TRICARE Pharmacy Benefits Program Reforms, 63574-63578 [2018-26562]
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63574
Federal Register / Vol. 83, No. 237 / Tuesday, December 11, 2018 / Rules and Regulations
Dated: December 4, 2018.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2018–26712 Filed 12–10–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[DOD–2018–HA–0062]
RIN 0720–AB75
TRICARE Pharmacy Benefits Program
Reforms
Office of the Secretary,
Department of Defense (DoD).
ACTION: Interim final rule.
AGENCY:
This interim final rule
implements Section 702 of the National
Defense Authorization Act for Fiscal
Year 2018 (NDAA FY18). The law
makes significant changes to the
TRICARE Pharmacy Benefits Program,
specifically it: Updates co-payment
requirements; authorizes a new process
for encouraging use of pharmaceutical
agents that provide the best clinical
effectiveness by excluding coverage for
particular pharmaceutical agents that
provide very little or no clinical
effectiveness relative to similar agents
and for giving preferential status to
agents that provide enhanced clinical
effectiveness; and authorizes special
reimbursement methods, amounts, and
procedures to encourage use or highvalue products and discourage use of
low-value products with respect to
pharmaceutical agents provided as part
of medical services from authorized
providers.
SUMMARY:
This interim final rule is
effective December 11, 2018. Comments
must be received by February 11, 2019.
FOR FURTHER INFORMATION CONTACT:
David W. Bobb, RPh, JD, Chief,
Pharmacy Operations, Defense Health
Agency (DHA), telephone (703) 681–
2890.
DATES:
SUPPLEMENTARY INFORMATION:
I. Executive Summary
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A. Purpose of the Interim Final Rule
This interim final rule implements
Section 702 of the National Defense
Authorization Act for Fiscal Year 2018
(NDAA FY18), which does three things:
(1) It updates cost-sharing requirements
for outpatient pharmaceutical
prescriptions filled by retail pharmacies
and the TRICARE mail order pharmacy
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program. (2) It authorizes a new
Uniform Formulary process for
encouraging use of pharmaceutical
agents in the TRICARE Pharmacy
Benefits Program that provide the best
clinical effectiveness by excluding
coverage for particular pharmaceutical
agents that provide very little or no
clinical effectiveness relative to similar
agents and giving preferential status to
agents that provide enhanced clinical
effectiveness. (3) It authorizes special
reimbursement methods, amounts, and
procedures to encourage use of highvalue products and discourage use of
low-value products with respect to
pharmaceutical agents provided as part
of medical services from authorized
providers. This interim final rule
implements each of these three statutory
changes. This is being issued as an
interim final rule in order to implement
expeditiously the reforms authorized by
Section 702, as specifically authorized
by subsection (b)(3) of that section.
Based on that clear Congressional
authority and intent, the Department
finds that obtaining public comment in
advance of issuing this rule is
impracticable, unnecessary, and
contrary to the public interest. Delaying
expeditious implementation by waiting
for public comments to this interim rule
not only delays the significant cost
savings to the government that will be
realized through implementation but
also continues to allow coverage of
pharmaceutical agents that do not
provide the best clinical effectiveness
for beneficiaries. In addition, subsection
(b)(3) of Section 702 states that ‘‘in order
to implement expeditiously the reforms
authorized . . . (A) the Secretary of
Defense may prescribe an interim final
rule, (B) not later than one year after
prescribing the interim final rule and
considering public comments with
respect to such interim final rule, by
prescribing a final rule.’’ Clearly
Congressional intent is to implement the
authorized reforms quickly.
Nonetheless, DoD invites public
comments on this rule and is committed
to considering all comments and issuing
a final rule as soon as practicable (but
not later than one year after issuance of
this interim final rule).
B. Legal Authority for the Regulatory
Action
This interim final rule is under the
primary authority of 10 U.S.C. 1074g,
1079 and 1086, and Section 702 of
NDAA–18. Specifically, section
702(b)(3) of NDAA–18 authorizes DoD
to ‘‘prescribe such changes to the
regulations implementing the TRICARE
program . . . by prescribing an interim
final rule.’’ TRICARE program
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regulations (32 CFR part 199) are issued
under statutory authorities including 10
U.S.C. 1074g (the Pharmacy Benefits
Program) and 10 U.S.C. 1079 and 1086
(TRICARE medical benefits). Section
702 of NDAA–18 amends both section
1074g and section 1079 (the section
1079 amendment being automatically
applicable to section 1086).
C. Summary of Major Provisions of the
Interim Final Rule
The major provisions of the interim
final rule are the following.
1. Updating Cost-Sharing. Under the
authority of section 1074g(a)(6), as
amended by Section 702(a) of NDAA
FY18, we are amending 32 CFR
199.21(i) to cross reference the statutory
changes.
2. Uniform Formulary Changes. Based
on section 1074g(a)(10), as added by
Section 702(b)(1) of NDAA FY 18, we
are changing the Uniform Formulary
process under 32 CFR 199.21(e) by
authorizing the exclusion of any
pharmaceutical agent that provides very
little or no clinical effectiveness relative
to similar agents, and preferential status
for pharmaceutical agents that have
enhanced clinical effectiveness relative
to similar agents.
3. Pharmaceutical Agents as Part of
Medical Services. Based on 10 U.S.C.
1079(q), as added by Section 702(b)(2)
of NDAA FY18, we are changing
provisions of 32 CFR 199.14 to
authorize the adoption of special
reimbursement methods, amounts and
procedures to encourage the use of high
value products and discourage the use
of low value products—both relative to
similar agents—in connection with
pharmaceutical agents provided as part
of outpatient medical services covered
by TRICARE.
II. Provisions of Interim Final Rule
A. Updating Co-Payments
The interim final rule amends 32 CFR
199.21(i)(2), which is the paragraph of
the TRICARE regulation that governs
cost-sharing amounts under the
Pharmacy Benefits Program. The
amended language simply cross
references the statutory specifications
on cost-sharing, including the table set
forth in 10 U.S.C. 1074g(a)(6)(A). This
table lists cost sharing amounts for the
years 2018 through 2027 for generic,
formulary, and non-formulary
pharmaceutical agents dispensed by
retail network pharmacies and the mail
order pharmacy program. Two
exceptions are that there is a $0 costshare for vaccines/immunizations
authorized as preventive care for
eligible beneficiaries and provided by
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retail network pharmacies and a $0 costshare for smoking cessation
pharmaceutical agents covered under
the smoking cessation program. Another
special rule under the statute is that for
survivors of members who die on active
duty and for disability retirees and their
families, cost-sharing increases will not
apply, and the 2017 amounts will
remain in effect. The interim final rule
also provides that for any year after
2027, the cost-sharing amounts will
reflect changes in the costs of
pharmaceutical agents and prescription
dispensing, calculated separately for
generic, formulary, and non-formulary
drugs in each applicable point of
service.
