[Federal Register Volume 75, Number 90 (Tuesday, May 11, 2010)]
[Proposed Rules]
[Pages 26160-26165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-11170]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 1

RIN 2900-AN42


Drug and Drug-Related Supply Promotion by Pharmaceutical Company 
Sales Representatives at VA Facilities

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule; republication.

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SUMMARY: The Department of Veterans Affairs (VA) is republishing the 
proposed rule document that was published on May 5, 2010, in the 
Federal Register to provide the address that the public needs to submit 
their comments. In that document, we inadvertently omitted the 
ADDRESSES section for public comments. As a convenience to the public, 
instead of merely publishing a correction document, we are republishing 
the entire proposed rule with the ADDRESSES section and a new 60-day 
comment period. These are the only two changes made to the proposed 
rule.
    The purposes of the proposed rule are to reduce or eliminate any 
potential for disruption in the patient care environment, manage 
activities and promotions at VA facilities, and provide sales 
representatives with a consistent standard of permissible business 
practice at VA facilities. It would also facilitate mutually beneficial 
relationships between VA and such sales representatives.

DATES: Comments must be received by VA on or before July 12, 2010.

ADDRESSES: Written comments may be submitted through http://www.Regulations.gov; by mail or hand delivery to the Director, 
Regulations Management (02REG), Department of Veterans Affairs, 810 
Vermont Ave., NW, Room 1068, Washington, DC 20420; or by fax to (202) 
273-9026. Comments should indicate that they are submitted in response 
to ``RIN 2900-AN42--Drug and Drug-Related Supply Promotion by 
Pharmaceutical Company Sales.'' 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 a.m. and 4:30 p.m., 
Monday through Friday (except holidays). Please call (202) 461-4902 
(this is not a toll-free number) for an appointment. In addition, 
during the comment period, comments may be viewed online through the 
Federal Docket Management System at http://www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Louis E. Cobuzzi, PBM Services (119), 
Veterans Health Administration, Department of Veterans Affairs, 810 
Vermont Avenue, NW., Washington, DC 20420; (202) 461-7362. (This is not 
a toll-free number).

SUPPLEMENTARY INFORMATION: On May 5, 2010, VA published this proposed 
rule in the Federal Register at 75 FR 24510, with an error. We 
inadvertently omitted the ADDRESSES section for public comments. We are 
republishing the proposed rule with the address information where the 
public can submit their comments and with a new 60-day comment period.
    Under 38 U.S.C. 303, the Secretary of Veterans Affairs is 
responsible for ``the proper execution and administration of all laws 
administered by the Department and for the control, direction, and 
management of the Department.'' The Secretary has authority to 
prescribe all rules necessary to carry out the laws administered by the 
Department, such as section 303 regarding control and management of the 
Department. See 38

[[Page 26161]]

