Medicare Program; Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for CY 2011, 68799-68802 [2010-28251]
Download as PDF
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Notices
We base our projections for CY 2011
on— (1) current historical data; and (2)
projection assumptions derived from
current law and the Mid-Session Review
of the President’s Fiscal Year 2011
Budget.
We estimate that in CY 2011,
39,315,092 people aged 65 years and
over will be entitled to benefits (without
premium payment) and that they will
incur about $212.435 billion in benefits
and related administrative costs. Thus,
the estimated monthly average per
capita amount is $450.28 and the
monthly premium is $450. The full
monthly premium reduced by 45
percent is $248.
IV. Costs to Beneficiaries
The CY 2011 premium of $450 is
approximately 2 percent lower than the
CY 2010 premium of $461.
We estimate that approximately
571,000 enrollees will voluntarily enroll
in Medicare Part A by paying the full
premium. We estimate an additional
40,000 enrollees will pay the reduced
premium. We estimate that the aggregate
savings to enrollees paying these
premiums in CY 2011, compared to the
amount that they paid in CY 2010, will
be about $78 million.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
V. Waiver of Proposed Notice and
Comment Period
We are not using notice and comment
rulemaking in this notification of
Medicare Part A premiums for CY 2011
as that procedure is unnecessary
because of the lack of discretion in the
statutory formula that is used to
calculate the premium and the solely
ministerial function that this notice
serves. The Administrative Procedure
Act (APA) permits agencies to waive
notice and comment rulemaking when
notice and public comment thereon are
unnecessary. On this basis, we waive
publication of a proposed notice and a
solicitation of public comments.
VI. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 35).
VII. Regulatory Impact Statement
We have examined the impacts of this
final rule as required by Executive
Order 12866 on Regulatory Planning
and Review (September 30, 1993), the
Regulatory Flexibility Act (RFA)
(September 19, 1980, Pub. L. 96–354),
VerDate Mar<15>2010
15:18 Nov 08, 2010
Jkt 223001
section 1102(b) of the Social Security
Act, section 202 of the Unfunded
Mandates Reform Act of 1995 (Pub. L.
104–4), Executive Order 13132 on
Federalism (August 4, 1999), and the
Congressional Review Act (5 U.S.C.
804(2)).
Executive Order 12866 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
in any 1 year). As stated in section IV
of this notice, we estimate that the
overall effect of these changes in the
Part A premium will be a savings to
voluntary enrollees (section 1818 and
section 1818A of the Act) of about $78
million. Therefore, this notice is a not
a major rule as defined in Title 5,
United States Code, section 804(2) and
is not an economically significant rule
under Executive Order 12866.
The RFA requires agencies to analyze
options for regulatory relief of small
businesses, if a rule has a significant
impact on a substantial number of small
entities. For purposes of the RFA, small
entities include small businesses,
nonprofit organizations, and
government agencies. Most hospitals
and most other providers and suppliers
are small entities, either by nonprofit
status or by having revenues of $7
million to $34.5 million in any 1 year.
Individuals and States are not included
in the definition of a small entity. We
have determined that this notice will
not have a significant economic impact
on a substantial number of small
entities. Therefore, we are not preparing
an analysis under the RFA.
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 and has
fewer than 100 beds. The Secretary has
determined that this notice will not
have a significant impact on the
operations of a substantial number of
small rural hospitals. Therefore, we are
not preparing an analysis under section
1102(b) of the Act.
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA)
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68799
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.
In 2010, that threshold is approximately
$135 million. This notice has no
consequential effect on State, local, or
tribal governments or on the private
sector. However, States are required to
pay the premiums for dually-eligible
beneficiaries.
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.
This notice will not have a substantial
effect on State or local governments.
