[Federal Register Volume 77, Number 250 (Monday, December 31, 2012)]
[Rules and Regulations]
[Pages 76865-76867]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31432]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AO58
Copayments for Medications in 2013
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.
But for this rulemaking, beginning on January 1, 2013, the copayment
amount would increase based on a formula set forth in regulation. The
maximum annual copayment amount payable by veterans would also
increase. For 2012, VA ``froze'' the copayment amount for veterans in
VA's health care system enrollment priority categories 2 through 6, but
allowed copayments to increase based on the regulatory formula for
veterans in priority categories 7 and 8. However, that formula did not
trigger an increase in the copayment amount for veterans in priority
categories 7 and 8. This rulemaking freezes copayments at the current
rate for veterans in priority categories 2 through 8 for 2013, and
thereafter resumes increasing copayments in accordance with the
regulatory formula.
DATES: Effective Date: This rule is effective on December 31, 2012.
Comments must be received on or before March 1, 2013.
ADDRESSES: Written comments may be submitted by email through http://www.regulations.gov; by mail or hand-delivery to Director, Regulation
Policy and Management (02REG), 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-AO58, Copayments for
Medications in 2013.'' Copies of comments received will be available
for public inspection in the Office of Regulation Policy and
Management, Room 1063B, 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: Kristin Cunningham, Director, Business
Policy, Chief Business Office, 810 Vermont Avenue NW., Washington, DC
20420, (202) 461-1599. (This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: Under 38 U.S.C. 1722A(a), VA must require
veterans to pay 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
[[Page 76866]]
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, for the period from July 1,
2010, through December 31, 2012, the copayment amount for veterans in
priority categories 2 through 6 of VA's health care system is $8. 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)(iv). For veterans in priority categories 7 and
8, the copayment amount from July 1, 2010, through December 31, 2011,
was $9. 38 CFR 17.110(b)(1)(iii). After December 31, 2011, copayments
for veterans in priority categories 7 and 8 were subject to the
regulatory formula; however, that formula did not trigger an increase
in the copayment amount, so it remains $9.
Current 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 categories 2 through 6.
Through December 31, 2012, 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 enrolled in one of VA's health care
enrollment system priority categories 2 through 6.
On December 20, 2011, we published a final rulemaking that
``froze'' copayments for veterans in priority categories 2 through 6 at
$8, through December 31, 2012. 76 FR 78824, Dec. 20, 2011. In that
rulemaking, we stated that this freeze was appropriate because this
group would be impacted more by the increase due to their likely
greater need for medical care as a result of their service-connected
disabilities or conditions. This continues to be true, and therefore we
are continuing to freeze copayments for these veterans for the next 12
months.
We also believe that a freeze of the copayment rate is now
appropriate for veterans enrolled in priority categories 7 and 8. Prior
rulemakings justified freezing copayment rates on the basis that higher
copayments reduced the utilization of VA pharmacy benefits. 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 conflict with each other when these
prescriptions are filled by VA. When non-VA providers are also issuing
prescriptions, there is a greater risk of adverse interactions and harm
to the patient because it is more difficult for each provider to know
if the patient is taking any other medications.
At the end of calendar year 2013, unless additional rulemaking is
initiated, VA will once again utilize the CPI-P methodology in Sec.
17.110(b)(1)(iv) to determine whether to increase copayments and
calculate any mandated increase in the copayment amount for veterans in
priority categories 2 through 8. At that time, the CPI-P as of
September 30, 2013, will be divided by the index as of September 30,
2001, which was 304.8. The ratio will then be multiplied by the
original copayment amount of $7. The copayment amount of the new
calendar year will be rounded down to the whole dollar amount. As
mandated by current Sec. 17.110(b)(2), the annual cap will be
calculated by increasing the cap by $120 for each $1 increase in the
copayment amount. Any change in the copayment amount and cap, along
with the associated calculations explaining the basis for the increase,
will be published in a Federal Register notice. Thus, the intended
effect of this rule is to temporarily prevent increases in copayment
amounts and the copayment cap for veterans in priority categories 2
through 8, following which copayments and the copayment cap will
increase as prescribed in current Sec. 17.110(b).
Administrative Procedure Act
In accordance with 5 U.S.C. 553(b)(B) and (d)(3), the Secretary of
Veterans Affairs finds that there is good cause 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. Increasing the copayment amount on January 1,
2013, might cause a significant financial hardship for some veterans.
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,'' which requires review by the Office
of Management and Budget (OMB), 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
[[Page 76867]]
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 to be a significant regulatory action under Executive
Order 12866.
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 an 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 given year. This 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. The interim final rule affects individuals and
has no impact on any 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 sections 603 and 604.
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic Assistance program number and title
for this rule 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. John R.
Gingrich, Chief of Staff, Department of Veterans Affairs, approved this
document on December 7, 2012, 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.
Approved: December 7, 2012.
John R. Gingrich,
Chief of Staff, Department of Veterans Affairs.
For the reasons set forth 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(a), and as noted in specific sections.
Sec. 17.110 [Amended]
0
2. Amend Sec. 17.110 as follows:
0
a. In paragraphs (b)(1)(ii) and (b)(2), remove ``December 31, 2012''
each place it appears and add, in each place, ``December 31, 2013''.
0
b. In paragraphs (b)(1)(iii) and (b)(1)(iv), remove ``December 31,
2011'' each place it appears and add, in each place, ``December 31,
2013''.
[FR Doc. 2012-31432 Filed 12-28-12; 8:45 am]
BILLING CODE 8320-01-P