82_FR_55593 82 FR 55370 - Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2018

82 FR 55370 - Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2018

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 82, Issue 223 (November 21, 2017)

Page Range55370-55378
FR Document2017-24877

This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2018. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2018, and the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2018 are $261.90 for aged enrollees and $295.00 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2018 is $134.00, which is equal to 50 percent of the monthly actuarial rate for aged enrollees (or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees) plus $3.00. (The 2017 standard premium rate was $134.00, which included the $3.00 repayment amount.) The Part B deductible for 2018 is $183.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, he or she will have to pay a total monthly premium of about 35, 50, 65, or 80 percent of the total cost of Part B coverage plus $4.20, $6.00, $7.80, or $9.60.

Federal Register, Volume 82 Issue 223 (Tuesday, November 21, 2017)
[Federal Register Volume 82, Number 223 (Tuesday, November 21, 2017)]
[Notices]
[Pages 55370-55378]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24877]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-8067-N]
RIN 0938-AS72


Medicare Program; Medicare Part B Monthly Actuarial Rates, 
Premium Rates, and Annual Deductible Beginning January 1, 2018

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces the monthly actuarial rates for aged 
(age 65 and over) and disabled (under age 65) beneficiaries enrolled in 
Part B of the Medicare Supplementary Medical Insurance (SMI) program 
beginning January 1, 2018. In addition, this notice announces the 
monthly premium for aged and disabled beneficiaries, the deductible for 
2018, and the income-related monthly adjustment amounts to be paid by 
beneficiaries with modified adjusted gross income above certain 
threshold amounts. The monthly actuarial rates for 2018 are $261.90 for 
aged enrollees and $295.00 for disabled enrollees. The standard monthly 
Part B premium rate for all enrollees for 2018 is $134.00, which is 
equal to 50 percent of the monthly actuarial rate for aged enrollees 
(or approximately 25 percent of the expected average total cost of Part 
B coverage for aged enrollees) plus $3.00. (The 2017 standard premium 
rate was $134.00, which included the $3.00 repayment amount.) The Part 
B deductible for 2018 is $183.00 for all Part B beneficiaries. If a 
beneficiary has to pay an income-related monthly adjustment, he or she 
will have to pay a total monthly premium of about 35, 50, 65, or 80 
percent of the total cost of Part B coverage plus $4.20, $6.00, $7.80, 
or $9.60.

DATES: Effective Date: January 1, 2018.

FOR FURTHER INFORMATION CONTACT: M. Kent Clemens, (410) 786-6391.

SUPPLEMENTARY INFORMATION: 

I. Background

    Part B is the voluntary portion of the Medicare program that pays 
all or part of the costs for physicians' services; outpatient hospital 
services; certain home health services; services furnished by rural 
health clinics, ambulatory surgical centers, and comprehensive 
outpatient rehabilitation facilities; and certain other medical and 
health services not covered by Medicare Part A, Hospital Insurance. 
Medicare Part B is available to individuals who are entitled to 
Medicare Part A, as well as to U.S. residents who have attained age 65 
and are citizens and to aliens who were lawfully admitted for permanent 
residence and have resided in the United States for 5 consecutive 
years. Part B requires enrollment and payment of monthly premiums, as 
described in 42 CFR part 407, subpart B, and part 408, respectively. 
The premiums paid by (or on behalf of) all enrollees fund approximately 
one-fourth of the total incurred costs, and transfers from the general 
fund of the Treasury pay approximately three-fourths of these costs.
    The Secretary of the Department of Health and Human Services (the 
Secretary) is required by section 1839 of the Social Security Act (the 
Act) to announce the Part B monthly actuarial rates for aged and 
disabled beneficiaries as well as the monthly Part B premium. The Part 
B annual deductible is included because its determination is directly 
linked to the aged actuarial rate.
    The monthly actuarial rates for aged and disabled enrollees are 
used to determine the correct amount of general revenue financing per 
beneficiary each month. These amounts, according to actuarial 
estimates, will equal, respectively, one-half of the expected average 
monthly cost of Part B for each aged enrollee (age 65 or over) and one-
half of the expected average monthly cost of Part B for each disabled 
enrollee (under age 65).
    The Part B deductible to be paid by enrollees is also announced. 
Prior to the Medicare Prescription Drug, Improvement, and Modernization 
Act of 2003 (MMA) (Pub. L. 108-173), the Part B deductible was set in 
statute. After setting the 2005 deductible amount at $110, section 629 
of the MMA (amending section 1833(b) of the Act) required that the Part 
B deductible be indexed beginning in 2006. The inflation factor to be 
used each year is the annual percentage increase in the Part B 
actuarial rate for enrollees age 65 and over. Specifically, the 2018 
Part B deductible is calculated by multiplying the 2017 deductible by 
the ratio of the 2018 aged actuarial rate to the 2017 aged actuarial 
rate. The amount determined under this formula is then rounded to the 
nearest $1.
    The monthly Part B premium rate to be paid by aged and disabled 
enrollees is also announced. (Although the costs to the program per 
disabled enrollee are different than for the aged, the statute provides 
that they pay the same premium amount.) Beginning with the passage of 
section 203 of the Social Security Amendments of 1972 (Pub. L.

[[Page 55371]]

92-603), the premium rate, which was determined on a fiscal-year basis, 
was limited to the lesser of the actuarial rate for aged enrollees, or 
the current monthly premium rate increased by the same percentage as 
the most recent general increase in monthly Title II Social Security 
benefits.
    However, the passage of section 124 of the Tax Equity and Fiscal 
Responsibility Act of 1982 (TEFRA) (Pub. L. 97-248) suspended this 
premium determination process. Section 124 of TEFRA changed the premium 
basis to 50 percent of the monthly actuarial rate for aged enrollees 
(that is, 25 percent of program costs for aged enrollees). Section 606 
of the Social Security Amendments of 1983 (Pub. L. 98-21), section 2302 
of the Deficit Reduction Act of 1984 (DEFRA 84) (Pub. L. 98-369), 
section 9313 of the Consolidated Omnibus Budget Reconciliation Act of 
1985 (COBRA 85) (Pub. L. 99-272), section 4080 of the Omnibus Budget 
Reconciliation Act of 1987 (OBRA 87) (Pub. L. 100-203), and section 
6301 of the Omnibus Budget Reconciliation Act of 1989 (OBRA 89) (Pub. 
L. 101-239) extended the provision that the premium be based on 50 
percent of the monthly actuarial rate for aged enrollees (that is, 25 
percent of program costs for aged enrollees). This extension expired at 
the end of 1990.
    The premium rate for 1991 through 1995 was legislated by section 
1839(e)(1)(B) of the Act, as added by section 4301 of the Omnibus 
Budget Reconciliation Act of 1990 (OBRA 90) (Pub. L. 101-508). In 
January 1996, the premium determination basis would have reverted to 
the method established by the 1972 Social Security Act Amendments. 
However, section 13571 of the Omnibus Budget Reconciliation Act of 1993 
(OBRA 93) (Pub. L. 103-66) changed the premium basis to 50 percent of 
the monthly actuarial rate for aged enrollees (that is, 25 percent of 
program costs for aged enrollees) for 1996 through 1998.
    Section 4571 of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-
33) permanently extended the provision that the premium be based on 50 
percent of the monthly actuarial rate for aged enrollees (that is, 25 
percent of program costs for aged enrollees).
    The BBA included a further provision affecting the calculation of 
the Part B actuarial rates and premiums for 1998 through 2003. Section 
4611 of the BBA modified the home health benefit payable under Part A 
for individuals enrolled in Part B. Under this section, beginning in 
1998, expenditures for home health services not considered ``post-
institutional'' are payable under Part B rather than Part A. However, 
section 4611(e)(1) of the BBA required that there be a transition from 
1998 through 2002 for the aggregate amount of the expenditures 
transferred from Part A to Part B. Section 4611(e)(2) of the BBA also 
provided a specific yearly proportion for the transferred funds. The 
proportions were one-sixth for 1998, one-third for 1999, one-half for 
2000, two-thirds for 2001, and five-sixths for 2002. For the purpose of 
determining the correct amount of financing from general revenues of 
the Federal Government, it was necessary to include only these 
transitional amounts in the monthly actuarial rates for both aged and 
disabled enrollees, rather than the total cost of the home health 
services being transferred.
    Section 4611(e)(3) of the BBA also specified, for the purpose of 
determining the premium, that the monthly actuarial rate for enrollees 
age 65 and over be computed as though the transition would occur for 
1998 through 2003 and that one-seventh of the cost be transferred in 
1998, two-sevenths in 1999, three-sevenths in 2000, four-sevenths in 
2001, five-sevenths in 2002, and six-sevenths in 2003. Therefore, the 
transition period for incorporating this home health transfer into the 
premium was 7 years while the transition period for including these 
services in the actuarial rate was 6 years.
    Section 811 of the MMA, which amended section 1839 of the Act, 
requires that, starting on January 1, 2007, the Part B premium a 
beneficiary pays each month be based on his or her annual income. 
Specifically, if a beneficiary's modified adjusted gross income is 
greater than the legislated threshold amounts (for 2018, $85,000 for a 
beneficiary filing an individual income tax return and $170,000 for a 
beneficiary filing a joint tax return), the beneficiary is responsible 
for a larger portion of the estimated total cost of Part B benefit 
coverage. In addition to the standard 25-percent premium, these 
beneficiaries now have to pay an income-related monthly adjustment 
amount. The MMA made no change to the actuarial rate calculation, and 
the standard premium, which will continue to be paid by beneficiaries 
whose modified adjusted gross income is below the applicable 
thresholds, still represents 25 percent of the estimated total cost to 
the program of Part B coverage for an aged enrollee. However, depending 
on income and tax filing status, a beneficiary can now be responsible 
for 35, 50, 65, or 80 percent of the estimated total cost of Part B 
coverage, rather than 25 percent. (For 2018 and subsequent years, the 
income thresholds are lower for the two highest income ranges because 
of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) 
(Pub. L. 114-10).) The end result of the higher premium is that the 
Part B premium subsidy is reduced, and less general revenue financing 
is required, for beneficiaries with higher income because they are 
paying a larger share of the total cost with their premium. That is, 
the premium subsidy continues to be approximately 75 percent for 
beneficiaries with income below the applicable income thresholds, but 
it will be reduced for beneficiaries with income above these 
thresholds. The MMA specified that there be a 5-year transition period 
to reach full implementation of this provision. However, section 5111 
of the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109-171) modified 
the transition to a 3-year period.
    Section 4732(c) of the BBA added section 1933(c) of the Act, which 
required the Secretary to allocate money from the Part B trust fund to 
the State Medicaid programs for the purpose of providing Medicare Part 
B premium assistance from 1998 through 2002 for the low-income Medicaid 
beneficiaries who qualify under section 1933 of the Act. This 
allocation, while not a benefit expenditure, was an expenditure of the 
trust fund and was included in calculating the Part B actuarial rates 
through 2002. For 2003 through 2015, the expenditure was made from the 
trust fund because the allocation was temporarily extended. However, 
because the extension occurred after the financing was determined, the 
allocation was not included in the calculation of the financing rates 
for these years. Section 211 of MACRA permanently extended this 
expenditure, which is included in the calculation of the Part B 
actuarial rates for 2016 and subsequent years.
    Another provision affecting the calculation of the Part B premium 
is section 1839(f) of the Act, as amended by section 211 of the 
Medicare Catastrophic Coverage Act of 1988 (MCCA 88) (Pub. L. 100-360). 
(The Medicare Catastrophic Coverage Repeal Act of 1989 (Pub. L. 101-
234) did not repeal the revisions to section 1839(f) of the Act made by 
MCCA 88.) Section 1839(f) of the Act, referred to as the ``hold-
harmless'' provision, provides that if an individual is entitled to 
benefits under section 202 or 223 of the Act (the Old-Age and Survivors 
Insurance Benefit and the Disability Insurance Benefit, respectively) 
and has the Part B premium deducted from these benefit payments, the 
premium increase will be reduced, if necessary, to avoid