B. Uniform Formulary Changes
The interim final rule amends 32 CFR
199.21(e)(3) to provide that the
Pharmacy and Therapeutics Committee
may recommend and the Director may,
after considering the comments and
recommendations of the Beneficiary
Advisory Panel, approve special
uniform formulary actions to encourage
use of pharmaceutical agents that
provide the best clinical effectiveness to
covered beneficiaries and DoD,
including consideration of better care,
healthier people, and smarter spending.
Such special actions may operate as
exceptions to the normal rules and
procedures. Specifically, the Pharmacy
and Therapeutics Committee may
recommend complete or partial
exclusion from the pharmacy benefits
program of any pharmaceutical agent
the Director determines provides very
little or no clinical effectiveness relative
to similar agents—i.e., other
pharmaceutical agents in the same drug
class—to covered beneficiaries and DoD.
A partial exclusion under this paragraph
may take the form (as one example) of
a limitation on the clinical conditions,
diagnoses, or indications for which the
pharmaceutical agent may be
prescribed. (As an example of this, offlabel uses of a pharmaceutical agent
may be disallowed.) A partial exclusion
may be implemented through
preauthorization or other means
recommended by the Pharmacy and
Therapeutics Committee. In the case of
a partial exclusion, a pharmaceutical
agent may be available on the nonformulary tier of the uniform formulary
for limited purposes and for other
purposes be excluded. In addition, the
Pharmacy and Therapeutics Committee
may recommend to the Director giving
preferential status—based on a
determination of enhanced clinical
effectiveness relative to other agents in
the same drug class—to any non-generic
pharmaceutical agent of the uniform
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formulary by treating it for purposes of
cost-sharing as a generic product.
C. Pharmaceutical Agents as Part of
Medical Services
The interim final rule amends 32 CFR
199.14(a)(6) and (j)(1) to provide that
TRICARE may adopt special
reimbursement methods, amounts, and
procedures to encourage the use of highvalue pharmaceutical agents as part of
medical services furnished in a hospital
outpatient setting or as part of any other
medical services provided to TRICARE
beneficiaries. Although TRICARE
generally follows Medicare’s
reimbursement methodology when
practicable for such medical services
which include medically necessary
administration of drugs, Section
702(b)(2) of NDAA FY18 authorizes the
adoption of special reimbursement
methods when determined appropriate
to encourage the use of high-value
pharmaceutical agents and discourage
the use of low-value agents. For
example, Medicare’s reimbursement
formula for physician-administered
drugs paid under Part B is Average Sales
Price (ASP) + 6%. Medicare and
TRICARE reimburse providers ASP + 6
percent for the drug regardless of the
price a provider pays for the drug.
Both Medicare and TRICARE
acknowledge that such payment for
physician-administered drugs does not
incentivize high-value clinically driven,
low cost drugs. To the contrary, the
payment methods for physicianadministered drugs using the ASP plus
6 percent raises many concerns
including that it may encourage the use
of more expensive drugs because the 6%
add-on generates more revenue for more
expensive drugs without regard to the
relative clinical value of the product
compared to other products in the same
drug class. In order to remove the
incentive for using higher priced
products that have no higher clinical
value, TRICARE may utilize the
authority provided by the NDAA–18 to
restructure—at least for certain selected
drug classes, or categories of
pharmaceuticals (identified in
coordination with the Pharmacy and
Therapeutics Committee, or other
entities as described in the
implementing instructions)—the
reimbursement amount. For example,
TRICARE is evaluating established the
ASP add-on as a percentage (likely 6
percent) of the median value of all drugs
in a particular class, rather than
attaching the 6% add-on to the ASP of
a particular drug. The specific
modifications to drug pricing for
physician-administered drugs
authorized by this IFR and NDAA FY18
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shall be published in TRICARE’s
implementing instructions (manuals) as
approved by the Director, DHA, and
shall be published on the health.mil
website. The amendment to
§ 199.14(j)(1) will authorize this.
III. Regulatory Procedures
Interim Final Rule Justification
This is being issued as an interim
final rule in order to implement
expeditiously the reforms authorized by
Section 702, as specifically authorized
by subsection (b)(3) of that section.
Based on that clear Congressional
authority and intent, the Department
finds that obtaining public comment in
advance of issuing this rule is
impracticable, unnecessary, and
contrary to the public interest.
Executive Order (E.O.) 13771,
‘‘Reducing Regulation and Controlling
Regulatory Costs’’
E.O. 13771 seeks to control costs
associated with the government
imposition of private expenditures
required to comply with Federal
regulations and to reduce regulations
that impose such costs. Consistent with
the analysis of transfer payments under
OMB Circular A–4, this interim final
rule does not involve regulatory costs
subject to E.O. 13771. Rather, this
interim final rule affects only health
care reimbursement payments under the
TRICARE program. Aside from the
‘‘housekeeping’’ change to the
regulation to incorporate the updated
copayment amounts enacted by
Congress, the interim final rule makes
two changes to the program: a new
authority under the Uniform Formulary
process and revised payment authority
for pharmaceutical agents as part of
medical services.
Executive Order 12866, ‘‘Regulatory
Planning and Review’’ and Executive
Order 13563, ‘‘Improving Regulation
and Regulatory Review’’
Executive Orders 13563 and 12866
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, distribute impacts, and equity).
Executive Order 13563 emphasizes the
importance of quantifying both costs
and benefits, of reducing costs, of
harmonizing rules, and of promoting
flexibility. This interim final rule has
been designated a ‘‘significant
regulatory action,’’ although not
economically significant, under section
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3(f) of Executive Order 12866.
Accordingly, this rule has been
reviewed by the Office of Management
and Budget (OMB).
The economic effect of these changes
is limited to government
reimbursements to health care
providers/suppliers that under Circular
A–4 are not considered as costs imposed
on the economy. The expected
reduction in government payments to
pharmaceutical companies is based on
some predicted increase in use of higher
value medications and a corresponding
decrease in the use of lower value
medications in drug classes where
different drugs have comparable clinical
effect. The expected value of this shift
in use of some medications—i.e., the
quantity of the transfer payments—is
$30 million per year.
An initial analysis identified a sample
group of candidate drugs that do not
offer additional therapeutic benefit over
other formulary items. By comparing the
current costs to those of a lower-priced
comparator and assuming similar
utilization rates, the average cost
avoidance was $1.5M/drug/year, with a
more conservative cost avoidance of
$1M/drug/year. When fully
implemented, this new process could
average 30 drugs per year at a
conservative cost avoidance of $1M/
drug/year.
Congressional Review Act, 5 U.S.C.
804(2)
Under the Congressional Review Act,
a major rule may not take effect until at
least 60 days after submission to
Congress of a report regarding the rule.
A major rule is one that would have an
annual effect on the economy of $100M
or more or have certain other impacts.
