Medicare Program; CY 2021 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts, 71916-71920 [2020-25024]
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Federal Register / Vol. 85, No. 219 / Thursday, November 12, 2020 / Notices
suppliers are small entities, either by
being nonprofit organizations or by
meeting the Small Business
Administration’s definition of a small
business (having revenues of less than
$8.0 million to $41.5 million in any 1
year). Individuals and states are not
included in the definition of a small
entity. This annual notice announces
the Medicare Part A premiums for CY
2021 and will have an impact on certain
Medicare beneficiaries. As a result, we
are not preparing an analysis for the
RFA because the Secretary has
determined that this notice will not
have a significant economic impact on
a substantial number of small entities.
In addition, section 1102(b) of the Act
requires us to prepare an RIA 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. This annual notice announces the
Medicare Part A premiums for CY 2021
and will have an impact on certain
Medicare beneficiaries. As a result, we
are not preparing an analysis for section
1102(b) of the Act, because the Secretary
has determined that this notice will not
have a significant impact on the
operations of a substantial number of
small rural hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule whose mandates require spending
in any 1 year of $100 million in 1995
dollars, updated annually for inflation.
In 2020, that threshold is approximately
$156 million. This notice does not
impose mandates that will have a
consequential effect of $156 million or
more on state, local, or tribal
governments or on the private sector.
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
direct effect on state or local
governments, preempt state law, or
otherwise have Federalism implications.
Executive Order 13771, titled
‘‘Reducing Regulation and Controlling
Regulatory Costs,’’ was issued on
January 30, 2017 (82 FR 9339, February
3, 2017). It has been determined that
this notice is a transfer notice that does
VerDate Sep<11>2014
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Jkt 253001
not impose more than de minimis costs
and thus is not a regulatory action for
the purposes of E.O. 13771.
In accordance with the provisions of
Executive Order 12866, this notice was
reviewed by the Office of Management
and Budget.
C. Congressional Review
Consistent with the Congressional
Review Act provisions of the Small
Business Regulatory Enforcement
Fairness Act of 1996 (5 U.S.C. 801 et
seq.), this notice has been transmitted to
the Congress and the Comptroller
General for review.
Dated: October 30, 2020.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
Dated: November 2, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
[FR Doc. 2020–25028 Filed 11–6–20; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–8074–N]
RIN 0938–AU14
Medicare Program; CY 2021 Inpatient
Hospital Deductible and Hospital and
Extended Care Services Coinsurance
Amounts
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) 2021
under Medicare’s Hospital Insurance
Program (Medicare Part A). The
Medicare statute specifies the formulae
used to determine these amounts. For
CY 2021, the inpatient hospital
deductible will be $1,484. The daily
coinsurance amounts for CY 2021 will
be: $371 for the 61st through 90th day
of hospitalization in a benefit period;
$742 for lifetime reserve days; and
$185.50 for the 21st through 100th day
of extended care services in a skilled
nursing facility in a benefit period.
DATES: The deductible and coinsurance
amounts announced in this notice are
effective on January 1, 2021.
FOR FURTHER INFORMATION CONTACT:
SUMMARY:
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Yaminee Thaker, (410) 786 7921 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 the
Secretary of the Department of Health
and Human Services (the Secretary) 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 calendar year
(CY).
II. Computing the Inpatient Hospital
Deductible for CY 2021
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 2021
for hospitals paid under the inpatient
prospective payment system is the
market basket percentage increase,
otherwise known as the market basket
update, reduced by an adjustment based
on changes in the economy-wide
productivity (the multifactor
productivity (MFP) adjustment) (see
section 1886(b)(3)(B)(xi)(II) of the Act).
Under section 1886(b)(3)(B)(viii) of the
Act, for FY 2021, the applicable
percentage increase for hospitals that do
not submit quality data as specified by
the Secretary is reduced by one quarter
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of the market basket update. We are
estimating that after accounting for
those hospitals receiving the lower
market basket update in the paymentweighted average update, the calculated
deductible will not be affected, since the
majority of hospitals submit quality data
and receive the full market basket
update. Section 1886(b)(3)(B)(ix) of the
Act requires that any hospital that is not
a meaningful electronic health record
(EHR) user (as defined in section
1886(n)(3) of the Act) will have threequarters of the market basket update
reduced by 100 percent for FY 2017 and
each subsequent FY. We are estimating
that after accounting for these hospitals
receiving the lower market basket
update, the calculated deductible will
not be affected, since the majority of
hospitals are meaningful EHR users and
are expected to receive the full market
basket update.
Under section 1886 of the Act, the
percentage increase used to update the
payment rates (or target amounts, as
applicable) for FY 2021 for hospitals
excluded from the inpatient prospective
payment system is as follows:
• The percentage increase for long
term care hospitals is the market basket
percentage increase reduced by the MFP
adjustment (see section 1886(m)(3)(A) of
the Act). In addition, these hospitals
may also be impacted by the quality
reporting adjustments and the siteneutral payment rates (see sections
1886(m)(5) and 1886(m)(6) of the Act).
