TITLE 12. HEALTH
STATE BOARD OF BEHAVIORAL HEALTH AND DEVELOPMENTAL SERVICES
Agency Decision
Title of Regulation: 12VAC35-105.
Rules and Regulations for Licensing Providers by the Department of Behavioral
Health and Developmental Services.
Statutory Authority: § 37.2-203 of the Code of
Virginia.
Name of Petitioner: R.C. Carter.
Nature of Petitioner's Request: To amend 12VAC35-105-520
(Risk management) in accordance with the Virginia Court of Appeals in Gregory
Allen Moyer v. Commonwealth of Virginia (2000), "when interpreting the law
one must consider other sections of law in determining legislative
intent," in order that the new Office of Licensing Associate Director of
State Operations develop and coordinate the oversight of the interpretation and
implementation of the additional 42 policies and procedures that providers are
required to have in writing in accordance with the HIPAA Act under Risk
Analysis and Risk Management which can be found under the following sections
45 CFR 164.306, 45 CFR 164.308, 45 CFR 164.310, 45 CFR
164.312, 45 CFR 164.314, and 45 CFR 164.316.
Agency Decision: No action.
Statement of Reason for Decision: The petition was
considered by the board at the regular meeting held on Wednesday, October 9,
2019, at Western State Hospital in Staunton, Virginia. After reviewing all of
the information received, the board declined to pursue the suggestions on the
matter for the following reasons:
1. Regulation 12VAC35-105-870 B 4 already states that the
provider's record management policy be consistent with applicable state and
federal laws including the Health Insurance Portability and Accountability Act
(HIPAA) (Public Law 104-191) and implementing regulations (45 CFR Parts 160,
162, and 164). Therefore, technically, compliance with these provisions is
already required under DBHDS licensing regulations.
2. There are federal agencies tasked with enforcement of HIPAA
including the U.S. Department of Health and Human Services (HHS) Office for
Civil Rights (OCR) and Centers for Medicare and Medicaid Services (CMS).
3. Currently, the way the Licensing Regulations (12VAC35-105)
are written, any changes that occur at the federal level are automatically
captured in the regulations because providers are only required compliance with
the federal law and do not include specific provisions. If the regulations are
changed to specifically include text from HIPAA, the regulations will have to
be changed every time that the federal laws change.
Agency Contact: Ruth Anne Walker, Director of Regulatory
Affairs, Department of Behavioral Health and Developmental Services, 1220 Bank
Street, 11th Floor, Richmond, VA 23219, telephone (804) 225-2252, or email ruthanne.walker@dbhds.virginia.gov.
VA.R. Doc. No. R20-05 Filed October 17, 2019, 12:56 p.m.
Agency Decision
Title of Regulation: 12VAC35-105.
Rules and Regulations for Licensing Providers by the Department of Behavioral
Health and Developmental Services.
Statutory Authority: § 37.2-203 of the Code of
Virginia.
Name of Petitioner: R.C. Carter.
Nature of Petitioner's Request: To develop a new regulation
requiring providers to (i) obtain verification from the Virginia Employment
Commission required under the Virginia Unemployment Compensation Act,
§ 60.2-212 C of the Code of Virginia and (ii) submit an SS-8 Form to the
Internal Revenue Service.
Agency Decision: No action.
Statement of Reason for Decision: The petition was
considered by the board at the regular meeting held on Wednesday, October 9,
2019, at Western State Hospital in Staunton, Virginia. After reviewing all of
the information received, the board declined to pursue the suggestions on the
matter for the following reasons:
1. DBHDS does not enforce compliance with the Virginia
Unemployment Compensation Act, other state employment law, or federal tax law.
2. The Office of Regulatory Affairs conducted substantial
research related to the use of contract employees (for the response to periodic
review draft) and as a result, draft regulations propose amendments (during the
planned response to periodic review 'overhaul' of the regulations) to account
for the misuse of contract employees in licensed services.
Agency Contact: Ruth Anne Walker, Director of Regulatory
Affairs, Department of Behavioral Health and Developmental Services, Jefferson
Building, 1220 Bank Street, 11th Floor, Richmond, VA 23219, telephone (804)
225-2252, or email ruthanne.walker@dbhds.virginia.gov.
