Copayments for Medications in 2015, 55544-55545 [2015-23162]

Download as PDF 55544 Federal Register / Vol. 80, No. 179 / Wednesday, September 16, 2015 / Rules and Regulations DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 17 RIN 2900–AP15 Copayments for Medications in 2015 Department of Veterans Affairs. Final rule. AGENCY: ACTION: This document adopts as a final rule, with changes, an interim final rule amending the Department of Veterans Affairs (VA) medical regulations to freeze the copayments required for certain medications provided by VA until December 31, 2015. Under that interim final rule, copayment amounts were maintained at the same rates as they were in 2014 (which were $8 for veterans in priority groups 2–6 and $9 for veterans in priority groups 7 and 8), and would have increased based on the prescription drug component of the Medical Consumer Price Index (CPI–P) on January 1, 2016. This final rule extends the current freeze for copayments through December 31, 2016. DATES: Effective date: This rule is effective on September 16, 2015. Applicability date: The provisions of this final rule shall apply to the copayments discussed herein as of January 1, 2015. FOR FURTHER INFORMATION CONTACT: Kristin Cunningham, Director, Business Policy, Chief Business Office (10NB), Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 382–2508. (This is not a toll-free number.) SUPPLEMENTARY INFORMATION: An interim final rule amending VA’s medical regulations concerning the copayment required for certain medications was published in the Federal Register on October 27, 2014. 79 FR 63819. VA invited interested persons to submit comments on the interim final rule on or before December 26, 2014, and we received four comments. All four commenters supported the interim final rule, which maintained copayment rates for medications at their current levels throughout 2015. One commenter disagreed with part of the rationale for the rule. VA explained in the interim final rule that part of the rationale for the rule is to reduce the incentive for veterans to seek care from other health care providers and plans, as fragmentation of care can increase the risk of adverse interactions and harm to the patient because it is more difficult Lhorne on DSK5TPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 13:48 Sep 15, 2015 Jkt 235001 for each provider to assess if the patient is taking any other medications. The commenter further recommended that VA should ensure the ability of non-VA providers to easily communicate with VA to treat patients, monitor prescriptions, and reduce wait times. Normally when VA authorizes care from a non-VA health care provider, we require the provider to submit medical record information to VA so that we have a complete account of what care and treatment was provided to a veteran. Many veterans receive care and services from other providers that are not authorized by VA, and in these situations, our health care providers may not have a complete account of the veteran’s care. To the extent that non-VA providers can and do share information with VA, the risk of an adverse event declines, and VA fully supports such efforts. However, since the effect of the rulemaking is to temporarily freeze certain copayments and not establish monitoring or communication standards, VA does not make any changes to this rulemaking. The commenter also urged VA to allow veterans to fill prescriptions written by civilian family physicians at VA pharmacies to reduce significant financial challenges for veterans and to maintain consistency with the delivery of pharmaceutical benefits to veterans. However, this recommendation is outside the scope of this rulemaking, which deals only with establishing copayment rates for medications prescribed by and filled by VA. Therefore, VA is not making any changes based on this comment. One commenter suggested extending the freeze for at least an additional two to three years, to alleviate what the commenter deemed an ‘‘undue hardship’’ on veterans caused by increased pharmacy copayments. To the extent that increased pharmacy copayments have been shown to reduce utilization of VA pharmacy benefits (as stated in the interim final rule), we agree with the commenter that extending the freeze for at least one additional year is in the best interest of veterans. We would therefore extend the freeze in this final rule to be effective through December 31, 2016. 