This final rule is not a major rule under
the Congressional Review Act.
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Public Law 96–354, ‘‘Regulatory
Flexibility Act’’ (RFA), (5 U.S.C. 601)
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Public Law 96–511, ‘‘Paperwork
Reduction Act’’ (44 U.S.C. Chapter 35)
This rulemaking does not contain a
‘‘collection of information’’
requirement, and will not impose
additional information collection
requirements on the public under Public
Law 96–511, ‘‘Paperwork Reduction
Act’’ (44 U.S.C. chapter 35).
Executive Order 13132, ‘‘Federalism’’
This interim final rule has been
examined for its impact under E.O.
13132, and it does not contain policies
that have federalism implications that
would have substantial direct effects on
the States, on the relationship between
the national Government and the States,
or on the distribution of powers and
responsibilities among the various
levels of Government. Therefore,
consultation with State and local
officials is not required.
List of Subjects in 32 CFR Part 199
Claims, Dental health, Health care,
Health insurance, Individuals with
disabilities, Mental health, Mental
health parity, Military personnel.
For the reasons stated in the
preamble, the DoD amends 32 CFR part
199 as set forth below:
PART 199—CIVILIAN HEALTH AND
MEDICAL PROGRAM OF THE
UNIFORMED SERVICES (CHAMPUS)
1. The authority citation for part 199
continues to read as follows:
■
The Regulatory Flexibility Act
requires that each Federal agency
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. This
interim final rule is not an economically
significant regulatory action, and it will
not have a significant impact on a
substantial number of small entities.
Therefore, this rule is not subject to the
requirements of the RFA.
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Public Law 104–4, Sec. 202, ‘‘Unfunded
Mandates Reform Act’’
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule whose mandates require spending
in any one year of $100M in 1995
dollars, updated annually for inflation.
That threshold level is currently
approximately $140M. This interim
final rule will not mandate any
requirements for state, local, or tribal
governments or the private sector.
Authority: 5 U.S.C. 301; 10 U.S.C. chapter
55.
2. Section 199.14 is amended by
revising paragraphs (a)(6)(i)(I) and
(a)(6)(ii), and by adding paragraph
(j)(1)(xi), to read as follows:
■
§ 199.14 Provider reimbursement
methods.
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(a) * * *
(6) * * *
(i) * * *
(I) Drugs administered other than by
oral method. Drugs administered other
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than by oral method provided on an
outpatient basis by hospitals are paid on
the same basis as drugs administered
other than by oral method covered by
the allowable charge method under
paragraph (j)(1) of this section.
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(ii) Outpatient services subject to
OPPS—(A) General. Outpatient services
provided in hospitals subject to
Medicare OPPS as specified in 42 CFR
413.65 and 42 CFR 419.20 will be paid
in accordance with the provisions
outlined in sections 1833t of the Social
Security Act and its implementing
Medicare regulation (42 CFR part 419)
subject to exceptions as authorized by
this paragraph (a)(6)(ii).
(B) Under the above governing
provisions, TRICARE will recognize to
the extent practicable, in accordance
with 10 U.S.C. 1089(j)(2), Medicare’s
OPPS reimbursement methodology to
include specific coding requirements,
ambulatory payment classifications
(APCs), nationally established APC
amounts and associated adjustments
(e.g., discounting across geographical
regions and outlier calculations).
(C) While TRICARE intends to remain
as true as possible to Medicare’s basic
OPPS methodology, there will be some
deviations required to accommodate
TRICARE’s unique benefit structure and
beneficiary population as authorized
under the provisions of 10 U.S.C.
1079(j)(2).
(D) TRICARE is also authorized to
deviate from Medicare’s basic OPPS
methodology to establish special
reimbursement methods, amounts, and
procedures to encourage use of highvalue products and discourage use of
low-value products with respect to
pharmaceutical agents provided as part
of medical services from authorized
providers. Therefore, drugs
administered other than oral method
provided on an outpatient basis by
hospitals are paid on the same basis as
drugs administered other than oral
method covered by the allowable charge
method under paragraph (j)(1) of this
section.
(E) Temporary transitional payment
adjustments (TTPAs). Temporary
transitional payment adjustments will
be in place for all hospitals, both
network and non-network, in order to
buffer the initial decline in payments
upon implementation of TRICARE’s
OPPS.
(1) For network hospitals. The
temporary transitional payment
adjustments will cover a four-year
period. The four-year transition will set
higher payment percentages for the ten
Ambulatory Payment Classification
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(APC) codes 604–609 and 613–616, with
reductions in each of the transition
years. For non-network hospitals, the
adjustments will cover a three year
period, with reductions in each of the
transition years. For network hospitals,
under the TTPAs, the APC payment
level for the five clinic visit APCs would
be set at 175 percent of the Medicare
APC level, while the five ER visit APCs
would be increased by 200 percent in
the first year of OPPS implementation.
In the second year, the APC payment
levels would be set at 150 percent of the
Medicare APC level for clinic visits and
175 percent for ER APCs. In the third
year, the APC visit amounts would be
set at 130 percent of the Medicare APC
level for clinic visits and 150 percent for
ER APCs. In the fourth year, the APC
visit amounts would be set at 115
percent of the Medicare APC level for
clinic visits and 130 percent for ER
APCs. In the fifth year, the TRICARE
and Medicare payment levels for the 10
APC visit codes would be identical.
(2) For non-network hospitals. Under
the TTPAs, the APC payment level for
the five clinic and ER visit APCs would
be set at 140 percent of the Medicare
APC level in the first year of OPPS
implementation. In the second year, the
APC payment levels would be set at 125
percent of the Medicare APC level for
clinic and ER visits. In the third year,
the APC visit amounts would be set at
110 percent of the Medicare APC level
for clinic and ER visits. In the fourth
year, the TRICARE and Medicare
payment levels for the 10 APC visit
codes would be identical.
(3) An additional temporary military
contingency payment adjustment
(TMCPA) will also be available at the
discretion of the Director, Defense
Health Agency (DHA), or a designee, at
any time after implementation to adopt,
modify and/or extend temporary
adjustments to OPPS payments for
TRICARE network hospitals deemed
essential for military readiness and
deployment in time of contingency
operations. Any TMCPAs to OPPS
payments shall be made only on the
basis of a determination that it is
impracticable to support military
readiness or contingency operations by
making OPPS payments in accordance
with the same reimbursement rules
implemented by Medicare. The criteria
for adopting, modifying, and/or
extending deviations and/or
adjustments to OPPS payments shall be
issued through TRICARE policies,
instructions, procedures and guidelines
as deemed appropriate by the Director,
DHA, or a designee. TMCPAs may also
be extended to non-network hospitals
on a case-by-case basis for specific
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procedures where it is determined that
the procedures cannot be obtained
timely enough from a network hospital.
For such case-by-case extensions,
‘‘Temporary’’ might be less than three
years at the discretion of the DHA
Director, or designee.