In accordance with the provisions of
Executive Order 12866, this notice was
reviewed by the Office of Management
and Budget.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance)
Dated: September 9, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
Dated: October 29, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010–28250 Filed 11–4–10; 2:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–8040–N]
RIN 0938–AP86
Medicare Program; Inpatient Hospital
Deductible and Hospital and Extended
Care Services Coinsurance Amounts
for CY 2011
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
inpatient hospital deductible and the
hospital and extended care services
coinsurance amounts for services
furnished in calendar year (CY) 2011
under Medicare’s Hospital Insurance
Program (Medicare Part A). The
Medicare statute specifies the formulae
used to determine these amounts. For
CY 2011, the inpatient hospital
SUMMARY:
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68800
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Notices
deductible will be $1132. The daily
coinsurance amounts for CY 2011 will
be—(a) $283 for the 61st through 90th
day of hospitalization in a benefit
period; (b) $566 for lifetime reserve
days; and (c) $141.50 for the 21st
through 100th day of extended care
services in a skilled nursing facility in
a benefit period.
DATES: Effective Date: This notice is
effective on January 1, 2011.
FOR FURTHER INFORMATION CONTACT:
Clare McFarland, (410) 786–6390 for
general information. Gregory J. Savord,
(410) 786–1521 for case-mix analysis.
SUPPLEMENTARY INFORMATION:
I. Background
Section 1813 of the Social Security
Act (the Act) provides for an inpatient
hospital deductible to be subtracted
from the amount payable by Medicare
for inpatient hospital services furnished
to a beneficiary. It also provides for
certain coinsurance amounts to be
subtracted from the amounts payable by
Medicare for inpatient hospital and
extended care services. Section
1813(b)(2) of the Act requires us to
determine and publish each year the
amount of the inpatient hospital
deductible and the hospital and
extended care services coinsurance
amounts applicable for services
furnished in the following CY.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
II. Computing the Inpatient Hospital
Deductible for CY 2011
Section 1813(b) of the Act prescribes
the method for computing the amount of
the inpatient hospital deductible. The
inpatient hospital deductible is an
amount equal to the inpatient hospital
deductible for the preceding CY,
adjusted by our best estimate of the
payment-weighted average of the
applicable percentage increases (as
defined in section 1886(b)(3)(B) of the
Act) used for updating the payment
rates to hospitals for discharges in the
fiscal year (FY) that begins on October
1 of the same preceding CY, and
adjusted to reflect changes in real casemix. The adjustment to reflect real casemix is determined on the basis of the
most recent case-mix data available. The
amount determined under this formula
is rounded to the nearest multiple of $4
(or, if midway between two multiples of
$4, to the next higher multiple of $4).
Under section 1886(b)(3)(B)(i)(XX) of
the Act, the percentage increase used to
update the payment rates for FY 2011
for hospitals paid under the inpatient
prospective payment system is the
market basket percentage increase,
otherwise known as the market basket
update, reduced by .25 percentage
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15:18 Nov 08, 2010
Jkt 223001
points. Under section 1886(b)(3)(B)(viii)
of the Act, hospitals will receive this
update only if they submit quality data
as specified by the Secretary. The
update for hospitals that do not submit
this data is reduced by 2.0 percentage
points. We are estimating that after
accounting for those hospitals receiving
the lower market basket update in the
payment-weighted average update, the
calculated deductible will remain the
same.
Under section 1886(b)(3)(B)(ii)(VIII) of
the Act, the percentage increase used to
update the payment rates for FY 2011
for hospitals excluded from the
inpatient prospective payment system is
the market basket percentage increase
reduced by .5 percentage points for
Long Term Care Hospitals and reduced
by .25 percentage points for Inpatient
Rehabilitation facilities and Psychiatric
Hospitals, defined according to section
1886(b)(3)(B)(iii) of the Act.
The market basket percentage increase
for 2011 is 2.6 percent, as announced in
the final rule with comment period
published in the Federal Register on
August 16, 2010 entitled, ‘‘Medicare
Program; Changes to the Hospital
Inpatient Prospective Payment Systems
for Acute Care Hospitals and Fiscal Year
2011 Rates; and Changes to the LongTerm Care Hospital Prospective
Payment System and Rate Years 2011
and 2010 Rates (IPPS/RY 2011 LTCH
PPS) (75 FR 50042–50677).’’ Therefore,
the percentage increase for hospitals
paid under the inpatient prospective
payment system is 2.35 percent. The
average payment percentage increase for
hospitals excluded from the inpatient
prospective payment system is 2.73
percent. Weighting these percentages in
accordance with payment volume, our
best estimate of the payment-weighted
average of the increases in the payment
rates for FY 2011 is 2.40 percent.
