Current through Register Vol. 46, No. 39, September 25, 2024
(a) Scope
of services. This section sets forth the requirements and procedures for
furnishing laboratory services and obtaining payment for laboratory services
under the medical assistance (MA) program. Payment for laboratory services is
limited to those medically necessary tests and procedures listed in the MA fee
schedule for laboratory services. The MA fee schedule for laboratory services
is available from the Department and may also be found in the Medicaid
Management Information System (MMIS) Provider Manual (Laboratory), which is
available by writing Computer Sciences Corporation, Health and Administrative
Services Division, 800 North Pearl Street, Albany, NY 12204. Copies may also be
obtained from the Department of Social Services, 40 North Pearl Street, Albany,
NY 12243. The manual is provided free of charge to every laboratory upon
enrollment in the MA program. Revisions to the manual are provided to
laboratories as revisions are made.
(b) Definitions.
(1)
(i)
Fiscal order for laboratory services means a qualified practitioner's
authenticated request to a clinical laboratory for the provision of a test,
examination and/or analysis on behalf of a recipient of MA. Authentication of
fiscal orders shall be by a qualified practitioner or by designation as
provided in subdivision (i) of this section and shall consist of either:
(a) handwritten signature of name or
initials; or
(b) electronic or
computer-generated signature of name or unique identifier acceptable to the
department.
All orders must show the ordering practitioner's: name,
address, telephone number, and MMIS provider identification number (or license
number of the ordering practitioner when such practitioner is not an enrolled
MA provider); and the name, date of birth, sex and MA identification number of
the recipient for whom services are ordered. The order must also contain at
least the date the test was ordered and the name of the test. The order must
meet any applicable New York State and Federal requirements governing the
ordering of laboratory services. The ordering practitioner must document in the
patient's clinical record the medical need for the fiscal order and the results
of each of the tests.
(ii) A standing order is a fiscal order, as
defined in subparagraph (i) of this paragraph which requests the provision of
one or more medically necessary examinations and/or analyses at defined
intervals over a period not to exceed 180 days (six months). The clinical
parameters for which standing orders are permitted are:
(a) cancer treatment recipients needing a CBC
and platelet count test;
(b)
diabetic recipients needing blood glucose level and glycohemoglobin tests
(including hemoglobin A1c);
(c)
cardiac recipients needing prothrombin time and digoxin level tests;
and
(d) recipients needing
monitoring of therapeutic levels of prescribed drugs. The ordering practitioner
must document in the patient's clinical record the medical need for the
standing order and the results of each of the tests.
(2) Laboratory means a facility
which meets the definition of a laboratory contained in title V of article 5 of
the Public Health Law.
(3)
Qualified practitioner means any licensed physician or other person who:
(i) provides services which are reimbursable
pursuant to section 365-a of the Social Services
Law;
(ii) is authorized by law to
use the findings of laboratory examinations; and
(iii) has not been excluded from
participation in the MA program.
(4) The MA fee schedule for laboratory
services means the fee schedule developed by the Department of Health and
approved by the Division of the Budget. The MA fee schedule for laboratory
services is included as part of the MMIS provider manual for
laboratories.
(c) Fiscal
order required.
(1) Laboratory services may
be provided by a laboratory only upon a fiscal order for laboratory services or
a copy of such order as permitted by paragraph (2) of this
subdivision.
(2) Laboratory
services may be provided on a referral basis by a laboratory upon receipt of an
unaltered copy of the fiscal order provided to the testing laboratory by a
forwarding laboratory which has the fiscal order for laboratory services on
file.
(d) Form required.
All fiscal orders for laboratory services must be written on:
(1) a qualified practitioner's prescription
form or imprinted stationery, with all tests to be performed listed
individually in writing by the practitioner; or
(2) a laboratory requisition, either hardcopy
or electronic, which is issued by a clinical laboratory and which permits the
selection of individual tests; or
(3) a pre-printed order form which is issued
by a facility certified under article 28 of the Public Health Law for
laboratory services to be provided by the hospital's laboratory.
(e) Where available.
(1) Laboratory services are available only
from laboratories which are currently enrolled in the MA program and which
either meet the Medicare conditions for coverage of services for independent
laboratories or meet the requirements for participation in the Medicare program
as a hospital.
(2) Laboratory
services may be obtained from a qualified practitioner pursuant to paragraph
(f)(3) of this section, provided that such practitioner is enrolled in the MA
program.
(f) Permits
required. A laboratory services provider must have the permits required by this
subdivision and must meet any applicable Federal requirements governing the
provision of laboratory services.
(1) A
laboratory must have a valid permit in the appropriate categories as required
by the Public Health Law.