• The percentage increase for
inpatient rehabilitation facilities is the
market basket percentage increase
reduced by a productivity adjustment in
accordance with section
1886(j)(3)(C)(ii)(I) of the Act. In
addition, these hospitals may also be
impacted by the quality reporting
adjustments (see section 1886(j)(7) of
the Act).
• The percentage increase used to
update the payment rate for inpatient
psychiatric facilities is the market
basket percentage increase reduced by
the MFP adjustment (see section
1886(s)(2)(A)(i) of the Act). In addition,
these hospitals may also be impacted by
the quality reporting adjustments (see
section 1886(s)(4) of the Act).
• The percentage increase used to
update the target amounts for other
types of hospitals that are excluded
from the inpatient prospective payment
system and that are paid on a reasonable
cost basis, subject to a rate-of-increase
ceiling, is the inpatient prospective
payment system operating market basket
percentage increase, which is described
at section 1886(b)(3)(B)(ii)(VIII) of the
Act and 42 CFR 413.40(c)(3). These
other types of hospitals include cancer
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hospitals, children’s hospitals, extended
neoplastic disease care hospitals, and
hospitals located outside the 50 states,
the District of Columbia, and Puerto
Rico.
The inpatient prospective payment
system market basket percentage
increase for FY 2021 is 2.4 percent and
the MFP adjustment is 0.0 percentage
point, as announced in the final rule
that appeared in the Federal Register on
September 18, 2020 entitled, ‘‘Hospital
Inpatient Prospective Payment Systems
for Acute Care Hospitals and the LongTerm Care Hospital Prospective
Payment System and Final Policy
Changes and Fiscal Year 2021 Rates;
Quality Reporting and Medicare and
Medicaid Promoting Interoperability
Programs Requirements for Eligible
Hospitals and Critical Access Hospitals’’
(85 FR 58432). Therefore, the percentage
increase for hospitals paid under the
inpatient prospective payment system
that submit quality data and are
meaningful EHR users is 2.4 percent
(that is, the FY 2021 market basket
update of 2.4 percent less the MFP
adjustment of 0.0 percentage point). The
average payment percentage increase for
hospitals excluded from the inpatient
prospective payment system is 2.34
percent. This average includes long term
care hospitals, inpatient rehabilitation
facilities, and other hospitals excluded
from the inpatient prospective payment
system. 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 2021 is 2.39 percent.
To develop the adjustment to reflect
changes in real case-mix, we first
calculated an average case-mix for each
hospital 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 inpatient
prospective payment system in FY 2020
compared to FY 2019. (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
2020. These bills represent a total of
about 6.1 million Medicare discharges
for FY 2020 and provide the most recent
case-mix data available at this time.
Based on these bills, the change in
average case-mix in FY 2020 is 2.8
percent. Based on these bills and past
experience, we expect the overall case
mix change to be 3.8 percent as the year
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progresses and more FY 2020 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. Real case-mix is that portion of
case-mix that is due to changes in the
mix of cases in the hospital and not due
to coding optimization. COVID–19 has
complicated the determination of real
case-mix increase. COVID–19 cases
typically have higher-weighted MS–
DRGs which would cause a real increase
in case-mix while hospitals have
experienced a reduction in lowerweighted cases which would also cause
a real increase in case-mix. We
compared the average case-mix for
February 2020 through July 2020
(COVID–19 period) with average casemix for October 2019 through January
2020 (pre-COVID–19 period). Since this
increase applies for only a portion of CY
2020, we allocated this increase by the
estimated discharges over the 2
periods—a 2.5 percent increase for FY
2020. The 1.3-percent residual case-mix
increase is a mixture of real case-mix
and coding optimization. Over the past
several years, we have observed total
case mix increases of about 0.5 percent
per year and have assumed that they are
real. Thus, since we do not have further
information at this time, we expect that
0.5 percent of the residual 1.3 percent
change in average case-mix for FY 2020
will be real. The combination of the 2.5percent COVID–19 effect and the
remaining residual 0.5-percent real casemix increase is a 3.0-percent increase in
real case-mix for FY 2020. Note that all
case-mix calculations do not include the
extra 20 percent adjustment in the MS–
DRG relative weights for COVID–19
cases. The extra 20-percent adjustment
is a payment artifact that should not be
included in the measurement of casemix.