To develop the adjustment to reflect
changes in real case-mix, we first
calculated for each hospital an average
case-mix that reflects the relative
costliness of that hospital’s mix of cases
compared to those of other hospitals.
We then computed the change in
average case-mix for hospitals paid
under the Medicare prospective
payment system in FY 2010 compared
to FY 2009. (We excluded from this
calculation hospitals whose payments
are not based on the inpatient
prospective payment system because
their payments are based on alternate
prospective payment systems or
reasonable costs.) We used Medicare
bills from prospective payment
hospitals that we received as of July
2010. These bills represent a total of
about 8.5 million Medicare discharges
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
for FY 2010 and provide the most recent
case-mix data available at this time.
Based on these bills, the change in
average case-mix in FY 2010 is 0.3
percent. Based on these bills and past
experience, we expect the overall case
mix change to be 0.5 percent as the year
progresses and more FY 2010 data
become available.
Section 1813 of the Act requires that
the inpatient hospital deductible be
adjusted only by that portion of the
case-mix change that is determined to
be real. In the FY 2011 IPPS/RY 2011
LTCH PPS final rule with comment
period, we indicated that we believe the
adoption of the Medicare severity-based
diagnosis-related groups (MS–DRGs) led
to increases in aggregate payments
without a corresponding increase in
actual patient severity of illness due to
the incentives for improved
documentation and coding. In that final
rule with comment period, we estimated
that changes in coding or classification
that do not reflect real change in casemix would be 0.0 percent for FY 2010.
Therefore, since we are expecting
overall case mix to increase by 0.5
percent and 0.0 percent of that to be
caused by coding changes, real case mix
changes resulted in an increase of 0.5
percent for FY 2010.
Thus, the estimate of the paymentweighted average of the applicable
percentage increases used for updating
the payment rates is 2.40 percent, and
the real case-mix adjustment factor for
the deductible is 0.5 percent. Therefore,
under the statutory formula, the
inpatient hospital deductible for
services furnished in CY 2011 is $1132.
This deductible amount is determined
by multiplying $1100 (the inpatient
hospital deductible for CY 2010) by the
payment-weighted average increase in
the payment rates of 1.0240 multiplied
by the increase in real case-mix of 1.005,
which equals $1132.03 and is rounded
to $1132.
III. Computing the Inpatient Hospital
and Extended Care Services
Coinsurance Amounts for CY 2011
The coinsurance amounts provided
for in section 1813 of the Act are
defined as fixed percentages of the
inpatient hospital deductible for
services furnished in the same CY. The
increase in the deductible generates
increases in the coinsurance amounts.
For inpatient hospital and extended care
services furnished in CY 2011, in
accordance with the fixed percentages
defined in the law, the daily
coinsurance for the 61st through 90th
day of hospitalization in a benefit
period will be $283 (one-fourth of the
inpatient hospital deductible); the daily
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68801
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Notices
coinsurance for lifetime reserve days
will be $566 (one-half of the inpatient
hospital deductible); and the daily
coinsurance for the 21st through 100th
day of extended care services in a
skilled nursing facility in a benefit
period will be $141.50 (one-eighth of
the inpatient hospital deductible).
IV. Cost to Medicare Beneficiaries
CYs 2010 and 2011, as well as the
number of each that is estimated to be
paid.
Table 1 below summarizes the
deductible and coinsurance amounts for
TABLE 1—PART A DEDUCTIBLE AND COINSURANCE AMOUNTS FOR CALENDAR YEARS 2010 AND 2011
Value
Number paid (in millions)
Type of cost sharing
2010
$1100
$275
$550
$137.50
Inpatient hospital deductible ........................................................................................
Daily coinsurance for 61st–90th Day ..........................................................................
Daily coinsurance for lifetime reserve days ................................................................
SNF coinsurance .........................................................................................................