U.S.C. 501(a). VA has implemented this authority, as it pertains to 
management of VA facilities, in 38 CFR part 1.
    VA proposes to amend 38 CFR part 1 to regulate access to VA medical 
facilities by sales representatives (including account managers and 
clinical liaisons) promoting drugs and drug-related supplies. 
Currently, many policies regarding access to VA facilities are 
established and maintained at the local level, either by Veterans 
Integrated Service Network (VISN) leaders or by administrators at 
particular facilities. A VISN, which we define in proposed Sec.  
1.220(a), is a network of all VA health care facilities located in a 
particular region. There are 21 such regions, and the areas that they 
service can be found at http://www.vacareers.va.gov/networks.cfm. The 
proposed rule would prescribe Department-wide rules that must be 
followed at the VISN and local levels. We note that the proposed rules 
are consistent with past VA policy and practice.
    VA proposes this rule to prescribe the circumstances under which 
sales representatives from pharmaceutical companies promoting drugs and 
drug-related supplies may be granted access to VA facilities. This rule 
is necessary to limit such access to those circumstances that benefit 
VA from an educational standpoint, while avoiding potential disturbance 
to patient care and ensuring compliance with standards of ethical 
conduct. Pharmaceutical sales representatives have heavy interaction 
with local VA staff each year, and this rule will ensure that their 
activities do not negatively affect the quality of patient care. The 
proposed rule would also assist these sales representatives by 
providing clear standards, applicable to all VA facilities nationwide, 
which are consistent with current practices at most VA facilities. The 
proposed rule would require the Chief of Pharmacy or other official 
responsible for such decisions to approve educational programs and 
materials presented or furnished by these sales representatives, so as 
to ensure that those programs and materials focus on clinician 
education as opposed to marketing of drugs and drug-related supplies. 
The proposed rule would generally deny sales representatives access to 
patient care areas in VA facilities to ensure patient privacy, and 
would require them to make appointments at the facilities they intend 
to visit as opposed to open and unrestricted access. Further, the 
proposed rule would prohibit sales representatives from furnishing any 
food to VA staff or gifts above the de minimis value set forth in the 
standards of ethical conduct for Federal employees, and would prohibit 
VA employees' personal acceptance of drug samples.
    We propose to designate this rule as Sec.  1.220. Currently, Sec.  
1.218, regarding security and law enforcement at VA facilities, 
describes general behavior that is prohibited on the grounds of VA 
property. Proposed Sec.  1.220, would govern the behavior of particular 
individuals (sales representatives) on the grounds of VA medical 
facilities, but is not a security and law enforcement provision as it 
is not our intention to prescribe a fine for failure to comply with 
this rule. (VA is required to provide for a fine and/or imprisonment 
for violations of the security and law enforcement provisions at Sec.  
1.218 (38 U.S.C. 901)).
    In proposed paragraph (a), we would set forth definitions 
applicable to this section. In particular, we would use current policy 
and practice to define ``Criteria-for-use'' as clinical criteria 
describing how certain drugs may be used in VA. The criteria-for-use 
are, and will continue to be, posted on VA's Web site at http://www.pbm.va.gov. The definition would note that local exceptions may 
apply ``for operational reasons.'' An example of the need for a local 
exception might be if a particular facility within a VISN (e.g., a 
Community-Based Outpatient Clinic (CBOC)) did not have a physician with 
the required expertise about a particular drug to prescribe. Under the 
exception, a primary care provider might direct that the drug be 
prescribed at a different facility within the VISN (e.g., a VA 
hospital) where a suitable physician could be found. We note that such 
exceptions at the local level are not posted on our website, or 
elsewhere, because they are subject to change and because they do not 
have any general effect on the approval of the drug for use within VA. 
For example, if the particular facility hires a physician with the 
required expertise to administer the drug within its approved criteria 
for use, or if a physician within the facility obtains such expertise 
through training. We also note that such exceptions have no effect on 
the use of the drug elsewhere within the VISN. Thus, these exceptions 
do not have a broad or national effect on pharmaceutical companies.
    We would broadly define ``drugs'' and ``drug-related supplies'' 
because we intend these terms to be inclusive of all items typically 
promoted by pharmaceutical sales representatives. Similarly, paragraph 
(a) would define ``VA medical facility'' as ``any property under the 
charge and control of VA used to provide medical benefits.'' These 
broad definitions would ensure that the proposed rule applies to the 
largest possible number of sales representatives and VA medical 
facilities, including but not limited to hospitals, CBOCs, nursing 
homes, and domiciliaries.
    We would define ``VA National Formulary (VANF) drugs and/or drug-
related supplies'' as ``any drug or drug-related supply that must be 
available for prescription at all VA medical facilities,'' and would 
provide the public with a means to obtain the most current list of such 
drugs or drug-related supplies. Non-VANF drugs or drug-related supplies 
would be defined as drugs or drug-related supplies that are not 
included on the list of VANF drugs or drug-related supplies.
    Proposed paragraph (b) would set forth the general rule applicable 
to the promotion of drugs and drug-related supplies. It would state 
that notwithstanding Sec.  1.218(a)(8), regarding soliciting, vending, 
and debt collection on VA property, VA would allow promotion in VA 
medical facilities of VANF and non-VANF drugs or drug-related supplies 
if the promotion is consistent with criteria-for-use, the drug is not 
classified as non-promotable, and the promotion is otherwise consistent 
with the proposed rule and with facility initiatives. It would clearly 
be against the interests of VA and our patients to allow a promotion 
that did not meet these three criteria, which are consistent with past 
policy and practice. This rule would be an exception to Sec.  
1.218(a)(8) because that rule bars solicitations ``of any kind'' on VA 
property, and otherwise precludes behavior (such as posting signs and 
distributing literature) that would be specifically authorized by Sec.  
1.220.
    Proposed paragraph (c) would apply only to the promotion of non-
VANF drugs or drug-related supplies without criteria-for-use. Such 
promotions are generally for new molecular entities or new indications 
for existing drugs, and such promotions must be regulated at the local 
level in order to allow for different clinical approaches. The 
promotion of new molecular entities would be permitted, but any 
decision allowing the promotion of such a drug would be reconsidered if 
the VANF committee reviews the drug and grants or denies VANF status. 
Because new molecular entities generally do not have a history of 
significant published studies in populations similar to the VA patient 
population and may not be part of an established drug class, it is 
important that the proposed rule allow VA medical professionals to 
become educated through the promotion of such drugs but, at the same 
time, ensure that