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(j) * * *
(1) * * *
(xi) Pharmaceutical agents utilized as
part of medically necessary medical
services. In general, the TRICAREdetermined allowed amount shall be
equal to an amount determined to be
appropriate, to the extent practicable, in
accordance with the same
reimbursement rules as apply to
payments for similar services under
Medicare. Under the authority of 10
U.S.C. 1079(q), in the case of any
pharmaceutical agent utilized as part of
medically necessary medical services,
the Director may adopt special
reimbursement methods, amounts, and
procedures to encourage the use of highvalue products and discourage the use
of low-value products, as determined by
the Director. For this purpose, the
Director may obtain recommendations
from the Pharmaceutical and
Therapeutics Committee under § 199.21
or other entities as the Director, DHA
deems appropriate with respect to the
relative value of products in a class of
products subject to this paragraph.
Among the special reimbursement
methods the Director may choose to
adopt under this paragraph is to
reimburse the average sales price of a
product plus a percentage of the median
of the average sales prices of products
in the product class or category. The
Director shall issue guidance regarding
the special reimbursement methods
adopted and the appropriate
reimbursement rates.
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■ 3. Section 199.21 is amended by
adding paragraph (e)(3), and by revising
paragraphs (i)(2)(ii), (iv), and (x), to read
as follows:
§ 199.21 TRICARE Pharmacy Benefits
Program.
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(e) * * *
(3) Special rules for best clinical
effectiveness. (i) Under the authority of
10 U.S.C. 1074g(a)(10), the Pharmacy
and Therapeutics Committee may
recommend and the Director may, after
considering the comments and
recommendations of the Beneficiary
Advisory Panel, approve special
uniform formulary actions to encourage
use of pharmaceutical agents that
provide the best clinical effectiveness to
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63577
covered beneficiaries and DoD,
including consideration of better care,
healthier people, and smarter spending.
Such special actions may operate as
exceptions to the normal rules and
procedures under 10 U.S.C. 1074g(a)(2),
(5) and (6) and the related provisions of
this section.
(ii) Actions under paragraph (e)(3)(i)
of this section may include a complete
or partial exclusion from the pharmacy
benefits program of any pharmaceutical
agent the Director determines provides
very little or no clinical effectiveness
relative to similar agents to covered
beneficiaries and DoD. A partial
exclusion under this paragraph may
take the form (as one example) of a
limitation on the clinical conditions,
diagnoses, or indications for which the
pharmaceutical agent may be
prescribed. A partial exclusion may be
implemented through any means
recommended by the Pharmacy and
Therapeutics Committee, including but
not limited to preauthorization under
paragraph (k) of this section. In the case
of a partial exclusion, a pharmaceutical
agent may be available on the nonformulary tier of the uniform formulary
for limited purposes and for other
purposes be excluded.
(iii) Actions under paragraph (e)(3)(i)
of this section may also include giving
preferential status to any non-generic
pharmaceutical agent of the uniform
formulary by treating it for purposes of
cost-sharing as a generic product.
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(i) * * *
(2) * * *
(ii) For pharmaceutical agents
obtained from a retail network
pharmacy, the cost share will be as
provided in 10 U.S.C. 1074g(a)(6),
except that there is a $0 cost-share for
vaccines/immunizations authorized as
preventive care for eligible beneficiaries.
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(iv) For pharmaceutical agents
obtained under the TRICARE mail order
program, the cost share will be as
provided in 10 U.S.C. 1074g(a)(6),
except that there is a $0 cost-share for
smoking cessation pharmaceutical
agents covered under the smoking
cessation program.
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(x) For any year after 2027, the costsharing amounts under this paragraph
shall be equal to the cost-sharing
amounts for the previous year adjusted
by an amount, if any, determined by the
Director to reflect changes in the costs
of pharmaceutical agents and
prescription dispensing, rounded to the
nearest dollar. These cost changes, if
any, will consider costs under the
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TRICARE pharmacy benefits program
calculated separately for each of the
following categories based on
prescriptions filled in the most recent
period for which TRICARE cost data are
available, updated to the current year, if
necessary, by appropriate industry data:
(A) Generic drugs in the retail point
of service;
(B) Formulary drugs in the retail point
of service;
(C) Generic drugs in the mail order
point of service;
(D) Formulary drugs in the mail order
point of service;
(E) Non-formulary drugs.
*
*
*
*
*
Dated: December 3, 2018.
Shelly E. Finke,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 2018–26562 Filed 12–10–18; 8:45 am]
BILLING CODE 5001–06–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2018–1052]
Safety Zone; Menominee River,
Marinette, WI
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
ACTION:
The Coast Guard will enforce
the safety zone on the Menominee River
in Marinette WI on December 15, 2018
from 10 a.m. to 12 p.m. This action is
necessary and intended to protect the
safety of life and property on navigable
waterways before, during and after the
launch of a naval vessel from Marinette
Marine on the Menominee River in
Marinette, WI. During the enforcement
period, the Coast Guard will enforce
restrictions upon, and control
movement of, vessels in the safety zone.
No person or vessel may enter into,
transit, or anchor within the safety zone
while it is being enforced unless
authorized by the Captain of the Port
Lake Michigan or a designated
representative.
SUMMARY:
The regulations in 33 CFR
165.929 will be enforced for safety zone
(f)(13), Table 165.929, from 10 a.m.
through 12 p.m. on December 15, 2018.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this notice of
enforcement, call or email marine event
coordinator MSTC Kaleena Carpino,
amozie on DSK3GDR082PROD with RULES
DATES:
VerDate Sep<11>2014
16:17 Dec 10, 2018
Jkt 247001
Prevention Department, Coast Guard
Sector Lake Michigan, Milwaukee, WI;
telephone (414) 747–7148, email D09SMB-SECLakeMichgan-WWM@uscg.mil.
The Coast
Guard will enforce the Operations at
Marinette Marine Safety Zone listed as
item (f)(13) in Table 165.929 of 33 CFR
165.929 on December 15, 2018 from 10
a.m. to 12 p.m. This action is being
taken to protect the safety of life and
property on navigable waterways of the
Menominee River, WI.
The safety zone will encompass all
waters of the Menominee river in the
vicinity of Marinette Marine
Corporation, from the Bridge Street
Bridge located in position 45°06.188′ n,
087°37.583′ w, then approximately .95
nm south east to a line crossing the river
perpendicularly passing through
positions 45°05.881′ n, 087°36.281′ w
and 45°05.725′ n, 087°36.385′ w (NAD
83). As specified in 33 CFR 165.929, all
vessels must obtain permission from the
Captain of the Port Lake Michigan or a
designated representative to enter, move
within or exit the safety zone while it
is enforced. Vessels or persons granted
permission to enter the safety zone must
obey all lawful orders or directions of
the Captain of the Port Lake Michigan
or a designated representative.