[[Page 55372]]

causing a decrease in the individual's net monthly payment. This 
decrease in payment occurs if the increase in the individual's Social 
Security benefit due to the cost-of-living adjustment under section 
215(i) of the Act is less than the increase in the premium. 
Specifically, the reduction in the premium amount applies if the 
individual is entitled to benefits under section 202 or 223 of the Act 
for November and December of a particular year and the individual's 
Part B premiums for December and the following January are deducted 
from the respective month's section 202 or 223 benefits. The hold-
harmless provision does not apply to beneficiaries who are required to 
pay an income-related monthly adjustment amount.
    A check for benefits under section 202 or 223 of the Act is 
received in the month following the month for which the benefits are 
due. The Part B premium that is deducted from a particular check is the 
Part B payment for the month in which the check is received. Therefore, 
a benefit check for November is not received until December, but 
December's Part B premium has been deducted from it.
    Generally, if a beneficiary qualifies for hold-harmless protection, 
the reduced premium for the individual for that January and for each of 
the succeeding 11 months is the greater of either--
     The monthly premium for January reduced as necessary to 
make the December monthly benefits, after the deduction of the Part B 
premium for January, at least equal to the preceding November's monthly 
benefits, after the deduction of the Part B premium for December; or
     The monthly premium for that individual for that December.
    In determining the premium limitations under section 1839(f) of the 
Act, the monthly benefits to which an individual is entitled under 
section 202 or 223 of the Act do not include retroactive adjustments or 
payments and deductions on account of work. Also, once the monthly 
premium amount is established under section 1839(f) of the Act, it will 
not be changed during the year even if there are retroactive 
adjustments or payments and deductions on account of work that apply to 
the individual's monthly benefits.
    Individuals who have enrolled in Part B late or who have re-
enrolled after the termination of a coverage period are subject to an 
increased premium under section 1839(b) of the Act. The increase is a 
percentage of the premium and is based on the new premium rate before 
any reductions under section 1839(f) of the Act are made.
    Section 1839 of the Act, as amended by section 601(a) of the 
Bipartisan Budget Act of 2015 (Pub. L. 114-74), specified that the 2016 
actuarial rate for enrollees age 65 and older be determined as if the 
hold-harmless provision did not apply. The premium revenue that was 
lost by using the resulting lower premium (excluding the foregone 
income-related premium revenue) was replaced by a transfer of general 
revenue from the Treasury, which will be repaid over time to the 
general fund.
    Starting in 2016, in order to repay the balance due (which includes 
the transfer amount and the foregone income-related premium revenue), 
the Part B premium otherwise determined will be increased by $3.00. 
These repayment amounts will be added to the Part B premium otherwise 
determined each year and paid back to the general fund of the Treasury 
and will continue until the balance due is paid back.
    High-income enrollees pay the $3 repayment amount plus an 
additional $1.20, $3.00, $4.80, or $6.60 in repayment as part of the 
income-related monthly adjustment amount (IRMAA) premium dollars, which 
reduce (dollar for dollar) the amount of general revenue received by 
Part B from the general fund of the Treasury. Because of this general 
revenue offset, the repayment IRMAA premium dollars are not included in 
the direct repayments made to the general fund of the Treasury from 
Part B in order to avoid a double repayment. (Only the $3.00 monthly 
repayment amounts are included in the direct repayments).
    These repayment amounts will continue until the total amount 
collected is equal to the beginning balance due. (In the final year of 
the repayment, the additional amounts may be modified to avoid an 
overpayment.) The repayment amounts (excluding the repayment amounts 
for high-income enrollees) are subject to the hold-harmless provision. 
The beginning balance due was $9,066,409,000, consisting of 
$1,625,761,000 in foregone income-related premium revenue plus a 
transfer amount of $7,440,648,000. It is estimated that $1,404,616,000 
will have been collected for repayment to the general fund by the end 
of 2017.

II. Provisions of the Notice

A. Notice of Medicare Part B Monthly Actuarial Rates, Monthly Premium 
Rates, and Annual Deductible

    The Medicare Part B monthly actuarial rates applicable for 2018 are 
$261.90 for enrollees age 65 and over and $295.00 for disabled 
enrollees under age 65. In section II.B. of this notice, we present the 
actuarial assumptions and bases from which these rates are derived. The 
Part B standard monthly premium rate for all enrollees for 2018 is 
$134.00.
    The following are the 2018 Part B monthly premium rates to be paid 
by (or on behalf of) beneficiaries who file either individual tax 
returns (and are single individuals, heads of households, qualifying 
widows or widowers with dependent children, or married individuals 
filing separately who lived apart from their spouses for the entire 
taxable year), or joint tax returns.

----------------------------------------------------------------------------------------------------------------
                                                                              Income-related
   Beneficiaries who file individual tax      Beneficiaries who file joint       monthly         Total monthly
            returns with income:                tax returns with income:    adjustment amount    premium amount
----------------------------------------------------------------------------------------------------------------
Less than or equal to $85,000..............  Less than or equal to                      $0.00            $134.00
                                              $170,000.
Greater than $85,000 and less than or equal  Greater than $170,000 and                  53.50             187.50
 to $107,000.                                 less than or equal to
                                              $214,000.
Greater than $107,000 and less than or       Greater than $214,000 and                 133.90             267.90
 equal to $133,500.                           less than or equal to
                                              $267,000.
Greater than $133,500 and less than or       Greater than $267,000 and                 214.30             348.30
 equal to $160,000.                           less than or equal to
                                              $320,000.
Greater than $160,000......................  Greater than $320,000........             294.60             428.60
----------------------------------------------------------------------------------------------------------------

    In addition, the monthly premium rates to be paid by (or on behalf 
of) beneficiaries who are married and lived with their spouses at any 
time during the taxable year, but who file separate

[[Page 55373]]

tax returns from their spouses, are as follows:

------------------------------------------------------------------------
 Beneficiaries who are married and
  lived with their spouses at any     Income-related
time during the year, but who file       monthly         Total monthly
  separate tax returns from their   adjustment amount    premium amount
             spouses:
------------------------------------------------------------------------
Less than or equal to $85,000.....              $0.00            $134.00
Greater than $85,000..............             294.60             428.60
------------------------------------------------------------------------

    The Part B annual deductible for 2018 is $183.00 for all 
beneficiaries.

B. Statement of Actuarial Assumptions and Bases Employed in Determining 
the Monthly Actuarial Rates and the Monthly Premium Rate for Part B 
Beginning January 2018

    The actuarial assumptions and bases used to determine the monthly 
actuarial rates and the monthly premium rates for Part B are 
established by the Centers for Medicare & Medicaid Services Office of 
the Actuary. The estimates underlying these determinations are prepared 
by actuaries meeting the qualification standards and following the 
actuarial standards of practice established by the Actuarial Standards 
Board.
1. Actuarial Status of the Part B Account in the Supplementary Medical 
Insurance Trust Fund
    Under section 1839 of the Act, the starting point for determining 
the standard monthly premium is the amount that would be necessary to 
finance Part B on an incurred basis. This is the amount of income that 
would be sufficient to pay for services furnished during that year 
(including associated administrative costs) even though payment for 
some of these services will not be made until after the close of the 
year. The portion of income required to cover benefits not paid until 
after the close of the year is added to the trust fund and used when 
needed.
    The premium rates are established prospectively and are, therefore, 
subject to projection error. Additionally, legislation enacted after 
the financing was established, but effective for the period in which 
the financing is set, may affect program costs. As a result, the income 
to the program may not equal incurred costs. Therefore, trust fund 
assets must be maintained at a level that is adequate to cover an 
appropriate degree of variation between actual and projected costs, and 
the amount of incurred, but unpaid, expenses. Numerous factors 
determine what level of assets is appropriate to cover variation 
between actual and projected costs. The three most important of these 
factors are (1) the difference from prior years between the actual 
performance of the program and estimates made at the time financing was 
established; (2) the likelihood and potential magnitude of expenditure 
changes resulting from enactment of legislation affecting Part B costs 
in a year subsequent to the establishment of financing for that year; 
and (3) the expected relationship between incurred and cash 
expenditures. These factors are analyzed on an ongoing basis, as the 
trends can vary over time.
    Table 1 summarizes the estimated actuarial status of the trust fund 
as of the end of the financing period for 2016 and 2017.

 Table 1--Estimated Actuarial Status of the Part B Account in the Supplementary Medical Insurance Trust Fund as
                                       of the End of the Financing Period
----------------------------------------------------------------------------------------------------------------
                                                                                                    Assets less
                     Financing period ending                        Assets (in      Liabilities     liabilities
                                                                     millions)     (in millions)   (in millions)
----------------------------------------------------------------------------------------------------------------
December 31, 2016...............................................         $87,983         $28,494         $59,489
December 31, 2017...............................................          79,236          30,559          48,677
----------------------------------------------------------------------------------------------------------------

2. Monthly Actuarial Rate for Enrollees Age 65 and Older
    The monthly actuarial rate for enrollees age 65 and older is one-
half of the sum of monthly amounts for (1) the projected cost of 
benefits; and (2) administrative expenses for each enrollee age 65 and 
older, after adjustments to this sum to allow for interest earnings on 
assets in the trust fund and an adequate contingency margin. The 
contingency margin is an amount appropriate to provide for possible 
variation between actual and projected costs and to amortize any 
surplus assets or unfunded liabilities.
    The monthly actuarial rate for enrollees age 65 and older for 2018 
is determined by first establishing per enrollee costs by type of 
service from program data through 2016 and then projecting these costs 
for subsequent years. The projection factors used for financing periods 
from January 1, 2015 through December 31, 2018 are shown in Table 2.
    As indicated in Table 3, the projected per enrollee amount required 
to pay for one-half of the total of benefits and administrative costs 
for enrollees age 65 and over for 2018 is $247.91. Based on current 
estimates, the assets associated with the aged Medicare beneficiaries 
at the end of 2017 are not sufficient to cover the amount of incurred, 
but unpaid, expenses and to provide for a significant degree of 
variation between actual and projected costs. Thus, a positive 
contingency margin is needed. The monthly actuarial rate of $261.90 
provides an adjustment of $15.88 for a contingency margin and -$1.89 
for interest earnings.
    The contingency margin for 2018 is affected by several factors. 
Starting in 2011, manufacturers and importers of brand-name 
prescription drugs pay a fee that is allocated to the Part B account of 
the SMI trust. For 2018, the total of these brand-name drug fees is 
estimated to be $4.1 billion. The contingency margin has been reduced 
to account for this additional revenue.
    Another factor affecting the contingency margin is attributable to 
the requirement that certain payment incentives, to encourage the 
development and use of health information technology (HIT) by Medicare 
physicians, are to be excluded from the premium determination. HIT 
positive incentive payments or penalties

[[Page 55374]]

will be directly offset through transfers with the general fund of the 
Treasury. The monthly actuarial rate includes an adjustment of $0.17 
for HIT incentives in 2018.
    The traditional goal for the Part B reserve has been that assets 
minus liabilities at the end of a year should represent between 15 and 
20 percent of the following year's total incurred expenditures. To 
accomplish this goal, a 17-percent reserve ratio, which is a fully 
adequate contingency reserve level, has been the normal target used to 
calculate the Part B premium. Assets at the end of 2017 are expected to 
be below the fully adequate level. The financing rates for 2018 are set 
to restore the asset level in the Part B account to the fully adequate 
level by the end of 2018 under current law. The actuarial rate of 
$261.90 per month for aged beneficiaries, as announced in this notice 
for 2018, reflects that combined effect of the factors previously 
described and the projected assumptions listed in Table 2.
3. Monthly Actuarial Rate for Disabled Enrollees
    Disabled enrollees are those persons under age 65 who are enrolled 
in Part B because of entitlement to Social Security disability benefits 
for more than 24 months or because of entitlement to Medicare under the 
end-stage renal disease (ESRD) program. Projected monthly costs for 
disabled enrollees (other than those with ESRD) are prepared in a 
manner parallel to the projection for the aged using appropriate 
actuarial assumptions (see Table 2). Costs for the ESRD program are 
projected differently because of the different nature of services 
offered by the program.
    As shown in Table 4, the projected per enrollee amount required to 
pay for one-half of the total of benefits and administrative costs for 
disabled enrollees for 2018 is $303.70. The monthly actuarial rate of 
$295.00 also provides an adjustment of -$2.73 for interest earnings and 
-$5.97 for a contingency margin, reflecting the same factors described 
previously for the aged actuarial rate at magnitudes appropriate to the 
disabled rate determination. Based on current estimates, the assets 
associated with the disabled Medicare beneficiaries at the end of 2017 
are sufficient to cover the amount of incurred, but unpaid, expenses 
and to provide for a significant degree of variation between actual and 
projected costs. A negative contingency margin is needed to maintain 
assets at an appropriate level.
    The actuarial rate of $295.00 per month for disabled beneficiaries, 
as announced in this notice for 2018, reflects the combined net effect 
of the factors described previously for aged beneficiaries and the 
projection assumptions listed in Table 2.
4. Sensitivity Testing
    Several factors contribute to uncertainty about future trends in 
medical care costs. It is appropriate to test the adequacy of the rates 
using alternative cost growth rate assumptions. The results of those 
assumptions are shown in Table 5. One set represents increases that are 
higher and, therefore, more pessimistic than the current estimate. The 
other set represents increases that are lower and, therefore, more 
optimistic than the current estimate. The values for the alternative 
assumptions were determined from a statistical analysis of the 
historical variation in the respective increase factors.
    As indicated in Table 5, the monthly actuarial rates would result 
in an excess of assets over liabilities of $65,598 million by the end 
of December 2018 under the cost growth rate assumptions shown in Table 
2 and assuming that the provisions of current law are fully 
implemented. This result amounts to 17.8 percent of the estimated total 
incurred expenditures for the following year.
    Assumptions that are somewhat more pessimistic (and that therefore 
test the adequacy of the assets to accommodate projection errors) 
produce a surplus of $16,355 million by the end of December 2018 under 
current law, which amounts to 3.9 percent of the estimated total 
incurred expenditures for the following year. Under fairly optimistic 
assumptions, the monthly actuarial rates would result in a surplus of 
$114,191 million by the end of December 2018, or 35.6 percent of the 
estimated total incurred expenditures for the following year.
    The sensitivity analysis indicates that the premium and general 
revenue financing established for 2018, together with existing Part B 
account assets, would be adequate to cover estimated Part B costs for 
2018 under current law should actual costs prove to be somewhat greater 
than expected.
5. Premium Rates and Deductible
    As determined in accordance with section 1839 of the Act, the 
following are the 2018 Part B monthly premium rates to be paid by 
beneficiaries who file either individual tax returns (and are single 
individuals, heads of households, qualifying widows or widowers with 
dependent children, or married individuals filing separately who lived 
apart from their spouses for the entire taxable year), or joint tax 
returns.

