[Federal Register Volume 69, Number 152 (Monday, August 9, 2004)]
[Proposed Rules]
[Pages 48184-48186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18106]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AL66


Patients' Rights

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

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

SUMMARY: This document proposes to amend VA's medical regulations to 
update the patients' rights regulation by bringing its provisions 
regarding medication, restraints and seclusion into conformity with 
current law and practice. The changes are primarily intended to clarify 
that it is permissible for VA patients to receive medication prescribed 
by any health care professional legally authorized to prescribe 
medication, and that it is permissible for any authorized licensed

[[Page 48185]]

health care professional to order the use of restraints and seclusion 
when necessary. We are also proposing to make nonsubstantive changes in 
the patients' rights regulation for purposes of clarification.

DATES: Comments must be received on or before October 8, 2004.

ADDRESSES: Written comments may be submitted by: mail or hand-delivery 
to Director, Regulations Management (00REG1), Department of Veterans 
Affairs, 810 Vermont Ave., NW., Room 1068, Washington, DC 20420; fax to 
(202) 273-9026; e-mail to [email protected]; or, through http://www.Regulations.gov. Comments should indicate that they are submitted 
in response to ``RIN 2900-AL66.'' 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: Audrey Drake, Program Director (108), 
Veterans Health Administration, Department of Veterans Affairs, 810 
Vermont Ave., NW., Washington, DC 20420, (202) 565-6740.

SUPPLEMENTARY INFORMATION: In 1982, the Department of Veterans Affairs 
published a final rule articulating patients' rights with respect to a 
wide array of matters including such things as clothing, worship, 
money, exercise, visitation and communication, grievances and 
confidentiality of information. The rule is currently set forth at 38 
CFR 17.33.
    Paragraph (e) of the current Sec.  17.33 addresses the topic of 
medications. The first sentence of the paragraph provides that 
``Patients have a right to be free from unnecessary or excessive 
medication.'' The remainder of the paragraph sets forth various 
procedures to ensure that patients will be free from unnecessary or 
excessive medication. Thus, the second sentence of paragraph (e) 
states, ``Except in an emergency, medication will be administered only 
on the written order of a physician in that patient's medical record.'' 
The paragraph further provides that a physician must countersign any 
telephonic prescription within 24 hours, that the attending physician 
will be responsible for all medication given or administered to a 
patient, and that the attending physician must review a patient's drug 
regimen at least every 30 days. Similarly, paragraph (d) of Sec.  17.33 
contains provisions stating that patients may be physically restrained 
or placed in seclusion only upon the written order of a physician.
    When VA promulgated the patients' rights rule in 1982, physicians 
were generally the only health care providers authorized to prescribe 
medication and order the use of restraints and seclusion. However, that 
is no longer the case. Under current law, other health care 
professionals are legally licensed to prescribe medication and 
typically do so in health care settings across the Nation. For example, 
licensed registered nurse practitioners are licensed to independently 
prescribe medication in virtually every state in the United States. 
Similarly, physicians are not the only licensed health care 
professionals that are authorized to order the use of restraints and 
seclusion.
    To update the patients' rights regulation, and bring its provisions 
regarding medication, restraints and seclusion into conformity with 
current law and practice, VA is proposing to eliminate the specific 
references to physicians in Sec.  17.33(d) and (e), and to substitute 
references to appropriate health care professionals. This proposed 
change would not in any way change the substantive patient protections 
in the regulation. Thus, the regulation would continue to provide that 
VA could administer medication and restrain patients and place them in 
seclusion only on the basis of a written order, that telephonic orders 
would have to be countersigned, and that VA would have to ensure review 
of a patient's drug regimen at least every 30 days.
    The proposed amendments would also delete references in the 
regulation to specific time limits on how long restraints or seclusion 
may be used before the health care professional must examine or 
reexamine the patient, and how frequently the patient must be 
monitored. Instead, the regulation would provide that restraints and 
seclusion could be used for a time period that is in compliance with 
current community and/or accreditation standards. Timeframes considered 
appropriate for the use of restraints and seclusion have changed over 
the years, and may change again in the future. To avoid having to 
change the regulation each time, VA believes it would be better to have 
the regulation state that those timeframes must be in compliance with 
the currently accepted community and/or accreditation standards or as 
is reasonable under existing circumstances.
    We are also proposing to make nonsubstantive changes for purposes 
of clarification in Sec.  17.33, including, with no intended change in 
meaning, using the term ``health care professional'' rather than 
``health or mental health professional'' or ``health professional.''