[[Page 26162]]

promotions are consistent with National policy.
    Proposed paragraphs (d) and (f) would be general rules applicable 
to educational programs and materials (paragraph (d)) and the behavior 
of sales representatives on the grounds of VA medical facilities 
(paragraph (f)). These rules would attempt to balance the benefits of 
such promotion against the need to maintain an appropriate clinical 
environment at VA facilities, safeguarding the peace and privacy of 
patients and ensuring that VA personnel are able to perform their jobs 
without unnecessary interference. The rules would also avoid any 
appearance of bias for or against particular drug manufacturers by 
closely regulating the use of advertising material and display of brand 
names, logos, and sponsorships. An appearance of bias in a drug 
promotion situation could significantly undermine the trust of patients 
or the public in VA doctors. Proposed paragraph (e), in addition to 
furthering the policies described above that support paragraphs (d) and 
(f), would regulate the receipt of gifts and donations to ensure that 
VA maintains appropriate relationships with drug companies and 
suppliers.
    In paragraph (g), we would set forth the consequences for 
noncompliance with this section. Any individual, or any company, that 
fails to comply with this section would be subject to limitations on 
the right to access VA facilities, which may include suspension of a 
sales representative's access privileges, or, in extreme cases, denying 
access to a company's entire sales force. Consistent with the 
Secretary's delegations of authority to the Under Secretary for Health 
and the Under Secretary's further delegation of authority to certain 
Veterans Health Administration officials, the proposed rule would 
authorize the director of the VA Medical Center of jurisdiction to 
issue appropriate orders restricting access to facilities under the 
director's control. This is the person who would be in the best 
position to determine whether any violation of the proposed rule 
requires restrictions on access to particular VA facilities or whether 
an opportunity for corrective action by the individual or company will 
suffice. In most cases, we expect that the infraction would be 
adequately addressed by the sales representative and no formal action 
would be required.
    Procedurally, paragraph (g) would require the director to notify 
the sales representative or company of the violation and any proposed 
restrictions on access privileges before issuing any final order. The 
director would be required to provide notice to a company's sales 
manager if the proposed action would result in a denial of access 
privileges for the company's entire sales force. Affected persons and 
companies would have 30 days after the date of the notice to provide 
the director a response; however, during that 30-day period the 
proposed action would be enforced. This is necessary to ensure that 
noncompliance does not continue during the 30-day period. After 
considering the requirements of the proposed rule, the circumstances of 
the improper conduct, and any response submitted by the sales 
representative or company, the director would either resolve the matter 
informally or issue a final order restricting access.
    Under proposed paragraph (g)(4), in cases where the director issues 
a final order suspending or permanently barring a company's entire 
sales force, the director would be required to provide notice of the 
company's right to a one-time appeal of the matter to the Under 
Secretary for Health. Any such request for the Under Secretary's review 
would be submitted to the director that issued the order within 30 days 
of the date of the order. The director would then forward the initial 
notice, the company's response, the director's order, and the company's 
request for review to the Under Secretary for a final decision. The 
director's order would be enforced until the Under Secretary's review 
is complete. This mechanism provides important due process to companies 
seeking to appeal such final orders.
    We note that in most cases, sales representatives are considerate 
of VA's needs and mission, and do not behave inappropriately. 
Accordingly, we do not envision that the proposed paragraph (g) would 
be invoked with regularity.

Executive Order 12866

    Executive Order 12866 directs agencies to assess all 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, 
and other advantages; distributive impacts; and equity). The Executive 
Order classifies a regulatory action as a ``significant regulatory 
action,'' requiring review by the Office of Management and Budget (OMB) 
unless OMB waives such review, if it is a 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 
the Executive Order.
    The economic, interagency, budgetary, legal, and policy 
implications of this proposed rule 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 expenditure by 
State, local, or tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any given year. This proposed rule would have no such 
effect on State, local, or tribal governments, or on the private 
sector.

