Ohio Administrative Code
Title 5160 - Ohio Department of Medicaid
Chapter 5160-10 - Medical Supplies, Durable Medical Equipment, Orthoses, and Prosthesis Providers
Section 5160-10-01 - Durable medical equipment, prostheses, orthoses, and supplies (DMEPOS): general provisions
Universal Citation: OH Admin Code 5160-10-01
Current through all regulations passed and filed through September 16, 2024
(A) Scope.
(1)
This rule sets
forth general coverage and payment policies for durable medical equipment
(DME), prostheses, orthotic devices, medical supplies, and supplier services
dispensed or rendered by an enrolled DMEPOS provider.
(2)
Additional
conditions specific to a particular DMEPOS item or service may be set forth in
other rules in this chapter of the Administrative Code.
(3)
Policies set
forth in other rules in this chapter supersede any provisions in this rule with
which they conflict.
(B) Definitions that apply to rules in this chapter of the Administrative Code.
(1)
"Base invoice
charge" is the amount charged for an item to a DMEPOS provider by a distributor
or manufacturer before the application of any discounts, rebates, or
adjustments.
(2)
"Certificate of medical necessity (CMN)" is a written
statement by a prescribing practitioner that presents clinical information
about an item and about the person for whom it was prescribed. This
information, which often is not included in the prescription itself, aids in
the determination of whether the particular item is the most medically
appropriate for an individual (or even medically necessary).
(a)
For many DMEPOS
items, a specific CMN form is identified in the relevant rule in this chapter
of the Administrative Code. Each identified CMN form bears the designation
'ODM' with a five-digit numeral. If no CMN form is identified, form ODM 01913,
"Certificate of Medical Necessity / Request for Need Verification: General
Medical Supplies and Equipment" (rev. 1/2024), may be used.
(b)
A CMN is not
invalidated by a change in an individual's status from one medicaid eligibility
category to another (e.g., from fee-for-service medicaid to medicaid managed
care).
(c)
An illegible CMN will not be accepted.
(3)
"Coverage" is the principle that medicaid payment is
routinely made for a particular medically necessary item or service. The
department maintains several payment schedules of covered items and services,
which are posted for reference on the department's web site. These schedules
are neither all-inclusive nor exclusive. Neither the appearance of an item or
service on a payment schedule nor its absence determines, in and of itself,
coverage or non-coverage.
(4)
"Date of service" is the date on which a DMEPOS service
is furnished or a DMEPOS item is dispensed directly to an individual.
(a)
For an item that
is shipped directly to a medicaid-eligible individual, the date of service is
either the shipping date or the delivery date. When the individual is to be
discharged from a hospital or long-term care facility, the date of service is
the date of discharge.
(b)
For an item that needs multiple fittings and special
construction, the date of service is the date of the first
fitting.
(5)
"Department" is the Ohio department of medicaid or,
when applicable, its designee. The address of the department's web site
is
http://medicaid.ohio.gov.
(6)
"DMEPOS item" is a collective term for a covered
durable medical equipment (DME) item, prosthetic device, orthotic device, or
medical supply item furnished by an eligible provider to a medicaid-eligible
individual.
(7)
"DMEPOS provider" is a collective term for the
following eligible providers:
(a)
A basic DME supplier, which furnishes items other than
life-sustaining or technologically sophisticated equipment in accordance with
Chapter 4752. of the Revised Code;
(b)
A specialized DME
supplier, which furnishes life-sustaining or technologically sophisticated
equipment in accordance with Chapter 4752. of the Revised Code;
and
(c)
An orthotics and prosthetics (O&P) supplier, which
furnishes orthotic and prosthetic devices in accordance with section
4779.02 of the Revised
Code.
(8)
"DMEPOS service" is a covered service, such as labor
for repair or replacement, that is furnished by an eligible provider and is
related directly to a DMEPOS item.
(9)
"Frequency limit"
is the average expected useful life of a DMEPOS item. A frequency limit is not
an absolute restriction but a general guideline and therefore may be exceeded
with medical justification. For certain DMEPOS items that can be dispensed in
multiple units (such as fasteners or items with left/right orientation), a
frequency limit applies to each unit that is requested.
(10)
"Long-term care
facility (LTCF)" is a collective term for a nursing facility (NF), a skilled
nursing facility (SNF), and an intermediate care facility for individuals with
intellectual disabilities (ICFIID).
(11)
"Medical
supplies."
