N.Y. Comp. Codes R. & Regs. tit. 18 § 505.5

Current through Register Vol. 46, No. 51, December 18, 2024

Section 505.5 - Durable medical equipment; medical/surgical supplies; orthotic and prosthetic appliances; orthopedic footwear

(a)Definitions.

(1) Durable medical equipment means devices and equipment, other than prosthetic or orthotic appliances, which have been ordered by a practitioner in the treatment of a specific medical condition and which have all of the following characteristics:

(i) can withstand repeated use for a protracted period of time;

(ii) are primarily and customarily used for medical purposes;

(iii) are generally not useful to a person in the absence of an illness or injury; and

(iv) are usually not fitted, designed or fashioned for a particular individual's use. Where equipment is intended for use by only one person, it may be either custom-made or customized.

(2) Medical/surgical supplies means items for medical use other than drugs, prosthetic or orthotic appliances, durable medical equipment, or orthopedic footwear which have been ordered by a practitioner in the treatment of a specific medical condition and which are usually:

(i) consumable;

(ii) nonreusable;

(iii) disposable;

(iv) for a specific rather than incidental purpose; and

(v) generally have no salvageable value.

(3) Orthotic appliances and devices mean those appliances and devices which are used to support a weak or deformed body member; or to restrict or eliminate motion in a diseased or injured part of the body.

(4) Orthopedic footwear means shoes, shoe modifications, or shoe additions which are used to correct, accommodate or prevent a physical deformity or range o f motion malfunction in a diseased or injured part of the ankle or foot; or to support a weak or deformed structure of the ankle or foot. Orthopedic shoes must have, at a minimum, the following features:

(i) Blucher or Bal construction;

(ii) leather construction or synthetic material of equal quality;

(iii) welt construction with a cement attached outsole or sewn on outsole;

(iv) upper portion properly fitted as to length and width; no unit sole; bottom sized to the last;

(v) closure appropriate to foot condition. Velcro strap or lace closure preferred except in circumstances when a patient is unable to use them;

(vi) full range of width, not just narrow, medium, wide; and

(vii) extended medial counter and firm heel counter.

(5) Prosthetic appliances and devices mean those appliances and devices (excluding artificial eyes and dental prostheses) ordered by a qualified practitioner which replace any missing part of the body.

(6) Practitioner means a physician, dentist, podiatrist, physician assistant, or nurse practitioner.

(7) Provider, for purposes of this section, means a pharmacy, certified home health agency, medical equipment and supply dealer, hospital, residential health facility, or clinic enrolled in the medical assistance program as a medical equipment dealer.

(8) The terms written order or fiscal order are used interchangeably in this section and mean any original, signed written order of a practitioner which requests durable medical equipment, prosthetic or orthotic appliances and devices, medical/surgical supplies, or orthopedic footwear.

(9) Acquisition cost means the line item cost to the provider. Shipping and handling charges are not reimbursable under the medical assistance program.

(10) Acquisition price means that price determined and periodically adjusted by the State Health Department, which it deems a prudent Medicaid provider would pay for a reasonable quantity of generically equivalent enteral products.

(b)Written order required.

(1) All durable medical equipment, medical/surgical supplies, orthotic and prosthetic appliances and devices, and orthopedic footwear may be furnished only upon a written order of a practitioner.

(i) The ordering of durable medical equipment, medical/surgical supplies, orthotic and prosthetic appliances and devices, and orthopedic footwear is limited to the practitioner's scope of practice.

(ii) The ordering of durable medical equipment, medical/surgical supplies, orthotic and prosthetic appliances and devices, and orthopedic footwear is limited to practitioners not excluded from participating in the medical assistance program.

(2) All orders must show the name, address, telephone number of the practitioner and the name and identification number of the recipient for whom ordered.

(3) When used in the context of an order for a prescription item, the order must also meet the requirements for a prescription under section 6810 of the Education Law. When used in the context of a nonprescription item, the order must also contain the following information: name of the item, quantity ordered, size, catalog number as necessary, directions for use, date ordered, and number of refills, if any.

(4) An original fiscal order for medical/surgical supplies must not be filled more than 14 days after it has been written by the practitioner unless prior approval or prior authorization is required for the item.

(i) An order for medical/surgical supplies will not be refilled unless the ordering practitioner has indicated the number of refills on the order. All refills must reference the original order.

(ii) The maximum number of refills permitted for medical/surgical supplies is found in the fee schedule for durable medical equipment, medical/surgical supplies, orthotic and prosthetic appliances and orthopedic footwear. The fee schedule for such equipment and supplies is available free of charge from the Medicaid fiscal agent's website.

(iii) No order can be refilled more than 180 days from the original date ordered.

(c)Review of claims.

