Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO:
KRS
205.560(1)(c),
213.141(2),
304.17A-258,
7
C.F.R. 246.2,
246.10
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
194A.050(1) requires the
secretary of the Cabinet for Health and Family Services to promulgate
administrative regulations necessary to operate the programs and fulfill the
responsibilities vested in the cabinet.
KRS
205.560(1)(c) requires the
cabinet to cover the cost of products for the treatment of inborn errors of
metabolism or genetic, gastrointestinal, and food allergic conditions,
consisting of therapeutic food, formulas, supplements, amino acid-based
elemental formula, or low-protein modified food products that are medically
necessary and administered under the direction of a physician. This
administrative regulation establishes the application and cost reimbursement
procedures for specialized food products.
Section
1. Definitions.
(1) "Amino
acid-based elemental formula" is defined by
KRS
304.17A-258(1)(c).
(2) "Low-protein modified food" is defined by
KRS
304.17A-258(1)(b).
(3) "Patient" means a person with one (1) or
more of the metabolic conditions listed in
KRS
205.560(1)(c).
(4) "Program" means the Kentucky Metabolic
Foods and Formulas program operated by the Cabinet for Health and Family
Services, Department for Public Health.
(5) "Specialized food product" means a
therapeutic food or formula, supplement, amino acid-based elemental formula, or
low-protein modified food product, which is medically indicated for therapeutic
treatment.
(6) "Uninsured patient"
means a patient who does not meet the criteria to receive Medicaid, K-CHIP,
Medicare, or WIC benefits, or whose private insurance coverage is exhausted or
denied.
(7) "Vendor" means an
individual or entity authorized to fill a prescription for specialized food
product for an uninsured patient.
(8) "WIC" is defined by
7
C.F.R. 246.2.
Section 2. Eligibility.
(1) An individual meeting the definition of
an uninsured patient shall be eligible to receive approval for financial
coverage of a specialized food product by the program.
(2) An uninsured patient seeking financial
coverage of a specialized food product shall submit to the program:
(a) Kentucky Metabolic Food and Formula
Provision Financial and Release of Information Form; and
(b) Written verification that an application
for WIC, Medicaid, Medicare, or K-CHIP was denied, and that private health
insurance has been exhausted or denied.
(3) On behalf of an uninsured patient seeking
financial coverage of a specialized food product, a licensed or certified
healthcare practitioner with prescriptive authority shall submit to the
program:
(a)
1. A Kentucky Metabolic Disease Program
Physician's Statement of Medical Necessity - Metabolic Disease Therapy form;
or
2. A certificate of medical
necessity; and
(b) A
prescription for the specialized food product.
(4) Eligibility for financial coverage shall
be renewed annually by submitting the documentation as required by subsection
(2) of this section.
(5) The cost
of the formula for a patient who is eligible for WIC shall be covered by the
WIC Program in accordance with
7 C.F.R.
246.10(e)(3)(i).
(6) The cost for food and formula for a
patient covered by private health insurance shall be paid under the terms of
the individual insurance policy, which shall meet or exceed the limit
established in
KRS
304.17A-258.
Section 3. Cost Reimbursement.
(1) Cost reimbursement shall be made directly
to the vendor filling a prescription for a specialized food product.
(2) To receive reimbursement of the actual
cost plus twenty (20) percent, a vendor shall submit the following documents to
the program:
(a) A prescription for the
specialized food product from a licensed or certified healthcare practitioner
with prescriptive authority;
(b) A
completed Authorization for Services, MFF-100; and
(c) An invoice from the supplier with the
patient name, service date, and cost to the vendor.
Section 4. Incorporation by
Reference.
(1) The following material is
incorporated by reference:
(a) "Kentucky
Metabolic Disease Program Physician's Statement of Medical Necessity -Metabolic
Disease Therapy", Rev. 2/19;
(b)
"Authorization for Services", MFF-100, 2/19; and
(c) "Kentucky Metabolic Food and Formula
Provision Financial and Release of Information Form", FRI-100, Rev.
2/19.
(2) This material
may be inspected, copied, or obtained, subject to applicable copyright law, at
the Department for Public Health, Division of Maternal and Child Health, 275
East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to
4:30 p.m.
STATUTORY AUTHORITY:
KRS
194A.050(1),
205.560(1)(c)