The estimated total increase in costs
to beneficiaries is about $900 million
(rounded to the nearest $10 million) due
to— (1) the increase in the deductible
and coinsurance amounts; and (2) the
change in the number of deductibles
and daily coinsurance amounts paid.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
V. Waiver of Proposed Notice and
Comment Period
The Medicare statute, as discussed
previously, requires publication of the
Medicare Part A inpatient hospital
deductible and the hospital and
extended care services coinsurance
amounts for services for each CY. The
amounts are determined according to
the statute. As has been our custom, we
use general notices, rather than notice
and comment rulemaking procedures, to
make the announcements. In doing so,
we acknowledge that, under the
Administrative Procedure Act (APA),
interpretive rules, general statements of
policy, and rules of agency organization,
procedure, or practice are excepted from
the requirements of notice and comment
rulemaking.
We considered publishing a proposed
notice to provide a period for public
comment. However, we may waive that
procedure if we find good cause that
prior notice and comment are
impracticable, unnecessary, or contrary
to the public interest. We find that the
procedure for notice and comment is
unnecessary because the formulae used
to calculate the inpatient hospital
deductible and hospital and extended
care services coinsurance amounts are
statutorily directed, and we can exercise
no discretion in following the formulae.
Moreover, the statute establishes the
time period for which the deductible
and coinsurance amounts will apply
and delaying publication would be
contrary to the public interest.
Therefore, we find good cause to waive
publication of a proposed notice and
solicitation of public comments.
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15:18 Nov 08, 2010
Jkt 223001
2011
$1132
$283
$566
$141.50
VI. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 35).
VII. Regulatory Impact Statement
We have examined the impacts of this
final rule as required by Executive
Order 12866 on Regulatory Planning
and Review (September 30, 1993), the
Regulatory Flexibility Act (RFA)
(September 19, 1980, Pub. L. 96–354),
section 1102(b) of the Social Security
Act, section 202 of the Unfunded
Mandates Reform Act of 1995 (Pub. L.
104–4), Executive Order 13132 on
Federalism (August 4, 1999), and the
Congressional Review Act (5
U.S.C.804(2)).
Executive Order 12866 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
in any 1 year). As stated in section IV
of this notice, we estimate that the total
increase in costs to beneficiaries
associated with this notice is about $900
million due to— (1) The increase in the
deductible and coinsurance amounts;
and (2) the change in the number of
deductibles and daily coinsurance
amounts paid. Therefore, this notice is
a major rule as defined in Title 5,
United States Code, section 804(2), and
is an economically significant rule
under Executive Order 12866.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
2010
8.40
2.25
1.13
42.41
2011
8.59
2.30
1.16
43.66
The RFA requires agencies to analyze
options for regulatory relief of small
businesses, if a rule has a significant
impact on a substantial number of small
entities. For purposes of the RFA, small
entities include small businesses,
nonprofit organizations, and
government agencies. Most hospitals
and most other providers and suppliers
are small entities, either by nonprofit
status or by having revenues of $7.0
million to $34.5 million in any 1 year.
Individuals and States are not included
in the definition of a small entity. We
have determined that this notice will
not have a significant economic impact
on a substantial number of small
entities. Therefore, we are not preparing
an analysis under the RFA.
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 and has
fewer than 100 beds. The Secretary has
determined that this notice will not
have a significant impact on the
operations of a substantial number of
small rural hospitals. Therefore, we are
not preparing an analysis under section
1102(b) of the Act.
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA)
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.
In 2010, that threshold is approximately
$135 million. This notice has no
consequential effect on State, local, or
Tribal governments or on the private
sector. However, States may be required
E:\FR\FM\09NON1.SGM
09NON1
68802
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Notices
to pay the deductibles and coinsurance
for dually-eligible beneficiaries.
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.
This notice will not have a substantial
effect on State or local governments.
In accordance with the provisions of
Executive Order 12866, this notice was
reviewed by the Office of Management
and Budget.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance)
Dated: September 9, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
Dated: October 29, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010–28251 Filed 11–4–10; 2:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Secretary’s Advisory Committee on
Heritable Disorders in Newborns and
Children; Notice of Meeting
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Secretary’s Advisory Committee on
Heritable Disorders in Newborns and
Children.
Dates and Times: January 27, 2011, 8:30
a.m. to 5 p.m. January 28, 2011, 8:30 a.m. to
3:30 p.m.