----------------------------------------------------------------------------------------------------------------
                                                                                  Income-related
 Beneficiaries who file individual tax returns  Beneficiaries who file joint tax      monthly      Total monthly
                 with income:                         returns with income:          adjustment    premium amount
                                                                                      amount
----------------------------------------------------------------------------------------------------------------
Less than or equal to $85,000.................  Less than or equal to $170,000..           $0.00         $134.00
Greater than $85,000 and less than or equal to  Greater than $170,000 and less             53.50          187.50
 $107,000.                                       than or equal to $214,000.
Greater than $107,000 and less than or equal    Greater than $214,000 and less            133.90          267.90
 to $133,500.                                    than or equal to $267,000.
Greater than $133,500 and less than or equal    Greater than $267,000 and less            214.30          348.30
 to $160,000.                                    than or equal to $320,000.
Greater than $160,000.........................  Greater than $320,000...........          294.60          428.60
----------------------------------------------------------------------------------------------------------------

    In addition, the monthly premium rates to be paid by beneficiaries 
who are married and lived with their spouses at any time during the 
taxable year, but who file separate tax returns from their spouses, are 
as follows:

[[Page 55375]]



------------------------------------------------------------------------
 Beneficiaries who are married and
  lived with their spouses at any     Income-related
time during the year, but who file       monthly         Total monthly
  separate tax returns from their   adjustment amount    premium amount
             spouses:
------------------------------------------------------------------------
Less than or equal to $85,000.....              $0.00            $134.00
Greater than $85,000..............             294.60             428.60
------------------------------------------------------------------------


                                                        Table 2--Projection Factors \1\ 12-Month Periods Ending December 31 of 2015-2018
                                                                                          [In percent]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Physicians' services                                 Other
                                                            --------------------------   Durable    Carrier lab    carrier     Outpatient  Home health    Hospital        Other        Managed
                       Calendar year                                        Residual     medical        \4\        services     hospital      agency      Lab \6\     intermediary       care
                                                               Fees \2\       \3\       equipment                    \5\                                              services \7\
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Aged:
    2015...................................................         -0.5          0.7          5.8          1.6          4.4          7.3          1.4          2.4             5.0          2.9
    2016...................................................         -0.3         -1.2        -10.4         -2.5          6.4          4.9         -0.6          2.9             2.1          3.4
    2017...................................................          0.4          1.0         -3.1          4.8          5.8          8.1          2.5          4.0             5.4          2.6
    2018...................................................         -0.2          2.0          5.1          0.0          4.3          7.8          3.0         -1.9            -4.6          6.4
Disabled:
    2015...................................................         -0.5          0.3          6.2          5.8          5.2          7.1         -1.1          0.4            10.1          3.1
    2016...................................................         -0.3         -0.5         -7.2        -14.0          6.9          5.5          0.0          5.2             7.2          4.9
    2017...................................................          0.4          1.1          0.2          3.3          7.3          7.5          3.1          2.9             5.7          3.5
    2018...................................................         -0.2          1.9          4.9         -0.1          4.8          7.7          3.4         -2.0            -4.4          6.6
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ All values for services other than managed care are per fee-for-service enrollee. Managed care values are per managed care enrollee.
\2\ As recognized for payment under the program.
\3\ Increase in the number of services received per enrollee and greater relative use of more expensive services.
\4\ Includes services paid under the lab fee schedule furnished in the physician's office or an independent lab.
\5\ Includes physician-administered drugs, ambulatory surgical center facility costs, ambulance services, parenteral and enteral drug costs, supplies, etc.
\6\ Includes services paid under the lab fee schedule furnished in the outpatient department of a hospital.
\7\ Includes services furnished in dialysis facilities, rural health clinics, federally qualified health centers, rehabilitation and psychiatric hospitals, etc.


    Table 3--Derivation of Monthly Actuarial Rate for Enrollees Age 65 and Over for Financing Periods Ending
                                   December 31, 2015 Through December 31, 2018
----------------------------------------------------------------------------------------------------------------
                                                      CY 2015         CY 2016         CY 2017         CY 2018
----------------------------------------------------------------------------------------------------------------
Covered services (at level recognized):
    Physician fee schedule......................          $75.43          $73.63          $72.71          $73.35
    Durable medical equipment...................            6.28            5.57            5.27            5.48
    Carrier lab \1\.............................            4.33            4.18            4.27            4.23
    Other carrier services \2\..................           22.51           23.72           24.47           25.26
    Outpatient hospital.........................           43.25           44.93           47.37           50.57
    Home health.................................            9.64            9.49            9.48            9.67
    Hospital lab \3\............................            2.25            2.29            2.33            2.26
    Other intermediary services \4\.............           17.25           17.44           17.92           16.94
    Managed care................................           78.97           83.20           89.11           96.37
                                                 ---------------------------------------------------------------
        Total services..........................          259.92          264.46          272.94          284.13
Cost sharing:
    Deductible..................................           -5.64           -6.35           -7.00           -7.00
    Coinsurance.................................          -27.95          -27.65          -27.79          -28.27
Sequestration of benefits.......................           -4.52           -4.61           -4.76           -4.97
HIT payment incentives..........................           -1.08           -0.56           -0.02            0.17
                                                 ---------------------------------------------------------------
        Total benefits..........................          220.73          225.29          233.37          244.04
Administrative expenses.........................            2.82            4.07            3.45            3.87
                                                 ---------------------------------------------------------------
Incurred expenditures...........................          223.55          229.36          236.82          247.91
Value of interest...............................           -1.86           -1.49           -1.67           -1.89
Contingency margin for projection error and to            -11.89            9.73           26.75           15.88
 amortize the surplus or deficit................
                                                 ---------------------------------------------------------------
        Monthly actuarial rate..................          209.80          237.60          261.90          261.90
----------------------------------------------------------------------------------------------------------------
\1\ Includes services paid under the lab fee schedule furnished in the physician's office or an independent lab.
\2\ Includes physician-administered drugs, ambulatory surgical center facility costs, ambulance services,
  parenteral and enteral drug costs, supplies, etc.
\3\ Includes services paid under the lab fee schedule furnished in the outpatient department of a hospital.
\4\ Includes services furnished in dialysis facilities, rural health clinics, federally qualified health
  centers, rehabilitation and psychiatric hospitals, etc.


[[Page 55376]]


 Table 4--Derivation of Monthly Actuarial Rate for Disabled Enrollees for Financing Periods Ending December 31,
                                         2015 Through December 31, 2018
----------------------------------------------------------------------------------------------------------------
                                                      CY 2015         CY 2016         CY 2017         CY 2018
----------------------------------------------------------------------------------------------------------------
Covered services (at level recognized):
    Physician fee schedule......................          $80.64          $78.54          $77.23          $77.31
    Durable medical equipment...................           12.28           11.17           10.85           11.18
    Carrier lab \1\.............................            7.19            6.08            6.09            5.98
    Other carrier services \2\..................           25.33           26.16           27.12           27.88
    Outpatient hospital.........................           61.51           63.46           66.36           70.26
    Home health.................................            7.94            7.75            7.73            7.84
    Hospital lab \3\............................            2.78            2.86            2.86            2.76
    Other intermediary services \4\.............           45.11           46.59           48.13           50.79
    Managed care................................           73.38           81.53           90.23           99.74
                                                 ---------------------------------------------------------------
        Total services..........................          316.16          324.13          336.60          353.74
Cost sharing:
    Deductible..................................           -5.27           -5.94           -6.54           -6.54
    Coinsurance.................................          -42.47          -42.17          -42.63          -43.95
Sequestration of benefits.......................           -5.37           -5.52           -5.75           -6.06
HIT payment incentives..........................           -1.14           -0.59           -0.02            0.17
                                                 ---------------------------------------------------------------
        Total benefits..........................          261.92          269.91          281.67          297.36
Administrative expenses.........................            3.34            4.88            5.70            6.34
                                                 ---------------------------------------------------------------
Incurred expenditures...........................          265.26          274.79          287.37          303.70
Value of interest...............................           -2.21           -2.56           -3.63           -2.73
Contingency margin for projection error and to             -8.25           10.37          -29.54           -5.97
 amortize the surplus or deficit................
                                                 ---------------------------------------------------------------
        Monthly actuarial rate..................          254.80          282.60          254.20          295.00
----------------------------------------------------------------------------------------------------------------
\1\ Includes services paid under the lab fee schedule furnished in the physician's office or an independent lab.
\2\ Includes physician-administered drugs, ambulatory surgical center facility costs, ambulance services,
  parenteral and enteral drug costs, supplies, etc.
\3\ Includes services paid under the lab fee schedule furnished in the outpatient department of a hospital.
\4\ Includes services furnished in dialysis facilities, rural health clinics, federally qualified health
  centers, rehabilitation and psychiatric hospitals, etc.


    Table 5--Actuarial Status of the Part B Account in the SMI Trust Fund Under Three Sets of Assumptions for
                                   Financing Periods Through December 31, 2018
----------------------------------------------------------------------------------------------------------------
                       As of December 31,                              2016            2017            2018
----------------------------------------------------------------------------------------------------------------
Actuarial status (in millions):
    Assets......................................................         $87,983         $79,236         $97,686
    Liabilities.................................................         $28,494         $30,559         $32,089
                                                                 -----------------------------------------------
    Assets less liabilities.....................................         $59,489         $48,677         $65,598
    Ratio \1\...................................................           18.9%           14.4%           17.8%
Low-cost projection:
    Actuarial status (in millions):
        Assets..................................................         $87,983         $96,444        $144,913
        Liabilities.............................................         $28,494         $28,647         $30,722
                                                                 -----------------------------------------------
        Assets less liabilities.................................         $59,489         $67,797        $114,191
        Ratio \1\...............................................           20.2%           22.2%           35.6%
High-cost projection:
    Actuarial status (in millions):
        Assets..................................................         $87,983         $63,188         $50,044
        Liabilities.............................................         $28,494         $32,342         $33,708
                                                                 -----------------------------------------------
        Assets less liabilities.................................         $59,489         $30,846         $16,335
        Ratio \1\...............................................           17.9%            8.3%            3.9%
----------------------------------------------------------------------------------------------------------------
\1\ Ratio of assets less liabilities at the end of the year to the total incurred expenditures during the
  following year, expressed as a percent.

III. 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.).

IV. Regulatory Impact Analysis

A. Statement of Need

    Section 1839 of the Act requires us to annually announce (that is, 
by September 30th of each year) the Part B monthly actuarial rates for 
aged and

[[Page 55377]]

disabled beneficiaries as well as the monthly Part B premium. We also 
announce the Part B annual deductible because its determination is 
directly linked to the aged actuarial rate.

B. Overall Impact

    We have examined the impacts of this notice 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), and the Congressional Review Act (5 U.S.C. 804(2)).
    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). A 
regulatory impact analysis (RIA) must be prepared for major notices 
with economically significant effects ($100 million or more in any one 
year). For 2018 the standard Part B premium rate, the Part B income-
related premium rates, and the Part B deductible are the same as the 
respective amounts for 2017. However, approximately 70 percent of Part 
B enrollees who were held harmless from the full increase in the Part B 
premium in 2017 will pay an increase in their Part B premium, which 
will have an annual effect on the economy of $100 million or more. As a 
result, this notice is economically significant under section 3(f)(1) 
of Executive Order 12866 and is a major action as defined under the 
Congressional Review Act (5 U.S.C. 804(2)).
    As discussed earlier, this notice announces that the monthly 
actuarial rates applicable for 2018 are $261.90 for enrollees age 65 
and over and $295.00 for disabled enrollees under age 65. It also 
announces the 2018 monthly Part B premium rates to be paid by 
beneficiaries who file either individual tax returns (and are single 
individuals, heads of households, qualifying widows or widowers with 
dependent children, or married individuals filing separately who lived 
apart from their spouses for the entire taxable year), or joint tax 
returns.

