[Federal Register: July 25, 2003 (Volume 68, Number 143)]
[Rules and Regulations]
[Page 43927-43930]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy03-8]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AL68
Medication Prescribed by Non-VA Physicians
AGENCY: Department of Veterans Affairs.
ACTION: Interim final rule.
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SUMMARY: This rule amends VA's medical regulations that govern the
provision of medication to veterans when the medication is prescribed
by non-VA physicians. The rule provides that, in limited circumstances,
VA may provide medication prescribed by a non-VA physician to veterans
enrolled in VA's health care system prior to July 25, 2003, if the
veterans have requested an initial appointment for primary care in a VA
health care facility before July 25, 2003, and were unable to obtain an
initial appointment for primary care within 30 days. The rule
establishes specific requirements that veterans must meet to receive
such medications and it establishes limits on the types and quantities
of medication VA may provide. VA's intent is to assist enrolled
veterans who have requested primary care appointments but who have not
been able to obtain one within 30 days.
DATES: Effective Date: This interim final rule is effective on July 25,
2003; except for 38 CFR 17.96(e) which is effective August 25, 2003.
Comment Dates: Comments on the rule must be received on or before
September 8, 2003; except that comments on the request for emergency
approval of the collection of information provisions must be received
on or before August 25, 2003.
Applicability Date: Benefits may be provided commencing September
22, 2003.
ADDRESSES: Mail or hand-deliver written comments to: Director,
Regulations Management (00REG1), Department of Veterans Affairs, 810
Vermont Ave., NW., Room 1068, Washington, DC 20420; or fax comments to
(202) 273-9026; or e-mail comments to OGCRegulations@mail.va.gov.
Comments should indicate that they are submitted in response to ``RIN
2900-AL68.'' All comments received will be available for public
inspection in the Office of Regulation Policy and Management, Room
1063B, between the hours of 8 a.m. and 4:30 p.m., Monday through Friday
(except holidays). Please call (202) 273-9515 for an appointment.
FOR FURTHER INFORMATION CONTACT: Kendra Drew, Chief Business Office
(16), at (202) 254-0329 and Virginia Torrise, Pharmacy Benefits
Management, Deputy Chief Consultant (119), at (202) 273-8426. These
individuals are in the Veterans Health Administration of the Department
of Veterans Affairs, located at 810 Vermont Avenue, NW., Washington, DC
20420.
SUPPLEMENTARY INFORMATION: Under existing law and regulations, a
veteran desiring medical care from VA must enroll in VA's health care
system, except for veterans whose service-connected disabilities are
50% or greater, or any veteran seeking treatment for a service-
connected condition. When a veteran first enrolls in the VA system, and
requests an appointment for care, VA schedules an appointment for a
visit with a primary care physician. During that first appointment, a
VA health care provider examines the veteran and determines what care
the veteran needs. That primary care physician generally learns from
the veteran what medication the veteran is taking, if any, assesses the
need for medication, and writes prescriptions for any needed
medication. Those prescriptions written by the VA physician are then
filled by a VA pharmacy.
In recent years, VA has faced an extraordinary increase in demand
for health care services. The increased demand has been caused, at
least in part, by veterans enrolling in the VA health care system to
obtain pharmacy benefits at no cost or at a reasonable cost. With
dramatically increased enrollment, VA has been unable to provide all
enrolled veterans with services in a timely manner. In many places that
means veterans may wait a considerable length of time to receive an
initial primary care visit. Many of those veterans have prescriptions,
written by non-VA physicians, that VA primary care physicians may
confirm and renew when the veterans are able to have initial primary
care visits. In an effort to ease the financial burden on enrolled
veterans currently waiting lengthy periods of time for their initial
primary care visits, VA will provide these veterans with medications
prior to their initial primary care visits at VA if these veterans
present valid prescriptions from their non-VA physicians. VA will fill
prescriptions written by non-VA physicians only for the period of time
such veterans are awaiting a scheduled appointment with a VA health
care provider. VA anticipates asking the veterans whether they want to
have the next available appointment, or whether they want to postpone
the initial appointment. VA will schedule the veterans' initial
appointments within the period covered by the prescriptions written by
their non-VA physicians. VA anticipates that some veterans will choose
to postpone the initial appointment, shortening waiting lists and
making appointment dates available to other veterans.