VA.R. Doc. No. R20-01 Filed October 17, 2019, 1:04 p.m.
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TITLE 16. LABOR AND EMPLOYMENT
SAFETY AND HEALTH CODES BOARD
Agency Decision
Title of Regulation: 16VAC25-60.
Administrative Regulation for the Virginia Occupational Safety and Health
Program.
Statutory Authority: §§ 40.1-6 and 40.1-22 of the
Code of Virginia.
Name of Petitioner: Robert R. Payne, University of
Alabama at Birmingham.
Nature of Petitioner's Request: 16VAC25-60-120 currently
provides as follows: "The employer shall comply with the manufacturer's
specifications and limitations applicable to the operation, training, use,
installation, inspection, testing, repair and maintenance of all machinery,
vehicles, tools, materials and equipment, unless specifically superseded by a
more stringent corresponding requirement in 29 CFR Part 1910. The use of
any machinery, vehicle, tool, material or equipment that is not in compliance
with any applicable requirement of the manufacturer is prohibited, and shall
either be identified by the employer as unsafe by tagging or locking the
controls to render them inoperable or be physically removed from its place of
use or operation." The petition requests the following language be added
to the end of the current regulation: "Any employer who is using
machinery, vehicles, tools, materials or equipment as part of a Process Safety
Management (PSM) covered process, as defined in 29 CFR 1910.119, may
adjust the operation, training, use, installation, inspection, testing, repair
or maintenance after completion of the following:
• Documenting the adjustment from the Manufacturer's
Specifications and Limitations (MS&L) in the Process Safety Information
(PSI),
• Completing the Management of Change (MOC) requirement
described in 29 CFR 1910.119(l) and
• Certification from a company executive that they have
examined this adjustment and that to the best of their knowledge the
information is true, accurate and complete."
Agency Decision: No action.
Statement of Reason for Decision: Having given due
consideration to the December 8, 2017, petition to amend the referenced
Virginia Occupational Safety and Health (VOSH) regulation, the Virginia Safety
and Health Codes Board at its meeting on June 14, 2018, voted unanimously to
deny the petition based on a briefing from the Commissioner of Labor and
Industry.
Summary of the Petition to Amend Process: On December 8, 2017,
Robert R. Payne, University of Alabama at Birmingham, submitted to the
Department of Labor and Industry a petition to amend 16VAC25-60-120 B pursuant
to § 2.2-4007 of the Code of Virginia (see Attachment A).
The Department of Labor and Industry's initial response to the
petition was filed on the Virginia Regulatory Town Hall on December 18, 2017.
The agency's plan to address the petition provided as follows: "In
accordance with § 2.2-4007 B of the Code of Virginia, the petition has been
filed with the Registrar of Regulations and will be published on January 8,
2018. Comment on the petition may be sent by email, regular mail or posted on
the Virginia Regulatory Town Hall at www.townhall.virginia.gov. Comments will
be requested until January 28, 2018. Following receipt of all comments on the
petition to amend the regulation, the Safety and Health Codes Board will decide
whether to make any changes to the regulatory language. This matter will be on
the board's agenda for its next regularly scheduled meeting following the end
of the comment period. The board does not currently have a meeting scheduled.
The board will issue a written decision on the petition within 90 days of the
close of the comment period, or within 14 days of its next meeting should the
board not meet within the initial 90 day period."
The petition was published in the Virginia Register of
Regulations on January 8, 2018, with a 21 day comment period ending January 28,
2018. No comments were received.
The board considered the petition at its meeting on June 14,
2018, (see pages 45-50 of the agenda posted to Town Hall from the June 14, 2018,
SHCB meeting at: https://townhall.virginia.gov/L/GetFile.cfm?File=meeting\92\27752\Agenda_DOLI_27752_v3.pdf.)
Summary of the Petition: The petition seeks to amend
16VAC25-60-120 B, which provides as follows: "B. The employer shall comply
with the manufacturer's specifications and limitations applicable to the
operation, training, use, installation, inspection, testing, repair and
maintenance of all machinery, vehicles, tools, materials and equipment, unless
specifically superseded by a more stringent corresponding requirement in 29 CFR
Part 1910. The use of any machinery, vehicle, tool, material or equipment that
is not in compliance with any applicable requirement of the manufacturer is
prohibited and shall either be identified by the employer as unsafe by tagging
or locking the controls to render them inoperable or be physically removed from
its place of use or operation."