----------------------------------------------------------------------------------------------------------------
                                                                              Income-related
   Beneficiaries who file individual tax      Beneficiaries who file joint       monthly         Total monthly
            returns with income:                tax returns with income:    adjustment amount    premium amount
----------------------------------------------------------------------------------------------------------------
Less than or equal to $85,000..............  Less than or equal to                      $0.00            $134.00
                                              $170,000.
Greater than $85,000 and less than or equal  Greater than $170,000 and                  53.50             187.50
 to $107,000.                                 less than or equal to
                                              $214,000.
Greater than $107,000 and less than or       Greater than $214,000 and                 133.90             267.90
 equal to $133,500.                           less than or equal to
                                              $267,000.
Greater than $133,500 and less than or       Greater than $267,000 and                 214.30             348.30
 equal to $160,000.                           less than or equal to
                                              $320,000.
Greater than $160,000......................  Greater than $320,000........             294.60             428.60
----------------------------------------------------------------------------------------------------------------

    In addition, the monthly premium rates to be paid by beneficiaries 
who are married and lived with their spouses at any time during the 
taxable year, but who file separate tax returns from their spouses, are 
also announced and listed in the following chart:

------------------------------------------------------------------------
 Beneficiaries who are married and
  lived with their spouses at any     Income-related
time during the year, but who file       monthly         Total monthly
  separate tax returns from their   adjustment amount    premium amount
             spouses:
------------------------------------------------------------------------
Less than or equal to $85,000.....              $0.00            $134.00
Greater than $85,000..............             294.60             428.60
------------------------------------------------------------------------

    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 small 
governmental jurisdictions. Individuals and states are not included in 
the definition of a small entity. This notice announces the monthly 
actuarial rates for aged (age 65 and over) and disabled (under 65) 
beneficiaries enrolled in Part B of the Medicare SMI program beginning 
January 1, 2018. Also, this notice announces the monthly premium for 
aged and disabled beneficiaries as well as the income-related monthly 
adjustment amounts to be paid by beneficiaries with modified adjusted 
gross income above certain threshold amounts. 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. As we discussed 
previously, 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 effect on a substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any one year of 
$100 million in 1995 dollars, updated annually for inflation. In 2017, 
that threshold is approximately $156

[[Page 55378]]

million. Part B enrollees who are also enrolled in Medicaid have their 
monthly Part B premiums paid by Medicaid. The cost to each state 
Medicaid program from the 2018 premium increase is estimated to be less 
than the threshold. This notice does not impose mandates that will have 
a consequential effect of the threshold amount 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 publishes a proposed rule (and subsequent 
final rule) that imposes substantial direct compliance costs on state 
and local governments, preempts state law, or otherwise has Federalism 
implications. We have determined that this notice does not 
significantly affect the rights, roles, and responsibilities of states. 
Accordingly, the requirements of Executive Order 13132 do not apply to 
this notice.
    In accordance with the provisions of Executive Order 12866, this 
notice was reviewed by the Office of Management and Budget.

V. Waiver of Proposed Notice

    The Medicare statute requires the publication of the monthly 
actuarial rates and the Part B premium amounts in September. We 
ordinarily use general notices, rather than notice and comment 
rulemaking procedures, to make such announcements. In doing so, we note 
that, under the Administrative Procedure Act, 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, for 
good cause, that prior notice and comment are impracticable, 
unnecessary, or contrary to the public interest. The statute 
establishes the time period for which the premium rates will apply, and 
delaying publication of the Part B premium rate such that it would not 
be published before that time would be contrary to the public interest. 
Moreover, we find that notice and comment are unnecessary because the 
formulas used to calculate the Part B premiums are statutorily 
directed. Therefore, we find good cause to waive publication of a 
proposed notice and solicitation of public comments.

    Dated: October 27, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: November 1, 2017.
Eric D. Hargan,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2017-24877 Filed 11-17-17; 4:15 pm]
 BILLING CODE 4120-01-P



                                                    55370                      Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Notices

                                                    hospitals. This analysis must conform to                DEPARTMENT OF HEALTH AND                              is available to individuals who are
                                                    the provisions of section 604 of the                    HUMAN SERVICES                                        entitled to Medicare Part A, as well as
                                                    RFA. For purposes of section 1102(b) of                                                                       to U.S. residents who have attained age
                                                    the Act, we define a small rural hospital               Centers for Medicare & Medicaid                       65 and are citizens and to aliens who
                                                    as a hospital that is located outside of                Services                                              were lawfully admitted for permanent
                                                    a metropolitan statistical area and has                 [CMS–8067–N]                                          residence and have resided in the
                                                    fewer than 100 beds. As discussed                                                                             United States for 5 consecutive years.
                                                    above, we are not preparing an analysis                 RIN 0938–AS72                                         Part B requires enrollment and payment
                                                    for section 1102(b) of the Act because                                                                        of monthly premiums, as described in
                                                                                                            Medicare Program; Medicare Part B                     42 CFR part 407, subpart B, and part
                                                    the Secretary has determined that this
                                                                                                            Monthly Actuarial Rates, Premium                      408, respectively. The premiums paid
                                                    notice will not have a significant impact
                                                                                                            Rates, and Annual Deductible                          by (or on behalf of) all enrollees fund
                                                    on the operations of a substantial
                                                                                                            Beginning January 1, 2018                             approximately one-fourth of the total
                                                    number of small rural hospitals.
                                                                                                            AGENCY: Centers for Medicare &                        incurred costs, and transfers from the
                                                       Section 202 of the Unfunded                                                                                general fund of the Treasury pay
                                                    Mandates Reform Act of 1995 also                        Medicaid Services (CMS), HHS.
                                                                                                            ACTION: Notice.
                                                                                                                                                                  approximately three-fourths of these
                                                    requires that agencies assess anticipated                                                                     costs.
                                                    costs and benefits before issuing any                                                                            The Secretary of the Department of
                                                                                                            SUMMARY:   This notice announces the
                                                    rule whose mandates require spending                                                                          Health and Human Services (the
                                                                                                            monthly actuarial rates for aged (age 65
                                                    in any 1 year of $100 million in 1995                   and over) and disabled (under age 65)                 Secretary) is required by section 1839 of
                                                    dollars, updated annually for inflation.                beneficiaries enrolled in Part B of the               the Social Security Act (the Act) to
                                                    In 2017, that threshold is approximately                Medicare Supplementary Medical                        announce the Part B monthly actuarial
                                                    $148 million. This notice does not                      Insurance (SMI) program beginning                     rates for aged and disabled beneficiaries
                                                    impose mandates that will have a                        January 1, 2018. In addition, this notice             as well as the monthly Part B premium.
                                                    consequential effect of $148 million or                 announces the monthly premium for                     The Part B annual deductible is
                                                    more on state, local, or tribal                         aged and disabled beneficiaries, the                  included because its determination is
                                                    governments or on the private sector.                   deductible for 2018, and the income-                  directly linked to the aged actuarial rate.
                                                       Executive Order 13771, titled                        related monthly adjustment amounts to                    The monthly actuarial rates for aged
                                                    ‘‘Reducing Regulation and Controlling                   be paid by beneficiaries with modified                and disabled enrollees are used to
                                                    Regulatory Costs,’’ was issued on                       adjusted gross income above certain                   determine the correct amount of general
                                                    January 30, 2017 (82 FR 9339, February                  threshold amounts. The monthly                        revenue financing per beneficiary each
                                                    3, 2017). It has been determined that                   actuarial rates for 2018 are $261.90 for              month. These amounts, according to
                                                    this notice is a transfer notice that does              aged enrollees and $295.00 for disabled               actuarial estimates, will equal,
                                                    not impose more than de minimis costs                   enrollees. The standard monthly Part B                respectively, one-half of the expected
                                                    and thus is not a regulatory action for                 premium rate for all enrollees for 2018               average monthly cost of Part B for each
                                                    the purposes of E.O. 13771.                             is $134.00, which is equal to 50 percent              aged enrollee (age 65 or over) and one-
                                                                                                            of the monthly actuarial rate for aged                half of the expected average monthly
                                                       Executive Order 13132 establishes                                                                          cost of Part B for each disabled enrollee
                                                    certain requirements that an agency                     enrollees (or approximately 25 percent
                                                                                                            of the expected average total cost of Part            (under age 65).
                                                    must meet when it promulgates a                                                                                  The Part B deductible to be paid by
                                                    proposed rule (and subsequent final                     B coverage for aged enrollees) plus
                                                                                                                                                                  enrollees is also announced. Prior to the
                                                    rule) that imposes substantial direct                   $3.00. (The 2017 standard premium rate
                                                                                                                                                                  Medicare Prescription Drug,
                                                    requirement costs on state and local                    was $134.00, which included the $3.00                 Improvement, and Modernization Act of
                                                    governments, preempts state law, or                     repayment amount.) The Part B                         2003 (MMA) (Pub. L. 108–173), the Part
                                                    otherwise has Federalism implications.                  deductible for 2018 is $183.00 for all                B deductible was set in statute. After
                                                    This notice will not have a substantial                 Part B beneficiaries. If a beneficiary has            setting the 2005 deductible amount at
                                                    direct effect on state or local                         to pay an income-related monthly                      $110, section 629 of the MMA
                                                    governments, preempt state law, or                      adjustment, he or she will have to pay                (amending section 1833(b) of the Act)
                                                    otherwise have Federalism implications.                 a total monthly premium of about 35,                  required that the Part B deductible be
                                                                                                            50, 65, or 80 percent of the total cost of            indexed beginning in 2006. The
                                                       Although this notice merely                          Part B coverage plus $4.20, $6.00, $7.80,
                                                    announces the Medicare Part A                                                                                 inflation factor to be used each year is
                                                                                                            or $9.60.                                             the annual percentage increase in the
                                                    deductible and coinsurance amounts for                  DATES: Effective Date: January 1, 2018.
                                                    CY 2018 and does not constitute a                                                                             Part B actuarial rate for enrollees age 65
                                                                                                            FOR FURTHER INFORMATION CONTACT: M.                   and over. Specifically, the 2018 Part B
                                                    substantive rule, we nevertheless
                                                    prepared this Impact Analysis in the                    Kent Clemens, (410) 786–6391.                         deductible is calculated by multiplying
                                                    interest of ensuring that the impacts of                SUPPLEMENTARY INFORMATION:                            the 2017 deductible by the ratio of the
                                                    this notice are fully understood.                                                                             2018 aged actuarial rate to the 2017 aged
                                                                                                            I. Background                                         actuarial rate. The amount determined
                                                      Dated: October 27, 2017.                                 Part B is the voluntary portion of the             under this formula is then rounded to
                                                    Seema Verma,                                            Medicare program that pays all or part                the nearest $1.
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                    Administrator, Centers for Medicare &                   of the costs for physicians’ services;                   The monthly Part B premium rate to
                                                    Medicaid Services.                                      outpatient hospital services; certain                 be paid by aged and disabled enrollees
                                                                                                            home health services; services furnished              is also announced. (Although the costs
                                                      Dated: November 1, 2017.
                                                                                                            by rural health clinics, ambulatory                   to the program per disabled enrollee are
                                                    Eric D. Hargan,                                         surgical centers, and comprehensive                   different than for the aged, the statute
                                                    Acting Secretary, Department of Health and              outpatient rehabilitation facilities; and             provides that they pay the same
                                                    Human Services.                                         certain other medical and health                      premium amount.) Beginning with the
                                                    [FR Doc. 2017–24913 Filed 11–17–17; 4:15 pm]            services not covered by Medicare Part                 passage of section 203 of the Social
                                                    BILLING CODE 4120–01–P                                  A, Hospital Insurance. Medicare Part B                Security Amendments of 1972 (Pub. L.