(a)
For purposes of this chapter of the Administrative Code,
this term applies to healthcare-related items delineated by the following
criteria:
(i)
They have a short useful life. They are expendable,
disposable, or non-durable. They are intended either for a single use or for
limited repeated use by one individual.
(ii)
They are
adjunctive in nature. They aid in the treatment or management of an illness,
injury, or condition.
(iii)
Their therapeutic effect is achieved through
application to the body and not through ingestion.
(b)
Medical supplies
include but are not limited to the following non-exhaustive list of
examples:
(i)
Incontinence garments;
(ii)
Syringes;
(iii)
Wound
dressings, including gauze;
(iv)
Catheters and
other urological items;
(v)
Ostomy care items; and
(vi)
Feeding
bags.
(c)
The following items are not medical supplies:
(i)
Enteral nutrition
products; and
(ii)
Parenteral nutrition products.
(d)
The
use of the term 'supply' meaning "quantity" (as in 'the supply of wheelchairs
on hand' or 'a three-month supply') does not make the items in question medical
supplies.
(e)
This definition is useful only in the consideration of
items for which no standard medicaid maximum payment amount has been
established.
(12)
"Need verification" is a process by which the
department determines whether to make payment for a DMEPOS item or service that
exceeds the established cost threshold or frequency guideline. Because need
verification is applied only to items or services for which medical necessity
has already been established or presumed, no extensive or in-depth clinical
assessment is necessary (as it is with prior authorization). One purpose of
need verification is to enable the department to consider whether the purchase
of a new piece of DME might be more cost-effective than continued
repair.
(13)
"Prior authorization (PA)" has the same meaning as in
rule 5160-1-31 of the Administrative
Code.
(14)
"Private residence" is a medicaid-eligible individual's
place of residence other than a long-term care facility (LTCF).
(15)
"Provider cost"
is the amount paid for an item by a DMEPOS provider to a distributor or
manufacturer after the application of any discounts, rebates, and adjustments
that are available to the provider at the time of claim submission.
Documentation of provider cost is subject to approval by the department; a
figure that has been entered, superimposed, modified, obscured, or obliterated
by the provider will not be accepted. Suitable documents for substantiating
provider cost include but are not limited to the following examples:
(a)
An invoice
submitted by the distributor or manufacturer to the provider;
(b)
A bona fide
quotation (quote) submitted by the distributor or manufacturer to the provider;
or
(c)
A standard distributor or manufacturer price list that
can be independently verified by the department.
(16)
"Starting date
for dispensing" is the first date on which a DMEPOS item is anticipated to be
dispensed on an ongoing basis. The date of signature does not determine the
starting date for dispensing.
(C) Coverage.
(1)
In general, in
accordance with Chapter 5160-3 of the Administrative Code, a LTCF is
responsible for ensuring that a resident of the LTCF gets medically necessary
DME items and medical supplies, either by providing such items and supplies
itself or by paying a DMEPOS provider to dispense them. In turn, the LTCF
receives medicaid per diem payment on the basis of its cost report. Therefore,
claims submitted to ODM or its designee by a DMEPOS provider for such items or
supplies furnished to LTCF residents will be denied. Any exceptions are set
forth in other rules in this chapter of the Administrative
Code.
(2)
Separate payment may be made for a prosthesis or
orthotic device supplied to a resident of a LTCF.
(3)
A medically
necessary DMEPOS item can be dispensed only by prescription. The following
provisions apply:
(a)
Eligible medicaid providers of the following types
having prescriptive authority under Ohio law may prescribe a DMEPOS item:
(i)
A
physician;
(ii)
A podiatrist;
(iii)
An advanced
practice registered nurse with a relevant specialty; or
(iv)
A physician
assistant.
(b)
Before writing a prescription for certain DMEPOS items,
a practitioner conducts a face-to-face encounter with the medicaid-eligible
individual and documents it in the individual's medical record. Items for which
an encounter is a prerequisite are listed on the web site of the centers for
medicare and medicaid services (CMS) at
http://www.cms.gov.
(c)
A single encounter can serve for twelve months as the
basis for a single prescription or for more than one prescription addressing
the same medical condition for which a DMEPOS item is being
prescribed.
(d)
The prescribing practitioner needs to be actively
involved in managing the medicaid-eligible individual's healthcare. The
department may disallow a prescription written by a practitioner who has no
professional relationship with the individual.
(e)
There needs to be
a direct relationship between the prescribed DMEPOS item and a medical
condition of the medicaid-eligible individual that the practitioner evaluates,
assesses, or actively treats during the encounter.
