81_FR_88352 81 FR 88117 - Extension of Pharmacy Copayments for Medications

81 FR 88117 - Extension of Pharmacy Copayments for Medications

DEPARTMENT OF VETERANS AFFAIRS

Federal Register Volume 81, Issue 235 (December 7, 2016)

Page Range88117-88120
FR Document2016-29337

The Department of Veterans Affairs (VA) amends its medical regulations concerning the copayment required for certain medications. This rulemaking freezes copayments at the current rate for veterans in priority groups 2 through 8 through February 26, 2017.

Federal Register, Volume 81 Issue 235 (Wednesday, December 7, 2016)
[Federal Register Volume 81, Number 235 (Wednesday, December 7, 2016)]
[Rules and Regulations]
[Pages 88117-88120]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-29337]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AP87


Extension of Pharmacy Copayments for Medications

AGENCY: Department of Veterans Affairs.

ACTION: Interim final rule.

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

SUMMARY: The Department of Veterans Affairs (VA) amends its medical 
regulations concerning the copayment required for certain medications. 
This rulemaking freezes copayments at the current rate for veterans in 
priority groups 2 through 8 through February 26, 2017.

DATES: Effective Date: This rule is effective on December 7, 2016.
    Comment date: Comments must be received on or before February 6, 
2017.

ADDRESSES: Written comments may be submitted by email through http://www.regulations.gov; by mail or hand-delivery to Director, Regulation 
Policy and Management (00REG), Department of Veterans Affairs, 810 
Vermont Avenue NW., Room 1068, Washington, DC 20420; or by fax to (202) 
273-9026. (This is not a toll-free number.) Comments should indicate 
that they are submitted in response to ``RIN 2900-AP87-Copayments for 
Medications in

[[Page 88118]]

2017.'' Copies of comments received will be available for public 
inspection in the Office of Regulation Policy and Management, Room 
1068, between the hours of 8:00 a.m. and 4:30 p.m. Monday through 
Friday (except holidays). Please call (202) 461-4902 for an 
appointment. (This is not a toll-free number.) In addition, during the 
comment period, comments may be viewed online through the Federal 
Docket Management System (FDMS) at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Bridget Souza, Office of Community 
Care (10D), Veterans Health Administration, Department of Veterans 
Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 382-2537. 
(This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: Under 38 U.S.C. 1722A(a), VA must require 
veterans to pay at least a $2 copayment for each 30-day supply of 
medication furnished on an outpatient basis for the treatment of a non-
service-connected disability or condition unless a veteran has a 
service-connected disability rated 50 percent or more, is a former 
prisoner of war, or has an annual income at or below the maximum annual 
rate of VA pension that would be payable if the veteran were eligible 
for pension. Under 38 U.S.C. 1722A(b), VA ``may,'' by regulation, 
increase that copayment amount and establish a maximum annual copayment 
amount (a ``cap''). We have consistently interpreted section 1722A(b) 
to mean that VA has discretion to determine the appropriate copayment 
amount and annual cap amount for medication furnished on an outpatient 
basis for covered treatment, provided that any decision by VA to 
increase the copayment amount or annual cap amount is the subject of a 
rulemaking proceeding. We have implemented this statute in 38 CFR 
17.110.
    Under 38 CFR 17.110(b)(1), veterans are obligated to pay VA a 
copayment for each 30-day or less supply of medication provided by VA 
on an outpatient basis (other than medication administered during 
treatment). Under the current regulation, the copayment amount for 
veterans in priority groups 2 through 6 of VA's health care system is 
$8 through December 31, 2016. 38 CFR 17.110(b)(1)(i). The copayment 
amount for veterans in priority groups 7 and 8 is $9 through December 
31, 2016. 38 CFR 17.110(b)(1)(ii). Thereafter, the copayment amount for 
all affected veterans is to be established using a formula based on the 
prescription drug component of the Medical Consumer Price Index (CPI-
P), set forth in 38 CFR 17.110(b)(1)(iii). Using this methodology would 
generally result in increased medication prices for veterans.
    Currently Sec.  17.110(b)(2) also includes a ``cap'' on the total 
amount of copayments in a calendar year for a veteran enrolled in one 
of VA's health care enrollment system priority groups 2 through 6. 
Through December 31, 2016, the annual cap is set at $960. Thereafter, 
the cap is to increase ``by $120 for each $1 increase in the copayment 
amount'' applicable to veterans in priority categories 2 through 6.
    On October 27, 2014, we published an interim final rulemaking that 
``froze'' copayments for veterans in priority categories 2 through 6 at 
$8 and for veterans in priority groups 7 and 8 at $9, through December 
31, 2015. 79 FR 63819. This interim final rule was made final on 
September 16, 2015. 79 FR 55545. In that final rulemaking, we extended 
the copayment freeze to be effective through December 31, 2016. We 
stated that this extended timeframe would permit the freeze to be in 
effect all of calendar year 2016 for the continued benefit of veterans, 
and would allow VA to continue to develop and publish proposed and 
final rules to implement a tiered copayment structure for certain 
medications, which will further align VA's medication copayment 
structure with other Federal agencies and the commercial sector. In 
these rulemakings, we stated that this freeze was appropriate because 
failure to take the action would result in higher copayments, and, as 
described in prior rulemakings, higher copayments reduced the 
utilization of VA pharmacy benefits and caused VA patients to instead 
rely on external providers for medications. 79 FR 63820. We continue to 
believe this to be the case. The ability to ensure that medications are 
taken as prescribed is essential to effective health care management. 
VA can monitor whether its patients are refilling prescriptions at 
regular intervals while also checking for medications that may interact 
with each other when these prescriptions are filled by VA. When both VA 
and non-VA providers are issuing prescriptions to a veteran, there is a 
greater risk of adverse interactions and harm to the patient because it 
is more difficult for each provider to assess whether the patient is 
taking any other medications.
    On January 5, 2016, we published a proposed rule that would 
establish a tiered medication copayment structure. 81 FR 196. In that 
proposed rule, we indicated that VA intended to publish a final rule 
that would make the proposed changes effective January 1, 2017. VA 
proposed an effective date of January 1, 2017 based on our assumption 
that the necessary system changes would be in place by that date to 
allow us to publish a final rule implementing a tiered medication 
copayment structure. VA will be unable to meet that timeline. However, 
VA thinks that the necessary changes will be in place in February 2017, 
and that a final rule establishing a tiered medication copayment regime 
can be published with an effective date of February 27, 2017.
    In this rulemaking, we are removing December 31, 2016, in each 
place it appears in paragraphs (b)(1)(i)-(iii) and (b)(2), and 
inserting February 26, 2017, to continue to keep copayment rates and 
caps at their current levels until the tiered copayment system is 
established.
    If we fail to extend the medication copayment freeze past December 
31, 2016, affected veterans would be subject to increased medication 
copayments until such time as the anticipated final rule implementing 
the tiered medication copayment structure is effective. In that case, 
beginning January 1, 2017, VA would use the CPI-P methodology in Sec.  
17.110(b)(1)(iii) to determine whether to increase copayments and 
calculate any mandated increase in the copayment amount for veterans in 
priority groups 2 through 8. At that time, the copayment amounts would 
be adjusted to a higher rate based on changes in the CPI-P over the 
past five years, and the annual copayment cap would also be raised by 
$120 for each $1 increase in the copayment amount. The end result would 
be increased medication copayments, and a higher annual cap on 
copayments until the effective date of the anticipated final rule 
implementing tiered medication copayments. VA believes this would not 
only have an adverse financial effect on veterans subject to medication 
copayments, but would also cause unnecessary confusion by making two 
changes to veterans' medication copayment amounts over a two-month 
period. Thus, the intended effect of this interim final rule is to 
prevent increases in copayment amounts and the copayment cap for 
veterans in priority groups 2 through 8 until VA has published a final 
rule establishing a new copayment structure. At that time, veterans' 
copayments will be determined according to the methodology contained in 
the final rule that VA will publish to establish a tiered copayment 
system. If VA has not established a new tiered copayment system by the 
end of February, copayments and the copayment cap will increase as 
prescribed in current

