1. (a) Activities of daily living mean basic self-care tasks such as dressing and undressing, self-feeding, bowel and bladder management, ambulation with or without the use of an assistive device, communication, functional transfers from one place to another, and personal hygiene and grooming.
2. (b) Assistive technology (AT) means those devices, controls, appliances, items, pieces of equipment, or supplies of either a communication or an adaptive type, determined necessary by a physician for purposes of the enrollee's habilitation, ability to function or safety in his or her current or desired residence which are not listed in the Medicaid Durable Medical Equipment (DME) Provider Manual at https://www.emedny.org/ProviderManuals/DME/index.aspx. Such technology may also be referred to as adaptive technology or adaptive equipment. In the event that a particular item or piece of equipment falls within the definition of both assistive technology and an environmental modification as defined in subdivision (m) of this section, it will be considered to be an environmental modification for purposes of these regulations.
3. (c) Birth-related neurological injury means an injury to the brain or spinal cord of a live infant caused by the deprivation of oxygen or mechanical injury that occurred in the course of labor, delivery or resuscitation or by other medical services provided or not provided during delivery admission that rendered the infant with a permanent and substantial motor impairment or with a developmental disability as that term is defined by section 1.03 of the Mental Hygiene Law, or both.
4. (d) Case manager means a person who performs the functions set out in section 69-10.4 of this Subpart.
5. (e) Claims assistance manager means the person or persons who perform(s) the functions set out in section 69-10.3 of this Subpart.
6. (f) Commissioner of Health or commissioner means the New York State Commissioner of Health.
7. (g) Commissioner of Taxation means the New York State Commissioner of Taxation and Finance.
8. (h) Delivery admission means a hospital admission for the specific purpose of giving birth.
9. (i) Department of Financial Services means the New York State Department of Financial Services.

10. (j) Durable medical equipment means devices and equipment that have been ordered by a physician in the treatment of a specific medical condition and that have all of the following characteristics:

    1. (1) can withstand repeated use for a protracted period of time;
    2. (2) are primarily and customarily used for medical purposes;
    3. (3) are generally not useful in the absence of an illness or injury;
    4. (4) are not usually fitted, designed or fashioned for a particular individual's use; and

    5. (5) if intended for use by only one patient, the equipment may be either custom-made or customized.

       For purposes of this Subpart, durable medical equipment also includes medical/surgical supplies, orthotic appliances and devices and orthopedic footwear as defined in 18 NYCRR section 505.5 and listed in the Medicaid DME Provider Manual at https://www.emedny.org/ProviderManuals/DME/index.aspx.

11. (k) Emergency means a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in placing the patient's health in serious jeopardy, serious impairment of bodily functions, or serious dysfunction of any bodily organ or part. Only a qualified ordering practitioner may determine, using his or her professional judgment, whether a situation constitutes an emergency.
12. (l) Enrollee means a qualified plaintiff accepted into the fund or for notification and decision making purposes only, the person authorized to act on his or her behalf; provided, however, that nothing in this Subpart shall be read to authorize payment or reimbursement of medical services provided to any person other than the qualified plaintiff.
13. (m) Environmental modification (emod) means an interior or exterior physical adaptation to the residence in which an enrollee lives that is necessary to ensure the health, welfare, and safety of the enrollee, enables him or her to function with greater independence in the community and/or helps avoid institutionalization and has been ordered by a physician. Emods include but are not limited to: ramps, widened doorways and handrails, roll-in showers, vertical lifts, elevators only when there is no other safe and cost effective alternative and cabinet and shelving adaptations. Emods do not include any routine home maintenance. Emods also do not include adaptations or modifications that are of general utility and that do not provide direct medical or remedial benefit to the enrollee. With respect to new construction, emods do not include modifications needed as a result of avoidable barriers created by the new construction floor plan.

14. (n) Experimental treatment means a drug, device, or treatment for which:

    1. (1) there is insufficient outcome data available from controlled clinical trials published in the peer-reviewed literature to substantiate its safety and effectiveness for the illness or injury involved; or
    2. (2) approval required from the FDA for marketing to the public has not been granted; or
    3. (3) a recognized national medical or dental society or regulatory agency has determined, in writing, that it is experimental or investigational, or for research purposes; or
    4. (4) it is a type of drug, device or treatment that is the subject of an investigational new drug treatment pursuant to 21 CFR section 312.21, or is the subject of an investigational device treatment pursuant to 21 CFR section 812.36; or
    5. (5) the written protocol or protocols used by the treating facility or by another facility studying the same drug, device, procedure, or treatment, states that it is experimental or investigational.
15. (o) Fund means the “New York State Medical Indemnity Fund” created pursuant to chapter 59 of the Laws of 2011 to provide a funding source for future health care costs associated with birth-related neurological injuries.
16. (p) Fund administrator means the Superintendent of Financial Services or any person or entity designated by the superintendent for purposes of administering the fund.
17. (q) Habilitation services mean services designed to provide assistance with the retention, acquisition or improvement of the enrollee's activities of daily living such as personal grooming and cleanliness, eating and dressing, communication, and mobilization; and when appropriate, the instrumental activities of daily living such as household chores, food preparation, mobility training for maximum independence involving local travel, including the use of public transportation, socially appropriate behavior, the development of basic health and safety skills, and simple money management.
18. (r) Hospital means a general hospital or a maternity hospital, including a birthing center located in a general hospital or a maternity hospital, a birthing center operating as a diagnostic and treatment center, or a midwifery birth center, as defined by section 2801 of the Public Health Law.
19. (s) Informal supports means those immediate family members, other family members, friends, volunteers, and other people in the enrollee's community who provide or are willing to provide unpaid care and services for the enrollee.
20. (t) Instrumental activities of daily living mean those functions not necessary for fundamental functioning but necessary for an individual to be able to live independently in the community such as taking medications as prescribed, performing housekeeping tasks, managing money, using the telephone or other form of communication, shopping for groceries and clothing, and managing transportation within the community.