The petition asks that the following language be added to
16VAC25-60-120 B: Any employer who is using machinery, vehicles, tools,
materials or equipment as part of a Process Safety Management (PSM) covered
process, as defined in 29 CFR (Code of Federal Regulations) 1910.119, may
adjust the operation, training, use, installation, inspection, testing, repair
or maintenance after completion of the following:
• Documenting the adjustment from the Manufacturer's
Specifications and Limitations (MS&L) in the Process Safety Information
(PSI)
• Completing the Management of Change (MOC) requirement
described in 29 CFR 1910.119 (1) and
• Certification from a company executive that they have
examined this adjustment and that to the best of their knowledge the
information is true, accurate and complete.
Decision: The board finds the following:
1. While the petitioner has identified one or more scenarios
where an employer operating a process safety management (PSM) work site may be
negatively impacted by 16VAC25-60.120 B, he is incorrect in stating that VOSH
regulations do not provide an option for employers to vary from the
requirements of 16VAC25-60.120 B.
The VOSH Administrative Regulations describe procedures for
employers to seek variances from VOSH regulations to address exactly the kind
of situations described by the petitioner: 16VAC25-60-190 (General provisions),
16VAC25-60-210 (Permanent variances), and 16VAC25-60-220 (Interim order).
The variance procedures provide employers the opportunity to
apply to the commissioner for either an interim order and/or a permanent
variance from an existing VOSH regulation. The application requires no special
form. The information can be forwarded by letter with attachments (e.g.,
written procedures, photographs, videos, diagrams, manufacturer's
specifications, etc.).
16VAC25-60-190 through 16VAC25-60-220 explain the different
forms of variances and describe the process for obtaining an interim order from
the Commissioner of Labor and Industry. Permanent variances are addressed in
16VAC25-60-210. Temporary variances are addressed in 16VAC25-60-200, but are
only used in special instances where an employer is unable to comply with a
standard before its effective date.
Interim orders are addressed in 16VAC25-60-220 and can be
obtained for a limited amount of time without going through the full notice and
comment procedures required for a permanent variance. Because interim orders
are not subject to public comment and receive expedited review by the
commissioner, the burden of proof for the employer in support of its interim
order request is higher than for a permanent variance (see 16VAC25-60-220 C
which requires "clear and convincing evidence" that employees will be
protected).
The variance application must address the general requirements
contained in 16VAC25-60-190 B l to 16VAC25-60-190 B 3 concerning
notification to employees and this department, and then specify the type of
variance requested: permanent variance, temporary variance and/or interim
order. The application must also address each of the documentation requirements
listed in 16VAC25-60-210 B for permanent variances and, as applicable, the
requirements in 16VAC25-60-220 B and 16VAC25-60-220 C for interim orders.
Once the commissioner issues a decision on the variance
request, any party may, within 15 days, file a notice of appeal with the Safety
and Health Codes Board.
2. Section 40.1-22(5) of the Code of Virginia provides that in
deciding whether to adopt or amend a regulation the Safety and Health Codes
Board shall take into consideration "experiences gained under this and
other health and safety laws." The Process Safety Management of Highly
Hazardous Chemicals (PSM) Standard, 1910.119, was originally adopted by OSHA
and the Safety and Health Codes Board in 1992. 16VAC25-60-120 B was adopted by
the board in 2006 after multiple notice and comment periods and a public
hearing. To the knowledge of department staff, no Virginia employer responsible
for operating a PSM covered work site has ever applied for a variance from
16VAC25-60-120 B or requested an interpretation of 16VAC25-60-120 B and its
application to a PSM covered work site in Virginia. Nor does the petitioner
identify a specific PSM work site in Virginia negatively impacted by
16VAC25-60-120 B.