Thus, the estimate of the paymentweighted average of the applicable
percentage increases used for updating
the payment rates is 2.39 percent, and
the real case-mix adjustment factor for
the deductible is 3.0 percent. Therefore,
using the statutory formula as stated in
section 1813(b) of the Act, we calculate
the inpatient hospital deductible for
services furnished in CY 2021 to be
$1,484. This deductible amount is
determined by multiplying $1,408 (the
inpatient hospital deductible for CY
2020 (84 FR 61619)) by the paymentweighted average increase in the
payment rates of 1.0239 multiplied by
the increase in real case-mix of 1.03,
which equals $1,484.90 and is rounded
to $1,484.
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III. Computing the Inpatient Hospital
and Extended Care Services
Coinsurance Amounts for CY 2021
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 2021, 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 $371 (one-fourth of the
inpatient hospital deductible as stated
in section 1813(a)(1)(A) of the Act); the
daily coinsurance for lifetime reserve
days will be $742 (one-half of the
inpatient hospital deductible as stated
in section 1813(a)(1)(B) of the Act); and
the daily coinsurance for the 21st
through 100th day of extended care
services in a skilled nursing facility
(SNF) in a benefit period will be
$185.50 (one-eighth of the inpatient
hospital deductible as stated in section
1813(a)(3) of the Act).
IV. Cost to Medicare Beneficiaries
The Table below summarizes the
deductible and coinsurance amounts for
CYs 2020 and 2021, as well as the
number of each that is estimated to be
paid.
PART A DEDUCTIBLE AND COINSURANCE AMOUNTS FOR CALENDAR YEARS 2020 AND 2021
Value
Number paid (in millions)
Type of cost sharing
2020
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 $2,450 million
(rounded to the nearest $10 million) due
to: (1) The increase in the deductible
and coinsurance amounts; and (2) the
increase in the number of deductibles
and daily coinsurance amounts paid.
We determine the increase in cost to
beneficiaries by calculating the
difference between the 2020 and 2021
deductible and coinsurance amounts
multiplied by the estimated increase in
the number of deductible and
coinsurance amounts paid.
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V. Waiver of Proposed Rulemaking
We ordinarily publish a notice of
proposed rulemaking in the Federal
Register and invite public comment
prior to a rule taking effect in
accordance with section 1871 of the Act
and section 553(b) of the Administrative
Procedure Act (APA). Section 1871(a)(2)
of the Act provides that no rule,
requirement, or other statement of
policy (other than a national coverage
determination) that establishes or
changes a substantive legal standard
governing the scope of benefits, the
payment for services, or the eligibility of
individuals, entities, or organizations to
furnish or receive services or benefits
under Medicare shall take effect unless
it is promulgated through notice and
comment rulemaking. Unless there is a
statutory exception, section 1871(b)(1)
of the Act generally requires the
Secretary to provide for notice of a
proposed rule in the Federal Register
and provide a period of not less than 60
days for public comment before
establishing or changing a substantive
legal standard regarding the matters
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$1,408
352
704
176.00
enumerated by the statute. Similarly,
under 5 U.S.C. 553(b) of the APA, the
agency is required to publish a notice of
proposed rulemaking in the Federal
Register before a substantive rule takes
effect. Section 553(d) of the APA and
section 1871(e)(1)(B)(i) of the Act
usually require a 30-day delay in
effective date after issuance or
publication of a rule, subject to
exceptions. Sections 553(b)(B) and
553(d)(3) of the APA provide for
exceptions from the advance notice and
comment requirement and the delay in
effective date requirements. Sections
1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the
Act also provide exceptions from the
notice and 60-day comment period and
the 30-day delay in effective date.
Section 553(b)(B) of the APA and
section 1871(b)(2)(C) of the Act
expressly authorize an agency to
dispense with notice and comment
rulemaking for good cause if the agency
makes a finding that notice and
comment procedures are impracticable,
unnecessary, or contrary to the public
interest.
The annual inpatient hospital
deductible and the hospital and
extended care services coinsurance
amounts announcement set forth in this
notice does not establish or change a
substantive legal standard regarding the
matters enumerated by the statute or
constitute a substantive rule which
would be subject to the notice
requirements in section 553(b) of the
APA. However, to the extent that an
opportunity for public notice and
comment could be construed as
required for this notice, we find good
cause to waive this requirement.