[[Page 88119]]

Sec.  17.110(b) in the absence of further rulemaking.

Administrative Procedure Act

    The Secretary of Veterans Affairs finds that there is good cause 
under 5 U.S.C. 553(b)(B) and (d)(3) to dispense with the opportunity 
for advance notice and opportunity for public comment and good cause to 
publish this rule with an immediate effective date. As stated above, 
this rule freezes at current rates the prescription drug copayment that 
VA charges certain veterans. The Secretary finds that it is 
impracticable and contrary to the public interest to delay this rule 
for the purpose of soliciting advance public comment or to have a 
delayed effective date. If the medication copayment freeze is not 
extended, on January 1, 2017, affected veterans would be subject to 
increased medication copayments based on changes to the CPI-P since 
2010, as well as an upward adjustment to the annual copayment cap. VA 
believes that this might cause a significant financial hardship for 
those affected veterans and may decrease patient adherence to medical 
plans and have other unpredictable negative health effects. Further, VA 
believes that failing to extend the current medication copayment 
freeze, without interruption, would likely result in confusion for the 
public and affected veterans because the new tiered medication 
copayment regime will go into effect within a relatively short period 
of time. Lastly, allowing the current medication copayment freeze to 
expire on December 31, 2016, would create programmatic issues that 
would be difficult for VA to administratively manage. Within a 60-day 
period IT algorithms that are currently in place would have to be 
removed, new copayment amounts and annual cap amounts would have to be 
calculated and implemented along with the necessary system changes, 
followed by application of the new IT changes necessary for 
establishing a new tiered medication copayment scheme.
    For the above reasons, the Secretary issues this rule as an interim 
final rule. VA will consider and address comments that are received 
within 60 days of the date this interim final rule is published in the 
Federal Register.

Effect of Rulemaking

    Title 38 of the Code of Federal Regulations, as revised by this 
interim final rulemaking, represents VA's implementation of its legal 
authority on this subject. Other than future amendments to this 
regulation or governing statutes, no contrary guidance or procedures 
are authorized. All existing or subsequent VA guidance must be read to 
conform with this rulemaking if possible or, if not possible, such 
guidance is superseded by this rulemaking.

Paperwork Reduction Act

    This interim final rule contains no provisions constituting a 
collection of information under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3521).

Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess the 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, and other advantages; distributive impacts; 
and equity). Executive Order 13563 (Improving Regulation and Regulatory 
Review) emphasizes the importance of quantifying both costs and 
benefits, reducing costs, harmonizing rules, and promoting flexibility. 
Executive Order 12866 (Regulatory Planning and Review) defines a 
``significant regulatory action,'' requiring review by the Office of 
Management and Budget (OMB), unless OMB waives such review, as ``any 
regulatory action that is likely to result in a rule that may: (1) Have 
an annual effect on the economy of $100 million or more or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, or tribal governments or communities; (2) 
Create a serious inconsistency or otherwise interfere with an action 
taken or planned by another agency; (3) Materially alter the budgetary 
impact of entitlements, grants, user fees, or loan programs or the 
rights and obligations of recipients thereof; or (4) Raise novel legal 
or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in this Executive Order.''
    The economic, interagency, budgetary, legal, and policy 
implications of this interim final rule have been examined, and it has 
been determined not to be a significant regulatory action under 
Executive Order 12866. VA's impact analysis can be found as a 
supporting document at http://www.regulations.gov, usually within 48 
hours after the rulemaking document is published. Additionally, a copy 
of the rulemaking and its impact analysis are available on VA's Web 
site.

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any one year. This interim final rule will have no such 
effect on State, local, and tribal governments, or on the private 
sector.