Place: Renaissance Washington, DC
Dupont Circle Hotel, 1143 New Hampshire
Avenue, NW., Washington, DC 20037.
Status: The meeting will be open to the
public with attendance limited to space
availability. Participants are asked to register
for the meeting by going to the registration
Web site at https://altarum.cvent.com/event/
SACHDNC012011. The registration deadline
is Tuesday, January 25, 2011. Individuals
who need special assistance, such as sign
language interpretation or other reasonable
accommodations should indicate their needs
on the registration Web site. The deadline for
special accommodation requests is Friday,
January 21, 2011. If there are technical
problems gaining access to the Web site,
please contact Maureen Ball, Meetings
Coordinator at conferences@altarum.org.
Purpose: The Secretary’s Advisory
Committee on Heritable Disorders in
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15:18 Nov 08, 2010
Jkt 223001
Newborns and Children (Advisory
Committee) was established to advise and
guide the Secretary regarding the most
appropriate application of universal newborn
screening tests, technologies, policies,
guidelines and programs for effectively
reducing morbidity and mortality in
newborns and children having or at risk for
heritable disorders. The Advisory Committee
also provides advice and recommendations
concerning the grants and projects authorized
under the Public Health Service Act, 42
U.S.C. 300b–10, (Heritable Disorders
Program) as amended in the Newborn
Screening Saves Lives Act of 2008.
Agenda: The meeting will include: (1)
Presentations from the following Advisory
Committee workgroups: Communications,
Health Information Technology, and
Evidence Review; (2) a report from a National
Survey of Recent and Prospective Mothers
about Newborn Screening; and (3)
presentations on the continued work and
reports of the Advisory Committee’s
subcommittees on laboratory standards and
procedures, follow-up and treatment, and
education and training. Proposed Agenda
items are subject to change as priorities
dictate. You can locate the Agenda,
Committee Roster and Charter, presentations,
and meeting materials at the home page of
the Advisory Committee’s Web site at
https://www.hrsa.gov/
heritabledisorderscommittee/.
Public Comments: Members of the public
can present oral comments during the public
comment periods of the meeting, which are
scheduled for both days of the meeting.
Those individuals who want to make a
comment are requested to register online by
Tuesday, January 25, 2011, at https://
altarum.cvent.com/event/SACHDNC012011.
Requests will contain the name, address,
telephone number, and any professional or
business affiliation of the person desiring to
make an oral presentation. Groups having
similar interests are requested to combine
their comments and present them through a
single representative. The list of public
comment participants will be posted on the
Web site. Written comments should be emailed via e-mail no later than Tuesday,
January 25, 2011, for consideration.
Comments should be submitted to Maureen
Ball, Meetings Coordinator, Conference and
Meetings Management, Altarum Institute,
1200 18th Street, NW., Suite 700,
Washington, DC 20036, telephone: 202 828–
5100; fax: 202 785–3083, or e-mail:
conferences@altarum.org.
Contact Person: Anyone interested in
obtaining other relevant information should
write or contact Alaina M. Harris, Maternal
and Child Health Bureau, Health Resources
and Services Administration, Room 18A–19,
Parklawn Building, 5600 Fishers Lane,
Rockville, Maryland 20857, Telephone (301)
443–0721, aharris@hrsa.gov. More
information on the Advisory Committee is
available at https://mchb.hrsa.gov/
heritabledisorderscommittee.
PO 00000
Frm 00055
Fmt 4703
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Dated: November 2, 2010.
Robert Hendricks,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2010–28188 Filed 11–8–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0369]
Report on the Performance of Drug
and Biologics Firms in Conducting
Postmarketing Requirements and
Commitments; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
Under the Food and Drug
Administration Modernization Act of
1997 (Modernization Act), the Food and
Drug Administration (FDA) is required
to report annually in the Federal
Register on the status of postmarketing
requirements and commitments
required of, or agreed upon by, holders
of approved drug and biological
products. This notice is the Agency’s
report on the status of the studies and
clinical trials that applicants have
agreed to or are required to conduct.
