TITLE 12. HEALTH
STATE BOARD OF HEALTH
Initial Agency Notice
Title of Regulation:
12VAC5-371. Regulations for the Licensure of Nursing Facilities.
Statutory Authority: §§ 32.1-12
and 32.1-127 of the Code of
Virginia.
Name of Petitioner: James Sherlock.
Nature of Petitioner's Request: Change Virginia Nursing
Facility Licensure Regulations to Align with Federal Medicare/Medicaid
Certification Regulations. The weaknesses of Virginia's nursing facility (NF)
and skilled nursing facility (SNF) system have been exposed by COVID-19 with
deadly consequences. Virginia's regulations applicable to these facilities may
be part of the problem. 12VAC5-371 Regulations for the Licensure of Nursing
Facilities published by the Board of Health conflict with and are more
permissive than the regulatory requirements for Medicare/Medicaid certification
in 42 CFR Part 483 -
Requirements for States and Long Term Care Facilities. The Virginia Department
of Health, the state agency contracted with the Centers for Medicare/Medicaid
Services to conduct certification inspections, must at least in theory enforce
both sets of regulations. However, the Virginia regulations have little
practical effect in that 95% of Virginia NFs and SNF's seek certification for
Medicare and/or Medicaid and thus must comply with the more stringent federal
regulations. Indeed many facilities contain both SNF and NF facilities and
swing beds in a single complex. Under Medicaid regulations, NFs are required to
meet virtually the same requirements that SNFs participating in Medicare must
meet. There is no reason that Virginia regulations for licensing the other 5.0%
should be different. I thus recommend Virginia nursing facility licensing
regulations either mirror or incorporate by reference 42 CFR Part 483. I also recommend that the Board
of Nursing review 18VAC90-19-250 (Criteria ford delegation) and other nursing
practice regulations to ensure they align with the federal rules for nursing
homes. I find important reasons why Virginia regulations should be aligned with
federal regulations for the same facilities, and no provision in the
Constitution of Virginia or existing Virginia law that prohibits such action. I
also see no requirement for additional funding to do so. A few of the federal
statutes or regulations allow for waivers in the presence of verified temporary
shortages of health personnel or in the presence of equivalent alternative
patient safeguards. CMS Medicare SNF waiver authority is re-delegated to the
CMS Regional Offices (ROs). Waivers for NFs to provide licensed personnel on a
24-hour basis repose with the states. Life safety code waivers for NFs and
Intermediate Care Facilities for Individuals with Intellectual Disabilities
(ICF/IIDs) are the responsibility of the states (See 42 CFR 483.470(j)(2)(A)). I suggest that on the
heels of the COVID-19 deaths, Virginia not waive or request a waiver for any
federal nursing home regulation. But if such waivers exist, they should appear
in the VAC in sequence with the federal regulation they waive. It will also
prove useful to create a single Nursing and Skilled Nursing Facilities section
of the VAC to offer a complete reference for operators and inspectors. Those
actions will resolve current regulatory chaos and clarify the state's waivers
of federal regulations. They will also save whatever time and cost has
historically been expended in drafting, seeking public comments, resolving
disagreements, and approving Virginia nursing facility licensure regulations
that are, in the main, irrelevant.
Agency Plan for Disposition of Request: In accordance
with Virginia law, the petition has been filed with the Registrar of
Regulations and will be published on July 6, 2020, and posted to the Virginia
Regulatory Town Hall at www.townhall.virginia.gov.
Comment on the petition will be accepted until July 27, 2020. Following receipt
of all comment on the petition, and within 90 days of July 27, 2020, the matter
will be considered by the State Health Commissioner, acting on behalf of the
board, in order to decide whether to grant or deny the petition or by the State
Board of Health.
Public Comment Deadline: July 26, 2020.
Agency Contact: Rebekah E.
Allen, Senior Policy Analyst, Virginia Department of Health, 9960 Mayland
Drive, Suite 401, Richmond, VA 23233, telephone (804) 367-2102, FAX (804)
527-4502, or email regulatorycomment@vdh.virginia.gov.
VA.R. Doc. No. R20-54 Filed June 11, 2020, 11:24 a.m.
Initial Agency Notice
Title of Regulation:
12VAC5-371. Regulations for the Licensure of Nursing Facilities.
Statutory Authority: §§ 32.1-12
and 32.1-127 of the Code of
Virginia.