Regulatory Flexibility Act

    The Secretary hereby certifies that this interim final rule will 
not have a significant economic impact on a substantial number of small 
entities as they are defined in the Regulatory Flexibility Act, 5 
U.S.C. 601-612. This interim final rule will temporarily freeze the 
copayments that certain veterans are required to pay for prescription 
drugs furnished by VA. This interim rule directly affects individual VA 
patients and will not directly affect small entities. Therefore, 
pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial 
and final regulatory flexibility analysis requirements of 5 U.S.C. 603 
and 604.

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for 
the programs affected by this document are as follows: 64.005, Grants 
to States for Construction of State Home Facilities; 64.007, Blind 
Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009, 
Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; 
64.011, Veterans Dental Care; 64.012, Veterans Prescription Service; 
64.013, Veterans Prosthetic Appliances; 64.014, Veterans State 
Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.016, 
Veterans State Hospital Care; 64.018, Sharing Specialized Medical 
Resources; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence; 
64.022, Veterans Home Based Primary Care; and 64.024, VA Homeless 
Providers Grant and Per Diem Program.

Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this 
document and authorized the undersigned to sign and submit the document 
to the Office of the Federal Register for publication electronically as 
an official document of the Department of Veterans Affairs. Gina S. 
Farrisee, Deputy Chief of Staff, Department of Veterans Affairs,

[[Page 88120]]

approved this document on October 3, 2016, for publication.

    Dated: December 2, 2016.
Michael Shores,
Acting Director, Regulation Policy & Management, Office of the 
Secretary, Department of Veterans Affairs.

List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, 
Claims, Day care, Dental health, Drug abuse, Foreign relations, 
Government contracts, Grant programs--health, Grant programs--veterans, 
Health care, Health facilities, Health professions, Health records, 
Homeless, Medical and dental schools, Medical devices, Medical 
research, Mental health programs, Nursing homes, Philippines, Reporting 
and recordkeeping requirements, Scholarships and fellowships, Travel 
and transportation expenses, Veterans.

    For the reasons set out in the preamble, VA amends 38 CFR part 17 
as follows:

PART 17--MEDICAL

0
1. The authority citation for part 17 continues to read as follows:

    Authority:  38 U.S.C. 501, and as noted in specific sections.
    Sections 17.640 and 17.647 also issued under Public Law 114-2, 
sec. 4.
    Sections 17.641 through 17.646 also issued under 38 U.S.C. 
501(a) and Public Law 114-2, sec. 4.


Sec.  17.110  [Amended]

0
2. Amend Sec.  17.110 as follows:
0
a. In paragraphs (b)(1)(i), (ii), and (iii), remove all references to 
``December 31, 2016'' and add in each place ``February 26, 2017''.
0
b. In paragraph (b)(2), remove all references to ``December 31, 2016'' 
and add in each place ``February 26, 2017''.

[FR Doc. 2016-29337 Filed 12-6-16; 8:45 am]
 BILLING CODE 8320-01-P



                                                                   Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Rules and Regulations                                             88117