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2021
2020
$1,484
371
742
185.50
5.81
1.31
0.65
28.82
2021
6.45
1.46
0.72
32.19
Section 1813(b)(2) of the Act requires
publication of the inpatient hospital
deductible and the hospital and
extended care services coinsurance
amounts between September 1 and
September 15 of the year preceding the
year to which they will apply. Further,
the statute requires that the agency
determine and publish the inpatient
hospital deductible and hospital and
extended care services coinsurance
amounts for each CY in accordance with
the statutory formulae, and we are
simply notifying the public of the
changes to the deductible and
coinsurance amounts for CY 2021. We
have calculated the inpatient hospital
deductible and hospital and extended
care services coinsurance amounts as
directed by the statute; the statute
establishes both when the deductible
and coinsurance amounts must be
published and the information that the
Secretary must factor into the
deductible and coinsurance amounts, so
we do not have any discretion in that
regard. We find notice and comment
procedures to be unnecessary for this
notice and we find good cause to waive
such procedures under section 553(b)(B)
of the APA and section 1871(b)(2)(C) of
the Act, if such procedures may be
construed to be required at all. Through
this notice, we are simply notifying the
public of the updates to the inpatient
hospital deductible and the hospital and
extended care services coinsurance
amounts, in accordance with the statute,
for CY 2021. As such, we also note that
even if notice and comment procedures
were required for this notice, for the
reasons stated above, we would find
good cause to waive the delay in
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effective date of the notice, as additional
delay would be contrary to the public
interest under section 1871(e)(1)(B)(ii)
of the Act. Publication of this notice is
consistent with section 1813(b)(2) of the
Act, and we believe that any potential
delay in the effective date of the notice,
if such delay were required at all, could
cause unnecessary confusion both for
the agency and Medicare beneficiaries.
VI. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
VII. Regulatory Impact Analysis
Although this notice does not
constitute a substantive rule, we
nevertheless prepared this Regulatory
Impact Analysis section in the interest
of ensuring that the impacts of this
notice are fully understood.
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A. Statement of Need
Section 1813(b)(2) of the Act requires
the Secretary to publish, between
September 1 and September 15 of each
year, the amounts of the inpatient
hospital deductible and hospital and
extended care services coinsurance
applicable for services furnished in the
following CY.
B. Overall Impact
We have examined the impacts of this
rule as required by Executive Order
12866 on Regulatory Planning and
Review (September 30, 1993), Executive
Order 13563 on Improving Regulation
and Regulatory Review (January 18,
2011), 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
(March 22, 1995; Pub. L. 104–4),
Executive Order 13132 on Federalism
(August 4, 1999), the Congressional
Review Act (5 U.S.C. 804(2)), and
Executive Order 13771 on Reducing
Regulation and Controlling Regulatory
Costs (January 30, 2017).
Executive Orders 12866 and 13563
direct 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
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equity). Section 3(f) of Executive Order
12866 defines a ‘‘significant regulatory
action’’ as an action that is likely to
result in a rule: (1) Having an annual
effect on the economy of $100 million
or more in any 1 year, or adversely and
materially affecting a sector of the
economy, productivity, competition,
jobs, the environment, public health or
safety, or state, local or tribal
governments or communities (also
referred to as ‘‘economically
significant’’); (2) creating a serious
inconsistency or otherwise interfering
with an action taken or planned by
another agency; (3) materially altering
the budgetary impacts of entitlement
grants, user fees, or loan programs or the
rights and obligations of recipients
thereof; or (4) raising novel legal or
policy issues arising out of legal
mandates, the President’s priorities, or
the principles set forth in the Executive
Order.
A regulatory impact analysis (RIA)
must be prepared for major rules with
economically significant effects ($100
million or more in any 1 year). Although
we do not consider this notice to
constitute a substantive rule, this notice
is economically significant under
section 3(f)(1) of Executive Order 12866.
As stated in section IV of this notice, we
estimate that the total increase in costs
to beneficiaries associated with this
notice is about $2,450 million due to: (1)
The increase in the deductible and
coinsurance amounts; and (2) the
increase in the number of deductibles
and daily coinsurance amounts paid.
The RFA requires agencies to analyze
options for regulatory relief of small
entities, 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 small
governmental jurisdictions. Most
hospitals and most other health care
providers and suppliers are small
entities, either by being nonprofit
organizations or by meeting the Small
Business Administration’s definition of
a small business (having revenues of
less than $8.0 million to $41.5 million
in any 1 year). Individuals and states are
not included in the definition of a small
entity. This annual notice announces
the Medicare Part A deductible and
coinsurance amounts for CY 2021 and
will have an impact on the Medicare
beneficiaries. As a result, we are not
preparing an analysis for the RFA
because the Secretary has determined
that this notice will not have a
significant economic impact on a
substantial number of small entities.
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
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71919
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. This annual notice
announces the Medicare Part A
deductible and coinsurance amounts for
CY 2021 and will have an impact on the
Medicare beneficiaries. As a result, we
are not preparing an analysis for section
1102(b) of the Act because the Secretary
has determined that this notice will not
have a significant impact on the
operations of a substantial number of
small rural hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule whose mandates require spending
in any 1 year of $100 million in 1995
dollars, updated annually for inflation.
In 2020, that threshold is approximately
$156 million. This notice does not
impose mandates that will have a
consequential effect of $156 million or
more on state, local, or tribal
governments or on the private sector.
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
direct effect on state or local
governments, preempt state law, or
otherwise have Federalism implications.
