New Mexico Register / Volume XXXIV, Issue 24 / December 19,
2023
TITLE 7 HEALTH
CHAPTER 7 HOSPITALS
PART 3 REQUIREMENTS
FOR RURAL EMERGENCY HOSPITALS
7.7.3.1 ISSUING
AGENCY: Division of Health Improvement, Department of Health.
[7.7.3.1 NMAC - N, 12/19/2023]
7.7.3.2 SCOPE: These
requirements apply to private and public hospitals that as of December 27, 2020,
were designated as a critical access hospital (CAH) by the centers for Medicare
and Medicaid services (CMS), or that were licensed as a hospital with not more
than 50 licensed beds and located in a county in a rural area as defined in
Section 1886(d)(2)(D) or Section 1886 (d)(8)(E) of the federal social security
act (the Act) and that provide rural emergency hospital (REH) services in the
facility 24 hours per day seven days a week by a physician, nurse practitioner,
clinical nurse specialist or physician assistant with a transfer agreement in
effect with a level I or II trauma center, that does not have an annual average
patient length of stay over 24 hours, and that satisfies all CMS requirements
for reimbursement as a rural emergency hospital (REH). Facilities that were enrolled as CAHs or rural
hospitals with not more than 50 beds as of December 27, 2020, and then
subsequently closed after that date, would also be eligible to seek REH
designation if they re-enroll in Medicare and meet all the conditions of participation
(COPs) and requirements for REH.
[7.7.3.2 NMAC - N, 12/19/2023]
7.7.3.3 STATUTORY
AUTHORITY:
The requirements set forth herein are promulgated by the secretary of
the department of health pursuant to the authority granted under Subsection E
of Section 9-7-6 NMSA 1978, Subsection D of Section 24-1-2, Subsection J of
Section 24-1-3 NMSA, Section 24-1-5 NMSA of the Public Health Act as amended,
and Section 24-1-5.12 N. M. S. A. 1978.
[7.7.3.3 NMAC - N, 12/19/2023]
7.7.3.4 DURATION: Permanent.
[7.7.3.4 NMAC - N, 12/19/2023]
7.7.3.5 EFFECTIVE
DATE:
December 19, 2023, unless a later date is cited at the end of a section.
[7.7.3.5 NMAC - N, 12/19/2023]
7.7.3.6 OBJECTIVE: Establish standards
for licensing REHs in order to ensure the provision of
emergency department services, observation care, and additional outpatient
medical and health services, if elected by the REH, that promote equity in
health care for those living in rural communities by facilitating access to needed
services.
[7.7.3.6 NMAC - N, 12/19/2023]
7.7.3.7 DEFINITIONS:
A. Definitions
beginning with “A”:
(1) “Act” means the federal social security
act.
(2) “Action plan” means the eligible
facility’s plan for conversion to an REH and the initiation of REH specific
services including the provision of emergency department services, observation
care and other medical and health services elected by the REH, submitted to the
department for recommended approval or denial pursuant to CMS COPs.
(4) “Annual license” means a
license issued for a one-year period to a hospital that has met all license
prior to the initial state licensing survey, or when the licensing authority
finds partial compliance with these requirements.
(5) “Applicant” means the
individual who, or organization which, applies for a license; if the applicant
is an organization, then the individual signing the application on behalf of the organization must have the authority to sign for the organization.
B. Definitions beginning with “B”: [RESERVED]
C. Definitions beginning with “C”:
“Critical access hospital” means
a hospital with special characteristics, duly certified as such by centers for Medicare
and Medicaid services (CMS) and is in compliance with
the conditions of participation for such facilities; such critical access
hospitals are deemed as meeting the intent of these requirements and may be
licensed accordingly by the licensing authority.
D. Definitions beginning
with “D”: “Department” means
the New Mexico department of health.
E. Definitions
beginning with “E”: [RESERVED]
F. Definitions beginning with “F”:
(1) “Facility” means:
(a) was a critical access hospital; or
(b) was a hospital as defined in 42
U.S.C. 1395ww(d)(1)(B) with not more than 50 beds located in a county (or
equivalent unit of local government) in a rural area (as defined in 42 U.S.C.
1395ww(d)(2)(D), or was a hospital as defined in 42 U.S.C. 1395ww(d)(8)(E) with
not more than 50 beds that was treated as being located in a rural area.