                                                  Consultation and Coordination with                         For the reasons discussed in the                    security zone. If permission is granted,
                                                  Indian Tribal Governments, because it                    preamble, the Coast Guard amends 33                   all persons and vessels must comply
                                                  does not have a substantial direct effect                CFR part 165 as follows:                              with the instructions of the COTP
                                                  on one or more Indian tribes, on the                                                                           Honolulu or his designated
                                                  relationship between the Federal                         PART 165—REGULATED NAVIGATION                         representative and proceed at the
                                                  Government and Indian tribes, or on the                  AREAS AND LIMITED ACCESS AREAS                        minimum speed necessary to maintain a
                                                  distribution of power and                                                                                      safe course while in the security zone.
                                                  responsibilities between the Federal                     ■ 1. The authority citation for part 165                 (4) The U.S. Coast Guard may be
                                                  Government and Indian tribes. If you                     continues to read as follows:                         assisted in the patrol and enforcement
                                                  believe this rule has implications for                     Authority: 33 U.S.C. 1226, 1231; 46 U.S.C.          of the security zone by Federal, State,
                                                  federalism or Indian tribes, please                      Chapter 701; 50 U.S.C. 191, 195; 33 CFR               and local agencies.
                                                  contact the person listed in the FOR                     1.05–1, 6.04–1, 6.04–6, and 160.5; Pub. L.               (d) Notice of enforcement. The COTP
                                                                                                           107–295, 116 Stat. 2064; Department of                Honolulu will provide notice of
                                                  FURTHER INFORMATION CONTACT section
                                                                                                           Homeland Security Delegation No. 0170.1
                                                  above.                                                                                                         enforcement of the security zone
                                                                                                           ■ 2. Add § 165.T14–1030 to read as                    described in this section by verbal radio
                                                  E. Unfunded Mandates Reform Act                          follows:                                              broadcasts, written notice to mariners,
                                                    The Unfunded Mandates Reform Act                                                                             and general public outreach.
                                                  of 1995 (2 U.S.C. 1531–1538) requires                    § 165.T14–1030      Security Zone; Kailua Bay,
                                                                                                                                                                    (e) Definitions. As used in this
                                                                                                           Oahu, HI.
                                                  Federal agencies to assess the effects of                                                                      section, designated representative
                                                  their discretionary regulatory actions. In                  (a) Location. The security zone area is            means any Coast Guard commissioned,
                                                  particular, the Act addresses actions                    located within the COTP Zone (See 33                  warrant, or petty officer who has been
                                                  that may result in the expenditure by a                  CFR 3.70–10) and encompasses two                      authorized by the COTP to assist in
                                                  State, local, or tribal government, in the               primary areas from the surface of the                 enforcing the security zone described in
                                                  aggregate, or by the private sector of                   water to the ocean floor: The navigable               paragraph (a) of this section.
                                                  $100,000,000 (adjusted for inflation) or                 waters of the Kawainui Canal, beginning
                                                                                                           at the North Kalaheo Avenue Road                        Dated: December 1, 2016.
                                                  more in any one year. Though this rule                                                                         M.C. Long,
                                                  will not result in such an expenditure,                  Bridge and continuing northeast into
                                                                                                           Kailua Bay; and the navigable waters of               Captain, U.S. Coast Guard, Captain of the
                                                  we do discuss the effects of this rule                                                                         Port, Honolulu.
                                                  elsewhere in this preamble.                              Kailua Bay beginning at Kapoho Point
                                                                                                           and extending in a southwesterly                      [FR Doc. 2016–29317 Filed 12–6–16; 8:45 am]
                                                  F. Environment                                           direction to the shore boundary of a                  BILLING CODE 9110–04–P
                                                    We have analyzed this rule under the                   property located at 123 Kailuana Loop,
                                                  Department of Homeland Security                          Kailua, HI 96734. The geographic
                                                  Management Directive 023–01 and                          coordinates of the zone include the                   DEPARTMENT OF VETERANS
                                                  Commandant Instruction M16475.lD,                        navigable waters of the Kawainui Canal                AFFAIRS
                                                  which guide the Coast Guard in                           beginning at a point 21°24′56″ N.,
                                                  complying with the National                              157°44′58″ W., then extending to                      38 CFR Part 17
                                                  Environmental Policy Act of 1969 (42                     21°25′27″ N., 157°44′21″ W. (Kapoho                   RIN 2900–AP87
                                                  U.S.C. 4321–4370f), and have                             Point) including all the waters to the
                                                  determined that this action is one of a                  west of a straight line to 21°25′11″ N.,              Extension of Pharmacy Copayments
                                                  category of actions that do not                          157°44′39″ W., and extending back to                  for Medications
                                                  individually or cumulatively have a                      the original point 21°24′56″ N.,
                                                                                                           157°44′58″ W.                                         AGENCY:    Department of Veterans Affairs.
                                                  significant effect on the human
                                                  environment. It is categorically                            (b) Effective period. This rule is                 ACTION:   Interim final rule.
                                                  excluded from further review under                       effective from-8 a.m. (HST) on December
                                                                                                           14, 2016, through 8 a.m. (HST) on                     SUMMARY:   The Department of Veterans
                                                  paragraph 34(g) of Figure 2–1 of the                                                                           Affairs (VA) amends its medical
                                                  Commandant Instruction. An                               January 4, 2017.
                                                                                                              (c) Regulations. The general                       regulations concerning the copayment
                                                  environmental analysis checklist                                                                               required for certain medications. This
                                                  supporting this determination and a                      regulations governing security zones
                                                                                                           contained in 33 CFR 165.33 apply to the               rulemaking freezes copayments at the
                                                  Categorical Exclusion Determination are                                                                        current rate for veterans in priority
                                                  available in the docket where indicated                  security zone created by this temporary
                                                                                                           final rule.                                           groups 2 through 8 through February 26,
                                                  under ADDRESSES.                                                                                               2017.
                                                                                                              (1) All persons and vessels are
                                                  G. Protest Activities                                    required to comply with the general                   DATES: Effective Date: This rule is
                                                    The Coast Guard respects the First                     regulations governing security zones                  effective on December 7, 2016.
                                                  Amendment rights of protesters.                          found in 33 CFR part 165.                                Comment date: Comments must be
                                                  Protesters are asked to contact the                         (2) Entry into or remaining in this                received on or before February 6, 2017.
                                                  person listed in the FOR FURTHER                         security zone is prohibited unless                    ADDRESSES: Written comments may be
                                                  INFORMATION CONTACT section to                           authorized by the COTP Honolulu or his                submitted by email through http://
                                                  coordinate protest activities so that your               designated representative.                            www.regulations.gov; by mail or hand-
                                                  message can be received without                             (3) Persons or vessels desiring to                 delivery to Director, Regulation Policy
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  jeopardizing the safety or security of                   transit the security zone identified in               and Management (00REG), Department
                                                  people, places or vessels.                               paragraph (a) of this section may contact             of Veterans Affairs, 810 Vermont
                                                                                                           the COTP of Honolulu through his                      Avenue NW., Room 1068, Washington,
                                                  List of Subjects in 33 CFR Part 165                      designated representatives at the                     DC 20420; or by fax to (202) 273–9026.
                                                    Harbors, Marine safety, Navigation                     Command Center via telephone: (808)                   (This is not a toll-free number.)
                                                  (water), Reporting and recordkeeping                     842–2600 and (808) 842–2601; fax: (808)               Comments should indicate that they are
                                                  requirements, Security measures, and                     842–2642; or on VHF channel 16 (156.8                 submitted in response to ‘‘RIN 2900–
                                                  Waterways.                                               Mhz) to request permission to transit the             AP87-Copayments for Medications in


                                             VerDate Sep<11>2014    16:02 Dec 06, 2016   Jkt 241001   PO 00000   Frm 00021   Fmt 4700   Sfmt 4700   E:\FR\FM\07DER1.SGM   07DER1


                                                  88118            Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Rules and Regulations

                                                  2017.’’ Copies of comments received                      17.110(b)(1)(iii). Using this methodology             proposed an effective date of January 1,
                                                  will be available for public inspection in               would generally result in increased                   2017 based on our assumption that the
                                                  the Office of Regulation Policy and                      medication prices for veterans.                       necessary system changes would be in
                                                  Management, Room 1068, between the                          Currently § 17.110(b)(2) also includes             place by that date to allow us to publish
                                                  hours of 8:00 a.m. and 4:30 p.m.                         a ‘‘cap’’ on the total amount of                      a final rule implementing a tiered
                                                  Monday through Friday (except                            copayments in a calendar year for a                   medication copayment structure. VA
                                                  holidays). Please call (202) 461–4902 for                veteran enrolled in one of VA’s health                will be unable to meet that timeline.
                                                  an appointment. (This is not a toll-free                 care enrollment system priority groups                However, VA thinks that the necessary
                                                  number.) In addition, during the                         2 through 6. Through December 31,                     changes will be in place in February
                                                  comment period, comments may be                          2016, the annual cap is set at $960.                  2017, and that a final rule establishing
                                                  viewed online through the Federal                        Thereafter, the cap is to increase ‘‘by               a tiered medication copayment regime
                                                  Docket Management System (FDMS) at                       $120 for each $1 increase in the                      can be published with an effective date
                                                  http://www.regulations.gov.                              copayment amount’’ applicable to                      of February 27, 2017.
                                                  FOR FURTHER INFORMATION CONTACT:                         veterans in priority categories 2 through                In this rulemaking, we are removing
                                                  Bridget Souza, Office of Community                       6.                                                    December 31, 2016, in each place it
                                                  Care (10D), Veterans Health                                 On October 27, 2014, we published an               appears in paragraphs (b)(1)(i)–(iii) and
                                                  Administration, Department of Veterans                   interim final rulemaking that ‘‘froze’’               (b)(2), and inserting February 26, 2017,
                                                  Affairs, 810 Vermont Avenue NW.,                         copayments for veterans in priority                   to continue to keep copayment rates and
                                                                                                           categories 2 through 6 at $8 and for                  caps at their current levels until the
                                                  Washington, DC 20420, (202) 382–2537.
                                                                                                           veterans in priority groups 7 and 8 at $9,            tiered copayment system is established.
                                                  (This is not a toll-free number.)
                                                                                                           through December 31, 2015. 79 FR
                                                  SUPPLEMENTARY INFORMATION: Under 38                                                                               If we fail to extend the medication
                                                                                                           63819. This interim final rule was made
                                                  U.S.C. 1722A(a), VA must require                         final on September 16, 2015. 79 FR                    copayment freeze past December 31,
                                                  veterans to pay at least a $2 copayment                  55545. In that final rulemaking, we                   2016, affected veterans would be subject
                                                  for each 30-day supply of medication                     extended the copayment freeze to be                   to increased medication copayments
                                                  furnished on an outpatient basis for the                 effective through December 31, 2016.                  until such time as the anticipated final
                                                  treatment of a non-service-connected                     We stated that this extended timeframe                rule implementing the tiered medication
                                                  disability or condition unless a veteran                 would permit the freeze to be in effect               copayment structure is effective. In that
                                                  has a service-connected disability rated                 all of calendar year 2016 for the                     case, beginning January 1, 2017, VA
                                                  50 percent or more, is a former prisoner                 continued benefit of veterans, and                    would use the CPI–P methodology in
                                                  of war, or has an annual income at or                    would allow VA to continue to develop                 § 17.110(b)(1)(iii) to determine whether
                                                  below the maximum annual rate of VA                      and publish proposed and final rules to               to increase copayments and calculate
                                                  pension that would be payable if the                     implement a tiered copayment structure                any mandated increase in the
                                                  veteran were eligible for pension. Under                 for certain medications, which will                   copayment amount for veterans in
                                                  38 U.S.C. 1722A(b), VA ‘‘may,’’ by                       further align VA’s medication                         priority groups 2 through 8. At that
                                                  regulation, increase that copayment                      copayment structure with other Federal                time, the copayment amounts would be
                                                  amount and establish a maximum                           agencies and the commercial sector. In                adjusted to a higher rate based on
                                                  annual copayment amount (a ‘‘cap’’).                     these rulemakings, we stated that this                changes in the CPI–P over the past five
                                                  We have consistently interpreted                         freeze was appropriate because failure                years, and the annual copayment cap
                                                  section 1722A(b) to mean that VA has                     to take the action would result in higher             would also be raised by $120 for each
                                                  discretion to determine the appropriate                  copayments, and, as described in prior                $1 increase in the copayment amount.
                                                  copayment amount and annual cap                          rulemakings, higher copayments                        The end result would be increased
                                                  amount for medication furnished on an                    reduced the utilization of VA pharmacy                medication copayments, and a higher
                                                  outpatient basis for covered treatment,                  benefits and caused VA patients to                    annual cap on copayments until the
                                                  provided that any decision by VA to                      instead rely on external providers for                effective date of the anticipated final
                                                  increase the copayment amount or                         medications. 79 FR 63820. We continue                 rule implementing tiered medication
                                                  annual cap amount is the subject of a                    to believe this to be the case. The ability           copayments. VA believes this would not
                                                  rulemaking proceeding. We have                           to ensure that medications are taken as               only have an adverse financial effect on
                                                  implemented this statute in 38 CFR                       prescribed is essential to effective health           veterans subject to medication
                                                  17.110.                                                  care management. VA can monitor                       copayments, but would also cause
                                                     Under 38 CFR 17.110(b)(1), veterans                   whether its patients are refilling                    unnecessary confusion by making two
                                                  are obligated to pay VA a copayment for                  prescriptions at regular intervals while              changes to veterans’ medication
                                                  each 30-day or less supply of                            also checking for medications that may                copayment amounts over a two-month
                                                  medication provided by VA on an                          interact with each other when these                   period. Thus, the intended effect of this
                                                  outpatient basis (other than medication                  prescriptions are filled by VA. When                  interim final rule is to prevent increases
                                                  administered during treatment). Under                    both VA and non-VA providers are                      in copayment amounts and the
                                                  the current regulation, the copayment                    issuing prescriptions to a veteran, there             copayment cap for veterans in priority
                                                  amount for veterans in priority groups 2                 is a greater risk of adverse interactions             groups 2 through 8 until VA has
                                                  through 6 of VA’s health care system is                  and harm to the patient because it is                 published a final rule establishing a new
                                                  $8 through December 31, 2016. 38 CFR                     more difficult for each provider to                   copayment structure. At that time,
                                                  17.110(b)(1)(i). The copayment amount                    assess whether the patient is taking any              veterans’ copayments will be
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                                                  for veterans in priority groups 7 and 8                  other medications.                                    determined according to the
                                                  is $9 through December 31, 2016. 38                         On January 5, 2016, we published a                 methodology contained in the final rule
                                                  CFR 17.110(b)(1)(ii). Thereafter, the                    proposed rule that would establish a                  that VA will publish to establish a tiered
                                                  copayment amount for all affected                        tiered medication copayment structure.                copayment system. If VA has not
                                                  veterans is to be established using a                    81 FR 196. In that proposed rule, we                  established a new tiered copayment
                                                  formula based on the prescription drug                   indicated that VA intended to publish a               system by the end of February,
                                                  component of the Medical Consumer                        final rule that would make the proposed               copayments and the copayment cap will
                                                  Price Index (CPI–P), set forth in 38 CFR                 changes effective January 1, 2017. VA                 increase as prescribed in current