21. (u) Nurse practitioner means an individual:

    1. (1) certified to practice as a nurse practitioner pursuant to article 139 of the New York State Education Law;
    2. (2) duly authorized to practice as a nurse practitioner or the equivalent of a nurse practitioner in any other state in the United States or in the District of Columbia; or
    3. (3) duly authorized to practice as a nurse practitioner or the equivalent of a nurse practitioner in another country.

22. (v) Physician means a physician licensed to:

    1. (1) practice in New York State pursuant to article 131 of the New York State Education Law;
    2. (2) duly authorized to practice in any other state in the United States or in the District of Columbia; or
    3. (3) duly authorized to practice as a physician in another country.

23. (w) Physician assistant means an individual:

    1. (1) licensed to practice as a physician assistant in New York State pursuant to article 131-B of the New York State Education Law;
    2. (2) duly authorized to practice as a physician assistant or the equivalent of a physician assistant in any other state in the United States or in the District of Columbia; or
    3. (3) duly authorized to practice as a physician assistant or the equivalent in another country.
24. (x) Prior approval means the process set forth in section 69-10.6 of this Subpart for review of proposed, non-routine expenditures such as emods, vehicle modifications, assistive technology, private duty nursing, planned specialist appointments and/or hospital treatment requiring travel and accommodations, hearing aids, custom made equipment, myo-electric limbs, treatment with specialty drugs, and experimental treatments and/or procedures, including the review process for any denial of a request for prior approval.

25. (y) Qualified plaintiff means every plaintiff or claimant who:

    1. (1) has been found by a jury or court to have sustained a birth-related neurological injury as the result of medical malpractice; or
    2. (2) has sustained a birth-related neurological injury as the result of alleged medical malpractice and has settled his or her lawsuit or claim therefor.

26. (z) Qualifying health care costs mean the future costs for medical, hospital, surgical, nursing, dental, rehabilitation services, habilitation services and custodial care; respite care, subject to a maximum of 1,080 hours per year unless prior approval has been obtained for additional respite care; durable medical equipment; environmental home modifications (emods), assistive technology, and vehicle modifications; prescription and over the counter medications when prescribed by a physician, dentist, nurse practitioner, certified nutritionist or physician assistant; psychological, social work, nutritional counseling, chiropractic, hospice and palliative care; transportation for purposes of health care related appointments in accordance with section 69-10.12 of this Subpart; copayments and deductibles for services, items, equipment or medication paid for by commercial insurance; and any other health care costs actually incurred for services rendered to and supplies utilized by a qualified plaintiff that his or her physician, physician assistant, or nurse practitioner, has stated in writing on his or her letterhead, or on the supervising or collaborating physician's letterhead, if applicable, is necessary to meet the qualified plaintiff's health care needs. The statement of necessity may be based on the assessment of a dentist, podiatrist, psychologist, physical therapist, occupational therapist, chiropractor, certified nutritionist or dietician, and/or speech pathologist. The fund administrator may make coverage of ongoing therapeutic services subject to the receipt of periodic treatment plans and progress reports. Qualifying health care costs shall not include:

    1. (1) any services, supplies, items or equipment potentially available to the enrollee under an Individualized Education Program, Preschool Supportive Health Services Program, Early Intervention Program or equivalent program in another country unless the enrollee’s parent or guardian can demonstrate that he or she made a reasonable effort to obtain the services, supplies, items or equipment through such program; or
    2. (2) any services, supplies, items, equipment or medications that any commercial insurance under which the enrollee is covered is legally obligated to provide.
27. (aa) Respite means the provision of paid intermittent, temporary substitute care, including care provided in an institutional setting, for the benefit of the primary caregiver, who is a family member, a guardian or other informal support functioning as the enrollee's non-paid primary caregiver, for the purpose of providing relief from the responsibilities of daily caregiving of the enrollee, including any substitute care provided to an enrollee and paid for by the fund because the primary caregiver is not at home because of work and/or school. All respite care in excess of 1,080 hours a year will require prior approval.

28. (ab) Specialty drug means a drug that is typically high in cost and has one or more of the following characteristics:

    1. (1) is a component of complex therapy for treatment of a complex disease;
    2. (2) requires specialized patient training and coordination of care prior to therapy initiation and/or during therapy;
    3. (3) requires unique patient adherence to treatment regimen and safety monitoring of the patient during treatment with the drug;
    4. (4) requires unique handling, shipping, and storage; and
    5. (5) presents a potential for significant waste because of the manner in which the drug is packaged/dispensed or the failure to follow accepted clinical protocols prior to administration to the patient or both.
29. (ac) Superintendent of Financial Services means the Superintendent of the New York State Department of Financial Services.
30. (ad) Usual and customary charges mean the usual, customary and reasonable (UCR) charges for services provided in private physician practices as described in section 69-10.21 of this Subpart.

31. (ae) Vehicle modifications mean:

    1. (1) adaptive equipment designed to enable an enrollee to operate a vehicle or be transported in a vehicle such as hand controls, deep dish steering wheels, spinner knobs, wheelchair lock down devices, parking brake extensions, foot controls, wheelchair lifts, left foot gas pedals; or
    2. (2) changes to the structure, internal design, or existing equipment of a vehicle such as replacement of the roof with elevated fiberglass top, floor cut-outs, extension of the steering column, raised door, repositioning of seats, wheelchair floor, and dashboard adaptations.

As used in this Subpart: