research and Quality, 540 Gaither Road, Rockville, Maryland 20850;
telephone (301) 427-1406, e-mail: mepspd@ahrq.gov, or visit the MEPS
Web site at: https://www.ahrq.gov/data/mepsix.htm.
The Secretary proposes to obtain a new baseline periodically
(generally on an annual basis) from the average total single premium
per enrolled employee at private-sector establishments that offer
health insurance, as reported by
[[Page 33421]]
the most recent MEPS-IC data. Because MEPS-IC data are collected
retrospectively, there is a time lag between when the data are
collected and when they are reported. Currently, this is a 2-year time
lag. Therefore, the Secretary proposes increasing or decreasing the
most recent MEPS-IC baseline by the annual percentage change(s) in the
average monthly premium costs for covered single workers from the most
recent Kaiser Family Foundation and Health Research and Educational
Trust (KFF/HRET) annual survey, ``Employer Health Benefits'' or other
authoritative sources that may be more accurate or appropriate in the
future. If another authoritative source is used, the Secretary will
publish a notice in the Federal Register announcing this change.
Since 1999, the KFF/HRET, independent non-profit organizations,
have conducted the ``Employer Health Benefits'' survey. This survey
collects prospective data from about 3,000 randomly selected public and
private employers on the cost of health insurance benefits per employee
per employer and combines the data for public and private employers.
Data are collected based on the anticipated cost of a health insurance
policy, not necessarily the actual cost because the data are collected
prospectively. For more information about this survey, visit the KFF/
HRET Web site at https://www.kff.org/insurance/index.cfm.
Using the KFF/HRET percentage change(s) to modify the baseline
number would make the calculation of the average cost of a health
insurance policy current, and would produce an accurate deduction from
the compensation award. We note that the KFF/HRET survey data are
reported the same year in which they are collected, and tend to have
comparable annual percentage increases or decreases to the subsequent
MEPS-IC data for the same years as detailed in the table in the
Economic and Regulatory Impact Section of this NPRM. The annual
percentage change as reported by the KFF/HRET survey provides a more
accurate modifier than the addition of the medical care component of
the CPI plus 2 percent, as has been used under the current regulation
because the medical care component of the CPI consists of the changes
in the costs of medical care (e.g. non-prescription drugs, medical
supplies, health insurance), not the actual cost of a health insurance
policy.
Given the current 2-year time lag, the calculation for 2005 would
be as follows. In August 2005, MEPS-IC published the annual 2003
average total single premium per enrolled employee at private-sector
establishments that provide health insurance. The figure published was
$3,481. This figure is divided by 12 months to determine the cost per
month of $290.08 which is the proposed new baseline figure for 2003.
The Secretary proposes that the baseline of $290.08 be increased or
decreased by the percentage change reported by the most recent KFF/HRET
survey. The percentage increase from 2003-2004 was 11.2 percent. By
adding this percentage increase, the calculated average monthly cost of
a health insurance policy in 2004 is $322.57. The KFF/HRET reported
increase from 2004-2005 was 9.2 percent. By adding this percentage
increase to the calculated $322.57 for 2004, the calculated average
monthly cost of a health insurance policy in 2005 would be $352.25.
Under the current methodology, the calculated average monthly cost of a
health insurance policy would be $374.82. If the revised calculation of
the new baseline is published in the Federal Register in final form
using this new methodology, the Secretary will include in the Final
Rule the latest calculation of the average cost of a health insurance
policy using the new methodology.
Since the KFF/HRET survey is published annually, the Department
will periodically (generally on an annual basis) recalculate the
average cost of a health insurance policy by obtaining a new baseline
from the latest MEPS-IC data and updating this baseline using the
percentage change(s) reported by the most recent data from KFF/HRET or
other authoritative source that may be more accurate or appropriate in
the future. The updated calculation will be published as a notice in
the Federal Register and filed with the Court.
This proposed methodology will result in a more accurate reflection
of the actual average cost of a health insurance policy as compared to
the figure reached under the current methodology. Because the amount of
compensation for lost wages is reduced by this figure for some
petitioners receiving compensation under the VICP, such petitioners
will receive a more accurate amount of compensation if the proposed
methodology is adopted.
The reduction in the compensation is done once and that is at the
time the award is made. It is based on the average cost of a health
insurance policy at that point in time. No further reductions are made
because of increases in the cost of a health insurance policy.
This proposed methodology will only apply to the determination of
lost wages after the effective date of the Final Rule. Awards already
made before this date will not be recalculated.
Economic and Regulatory Impact
Regulatory Flexibility Act and Executive Order 12866
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, when rulemaking is
necessary, to select regulatory approaches that provide the greatest
net benefits (including potential economic, environmental, public
health, safety distributive and equity effects). In addition, under the
Regulatory Flexibility Act of 1980 (RFA), if a rule has a significant
economic effect on a substantial number of small entities, the
Secretary must specifically consider the economic effect of a rule on
small entities and analyze regulatory options that could lessen the
impact of the rule. Executive Order 12866 requires that all regulations
reflect consideration of alternatives, of costs, of benefits, of
incentives, of equity, and of available information.
Regulations must meet certain standards, such as avoiding an
unnecessary burden. Regulations that are ``significant'' because of
cost, adverse effects on the economy, inconsistency with other agency
actions, effects on the budget, or novel legal or policy issues,
require special analysis. In the Secretary's view, the amendment
proposed in this notice would require minimal resources to implement,
if any. Therefore, in accordance with the RFA, and the Small Business
Regulatory Enforcement Fairness Act of 1996, which amended the RFA, the
Secretary certifies that the amendment proposed by this rule will not
affect any entities defined as small under this Act and will not have a
significant impact on a substantial number of small entities.
The change proposed here does not meet the criteria for a major
rule as defined by Executive Order 12866 and would have no major effect
on the economy or Federal expenditures. The Secretary has determined
that the proposed rule is not a ``major rule''' within the meaning of
the statute providing for Congressional Review of Agency Rulemaking, 5
U.S.C. 801. The Secretary conducted a cost analysis of the current
versus the proposed methodology. The difference in using the current
vs. proposed methodologies was calculated for a single claim. This
difference was multiplied by the annual average percent of claims
compensated that include this calculation (20
[[Page 33422]]
percent). The proposed methodology is estimated to increase the annual
total amount of awards by $50,000. Therefore, the additional cost to
the Federal government will be about $50,000 per year.
The table below compares the average cost of a health insurance
policy using MEPS-IC only, KFF/HRET only and the proposed methodology.
----------------------------------------------------------------------------------------------------------------
Proposed
Year KFF/HRET only MEPS-IC only methodology
----------------------------------------------------------------------------------------------------------------
2000............................................................ $202 $221.22 \1\$206.44
2001............................................................ 221 240.77 \2\ 232.46
2002............................................................ 255 265.75 \3\ 276.98
2003............................................................ 282 290.08 \4\ 309.61
2004............................................................ 308 N/A \5\ 336.59
2005............................................................ 335 N/A \6\ 352.25
----------------------------------------------------------------------------------------------------------------
N/A--Not available due to 2-year lag in reporting data.
\1\ 1998 MEPS-IC increased by 1999 and 2000 percent changes from KFF/HRET.
\2\ 1999 MEPS-IC increased by 2000 and 2001 percent changes from KFF/HRET.
\3\ 2000 MEPS-IC increased by 2001and 2002 percent changes from KFF/HRET.
\4\ 2001 MEPS-IC increased by 2002 and 2003 percent changes from KFF/HRET.
\5\ 2002 MEPS-IC increased by 2003 and 2004 percent changes from KFF/HRET.
\6\ 2003 MEPS-IC increased by 2004 and 2005 percent changes from KFF/HRET.
The table below shows a comparison of the average cost of a health
insurance policy using the current and proposed methodologies, and the
percent change between these methodologies.