This notice of enforcement is issued
under authority of 33 CFR 165.929;
Safety Zones; Annual events requiring
safety zones in the Captain of the Port
Lake Michigan zone, and 5 U.S.C.
552(a). In addition to this publication in
the Federal Register, the Coast Guard
will provide the maritime community
with advance notification for the
enforcement of this zone via Broadcast
Notice to Mariners or Local Notice to
Mariners.
The Captain of the Port Lake
Michigan or a designated representative
will inform the public through a
Broadcast Notice to Mariners of any
changes in the planned schedule. The
Captain of the Port Lake Michigan or a
representative may be contacted via
Channel 16, VHF–FM or at (414) 747–
7182
SUPPLEMENTARY INFORMATION:
Dated: November 27, 2018.
Thomas J. Stuhlreyer
Captain, U.S. Coast Guard, Captain of the
Port Lake Michigan .
[FR Doc. 2018–26719 Filed 12–10–18; 8:45 am]
BILLING CODE 9110–04–P
PO 00000
Frm 00020
Fmt 4700
Sfmt 4700
POSTAL SERVICE
39 CFR Part 111
Change Address Quality Threshold for
Intelligent Mail Package Barcode
Postal ServiceTM.
ACTION: Interim final rule with request
for comments.
AGENCY:
The Postal Service is revising
Mailing Standards of the United States
Postal Service, Domestic Mail Manual
(DMM®) section 204.2.1.8 to update the
Address Quality (AQ) Compliance
threshold for all mailers who enter
commercial parcels.
DATES: Effective date: January 31, 2019.
Comment deadline: Comments must
be received on or before December 31,
2018.
ADDRESSES: Mail or deliver written
comments to the manager, Product
Classification, U.S. Postal Service®, 475
L’Enfant Plaza SW, Room 4446,
Washington, DC 20260–5015. If sending
comments by email, include the name
and address of the commenter and send
to ProductClassification@usps.gov, with
a subject line of ‘‘Change Address
Quality-IMpb.’’ Faxed comments are not
accepted. You may inspect and
photocopy all written comments, by
appointment only, at USPS®
Headquarters Library, 475 L’Enfant
Plaza SW, 11th Floor North,
Washington, DC, 20260. These records
are available for review on Monday
through Friday, 9 a.m.–4 p.m., by
calling 202–268–2906.
FOR FURTHER INFORMATION CONTACT:
Malaki Gravely at (202) 268–7553 or
Malaki.l.gravely@usps.gov.
SUPPLEMENTARY INFORMATION: The Postal
Service will increase the IMpb® Address
Quality (AQ) threshold from 89 percent
to 90 percent. The effective date of the
new IMpb Address Quality threshold
will coincide with the effective date for
the previously determined threshold
increases for Manifest Quality (MQ) and
Barcode Quality (BQ).
SUMMARY:
Background
On February 27, 2018, the Postal
Service published a proposed rule,
Federal Register Notice (83 FR 8399)
Proposed Changes to Validations for
IMpb to announce its proposal to add
new IMpb compliance validations for
Barcode Quality (BQ), Address Quality
(AQ), and (Shipping Services File)
Manifest Quality (MQ) metrics. The
proposed rule also reflected IMpb
threshold increases for Barcode Quality
and (Shipping Services File) Manifest
Quality. In addition, the Postal Service
provided notice to work in partnership
E:\FR\FM\11DER1.SGM
11DER1
Agencies
[Federal Register Volume 83, Number 237 (Tuesday, December 11, 2018)]
[Rules and Regulations]
[Pages 63574-63578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26562]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[DOD-2018-HA-0062]
RIN 0720-AB75
TRICARE Pharmacy Benefits Program Reforms
AGENCY: Office of the Secretary, Department of Defense (DoD).
ACTION: Interim final rule.
-----------------------------------------------------------------------
SUMMARY: This interim final rule implements Section 702 of the National
Defense Authorization Act for Fiscal Year 2018 (NDAA FY18). The law
makes significant changes to the TRICARE Pharmacy Benefits Program,
specifically it: Updates co-payment requirements; authorizes a new
process for encouraging use of pharmaceutical agents that provide the
best clinical effectiveness by excluding coverage for particular
pharmaceutical agents that provide very little or no clinical
effectiveness relative to similar agents and for giving preferential
status to agents that provide enhanced clinical effectiveness; and
authorizes special reimbursement methods, amounts, and procedures to
encourage use or high-value products and discourage use of low-value
products with respect to pharmaceutical agents provided as part of
medical services from authorized providers.
DATES: This interim final rule is effective December 11, 2018. Comments
must be received by February 11, 2019.
FOR FURTHER INFORMATION CONTACT: David W. Bobb, RPh, JD, Chief,
Pharmacy Operations, Defense Health Agency (DHA), telephone (703) 681-
2890.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Purpose of the Interim Final Rule
This interim final rule implements Section 702 of the National
Defense Authorization Act for Fiscal Year 2018 (NDAA FY18), which does
three things: (1) It updates cost-sharing requirements for outpatient
pharmaceutical prescriptions filled by retail pharmacies and the
TRICARE mail order pharmacy program. (2) It authorizes a new Uniform
Formulary process for encouraging use of pharmaceutical agents in the
TRICARE Pharmacy Benefits Program that provide the best clinical
effectiveness by excluding coverage for particular pharmaceutical
agents that provide very little or no clinical effectiveness relative
to similar agents and giving preferential status to agents that provide
enhanced clinical effectiveness. (3) It authorizes special
reimbursement methods, amounts, and procedures to encourage use of
high-value products and discourage use of low-value products with
respect to pharmaceutical agents provided as part of medical services
from authorized providers. This interim final rule implements each of
these three statutory changes. This is being issued as an interim final
rule in order to implement expeditiously the reforms authorized by
Section 702, as specifically authorized by subsection (b)(3) of that
section. Based on that clear Congressional authority and intent, the
Department finds that obtaining public comment in advance of issuing
this rule is impracticable, unnecessary, and contrary to the public
interest. Delaying expeditious implementation by waiting for public
comments to this interim rule not only delays the significant cost
savings to the government that will be realized through implementation
but also continues to allow coverage of pharmaceutical agents that do
not provide the best clinical effectiveness for beneficiaries. In
addition, subsection (b)(3) of Section 702 states that ``in order to
implement expeditiously the reforms authorized . . . (A) the Secretary
of Defense may prescribe an interim final rule, (B) not later than one
year after prescribing the interim final rule and considering public
comments with respect to such interim final rule, by prescribing a
final rule.'' Clearly Congressional intent is to implement the
authorized reforms quickly. Nonetheless, DoD invites public comments on
this rule and is committed to considering all comments and issuing a
final rule as soon as practicable (but not later than one year after
issuance of this interim final rule).