(f)
Each prescription
should specify a quantity (e.g., "TID," "thirty per month"). An unstated
quantity is assumed to be one unit.
(g)
Unless a law,
regulation, rule, or the prescription itself states otherwise, a prescription
is assumed to be valid for one year.
(4)
DMEPOS items and
services for which payment is subject to PA are so indicated in the applicable
DMEPOS payment schedule.
(a)
The following DMEPOS items are always subject to
PA:
(i)
A "not
otherwise specified," "miscellaneous," or "unlisted" item or service;
and
(ii)
Used DME.
(b)
When PA is given,
it may specify a quantity, manufacturer, model, part number, or other
information identifying a particular item. When such identifying information is
present, a provider may supply and subsequently submit claims for the specified
items only. No changes or substitutions are allowed without explicit
authorization by the department.
(c)
The department,
on the basis of clinical indications, may grant PA for an item other than one
that has been requested.
(5)
If a
medicaid-eligible individual dies after measurements for a prescribed custom
item have been taken but before the item has been dispensed, then payment for
the item may be made under the following conditions:
(a)
The code set
description for the item indicates that it is designed or intended for a
specific individual;
(b)
The item is substantially complete and cannot be
modified for use by another individual;
(c)
No information
available to the provider indicated that the death of the individual was
imminent;
(d)
The provider can document the date of measurement;
and
(e)
On the claim, the provider reports the date of
measurement as the date of service.
(6)
Any request for a
DMEPOS item or service needs to originate with an individual medicaid-eligible
individual, the individual's authorized representative, or a medical
practitioner acting as the prescriber with the individual's full knowledge and
consent. A request that is determined by the department to have resulted from a
mass screening or examination will be denied.
(7)
When instruction
in the safe and appropriate use of a particular DMEPOS item is indicated, it is
the responsibility of the provider to ensure that the medicaid-eligible
individual or someone authorized to assist the individual has received such
instruction.
(8)
Payment for repair of a DME item, prosthetic device, or
orthotic device or for purchase of a related medical supply item or service can
be made only if the medical necessity of the DME item, prosthetic device, or
orthotic device itself has been established.
(a)
The medical
necessity of an item purchased by the department is established during the
purchasing process.
(b)
For an item not purchased by the department, medical
necessity may be documented on an appropriate medicaid certificate of medical
necessity, on a prescription that addresses all specified criteria, or on any
other form that is acceptable to the department.
(c)
No additional
documentation of medical necessity is needed for subsequent repairs made to an
item.
(d)
The determination that an item not purchased by the
department is medically necessary does not indicate that the item would be
authorized for purchase.
(9)
The initial
payment for covered repair, maintenance, parts, accessories, or supplies for a
DME item that is owned by an individual but has not been purchased by the
department is subject to PA. Whether payment for subsequent items or services
is subject to PA depends on the item or service.
(10)
Proof is needed
to show that a DMEPOS item has been delivered to the intended medicaid-eligible
individual.
(a)
Providers, their employees, and anyone else having a
financial interest in the delivery of DMEPOS items are not permitted to accept
delivery of an item on behalf of an individual.
(b)
If a provider
delivers directly to a medicaid-eligible individual, then acceptable proof of
delivery includes the signature of the individual or the individual's
authorized representative. For a DMEPOS item delivered to a resident of a LTCF,
the LTCF is responsible for furnishing proof of delivery.
(c)
If a provider
uses a third-party shipper, then acceptable proof of delivery includes the
shipper's tracking slip or a returned postage-paid delivery
invoice.
(d)
If a signature obtained physically at the time of
delivery is not legible, then the provider or shipper records the name of the
person accepting delivery and the relationship of the person to the
medicaid-eligible individual. If the provider or shipper records such
information for a particular person and maintains it in a readily accessible
format, then on subsequent deliveries only the signature is
needed.
(11)
If more than one DMEPOS item or service will meet a
medicaid-eligible individual's needs, then the maximum payment amount cannot
exceed the least costly alternative, in accordance with rule
5160-1-01 of the Administrative
Code.