Paperwork Reduction Act

    The proposed rule does not contain any collections of information 
under the Paperwork Reduction Act (44 U.S.C. 3501-3520).

Regulatory Flexibility Act

    The Secretary hereby certifies that this proposed rule 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 proposed rule would not cause a significant 
economic impact on health care providers, suppliers, or other small 
entities. The proposed rule generally concerns the promotion of drugs 
by large pharmaceutical companies and only a small portion of the 
business of such entities concerns VA beneficiaries. Therefore, 
pursuant to 5 U.S.C. 605(b), this proposed 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 and titles are 
64.009 Veterans Medical Care Benefits,

[[Page 26163]]

64.010 Veterans Nursing Home Care and 64.011 Veterans Dental Care.

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 30, 2009, for publication.

List of Subjects in 38 CFR Part 1

    Administrative practice and procedure, Archives and records, 
Cemeteries, Claims, Courts, Crime, Flags, Freedom of Information, 
Government employees, Government property, Infants and children, 
Inventions and patents, Parking, Penalties, Privacy, Reporting and 
recordkeeping requirements, Seals and insignia, Security measures, 
Wages.

    Dated: May 7, 2010.
Robert C. McFetridge,
Director, Regulation Policy and Management, Office of the General 
Counsel.
    For the reasons set forth in the preamble, the Department of 
Veterans Affairs proposes to amend 38 CFR part 1 as follows:

PART 1--GENERAL PROVISIONS

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

    Authority: 38 U.S.C. 501(a), and as noted in specific sections.

    2. Add Sec.  1.220 to read as follows:


Sec.  1.220  Promotion of drugs and drug-related supplies at VA medical 
facilities.

    (a) Definitions. For the purposes of this section:
    Criteria-for-use means clinical criteria developed by the 
Department of Veterans Affairs (VA) at a National level that describe 
how certain drugs may be used. VA's criteria-for-use are available to 
the public at http://www.pbm.va.gov. Exceptions may be applied at the 
local level for operational reasons.
    Drugs means pharmaceuticals or chemicals intended for use by a 
patient or, in some cases, for medical research.
    Drug-related supplies means supplies related to the use of a drug, 
such as test strips or testing devices.
    New molecular entity refers to an active ingredient that has never 
before been marketed in the United States in any form.
    Non-VANF drugs or drug-related supplies are drugs or drug-related 
supplies that do not appear on the VA National Formulary.
    VA medical facility means any property under the charge and control 
of VA used to provide medical benefits, including Community-Based 
Outpatient Clinics and similar facilities.
    VA National Formulary (VANF) drugs and/or drug-related supplies 
means any drug or drug-related supply that must be available for 
prescription at all VA medical facilities. A list of VANF drugs or 
drug-related supplies is available at www.pbm.va.gov, or may be 
requested by contacting the local office of the Chief of Pharmacy 
Services.
    Veterans Integrated Service Network (VISN) means one of the 21 
networks of VA medical facilities.
    (b) Permissible promotion of drugs and drug-related supplies. 
Notwithstanding Sec.  1.218(a)(8), VA will allow promotion in VA 
medical facilities of VANF and non-VANF drugs or drug-related supplies 
if all of the following are true:
    (1) The promotion is consistent with any existing criteria-for-use.
    (2) The drug or drug-related supply has not been classified by VA 
as non-promotable. A list of the drugs or drug-related supplies 