(2) “Financial interest” means any
equity, security, lease or debt interest in the
hospital; financial interest also includes any equity, security, and lease or
debt interest in any real property used by the hospital or in any entity that
receives compensation arising from the use of real property by the hospital.
G. Definitions
beginning with “G”: [RESERVED]
H. Definitions
beginning with “H”:
(1) “HHS” means U.S. department of health
and human services.
(2) “Hospital” means a facility offering
in-patient services, nursing, overnight care on a 24-hour basis for diagnosing,
treating, and providing medical, psychological or
surgical care for three or more separate individuals who have a physical or
mental illness, disease, injury, a rehabilitative condition or are pregnant.
I. Definitions
beginning with “I”: [RESERVED]
J. Definitions
beginning with “J”: [RESERVED]
K. Definitions beginning with “K”: [RESERVED]
L. Definitions
beginning with “L”:
(1) “Licensee” means the person(s)
who, or organization which, has an ownership, leasehold, or similar interest in
the hospital and in whose name a license has been issued and who is legally
responsible for compliance with these requirements.
(2) “Licensing authority” means the division within the department
vested with the authority to enforce these requirements.
M. Definitions
beginning with “M”: [RESERVED]
N. Definitions beginning with “N”: [RESERVED]
O. Definitions beginning with “O”: [RESERVED]
P. Definitions beginning with “P”: [RESERVED]
Q. Definitions beginning with “Q”: [RESERVED]
R. Definitions beginning with “R”:
(1) “Rural emergency hospital” or “REH”
means a facility, as defined above, that:
(a) is enrolled under as defined in 42
U.S.C. 1395cc(j), which relates to the enrollment process for providers of
services and suppliers, submits the additional information described in 42
U.S.C. 1395x(kkk)(4)(A) related to providing an
action plan, describing any outpatient services offered and the proposed use of
the additional facility payment to REHs, for purposes of such enrollment, and
makes the detailed transition plan described in clause (i)
of such paragraph available to the public, in a form and manner determined
appropriate by the U. S. secretary of health & human services (HHS);
(b) does not provide any acute care
inpatient services, other than those as defined in 42 U. S. C. 1395x(kkk)(6)(A). REHs are prohibited from providing inpatient
services, except those furnished in a it that is a
distinct part licensed as a skilled nursing facility to furnish post-hospital
extended care services.
(c) has in effect a transfer agreement
with a level I or level II trauma center;
(d) meets:
(i) licensure
requirements as described in 42 U.S.C. 1395x(kkk)(5);
(ii) the requirements of a staffed
emergency department as described in 42 U.S.C. 1395x(kkk)(1)(B);
(iii) such staff training and certification
requirements as the HHS secretary may require;
(iv) conditions of participation applicable
to critical access hospitals, with respect to emergency services as defined in
42 CFR 485.618 (or any successor regulation) and hospital emergency departments
under this subchapter, as determined applicable by the HHS secretary as defined
in 42 U.S.C. 1395x(kkk).
(e) is an entity that operates for the
purpose of providing emergency department services, observation care, and other
outpatient medical and health services specified by the DOH Secretary in which
the annual per patient average length of stay does not exceed 24 hours, as set
forth in 42 CFR Part 485 (kkk)(1)(A), § 485.502.
(2) “Rural emergency hospital services”
means the following services furnished by a rural emergency hospital:
(a) emergency department services and
observation care; and
(b) At the election of the rural
emergency hospital, with respect to services furnished on an outpatient basis,
other medical and health services as specified by the HHS secretary through
rulemaking as set forth in 42 U.S.C. 1395x (kkk)(1).
S. Definitions
beginning with “S”: “Secretary”
means the secretary of the New Mexico department of health.
T. Definitions beginning
with “T”: [RESERVED]
U. Definitions beginning with “U”: [RESERVED]
V. Definitions
beginning with “V”: “Variance” means
an act on the part of the licensing authority to refrain from enforcing
compliance with a portion or portions of these requirements for an unspecified period of time where the granting of a variance will not
create a danger to the health, safety, or welfare of patients or staff of a
hospital and is at the sole discretion of the licensing authority.
W. Definitions beginning with “W”: “Waive/waiver” means an act on the part
of the licensing authority to refrain from enforcing compliance with a portion
or portions of these requirements for a limited period of
time less than one year, provided the health, safety, or welfare of
patients and staff are not in danger; waivers are issued at the sole discretion
of the licensing authority.
