N.Y. Comp. Codes R. & Regs. tit. 18 § 505.7

Current through Register Vol. 46, No. 45, November 2, 2024

Section 505.7 - Laboratory services

(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.

N.Y. Comp. Codes R. & Regs. Tit. 18 § 505.7