classified by VA as non-promotable is available at www.pbm.va.gov, or 
may be requested by contacting the local office of the Chief of 
Pharmacy Services.
    (3) The promotion is otherwise consistent with this section.
    (4) The promotion is consistent with facility initiatives.
    (c) Promotion of non-VANF drugs and drug-related supplies without 
criteria-for-use. Under paragraph (b) of this section, non-VANF drugs 
or drug-related supplies must be promoted consistent with any existing 
criteria-for-use. Non-VANF drugs without criteria-for-use may be 
promoted only if:
    (1) Specifically permitted by the VISN Pharmacy Executive;
    (2) Authorized by the Chief of Pharmacy with jurisdiction over the 
VA medical facility at which the promotion occurs; and
    (3) In a case where a VISN Formulary Leader has permitted the 
promotion of a new molecular entity prior to any decision regarding its 
VANF status, such permission must be reconsidered if the new molecular 
entity:
    (i) Is subsequently granted VANF status but is labeled non-
promotable; or
    (ii) A decision is made to deny VANF status.
    (d) Educational programs and materials. All educational programs 
and materials must be approved by the person at the VA medical facility 
to whom such approval responsibility has been delegated under local 
policy, usually the Chief of Pharmacy Services. A summary of the 
program and all materials must be provided well in advance of the 
proposed date so that a determination of the program's suitability can 
be made. Programs and materials must conform to the following 
guidelines:
    (1) Industry sponsorship must be disclosed in the introductory 
remarks and in the announcement brochure. Sponsorship includes any 
contribution, whether in the form of staple goods, personnel, or 
financing, intended to support the program.
    (2) Marketing activities cannot be conducted during an educational 
program.
    (3) Promotional materials are not to be placed in any patient care 
area.
    (4) Programs or materials must not offer patients an opportunity to 
participate in manufacturer sponsored programs and/or require the 
furnishing of Protected Health Information.
    (5) Patient education materials must not contain the name or logo 
of the pharmaceutical manufacturer or be used for promotion of specific 
medications; unless the VA Pharmacy Benefits Management Service 
determines that the logo or name is inconspicuous and legal 
requirements (e.g., trademark requirements) make their removal 
impractical. Even if such materials are approved by the VA National 
Formulary committee, the materials must otherwise be approved by the 
local facility in accordance with paragraph (d) of this section.
    (6) Programs or materials regarding a new drug, drug-related 
supply, or a new therapeutic indication for a drug, which is already on 
the VANF but has not yet been reviewed by VA, must be clearly 
identified as such.
    (7) Programs or materials focusing primarily on non-VANF drugs or 
drug-related supplies are discouraged; such programs or materials, as 
well as programs or materials regarding VANF drugs or drug-related 
supplies with restrictions, must be clearly identified as such.
    (e) Providing gifts, drugs or other promotional items to VA 
employees or facilities.
    (1) General. No sales representative may give, and no VA employee 
may receive, any item (including but not limited to promotional 
materials, continuing education materials, textbooks, entertainment, 
and gratuities) that exceeds the value permissible for acceptance under 
government ethical rules (5 CFR 2635.204(a)). However, such items may 
be donated to a medical center library or individual department