X. Definitions
beginning with “X”: [RESERVED]
Y. Definitions
beginning with “Y”: [RESERVED]
Z. Definitions
beginning with “Z”: [RESERVED]
[7.7.3.7 NMAC - N, 12/19/2023]
7.7.3.8 GENERAL
REQUIREMENTS:
A. Eligibility: The
following facilities that were enrolled and certified to participate in
Medicare as of December 27, 2020, are eligible to be an REH:
(1) CAHs;
(2) A
subsection (d) hospital (as defined in section 1886(d)(1)(B) of the Social
Security Act (the Act) with not more than 50 beds located in a county (or
equivalent unit of local government) in a rural area (as defined in section
1886(d)(2)(D) of the Act) (referred to as rural hospital);
(3) A
subsection (d) hospital (as so defined) with not more than 50 beds that was
treated as being located in a rural area pursuant to
section 1886(d)(8)(E) of the Act (referred to as rural hospital);
(4) Facilities
that were enrolled as CAHs or rural hospitals with not more than 50 beds as of
December 27, 2020, and then subsequently closed after that date, would also be
eligible to seek REH designation if they re-enroll in Medicare and meet all the
COPs and requirements for REHs.
B. Action plan: An action plan must be submitted to the
department by the eligible facility to initiate REH services. The action plan outlines the facility’s plan
for conversion to an REH and the initiation of REH specific services including
the provision of emergency department services, observation care and other
medical and health services elected by the REH. This should include details regarding staffing
provisions and the number and type of qualified staff for the provision of REH
services, as set forth in the CMS COPs.
(1) The
action plan must include a detailed transition plan that lists the following:
(a) specific
services the facility will retain;
(b) specific
services the facility will modify;
(c) specific
services the facility will add; and
(d) specific
services the facility will discontinue.
(2) The
facility must include a description of services that the facility intends to
furnish on an outpatient basis if elected by the REH.
(3) The
facility must also include information regarding how the facility intends to
use the additional facility payment. This
includes a description of the services that the additional facility payment
would be supporting such as the operation and maintenance of the facility and
furnishing of services (i.e., telehealth services, ambulance services, etc.).
(4) Eligible
facilities may submit the action plan and additional information on letterhead
or use the model template available on the CMS website. The submission should be signed by the
facility’s legal representative or administrator.
(5) The
department will forward the action plan and information along with its
recommendation for approval or denial to the designated CMS location for review
and approval of the action plan components. The CMS location will make a final
determination and notify the Medicare Administrative Contractor (MAC) once the
enrollment package is complete and has been reviewed and approved.
(6) The
action plan and information must include all the required elements as specified
in Paragraph (1)-(3) of Subsection B of Section 7.7.3.8 NMAC. Missing or incomplete information may delay
the conversion and enrollment process for eligible facilities applying to
become an REH.
(7) In
accordance with section 1861(kkk)(2)(A) of the Act,
action plans will be available to the public and will eventually be posted on
the CMS website.
C. Transfer
Agreement: Pursuant to section 1861(kkk)(2) of the Act and 42 CFR § 485.538 “Condition of
Participation: Agreements”, the REH is required to have a transfer agreement
with at least one Medicare-certified hospital that is designated as a level I
or level II trauma center. The agreement
is intended to ensure an appropriate referral and transfer process is in place
for patients requiring emergency care and continued care services beyond the
capabilities of the REH. In order to document compliance, a copy of the transfer
agreement should be submitted to the department along with the action plan.
D. Attestation:
(1) An
REH is required to meet the COPs for Rural Emergency Hospitals set forth at
Subpart E of 42 CFR Part 485 (§ 485.500 - § 485.546). Other than the requirement that the REH submit
its agreement with a nearby trauma center, eligible facilities converting to an
REH may self-attest to meeting the REH COPs and will not require an automatic
on-site initial survey as eligible facilities are expected to be in full
compliance with the existing CAH and hospital requirements at the time of the
request for conversion.
(2) Facilities
may submit the attestation for compliance with the REH COPs along with the
action plan and copy of the transfer agreement to the licensing authority. The attestation may be completed on facility letterhead or the model template provided on the CMS website
may be used. The attestation should be
signed by the facility’s legal representative or administrator.