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 medication copayments, which will further align VA’s medication copayment structure with other Federal agencies and the commercial sector. PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 Therefore, VA is extending the copay freeze in this final rule to be effective through December 31, 2016. VA is adding an applicability date paragraph to the preamble to clarify that the amendments made by this rulemaking applied to the copayments discussed herein as of January 1, 2015. This is a clarifying, non-substantive change. Based on the rationale set out here and in the interim final rule, VA is adopting the provisions of the interim final rule as a final rule with the change to extend the freeze as described above. Effect of Rulemaking Title 38 of the Code of Federal Regulations, as revised by this 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 final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3521). Regulatory Flexibility Act The Secretary hereby certifies that this 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 final rule will temporarily freeze the copayments that certain veterans are required to pay for prescription drugs furnished by VA. This final rule directly affects only individuals and will not directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the final regulatory flexibility analysis requirements of 5 U.S.C. 604. 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, E:\FR\FM\16SER1.SGM 16SER1 Federal Register / Vol. 80, No. 179 / Wednesday, September 16, 2015 / Rules and Regulations Lhorne on DSK5TPTVN1PROD with RULES 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 regulatory action have been examined, and it has been determined that it is a significant regulatory action under Executive Order 12866 because it is likely to result in a regulatory action that may have an annual effect on the economy of $100 million or more. 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 at http://www.va.gov/orpm/, by following the link for VA Regulations Published from FY 2004 through fiscal year to date. Congressional Review Act VA has determined that this regulatory action is considered a major rule under the Congressional Review Act, 5 U.S.C. 801–08, because it may result in an annual effect on the economy of $100 million or more. In the preamble to the interim final rule (79 FR 63819, 63821), we stated that although this regulatory action may constitute a major rule within the meaning of the Congressional Review Act, 5 U.S.C. 804(2), it was not subject to the 60-day delay in effective date applicable to major rules under 5 U.S.C. 801(a)(3) because the Secretary found that good cause existed under 5 U.S.C. 808(2) and made this regulatory action effective on January 1, 2015, consistent with the reasons given for the publication of this regulatory action as an interim final VerDate Sep<11>2014 13:48 Sep 15, 2015 Jkt 235001 rule. Increasing the copayment amount on January 1, 2015, might have caused a significant financial hardship for some veterans and may have decreased patient adherence to medical plans, and could have had other unpredictable negative health effects. VA anticipates the same risk for financial hardship and decreased patient adherence if copayments were increased in calendar year 2016, and has therefore extended the freeze through December 31, 2016. Accordingly, the Secretary found that additional advance notice and public procedure thereon were impractical, unnecessary, and contrary to the public interest. In accordance with 5 U.S.C. 801(a)(1), VA submitted to the Comptroller General and to Congress a copy of this regulatory action and VA’s Regulatory Impact Analysis. 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 final rule will have no such effect on State, local, and tribal governments, or on the private sector. 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. Robert L. Nabors II, Chief of Staff, PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 55545 Department of Veterans Affairs, approved this document on May 5, 2015, for publication. 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. Dated: September 10, 2015. Michael P. Shores, Chief Impact Analyst, Office of Regulation Policy & Management, Office of the General Counsel, Department of Veterans Affairs. For the reasons set out in the preamble, VA amends 38 CFR part 17 as follows: PART 17—MEDICAL 1. The authority citation for part 17 continues to read as follows: ■ Authority: 38 U.S.C. 501, and as noted in specific sections. § 17.110 [Amended] 2. Amend § 17.110 in paragraphs (b)(1)(i) through (iii) and (b)(2), by removing all references to ‘‘December 31, 2015’’ and adding in their place ‘‘December 31, 2016’’. ■ [FR Doc. 2015–23162 Filed 9–15–15; 8:45 am] BILLING CODE 8320–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA–R07–OAR–2015–0520; FRL–9934–00– Region 7] Approval and Promulgation of Air Quality Implementation Plans; State of Missouri; Control of NOX Emissions From Large Stationary Internal Combustion Engines Environmental Protection Agency (EPA). ACTION: Direct final rule. AGENCY: The Environmental Protection Agency (EPA) is taking direct final action to approve revisions to the State Implementation Plan (SIP) for the State of Missouri submitted on October 17, 2013. These revisions remove SUMMARY: E:\FR\FM\16SER1.SGM 16SER1