Executive Order 13771, titled
‘‘Reducing Regulation and Controlling
Regulatory Costs,’’ was issued on
January 30, 2017 (82 FR 9339, February
3, 2017). It has been determined that
this notice is a transfer notice that does
not impose more than de minimis costs
and thus is not a regulatory action for
the purposes of E.O. 13771.
In accordance with the provisions of
Executive Order 12866, this notice was
reviewed by the Office of Management
and Budget.
C. Congressional Review
Consistent with the Congressional
Review Act provisions of the Small
Business Regulatory Enforcement
Fairness Act of 1996 (5 U.S.C. 801 et
seq.), this notice has been transmitted to
the Congress and the Comptroller
General for review.
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Federal Register / Vol. 85, No. 219 / Thursday, November 12, 2020 / Notices
Dated: October 30, 2020.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
Dated: November 2, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
[FR Doc. 2020–25024 Filed 11–6–20; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–0530]
Voluntary Disclosure of Sesame as an
Allergen: Draft Guidance for Industry;
Availability; Agency Information
Collection Activities; Proposed
Collection; Comment Request
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
guidance for industry entitled
‘‘Voluntary Disclosure of Sesame as an
Allergen.’’ The draft guidance, when
finalized, will provide food
manufacturers with FDA’s current views
on sesame as an allergen and will
provide recommendations to voluntarily
disclose sesame in certain
circumstances where such disclosure is
not currently required. The guidance is
intended to help individuals who are
allergic to sesame identify those foods
that may contain sesame as an
ingredient. This draft guidance is not
final nor is it in effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by January 11, 2021 to ensure that we
consider your comment on the draft
guidance before we begin work on the
final version of the guidance. Submit
electronic or written comments on the
proposed collection of information in
the draft guidance by January 11, 2021.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
VerDate Sep<11>2014
17:07 Nov 10, 2020
Jkt 253001
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2020–D–0530 for ‘‘Voluntary Disclosure
of Sesame as an Allergen: Guidance for
Industry.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ We
will review this copy, including the
claimed confidential information, in our
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the Office
of Nutrition and Food Labeling, Food
Labeling and Standards Staff, Center for
Food Safety and Applied Nutrition,
Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740.
Send two self-addressed adhesive labels
to assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance: Carol
D’lima, Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2371.
With regard to the proposed collection
of information: Domini Bean, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
5733, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a draft guidance for industry entitled
‘‘Voluntary Disclosure of Sesame as an
Allergen.’’ We are issuing this draft
guidance consistent with our good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on this topic. It does
not establish any rights for any person
E:\FR\FM\12NON1.SGM
12NON1
Agencies
[Federal Register Volume 85, Number 219 (Thursday, November 12, 2020)]
[Notices]
[Pages 71916-71920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25024]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-8074-N]
RIN 0938-AU14
Medicare Program; CY 2021 Inpatient Hospital Deductible and
Hospital and Extended Care Services Coinsurance Amounts
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the inpatient hospital deductible and
the hospital and extended care services coinsurance amounts for
services furnished in calendar year (CY) 2021 under Medicare's Hospital
Insurance Program (Medicare Part A). The Medicare statute specifies the
formulae used to determine these amounts. For CY 2021, the inpatient
hospital deductible will be $1,484. The daily coinsurance amounts for
CY 2021 will be: $371 for the 61st through 90th day of hospitalization
in a benefit period; $742 for lifetime reserve days; and $185.50 for
the 21st through 100th day of extended care services in a skilled
nursing facility in a benefit period.
DATES: The deductible and coinsurance amounts announced in this notice
are effective on January 1, 2021.
FOR FURTHER INFORMATION CONTACT:
Yaminee Thaker, (410) 786 7921 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 the Secretary of
the Department of Health and Human Services (the Secretary) 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 calendar
year (CY).
II. Computing the Inpatient Hospital Deductible for CY 2021
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 2021 for hospitals
paid under the inpatient prospective payment system is the market
basket percentage increase, otherwise known as the market basket
update, reduced by an adjustment based on changes in the economy-wide
productivity (the multifactor productivity (MFP) adjustment) (see
section 1886(b)(3)(B)(xi)(II) of the Act). Under section
1886(b)(3)(B)(viii) of the Act, for FY 2021, the applicable percentage
increase for hospitals that do not submit quality data as specified by
the Secretary is reduced by one quarter
[[Page 71917]]
of the market basket update. 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 not be
affected, since the majority of hospitals submit quality data and
receive the full market basket update. Section 1886(b)(3)(B)(ix) of the
Act requires that any hospital that is not a meaningful electronic
health record (EHR) user (as defined in section 1886(n)(3) of the Act)
will have three-quarters of the market basket update reduced by 100
percent for FY 2017 and each subsequent FY. We are estimating that
after accounting for these hospitals receiving the lower market basket
update, the calculated deductible will not be affected, since the
majority of hospitals are meaningful EHR users and are expected to
receive the full market basket update.