B. Legal Authority for the Regulatory Action
This interim final rule is under the primary authority of 10 U.S.C.
1074g, 1079 and 1086, and Section 702 of NDAA-18. Specifically, section
702(b)(3) of NDAA-18 authorizes DoD to ``prescribe such changes to the
regulations implementing the TRICARE program . . . by prescribing an
interim final rule.'' TRICARE program regulations (32 CFR part 199) are
issued under statutory authorities including 10 U.S.C. 1074g (the
Pharmacy Benefits Program) and 10 U.S.C. 1079 and 1086 (TRICARE medical
benefits). Section 702 of NDAA-18 amends both section 1074g and section
1079 (the section 1079 amendment being automatically applicable to
section 1086).
C. Summary of Major Provisions of the Interim Final Rule
The major provisions of the interim final rule are the following.
1. Updating Cost-Sharing. Under the authority of section
1074g(a)(6), as amended by Section 702(a) of NDAA FY18, we are amending
32 CFR 199.21(i) to cross reference the statutory changes.
2. Uniform Formulary Changes. Based on section 1074g(a)(10), as
added by Section 702(b)(1) of NDAA FY 18, we are changing the Uniform
Formulary process under 32 CFR 199.21(e) by authorizing the exclusion
of any pharmaceutical agent that provides very little or no clinical
effectiveness relative to similar agents, and preferential status for
pharmaceutical agents that have enhanced clinical effectiveness
relative to similar agents.
3. Pharmaceutical Agents as Part of Medical Services. Based on 10
U.S.C. 1079(q), as added by Section 702(b)(2) of NDAA FY18, we are
changing provisions of 32 CFR 199.14 to authorize the adoption of
special reimbursement methods, amounts and procedures to encourage the
use of high value products and discourage the use of low value
products--both relative to similar agents--in connection with
pharmaceutical agents provided as part of outpatient medical services
covered by TRICARE.
II. Provisions of Interim Final Rule
A. Updating Co-Payments
The interim final rule amends 32 CFR 199.21(i)(2), which is the
paragraph of the TRICARE regulation that governs cost-sharing amounts
under the Pharmacy Benefits Program. The amended language simply cross
references the statutory specifications on cost-sharing, including the
table set forth in 10 U.S.C. 1074g(a)(6)(A). This table lists cost
sharing amounts for the years 2018 through 2027 for generic, formulary,
and non-formulary pharmaceutical agents dispensed by retail network
pharmacies and the mail order pharmacy program. Two exceptions are that
there is a $0 cost-share for vaccines/immunizations authorized as
preventive care for eligible beneficiaries and provided by
[[Page 63575]]
retail network pharmacies and a $0 cost-share for smoking cessation
pharmaceutical agents covered under the smoking cessation program.
Another special rule under the statute is that for survivors of members
who die on active duty and for disability retirees and their families,
cost-sharing increases will not apply, and the 2017 amounts will remain
in effect. The interim final rule also provides that for any year after
2027, the cost-sharing amounts will reflect changes in the costs of
pharmaceutical agents and prescription dispensing, calculated
separately for generic, formulary, and non-formulary drugs in each
applicable point of service.
B. Uniform Formulary Changes
The interim final rule amends 32 CFR 199.21(e)(3) to provide that
the Pharmacy and Therapeutics Committee may recommend and the Director
may, after considering the comments and recommendations of the
Beneficiary Advisory Panel, approve special uniform formulary actions
to encourage use of pharmaceutical agents that provide the best
clinical effectiveness to covered beneficiaries and DoD, including
consideration of better care, healthier people, and smarter spending.
Such special actions may operate as exceptions to the normal rules and
procedures. Specifically, the Pharmacy and Therapeutics Committee may
recommend complete or partial exclusion from the pharmacy benefits
program of any pharmaceutical agent the Director determines provides
very little or no clinical effectiveness relative to similar agents--
i.e., other pharmaceutical agents in the same drug class--to covered
beneficiaries and DoD. A partial exclusion under this paragraph may
take the form (as one example) of a limitation on the clinical
conditions, diagnoses, or indications for which the pharmaceutical
agent may be prescribed. (As an example of this, off-label uses of a
pharmaceutical agent may be disallowed.) A partial exclusion may be
implemented through preauthorization or other means recommended by the
Pharmacy and Therapeutics Committee. In the case of a partial
exclusion, a pharmaceutical agent may be available on the non-formulary
tier of the uniform formulary for limited purposes and for other
purposes be excluded. In addition, the Pharmacy and Therapeutics
Committee may recommend to the Director giving preferential status--
based on a determination of enhanced clinical effectiveness relative to
other agents in the same drug class--to any non-generic pharmaceutical
agent of the uniform formulary by treating it for purposes of cost-
sharing as a generic product.
C. Pharmaceutical Agents as Part of Medical Services
The interim final rule amends 32 CFR 199.14(a)(6) and (j)(1) to
provide that TRICARE may adopt special reimbursement methods, amounts,
and procedures to encourage the use of high-value pharmaceutical agents
as part of medical services furnished in a hospital outpatient setting
or as part of any other medical services provided to TRICARE
beneficiaries. Although TRICARE generally follows Medicare's
reimbursement methodology when practicable for such medical services
which include medically necessary administration of drugs, Section
702(b)(2) of NDAA FY18 authorizes the adoption of special reimbursement
methods when determined appropriate to encourage the use of high-value
pharmaceutical agents and discourage the use of low-value agents. For
example, Medicare's reimbursement formula for physician-administered
drugs paid under Part B is Average Sales Price (ASP) + 6%. Medicare and
TRICARE reimburse providers ASP + 6 percent for the drug regardless of
the price a provider pays for the drug.
Both Medicare and TRICARE acknowledge that such payment for
physician-administered drugs does not incentivize high-value clinically
driven, low cost drugs. To the contrary, the payment methods for
physician-administered drugs using the ASP plus 6 percent raises many
concerns including that it may encourage the use of more expensive
drugs because the 6% add-on generates more revenue for more expensive
drugs without regard to the relative clinical value of the product
compared to other products in the same drug class. In order to remove
the incentive for using higher priced products that have no higher
clinical value, TRICARE may utilize the authority provided by the NDAA-
18 to restructure--at least for certain selected drug classes, or
categories of pharmaceuticals (identified in coordination with the
Pharmacy and Therapeutics Committee, or other entities as described in
the implementing instructions)--the reimbursement amount. For example,
TRICARE is evaluating established the ASP add-on as a percentage
(likely 6 percent) of the median value of all drugs in a particular
class, rather than attaching the 6% add-on to the ASP of a particular
drug. The specific modifications to drug pricing for physician-
administered drugs authorized by this IFR and NDAA FY18 shall be
published in TRICARE's implementing instructions (manuals) as approved
by the Director, DHA, and shall be published on the health.mil website.
The amendment to Sec. 199.14(j)(1) will authorize this.