(1) The identity of the practitioner who ordered the durable medical equipment, medical/surgical supply, prosthetic or orthotic appliance or device, or orthopedic footwear must be recorded by the provider on the claim for payment by entering in the license or MMIS provider identification number of the practitioner where indicated.

(2) Written orders for durable medical equipment, medical/surgical supplies, prosthetic or orthotic devices, or orthopedic footwear must be maintained by the provider submitting the claim for audit by the department or other authorized agency for six years from the date of payment.

(3) The financial liability of the ordering practitioner as well as the provider of any durable medical equipment, medical/surgical supplies, orthotic and prosthetic appliances or devices or orthopedic footwear determined on audit not to be medically necessary is set forth in Part 518 of this Title.

(d)Payment.

(1) General payment policy. General payment policy.

(i) Payment for durable medical equipment, medical/surgical supplies, orthotic and prosthetic appliances and devices, and orthopedic footwear is limited to providers enrolled in the medical assistance program as medical equipment dealers. Payment for medical/surgical supplies is also available to providers enrolled in the medical assistance program as pharmacies.

(ii) Reimbursement amounts are payment in full. No separate or additional payments will be made for shipping, handling, delivery or necessary fittings and adjustments.

(iii) Payment will not be made for items provided by a facility or organization when the cost of these items is included in the rate.

(iv) Payment for items provided by a not-for-profit provider will be made at the acquisition cost.

(v) Any insurance payments including Medicare must be applied against the total purchase price of the item.

(vi) Reimbursement amounts for unlisted items are determined by the New York State Department of Health and must not exceed the lower of:

(a) the acquisition cost to the provider plus 50 percent; or

(b) the usual and customary price charged to the general public.

(vii) The provider is responsible for any needed replacements or repairs that are due to defects in quality, or workmanship.

(2) Payment for durable medical equipment. Payment for durable medical equipment.

(i) Payment for purchase of durable medical equipment must not exceed the lower of:

(a) the maximum reimbursable amount as shown in the fee schedule for durable medical equipment, medical/surgical supplies, orthotics and prosthetic appliances and orthopedic footwear; the maximum reimbursable amount will be determined for each item of durable medical equipment based on an average cost of products representative of that item; or

(b) the usual and customary price charged to the general public for the same or similar products.

(ii) When there is no price listed in the fee schedule for durable medical equipment, medical/surgical supplies, orthotics and prosthetic appliances and orthopedic footwear, payment for purchase of durable medical equipment must not exceed the lower of:

(a) acquisition cost as established by invoice detailing the line item cost to the provider from a manufacturer or wholesaler net of any rebates, discounts or valuable consideration, mailing, shipping, handling, insurance or sales tax plus 50 percent; or

(b) the usual and customary price charged to the general public for the same or similar products.

(iii) When the primary payor is Medicare, payment for the purchase of durable medical equipment shall be the amount approved by title XVIII of the Medicare Program.

(iv) All rentals of durable medical equipment, except those subject to partial reimbursement under the Medicare program, require prior approval from the New York State Department of Health. The rental payment must not exceed the lower of the monthly rental charge to the general public or the price determined by the New York State Department of Health. The total accumulated monthly rental charges may not exceed the actual purchase price of the item. Rental payment includes all necessary equipment, delivery, maintenance and repair costs, parts, supplies and services for equipment set-up, maintenance and replacement of worn essential accessories or parts.

(3) Payment for medical/surgical supplies. Payment for medical/surgical supplies.

(i) Payment for medical/surgical supplies listed in the fee schedule for durable medical equipment, medical/surgical supplies, orthotic and prosthetic appliances and orthopedic footwear must not exceed the lower of:

(a) the price as shown in the fee schedule for durable medical equipment, medical/surgical supplies, orthotic and prosthetic appliances and orthopedic footwear; or

(b) the usual and customary price charged to the general public.

(ii) The fee schedule for medical/surgical supplies is available from the department and is also contained in the department's MMIS Provider Manual (Durable Medical Equipment, Medical/Surgical Supplies, Orthotic and Prosthetic Appliances). Copies of the manual may be obtained by writing Computer Sciences Corporation, Health and Administrative Services Division, 800 North Pearl St., Albany, NY 12204. Copies may also be obtained from the Department of Social Services, 40 North Pearl St., Albany, NY 12243. The manuals are provided free of charge to every provider of durable medical equipment, medical/surgical supplies, orthotic and prosthetic appliances and orthopedic footwear at the time of enrollment in the MA program.

(4) Payment for orthotic and prosthetic appliances and devices.

(i) Payment for prosthetic and orthotic appliances and devices must not exceed the lower of:

(a) the price as shown in the fee schedule for durable medical equipment, medical/surgical supplies, orthotic and prosthetic appliances and orthopedic footwear; or

(b) the usual and customary price charged to the general public.