                                               VerDate Sep<11>2014   18:56 Nov 20, 2017   Jkt 244001   PO 00000   Frm 00027   Fmt 4703   Sfmt 4703   E:\FR\FM\21NON1.SGM   21NON1


                                                                               Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Notices                                           55371

                                                    92–603), the premium rate, which was                    Part B rather than Part A. However,                   thresholds are lower for the two highest
                                                    determined on a fiscal-year basis, was                  section 4611(e)(1) of the BBA required                income ranges because of the Medicare
                                                    limited to the lesser of the actuarial rate             that there be a transition from 1998                  Access and CHIP Reauthorization Act of
                                                    for aged enrollees, or the current                      through 2002 for the aggregate amount                 2015 (MACRA) (Pub. L. 114–10).) The
                                                    monthly premium rate increased by the                   of the expenditures transferred from                  end result of the higher premium is that
                                                    same percentage as the most recent                      Part A to Part B. Section 4611(e)(2) of               the Part B premium subsidy is reduced,
                                                    general increase in monthly Title II                    the BBA also provided a specific yearly               and less general revenue financing is
                                                    Social Security benefits.                               proportion for the transferred funds.                 required, for beneficiaries with higher
                                                       However, the passage of section 124                  The proportions were one-sixth for                    income because they are paying a larger
                                                    of the Tax Equity and Fiscal                            1998, one-third for 1999, one-half for                share of the total cost with their
                                                    Responsibility Act of 1982 (TEFRA)                      2000, two-thirds for 2001, and five-                  premium. That is, the premium subsidy
                                                    (Pub. L. 97–248) suspended this                         sixths for 2002. For the purpose of                   continues to be approximately 75
                                                    premium determination process.                          determining the correct amount of                     percent for beneficiaries with income
                                                    Section 124 of TEFRA changed the                        financing from general revenues of the                below the applicable income thresholds,
                                                    premium basis to 50 percent of the                      Federal Government, it was necessary to               but it will be reduced for beneficiaries
                                                    monthly actuarial rate for aged enrollees               include only these transitional amounts               with income above these thresholds.
                                                    (that is, 25 percent of program costs for               in the monthly actuarial rates for both               The MMA specified that there be a 5-
                                                    aged enrollees). Section 606 of the                     aged and disabled enrollees, rather than              year transition period to reach full
                                                    Social Security Amendments of 1983                      the total cost of the home health                     implementation of this provision.
                                                    (Pub. L. 98–21), section 2302 of the                    services being transferred.                           However, section 5111 of the Deficit
                                                    Deficit Reduction Act of 1984 (DEFRA                       Section 4611(e)(3) of the BBA also                 Reduction Act of 2005 (DRA) (Pub. L.
                                                    84) (Pub. L. 98–369), section 9313 of the               specified, for the purpose of                         109–171) modified the transition to a 3-
                                                    Consolidated Omnibus Budget                             determining the premium, that the                     year period.
                                                    Reconciliation Act of 1985 (COBRA 85)                   monthly actuarial rate for enrollees age                 Section 4732(c) of the BBA added
                                                    (Pub. L. 99–272), section 4080 of the                   65 and over be computed as though the                 section 1933(c) of the Act, which
                                                    Omnibus Budget Reconciliation Act of                    transition would occur for 1998 through               required the Secretary to allocate money
                                                    1987 (OBRA 87) (Pub. L. 100–203), and                   2003 and that one-seventh of the cost be              from the Part B trust fund to the State
                                                    section 6301 of the Omnibus Budget                      transferred in 1998, two-sevenths in                  Medicaid programs for the purpose of
                                                    Reconciliation Act of 1989 (OBRA 89)                    1999, three-sevenths in 2000, four-                   providing Medicare Part B premium
                                                    (Pub. L. 101–239) extended the                          sevenths in 2001, five-sevenths in 2002,              assistance from 1998 through 2002 for
                                                    provision that the premium be based on                  and six-sevenths in 2003. Therefore, the              the low-income Medicaid beneficiaries
                                                    50 percent of the monthly actuarial rate                transition period for incorporating this              who qualify under section 1933 of the
                                                    for aged enrollees (that is, 25 percent of              home health transfer into the premium                 Act. This allocation, while not a benefit
                                                    program costs for aged enrollees). This                 was 7 years while the transition period               expenditure, was an expenditure of the
                                                    extension expired at the end of 1990.                   for including these services in the                   trust fund and was included in
                                                       The premium rate for 1991 through                    actuarial rate was 6 years.                           calculating the Part B actuarial rates
                                                    1995 was legislated by section                             Section 811 of the MMA, which                      through 2002. For 2003 through 2015,
                                                    1839(e)(1)(B) of the Act, as added by                   amended section 1839 of the Act,                      the expenditure was made from the trust
                                                    section 4301 of the Omnibus Budget                      requires that, starting on January 1,                 fund because the allocation was
                                                    Reconciliation Act of 1990 (OBRA 90)                    2007, the Part B premium a beneficiary                temporarily extended. However,
                                                    (Pub. L. 101–508). In January 1996, the                 pays each month be based on his or her                because the extension occurred after the
                                                    premium determination basis would                       annual income. Specifically, if a                     financing was determined, the
                                                    have reverted to the method established                 beneficiary’s modified adjusted gross                 allocation was not included in the
                                                    by the 1972 Social Security Act                         income is greater than the legislated                 calculation of the financing rates for
                                                    Amendments. However, section 13571                      threshold amounts (for 2018, $85,000                  these years. Section 211 of MACRA
                                                    of the Omnibus Budget Reconciliation                    for a beneficiary filing an individual                permanently extended this expenditure,
                                                    Act of 1993 (OBRA 93) (Pub. L. 103–66)                  income tax return and $170,000 for a                  which is included in the calculation of
                                                    changed the premium basis to 50                         beneficiary filing a joint tax return), the           the Part B actuarial rates for 2016 and
                                                    percent of the monthly actuarial rate for               beneficiary is responsible for a larger               subsequent years.
                                                    aged enrollees (that is, 25 percent of                  portion of the estimated total cost of                   Another provision affecting the
                                                    program costs for aged enrollees) for                   Part B benefit coverage. In addition to               calculation of the Part B premium is
                                                    1996 through 1998.                                      the standard 25-percent premium, these                section 1839(f) of the Act, as amended
                                                       Section 4571 of the Balanced Budget                  beneficiaries now have to pay an                      by section 211 of the Medicare
                                                    Act of 1997 (BBA) (Pub. L. 105–33)                      income-related monthly adjustment                     Catastrophic Coverage Act of 1988
                                                    permanently extended the provision                      amount. The MMA made no change to                     (MCCA 88) (Pub. L. 100–360). (The
                                                    that the premium be based on 50                         the actuarial rate calculation, and the               Medicare Catastrophic Coverage Repeal
                                                    percent of the monthly actuarial rate for               standard premium, which will continue                 Act of 1989 (Pub. L. 101–234) did not
                                                    aged enrollees (that is, 25 percent of                  to be paid by beneficiaries whose                     repeal the revisions to section 1839(f) of
                                                    program costs for aged enrollees).                      modified adjusted gross income is                     the Act made by MCCA 88.) Section
                                                       The BBA included a further provision                 below the applicable thresholds, still                1839(f) of the Act, referred to as the
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                                                    affecting the calculation of the Part B                 represents 25 percent of the estimated                ‘‘hold-harmless’’ provision, provides
                                                    actuarial rates and premiums for 1998                   total cost to the program of Part B                   that if an individual is entitled to
                                                    through 2003. Section 4611 of the BBA                   coverage for an aged enrollee. However,               benefits under section 202 or 223 of the
                                                    modified the home health benefit                        depending on income and tax filing                    Act (the Old-Age and Survivors
                                                    payable under Part A for individuals                    status, a beneficiary can now be                      Insurance Benefit and the Disability
                                                    enrolled in Part B. Under this section,                 responsible for 35, 50, 65, or 80 percent             Insurance Benefit, respectively) and has
                                                    beginning in 1998, expenditures for                     of the estimated total cost of Part B                 the Part B premium deducted from these
                                                    home health services not considered                     coverage, rather than 25 percent. (For                benefit payments, the premium increase
                                                    ‘‘post-institutional’’ are payable under                2018 and subsequent years, the income                 will be reduced, if necessary, to avoid


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                                                    55372                         Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Notices

                                                    causing a decrease in the individual’s                         once the monthly premium amount is                             repayment IRMAA premium dollars are
                                                    net monthly payment. This decrease in                          established under section 1839(f) of the                       not included in the direct repayments
                                                    payment occurs if the increase in the                          Act, it will not be changed during the                         made to the general fund of the Treasury
                                                    individual’s Social Security benefit due                       year even if there are retroactive                             from Part B in order to avoid a double
                                                    to the cost-of-living adjustment under                         adjustments or payments and                                    repayment. (Only the $3.00 monthly
                                                    section 215(i) of the Act is less than the                     deductions on account of work that                             repayment amounts are included in the
                                                    increase in the premium. Specifically,                         apply to the individual’s monthly                              direct repayments).
                                                    the reduction in the premium amount                            benefits.
                                                                                                                      Individuals who have enrolled in Part                          These repayment amounts will
                                                    applies if the individual is entitled to
                                                                                                                   B late or who have re-enrolled after the                       continue until the total amount
                                                    benefits under section 202 or 223 of the
                                                    Act for November and December of a                             termination of a coverage period are                           collected is equal to the beginning
                                                    particular year and the individual’s Part                      subject to an increased premium under                          balance due. (In the final year of the
                                                    B premiums for December and the                                section 1839(b) of the Act. The increase                       repayment, the additional amounts may
                                                    following January are deducted from the                        is a percentage of the premium and is                          be modified to avoid an overpayment.)
                                                    respective month’s section 202 or 223                          based on the new premium rate before                           The repayment amounts (excluding the
                                                    benefits. The hold-harmless provision                          any reductions under section 1839(f) of                        repayment amounts for high-income
                                                    does not apply to beneficiaries who are                        the Act are made.                                              enrollees) are subject to the hold-
                                                    required to pay an income-related                                 Section 1839 of the Act, as amended                         harmless provision. The beginning
                                                    monthly adjustment amount.                                     by section 601(a) of the Bipartisan                            balance due was $9,066,409,000,
                                                      A check for benefits under section 202                       Budget Act of 2015 (Pub. L. 114–74),                           consisting of $1,625,761,000 in foregone
                                                    or 223 of the Act is received in the                           specified that the 2016 actuarial rate for                     income-related premium revenue plus a
                                                    month following the month for which                            enrollees age 65 and older be                                  transfer amount of $7,440,648,000. It is
                                                    the benefits are due. The Part B                               determined as if the hold-harmless                             estimated that $1,404,616,000 will have
                                                    premium that is deducted from a                                provision did not apply. The premium                           been collected for repayment to the
                                                    particular check is the Part B payment                         revenue that was lost by using the                             general fund by the end of 2017.
                                                    for the month in which the check is                            resulting lower premium (excluding the
                                                    received. Therefore, a benefit check for                       foregone income-related premium                                II. Provisions of the Notice
                                                    November is not received until                                 revenue) was replaced by a transfer of                         A. Notice of Medicare Part B Monthly
                                                    December, but December’s Part B                                general revenue from the Treasury,                             Actuarial Rates, Monthly Premium
                                                    premium has been deducted from it.                             which will be repaid over time to the                          Rates, and Annual Deductible
                                                      Generally, if a beneficiary qualifies for                    general fund.
                                                    hold-harmless protection, the reduced                             Starting in 2016, in order to repay the                        The Medicare Part B monthly
                                                    premium for the individual for that                            balance due (which includes the                                actuarial rates applicable for 2018 are
                                                    January and for each of the succeeding                         transfer amount and the foregone                               $261.90 for enrollees age 65 and over
                                                    11 months is the greater of either—                            income-related premium revenue), the                           and $295.00 for disabled enrollees
                                                      • The monthly premium for January                            Part B premium otherwise determined                            under age 65. In section II.B. of this
                                                    reduced as necessary to make the                               will be increased by $3.00. These                              notice, we present the actuarial
                                                    December monthly benefits, after the                           repayment amounts will be added to the                         assumptions and bases from which
                                                    deduction of the Part B premium for                            Part B premium otherwise determined                            these rates are derived. The Part B
                                                    January, at least equal to the preceding                       each year and paid back to the general                         standard monthly premium rate for all
                                                    November’s monthly benefits, after the                         fund of the Treasury and will continue                         enrollees for 2018 is $134.00.
                                                    deduction of the Part B premium for                            until the balance due is paid back.
                                                    December; or                                                      High-income enrollees pay the $3                               The following are the 2018 Part B
                                                      • The monthly premium for that                               repayment amount plus an additional                            monthly premium rates to be paid by (or
                                                    individual for that December.                                  $1.20, $3.00, $4.80, or $6.60 in                               on behalf of) beneficiaries who file
                                                      In determining the premium                                   repayment as part of the income-related                        either individual tax returns (and are
                                                    limitations under section 1839(f) of the                       monthly adjustment amount (IRMAA)                              single individuals, heads of households,
                                                    Act, the monthly benefits to which an                          premium dollars, which reduce (dollar                          qualifying widows or widowers with
                                                    individual is entitled under section 202                       for dollar) the amount of general                              dependent children, or married
                                                    or 223 of the Act do not include                               revenue received by Part B from the                            individuals filing separately who lived
                                                    retroactive adjustments or payments and                        general fund of the Treasury. Because of                       apart from their spouses for the entire
                                                    deductions on account of work. Also,                           this general revenue offset, the                               taxable year), or joint tax returns.