Under section 1886 of the Act, the percentage increase used to
update the payment rates (or target amounts, as applicable) for FY 2021
for hospitals excluded from the inpatient prospective payment system is
as follows:
The percentage increase for long term care hospitals is
the market basket percentage increase reduced by the MFP adjustment
(see section 1886(m)(3)(A) of the Act). In addition, these hospitals
may also be impacted by the quality reporting adjustments and the site-
neutral payment rates (see sections 1886(m)(5) and 1886(m)(6) of the
Act).
The percentage increase for inpatient rehabilitation
facilities is the market basket percentage increase reduced by a
productivity adjustment in accordance with section 1886(j)(3)(C)(ii)(I)
of the Act. In addition, these hospitals may also be impacted by the
quality reporting adjustments (see section 1886(j)(7) of the Act).
The percentage increase used to update the payment rate
for inpatient psychiatric facilities is the market basket percentage
increase reduced by the MFP adjustment (see section 1886(s)(2)(A)(i) of
the Act). In addition, these hospitals may also be impacted by the
quality reporting adjustments (see section 1886(s)(4) of the Act).
The percentage increase used to update the target amounts
for other types of hospitals that are excluded from the inpatient
prospective payment system and that are paid on a reasonable cost
basis, subject to a rate-of-increase ceiling, is the inpatient
prospective payment system operating market basket percentage increase,
which is described at section 1886(b)(3)(B)(ii)(VIII) of the Act and 42
CFR 413.40(c)(3). These other types of hospitals include cancer
hospitals, children's hospitals, extended neoplastic disease care
hospitals, and hospitals located outside the 50 states, the District of
Columbia, and Puerto Rico.
The inpatient prospective payment system market basket percentage
increase for FY 2021 is 2.4 percent and the MFP adjustment is 0.0
percentage point, as announced in the final rule that appeared in the
Federal Register on September 18, 2020 entitled, ``Hospital Inpatient
Prospective Payment Systems for Acute Care Hospitals and the Long-Term
Care Hospital Prospective Payment System and Final Policy Changes and
Fiscal Year 2021 Rates; Quality Reporting and Medicare and Medicaid
Promoting Interoperability Programs Requirements for Eligible Hospitals
and Critical Access Hospitals'' (85 FR 58432). Therefore, the
percentage increase for hospitals paid under the inpatient prospective
payment system that submit quality data and are meaningful EHR users is
2.4 percent (that is, the FY 2021 market basket update of 2.4 percent
less the MFP adjustment of 0.0 percentage point). The average payment
percentage increase for hospitals excluded from the inpatient
prospective payment system is 2.34 percent. This average includes long
term care hospitals, inpatient rehabilitation facilities, and other
hospitals excluded from the inpatient prospective payment system.
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 2021 is 2.39 percent.
To develop the adjustment to reflect changes in real case-mix, we
first calculated an average case-mix for each hospital 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 inpatient prospective payment
system in FY 2020 compared to FY 2019. (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 2020. These bills represent a total of about 6.1 million
Medicare discharges for FY 2020 and provide the most recent case-mix
data available at this time. Based on these bills, the change in
average case-mix in FY 2020 is 2.8 percent. Based on these bills and
past experience, we expect the overall case mix change to be 3.8
percent as the year progresses and more FY 2020 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. Real case-mix is that portion of case-mix
that is due to changes in the mix of cases in the hospital and not due
to coding optimization. COVID-19 has complicated the determination of
real case-mix increase. COVID-19 cases typically have higher-weighted
MS-DRGs which would cause a real increase in case-mix while hospitals
have experienced a reduction in lower-weighted cases which would also
cause a real increase in case-mix. We compared the average case-mix for
February 2020 through July 2020 (COVID-19 period) with average case-mix
for October 2019 through January 2020 (pre-COVID-19 period). Since this
increase applies for only a portion of CY 2020, we allocated this
increase by the estimated discharges over the 2 periods--a 2.5 percent
increase for FY 2020. The 1.3-percent residual case-mix increase is a
mixture of real case-mix and coding optimization. Over the past several
years, we have observed total case mix increases of about 0.5 percent
per year and have assumed that they are real. Thus, since we do not
have further information at this time, we expect that 0.5 percent of
the residual 1.3 percent change in average case-mix for FY 2020 will be
real. The combination of the 2.5-percent COVID-19 effect and the
remaining residual 0.5-percent real case-mix increase is a 3.0-percent
increase in real case-mix for FY 2020. Note that all case-mix
calculations do not include the extra 20 percent adjustment in the MS-
DRG relative weights for COVID-19 cases. The extra 20-percent
adjustment is a payment artifact that should not be included in the
measurement of case-mix.
