Current through Register Vol. 46, No. 39, September 25, 2024
(a)
Standard
certification.
An initial or amended operating certificate shall be issued
by the office upon approval of an application through either a full or
administrative review process, in accordance with section
810.8 or
810.9 of this Part, as
applicable.
(b)
Temporary certification.
(1)
Emergency certification.
(i) Whenever deemed
necessary, the commissioner may issue an emergency operating certificate to a
certified provider to continue services in the event of a threat or imminent
threat of a catastrophic or emergency loss of available services.
(ii) The provider of services must
demonstrate to the office that it meets the requirements of paragraph (3) of
this subdivision. The commissioner may require any additional information
necessary to assure the safe and efficient operation of the facility.
(iii) An emergency operating certificate to
provide services shall be effective upon issuance, for a period established by
the commissioner, but not to exceed 120 days.
(iv) The commissioner may extend the
emergency authorization to provide services for one additional period not to
exceed 120 days.
(2)
Conditional certification.
(i) Prior to the
issuance or renewal of an operating certificate, a conditional operating
certificate may be issued which requires the provider to meet specified
conditions in order to maintain its authorization to provide services, and may
carry with it a fine or penalty imposed by the office.
(ii) A conditional operating certificate to
provide services shall be effective upon issuance, for a period established by
the commissioner.
(3)
Provisional certification.
(i) A provisional
operating certificate will be issued upon approval of the application for
authorization to provide services.
(ii) A provisional operating certificate to
provide services shall be effective upon issuance, for a period established by
the commissioner.
(4)
Approval and issuance of temporary operating certificates. Prior to the
issuance of any temporary operating certificate in accordance with this
subdivision, the office may require that a provider demonstrate the following:
(i) that sufficient levels of staff are
employed to effectively support the services to be provided;
(ii) that services will be provided in a safe
and efficient manner;
(iii) that,
upon inspection, the physical plant and space meets office regulations and
standards;
(iv) that financial
resources are available to meet operating expenses; and
(v) any other information necessary to assure
the safe and efficient operation of the facility.
(5) The provider of services shall
acknowledge that it understands the temporary nature of the emergency or
conditional operating certificate to provide services and that such
certification confers no right to an operating certificate.
(c)
Additional
locations.
(1) A certified provider of
outpatient addiction services may operate at one or more additional locations
with the approval of the commissioner.
(2) For purposes of this section, an
additional location is a place open to the public for the provision of
addiction outpatient services which is dependent upon and subordinate to the
main location of the provider of services for operation, administration and
supervisory activities.
(3) The
provider of service shall apply for the additional location approval by
completing an application prescribed by the commissioner, clearly indicating
the characteristics of the space, the schedule of services, the staffing,
demonstrating an involvement or engagement with the community and other
relevant information. Each such additional location shall be considered for
approval by the commissioner where the provider of services shows a clear need
for access to outpatient services at the site proposed as well as a financial
and programmatic ability to provide the service.
(4) Each additional location shall have
adequate space to allow for the type and volume of services planned at the
location. Unless impractical, patient evaluation and medical services shall
also be conducted by professional staff of the main location.
(5) There shall be sufficient staffing,
including an appropriate number of qualified health professionals as defined in
this title, to provide the proposed type and volume of services during the
hours the location is open. Procedures shall be established to insure that
utilization review and case supervision shall be conducted by professional
staff of the main location.
(6)
Policies and procedures shall be developed which describe the subordinate
relationship of the additional location to the main location, ensure that all
operating regulations are met, and ensure that each person served primarily at
an additional location has access to, as needed, the same character and quality
of service available to persons served at any other location.
(7) The application shall be reviewed in
accordance with section
810.9 of this Part.
(8) If the Office proposes to limit approval
of an application for an additional location, or if there has been an adverse
recommendation of the local governmental unit, the Office shall offer the
applicant an opportunity to submit the application for full review in
accordance with section
810.8 of this Part. If either the
applicant or the local governmental unit objects to the Office's recommendation
to either limit approval of the application, or submit the application for full
review, either the applicant or the local governmental unit may request an
administrative appeal in accordance with Part 831 of the Title.
(9)
Opioid Treatment Programs.
Medication units established as an additional location of an
Opioid Treatment Program certified pursuant to Part 822 of this Title, whether
mobile, stand alone or integrated within another certified program, shall be
required to meet all applicable federal rules, regulations and any guidance
issued by the Office.