Name of Petitioner: Vic
Nicholls.
Nature of Petitioner's Request: Virginia regulations must be changed to conform to federal
Medicare and Medicaid regulations for long-term care facilities to comply with
the clear direction of § 32.1-127 of the Code of Virginia. That law
requires that Virginia regulations for hospitals and nursing homes
"conform" to "health and safety standards established under
provisions of Title XVIII (Medicare) and Title XIX (Medicaid) of the Social
Security Act." 42 Code of Federal Regulations (CFR) Part 483 ‐ Requirements
for States and Long Term Care Facilities regulates Medicare and Medicaid
certification pursuant to Title XVIII and Title XIX requirements. 12VAC5-371,
Regulations for the Licensure of Nursing Facilities contains Virginia licensure
regulations for the same facilities. The Virginia licensure regulations not
only do not conform to their federal certification counterparts but are weaker
across the board. Ninety-Five percent of Virginia NFs and SNF's seek certification
for Medicare and/or Medicaid and thus must comply with the more stringent
federal regulations. There is no reason that Virginia regulations for licensing
the other 5.0% should be different, and by Virginia law they may not be. A few
of the federal regulations allow for waivers in the presence of verified
temporary shortages of health personnel or in the presence of equivalent
alternative patient safeguards. CMS Medicare SNF waiver authority is
re-delegated to the CMS Regional Offices (ROs). Waivers for NFs to provide
licensed personnel on a 24-hour basis repose with the states. Life safety code
waivers for NFs and Intermediate Care Facilities for Individuals with
Intellectual Disabilities (ICF/IIDs) are the responsibility of the states (See
42 CFR 483.470(j)(2)(A)).I recommend that the Board of Health delete the
current contents of 12VAC5-371 and incorporate by reference 42 CFR Part
483 to comply with Virginia law. Incorporation by reference rather that
mirroring the language will ensure that they are always in compliance with
Virginia law and always up to date. I also recommend that the Board of Nursing
review 18VAC90-19-250 (Criteria for delegation) and other nursing practice
regulations to ensure they conform to the federal rules for nursing homes and
hospitals. Similarly, the Department of Medical Assistance Services (DMAS)
should review its regulations for conformity. A list of waived and emergency
regulations, whether for a single home or for the industry, can be maintained
on a web page of the Department of Health.
Agency Plan for Disposition of Request: In accordance with Virginia law, the
petition has been filed with the Registrar of Regulations and will be published
on July 6, 2020, and posted to the Virginia Regulatory Town Hall at www.townhall.virginia.gov. Comment on the petition will be
accepted until July 27, 2020. Following receipt of all comment on the petition,
and within 90 days of July 27, 2020, the matter will be considered by the State
Health Commissioner, acting on behalf of the board, in order to decide whether
to grant or deny the petition or by the State Board of Health.
Public Comment Deadline: July 26, 2020.
Agency Contact: Rebekah E. Allen, Senior Policy Analyst,
Virginia Department of Health, 9960 Mayland Drive, Suite 401, Richmond, VA
23233, telephone (804) 367-2102, FAX (804) 527-4502, or email regulatorycomment@vdh.virginia.gov.
VA.R. Doc. No. R20-53 Filed June 11, 2020, 11:28 p.m.
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TITLE 24. TRANSPORTATION AND MOTOR
VEHICLES
COMMISSION ON THE VIRGINIA ALCOHOL SAFETY ACTION PROGRAM
Agency Decision
Title of Regulation: 24VAC35-60.
Ignition Interlock Program Regulations.
Statutory Authority: § 18.2-270.2 of the Code of Virginia.
Name of Petitioner: Cynthia
Hites.
Nature of Petitioner's Request: "I, Cynthia Hites,
a citizen of the Commonwealth of Virginia, pursuant to § 2.2-4007 of the
Code of Virginia, do humbly submit this petition for the following amendment to
Virginia Administrative Code 24VAC35-60-70 F 3 (Ignition Interlock
Regulations). This petition does not seek to address ethanol specificity, as it
is already established by law. 24VAC35-60-70 states Virginia ignition interlock
machines "shall be alcohol specific," and 24VAC35-60-20 defines that
alcohol as ethyl alcohol (C2H5OH). The machines shall be
ethanol specific, and that is not in question. This petition directly addresses
the state's usage of the electrochemical fuel cell for ignition interlock, and
because it cannot meet the standards set forth by law, avenues must be opened
to improve the science behind breath testing. The electrochemical fuel cell is
a simple and unsophisticated tool used to detect alcohol, which, in chemistry,
as in this context, does not mean drinking liquor, but simply means any organic
compound that contains one or more hydroxl groups attached to a carbon atom.
