[Federal Register Volume 70, Number 213 (Friday, November 4, 2005)]
[Rules and Regulations]
[Pages 67093-67095]
From the Federal Register Online via the Government Printing 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.
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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.
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2. Section 17.33 is amended by:
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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]
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