III. Regulatory Procedures
Interim Final Rule Justification
This is being issued as an interim final rule in order to implement
expeditiously the reforms authorized by Section 702, as specifically
authorized by subsection (b)(3) of that section. Based on that clear
Congressional authority and intent, the Department finds that obtaining
public comment in advance of issuing this rule is impracticable,
unnecessary, and contrary to the public interest.
Executive Order (E.O.) 13771, ``Reducing Regulation and Controlling
Regulatory Costs''
E.O. 13771 seeks to control costs associated with the government
imposition of private expenditures required to comply with Federal
regulations and to reduce regulations that impose such costs.
Consistent with the analysis of transfer payments under OMB Circular A-
4, this interim final rule does not involve regulatory costs subject to
E.O. 13771. Rather, this interim final rule affects only health care
reimbursement payments under the TRICARE program. Aside from the
``housekeeping'' change to the regulation to incorporate the updated
copayment amounts enacted by Congress, the interim final rule makes two
changes to the program: a new authority under the Uniform Formulary
process and revised payment authority for pharmaceutical agents as part
of medical services.
Executive Order 12866, ``Regulatory Planning and Review'' and Executive
Order 13563, ``Improving Regulation and Regulatory Review''
Executive Orders 13563 and 12866 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, distribute impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This interim final rule has been designated a
``significant regulatory action,'' although not economically
significant, under section
[[Page 63576]]
3(f) of Executive Order 12866. Accordingly, this rule has been reviewed
by the Office of Management and Budget (OMB).
The economic effect of these changes is limited to government
reimbursements to health care providers/suppliers that under Circular
A-4 are not considered as costs imposed on the economy. The expected
reduction in government payments to pharmaceutical companies is based
on some predicted increase in use of higher value medications and a
corresponding decrease in the use of lower value medications in drug
classes where different drugs have comparable clinical effect. The
expected value of this shift in use of some medications--i.e., the
quantity of the transfer payments--is $30 million per year.
An initial analysis identified a sample group of candidate drugs
that do not offer additional therapeutic benefit over other formulary
items. By comparing the current costs to those of a lower-priced
comparator and assuming similar utilization rates, the average cost
avoidance was $1.5M/drug/year, with a more conservative cost avoidance
of $1M/drug/year. When fully implemented, this new process could
average 30 drugs per year at a conservative cost avoidance of $1M/drug/
year.
Congressional Review Act, 5 U.S.C. 804(2)
Under the Congressional Review Act, a major rule may not take
effect until at least 60 days after submission to Congress of a report
regarding the rule. A major rule is one that would have an annual
effect on the economy of $100M or more or have certain other impacts.
This final rule is not a major rule under the Congressional Review Act.
Public Law 96-354, ``Regulatory Flexibility Act'' (RFA), (5 U.S.C. 601)
The Regulatory Flexibility Act requires that each Federal agency
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. This interim final
rule is not an economically significant regulatory action, and it will
not have a significant impact on a substantial number of small
entities. Therefore, this rule is not subject to the requirements of
the RFA.
Public Law 104-4, Sec. 202, ``Unfunded Mandates Reform Act''
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any one year of
$100M in 1995 dollars, updated annually for inflation. That threshold
level is currently approximately $140M. This interim final rule will
not mandate any requirements for state, local, or tribal governments or
the private sector.
Public Law 96-511, ``Paperwork Reduction Act'' (44 U.S.C. Chapter 35)
This rulemaking does not contain a ``collection of information''
requirement, and will not impose additional information collection
requirements on the public under Public Law 96-511, ``Paperwork
Reduction Act'' (44 U.S.C. chapter 35).
Executive Order 13132, ``Federalism''
This interim final rule has been examined for its impact under E.O.
13132, and it does not contain policies that have federalism
implications that would have substantial direct effects on the States,
on the relationship between the national Government and the States, or
on the distribution of powers and responsibilities among the various
levels of Government. Therefore, consultation with State and local
officials is not required.
List of Subjects in 32 CFR Part 199
Claims, Dental health, Health care, Health insurance, Individuals
with disabilities, Mental health, Mental health parity, Military
personnel.
For the reasons stated in the preamble, the DoD amends 32 CFR part
199 as set forth below:
PART 199--CIVILIAN HEALTH AND MEDICAL PROGRAM OF THE UNIFORMED
SERVICES (CHAMPUS)
0
1. The authority citation for part 199 continues to read as follows:
Authority: 5 U.S.C. 301; 10 U.S.C. chapter 55.
0
2. Section 199.14 is amended by revising paragraphs (a)(6)(i)(I) and
(a)(6)(ii), and by adding paragraph (j)(1)(xi), to read as follows:
Sec. 199.14 Provider reimbursement methods.
* * * * *
(a) * * *
(6) * * *
(i) * * *
(I) Drugs administered other than by oral method. Drugs
administered other than by oral method provided on an outpatient basis
by hospitals are paid on the same basis as drugs administered other
than by oral method covered by the allowable charge method under
paragraph (j)(1) of this section.
* * * * *
(ii) Outpatient services subject to OPPS--(A) General. Outpatient
services provided in hospitals subject to Medicare OPPS as specified in
42 CFR 413.65 and 42 CFR 419.20 will be paid in accordance with the
provisions outlined in sections 1833t of the Social Security Act and
its implementing Medicare regulation (42 CFR part 419) subject to
exceptions as authorized by this paragraph (a)(6)(ii).
(B) Under the above governing provisions, TRICARE will recognize to
the extent practicable, in accordance with 10 U.S.C. 1089(j)(2),
Medicare's OPPS reimbursement methodology to include specific coding
requirements, ambulatory payment classifications (APCs), nationally
established APC amounts and associated adjustments (e.g., discounting
across geographical regions and outlier calculations).
(C) While TRICARE intends to remain as true as possible to
Medicare's basic OPPS methodology, there will be some deviations
required to accommodate TRICARE's unique benefit structure and
beneficiary population as authorized under the provisions of 10 U.S.C.
1079(j)(2).
(D) TRICARE is also authorized to deviate from Medicare's basic
OPPS methodology to establish special reimbursement methods, amounts,
and procedures to encourage use of high-value products and discourage
use of low-value products with respect to pharmaceutical agents
provided as part of medical services from authorized providers.
Therefore, drugs administered other than oral method provided on an
outpatient basis by hospitals are paid on the same basis as drugs
administered other than oral method covered by the allowable charge
method under paragraph (j)(1) of this section.
(E) Temporary transitional payment adjustments (TTPAs). Temporary
transitional payment adjustments will be in place for all hospitals,
both network and non-network, in order to buffer the initial decline in
payments upon implementation of TRICARE's OPPS.
