[Federal Register Volume 70, Number 213 (Friday, November 4, 2005)]
[Rules and Regulations]
[Pages 67093-67095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-21976]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AL66


Patients' Rights

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: This final rule amends Department of Veterans Affairs (VA) 
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 appropriate health care 
professional authorized to prescribe medication, and that it is 
permissible for any authorized licensed health care professional to 
order the use of restraints and seclusion when necessary. The rule also 
makes nonsubstantive changes in the patients' rights regulation for 
purposes of clarification.

DATES: Effective Date: December 5, 2005.

FOR FURTHER INFORMATION CONTACT: Audrey Drake, Program Director (108), 
Veterans Health Administration, Department of Veterans Affairs, 810 
Vermont Ave., NW., Washington, DC 20420, (202) 273-9237. (This is not a 
toll-free number.)

SUPPLEMENTARY INFORMATION: In a document published in the Federal 
Register on August 9, 2004 (69 FR 48184), we published a proposed rule 
amending VA's medical regulations at 38 CFR part 17 to update the 
patients' rights regulation by bringing its provisions regarding 
medication, restraints, and seclusion into conformity with current law 
and practice. We provided a 60-day comment period that ended on October 
8, 2004. We received four comments. Based on the rationale set forth in 
the proposed rule and this document, we are adopting the proposed rule 
as a final rule.
    One commenter expressed support for expanding the scope of health 
care professionals authorized to prescribe medication, and recognizing 
that licensed health care professionals other than physicians are 
authorized to order seclusion and restraint. The commenter expressed 
concern, however, that the reference to ``appropriate licensed health 
care professional'' might be interpreted as requiring that the 
authority to order restraint and seclusion be granted in the State 
licensing law rather than in some other State law. The commenter states 
that this is a crucial distinction because the authority for 
psychologists to order restraint and seclusion is not necessarily found 
in State licensing laws. The commenter asserts that such authority may 
be found in State laws governing health care institutions, or 
identifying patients' rights. The commenter recommends clarifying this 
point in the preamble to the regulation.
    With regard to this issue, we note that the reference in the 
regulation to an ``appropriate licensed health care professional'' was 
not intended to require that the authority of a health care 
professional to order restraint and seclusion be specifically contained 
in State licensing law, or any State law, for that matter. Licensed 
health care professionals working in VA facilities may order the use of 
restraints and seclusion consistent with Federal, not State law. VA 
determines which health care providers are deemed ``appropriate 
licensed health care professionals'' for purposes of ordering restraint 
and seclusion through the privileging and credentialing process as 
outlined in VA policies and handbooks. No changes are made based on 
this comment.
    One commenter opposed the rule because it would eliminate all 
references to physicians and replace those references with the words 
``appropriate licensed health care professional.'' The commenter stated 
that there are clear and convincing differences between the training 
and education of physicians and other health care professionals, and 
that physicians should oversee the care of patients. The commenter 
states that although this can be done using a team approach, the 
physician should provide the diagnosis and determine the course of 
treatment. The commenter expressed concern with the expanding scope of 
practice for non-physician providers within the Veterans Health 
Administration and throughout the health care delivery system.
    VA's policy is to provide high quality health care to patients. 
This is accomplished through the proper utilization of a variety of 
well-qualified and appropriately credentialed health care providers. In 
VA, non-physician health care providers commonly provide a diagnosis 
for patients and determine the course of treatment within their scope 
of practice. Nation-wide, written VA policy establishes medication-
prescribing authority for Clinical Nurse Specialists, Nurse 
Practitioners, Clinical Pharmacy Specialists, and Physicians 
Assistants. Written VA policy requires that procedures be in place to 
ensure that these practitioners are prescribing within their identified 
scope of practice, and licensure when appropriate, and that the scope 
of practice for credentialed health care providers is approved in 
accordance with written VHA policy. No changes are made based on these 
comments.
    Two commenters expressed support for the proposed revision to this 
regulation. No changes are made based on these comments.
    One nonsubstantive clarifying change has been made to this final 
rule. Longstanding provisions in Sec.  17.33(e) require that an 
attending physician review the drug regimen of each patient at least 
every thirty days. In this final rule we are changing ``patient'' to 
``inpatient'' to more clearly reflect the scope of this provision. This 
change does not alter the scope of the rule but merely clarifies VA's 
intent and longstanding interpretation that the thirty-day requirement 
is specific to inpatient treatment. As explained in the notice of 
proposed rulemaking, we are further clarifying that the review must be 
conducted by an appropriate health care provider.
    Based on the rationale set forth in the proposed rule and this 
document, VA is adopting the provisions of the proposed rule as a final 
rule with the change noted above.