(ii) Payment for orthotists and prosthetists for home visits is set forth in the fee schedule for durable medical equipment, medical/surgical supplies, prosthetic and orthotic appliances and orthopedic footwear.

(iii) The fee schedule for orthotic and prosthetic appliances and devices is available free of charge from the Medicaid fiscal agent's website.

(5) Payment for orthopedic footwear. Payment for orthopedic footwear.

(i) Payment for orthopedic footwear must not exceed the lower of:

(a) the maximum reimbursable amount as shown in the fee schedule for durable medical equipment, medical/surgical supplies, orthotics and prosthetic appliances and orthopedic footwear; the maximum reimbursable amount will be determined for each item of footwear based on an average cost of products representative of that item; or

(b) the usual and customary price charged to the general public for the same or similar products.

(ii) Orthopedic shoes must be provided by a provider who has submitted proof of certification or approval from the American Board for Certification in Orthotics and Prosthetics.

(6) Payment for oxygen must not exceed the lower of:

(i) the acquisition cost to the provider plus 50 percent; or

(ii) the usual and customary price charged to the general public.

(7) Payment for hearing aid batteries is reimbursed at retail less 20 percent updated on a periodic basis.

(8) Payment for enteral therapy must not exceed the lower of:

(i) the acquisition price plus 30 percent for generically equivalent products as shown in the fee schedule for durable medical equipment, medical surgical supplies, prosthetic and orthotic appliances and orthopedic footwear; or

(ii) the usual and customary charge to the general public.

(e)Service limitations.

(1) Items of durable medical equipment, medical/surgical supplies, orthotic and prosthetic appliances and devices, and orthopedic footwear are limited in their amount and frequency and require prior authorization. Service limits and prior authorization requirements are listed in the provider manual at the Medicaid fiscal agent's website.

(2) From time to time the department may impose additional service limitations on items of durable medical equipment, medical/surgical supplies, orthotic and prosthetic appliances and devices or orthopedic footwear. The department will notify providers in writing before it implements additional limitations.

(3) The department may allow exceptions to the limitations established under this paragraph where the ordering practitioner attests to medical necessity and the item must be replaced because it is worn or has been lost or stolen.

(f)Prior approval and prior authorization requirements.

(1) Orthopedic shoes can be provided only on the basis of an examination by and a signed, original written fiscal order of, a qualified physician or podiatrist and upon the prior authorization of the department.

(2) From time to time the department may require the prior authorization of items of durable medical equipment, medical/surgical supplies, orthotic or prosthetic appliances and devices, or orthopedic footwear. When prior authorization is required for these items, the items can be provided only on the basis of an examination by, and a signed, original written fiscal order of, a qualified practitioner and upon the prior authorization of the department. Providers will be notified in writing by the department before it implements requirements for the prior authorization of any item.

(3) When an appliance or device is recommended by a qualified practitioner on the staff of a state mental hygiene facility for a medical assistance recipient in the family care program, prior approval or authorization is not required.

(g) Benefit limitations. The department shall establish defined benefit limits for certain Medicaid services as part of its Medicaid State Plan. The department shall not allow exceptions to defined benefit limi tations. The department has established defined benefit limits on enteral nutritional formulas. Enteral nutritional formulas are limited to coverage for:

(1) tube-fed individuals who cannot chew or swallow food and must obtain nutrition through formula via tube;

(2) individuals with rare inborn metabolic disorders requiring specific medical formulas to provide essential nutrients no t available through any other means;

(3) children under age 21 when caloric and dietary nutrients from food cannot be absorbed or metabolized; and

(4) persons with a diagnosis of HIV infection, AIDS, or HIVrelated illness, or other disease or condition, who are oral-fed and who:

(i) require supplemental nutrition, demonstrate documented compliance with an appropriate medical and nutritional pla n of care, and have a body mass index under 18.5 as defined by the Centers for Disease Control, up to 1,000 calories per day; or

(ii) require supplemental nutrition, demonstrate documented compliance with an appropriate medical and nutritio nal plan of care, and have a body mass index under 22 as defined by the Cente rs for Disease Control and a documented, unintentional weight los s of five percent or more within the previous six month period, up to 1,000 calories per day; or

(iii) require total nutritional support, have a permanent structural limitation that prevents the chewing of food, and the placement of a feeding tube is medically contraindicated.

N.Y. Comp. Codes R. & Regs. Tit. 18 § 505.5

Amended, New York State Register April 30, 2014/Volume XXXVI, Issue 17, eff.4/30/2014

Amended New York State Register February 27, 2019/Volume XLI, Issue 09, eff. 2/27/2019