FOR FURTHER INFORMATION CONTACT:
Cathryn C. Lee, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6464,
Silver Spring, MD 20993–0002, 301–
796–0700; or
Robert Yetter, Center for Biologics
Evaluation and Research (HFM–25),
Food and Drug Administration, 1400
Rockville Pike, Rockville, MD 20852,
301–827–0373.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
A. The Modernization Act
Section 130(a) of the Modernization
Act (Pub. L. 105–115) amended the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) by adding a new
provision requiring reports of certain
postmarketing studies, including
clinical trials, for human drug and
biological products (section 506B of the
FD&C Act (21 U.S.C. 356b)). Section
506B of the FD&C Act provides FDA
with additional authority to monitor the
progress of a postmarketing study or
clinical trial that an applicant has been
required to or has agreed to conduct by
requiring the applicant to submit a
report annually providing information
E:\FR\FM\09NON1.SGM
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Agencies
[Federal Register Volume 75, Number 216 (Tuesday, November 9, 2010)]
[Notices]
[Pages 68799-68802]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28251]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-8040-N]
RIN 0938-AP86
Medicare Program; Inpatient Hospital Deductible and Hospital and
Extended Care Services Coinsurance Amounts for CY 2011
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces the inpatient hospital deductible and
the hospital and extended care services coinsurance amounts for
services furnished in calendar year (CY) 2011 under Medicare's Hospital
Insurance Program (Medicare Part A). The Medicare statute specifies the
formulae used to determine these amounts. For CY 2011, the inpatient
hospital
[[Page 68800]]
deductible will be $1132. The daily coinsurance amounts for CY 2011
will be--(a) $283 for the 61st through 90th day of hospitalization in a
benefit period; (b) $566 for lifetime reserve days; and (c) $141.50 for
the 21st through 100th day of extended care services in a skilled
nursing facility in a benefit period.
DATES: Effective Date: This notice is effective on January 1, 2011.
FOR FURTHER INFORMATION CONTACT: Clare McFarland, (410) 786-6390 for
general information. Gregory J. Savord, (410) 786-1521 for case-mix
analysis.
SUPPLEMENTARY INFORMATION:
I. Background
Section 1813 of the Social Security Act (the Act) provides for an
inpatient hospital deductible to be subtracted from the amount payable
by Medicare for inpatient hospital services furnished to a beneficiary.
It also provides for certain coinsurance amounts to be subtracted from
the amounts payable by Medicare for inpatient hospital and extended
care services. Section 1813(b)(2) of the Act requires us to determine
and publish each year the amount of the inpatient hospital deductible
and the hospital and extended care services coinsurance amounts
applicable for services furnished in the following CY.
II. Computing the Inpatient Hospital Deductible for CY 2011
Section 1813(b) of the Act prescribes the method for computing the
amount of the inpatient hospital deductible. The inpatient hospital
deductible is an amount equal to the inpatient hospital deductible for
the preceding CY, adjusted by our best estimate of the payment-weighted
average of the applicable percentage increases (as defined in section
1886(b)(3)(B) of the Act) used for updating the payment rates to
hospitals for discharges in the fiscal year (FY) that begins on October
1 of the same preceding CY, and adjusted to reflect changes in real
case-mix. The adjustment to reflect real case-mix is determined on the
basis of the most recent case-mix data available. The amount determined
under this formula is rounded to the nearest multiple of $4 (or, if
midway between two multiples of $4, to the next higher multiple of $4).
Under section 1886(b)(3)(B)(i)(XX) of the Act, the percentage
increase used to update the payment rates for FY 2011 for hospitals
paid under the inpatient prospective payment system is the market
basket percentage increase, otherwise known as the market basket
update, reduced by .25 percentage points. Under section
1886(b)(3)(B)(viii) of the Act, hospitals will receive this update only
if they submit quality data as specified by the Secretary. The update
for hospitals that do not submit this data is reduced by 2.0 percentage
points. We are estimating that after accounting for those hospitals
receiving the lower market basket update in the payment-weighted
average update, the calculated deductible will remain the same.
Under section 1886(b)(3)(B)(ii)(VIII) of the Act, the percentage
increase used to update the payment rates for FY 2011 for hospitals
excluded from the inpatient prospective payment system is the market
basket percentage increase reduced by .5 percentage points for Long
Term Care Hospitals and reduced by .25 percentage points for Inpatient
Rehabilitation facilities and Psychiatric Hospitals, defined according
to section 1886(b)(3)(B)(iii) of the Act.
