(a) As a condition for enrollment, or
continued enrollment, in the Medi-Cal program, an applicant or provider of
durable medical equipment and medical supplies shall:
(1) Maintain a business address, as defined
in Section
51000.3, that is accessible to the
general public. Each provider shall keep, maintain, and have readily
retrievable at their business address those records specified in Section
51476.
(2) Maintain a business telephone, as defined
in Section
51000.4, at the business address.
The business telephone number shall be listed under the name of the business
and in the business portion of the local telephone company directory.
(3) Maintain comprehensive liability
insurance that covers both the applicant's or provider's place of business and
any and all customers and employees of the applicant or provider.
(4) Fill orders from its inventory or by
contracting with other companies for the purchase of items necessary to fill
the order. Items may be fabricated or fitted for sale only from supplies
purchased under contract.
(5)
Obtain and maintain all state and local licenses and permits necessary to
provide the services, goods, supplies, or merchandise being provided, including
but not limited to, the licenses specified below:
(A) One or more of the licenses issued by the
Bureau of Home Furnishings and Thermal Insulation of the Department of Consumer
Affairs, as applicable to the applicant's or provider's business activity:
1. If the applicant or provider intends to
rent or currently rents beds, a Sanitizer's License, a Furniture and Bedding
Manufacturer's License, a Custom Upholsterer's License, a Retail Furniture and
Bedding Dealer's License, or a Retail Bedding License.
2. If the applicant or provider intends to
sell, or currently sells beds, a Retail Bedding Dealer's License, an Importer's
License, a Furniture and Bedding Manufacturer's License, a Wholesale Furniture
and Bedding Dealer's License, or a Retail Furniture and Bedding Dealer's
License.
3. If the applicant or
provider intends to sell, or currently sells wheelchairs, a Retail Furniture
Dealer's License, an Importer's License, a Furniture and Bedding Manufacturer's
License, a Wholesale Furniture and Bedding Dealer's License, a Custom
Upholsterer's License, or a Retail Furniture and Bedding Dealer's
License.
(B) Licenses
issued by the Board of Pharmacy entitled "Medical Device Retailer Original
Certificate," and "Medical Device Retailer Original Exemptee Certificate," if
the applicant or provider intends to provide, or currently provides, ostomy
supplies, oxygen equipment and supplies, urinary catheters, bags, and related
supplies.
(6) Have
written policies and/or procedures that ensures all the following:
(A) Beneficiaries shall be advised that:
1. Medi-Cal may approve rental or purchase of
durable medical equipment on behalf of the beneficiary.
2. Except for life support equipment, such as
ventilators, when previously paid rental charges equal the maximum allowable
purchase price of the rented item, the item is considered to have been
purchased and no further reimbursement to the provider shall be made for the
beneficiary's use of the item, unless repair and maintenance is separately
authorized.
(B) All
warranties, expressed and implied, shall be honored and neither the beneficiary
nor the Medi-Cal program shall be charged for the repair or replacement of
Medi-Cal covered items or for services covered under warranty.
(C) Beneficiaries shall be provided with
necessary information and instructions on how to use items safely and
effectively.
(D) Questions or
complaints from beneficiaries about items that are sold or rented shall be
responded to within 10 calendar days of the date the beneficiary contacts the
provider.
(E) Maintenance and/or
repair or items shall be provided directly, or through a service contract with
another company.
(F) Returns of
substandard or unsuitable items shall be accepted from beneficiaries.
Substandard or unsuitable items shall be replaced by the provider at no
additional cost to the beneficiary or the Medi-Cal program. For the purposes of
this section only, the following shall apply:
1. A "substandard item" shall have the same
meaning specified in Section
14043.1, Welfare and Institutions
(W&I) Code.
2. An "unsuitable
item" is an item that, when in actual use, does not meet the medical needs of
the beneficiary when the beneficiary's medical condition has not significantly
changed since the item was fitted or sold.
(G) In addition to the written polices and
procedures specified in (A) through (F), above, a durable medical equipment and
medical supply applicant or provider who holds a license as a medical device
retailer, or a medical device retailer exemptee, and provides dangerous drugs
or dangerous devices, as defined in Section
4022, Business and Professions
(B&P) Code, shall meet the standards specified in Section
4131, B&P Code, and have
written policies and procedures that meet the requirements of Section
4132, B&P
Code.
(b)
Consumer information, such as copies of warranties and product information, a
copy of the written policies and/or procedures required by subsection (a)(6),
above, and a copy of the participation standards specified in this Section
shall be provided to each beneficiary to whom a Medi-Cal reimbursed item is
provided.
(c) Applicants and
enrolled providers shall be subject to an onsite inspection, as permitted by
Section
14043.37, W&I Code, or an
unannounced visit, as permitted by Section
14043.7, W&I Code, to ensure
the requirements of this section have been met.
Notes
Cal. Code Regs. Tit. 22, §
51224.5
1. New
section filed 10-24-2000 as an emergency and submitted to OAL for printing only
pursuant to Section
78, Chapter 146, Statutes of 1999;
operative 10-24-2000 (Register 2000, No. 43). A Certificate of Compliance must
be transmitted to OAL by 4-23-2001 or emergency language will be repealed by
operation of law on the following day.
2. Editorial correction of
HISTORY 1 (Register 2001, No. 14).
3. New section refiled 4-4-2001
as an emergency and submitted to OAL for printing only pursuant to Section
78, Chapter 146, Statutes of 1999;
operative 4-4-2001 (Register 2001, No. 14). A Certificate of Compliance must be
transmitted to OAL by 8-2-2001 or emergency language will be repealed by
operation of law on the following day.
4. Certificate of Compliance
as to 4-4-2001 order transmitted to OAL 7-31-2001 and filed 9-5-2001 (Register
2001, No. 36).
Note: Authority cited: Sections
10725,
14105
and
14124.5,
Welfare and Institutions Code; and Section
78, Chapter 146, Statutes of 1999.
Reference: Sections
4022,
4130,
4131,
4132,
19051,
19055
and
19059.5,
Business and Professions Code; and Sections
14043.37,
14043.7,
14043.75,
14059
and
14132(m),
Welfare and Institutions Code.
1. New section
filed 10-24-2000 as an emergency and submitted to OAL for printing only
pursuant to Section 78, Chapter 146, Statutes of 1999; operative 10-24-2000
(Register 2000, No. 43). A Certificate of Compliance must be transmitted to OAL
by 4-23-2001 or emergency language will be repealed by operation of law on the
following day.
2. Editorial correction of History 1 (Register 2001,
No. 14).
3. New section refiled 4-4-2001 as an emergency and
submitted to OAL for printing only pursuant to Section 78, Chapter 146,
Statutes of 1999; operative 4-4-2001 (Register 2001, No. 14). A Certificate of
Compliance must be transmitted to OAL by 8-2-2001 or emergency language will be
repealed by operation of law on the following day.
4. Certificate
of Compliance as to 4-4-2001 order transmitted to OAL 7-31-2001 and filed
9-5-2001 (Register 2001, No. 36).