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 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 (adjusted annually for 
inflation) in any given year. This final 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).

[[Page 67094]]

Executive Order 12866

    VA has examined the economic implications of this proposed rule as 
required by 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). Executive Order 12866 classifies a 
rule as significant if it meets any one of a number of specified 
conditions, including: having an annual effect on the economy of $100 
million, adversely affecting a sector of the economy in a material way, 
adversely affecting competition, or adversely affecting jobs. A 
regulation is also considered a significant regulatory action if it 
raises novel legal or policy issues.
    VA concludes that this final rule does not meet the economic 
significance threshold of $100 million effect on the economy in any one 
year under section 3(f)(1). VA concludes, however, that this final rule 
is a significant regulatory action under the Executive Order since it 
raises novel legal and policy issues under section 3(f)(4).

Regulatory Flexibility Act

    The Secretary of Veterans Affairs (VA) hereby certifies that this 
regulatory amendment will not have a significant economic impact on a 
substantial number of small entities as they are defined in the 
Regulatory Flexibility Act, 5 U.S.C. 601-612. This amendment will 
affect only veterans receiving certain VA benefits and does not affect 
any small entities. 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 and titles for 
the programs affected by this document are 64.005, Grants to States for 
the Construction of State Homes; 64.007, Blind Rehabilitation Centers; 
64.008, Veterans Domiciliary Care; 64.009, Veterans Medical Care 
Benefits; 64.010, Veterans Nursing Home Care; 64.011, Veterans Dental 
Care; 64.012, Veterans Prescription Service; 64.013, Veterans 
Prosthetic Appliances; 64.014, Veterans State Domiciliary Care; 64.015, 
Veterans State Nursing Home Care; 64.016, Veterans State Hospital Care; 
64.018, Sharing Specialized Medical Resources; 64.019, Veterans 
Rehabilitation Alcohol and Drug Dependence; and 64.022, Veterans Home 
Based Primary Care.

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 13, 2005
Gordon H. Mansfield,
Deputy Secretary of Veterans Affairs.

0
For the reasons set out in the preamble, 38 CFR part 17 is amended as 
set forth below:

PART 17--MEDICAL

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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 17.33 is amended by:
0
a. In paragraph (b) introductory text, removing ``paragraph (c)'' and 
adding, in its place, ``paragraphs (c) and (d)''.
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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''.
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c. In paragraph (c)(1)(ii), removing ``detaining'' and adding, in its 
place, ``detailing''.
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d. In paragraph (c)(2) introductory text, removing ``this paragraph'' 
and adding, in its place, ``paragraph (c) of this section''.
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e. In paragraph (c)(3), removing ``(c)(1)'' and adding, in its place, 
``(b)''.
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f. In paragraph (c)(4), removing ``pursuant to this paragraph'', and 
adding, in its place, ``under paragraph (c) of this section''.
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g. In paragraph (c)(5), removing ``orders'' and adding, in its place, 
``orders under paragraph (c) of this section''.
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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 an appropriate licensed 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

[[Page 67095]]

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 
inpatient 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. 05-21976 Filed 11-3-05; 8:45 am]
BILLING CODE 8320-01-P