These alcohols include, but are not limited to: Sorbitol (C6H14O6),
Isopropanol (C3H8O), Cholesterol (C27H46O),
Xylitol (C5H7(OH)5), Erythritol (C4H10O4),
Methanol (CH4O), Menthol (C10H20O), and
Cortisol (C21H30O5). For this reason, Virginia
law 24VAC35-60-20 explicitly defines alcohol as the compound C2H5OH,
which is ethanol. Being non-ethanol specific, the electrochemical fuel cell
measures and records citizen's private biological medical information and
misconstrues it falsely as ethanol. I believe this is an invasion of the
medical privacy afforded by the Health Insurance Portability and Affordability
Act. Measuring a litany of bodily organic compounds and claiming them to be
ethanol is unethical, invasive, and totally misleading to the general public.
It goes against the intent of the statute. To have any lesser standard than
ethanol specificity is a disservice to society, and because the electrochemical
fuel cell measures an unknown and inexhaustive set of compounds, its usage must
be suspended until such time a device can be proven to meet the standards set
forth by 24VAC35-60-20 and 24VAC35-60-70. Currently, 24VAC35-60-70 F 3 states: '3.
The ignition interlock device shall be alcohol specific, using an
electrochemical fuel cell that reacts to and measures ethanol, minimizing
positive results from other substances.' This petition seeks to change the
wording from 'an electrochemical fuel cell' to 'technology' and to change the
word 'minimizing' to 'eliminating,' thus reading: '3. The ignition interlock
device shall be alcohol specific, using technology that reacts to and measures
ethanol, eliminating positive results from other substances.' A device that
detects and measures only drinking alcohol is a product of science fiction.
Electrochemical fuel cells measure and collect private health data and bodily
emissions, aside from drinking alcohol, then uses that private health data to
falsely accuse citizens of ethanol ingestion. Continued usage of
electrochemical fuel cells for this purpose constitutes nothing less than
governmental gaslighting."
Agency Decision: Request denied.
Statement of Reason for
Decision: The term
"alcohol-specific" began to be used in industry terminology years ago
in order to differentiate early ignition interlocks from second generation
interlocks. The early interlocks employed semiconductor (nonspecific) alcohol
sensors. These semiconductor-type (Taguchi) interlocks did not hold calibration
very well, were sensitive to altitude variation, and reacted positively to
non-alcohol sources. By the early 1990s, the industry began to produce
"second generation" interlocks with reliable and accurate fuel cell
sensors, that were referred to as being "alcohol specific."
"Alcohol-specific," as the language has come to be understood, does
not mean the devices are totally ethanol specific, it just means they have high
specificity to drinking alcohol or ethanol. It is extremely unlikely that the
breath of a living human would contain any other substance to which fuel cell
sensors will respond. Other types of alcohols (non-drinking) such as methanol
or isopropanol to which the ignition interlock would yield a positive result
are toxic and potentially lethal when consumed. As a safeguard though, VASAP
has procedures in place to enable offenders to retest whenever they suspect a
positive test is due to residual mouth alcohol (from something such as mouthwash)
or a non-breath source such as hand sanitizer. Positive results, other than
from consumed ethanol, can be minimized or eliminated by following the proper
breath testing procedures and agreed terms of the ignition interlock contract.
All current ignition interlocks in Virginia are required to meet National
Highway Traffic Safety Administration standards as found in NHTSA's Model
Specifications for Ignition Interlock Devices. The definition of
"alcohol" found in the ignition interlock regulations is consistent
with the definition for "alcohol" found in the Code of Virginia and
NHTSA's model specifications. The subject matter of this petition has already
been addressed in whole or in part by the commission in previous petitions.
Therefore, no action was taken by the commission on this petition.
Agency Contact: Richard
Foy, Field Service Specialist, Commission on the Virginia Alcohol Safety Action
Program, 701 East Franklin Street, Suite 1110, Richmond VA 23219, telephone
(804) 786-5895, or email rfoy@vasap.virginia.gov.
VA.R. Doc. No. R19-37 Filed June 6, 2020, 12:01 a.m.