                                                                                                                                                                                            Income-related
                                                      Beneficiaries who file individual tax returns with                     Beneficiaries who file joint tax returns with                     monthly          Total monthly
                                                                           income:                                                            income:                                         adjustment      premium amount
                                                                                                                                                                                                amount

                                                    Less than or equal to $85,000 ...............................       Less than or equal to $170,000 .............................                  $0.00           $134.00
                                                    Greater than $85,000 and less than or equal to                      Greater than $170,000 and less than or equal to                               53.50            187.50
                                                      $107,000.                                                           $214,000.
                                                    Greater than $107,000 and less than or equal to                     Greater than $214,000 and less than or equal to                              133.90            267.90
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                                                      $133,500.                                                           $267,000.
                                                    Greater than $133,500 and less than or equal to                     Greater than $267,000 and less than or equal to                              214.30            348.30
                                                      $160,000.                                                           $320,000.
                                                    Greater than $160,000 ...........................................   Greater than $320,000 ...........................................            294.60            428.60



                                                      In addition, the monthly premium                             beneficiaries who are married and lived                        the taxable year, but who file separate
                                                    rates to be paid by (or on behalf of)                          with their spouses at any time during



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                                                                                       Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Notices                                                                               55373

                                                    tax returns from their spouses, are as
                                                    follows:

                                                                                                                                                                                                              Income-related
                                                       Beneficiaries who are married and lived with their spouses at any time during the year, but who file                                                      monthly                 Total monthly
                                                                                    separate tax returns from their spouses:                                                                                    adjustment             premium amount
                                                                                                                                                                                                                  amount

                                                    Less than or equal to $85,000 ....................................................................................................................                     $0.00                $134.00
                                                    Greater than $85,000 ..................................................................................................................................               294.60                 428.60



                                                       The Part B annual deductible for 2018                               standard monthly premium is the                                          actual and projected costs, and the
                                                    is $183.00 for all beneficiaries.                                      amount that would be necessary to                                        amount of incurred, but unpaid,
                                                                                                                           finance Part B on an incurred basis. This                                expenses. Numerous factors determine
                                                    B. Statement of Actuarial Assumptions
                                                                                                                           is the amount of income that would be                                    what level of assets is appropriate to
                                                    and Bases Employed in Determining the
                                                                                                                           sufficient to pay for services furnished                                 cover variation between actual and
                                                    Monthly Actuarial Rates and the                                        during that year (including associated
                                                    Monthly Premium Rate for Part B                                                                                                                 projected costs. The three most
                                                                                                                           administrative costs) even though                                        important of these factors are (1) the
                                                    Beginning January 2018                                                 payment for some of these services will                                  difference from prior years between the
                                                      The actuarial assumptions and bases                                  not be made until after the close of the                                 actual performance of the program and
                                                    used to determine the monthly actuarial                                year. The portion of income required to                                  estimates made at the time financing
                                                    rates and the monthly premium rates for                                cover benefits not paid until after the                                  was established; (2) the likelihood and
                                                    Part B are established by the Centers for                              close of the year is added to the trust                                  potential magnitude of expenditure
                                                    Medicare & Medicaid Services Office of                                 fund and used when needed.                                               changes resulting from enactment of
                                                    the Actuary. The estimates underlying                                     The premium rates are established
                                                                                                                                                                                                    legislation affecting Part B costs in a
                                                    these determinations are prepared by                                   prospectively and are, therefore, subject
                                                                                                                                                                                                    year subsequent to the establishment of
                                                    actuaries meeting the qualification                                    to projection error. Additionally,
                                                                                                                                                                                                    financing for that year; and (3) the
                                                    standards and following the actuarial                                  legislation enacted after the financing
                                                                                                                           was established, but effective for the                                   expected relationship between incurred
                                                    standards of practice established by the
                                                                                                                           period in which the financing is set,                                    and cash expenditures. These factors are
                                                    Actuarial Standards Board.
                                                                                                                           may affect program costs. As a result,                                   analyzed on an ongoing basis, as the
                                                    1. Actuarial Status of the Part B Account                              the income to the program may not                                        trends can vary over time.
                                                    in the Supplementary Medical                                           equal incurred costs. Therefore, trust                                      Table 1 summarizes the estimated
                                                    Insurance Trust Fund                                                   fund assets must be maintained at a                                      actuarial status of the trust fund as of
                                                      Under section 1839 of the Act, the                                   level that is adequate to cover an                                       the end of the financing period for 2016
                                                    starting point for determining the                                     appropriate degree of variation between                                  and 2017.

                                                    TABLE 1—ESTIMATED ACTUARIAL STATUS OF THE PART B ACCOUNT IN THE SUPPLEMENTARY MEDICAL INSURANCE TRUST
                                                                                  FUND AS OF THE END OF THE FINANCING PERIOD
                                                                                                                                                                                                                                           Assets less
                                                                                                                                                                                                     Assets              Liabilities
                                                                                                      Financing period ending                                                                                                                liabilities
                                                                                                                                                                                                  (in millions)        (in millions)       (in millions)

                                                    December 31, 2016 .....................................................................................................................               $87,983           $28,494             $59,489
                                                    December 31, 2017 .....................................................................................................................                79,236            30,559              48,677



                                                    2. Monthly Actuarial Rate for Enrollees                                program data through 2016 and then                                       contingency margin and ¥$1.89 for
                                                    Age 65 and Older                                                       projecting these costs for subsequent                                    interest earnings.
                                                                                                                           years. The projection factors used for                                      The contingency margin for 2018 is
                                                      The monthly actuarial rate for                                       financing periods from January 1, 2015                                   affected by several factors. Starting in
                                                    enrollees age 65 and older is one-half of                              through December 31, 2018 are shown                                      2011, manufacturers and importers of
                                                    the sum of monthly amounts for (1) the                                 in Table 2.                                                              brand-name prescription drugs pay a fee
                                                    projected cost of benefits; and (2)                                       As indicated in Table 3, the projected                                that is allocated to the Part B account of
                                                    administrative expenses for each                                       per enrollee amount required to pay for                                  the SMI trust. For 2018, the total of
                                                    enrollee age 65 and older, after                                       one-half of the total of benefits and                                    these brand-name drug fees is estimated
                                                    adjustments to this sum to allow for                                   administrative costs for enrollees age 65                                to be $4.1 billion. The contingency
                                                    interest earnings on assets in the trust                               and over for 2018 is $247.91. Based on                                   margin has been reduced to account for
                                                    fund and an adequate contingency                                       current estimates, the assets associated                                 this additional revenue.
                                                    margin. The contingency margin is an
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                                                                                                                           with the aged Medicare beneficiaries at                                     Another factor affecting the
                                                    amount appropriate to provide for                                      the end of 2017 are not sufficient to                                    contingency margin is attributable to the
                                                    possible variation between actual and                                  cover the amount of incurred, but                                        requirement that certain payment
                                                    projected costs and to amortize any                                    unpaid, expenses and to provide for a                                    incentives, to encourage the
                                                    surplus assets or unfunded liabilities.                                significant degree of variation between                                  development and use of health
                                                      The monthly actuarial rate for                                       actual and projected costs. Thus, a                                      information technology (HIT) by
                                                    enrollees age 65 and older for 2018 is                                 positive contingency margin is needed.                                   Medicare physicians, are to be excluded
                                                    determined by first establishing per                                   The monthly actuarial rate of $261.90                                    from the premium determination. HIT
                                                    enrollee costs by type of service from                                 provides an adjustment of $15.88 for a                                   positive incentive payments or penalties


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                                                    55374                          Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Notices

                                                    will be directly offset through transfers                       one-half of the total of benefits and                            of assets over liabilities of $65,598
                                                    with the general fund of the Treasury.                          administrative costs for disabled                                million by the end of December 2018
                                                    The monthly actuarial rate includes an                          enrollees for 2018 is $303.70. The                               under the cost growth rate assumptions
                                                    adjustment of $0.17 for HIT incentives                          monthly actuarial rate of $295.00 also                           shown in Table 2 and assuming that the
                                                    in 2018.                                                        provides an adjustment of ¥$2.73 for                             provisions of current law are fully
                                                       The traditional goal for the Part B                          interest earnings and ¥$5.97 for a                               implemented. This result amounts to
                                                    reserve has been that assets minus                              contingency margin, reflecting the same                          17.8 percent of the estimated total
                                                    liabilities at the end of a year should                         factors described previously for the aged                        incurred expenditures for the following
                                                    represent between 15 and 20 percent of                          actuarial rate at magnitudes appropriate                         year.
                                                    the following year’s total incurred                             to the disabled rate determination.
                                                    expenditures. To accomplish this goal, a                        Based on current estimates, the assets                              Assumptions that are somewhat more
                                                    17-percent reserve ratio, which is a fully                      associated with the disabled Medicare                            pessimistic (and that therefore test the
                                                    adequate contingency reserve level, has                         beneficiaries at the end of 2017 are                             adequacy of the assets to accommodate
                                                    been the normal target used to calculate                        sufficient to cover the amount of                                projection errors) produce a surplus of
                                                    the Part B premium. Assets at the end                           incurred, but unpaid, expenses and to                            $16,355 million by the end of December
                                                    of 2017 are expected to be below the                            provide for a significant degree of                              2018 under current law, which amounts
                                                    fully adequate level. The financing rates                       variation between actual and projected                           to 3.9 percent of the estimated total
                                                    for 2018 are set to restore the asset level                     costs. A negative contingency margin is                          incurred expenditures for the following
                                                    in the Part B account to the fully                              needed to maintain assets at an                                  year. Under fairly optimistic
                                                    adequate level by the end of 2018 under                         appropriate level.                                               assumptions, the monthly actuarial rates
                                                    current law. The actuarial rate of                                The actuarial rate of $295.00 per                              would result in a surplus of $114,191
                                                    $261.90 per month for aged                                      month for disabled beneficiaries, as                             million by the end of December 2018, or
                                                    beneficiaries, as announced in this                             announced in this notice for 2018,                               35.6 percent of the estimated total
                                                    notice for 2018, reflects that combined                         reflects the combined net effect of the                          incurred expenditures for the following
                                                    effect of the factors previously described                      factors described previously for aged
                                                                                                                                                                                     year.
                                                    and the projected assumptions listed in                         beneficiaries and the projection
                                                    Table 2.                                                        assumptions listed in Table 2.                                      The sensitivity analysis indicates that
                                                                                                                                                                                     the premium and general revenue
                                                    3. Monthly Actuarial Rate for Disabled                          4. Sensitivity Testing                                           financing established for 2018, together
                                                    Enrollees                                                          Several factors contribute to                                 with existing Part B account assets,
                                                       Disabled enrollees are those persons                         uncertainty about future trends in                               would be adequate to cover estimated
                                                    under age 65 who are enrolled in Part                           medical care costs. It is appropriate to                         Part B costs for 2018 under current law
                                                    B because of entitlement to Social                              test the adequacy of the rates using                             should actual costs prove to be
                                                    Security disability benefits for more                           alternative cost growth rate                                     somewhat greater than expected.
                                                    than 24 months or because of                                    assumptions. The results of those
                                                    entitlement to Medicare under the end-                          assumptions are shown in Table 5. One                            5. Premium Rates and Deductible
                                                    stage renal disease (ESRD) program.                             set represents increases that are higher
                                                    Projected monthly costs for disabled                            and, therefore, more pessimistic than                               As determined in accordance with
                                                    enrollees (other than those with ESRD)                          the current estimate. The other set                              section 1839 of the Act, the following
                                                    are prepared in a manner parallel to the                        represents increases that are lower and,                         are the 2018 Part B monthly premium
                                                    projection for the aged using                                   therefore, more optimistic than the                              rates to be paid by beneficiaries who file
                                                    appropriate actuarial assumptions (see                          current estimate. The values for the                             either individual tax returns (and are
                                                    Table 2). Costs for the ESRD program are                        alternative assumptions were                                     single individuals, heads of households,
                                                    projected differently because of the                            determined from a statistical analysis of                        qualifying widows or widowers with
                                                    different nature of services offered by                         the historical variation in the respective                       dependent children, or married
                                                    the program.                                                    increase factors.                                                individuals filing separately who lived
                                                       As shown in Table 4, the projected                              As indicated in Table 5, the monthly                          apart from their spouses for the entire
                                                    per enrollee amount required to pay for                         actuarial rates would result in an excess                        taxable year), or joint tax returns.