(12)
No separate payment will be made under this chapter of
the Administrative Code for the following items or services:
(a)
Items presumed to
be non-medical in nature and for which no medical necessity can therefore be
demonstrated, including but not limited to the following examples:
(i)
Environmental
control devices;
(ii)
Items that are intended solely for the comfort or
convenience of the user and have no medical benefit;
(iii)
Physical
fitness equipment;
(iv)
Precautionary items (e.g., emergency alert
systems);
(v)
Training equipment (e.g., speech-teaching
machines);
(vi)
Communication aids, except as specified elsewhere in
this chapter of the Administrative Code;
(vii)
Educational
aids; and
(viii)
Hygiene equipment (e.g., bidets);
(b)
Routine over-the-counter treatment supplies (e.g., adhesive
bandages, antiseptic solutions, antibiotic ointments) and personal hygiene
items (e.g., soap, diapers for children younger than three years of
age);
(c)
Medical supplies or DME items that are used during a
visit with a healthcare practitioner (i.e., that are incidental to a
professional service) in an appropriate healthcare setting or in the
medicaid-eligible individual's private residence;
(d)
Items or services
that are covered under manufacturer or dealer warranty;
(e)
Items or services
for which full remuneration is made through other payment
mechanisms;
(f)
Costs of delivery (including postage), setup and
assembly, pickup, and routine cleaning and maintenance associated with a
covered DME item;
(g)
Labor, measuring, casting, fitting, travel by the
supplier, and shipping or mailing associated with a covered orthotic device or
prosthesis;
(h)
Maintenance and repair of DME during a rental
period;
(i)
Supporting wires, power supplies, cables, or attachment
kits;
(j)
Related supplies and accessories that are dispensed
either during a rental period or with the dispensing or delivery of a purchased
DME item and for which no payment amount exists for separate purchase or
rental;
(k)
A service call in addition to materials and
labor;
(l)
Repairs, adjustments, or modifications that are made
within ninety days after delivery or during the total rental period, unless
necessitated by major changes in the medicaid-eligible individual's
condition;
(m)
Instruction of the medicaid-eligible individual or the
individual's authorized representative in the safe use of an item;
and
(n)
Education, training, instruction, counseling, or
monitoring conducted in support of an individual's ordered treatment
plan.
(13)
The use of an item in conjunction with a piece of DME
does not in itself make the item an accessory. A smart phone, for example, is
not an accessory.
(14)
Payment is not available for DMEPOS items that
duplicate or conflict with another item currently in the medicaid-eligible
individual's possession, regardless of payment or supply source. Providers are
responsible for ascertaining whether duplication or conflict
exists.
(15)
Certain DMEPOS items may be dispensed on a recurring
basis. A provider is to confirm a medicaid-eligible individual's current need
before the next delivery. If DMEPOS items are routinely delivered without
necessary confirmation of need, then any payment for excess quantities is
subject to recovery.
(16)
Most covered DME items are purchased and become the
property of the medicaid-eligible individual. Some covered DME items that need
ongoing servicing are rented exclusively. Some covered DME items may be rented
on a short-term basis, purchased, or rented and then purchased.
(a)
The short-term
rental of a covered DME item other than a wheelchair is subject to PA, which
may be given if rental is determined to be more cost-effective than
purchase.
(b)
Unless a different length of time is specified
elsewhere in this chapter of the Administrative Code, the initial rental period
does not exceed six months.
(c)
PA may be given
for additional rental periods.
(d)
Regardless of its
authorized length, a rental period ends when the rented item is no longer
medically necessary.
(e)
A monthly rental payment secures the rented item for
the entire calendar month.
(f)
During a rental
period and for ninety days afterward, the cumulative rental amounts paid for a
particular "rental/purchase" DME item apply toward purchase.
(g)
The department
reserves the right to determine whether an item will be rented or
purchased.
(17)
Medical supply items such as gauze pads and wound
fillers/packing are dispensed in bulk. No payment amount per unit has been
established for such items; instead, an overall payment limit per period is
specified. The charge submitted by the provider cannot exceed one hundred
forty-seven per cent of the provider cost for the quantity of the
item.
(18)
The purchase of torsion cables may be authorized only
for the treatment of children with neuromuscular diseases and related
conditions. Requests for torsion cables to treat positional deformities will be
denied because of anticipated resolution that occurs with
maturation.
(19)
A provider may furnish a DMEPOS item or service before
obtaining a completed CMN but cannot submit a claim until the item or service
has been furnished.
(20)
A request for PA or need verification may be denied in
cases involving malicious damage, neglect, culpable irresponsibility, or
wrongful disposition.
(21)
Only the department can determine coverage. Providers
cannot decide on their own that an item or service is not covered or would not
be covered with PA. Providers should submit a PA request to obtain an official
decision.
(D) Documentation.