(1) For network hospitals. The temporary transitional payment
adjustments will cover a four-year period. The four-year transition
will set higher payment percentages for the ten Ambulatory Payment
Classification
[[Page 63577]]
(APC) codes 604-609 and 613-616, with reductions in each of the
transition years. For non-network hospitals, the adjustments will cover
a three year period, with reductions in each of the transition years.
For network hospitals, under the TTPAs, the APC payment level for the
five clinic visit APCs would be set at 175 percent of the Medicare APC
level, while the five ER visit APCs would be increased by 200 percent
in the first year of OPPS implementation. In the second year, the APC
payment levels would be set at 150 percent of the Medicare APC level
for clinic visits and 175 percent for ER APCs. In the third year, the
APC visit amounts would be set at 130 percent of the Medicare APC level
for clinic visits and 150 percent for ER APCs. In the fourth year, the
APC visit amounts would be set at 115 percent of the Medicare APC level
for clinic visits and 130 percent for ER APCs. In the fifth year, the
TRICARE and Medicare payment levels for the 10 APC visit codes would be
identical.
(2) For non-network hospitals. Under the TTPAs, the APC payment
level for the five clinic and ER visit APCs would be set at 140 percent
of the Medicare APC level in the first year of OPPS implementation. In
the second year, the APC payment levels would be set at 125 percent of
the Medicare APC level for clinic and ER visits. In the third year, the
APC visit amounts would be set at 110 percent of the Medicare APC level
for clinic and ER visits. In the fourth year, the TRICARE and Medicare
payment levels for the 10 APC visit codes would be identical.
(3) An additional temporary military contingency payment adjustment
(TMCPA) will also be available at the discretion of the Director,
Defense Health Agency (DHA), or a designee, at any time after
implementation to adopt, modify and/or extend temporary adjustments to
OPPS payments for TRICARE network hospitals deemed essential for
military readiness and deployment in time of contingency operations.
Any TMCPAs to OPPS payments shall be made only on the basis of a
determination that it is impracticable to support military readiness or
contingency operations by making OPPS payments in accordance with the
same reimbursement rules implemented by Medicare. The criteria for
adopting, modifying, and/or extending deviations and/or adjustments to
OPPS payments shall be issued through TRICARE policies, instructions,
procedures and guidelines as deemed appropriate by the Director, DHA,
or a designee. TMCPAs may also be extended to non-network hospitals on
a case-by-case basis for specific procedures where it is determined
that the procedures cannot be obtained timely enough from a network
hospital. For such case-by-case extensions, ``Temporary'' might be less
than three years at the discretion of the DHA Director, or designee.
* * * * *
(j) * * *
(1) * * *
(xi) Pharmaceutical agents utilized as part of medically necessary
medical services. In general, the TRICARE-determined allowed amount
shall be equal to an amount determined to be appropriate, to the extent
practicable, in accordance with the same reimbursement rules as apply
to payments for similar services under Medicare. Under the authority of
10 U.S.C. 1079(q), in the case of any pharmaceutical agent utilized as
part of medically necessary medical services, the Director may adopt
special reimbursement methods, amounts, and procedures to encourage the
use of high-value products and discourage the use of low-value
products, as determined by the Director. For this purpose, the Director
may obtain recommendations from the Pharmaceutical and Therapeutics
Committee under Sec. 199.21 or other entities as the Director, DHA
deems appropriate with respect to the relative value of products in a
class of products subject to this paragraph. Among the special
reimbursement methods the Director may choose to adopt under this
paragraph is to reimburse the average sales price of a product plus a
percentage of the median of the average sales prices of products in the
product class or category. The Director shall issue guidance regarding
the special reimbursement methods adopted and the appropriate
reimbursement rates.
* * * * *
0
3. Section 199.21 is amended by adding paragraph (e)(3), and by
revising paragraphs (i)(2)(ii), (iv), and (x), to read as follows:
Sec. 199.21 TRICARE Pharmacy Benefits Program.
* * * * *
(e) * * *
(3) Special rules for best clinical effectiveness. (i) Under the
authority of 10 U.S.C. 1074g(a)(10), the Pharmacy and Therapeutics
Committee may recommend and the Director may, after considering the
comments and recommendations of the Beneficiary Advisory Panel, approve
special uniform formulary actions to encourage use of pharmaceutical
agents that provide the best clinical effectiveness to covered
beneficiaries and DoD, including consideration of better care,
healthier people, and smarter spending. Such special actions may
operate as exceptions to the normal rules and procedures under 10
U.S.C. 1074g(a)(2), (5) and (6) and the related provisions of this
section.
(ii) Actions under paragraph (e)(3)(i) of this section may include
a complete or partial exclusion from the pharmacy benefits program of
any pharmaceutical agent the Director determines provides very little
or no clinical effectiveness relative to similar agents to covered
beneficiaries and DoD. A partial exclusion under this paragraph may
take the form (as one example) of a limitation on the clinical
conditions, diagnoses, or indications for which the pharmaceutical
agent may be prescribed. A partial exclusion may be implemented through
any means recommended by the Pharmacy and Therapeutics Committee,
including but not limited to preauthorization under paragraph (k) of
this section. In the case of a partial exclusion, a pharmaceutical
agent may be available on the non-formulary tier of the uniform
formulary for limited purposes and for other purposes be excluded.
(iii) Actions under paragraph (e)(3)(i) of this section may also
include giving preferential status to any non-generic pharmaceutical
agent of the uniform formulary by treating it for purposes of cost-
sharing as a generic product.
* * * * *
(i) * * *
(2) * * *
(ii) For pharmaceutical agents obtained from a retail network
pharmacy, the cost share will be as provided in 10 U.S.C. 1074g(a)(6),
except that there is a $0 cost-share for vaccines/immunizations
authorized as preventive care for eligible beneficiaries.
* * * * *
(iv) For pharmaceutical agents obtained under the TRICARE mail
order program, the cost share will be as provided in 10 U.S.C.
1074g(a)(6), except that there is a $0 cost-share for smoking cessation
pharmaceutical agents covered under the smoking cessation program.
* * * * *
(x) For any year after 2027, the cost-sharing amounts under this
paragraph shall be equal to the cost-sharing amounts for the previous
year adjusted by an amount, if any, determined by the Director to
reflect changes in the costs of pharmaceutical agents and prescription
dispensing, rounded to the nearest dollar. These cost changes, if any,
will consider costs under the
[[Page 63578]]
TRICARE pharmacy benefits program calculated separately for each of the
following categories based on prescriptions filled in the most recent
period for which TRICARE cost data are available, updated to the
current year, if necessary, by appropriate industry data:
(A) Generic drugs in the retail point of service;
(B) Formulary drugs in the retail point of service;
(C) Generic drugs in the mail order point of service;
(D) Formulary drugs in the mail order point of service;
(E) Non-formulary drugs.
* * * * *
Dated: December 3, 2018.
Shelly E. Finke,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2018-26562 Filed 12-10-18; 8:45 am]
BILLING CODE 5001-06-P