The market basket percentage increase for 2011 is 2.6 percent, as
announced in the final rule with comment period published in the
Federal Register on August 16, 2010 entitled, ``Medicare Program;
Changes to the Hospital Inpatient Prospective Payment Systems for Acute
Care Hospitals and Fiscal Year 2011 Rates; and Changes to the Long-Term
Care Hospital Prospective Payment System and Rate Years 2011 and 2010
Rates (IPPS/RY 2011 LTCH PPS) (75 FR 50042-50677).'' Therefore, the
percentage increase for hospitals paid under the inpatient prospective
payment system is 2.35 percent. The average payment percentage increase
for hospitals excluded from the inpatient prospective payment system is
2.73 percent. Weighting these percentages in accordance with payment
volume, our best estimate of the payment-weighted average of the
increases in the payment rates for FY 2011 is 2.40 percent.
To develop the adjustment to reflect changes in real case-mix, we
first calculated for each hospital an average case-mix that reflects
the relative costliness of that hospital's mix of cases compared to
those of other hospitals. We then computed the change in average case-
mix for hospitals paid under the Medicare prospective payment system in
FY 2010 compared to FY 2009. (We excluded from this calculation
hospitals whose payments are not based on the inpatient prospective
payment system because their payments are based on alternate
prospective payment systems or reasonable costs.) We used Medicare
bills from prospective payment hospitals that we received as of July
2010. These bills represent a total of about 8.5 million Medicare
discharges for FY 2010 and provide the most recent case-mix data
available at this time. Based on these bills, the change in average
case-mix in FY 2010 is 0.3 percent. Based on these bills and past
experience, we expect the overall case mix change to be 0.5 percent as
the year progresses and more FY 2010 data become available.
Section 1813 of the Act requires that the inpatient hospital
deductible be adjusted only by that portion of the case-mix change that
is determined to be real. In the FY 2011 IPPS/RY 2011 LTCH PPS final
rule with comment period, we indicated that we believe the adoption of
the Medicare severity-based diagnosis-related groups (MS-DRGs) led to
increases in aggregate payments without a corresponding increase in
actual patient severity of illness due to the incentives for improved
documentation and coding. In that final rule with comment period, we
estimated that changes in coding or classification that do not reflect
real change in case-mix would be 0.0 percent for FY 2010. Therefore,
since we are expecting overall case mix to increase by 0.5 percent and
0.0 percent of that to be caused by coding changes, real case mix
changes resulted in an increase of 0.5 percent for FY 2010.
Thus, the estimate of the payment-weighted average of the
applicable percentage increases used for updating the payment rates is
2.40 percent, and the real case-mix adjustment factor for the
deductible is 0.5 percent. Therefore, under the statutory formula, the
inpatient hospital deductible for services furnished in CY 2011 is
$1132. This deductible amount is determined by multiplying $1100 (the
inpatient hospital deductible for CY 2010) by the payment-weighted
average increase in the payment rates of 1.0240 multiplied by the
increase in real case-mix of 1.005, which equals $1132.03 and is
rounded to $1132.
III. Computing the Inpatient Hospital and Extended Care Services
Coinsurance Amounts for CY 2011
The coinsurance amounts provided for in section 1813 of the Act are
defined as fixed percentages of the inpatient hospital deductible for
services furnished in the same CY. The increase in the deductible
generates increases in the coinsurance amounts. For inpatient hospital
and extended care services furnished in CY 2011, in accordance with the
fixed percentages defined in the law, the daily coinsurance for the
61st through 90th day of hospitalization in a benefit period will be
$283 (one-fourth of the inpatient hospital deductible); the daily
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coinsurance for lifetime reserve days will be $566 (one-half of the
inpatient hospital deductible); and the daily coinsurance for the 21st
through 100th day of extended care services in a skilled nursing
facility in a benefit period will be $141.50 (one-eighth of the
inpatient hospital deductible).
IV. Cost to Medicare Beneficiaries
Table 1 below summarizes the deductible and coinsurance amounts for
CYs 2010 and 2011, as well as the number of each that is estimated to
be paid.