(2) An
out-of-state laboratory which provides services on behalf of recipients of MA
who receive necessary medical care while temporarily absent from the State and
which is not subject to the requirements of paragraph (1) of this subdivision,
must be currently licensed or certified by the appropriate state agency of the
State in which it is located and must meet the requirements of paragraph (e)(1)
of this section.
(3) A qualified
practitioner who does not hold a currently valid laboratory permit may only
provide laboratory services which are listed in the MA fee schedule of the
Medicaid Management Information System Provider Manual for that practitioner's
services. These services must be provided in the practitioner's office in the
course of treating his or her own patients and may be billed directly by the
practitioner. The manuals are available from Computer Sciences Corporation,
Health and Administrative Services Division, 800 North Pearl Street, Albany, NY
12204. Copies also may be obtained from the Department of Social Services, 40
North Pearl Street, Albany, NY 12243. The applicable MMIS provider manual is
provided free of charge to every practitioner upon enrollment in the MA
program. Revisions to the various manuals are provided to practitioners as
revisions are made.
(g)
Payment.
(1) Payment for laboratory services
will be in an amount equal to the lower of: the amount specified in the MA fee
schedule for laboratory services or the fee charged for laboratory services
provided to the general public by the laboratory.
(2) Payment for laboratory services will be
made only when the results of the ordered tests have been provided in writing
to the ordering practitioner.
(3)
Payment for laboratory services will be made only to the laboratory services
provider actually performing the test.
(4) Payment for laboratory services provided
by independent laboratories will be made only for individually ordered tests.
No payment will be made for tests ordered as groupings or combinations of tests
or for individual tests ordered on a laboratory order form issued by an
independent laboratory which also contains an order for one or more groups or
combinations of tests. Each test must be separately ordered by a qualified
practitioner as defined in paragraph (b)(3) of this section.
(5) No payment will be made for tests
repeated at the request of the ordering practitioner when the results of the
original test are not consistent with the clinical findings.
(6) No payment will be made for tests
performed on specimens which are not acceptable for testing pursuant to
Department of Health regulations contained in 10 NYCRR Part 58.
(7) No payment will be made on a
fee-for-service basis for laboratory services ordered for an MA recipient on
either an in-patient or out-patient basis when the cost of providing laboratory
services has been included in the MA rate of payment for the provider of such
in- patient or out-patient care.
(h) Utilization threshold.
(1) This subdivision describes the
utilization threshold that the department has established for laboratory
services. Part 503 of this Title authorizes the department to establish a
utilization threshold for specific recipients and for specific provider
services types, including laboratory services. Part 503 also describes the
application of the utilization threshold, the services and procedures excluded
from the utilization threshold for all provider service types subject to a
threshold, the method for obtaining an exemption from or increase in the
utilization threshold, notices, and the right to a fair hearing in certain
situations.
(2) General rule. The
department will pay for up to 18 laboratory service procedures in a benefit
year. For purposes of this subdivision, a procedure consists of all services
which are claimed for a single date of service and which are represented by a
single laboratory procedure code, as listed and defined in the MA fee schedule
for laboratory services.
(i) Designation of authority to complete
laboratory test order form(s). A practitioner ordering laboratory services may
designate to personnel/staff the authority to complete laboratory test order
forms and sign (authenticate) the form on the practitioner's behalf. The
practitioner remains responsible for any tests ordered on the practitioner's
behalf by personnel/staff that the practitioner has designated, just as though
the practitioner had completed and/or signed the order personally.
(j) Electronic system security and
confidentiality. Safeguards to ensure security and confidentiality shall
include but not be limited to:
(1) the
assignment, as appropriate, of a unique identifier assigned in a confidential
manner;
(2) the certification in
writing by the practitioner and the practitioner's authorized user that each
identifier assigned is confidential and is available and accessible only to the
person authorized to use the electronic or computer authentication
system;
(3) policies and procedures
to ensure the security of electronic or computer equipment from unwarranted
access;
(4) policies and procedures
that restrict access to information and data to those individuals who have need
and permission for such access;
(5)
and a means to track access by users.
(k) Verification process. Practitioners shall
implement an ongoing verification process to ensure that electronic
communications and entries, or delegated laboratory order completion are
accurate including but not limited to:
(1) for
electronic orders, protocols for ensuring that incomplete entries of documents
are not accepted or implemented until reviewed, completed and verified by the
author;
(2) for delegated orders
(either manual or electronic) a process implemented as part of the
practitioner's quality assurance activities that provides for review to verify
the accuracy and integrity of the system; and
(3) written procedures, which ensure that
only personnel authorized by the practitioner can generate the completed
laboratory order forms.
(l) The practitioner shall have procedures in
place to modify or terminate use of any assigned identifier in cases of abuse
or misuse or if practice privileges are suspended, restricted, terminated or
curtailed or employment or affiliation ends.