                                                                                                                                                                                                        Income-related   Total monthly
                                                    Beneficiaries who file individual tax returns with                                                                                                     monthly
                                                                                                                                Beneficiaries who file joint tax returns with income:                                      premium
                                                    income:                                                                                                                                               adjustment        amount
                                                                                                                                                                                                            amount

                                                    Less than or equal to $85,000 .....................................       Less than or equal to $170,000 ...................................                $0.00         $134.00
                                                    Greater than $85,000 and less than or equal to                            Greater than $170,000 and less than or equal to                                   53.50          187.50
                                                      $107,000.                                                                 $214,000.
                                                    Greater than $107,000 and less than or equal to                           Greater than $214,000 and less than or equal to                                  133.90           267.90
                                                      $133,500.                                                                 $267,000.
                                                    Greater than $133,500 and less than or equal to                           Greater than $267,000 and less than or equal to                                  214.30           348.30
                                                      $160,000.                                                                 $320,000.
                                                    Greater than $160,000 .................................................   Greater than $320,000 .................................................          294.60           428.60
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                                                      In addition, the monthly premium                              married and lived with their spouses at                          who file separate tax returns from their
                                                    rates to be paid by beneficiaries who are                       any time during the taxable year, but                            spouses, are as follows:




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                                                                                          Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Notices                                                                             55375

                                                                                                                                                                                                                 Income-related           Total monthly
                                                    Beneficiaries who are married and lived with their spouses at any time during the year, but who file                                                            monthly                 premium
                                                    separate tax returns from their spouses:                                                                                                                       adjustment                amount
                                                                                                                                                                                                                     amount

                                                    Less than or equal to $85,000 ....................................................................................................................                         $0.00              $134.00
                                                    Greater than $85,000 ..................................................................................................................................                   294.60               428.60


                                                                             TABLE 2—PROJECTION FACTORS 1 12-MONTH PERIODS ENDING DECEMBER 31 OF 2015–2018
                                                                                                                                                             [In percent]

                                                                                Physicians’ services                   Durable                                   Other          Outpatient      Home             Hospital           Other       Managed
                                                     Calendar year                                                     medical           Carrier lab 4          carrier          hospital      health             Lab 6         intermediary      care
                                                                                Fees 2            Residual 3          equipment                                services 5                      agency                             services 7

                                                    Aged:
                                                        2015      .......            ¥0.5                  0.7                 5.8                  1.6                   4.4           7.3           1.4               2.4              5.0             2.9
                                                        2016      .......            ¥0.3                 ¥1.2               ¥10.4                 ¥2.5                   6.4           4.9          ¥0.6               2.9              2.1             3.4
                                                        2017      .......             0.4                  1.0                ¥3.1                  4.8                   5.8           8.1           2.5               4.0              5.4             2.6
                                                        2018      .......            ¥0.2                  2.0                 5.1                  0.0                   4.3           7.8           3.0              ¥1.9             ¥4.6             6.4
                                                    Disabled:
                                                        2015      .......            ¥0.5                  0.3                 6.2                 5.8                    5.2           7.1          ¥1.1               0.4             10.1             3.1
                                                        2016      .......            ¥0.3                 ¥0.5                ¥7.2               ¥14.0                    6.9           5.5           0.0               5.2              7.2             4.9
                                                        2017      .......             0.4                  1.1                 0.2                 3.3                    7.3           7.5           3.1               2.9              5.7             3.5
                                                        2018      .......            ¥0.2                  1.9                 4.9                ¥0.1                    4.8           7.7           3.4              ¥2.0             ¥4.4             6.6
                                                      1 Allvalues for services other than managed care are per fee-for-service enrollee. Managed care values are per managed care enrollee.
                                                      2 As  recognized for payment under the program.
                                                      3 Increase in the number of services received per enrollee and greater relative use of more expensive services.
                                                      4 Includes services paid under the lab fee schedule furnished in the physician’s office or an independent lab.
                                                      5 Includes physician-administered drugs, ambulatory surgical center facility costs, ambulance services, parenteral and enteral drug costs, supplies, etc.
                                                      6 Includes services paid under the lab fee schedule furnished in the outpatient department of a hospital.
                                                      7 Includes services furnished in dialysis facilities, rural health clinics, federally qualified health centers, rehabilitation and psychiatric hospitals, etc.



                                                         TABLE 3—DERIVATION OF MONTHLY ACTUARIAL RATE FOR ENROLLEES AGE 65 AND OVER FOR FINANCING PERIODS
                                                                               ENDING DECEMBER 31, 2015 THROUGH DECEMBER 31, 2018
                                                                                                                                                                                CY 2015             CY 2016                 CY 2017            CY 2018

                                                    Covered services (at level recognized):
                                                       Physician fee schedule .............................................................................                           $75.43                  $73.63             $72.71            $73.35
                                                       Durable medical equipment ......................................................................                                 6.28                    5.57               5.27              5.48
                                                       Carrier lab 1 ...............................................................................................                    4.33                    4.18               4.27              4.23
                                                       Other carrier services 2 .............................................................................                          22.51                   23.72              24.47             25.26
                                                       Outpatient hospital ....................................................................................                        43.25                   44.93              47.37             50.57
                                                       Home health .............................................................................................                        9.64                    9.49               9.48              9.67
                                                       Hospital lab 3 .............................................................................................                     2.25                    2.29               2.33              2.26
                                                       Other intermediary services 4 ...................................................................                               17.25                   17.44              17.92             16.94
                                                       Managed care ...........................................................................................                        78.97                   83.20              89.11             96.37

                                                            Total services ....................................................................................                       259.92                  264.46             272.94            284.13
                                                    Cost sharing:
                                                        Deductible .................................................................................................                   ¥5.64               ¥6.35                 ¥7.00             ¥7.00
                                                        Coinsurance ..............................................................................................                    ¥27.95              ¥27.65                ¥27.79            ¥28.27
                                                    Sequestration of benefits .................................................................................                        ¥4.52               ¥4.61                 ¥4.76             ¥4.97
                                                    HIT payment incentives ...................................................................................                         ¥1.08               ¥0.56                 ¥0.02              0.17

                                                            Total benefits .....................................................................................                      220.73                  225.29             233.37            244.04
                                                    Administrative expenses ..................................................................................                          2.82                    4.07               3.45              3.87

                                                    Incurred expenditures ......................................................................................                      223.55                  229.36             236.82            247.91
                                                    Value of interest ...............................................................................................                 ¥1.86                   ¥1.49              ¥1.67             ¥1.89
                                                    Contingency margin for projection error and to amortize the surplus or def-
                                                      icit .................................................................................................................          ¥11.89                    9.73              26.75             15.88
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                                                                  Monthly actuarial rate ........................................................................                     209.80                  237.60             261.90            261.90
                                                       1 Includes       services paid under the lab fee schedule furnished in the physician’s office or an independent lab.
                                                       2 Includes       physician-administered drugs, ambulatory surgical center facility costs, ambulance services, parenteral and enteral drug costs, sup-
                                                    plies, etc.
                                                       3 Includes services paid under the lab fee schedule furnished in the outpatient department of a hospital.
                                                       4 Includes services furnished in dialysis facilities, rural health clinics, federally qualified health centers, rehabilitation and psychiatric hospitals,
                                                    etc.




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                                                    55376                                 Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Notices

                                                          TABLE 4—DERIVATION OF MONTHLY ACTUARIAL RATE FOR DISABLED ENROLLEES FOR FINANCING PERIODS ENDING
                                                                                   DECEMBER 31, 2015 THROUGH DECEMBER 31, 2018
                                                                                                                                                                                   CY 2015               CY 2016          CY 2017      CY 2018

                                                    Covered services (at level recognized):
                                                       Physician fee schedule .............................................................................                                $80.64            $78.54           $77.23        $77.31
                                                       Durable medical equipment ......................................................................                                     12.28             11.17            10.85         11.18
                                                       Carrier lab 1 ...............................................................................................                         7.19              6.08             6.09          5.98
                                                       Other carrier services 2 .............................................................................                               25.33             26.16            27.12         27.88
                                                       Outpatient hospital ....................................................................................                             61.51             63.46            66.36         70.26
                                                       Home health .............................................................................................                             7.94              7.75             7.73          7.84
                                                       Hospital lab 3 .............................................................................................                          2.78              2.86             2.86          2.76
                                                       Other intermediary services 4 ...................................................................                                    45.11             46.59            48.13         50.79
                                                       Managed care ...........................................................................................                             73.38             81.53            90.23         99.74

                                                            Total services ....................................................................................                            316.16            324.13           336.60        353.74
                                                    Cost sharing:
                                                        Deductible .................................................................................................                      ¥5.27              ¥5.94            ¥6.54         ¥6.54
                                                        Coinsurance ..............................................................................................                       ¥42.47             ¥42.17           ¥42.63        ¥43.95
                                                    Sequestration of benefits .................................................................................                           ¥5.37              ¥5.52            ¥5.75         ¥6.06
                                                    HIT payment incentives ...................................................................................                            ¥1.14              ¥0.59            ¥0.02          0.17

                                                            Total benefits .....................................................................................                           261.92            269.91           281.67        297.36
                                                    Administrative expenses ..................................................................................                               3.34              4.88             5.70          6.34

                                                    Incurred expenditures ......................................................................................                           265.26            274.79           287.37        303.70
                                                    Value of interest ...............................................................................................                      ¥2.21             ¥2.56            ¥3.63         ¥2.73
                                                    Contingency margin for projection error and to amortize the surplus or def-
                                                      icit .................................................................................................................               ¥8.25              10.37          ¥29.54         ¥5.97

                                                                  Monthly actuarial rate ........................................................................                          254.80            282.60           254.20        295.00
                                                       1 Includes      services paid under the lab fee schedule furnished in the physician’s office or an independent lab.
                                                       2 Includes      physician-administered drugs, ambulatory surgical center facility costs, ambulance services, parenteral and enteral drug costs, sup-
                                                    plies, etc.
                                                       3 Includes services paid under the lab fee schedule furnished in the outpatient department of a hospital.
                                                       4 Includes services furnished in dialysis facilities, rural health clinics, federally qualified health centers, rehabilitation and psychiatric hospitals,
                                                    etc.

                                                     TABLE 5—ACTUARIAL STATUS OF THE PART B ACCOUNT IN THE SMI TRUST FUND UNDER THREE SETS OF ASSUMPTIONS
                                                                               FOR FINANCING PERIODS THROUGH DECEMBER 31, 2018

                                                                                                             As of December 31,                                                                           2016             2017           2018

                                                    Actuarial status (in millions):
                                                        Assets ...................................................................................................................................          $87,983          $79,236       $97,686
                                                        Liabilities ...............................................................................................................................         $28,494          $30,559       $32,089

                                                       Assets less liabilities .............................................................................................................                $59,489          $48,677       $65,598
                                                       Ratio 1 ...................................................................................................................................           18.9%            14.4%         17.8%
                                                    Low-cost projection:
                                                       Actuarial status (in millions):
                                                            Assets ............................................................................................................................             $87,983          $96,444      $144,913
                                                            Liabilities ........................................................................................................................            $28,494          $28,647       $30,722

                                                            Assets less liabilities .....................................................................................................                   $59,489          $67,797      $114,191
                                                            Ratio 1 ............................................................................................................................             20.2%            22.2%         35.6%
                                                    High-cost projection:
                                                        Actuarial status (in millions):
                                                            Assets ............................................................................................................................             $87,983          $63,188       $50,044
                                                            Liabilities ........................................................................................................................            $28,494          $32,342       $33,708

                                                                  Assets less liabilities .....................................................................................................             $59,489          $30,846       $16,335
                                                                  Ratio 1 ............................................................................................................................       17.9%             8.3%          3.9%
                                                       1 Ratio    of assets less liabilities at the end of the year to the total incurred expenditures during the following year, expressed as a percent.
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                                                    III. Collection of Information                                               Consequently, there is no need for                                      IV. Regulatory Impact Analysis
                                                    Requirements                                                                 review by the Office of Management and
                                                                                                                                                                                                         A. Statement of Need
                                                                                                                                 Budget under the authority of the
                                                      This document does not impose                                              Paperwork Reduction Act of 1995 (44                                       Section 1839 of the Act requires us to
                                                    information collection requirements—                                         U.S.C. 3501 et seq.).                                                   annually announce (that is, by
                                                    that is, reporting, recordkeeping, or                                                                                                                September 30th of each year) the Part B
                                                    third-party disclosure requirements.                                                                                                                 monthly actuarial rates for aged and


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                                                                                       Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Notices                                                                      55377

                                                    disabled beneficiaries as well as the                                     Executive Orders 12866 and 13563                                      annual effect on the economy of $100
                                                    monthly Part B premium. We also                                        direct agencies to assess all costs and                                  million or more. As a result, this notice
                                                    announce the Part B annual deductible                                  benefits of available regulatory                                         is economically significant under
                                                    because its determination is directly                                  alternatives and, if regulation is                                       section 3(f)(1) of Executive Order 12866
                                                    linked to the aged actuarial rate.                                     necessary, to select regulatory                                          and is a major action as defined under
                                                                                                                           approaches that maximize net benefits                                    the Congressional Review Act (5 U.S.C.
                                                    B. Overall Impact                                                      (including potential economic,                                           804(2)).
                                                                                                                           environmental, public health and safety
                                                      We have examined the impacts of this                                                                                                             As discussed earlier, this notice
                                                                                                                           effects, distributive impacts, and
                                                    notice as required by Executive Order                                  equity). A regulatory impact analysis                                    announces that the monthly actuarial
                                                    12866 on Regulatory Planning and                                       (RIA) must be prepared for major                                         rates applicable for 2018 are $261.90 for
                                                    Review (September 30, 1993), Executive                                 notices with economically significant                                    enrollees age 65 and over and $295.00
                                                    Order 13563 on Improving Regulation                                    effects ($100 million or more in any one                                 for disabled enrollees under age 65. It
                                                    and Regulatory Review (January 18,                                     year). For 2018 the standard Part B                                      also announces the 2018 monthly Part B
                                                    2011), the Regulatory Flexibility Act                                  premium rate, the Part B income-related                                  premium rates to be paid by
                                                    (RFA) (September 19, 1980, Pub. L. 96–                                 premium rates, and the Part B                                            beneficiaries who file either individual
                                                    354), section 1102(b) of the Social                                    deductible are the same as the                                           tax returns (and are single individuals,
                                                    Security Act, section 202 of the                                       respective amounts for 2017. However,                                    heads of households, qualifying widows
                                                    Unfunded Mandates Reform Act of 1995                                   approximately 70 percent of Part B                                       or widowers with dependent children,
                                                    (March 22, 1995, Pub. L. 104–4),                                       enrollees who were held harmless from                                    or married individuals filing separately
                                                    Executive Order 13132 on Federalism                                    the full increase in the Part B premium                                  who lived apart from their spouses for
                                                    (August 4, 1999), and the Congressional                                in 2017 will pay an increase in their                                    the entire taxable year), or joint tax
                                                    Review Act (5 U.S.C. 804(2)).                                          Part B premium, which will have an                                       returns.