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                                                                   Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Rules and Regulations                                         88119

                                                  § 17.110(b) in the absence of further                    existing or subsequent VA guidance                    Unfunded Mandates
                                                  rulemaking.                                              must be read to conform with this                        The Unfunded Mandates Reform Act
                                                                                                           rulemaking if possible or, if not                     of 1995 requires, at 2 U.S.C. 1532, that
                                                  Administrative Procedure Act
                                                                                                           possible, such guidance is superseded                 agencies prepare an assessment of
                                                     The Secretary of Veterans Affairs                     by this rulemaking.
                                                  finds that there is good cause under 5                                                                         anticipated costs and benefits before
                                                  U.S.C. 553(b)(B) and (d)(3) to dispense                  Paperwork Reduction Act                               issuing any rule that may result in the
                                                  with the opportunity for advance notice                                                                        expenditure by State, local, and tribal
                                                                                                             This interim final rule contains no                 governments, in the aggregate, or by the
                                                  and opportunity for public comment                       provisions constituting a collection of
                                                  and good cause to publish this rule with                                                                       private sector, of $100 million or more
                                                                                                           information under the Paperwork                       (adjusted annually for inflation) in any
                                                  an immediate effective date. As stated                   Reduction Act of 1995 (44 U.S.C. 3501–
                                                  above, this rule freezes at current rates                                                                      one year. This interim final rule will
                                                                                                           3521).                                                have no such effect on State, local, and
                                                  the prescription drug copayment that
                                                  VA charges certain veterans. The                         Executive Orders 12866 and 13563                      tribal governments, or on the private
                                                  Secretary finds that it is impracticable                                                                       sector.
                                                                                                              Executive Orders 12866 and 13563
                                                  and contrary to the public interest to                   direct agencies to assess the costs and               Regulatory Flexibility Act
                                                  delay this rule for the purpose of                       benefits of available regulatory
                                                  soliciting advance public comment or to                                                                          The Secretary hereby certifies that
                                                                                                           alternatives and, when regulation is                  this interim final rule will not have a
                                                  have a delayed effective date. If the                    necessary, to select regulatory
                                                  medication copayment freeze is not                                                                             significant economic impact on a
                                                                                                           approaches that maximize net benefits                 substantial number of small entities as
                                                  extended, on January 1, 2017, affected                   (including potential economic,
                                                  veterans would be subject to increased                                                                         they are defined in the Regulatory
                                                                                                           environmental, public health and safety               Flexibility Act, 5 U.S.C. 601–612. This
                                                  medication copayments based on
                                                                                                           effects, and other advantages;                        interim final rule will temporarily freeze
                                                  changes to the CPI–P since 2010, as well
                                                                                                           distributive impacts; and equity).                    the copayments that certain veterans are
                                                  as an upward adjustment to the annual
                                                                                                           Executive Order 13563 (Improving                      required to pay for prescription drugs
                                                  copayment cap. VA believes that this
                                                                                                           Regulation and Regulatory Review)                     furnished by VA. This interim rule
                                                  might cause a significant financial
                                                                                                           emphasizes the importance of                          directly affects individual VA patients
                                                  hardship for those affected veterans and
                                                                                                           quantifying both costs and benefits,                  and will not directly affect small
                                                  may decrease patient adherence to
                                                                                                           reducing costs, harmonizing rules, and                entities. Therefore, pursuant to 5 U.S.C.
                                                  medical plans and have other
                                                                                                           promoting flexibility. Executive Order                605(b), this rulemaking is exempt from
                                                  unpredictable negative health effects.
                                                                                                           12866 (Regulatory Planning and                        the initial and final regulatory flexibility
                                                  Further, VA believes that failing to
                                                  extend the current medication                            Review) defines a ‘‘significant                       analysis requirements of 5 U.S.C. 603
                                                  copayment freeze, without interruption,                  regulatory action,’’ requiring review by              and 604.
                                                  would likely result in confusion for the                 the Office of Management and Budget
                                                                                                           (OMB), unless OMB waives such                         Catalog of Federal Domestic Assistance
                                                  public and affected veterans because the
                                                  new tiered medication copayment                          review, as ‘‘any regulatory action that is              The Catalog of Federal Domestic
                                                  regime will go into effect within a                      likely to result in a rule that may: (1)              Assistance numbers and titles for the
                                                  relatively short period of time. Lastly,                 Have an annual effect on the economy                  programs affected by this document are
                                                  allowing the current medication                          of $100 million or more or adversely                  as follows: 64.005, Grants to States for
                                                  copayment freeze to expire on December                   affect in a material way the economy, a               Construction of State Home Facilities;
                                                  31, 2016, would create programmatic                      sector of the economy, productivity,                  64.007, Blind Rehabilitation Centers;
                                                  issues that would be difficult for VA to                 competition, jobs, the environment,                   64.008, Veterans Domiciliary Care;
                                                  administratively manage. Within a 60-                    public health or safety, or State, local,             64.009, Veterans Medical Care Benefits;
                                                  day period IT algorithms that are                        or tribal governments or communities;                 64.010, Veterans Nursing Home Care;
                                                  currently in place would have to be                      (2) Create a serious inconsistency or                 64.011, Veterans Dental Care; 64.012,
                                                  removed, new copayment amounts and                       otherwise interfere with an action taken              Veterans Prescription Service; 64.013,
                                                  annual cap amounts would have to be                      or planned by another agency; (3)                     Veterans Prosthetic Appliances; 64.014,
                                                  calculated and implemented along with                    Materially alter the budgetary impact of              Veterans State Domiciliary Care; 64.015,
                                                  the necessary system changes, followed                   entitlements, grants, user fees, or loan              Veterans State Nursing Home Care;
                                                  by application of the new IT changes                     programs or the rights and obligations of             64.016, Veterans State Hospital Care;
                                                  necessary for establishing a new tiered                  recipients thereof; or (4) Raise novel                64.018, Sharing Specialized Medical
                                                  medication copayment scheme.                             legal or policy issues arising out of legal           Resources; 64.019, Veterans
                                                     For the above reasons, the Secretary                  mandates, the President’s priorities, or              Rehabilitation Alcohol and Drug
                                                  issues this rule as an interim final rule.               the principles set forth in this Executive            Dependence; 64.022, Veterans Home
                                                  VA will consider and address comments                    Order.’’                                              Based Primary Care; and 64.024, VA
                                                  that are received within 60 days of the                     The economic, interagency,                         Homeless Providers Grant and Per Diem
                                                  date this interim final rule is published                budgetary, legal, and policy                          Program.
                                                  in the Federal Register.                                 implications of this interim final rule
                                                                                                           have been examined, and it has been                   Signing Authority
                                                  Effect of Rulemaking                                     determined not to be a significant                      The Secretary of Veterans Affairs, or
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                                                     Title 38 of the Code of Federal                       regulatory action under Executive Order               designee, approved this document and
                                                  Regulations, as revised by this interim                  12866. VA’s impact analysis can be                    authorized the undersigned to sign and
                                                  final rulemaking, represents VA’s                        found as a supporting document at                     submit the document to the Office of the
                                                  implementation of its legal authority on                 http://www.regulations.gov, usually                   Federal Register for publication
                                                  this subject. Other than future                          within 48 hours after the rulemaking                  electronically as an official document of
                                                  amendments to this regulation or                         document is published. Additionally, a                the Department of Veterans Affairs. Gina
                                                  governing statutes, no contrary guidance                 copy of the rulemaking and its impact                 S. Farrisee, Deputy Chief of Staff,
                                                  or procedures are authorized. All                        analysis are available on VA’s Web site.              Department of Veterans Affairs,