(3) The
department will review the additional information for completeness and confirm
compliance with any applicable state licensure requirements. Once the additional information has been reviewed,
the department will forward the additional information to the designated CMS
location, along with a recommendation for certification or denial.
(4) The
designated CMS location is responsible for making the final determination for
certification of the REH. The effective
date will be based upon the date the application package was determined to be
complete and approved by the designated CMS location for meeting all REH
requirements. For facilities that
require an on-site initial survey, the effective date will be based on current
CMS policy, which is the exit day of survey if no deficiencies are cited, or in
the alternative, if deficiencies are noted, the date an acceptable plan of
correction was approved (see further guidance at 42 CFR §489.13).
E. Types of licenses:
(1) “Annual license”: an annual
license is issued for a one-year period to a hospital that has met all
requirements of these requirements.
(2) “Temporary
license”: the licensing authority may, at its sole discretion, issue a temporary
license prior to the initial state survey, or when the licensing authority
finds partial compliance with these requirements. Facilities that were eligible as of December
27, 2020, which subsequently closed and re-enrolled in Medicare would require
an initial on-site survey by the licensing authority. These facilities do not have to submit an
attestation, as required in Subsection D of 7.7.3.8 NMAC, as an on-site initial
survey will be performed to determine the facility is operational and in
compliance with the REH requirements.
(a) a temporary license shall cover a period
of time, not to exceed 120 days, during which the facility must correct
all specified deficiencies:
(b) in accordance with Subsection
D of Section 24-1-5 NMSA 1978, no more than two consecutive temporary licenses
shall be issued.
(3) “Amended license”: a licensee must apply to the licensing
authority for an amended license when there are reported events, including but
not limited to a change of administrator, name, or capacity. The application
shall:
(a) be on a form provided by
the licensing authority;
(b) be accompanied by the
required fee for an amended license; and
(c) be submitted at least 10 working days
prior to the change.
[7.7.3.8 NMAC - N, 12/19/2023]
7.7.3.9 LICENSE RENEWAL:
A. The licensee must submit a renewal application on forms
provided by the licensing authority, along with the required fee prior to the
expiration of the current license.
B. Upon receipt of the renewal application and the required
fee prior to expiration of current license, the licensing authority will issue
a new license effective the day following the date of expiration of the current
license if the facility is in substantial compliance with these requirements.
[7.7.3.9 NMAC - N,
12/19/2023]
7.7.3.10 POSTING: The license, or
a copy thereof, shall be conspicuously posted in a location accessible to
public view within the hospital.
[7.7.3.10 NMAC - N, 12/19/2023]
7.7.3.11 NON-TRANSFERABLE REGISTRATION OF
LICENSE: A license shall not be transferred by assignment or otherwise to other
persons or locations. The license shall
be void and must be returned to the licensing authority when any one of the
following situations occur:
A. ownership of the hospital changes;
B. the facility changes location;
C. the licensee of the hospital changes; or
D. the hospital discontinues operation.
[7.7.3.11 NMAC - N, 12/19/2023]
7.7.3.12 EXPIRATION OF LICENSE: A license will
expire at midnight on the day indicated on the license as the expiration date,
unless sooner renewed, suspended, or revoked, or:
A. on the day a facility discontinues operation; or
B. on the day a facility is sold, leased, otherwise changes
ownership or licensee; or
C. on the day a facility changes location.
[7.7.2.12 NMAC - N, 12/19/2023]
7.7.3.13 SUSPENSION OF LICENSE WITHOUT
PRIOR HEARING: In accordance with Subsection H of Section 24-1-5 NMSA 1978, if the
licensing authority determines immediate action is required to protect human
health and safety, the licensing authority may suspend a license. A hearing must be held in accordance with the
regulations governing adjudicatory hearings, New Mexico department of health, 7.1.2
NMAC.
[7.7.2.13 NMAC - N, 12/19/2023]
7.7.3.14 GROUNDS FOR REVOCATION OR SUSPENSION
OF LICENSE, DENIAL OF INITIAL OR RENEWAL APPLICATION FOR LICENSE, OR IMPOSITION
OF INTERMEDIATE SANCTIONS OR CIVIL MONETARY PENALTIES:
A. A
license may be denied, revoked or suspended, or
intermediate sanctions or civil monetary penalties may be imposed after notice
and opportunity for a hearing, for any of the following reasons:
(1) failure
to comply with any provision of this rule;
(2) failure
to allow a survey by authorized representatives of the licensing authority;
(3) permitting
any person while active in the operation of a facility licensed pursuant to this
rule to be impaired by the use of prescribed or
non-prescribed drugs, including alcohol;
(4) misrepresentation
or falsification of any information provided to the licensing authority;
(5) the
discovery of repeat violations of these requirements during surveys; or
(6) the
failure to provide the required care and services as outlined by this rule.