                                                                                                                                                                                                              Income-related    Total monthly
                                                    Beneficiaries who file individual tax returns with                           Beneficiaries who file joint tax returns with                                   monthly          premium
                                                    income:                                                                      income:                                                                        adjustment         amount
                                                                                                                                                                                                                  amount

                                                    Less than or equal to $85,000 ...............................                Less than or equal to $170,000 .............................                           $0.00          $134.00
                                                    Greater than $85,000 and less than or equal to                               Greater than $170,000 and less than or equal to                                        53.50           187.50
                                                      $107,000.                                                                    $214,000.
                                                    Greater than $107,000 and less than or equal to                              Greater than $214,000 and less than or equal to                                       133.90           267.90
                                                      $133,500.                                                                    $267,000.
                                                    Greater than $133,500 and less than or equal to                              Greater than $267,000 and less than or equal to                                       214.30           348.30
                                                      $160,000.                                                                    $320,000.
                                                    Greater than $160,000 ...........................................            Greater than $320,000 ...........................................                     294.60           428.60



                                                      In addition, the monthly premium                                     any time during the taxable year, but                                    spouses, are also announced and listed
                                                    rates to be paid by beneficiaries who are                              who file separate tax returns from their                                 in the following chart:
                                                    married and lived with their spouses at

                                                                                                                                                                                                              Income-related    Total monthly
                                                    Beneficiaries who are married and lived with their spouses at any time during the year, but who file                                                         monthly          premium
                                                    separate tax returns from their spouses:                                                                                                                    adjustment         amount
                                                                                                                                                                                                                  amount

                                                    Less than or equal to $85,000 ....................................................................................................................                  $0.00          $134.00
                                                    Greater than $85,000 ..................................................................................................................................            294.60           428.60



                                                      The RFA requires agencies to analyze                                 adjustment amounts to be paid by                                         as a hospital that is located outside of
                                                    options for regulatory relief of small                                 beneficiaries with modified adjusted                                     a Metropolitan Statistical Area and has
                                                    businesses, if a rule has a significant                                gross income above certain threshold                                     fewer than 100 beds. As we discussed
                                                    impact on a substantial number of small                                amounts. As a result, we are not                                         previously, we are not preparing an
                                                    entities. For purposes of the RFA, small                               preparing an analysis for the RFA                                        analysis for section 1102(b) of the Act
                                                    entities include small businesses,                                     because the Secretary has determined                                     because the Secretary has determined
                                                    nonprofit organizations, and small                                     that this notice will not have a                                         that this notice will not have a
                                                    governmental jurisdictions. Individuals                                significant economic impact on a                                         significant effect on a substantial
                                                    and states are not included in the                                     substantial number of small entities.                                    number of small rural hospitals.
                                                    definition of a small entity. This notice                                 In addition, section 1102(b) of the Act                                  Section 202 of the Unfunded
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                    announces the monthly actuarial rates                                  requires us to prepare a regulatory                                      Mandates Reform Act of 1995 (UMRA)
                                                    for aged (age 65 and over) and disabled                                impact analysis if a rule may have a                                     also requires that agencies assess
                                                    (under 65) beneficiaries enrolled in Part                              significant impact on the operations of                                  anticipated costs and benefits before
                                                    B of the Medicare SMI program                                          a substantial number of small rural                                      issuing any rule whose mandates
                                                    beginning January 1, 2018. Also, this                                  hospitals. This analysis must conform to                                 require spending in any one year of
                                                    notice announces the monthly premium                                   the provisions of section 604 of the                                     $100 million in 1995 dollars, updated
                                                    for aged and disabled beneficiaries as                                 RFA. For purposes of section 1102(b) of                                  annually for inflation. In 2017, that
                                                    well as the income-related monthly                                     the Act, we define a small rural hospital                                threshold is approximately $156


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                                                    55378                      Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Notices

                                                    million. Part B enrollees who are also                    Dated: October 27, 2017.                            gain approval of a new drug application
                                                    enrolled in Medicaid have their                         Seema Verma,                                          (NDA).
                                                    monthly Part B premiums paid by                         Administrator, Centers for Medicare &                    The 1984 amendments include what
                                                    Medicaid. The cost to each state                        Medicaid Services.                                    is now section 505(j)(7) of the Federal
                                                    Medicaid program from the 2018                            Dated: November 1, 2017.                            Food, Drug, and Cosmetic Act (21 U.S.C.
                                                    premium increase is estimated to be less                Eric D. Hargan,                                       355(j)(7)), which requires FDA to
                                                    than the threshold. This notice does not                Acting Secretary, Department of Health and
                                                                                                                                                                  publish a list of all approved drugs.
                                                    impose mandates that will have a                        Human Services.                                       FDA publishes this list as part of the
                                                                                                                                                                  ‘‘Approved Drug Products With
                                                    consequential effect of the threshold                   [FR Doc. 2017–24877 Filed 11–17–17; 4:15 pm]
                                                                                                                                                                  Therapeutic Equivalence Evaluations,’’
                                                    amount or more on state, local, or tribal               BILLING CODE 4120–01–P
                                                                                                                                                                  which is known generally as the
                                                    governments or on the private sector.                                                                         ‘‘Orange Book.’’ Under FDA regulations,
                                                      Executive Order 13132 establishes                                                                           drugs are removed from the list if the
                                                                                                            DEPARTMENT OF HEALTH AND
                                                    certain requirements that an agency                                                                           Agency withdraws or suspends
                                                                                                            HUMAN SERVICES
                                                    must meet when it publishes a proposed                                                                        approval of the drug’s NDA or ANDA
                                                    rule (and subsequent final rule) that                   Food and Drug Administration                          for reasons of safety or effectiveness or
                                                    imposes substantial direct compliance                                                                         if FDA determines that the listed drug
                                                    costs on state and local governments,                   [Docket Nos. FDA–2017–P–3989, FDA–                    was withdrawn from sale for reasons of
                                                    preempts state law, or otherwise has                    2017–P–4195, FDA–2017–P–5114, FDA–                    safety or effectiveness (21 CFR 314.162).
                                                                                                            2017–P–5909, FDA–2017–P–5910, and FDA–                   A person may petition the Agency to
                                                    Federalism implications. We have
                                                                                                            2017–P–5967]                                          determine, or the Agency may
                                                    determined that this notice does not
                                                    significantly affect the rights, roles, and                                                                   determine on its own initiative, whether
                                                                                                            Determination That TRINTELLIX                         a listed drug was withdrawn from sale
                                                    responsibilities of states. Accordingly,                (Vortioxetine Hydrobromide) Oral                      for reasons of safety or effectiveness.
                                                    the requirements of Executive Order                     Tablet, EQ 15 Milligram Base, Was Not                 This determination may be made at any
                                                    13132 do not apply to this notice.                      Withdrawn From Sale for Reasons of                    time after the drug has been withdrawn
                                                      In accordance with the provisions of                  Safety or Effectiveness                               from sale, but must be made prior to
                                                    Executive Order 12866, this notice was                  AGENCY:    Food and Drug Administration,              approving an ANDA that refers to the
                                                    reviewed by the Office of Management                    HHS.                                                  listed drug (§ 314.161 (21 CFR 314.161)).
                                                    and Budget.                                                                                                   FDA may not approve an ANDA that
                                                                                                            ACTION:   Notice.
                                                                                                                                                                  does not refer to a listed drug.
                                                    V. Waiver of Proposed Notice                                                                                     TRINTELLIX (vortioxetine
                                                                                                            SUMMARY:    The Food and Drug
                                                                                                            Administration (FDA or Agency) has                    hydrobromide) oral tablets, EQ 5 mg
                                                      The Medicare statute requires the
                                                                                                            determined that TRINTELLIX                            base, EQ 10 mg base, EQ 15 mg base,
                                                    publication of the monthly actuarial
                                                                                                            (vortioxetine hydrobromide) oral tablet,              and EQ 20 mg base, are the subject of
                                                    rates and the Part B premium amounts                                                                          NDA 204447, held by Takeda
                                                    in September. We ordinarily use general                 equivalent to (EQ) 15 milligram (mg)
                                                                                                            base, was not withdrawn from sale for                 Pharmaceuticals, USA, Inc., and
                                                    notices, rather than notice and comment                                                                       initially approved on September 30,
                                                    rulemaking procedures, to make such                     reasons of safety or effectiveness. This
                                                                                                            determination will allow FDA to                       2013. TRINTELLIX is indicated for the
                                                    announcements. In doing so, we note                                                                           treatment of major depressive disorder.
                                                    that, under the Administrative                          approve abbreviated new drug
                                                                                                                                                                     TRINTELLIX (vortioxetine
                                                                                                            applications (ANDAs) for vortioxetine
                                                    Procedure Act, interpretive rules,                                                                            hydrobromide) oral tablets, EQ 5 mg
                                                                                                            hydrobromide oral tablet, 15 mg base, if
                                                    general statements of policy, and rules                                                                       base, EQ 10 mg base, and EQ 20 mg
                                                                                                            all other legal and regulatory
                                                    of agency organization, procedure, or                                                                         base, are listed in the ‘‘Prescription Drug
                                                                                                            requirements are met.
                                                    practice are excepted from the                                                                                Product List’’ section of the Orange
                                                                                                            FOR FURTHER INFORMATION CONTACT:                      Book, and TRINTELLIX (vortioxetine
                                                    requirements of notice and comment
                                                                                                            Meadow W. Platt, Center for Drug                      hydrobromide) oral tablet, EQ 15 mg
                                                    rulemaking.
                                                                                                            Evaluation and Research, Food and                     base, is listed in the ‘‘Discontinued Drug
                                                      We considered publishing a proposed                   Drug Administration, 10903 New                        Product List’’ section of the Orange
                                                    notice to provide a period for public                   Hampshire Ave., Bldg. 51, Rm. 6228,                   Book. Takeda Pharmaceuticals, USA,
                                                    comment. However, we may waive that                     Silver Spring, MD 20993–0002, 301–                    Inc., has never marketed TRINTELLIX
                                                    procedure if we find, for good cause,                   796–1830.                                             (vortioxetine hydrobromide) oral tablet,
                                                    that prior notice and comment are                       SUPPLEMENTARY INFORMATION: In 1984,                   EQ 15 mg base. In previous instances
                                                    impracticable, unnecessary, or contrary                 Congress enacted the Drug Price                       (see, e.g., 72 FR 9763 (March 5, 2007),
                                                    to the public interest. The statute                     Competition and Patent Term                           61 FR 25497 (May 21, 1996)), the
                                                    establishes the time period for which                   Restoration Act of 1984 (Pub. L. 98–417)              Agency has determined that, for
                                                    the premium rates will apply, and                       (the 1984 amendments), which                          purposes of §§ 314.161 and 314.162,
                                                    delaying publication of the Part B                      authorized the approval of duplicate                  never marketing an approved drug
                                                    premium rate such that it would not be                  versions of drug products under an                    product is equivalent to withdrawing
                                                    published before that time would be                     ANDA procedure. ANDA applicants                       the drug from sale.
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                    contrary to the public interest.                        must, with certain exceptions, show that                 Lachman Consultant Services, Inc.;
                                                    Moreover, we find that notice and                       the drug for which they are seeking                   INC Research, LLC; Locke Lord, LLP;
                                                    comment are unnecessary because the                     approval contains the same active                     Goodwin Procter, LLP; Cipla USA Inc.;
                                                    formulas used to calculate the Part B                   ingredient in the same strength and                   and Apotex, Inc., submitted citizen
                                                    premiums are statutorily directed.                      dosage form as the ‘‘listed drug,’’ which             petitions dated June 29, 2017; July 12,
                                                    Therefore, we find good cause to waive                  is a version of the drug that was                     2017; August 21, 2017; September 25,
                                                    publication of a proposed notice and                    previously approved. ANDA applicants                  2017; September 25, 2017; and
                                                    solicitation of public comments.                        do not have to repeat the extensive                   September 27, 2017, respectively
                                                                                                            clinical testing otherwise necessary to               (Docket Nos. FDA–2017–P–3989, FDA–


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Document Created: 2017-11-21 00:43:01
Document Modified: 2017-11-21 00:43:01
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesEffective Date: January 1, 2018.
ContactM. Kent Clemens, (410) 786-6391.
FR Citation82 FR 55370 
RIN Number0938-AS72

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