(1)
When a request is
made for PA, the following accompanying documentation is needed:
(a)
A completed
CMN:
(i)
For a
DMEPOS item that is dispensed once (such as a wheelchair), the provider submits
one completed CMN; or
(ii)
For a DMEPOS item that will be needed indefinitely, for
a lifetime, or on a recurring or ongoing basis, the provider takes the
following steps:
(a)
The provider obtains and submits an initial completed
CMN;
(b)
Each year thereafter the provider obtains and submits
an updated prescription no sooner than ninety days before the expiration of the
current prescription; and
(c)
If the updated prescription indicates a change in the
need for a DMEPOS item, the provider obtains a new completed
CMN;
(b)
Related information, such as a full description of any
similar item currently in possession of the medicaid-eligible individual or an
explanation of a change in the individual's condition that warrants a change in
equipment;
(c)
For a preparatory prosthesis, the reason for the
amputation, the date of the amputation, and an explanation of the benefit to be
derived from having the medicaid-eligible individual use a preparatory
prosthesis before a definitive prosthesis is designed;
(d)
For a "not
otherwise specified," "miscellaneous," or "unlisted" item, a complete
description of the item (including, as applicable, the manufacturer, model or
style, and size), a list of all bundled components, and an itemization of all
charges; and
(e)
Any other information requested by the department, as
detailed in this chapter of the Administrative Code.
(2)
A claim for an
item or service that exceeds the specified maximum quantity or frequency but is
not otherwise subject to PA is subject to need verification. Documentation of
need may be made either on the CMN associated with the item or service or on
form ODM 01913.
(3)
For each claim, whether or not it is subject to PA or
need verification, the provider cannot legitimately receive payment until
necessary supporting documents have been obtained and placed in the provider's
files. These documents include the prescription and any applicable items from
the following non-exhaustive list of examples:
(a)
A completed
CMN;
(b)
Practitioner orders or chart notes;
(c)
Any record
indicating a change in an individual's needs or plan of care;
(d)
Proof of
delivery;
(e)
Confirmation that the medicaid-eligible individual or
the individual's authorized representative has been instructed in the safe use
of the DMEPOS item;
(f)
A copy of the manufacturer's or dealer's warranty;
and
(g)
A record of any repair or service that has been
performed on equipment not paid for by medicaid.
(E) Claim payment.
(1)
The payment amount specified in another rule in this chapter of the
Administrative Code supersedes any payment amount established by provisions in
this rule.
(2)
For a covered DMEPOS item or service represented by a
new or newly adopted healthcare common procedure coding system (HCPCS)
procedure code, the initial maximum payment amount may be established in
accordance with rule
5160-1-60 of the Administrative
Code. New or newly adopted HCPCS codes are published in a separate table on the
department's web site and remain there until the appropriate DMEPOS payment
schedules can be updated.
(3)
For any covered DMEPOS item or service not represented
by a new or newly adopted HCPCS procedure code, the payment amount is the
lesser of the submitted charge (which is to reflect any discounts or rebates
available to the provider at the time of claim submission but need not reflect
subsequent discounts or rebates) or the first applicable medicaid maximum from
the following ordered list:
(a)
The amount listed in the appendix to this
rule;
(b)
For a "by report" DMEPOS item or service, an amount
determined on a case-by-case basis;
(c)
For an item for
which payment is determined by PA, the relevant amount specified in the
following list:
(i)
A supply item, one hundred forty-seven per cent of the
provider cost;
(ii)
A wheelchair, wheelchair item, standing frame, gait
trainer, or other DMEPOS item that incorporates complex rehabilitation
technology, one hundred twenty per cent of the base invoice
charge;
(iii)
An enteral nutrition product, one hundred eighty-five
per cent of the provider cost; or
(iv)
Any other
non-supply DMEPOS item or service, an amount determined on a case-by-case
basis;
(d)
For the authorized purchase of a DMEPOS item in used
condition, eighty per cent of the payment amount for the item in new
condition;
(e)
For monthly payment for a "rental/purchase" DME item,
ten per cent of the medicaid maximum specified for purchase; or
(f)
For a
professional service for which separate payment is made (such as an
evaluation), the applicable amount listed in appendix DD to rule
5160-1-60 of the Administrative
Code.
(4)
In accordance with the principle stated in rule
5160-1-60 of the Administrative
Code concerning correct coding, a "not otherwise specified," "miscellaneous,"
or "unlisted" procedure code of the appropriate DMEPOS type may be reported on
a claim only if no other code listed on a payment schedule adequately
represents the item or service. The department may deny a claim that omits
necessary information or that includes a "not otherwise specified,"
"miscellaneous," or "unlisted" procedure code when an appropriate
procedure-specific code is available.
Replaces: 5160-10-01
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