[[Page 26164]]

for use by all employees, in accordance with local policies. Gifts of 
travel in support of VA staff official travel may be accepted by the 
Department subject to advance legal review in accordance with 31 U.S.C. 
1353, 41 CFR part 304, and VA policy regarding such gifts.
    (2) Donations of drugs and drug-related supplies. Drug samples and 
free drug-related supplies must be approved by the person at the 
medical facility to whom such responsibility is delegated under local 
policy, usually the Director. Information pertaining to the trial use 
of these drugs or drug-related supplies must be forwarded to the VISN 
Pharmacy Executive or VISN Formulary Committee. Drugs or drug-related 
supplies donated for the intended purpose of patient use must be 
delivered to the Office of the Chief of Pharmacy Services for proper 
storage, documentation and dispensing. These donated items must not be 
labeled ``sample,'' ``professional sample,'' or similar words, unless 
VA grants an exception in the interests of patient care. Drug or supply 
samples may not be provided to VA staff for their personal use.
    (3) Donations of food. Sales representatives may not provide food 
items of any type or any value to VA staff (including volunteers and 
without compensation employees) or bring food items into VA medical 
facilities for use by non-VA staff (e.g., employees of affiliates). 
This constraint applies to all sales representatives who have business 
relationships with VA Clinical Services.
    (f) Conduct of sales representatives. In addition to any other 
rules in this section, sales representatives (i.e., promoters) of drugs 
and drug-related supplies must conform to the following:
    (1) Sales representatives must provide accurate information. Sales 
representatives must ensure that all drugs or drug-related supplies are 
discussed, displayed and represented accurately, in accordance with any 
applicable Food and Drug Administration and VANF guidelines and 
restrictions.
    (2) Contacts are to be by appointment only. In order to minimize 
the potential for disruption of patient care activities, a sales 
representative must schedule an appointment before each specific visit. 
Access to VA medical facilities by a sales representative without an 
appointment is not permitted under any circumstances. VA medical 
facilities may develop a list of individuals or departments that do not 
wish to be called-on by sales representatives. A sales representative 
must not attempt to make appointments with individuals or departments 
on the list. The list may be obtained at the local office of the Chief 
of Pharmacy Services.
    (3) Contacts with VA staff without an appointment. A sales 
representative visiting a VA medical facility for a scheduled 
appointment may not initiate requests for meetings with other VA staff; 
however, sales representatives may respond to requests initiated by VA 
staff during the visit.
    (4) Paging VA employees. The sales representative may not use the 
public address (paging) system to locate any VA employee. Contacts 
using the electronic paging system (beepers) are permissible only if 
specifically requested by the VA employee.
    (5) Marketing to students. Sales representatives are prohibited 
from marketing to medical, pharmacy, nursing and other health 
profession students (including residents). Exceptions may be permitted 
when approved by, and conducted in the presence of, their clinical 
staff member.
    (6) Attendance at conferences. A sales representative is not 
allowed to attend a medical center conference where patient-specific 
material is discussed or presented.
    (7) Patient care areas. Sales representatives generally may not 
wait for scheduled appointments or make presentations in patient-care 
areas, but may briefly travel through them, when necessary, to meet in 
a staff member's office. Patient-care areas include, but are not 
limited to:
    (i) Patient rooms and ward areas where patients may be encountered;
    (ii) Clinic examination rooms;
    (iii) Nurses stations;
    (iv) Intensive care units;
    (v) Operating room suites;
    (vi) Emergency rooms;
    (vii) Urgent care centers; and
    (viii) Ambulatory treatment centers.
    (g) Failure to properly promote drugs or drug-related supplies 
within VA.
    (1) A sales representative's commercial visiting privileges at one 
or more VA medical facilities may be restricted by the written order of 
the director of the VA medical center of jurisdiction if the director 
determines the sales representative failed to comply with the 
requirements of this section. The director will notify the 
representative of the noncompliance and of the director's proposed 
action under paragraph (g)(3) of this section. The director will also 
notify the manager or other appropriate supervisor of the sales force 
if there have been instances of widespread misconduct by an individual, 
or by multiple representatives of the same sales force, and the 
director proposes to suspend or permanently revoke the sales force's 
commercial visiting privileges at one or more VA medical facilities. 
The notice will offer 30 days to provide a response; however, the 
proposed action will be enforced effective the date of the notice.
    (2) At the end of the 30-day period for a response, or after the 
director receives a timely response, the director may, as appropriate 
to prevent future noncompliance, issue a written order suspending or 
permanently revoking the sales representative's or sales force's 
commercial visiting privileges, impose a lesser sanction, or decide 
that no further action is required. In determining the appropriate 
action, the director shall consider the requirements of this section, 
the circumstances of the improper conduct, any prior acts of misconduct 
by the same sales representative or sales force, any response submitted 
by the sales representative or sales force manager, and any prior 
orders issued or other actions taken with respect to similar acts of 
misconduct. Any final order issued by the director shall include a 
summary of the circumstances of the violation, a listing of the 
specific provisions of this section that the sales representative or 
sales force violated, and the bases for the director's determination 
regarding the appropriate remedial action.
    (3) Actions that may be imposed under this section include 
limitation, suspension, or permanent revocation of commercial visiting 
privileges at one or more VA medical facilities. Instances of 
widespread misconduct by an individual or multiple sales 
representatives may result in the imposition of a VISN-wide or VA-wide 
limitation, suspension, or revocation of commercial visiting privileges 
of the entire sales force of a given manufacturer, if necessary to 
prevent further noncompliance. The director will provide the sales 
representative or sales force manager written notice of any final order 
issued under this section.
    (4) Notice concerning a final order suspending or permanently 
revoking an entire sales force's commercial visiting privileges shall 
include specific notice concerning the right to appeal the director's 
order to the Under Secretary for Health. The sales force manager or 
other corporate representative may request the Under Secretary's review 
within 30 days of the date of the director's order by submitting a 
written request to the director. The director shall forward the initial 
notice, any response, the final order, and the request for review to 
the Under Secretary for a final VA decision. VA will enforce the 
director's order while it

[[Page 26165]]

is under review by the Under Secretary. The director will provide the 
individual who made the request written notice of the Under Secretary's 
decision.

(Authority: 38 U.S.C. 501)
[FR Doc. 2010-11170 Filed 5-10-10; 8:45 am]
BILLING CODE 8320-01-P