Thus, the estimate of the payment-weighted average of the
applicable percentage increases used for updating the payment rates is
2.39 percent, and the real case-mix adjustment factor for the
deductible is 3.0 percent. Therefore, using the statutory formula as
stated in section 1813(b) of the Act, we calculate the inpatient
hospital deductible for services furnished in CY 2021 to be $1,484.
This deductible amount is determined by multiplying $1,408 (the
inpatient hospital deductible for CY 2020 (84 FR 61619)) by the
payment-weighted average increase in the payment rates of 1.0239
multiplied by the increase in real case-mix of 1.03, which equals
$1,484.90 and is rounded to $1,484.
[[Page 71918]]
III. Computing the Inpatient Hospital and Extended Care Services
Coinsurance Amounts for CY 2021
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 2021, 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
$371 (one-fourth of the inpatient hospital deductible as stated in
section 1813(a)(1)(A) of the Act); the daily coinsurance for lifetime
reserve days will be $742 (one-half of the inpatient hospital
deductible as stated in section 1813(a)(1)(B) of the Act); and the
daily coinsurance for the 21st through 100th day of extended care
services in a skilled nursing facility (SNF) in a benefit period will
be $185.50 (one-eighth of the inpatient hospital deductible as stated
in section 1813(a)(3) of the Act).
IV. Cost to Medicare Beneficiaries
The Table below summarizes the deductible and coinsurance amounts
for CYs 2020 and 2021, as well as the number of each that is estimated
to be paid.
Part A Deductible and Coinsurance Amounts for Calendar Years 2020 and 2021
----------------------------------------------------------------------------------------------------------------
Value Number paid (in millions)
Type of cost sharing ---------------------------------------------------------------
2020 2021 2020 2021
----------------------------------------------------------------------------------------------------------------
Inpatient hospital deductible................... $1,408 $1,484 5.81 6.45
Daily coinsurance for 61st-90th Day............. 352 371 1.31 1.46
Daily coinsurance for lifetime reserve days..... 704 742 0.65 0.72
SNF coinsurance................................. 176.00 185.50 28.82 32.19
----------------------------------------------------------------------------------------------------------------
The estimated total increase in costs to beneficiaries is about
$2,450 million (rounded to the nearest $10 million) due to: (1) The
increase in the deductible and coinsurance amounts; and (2) the
increase in the number of deductibles and daily coinsurance amounts
paid. We determine the increase in cost to beneficiaries by calculating
the difference between the 2020 and 2021 deductible and coinsurance
amounts multiplied by the estimated increase in the number of
deductible and coinsurance amounts paid.
V. Waiver of Proposed Rulemaking
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comment prior to a rule taking
effect in accordance with section 1871 of the Act and section 553(b) of
the Administrative Procedure Act (APA). Section 1871(a)(2) of the Act
provides that no rule, requirement, or other statement of policy (other
than a national coverage determination) that establishes or changes a
substantive legal standard governing the scope of benefits, the payment
for services, or the eligibility of individuals, entities, or
organizations to furnish or receive services or benefits under Medicare
shall take effect unless it is promulgated through notice and comment
rulemaking. Unless there is a statutory exception, section 1871(b)(1)
of the Act generally requires the Secretary to provide for notice of a
proposed rule in the Federal Register and provide a period of not less
than 60 days for public comment before establishing or changing a
substantive legal standard regarding the matters enumerated by the
statute. Similarly, under 5 U.S.C. 553(b) of the APA, the agency is
required to publish a notice of proposed rulemaking in the Federal
Register before a substantive rule takes effect. Section 553(d) of the
APA and section 1871(e)(1)(B)(i) of the Act usually require a 30-day
delay in effective date after issuance or publication of a rule,
subject to exceptions. Sections 553(b)(B) and 553(d)(3) of the APA
provide for exceptions from the advance notice and comment requirement
and the delay in effective date requirements. Sections 1871(b)(2)(C)
and 1871(e)(1)(B)(ii) of the Act also provide exceptions from the
notice and 60-day comment period and the 30-day delay in effective
date. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act
expressly authorize an agency to dispense with notice and comment
rulemaking for good cause if the agency makes a finding that notice and
comment procedures are impracticable, unnecessary, or contrary to the
public interest.
The annual inpatient hospital deductible and the hospital and
extended care services coinsurance amounts announcement set forth in
this notice does not establish or change a substantive legal standard
regarding the matters enumerated by the statute or constitute a
substantive rule which would be subject to the notice requirements in
section 553(b) of the APA. However, to the extent that an opportunity
for public notice and comment could be construed as required for this
notice, we find good cause to waive this requirement.