Based on the "experiences gained" under § 1910.119
and 16VAC25-60-120 B, it does not appear that a significant enough number of
PSM employers/employees are impacted negatively in Virginia by 16VAC25-60-120 B
to warrant the undertaking of a potentially costly and time consuming
regulatory amendment process; particularly when VOSH variance procedures
discussed above may be used by PSM employers on a case-by-case basis to address
the situations described by the petitioner. Should the department ultimately
receive a significant number of variance requests on this issue, it stated that
it will reconsider its recommendation on this petition to amend.
3. While the department has not researched in depth the
ramifications of an amendment to 16VAC25-60-120 B that would permit an employer
to violate manufacturer's specifications and limitations without first
contacting the manufacturer and/or a governing body, such as the VOSH Program,
it would appear that there would be significant legal and liability
ramifications and complexities involved in any proposed rulemaking that could
affect such a potentially broad range of manufactured items.
PSM facilities by their very nature also involve the handling
of large amounts of highly hazardous chemicals, and in the event of a failure
can result in catastrophic consequences for the worksite, its employees and
potentially the surrounding community and the environment. The advantages of
addressing the petitioner's concerns with employers on a case-by-case basis
through a relatively stream-lined process, and one which includes the
opportunity for interaction with the manufacturer, as well as notice and
comment to affected employees and the general public, are apparent.
ATTACHMENT A
§ 2.2-4007 of the Code of Virginia. Petitions for new or
amended regulations; opportunity for public comment.
A. Any person may petition an agency to request the agency to
develop a new regulation or amend an existing regulation. The petition shall
state (i) the substance and purpose of the rulemaking that is requested,
including reference to any applicable Virginia Administrative Code sections,
and (ii) reference to the legal authority of the agency to take the action
requested.
B. Within 14 days of receiving a petition, the agency shall
send a notice identifying the petitioner, the nature of the petitioner's
request and the agency's plan for disposition of the petition to the Registrar
for publication in the Virginia Register of Regulations in accordance with the
provisions of subsection B of § 2.2-4031 C of the Code of Virginia. A
21-day period for acceptance of written public comment on the petition shall be
provided after publication in the Virginia Register. The agency shall issue a
written decision to grant or deny the petitioner's request within 90 days
following the close of the comment period. However, if the rulemaking authority
is vested in an entity that has not met within that 90-day period, the entity
shall issue a written decision no later than 14 days after it next meets. The
written decision issued by the agency shall include a statement of its reasons
and shall be submitted to the Registrar for publication in the Virginia Register
of Regulations. Agency decisions to initiate or not initiate rulemaking in
response to petitions shall not be subject to judicial review.
Agency Contact: Jay Withrow, Director, Division of Legal
Support, VPP, ORA, OPP, Department of Labor and Industry, Main Street Centre,
600 East Main Street, Richmond, VA 23219, telephone (804) 786-9873, or email jay.withrow@doli.virginia.gov.
VA.R. Doc. No. R18-14 Filed October 9, 2019, 12:57 p.m.
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TITLE 18. PROFESSIONAL AND
OCCUPATIONAL LICENSING
BOARD OF MEDICINE
Initial Agency Notice
Title of Regulation: 18VAC85-80. Regulations Governing the Practice of
Physician Assistants.
Statutory Authority: § 54.1-2400 of the Code of Virginia.
Name of Petitioner: Virginia Academy of Physician
Assistants.
Nature of Petitioner's Request: To eliminate the
requirement for the name of a patient care team physician to appear on a
prescription written by a physician assistant for a controlled substance in Schedules
II through V.
Agency Plan for Disposition of Request: In accordance
with Virginia law, the petition has been filed with the Virginia Registrar of
Regulations and will be published on November 11, 2019, and posted on the
Virginia Regulatory Town Hall at www.townhall.virginia.gov. Comment on
the petition will be requested until December 11, 2019, and may be posted on
the Town Hall or sent to the board. Following receipt of all comments on the
petition to amend regulations, the matter will be considered by the Advisory
Board on Physician Assistants at its next meeting following the close of
comment.
Public Comment Deadline: December 11, 2019.
Agency Contact: William L. Harp, M.D., Executive
Director, Board of Medicine, 9960 Mayland Drive, Suite 300, Richmond, VA 23233,
telephone (804) 367-4558, or email william.harp@dhp.virginia.gov.
VA.R. Doc. No. R20-14 Filed October 15, 2019, 8:53 a.m.