VA anticipates that in the near future, it will be able to provide
all enrolled veterans with primary care in a timely manner. That would
effectively eliminate the need for providing medications under this
rule. However, it is important that VA have such regulations in place
until such time as waiting periods can be reduced.
VA is undertaking this rulemaking pursuant to its authority under
38 U.S.C. 1710(a) to furnish needed medical services. As clarified in
paragraph (a) of this rule, VA does not generally fill prescriptions
for veterans that are written by non-VA physicians. Instead, VA usually
provides only medications prescribed by VA physicians or VA contractors
retained for that purpose. This is consistent with the primary purpose
of the Veterans Health Administration, which is to provide integrated
comprehensive health care for veterans, not simply act as a conduit for
furnishing prescription medications.
In light of the backlog of veterans seeking VA care, however, the
Secretary has determined that the filling of some prescriptions written
by non-VA physicians is needed during the period of time such veterans
are awaiting a scheduled appointment with a VA health care provider. As
a result, paragraph (b) of this rule states that beginning September
22, 2003, VA may furnish medications for veterans enrolled in VA's
health care system prior to July 25, 2003, if the veterans have
requested an initial appointment for primary care in a VA health care
facility before July 25, 2003, and the next available appointment date
is scheduled more than 30 days after the veteran requests the
appointment. VA chose the 30-day limitation because it is generally
considered reasonable in the community at large to expect that one
could obtain a first time primary care visit with a physician within 30
days. VA chose to limit the provision of medications in question to
only those veterans enrolled prior to July 25, 2003, in order to
specifically address the
[[Page 43928]]
problems of currently enrolled veterans facing lengthy waits for
initial primary care appointments in a cost-effective manner. (See 38
U.S.C. 1706(a) requiring VA to ``design, establish and manage health
care programs in such a manner as to promote cost-effective delivery of
health care services''). Moreover, without these limitations, the very
issuance of the new rule could invite an influx of new enrollments and
requests for appointments, exacerbating the wait-time problem the rule
is intended to address. This rule also should benefit those who enroll
after the effective date or attempt to make appointments after that
date. By allowing those presently enrolled and waiting more than 30
days to reschedule appointments at dates closer to expiration of
presently held non-VA prescriptions, additional near term appointments
should become available for those who are not entitled to this limited
benefit. Thus, the out-of-pocket costs for prescriptions filled while
waiting for VA appointments should also be reduced for those not
specifically included in this rule because their waiting time should be
reduced.
Paragraph (c) of this rule states that VA may furnish an amount of
medication that will appropriately meet the treatment needs of veterans
until the date of the veterans' initial appointment for primary care in
a VA facility. If veterans choose to postpone their initial appointment
date until they have used all of the medication prescribed by the non-
VA provider, VA will furnish the amount prescribed, including refills.
VA will furnish such medications consistent with long-standing pharmacy
practices. The decision on the precise quantity of medication that
would be needed is generally considered to be a medical determination
and would be left to appropriate VA clinicians including pharmacists.
Paragraph (d) of this rule states that if VA reschedules an initial
appointment for primary care in a VA health care facility for veterans
eligible under this rule, or if veterans reschedule their appointments
for good reasons, as determined by the local VA medical facility, VA
may furnish the eligible veterans with a quantity of medication that is
sufficient to meet the treatment needs of the veterans until the date
of the veterans' rescheduled appointments for primary care in a VA
health care facility. If VA reschedules veterans' initial primary care
visits, it is reasonable that VA would provide additional medication to
meet the veterans' needs until the date of their rescheduled
appointments. VA also understands that there are occasions when, for
good cause, veterans might be forced to cancel appointments. For
example, if the veteran had to reschedule an appointment because of
inclement weather, or because of the illness or death of a family
member, VA would not disqualify the veteran from continuing to receive
the benefits of this remedial program. However, VA would not furnish
medications to veterans who simply cancel or reschedule and extend
their appointments without good reasons.