----------------------------------------------------------------------------------------------------------------
Percent change
Year Current Proposed (current vs.
methodology methodology proposed)
----------------------------------------------------------------------------------------------------------------
2000............................................................ $276.28 $206.44 -25
2001............................................................ 294.24 232.46 -21
2002............................................................ 313.78 276.98 -12
2003............................................................ 332.60 309.61 -7
2004............................................................ 353.81 336.59 -5
2005............................................................ 374.82 352.25 -6
----------------------------------------------------------------------------------------------------------------
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
Unfunded Mandates Reform Act of 1995
The Secretary has determined that the amendment proposed in this
notice would not have effects on State, local, and tribal governments
and on the private sector such as to require consultation under the
Unfunded Mandates Reform Act of 1995.
Federalism Impact Statement
The Secretary has also reviewed this proposed rule in accordance
with Executive Order 13132 regarding federalism, and has determined
that it does not have ``federalism implications.'' The proposed rule
would not ``have substantial direct effects on the States, or on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.''
Impact on Family Well-Being
This proposed rule will not adversely affect the following elements
of family well-being: family safety, family stability, marital
commitment; parental rights in the education, nurture and supervision
of their children; family functioning, disposable income or poverty; or
the behavior and personal responsibility of youth, as determined under
section 654(c) of the Treasury and General Government Appropriations
Act of 1999.
Impact of the New Rule
If the amendment proposed in this notice is adopted, Sec. 100.2
will be revised to incorporate a new methodology for calculating the
average cost of a health insurance policy. As explained in this notice,
we expect this new methodology to result in a more accurate reflection
of the actual average cost of a health insurance policy as compared to
the figure reached under the methodology that is currently used which
resulted in a number that was too high in the past.
Paperwork Reduction Act of 1980
This proposed rule has no information collection requirements.
List of Subjects
Biologics, Compensation, Health insurance, Immunizations.
Dated: May 25, 2006.
Elizabeth M. Duke,
Administrator, HRSA.
Approved: February 28, 2006.
Michael O. Leavitt,
Secretary.
For the reasons stated above, HHS proposes to amend part 100 of 42
CFR as follows:
PART 100--VACCINE INJURY COMPENSATION
1. The authority section for 42 CFR part 100 is revised to read as
follows:
Authority: Secs. 312 and 313 of Pub. L. 99-660, 100 Stat. 3779-
3782 (42 U.S.C. 300aa-1 note); sec. 2114(c) and (e) of the PHS Act
(42 U.S.C. 300aa-14(c) and (e)); sec. 2115(a)(3)(B) of the PHS Act
(42 U.S.C. 300aa-15(a)(3)(B)); sec. 904(b) of Pub. L. 105-34, 111
Stat. 873; sec. 1503 of Pub. L. 105-277, 112 Stat. 2681-741; and
sec. 523(a) of Pub. L. 106-170, 113 Stat. 1927-1928.
2. Section 100.2 is revised to read as follows:
Sec. 100.2 Average cost of a health insurance policy.
For purposes of determining the amount of compensation under the
VICP, section 2115(a)(3)(B) of the PHS
[[Page 33423]]
Act, 42 U.S.C. 300aa-15(a)(3)(B), provides that certain individuals are
entitled to receive an amount reflecting lost earnings, less certain
deductions. One of the deductions is the average cost of a health
insurance policy, as determined by the Secretary. The Secretary has
determined that the average cost of a health insurance policy is
$352.25 for 2005. This figure is calculated periodically (generally on
an annual basis) using the most recent Medical Expenditure Panel
Survey-Insurance Component (MEPS-IC) data available as the baseline for
the average monthly cost of a health insurance policy. This baseline is
adjusted by the annual percentage increase/decrease obtained from the
most recent annual Kaiser Family Foundation and Health Research and
Educational Trust (KFF/HRET) Employer Health Benefits survey or other
authoritative source that may be more accurate or appropriate in the
future. The revised amount will be effective upon its delivery by the
Secretary to the United States Court of Federal Claims, and the amount
will be published as a notice in the Federal Register periodically
(generally on an annual basis).
[FR Doc. E6-8992 Filed 6-8-06; 8:45 am]
BILLING CODE 4165-15-P