Section 1813(b)(2) of the Act requires publication of the inpatient
hospital deductible and the hospital and extended care services
coinsurance amounts between September 1 and September 15 of the year
preceding the year to which they will apply. Further, the statute
requires that the agency determine and publish the inpatient hospital
deductible and hospital and extended care services coinsurance amounts
for each CY in accordance with the statutory formulae, and we are
simply notifying the public of the changes to the deductible and
coinsurance amounts for CY 2021. We have calculated the inpatient
hospital deductible and hospital and extended care services coinsurance
amounts as directed by the statute; the statute establishes both when
the deductible and coinsurance amounts must be published and the
information that the Secretary must factor into the deductible and
coinsurance amounts, so we do not have any discretion in that regard.
We find notice and comment procedures to be unnecessary for this notice
and we find good cause to waive such procedures under section 553(b)(B)
of the APA and section 1871(b)(2)(C) of the Act, if such procedures may
be construed to be required at all. Through this notice, we are simply
notifying the public of the updates to the inpatient hospital
deductible and the hospital and extended care services coinsurance
amounts, in accordance with the statute, for CY 2021. As such, we also
note that even if notice and comment procedures were required for this
notice, for the reasons stated above, we would find good cause to waive
the delay in
[[Page 71919]]
effective date of the notice, as additional delay would be contrary to
the public interest under section 1871(e)(1)(B)(ii) of the Act.
Publication of this notice is consistent with section 1813(b)(2) of the
Act, and we believe that any potential delay in the effective date of
the notice, if such delay were required at all, could cause unnecessary
confusion both for the agency and Medicare beneficiaries.
VI. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. Consequently, there is no need for review by the Office
of Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
VII. Regulatory Impact Analysis
Although this notice does not constitute a substantive rule, we
nevertheless prepared this Regulatory Impact Analysis section in the
interest of ensuring that the impacts of this notice are fully
understood.
A. Statement of Need
Section 1813(b)(2) of the Act requires the Secretary to publish,
between September 1 and September 15 of each year, the amounts of the
inpatient hospital deductible and hospital and extended care services
coinsurance applicable for services furnished in the following CY.
B. Overall Impact
We have examined the impacts of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), 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 (March 22,
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4,
1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive
Order 13771 on Reducing Regulation and Controlling Regulatory Costs
(January 30, 2017).
Executive Orders 12866 and 13563 direct 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). Section
3(f) of Executive Order 12866 defines a ``significant regulatory
action'' as an action that is likely to result in a rule: (1) Having an
annual effect on the economy of $100 million or more in any 1 year, or
adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local or tribal governments or communities (also
referred to as ``economically significant''); (2) creating a serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order.
A regulatory impact analysis (RIA) must be prepared for major rules
with economically significant effects ($100 million or more in any 1
year). Although we do not consider this notice to constitute a
substantive rule, this notice is economically significant under section
3(f)(1) of Executive Order 12866. As stated in section IV of this
notice, we estimate that the total increase in costs to beneficiaries
associated with this notice is about $2,450 million due to: (1) The
increase in the deductible and coinsurance amounts; and (2) the
increase in the number of deductibles and daily coinsurance amounts
paid.
The RFA requires agencies to analyze options for regulatory relief
of small entities, 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 small
governmental jurisdictions. Most hospitals and most other health care
providers and suppliers are small entities, either by being nonprofit
organizations or by meeting the Small Business Administration's
definition of a small business (having revenues of less than $8.0
million to $41.5 million in any 1 year). Individuals and states are not
included in the definition of a small entity. This annual notice
announces the Medicare Part A deductible and coinsurance amounts for CY
2021 and will have an impact on the Medicare beneficiaries. As a
result, we are not preparing an analysis for the RFA because the
Secretary has determined that this notice will not have a significant
economic impact on a substantial number of small entities.
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. This annual notice
announces the Medicare Part A deductible and coinsurance amounts for CY
2021 and will have an impact on the Medicare beneficiaries. As a
result, we are not preparing an analysis for section 1102(b) of the Act
because the Secretary has determined that this notice will not have a
significant impact on the operations of a substantial number of small
rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2020, that
threshold is approximately $156 million. This notice does not impose
mandates that will have a consequential effect of $156 million or more
on state, local, or tribal governments or on the private sector.
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 direct effect on
state or local governments, preempt state law, or otherwise have
Federalism implications.
Executive Order 13771, titled ``Reducing Regulation and Controlling
Regulatory Costs,'' was issued on January 30, 2017 (82 FR 9339,
February 3, 2017). It has been determined that this notice is a
transfer notice that does not impose more than de minimis costs and
thus is not a regulatory action for the purposes of E.O. 13771.
In accordance with the provisions of Executive Order 12866, this
notice was reviewed by the Office of Management and Budget.
C. Congressional Review
Consistent with the Congressional Review Act provisions of the
Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C.
801 et seq.), this notice has been transmitted to the Congress and the
Comptroller General for review.
[[Page 71920]]
Dated: October 30, 2020.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
Dated: November 2, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-25024 Filed 11-6-20; 4:15 pm]
BILLING CODE 4120-01-P