Paragraph (e) of this rule states that VA may furnish medications
beginning on September 22, 2003, only if veterans provide VA with
written current prescriptions for their medications signed by duly
licensed physicians within the previous 90 days. To ensure the health
and safety of veterans, VA will only fill prescriptions when veterans
present VA with written prescriptions signed by licensed physicians. VA
will not accept prescriptions called in by veterans' non-VA pharmacies
or non-VA health care providers. VA lacks the resources to accept and
manage those calls.
Paragraph (f) of this rule states that VA may furnish only
medication under paragraph (b) that (1) must be dispensed by
prescription, (2) is not an over-the-counter medication, (3) is not
listed as a controlled substance under schedule I through V of the
Comprehensive Drug Abuse Prevention and Control Act, 21 U.S.C. 812, (4)
is included on VA's National Formulary, unless VA determines a non-
Formulary medication is medically necessary, and (5) is not an acute
medication, intravenous medication, nor one required to be administered
only by a medical professional. By providing only medications that must
be dispensed by prescription, VA is not furnishing over-the-counter
drugs. Veterans can easily purchase over-the-counter medications
without regard to whether they are able to schedule visits with a
physician. For patient health and safety reasons, VA will not furnish
controlled substances without a VA physician first seeing the patient
and ordering the medication. VA will furnish veterans with medications
prescribed by non-VA physicians only if the medication is on VA's
National Formulary, or approved in advance through a special approval
process. If a veteran provides VA with a prescription for medications
that are not on VA's formulary, VA will contact the physician who wrote
the prescription to determine whether a medication on VA's formulary is
appropriate, and if not, the medical reasons why it is not appropriate.
If VA determines that a medication is medically necessary, but is not
on VA's formulary, VA will provide that medication. Finally, acute
medications, intravenous medications, and medications required to be
administered only by a medical professional will not be furnished
because under this rule prescriptions will be filled only by mail.
Paragraph (g) of this rule provides that the existing copayment
requirements applicable to VA furnishing medication will apply to
medications furnished under this rule. Statutes (e.g., 38 U.S.C. 1722A)
require application of the copayment requirements.
Paragraph (h) of this rule provides that VA will furnish
medications under this rule only by having the medication mailed to the
veteran, typically by one of VA's Consolidated Mail Out-patient
Pharmacies, or with VA contract pharmacies. Therefore, this benefit is
not useful for veterans who require acute medications, intravenous
medications, or medications to be administered only by a medical
professional. VA pharmacies will not directly furnish medications or
reimburse veterans for medications that they obtain from non-VA
pharmacies.
Paragraph (i) of this rule restates, with no substantive change,
longstanding regulatory provisions regarding prescriptions found in
Sec. 17.96.
Administrative Procedure Act
Pursuant to 5 U.S.C. 553, we have found for this rule that notice
and public procedure are impracticable, unnecessary, and contrary to
the public interest, and that we have good cause to dispense with
notice and comment on this rule and to dispense with a 30-day delay of
its effective date. This is an effort to ease the financial burden on
enrolled veterans currently waiting lengthy periods of time for their
initial primary care visits. Delaying implementation of this benefit
would only exacerbate the problems veterans are experiencing while
waiting for VA treatment.
Unfunded Mandates
The Unfunded Mandates Reform Act requires, at 2 U.S.C. 1532, that
agencies prepare an assessment of anticipated costs and benefits before
developing any rule that may result in an expenditure by State, local,
or tribal governments, in the aggregate, or by the private sector of
$100 million or more in any given year. This proposed amendment would
have no such effect on State, local, or tribal governments, or the
private sector.
[[Page 43929]]
Paperwork Reduction Act
OMB assigns a control number for each collection of information it
approves. Except for emergency approvals under 44 U.S.C. 3507(j), VA
may not conduct or sponsor, and a person is not required to respond to,
a collection of information unless it displays a currently valid OMB
control number.
The interim final rule at Sec. 17.96(e) contains collections of
information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).