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

Paperwork Reduction Act

    This document contains no provisions constituting a collection of 
information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).

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 proposed 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 proposed amendment would not 
directly affect any small entities. Only individuals could be directly 
affected. 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

    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.


[[Page 48186]]


    Approved: June 2, 2004.
Anthony J. Principi,
Secretary of Veterans Affairs.
    For the reasons set out in the preamble, VA proposes to amend 38 
CFR part 17 as set forth below:

PART 17--MEDICAL

    1. The authority citation for part 17 continues to read as follows:

    Authority: 38 U.S.C. 501, 1721, unless otherwise noted.

    2. Section 17.33 is amended by:
    a. In paragraph (b) introductory text, removing ``paragraph (c)'' 
and adding, in its place, ``paragraphs (c) and (d)''.
    b. In paragraphs (c)(1) introductory text, (c)(2) introductory 
text, and (c)(2)(iv), removing ``health or mental health professional'' 
and adding, in its place, ``health care professional''.
    c. In paragraph (c)(1)(ii), removing ``detaining'' and adding, in 
its place, ``detailing''.
    d. In paragraph (c)(2) introductory text, removing ``this 
paragraph'' and adding, in its place, ``paragraph (c) of this 
section''.
    e. In paragraph (c)(3), removing ``(c)(1)'' and adding, in its 
place, ``(b)''.
    f. In paragraph (c)(4), removing ``pursuant to this paragraph'', 
and adding, in its place, ``under paragraph (c) of this section''.
    g. In paragraph (c)(5), removing ``orders'' and adding, in its 
place, ``orders under paragraph (c) of this section''.
    h. Revising paragraphs (d)(1), (d)(2), and (e).
    The revisions read as follows:


Sec.  17.33  Patients' rights.

* * * * *
    (d) * * * (1) Each patient has the right to be free from physical 
restraint or seclusion except in situations in which there is a 
substantial risk of imminent harm by the patient to himself, herself, 
or others and less restrictive means of preventing such harm have been 
determined to be inappropriate or insufficient. Patients will be 
physically restrained or placed in seclusion only on the written order 
of an appropriate licensed health care professional. The reason for any 
restraint order will be clearly documented in the progress notes of the 
patient's medical record. The written order may be entered on the basis 
of telephonic authority, but in such an event, an appropriate licensed 
health care professional must examine the patient and sign a written 
order within an appropriate timeframe that is in compliance with 
current community and/or accreditation standards. In emergency 
situations, where inability to contact an appropriate licensed health 
care professional prior to restraint is likely to result in immediate 
harm to the patient or others, the patient may be temporarily 
restrained by a member of the staff until appropriate authorization can 
be received from a health care professional. Use of restraints or 
seclusion may continue for a period of time that does not exceed 
current community and/or accreditation standards, within which time an 
appropriate licensed health care professional shall again be consulted 
to determine if continuance of such restraint or seclusion is required. 
Restraint or seclusion may not be used as a punishment, for the 
convenience of staff, or as a substitute for treatment programs.
    (2) While in restraint or seclusion, the patient must be seen 
within appropriate timeframes in compliance with current community and/
or accreditation standards:
    (i) By an appropriate health care professional who will monitor and 
chart the patient's physical and mental condition; and
    (ii) By other ward personnel as frequently as is reasonable under 
existing circumstances.
* * * * *
    (e) Medication. Patients have a right to be free from unnecessary 
or excessive medication. Except in an emergency, medication will be 
administered only on a written order of an appropriate health care 
professional in that patient's medical record. The written order may be 
entered on the basis of telephonic authority received from an 
appropriate health care professional, but in such event, the written 
order must be countersigned by an appropriate health care professional 
within 24 hours of the ordering of the medication. An appropriate 
health care professional will be responsible for all medication given 
or administered to a patient. A review by an appropriate health care 
professional of the drug regimen of each patient shall take place at 
least every thirty (30) days. It is recognized that administration of 
certain medications will be reviewed more frequently. Medication shall 
not be used as punishment, for the convenience of the staff, or in 
quantities which interfere with the patient's treatment program.
* * * * *
[FR Doc. 04-18106 Filed 8-6-04; 8:45 am]
BILLING CODE 8320-01-P