[Federal Register Volume 68, Number 143 (Friday, July 25, 2003)]
[Rules and Regulations]
[Pages 43927-43930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19011]


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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 [email protected]. 
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]
BILLING CODE 8320-01-P