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                                                  88120            Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Rules and Regulations

                                                  approved this document on October 3,                     to the proposed rules, one rule was                   requested a review of competitive
                                                  2016, for publication.                                   revised to alleviate confusion and                    products’ share of institutional costs.3
                                                    Dated: December 2, 2016.                               another revision was administrative in                   The instant rulemaking stems from
                                                                                                           nature.                                               the Commission’s findings in Order No.
                                                  Michael Shores,
                                                                                                           DATES: Effective January 6, 2017.
                                                                                                                                                                 3506 on Proposal One. In that order, the
                                                  Acting Director, Regulation Policy &                                                                           Commission found that a portion of
                                                  Management, Office of the Secretary,                     FOR FURTHER INFORMATION CONTACT:
                                                  Department of Veterans Affairs.
                                                                                                                                                                 inframarginal costs (those inframarginal
                                                                                                           David A. Trissell, General Counsel, at                costs calculated as part of a product’s
                                                  List of Subjects in 38 CFR Part 17                       202–789–6820.                                         incremental cost) have a reliably
                                                                                                           SUPPLEMENTARY INFORMATION:                            identifiable causal relationship to
                                                     Administrative practice and
                                                  procedure, Alcohol abuse, Alcoholism,                    Regulatory History                                    products. Order No. 3506 at 61.
                                                  Claims, Day care, Dental health, Drug                                                                          Therefore, pursuant to Order No. 3506,
                                                                                                             81 FR 63448 (Sept. 15, 2016).
                                                  abuse, Foreign relations, Government                                                                           attributable costs must also include
                                                  contracts, Grant programs—health,                        Table of Contents                                     those inframarginal costs calculated as
                                                  Grant programs—veterans, Health care,                    I. Introduction
                                                                                                                                                                 part of a competitive product’s
                                                  Health facilities, Health professions,                   II. Background                                        incremental costs (in addition to a
                                                  Health records, Homeless, Medical and                    III. Review and Analysis of Comments                  product’s volume-variable costs and
                                                  dental schools, Medical devices,                         IV. Changes to Proposed Rules                         product-specific fixed costs).4
                                                  Medical research, Mental health                          V. Ordering Paragraphs                                   As noted above, on October 19, 2016,
                                                  programs, Nursing homes, Philippines,                                                                          the Commission issued the Errata to
                                                                                                           I. Introduction                                       clarify the definition of inframarginal
                                                  Reporting and recordkeeping
                                                  requirements, Scholarships and                              On September 9, 2016, the                          costs described in Order No. 3506. See
                                                  fellowships, Travel and transportation                   Commission issued proposed rules                      Errata. Generally, when defining
                                                  expenses, Veterans.                                      consisting of necessary changes,                      inframarginal costs, the Errata replaced
                                                                                                           resulting from Order No. 3506, that                   the phrase ‘‘do not vary directly with
                                                     For the reasons set out in the                        specifically define or describe                       volume,’’ with the phrase ‘‘are not
                                                  preamble, VA amends 38 CFR part 17 as                    attributable costs.1 For the reasons                  volume-variable costs.’’ Id. at 1–2. The
                                                  follows:                                                 discussed below, the Commission                       revised definition of inframarginal costs
                                                  PART 17—MEDICAL                                          adopts final rules on this topic, with                does not impact the Commission’s
                                                                                                           minor revisions to the proposed rules as              findings in Order No. 3506. However,
                                                  ■ 1. The authority citation for part 17                  discussed in chapter IV.                              the definition cited in Order No. 3507,
                                                  continues to read as follows:                            II. Background                                        ‘‘[i]nframarginal costs are variable costs
                                                     Authority: 38 U.S.C. 501, and as noted in                                                                   that do not vary directly with volume,’’
                                                                                                              On September 9, 2016, the                          would now be cited as ‘‘[i]nframarginal
                                                  specific sections.
                                                     Sections 17.640 and 17.647 also issued                Commission issued Order No. 3506 after                costs are variable costs that are not
                                                  under Public Law 114–2, sec. 4.                          consideration of a United Parcel                      volume-variable costs.’’ Id. at 1; Order
                                                     Sections 17.641 through 17.646 also issued            Service, Inc. (UPS) petition which                    No. 3507 at 4; see also Order No. 3506
                                                  under 38 U.S.C. 501(a) and Public Law 114–               sought to make changes to the                         at 10.
                                                  2, sec. 4.                                               methodologies employed by the Postal
                                                                                                           Service to account for the costs of the               III. Review and Analysis of Comments
                                                  § 17.110    [Amended]
                                                                                                           Postal Service’s products in its periodic                On October 17, 2016, the Commission
                                                  ■ 2. Amend § 17.110 as follows:                          reports.2 In Proposal One, UPS                        received comments from Amazon
                                                  ■ a. In paragraphs (b)(1)(i), (ii), and (iii),           recommended that the Postal Service                   Fulfillment Services, Inc. (Amazon),5
                                                  remove all references to ‘‘December 31,                  calculate and attribute inframarginal                 the Public Representative,6 and the
                                                  2016’’ and add in each place ‘‘February                  costs to individual products in addition              Postal Service.7 On October 18, 2016,
                                                  26, 2017’’.                                              to the currently attributed volume-                   the Commission received comments
                                                  ■ b. In paragraph (b)(2), remove all                     variable and product-specific fixed                   from UPS8 and, on October 20, 2016, it
                                                  references to ‘‘December 31, 2016’’ and                  costs. Petition, Proposal One at 1.
                                                  add in each place ‘‘February 26, 2017’’.                 Proposal Two dealt with reclassifying                    3 Petition, Proposal Three at 1. The Commission