Accordingly, under section 3507(d) of the Act, VA has submitted a copy
of this rulemaking action to OMB for its review of the collections of
information. We have requested OMB to approve the collection of
information on an emergency basis by August 25, 2003. If OMB does not
approve the collections of information as requested, we will
immediately remove Sec. 17.96(e) or take such other action as is
directed by OMB.
We are also seeking an approval of the information collection on a
non-emergency basis. Accordingly, we are also requesting comments on
the collection of information provisions contained in Sec. 17.96(e) on
a non-emergency basis. Comments must be submitted by September 23,
2003.
OMB assigns a control number for each collection of information it
approves. VA may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number.
Comments on the collections of information should be submitted to
the Office of Management and Budget, Attention: Desk Officer for the
Department of Veterans Affairs, Office of Information and Regulatory
Affairs, Washington, DC 20503, or faxed to 202 395-6974, with copies
mailed or hand-delivered to: Director, Regulations Management (00REG1),
Department of Veterans Affairs, 810 Vermont Ave., NW., Room 1068,
Washington, DC 20420. Comments should indicate that they are submitted
in response to ``RIN 2900-AL68.''
Title: Medication Prescribed by non-VA Physicians.
Summary of collection of information: The interim final rule at
Sec. 17.96(e) contains application provisions for written
prescriptions and information requirements. The interim rule at Sec.
17.96(e) contains requirements for provision of medication to veterans
when the medication is prescribed by non-VA physicians.
Application Provisions for Written Prescriptions and Information
Requirements.
Description of the need for information and proposed use of
information: This information is needed to determine eligibility for
provision of medication to veterans when the medication is prescribed
by non-VA physicians.
Description of likely respondents: veterans and treating
physicians.
Estimated number of respondents per year: 181,723.
Estimated frequency of responses per year: 1.
Estimated total annual reporting and recordkeeping burden: 33,316
hours.
Estimated annual burden per collection: 11 minutes.
The Department considers comments by the public on collections of
information in--
[sbull] Evaluating whether the collections of information are
necessary for the proper performance of the functions of the
Department, including whether the information will have practical
utility;
[sbull] Evaluating the accuracy of the Department's estimate of the
burden of the collections of information, including the validity of the
methodology and assumptions used;
[sbull] Enhancing the quality, usefulness, and clarity of the
information to be collected; and
[sbull] Minimizing the burden of the collections of information on
those who are to respond, including responses through the use of
appropriate automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology, e.g.,
permitting electronic submission of responses.
OMB is required to make a decision concerning the collections of
information contained in this rule between 30 and 60 days after
publication of this document in the Federal Register. Therefore, a
comment to OMB is best assured of having its full effect if OMB
receives it within 30 days of publication. This does not affect the
deadline for the public to comment on the interim final rule.
Executive Order 12866
The Office of Management and Budget has reviewed this document
under Executive Order 12866.
Regulatory Flexibility Act
The Secretary hereby certifies that this regulatory amendment would
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 amendment would not directly affect any small
entities. Only individuals could be directly affected. Therefore,
pursuant to 5 U.S.C. 605(b), this amendment is exempt from the initial
and final regulatory flexibility analysis requirements of sections 603
and 604.
Catalog of Federal Domestic Assistance Numbers
The Catalog of Federal Domestic Assistance numbers for the programs
affected by this document are 64.005, 64.007, 64.008, 64.009, 64.010,
64.011, 64.012, 64.013, 64.014, 64.015, 64.016, 64.018, 64.019, 64.022,
and 64.025.
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: July 17, 2003.
Anthony J. Principi,
Secretary of Veterans Affairs.
0
For the reasons set out in the preamble, VA is amending 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, 1721, unless otherwise noted.
0
2. Section 17.96 is revised to read as follows:
Sec. 17.96 Medication prescribed by non-VA physicians.
(a) General. VA may not furnish a veteran with medication
prescribed by a duly licensed physician who is not an employee of the
VA or is not providing care to the veteran under a contract with the
VA, except as provided in paragraphs (b) through (i) of this section.
(b) Medication furnished prior to an initial primary care
appointment. Beginning on September 22, 2003, VA may furnish medication
prescribed by a non-VA physician for a veteran enrolled under Sec.