B. For
the purposes of calculating civil monetary penalties, penalty rates will be
applied as set forth in Subparagraph (d) of Paragraph (3) of Subsection B of
7.1.8.16 NMAC.
[7.7.3.14 NMAC - N, 12/19/2023]
7.7.3.15 HEARING
PROCEDURES:
A. An
applicant or licensee subject to an adverse action may request an
administrative appeal.
B. Hearing
procedures for an administrative appeal of an adverse action taken by the
licensing authority against the hospital as outlined in Section 13 and 14 above
will be held in accordance with adjudicatory hearings, New Mexico department of
health, 7.1.2. NMAC.
C. A
copy of the adjudicatory hearing procedures will be furnished to the hospital
at the time an adverse action is taken against the licensee by the licensing
authority. A copy may be requested at
any time by contacting the licensing authority.
[7.7.2.15 NMAC - N, 12/19/2023]
7.7.3.16 WAIVERS AND VARIANCES:
A. Applications: All
applications for the grant of a waiver or variance shall be made in writing to
the licensing authority, specifying the following:
(1) the rule, regulation, or code from
which the waiver or variance is requested;
(2) the time period
for which the waiver or variance is requested;
(3) if the request is for a variance, the
specific alternative action which the facility proposes;
(4) the reasons for request; and
(5) an explanation of why the health,
safety, and welfare of the residents or staff are not endangered by the
condition.
B. Requests for a waiver or variance may be made at any
time.
C. The licensing authority may require additional information
from the hospital prior to acting on the request.
(1) Grants and denials. The licensing authority shall grant or deny
each request for waiver or variance in writing.
(a) Notice of a denial shall contain the
reasons for denial.
(b) The decisions to grant, modify, or
deny a request for a waiver or variance is subject to
appeal one time only.
(2) The terms of a requested waiver or variance
may be modified upon agreement between the licensing authority and the
hospital.
D. The licensing authority may impose whatever conditions on
the granting of a waiver or variance it considers necessary.
E. The licensing authority may limit the duration of any
waiver.
[7.7.3.16 NMAC - N, 12/19/2023]
7.7.3.17 Compliance with existing requirements: An
REH shall comply with the following:
A. 42 CFR Part 485, Subpart E (relating
to conditions of participation: Rural
Emergency Hospitals (REHs).
B. In addition to the conditions of
participation at 42 CFR Part 485, Subpart E, the hospital shall comply with 7.7.2
NMAC to the extent it does not conflict with the conditions of participation.
[7.7.3.17 NMAC - N, 12/19/2023]
7.7.3.18 INCORPORATED AND RELATED CODES: The facilities that
are subject to this rule are also subject to other state rules, codes and
standards that may, from time to time, be amended. This includes but is not
limited to the following:
A. Health facility licensure fees and
procedures, department of health, 7.1.7 NMAC.
B. Health facility sanctions and civil
monetary penalties, department of health, 7.1.8 NMAC.
C. Adjudicatory hearings for licensed
facilities, department of health, 7.1.2 NMAC.
D. Caregiver’s criminal history
screening requirements, 7.1.9 NMAC.
E. Employee abuse registry, 7.1.12
NMAC.
F. Incident reporting, intake
processing and training requirements, 7.1.13 NMAC.
G. New Mexico Administrative Code,
Title 14 Housing and Construction, chapters 5 through 12.
[7.7.3.18 NMAC - N, 12/19/2023]
NMAC History:
[RESERVED]
History of
Repealed Material: [RESERVED]
Other
History: 7.7.3 NMAC,
Hospitals - Requirements for Rural Emergency Hospitals filed 6/12/2023 as an
emergency new rule expired by operation of law on 12/13/2023 has been
permanently replaced by 7.7.3 NMAC, Hospitals - Requirements for Rural
Emergency Hospitals effective 12/19/2023.