Table 1--Part A Deductible and Coinsurance Amounts for Calendar Years 2010 and 2011
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Value Number paid (in
---------------------------- millions)
Type of cost sharing -------------------------
2010 2011 2010 2011
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Inpatient hospital deductible............................. $1100 $1132 8.40 8.59
Daily coinsurance for 61st-90th Day....................... $275 $283 2.25 2.30
Daily coinsurance for lifetime reserve days............... $550 $566 1.13 1.16
SNF coinsurance........................................... $137.50 $141.50 42.41 43.66
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The estimated total increase in costs to beneficiaries is about
$900 million (rounded to the nearest $10 million) due to-- (1) the
increase in the deductible and coinsurance amounts; and (2) the change
in the number of deductibles and daily coinsurance amounts paid.
V. Waiver of Proposed Notice and Comment Period
The Medicare statute, as discussed previously, requires publication
of the Medicare Part A inpatient hospital deductible and the hospital
and extended care services coinsurance amounts for services for each
CY. The amounts are determined according to the statute. As has been
our custom, we use general notices, rather than notice and comment
rulemaking procedures, to make the announcements. In doing so, we
acknowledge that, under the Administrative Procedure Act (APA),
interpretive rules, general statements of policy, and rules of agency
organization, procedure, or practice are excepted from the requirements
of notice and comment rulemaking.
We considered publishing a proposed notice to provide a period for
public comment. However, we may waive that procedure if we find good
cause that prior notice and comment are impracticable, unnecessary, or
contrary to the public interest. We find that the procedure for notice
and comment is unnecessary because the formulae used to calculate the
inpatient hospital deductible and hospital and extended care services
coinsurance amounts are statutorily directed, and we can exercise no
discretion in following the formulae. Moreover, the statute establishes
the time period for which the deductible and coinsurance amounts will
apply and delaying publication would be contrary to the public
interest. Therefore, we find good cause to waive publication of a
proposed notice and solicitation of public comments.
VI. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995 (44 U.S.C. 35).
VII. Regulatory Impact Statement
We have examined the impacts of this final rule as required by
Executive Order 12866 on Regulatory Planning and Review (September 30,
1993), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub.
L. 96-354), section 1102(b) of the Social Security Act, section 202 of
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), Executive
Order 13132 on Federalism (August 4, 1999), and the Congressional
Review Act (5 U.S.C.804(2)).
Executive Order 12866 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 in any 1 year). As stated in
section IV of this notice, we estimate that the total increase in costs
to beneficiaries associated with this notice is about $900 million due
to-- (1) The increase in the deductible and coinsurance amounts; and
(2) the change in the number of deductibles and daily coinsurance
amounts paid. Therefore, this notice is a major rule as defined in
Title 5, United States Code, section 804(2), and is an economically
significant rule under Executive Order 12866.
The RFA requires agencies to analyze options for regulatory relief
of small businesses, if a rule has a significant impact on a
substantial number of small entities. For purposes of the RFA, small
entities include small businesses, nonprofit organizations, and
government agencies. Most hospitals and most other providers and
suppliers are small entities, either by nonprofit status or by having
revenues of $7.0 million to $34.5 million in any 1 year. Individuals
and States are not included in the definition of a small entity. We
have determined that this notice will not have a significant economic
impact on a substantial number of small entities. Therefore, we are not
preparing an analysis under the RFA.
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 and has fewer than 100 beds. The Secretary has
determined that this notice will not have a significant impact on the
operations of a substantial number of small rural hospitals. Therefore,
we are not preparing an analysis under section 1102(b) of the Act.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA)
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. In 2010, that
threshold is approximately $135 million. This notice has no
consequential effect on State, local, or Tribal governments or on the
private sector. However, States may be required
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to pay the deductibles and coinsurance for dually-eligible
beneficiaries.
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. This notice will not have a substantial effect on State
or local governments.
In accordance with the provisions of Executive Order 12866, this
notice was reviewed by the Office of Management and Budget.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance)
Dated: September 9, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
Dated: October 29, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010-28251 Filed 11-4-10; 2:15 pm]
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