                                                  [FR Doc. 2016–29337 Filed 12–6–16; 8:45 am]              some fixed costs as fully or partially                declined to consider Proposal Three as it planned
                                                                                                                                                                 to initiate its 5-year review pursuant to 39 U.S.C.
                                                  BILLING CODE 8320–01–P                                   variable, and attributing those costs to              3633(b) following Order No. 3506’s issuance. Order
                                                                                                           products. Petition, Proposal Two at 1.                No. 3506 at 124, 125; see also Docket No. RM2017–
                                                                                                           UPS also filed a third proposal, which                1, Order No. 3624, Advance Notice of Proposed
                                                                                                                                                                 Rulemaking to Evaluate the Institutional Cost
                                                  POSTAL REGULATORY COMMISSION                                                                                   Contribution Requirement for Competitive
                                                                                                              1 Notice of Proposed Rulemaking on Changes
                                                                                                                                                                 Products, November 22, 2016.
                                                  39 CFR Parts 3015 and 3060                               Concerning Attributable Costing, September 9, 2016       4 On October 7, 2016, UPS appealed Order No.
                                                                                                           (Order No. 3507). See also Docket No. RM2016–2,
                                                                                                           Order Concerning United Parcel Service, Inc.’s        3506 to the United States Court of Appeals for the
                                                  [Docket No. RM2016–13; Order No. 3641]                                                                         District of Columbia Circuit. United Parcel Service,
                                                                                                           Proposed Changes to Postal Service Costing
                                                                                                           Methodologies (UPS Proposals One, Two, and            Inc. v. Postal Regulatory Commission, No. 16–1354
                                                  Changes to Attributable Costing                                                                                (D.C. Cir. filed Oct. 7, 2016) (Case No. 16–1354).
                                                                                                           Three), September 9, 2016 (Order No. 3506).
                                                                                                                                                                    5 Comments of Amazon Fulfillment Services, Inc.,
                                                  AGENCY:     Postal Regulatory Commission.                Discussed in greater detail below, the Commission
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                                                                                                           issued an errata related to Order No. 3506. Docket    October 17, 2016 (Amazon Comments).
                                                  ACTION:    Final rule.                                   No. RM2016–2, Notice of Errata, October 19, 2016         6 Public Representative Comments, October 17,

                                                                                                           (Errata). Any reference to Order No. 3506 refers to   2016 (PR Comments).
                                                  SUMMARY:    The Commission is issuing a                  the updated version including the changes                7 Comments of the United States Postal Service in

                                                  set of final rules amending some                         identified in the Errata.                             Response to Order No. 3507, October 17, 2016
                                                  existing Commission rules related to                        2 See generally Order No. 3506. See also Docket    (Postal Service Comments).
                                                                                                           No. RM2016–2, Petition of United Parcel Service,         8 United Parcel Service, Inc.’s Comments on
                                                  attributable costing. The final rules are                Inc. for the Initiation of Proceedings to Make        Notice of Proposed Rulemaking on Changes
                                                  consistent with methodology changes                      Changes to Postal Service Costing Methodologies,      Concerning Attributable Costing, October 18, 2016
                                                  approved by the Commission. Relative                     October 8, 2015 (Petition).                           (UPS Comments). UPS also filed a motion for late



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Document Created: 2016-12-07 05:31:16
Document Modified: 2016-12-07 05:31:16
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionInterim final rule.
ContactBridget Souza, Office of Community Care (10D), Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 382-2537. (This is not a toll-free number.)
FR Citation81 FR 88117 
RIN Number2900-AP87
CFR AssociatedAdministrative Practice and Procedure; Alcohol Abuse; Alcoholism; Claims; Day Care; Dental Health; Drug Abuse; Foreign Relations; Government Contracts; Grant Programs-Health; Grant Programs-Veterans; Health Care; Health Facilities; Health Professions; Health Records; Homeless; Medical and Dental Schools; Medical Devices; Medical Research; Mental Health Programs; Nursing Homes; Philippines; Reporting and Recordkeeping Requirements; Scholarships and Fellowships; Travel and Transportation Expenses and Veterans

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