17.36 of this part prior to July 25, 2003, who had prior to July 25,
2003, requested an initial appointment for primary care in a VA health
care facility, and the next available appointment date was more than 30
days from the date of the request.
(c) Quantity of medication. VA may furnish a quantity of medication
under
[[Page 43930]]
paragraph (b) of this section that is sufficient to appropriately meet
the treatment needs of the veteran until the date of the veteran's
initial appointment for primary care in a VA health care facility.
(d) Appointment cancellation. If VA reschedules a veteran eligible
under paragraph (b) for an initial appointment for primary care in a VA
health care facility, or if such a veteran reschedules the appointment
for good cause, as determined by the local VA treatment facility, VA
may furnish the eligible veteran with a quantity of medication under
paragraph (b) of this section that is sufficient to appropriately meet
the treatment needs of the veteran until the date of the veteran's
rescheduled appointment for primary care in a VA health care facility.
(e) Written prescription and information requirements. VA may
furnish medication under paragraph (b) of this section only if the
veteran provides VA with a written prescription for the medication
signed by a duly licensed physician within the previous 90 days.
(1) The veteran must furnish the following information:
(i) Name;
(ii) Date of Birth;
(iii) Social Security Number;
(iv) Home address;
(v) Phone number (with area code);
(vi) Name of Health Insurance Company and Health Insurance Policy
Number;
(vii) List of any allergies;
(viii) History of any adverse reaction to any medication;
(ix) List of current medications, including over-the-counter
medications or herbal supplements; and
(x) Indication of whether the VA pharmacist may call a non-VA
physician for information regarding medications.
(2) The non-VA physician must furnish the following information:
(i) Name;
(ii) Group practice name;
(iii) Social Security Number or Tax ID number;
(iv) License Number;
(v) Office address;
(vi) Phone number and fax number; and
(vii) E-mail address.
(f) Medications that may be furnished. VA may furnish medication
under paragraph (b) of this section only if the medication:
(1) Must be dispensed by prescription;
(2) Is not an over-the-counter medication;
(3) Is not listed as a controlled substance under schedule I
through V of the Comprehensive Drug Abuse Prevention and Control Act,
21 U.S.C. 812;
(4) Is included on VA's National Formulary, unless VA determines a
non-Formulary medication is medically necessary; and
(5) Is not an acute medication, an intravenous medication nor one
required to be administered only by a medical professional.
(g) Copayments. Copayment provisions in Sec. 17.110 of this part
apply to medication furnished under paragraph (b) of this section.
(h) Mailing of Medications. VA may furnish medication under
paragraph (b) of this section only by having the medication mailed to
the veteran.
(i) Medications for veterans receiving increased compensation or
pension. Any prescription, which is not part of authorized Department
of Veterans Affairs hospital or outpatient care, for drugs and
medicines ordered by a private or non-Department of Veterans Affairs
doctor of medicine or doctor of osteopathy duly licensed to practice in
the jurisdiction where the prescription is written, shall be filled by
a Department of Veterans Affairs pharmacy or a non-VA pharmacy in a
state home under contract with VA for filling prescriptions for
patients in state homes, provided:
(1) The prescription is for:
(i) A veteran who by reason of being permanently housebound or in
need of regular aid and attendance is in receipt of increased
compensation under 38 U.S.C. chapter 11, or increased pension under
section 3.1(u) (Section 306 Pension) or section 3.1(w) (Improved
Pension), of this title, as a veteran of the Mexican Border Period,
World War I, World War II, the Korean Conflict, or the Vietnam Era (or,
although eligible for such pension, is in receipt of compensation as
the greater benefit), or
(ii) A veteran in need of regular aid and attendance who was
formerly in receipt of increased pension as described in paragraph
(a)(1) of this section whose pension has been discontinued solely by
reason of excess income, but only so long as such veteran's annual
income does not exceed the maximum annual income limitation by more
than $ 1,000, and
(2) The drugs and medicines are prescribed as specific therapy in
the treatment of any of the veteran's illnesses or injuries.
(Authority: 38 U.S.C. 1706, 1710, 17.12(d))
[FR Doc. 03-19011 Filed 7-24-03; 8:45 am]
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