Agencies

[Federal Register Volume 80, Number 179 (Wednesday, September 16, 2015)]
[Rules and Regulations]
[Pages 55544-55545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23162]



[[Page 55544]]

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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AP15


Copayments for Medications in 2015

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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

SUMMARY: This document adopts as a final rule, with changes, an interim 
final rule amending the Department of Veterans Affairs (VA) medical 
regulations to freeze the copayments required for certain medications 
provided by VA until December 31, 2015. Under that interim final rule, 
copayment amounts were maintained at the same rates as they were in 
2014 (which were $8 for veterans in priority groups 2-6 and $9 for 
veterans in priority groups 7 and 8), and would have increased based on 
the prescription drug component of the Medical Consumer Price Index 
(CPI-P) on January 1, 2016. This final rule extends the current freeze 
for copayments through December 31, 2016.

DATES: Effective date: This rule is effective on September 16, 2015.
    Applicability date: The provisions of this final rule shall apply 
to the copayments discussed herein as of January 1, 2015.

FOR FURTHER INFORMATION CONTACT: Kristin Cunningham, Director, Business 
Policy, Chief Business Office (10NB), Veterans Health Administration, 
Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 
20420, (202) 382-2508. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: An interim final rule amending VA's medical 
regulations concerning the copayment required for certain medications 
was published in the Federal Register on October 27, 2014. 79 FR 63819.
    VA invited interested persons to submit comments on the interim 
final rule on or before December 26, 2014, and we received four 
comments. All four commenters supported the interim final rule, which 
maintained copayment rates for medications at their current levels 
throughout 2015. One commenter disagreed with part of the rationale for 
the rule. VA explained in the interim final rule that part of the 
rationale for the rule is to reduce the incentive for veterans to seek 
care from other health care providers and plans, as fragmentation of 
care can increase the risk of adverse interactions and harm to the 
patient because it is more difficult for each provider to assess if the 
patient is taking any other medications.
    The commenter further recommended that VA should ensure the ability 
of non-VA providers to easily communicate with VA to treat patients, 
monitor prescriptions, and reduce wait times. Normally when VA 
authorizes care from a non-VA health care provider, we require the 
provider to submit medical record information to VA so that we have a 
complete account of what care and treatment was provided to a veteran. 
Many veterans receive care and services from other providers that are 
not authorized by VA, and in these situations, our health care 
providers may not have a complete account of the veteran's care. To the 
extent that non-VA providers can and do share information with VA, the 
risk of an adverse event declines, and VA fully supports such efforts. 
However, since the effect of the rulemaking is to temporarily freeze 
certain copayments and not establish monitoring or communication 
standards, VA does not make any changes to this rulemaking.
    The commenter also urged VA to allow veterans to fill prescriptions 
written by civilian family physicians at VA pharmacies to reduce 
significant financial challenges for veterans and to maintain 
consistency with the delivery of pharmaceutical benefits to veterans. 
However, this recommendation is outside the scope of this rulemaking, 
which deals only with establishing copayment rates for medications 
prescribed by and filled by VA. Therefore, VA is not making any changes 
based on this comment.
    One commenter suggested extending the freeze for at least an 
additional two to three years, to alleviate what the commenter deemed 
an ``undue hardship'' on veterans caused by increased pharmacy 
copayments. To the extent that increased pharmacy copayments have been 
shown to reduce utilization of VA pharmacy benefits (as stated in the 
interim final rule), we agree with the commenter that extending the 
freeze for at least one additional year is in the best interest of 
veterans. We would therefore extend the freeze in this final rule to be 
effective through December 31, 2016. 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 medication copayments, which will further align 
VA's medication copayment structure with other Federal agencies and the 
commercial sector. Therefore, VA is extending the copay freeze in this 
final rule to be effective through December 31, 2016.
    VA is adding an applicability date paragraph to the preamble to 
clarify that the amendments made by this rulemaking applied to the 
copayments discussed herein as of January 1, 2015. This is a 
clarifying, non-substantive change.
    Based on the rationale set out here and in the interim final rule, 
VA is adopting the provisions of the interim final rule as a final rule 
with the change to extend the freeze as described above.

Effect of Rulemaking

    Title 38 of the Code of Federal Regulations, as revised by this 
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 final rule contains no provisions constituting a collection of 
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521).

Regulatory Flexibility Act

    The Secretary hereby certifies that this 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 final rule will temporarily freeze the copayments that 
certain veterans are required to pay for prescription drugs furnished 
by VA. This final rule directly affects only individuals and will not 
directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), 
this rulemaking is exempt from the final regulatory flexibility 
analysis requirements of 5 U.S.C. 604.

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,

[[Page 55545]]

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 regulatory action have been examined, and it has 
been determined that it is a significant regulatory action under 
Executive Order 12866 because it is likely to result in a regulatory 
action that may have an annual effect on the economy of $100 million or 
more. 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 at 
http://www.va.gov/orpm/, by following the link for VA Regulations 
Published from FY 2004 through fiscal year to date.

Congressional Review Act

    VA has determined that this regulatory action is considered a major 
rule under the Congressional Review Act, 5 U.S.C. 801-08, because it 
may result in an annual effect on the economy of $100 million or more. 
In the preamble to the interim final rule (79 FR 63819, 63821), we 
stated that although this regulatory action may constitute a major rule 
within the meaning of the Congressional Review Act, 5 U.S.C. 804(2), it 
was not subject to the 60-day delay in effective date applicable to 
major rules under 5 U.S.C. 801(a)(3) because the Secretary found that 
good cause existed under 5 U.S.C. 808(2) and made this regulatory 
action effective on January 1, 2015, consistent with the reasons given 
for the publication of this regulatory action as an interim final rule. 
Increasing the copayment amount on January 1, 2015, might have caused a 
significant financial hardship for some veterans and may have decreased 
patient adherence to medical plans, and could have had other 
unpredictable negative health effects. VA anticipates the same risk for 
financial hardship and decreased patient adherence if copayments were 
increased in calendar year 2016, and has therefore extended the freeze 
through December 31, 2016. Accordingly, the Secretary found that 
additional advance notice and public procedure thereon were 
impractical, unnecessary, and contrary to the public interest. In 
accordance with 5 U.S.C. 801(a)(1), VA submitted to the Comptroller 
General and to Congress a copy of this regulatory action and VA's 
Regulatory Impact Analysis.

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 final rule will have no such effect on 
State, local, and tribal governments, or on the private sector.

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. Robert L. 
Nabors II, Chief of Staff, Department of Veterans Affairs, approved 
this document on May 5, 2015, for publication.

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.

    Dated: September 10, 2015.
Michael P. Shores,
Chief Impact Analyst, Office of Regulation Policy & Management, Office 
of the General Counsel, Department of Veterans Affairs.

    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.

Sec.  17.110  [Amended]

0
2. Amend Sec.  17.110 in paragraphs (b)(1)(i) through (iii) and (b)(2), 
by removing all references to ``December 31, 2015'' and adding in their 
place ``December 31, 2016''.

[FR Doc. 2015-23162 Filed 9-15-15; 8:45 am]
 BILLING CODE 8320-01-P