Title 907 | Chapter 001 | Regulation 028REG
PROPOSED
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PREVIOUS VERSION
The previous document that this document is based upon is available.
CABINET FOR HEALTH AND FAMILY SERVICES
Department for Medicaid Services
Division of Healthcare Policy
(Amendment)
907 KAR 1:028.Independent laboratory and radiological service coverage and reimbursement.
Section 1.
Definitions.(1)
"CLIA" means the Clinical Laboratory Improvement Amendments, 42 C.F.R. Part 493.(2)
"CMS" means the Centers for Medicare and Medicaid Services.(3)
"Covered benefit" or "covered service" means an independent laboratory or radiological service for which the department shall reimburse.(4)
"CPT" means the current procedural terminology coding system.(5)
"Department" means the Department for Medicaid Services or its designee.(6)
"Incidental" means a medical procedure or service which:(a)
1.
Is performed at the same time as a more complex primary procedure or service; and2.
Requires little additional resources; or(b)
Is clinically integral to the performance of the primary procedure or service.(7)
"Independent laboratory" means a laboratory which:(a)
Is certified by CMS under the CLIA to perform laboratory services;(b)
Is independent of an institutional setting;(c)
Is a Medicare-participating facility;(d)
Meets the requirements established in 42 C.F.R. Part 493 regarding laboratory certification, registration, or other accreditation as appropriate; and(e)
Is a Medicaid-enrolled provider.(8)
"Laboratory director" means an individual meeting the director of laboratory qualifications established in KRS 333.090(1), (2), or (3).(9)
"Medicaid-enrolled provider" means a provider participating in the Kentucky Medicaid Program in accordance with 907 KAR 1:671 and 1:672.(10)
"Medically necessary" or "medical necessity" means a covered benefit determined to be needed in accordance with 907 KAR 3:130.(11)
"Medicare-participating" means certified by CMS and accepting reimbursement from Medicare.(12)
"Mutually exclusive" means two (2) laboratory or radiological services:(a)
Not reasonably provided in conjunction with one (1) another during the same patient encounter on the same date of service; or(b)
Representing:1.
Duplicate or very similar items; or2.
Medically inappropriate use of CPT codes.(13)
"Prescriber" means a physician, podiatrist, optometrist, dentist, oral surgeon, advanced registered nurse practitioner, or physician's assistant who:(a)
Is acting within the legal scope of clinical practice under the licensing laws of the state in which the health care provider's medical practice is located;(b)
Is in good standing with:1.
The licensure board of jurisdiction for the provider's practice; and2.
CMS;(c)
Has the legal authority to write an order for a medically necessary service for the recipient; and(d)
If enrolled as a Kentucky Medicaid provider, is in compliance with all requirements of 907 KAR 1:671 and 1:672.(14)
"Radiological service" means a service in which X-rays or rays from radioactive substances are used for diagnostic or therapeutic purposes.(15)
"Recipient" is defined in KRS 205.8451(9).(16)
"Usual and customary" means the uniform amount which a provider charges the general public for a specific procedure or service.Section 2.
Coverage.(1)
The department shall reimburse for a procedure provided by an independent laboratory if the procedure:(a)
Is one that the laboratory is certified to provide by Medicare and in accordance with 907 KAR 1:575;(b)
(c)
Is prescribed in writing or by electronic request by a physician, podiatrist, dentist, oral surgeon, advanced registered nurse practitioner, or optometrist; and(c)(d)
Is supervised by a laboratory director.(2)
The department shall reimburse for a radiological service if the service:(a)
Is provided by a facility that:1.
Is licensed to provide radiological services;2.
Meets the requirements established in 42 C.F.R. 440.30;3.
Is certified by Medicare to provide the given service;4.
Is a Medicare-participating facility;5.
Meets the requirements established in 42 C.F.R. Part 493 regarding laboratory certification, registration, or other accreditation as appropriate; and6.
Is a Medicaid-enrolled provider;(b)
Is prescribed in writing or by electronic request by a physician, oral surgeon, dentist, podiatrist, optometrist, advanced registered nurse practitioner, or a physician's assistant;(c)
Is provided under the direction or supervision of a licensed physician(d)
Section 3.
Exclusions. The department shall not reimburse for an independent laboratory or radiological service under this administrative regulation for the following services or procedures:(1)
(2)
(3)
A service provided to a resident of a nursing facility or an intermediate care facility for individuals with an intellectual disability; or(2)(4)
A court-ordered laboratory or toxicology test.Section 4.
Reimbursement.(1)
The department shall reimburse an independent laboratory the current Medicare rate established by CMS:(a)
For Kentucky;(b)
For the covered service or procedure; and(c)
In accordance with 42 U.S.C. 1395l(h)(1)(A).(2)
Reimbursement for a service provided by an independent laboratory shall not exceed the limit established in 42 U.S.C. 1396b(i)(7).(3)
The department shall reimburse a Medicaid-enrolled provider licensed to provide radiological services:(a)
The provider's usual and customary charge for the service; and(b)
Not to exceed sixty (60) percent of the upper payment limit established for the procedure in the Medicaid physician fee schedule pursuant to 907 KAR 3:010.Section 5.
Provider Participation Conditions.(1)
To be reimbursed by the department for a service provided in accordance with this administrative regulation, a provider of independent laboratory services or radiological services shall:(a)
Be a Medicaid-enrolled provider;(b)
Comply with all relevant provisions of KAR Title 907(c)
Comply with the requirements regarding the confidentiality of personal records pursuant to 42 U.S.C. 1320d-8 and 45 C.F.R. parts 160 and 164; and(d)
Annually submit documentation of:1.
Current CLIA certification to the department if the provider is an independent laboratory; and2.
A current radiological license to the department if the provider provides radiological services.(2)
A provider may bill a recipient for a service not covered by the department if the provider informed the recipient of noncoverage prior to providing the service.Section 6.
Appeal Rights.(1)
An appeal of a department decision regarding a recipient based upon an application of this administrative regulation shall be in accordance with 907 KAR 1:563.(2)
An appeal of a department decision regarding Medicaid eligibility of an individual shall be in accordance with 907 KAR 1:560.(3)
An appeal of a department decision regarding a Medicaid provider based upon an application of this administrative regulation shall be in accordance with 907 KAR 1:671.LISA D. LEE, Commissioner
ERIC C. FRIEDLANDER, Secretary
APPROVED BY AGENCY: September 30, 2024
FILED WITH LRC: October 9, 2024 at 1:30 p.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall, if requested, be held on December 23, 2024, at 9:00 a.m. using the CHFS Office of Legislative and Regulatory Affairs Zoom meeting room. The Zoom invitation will be emailed to each requestor the week prior to the scheduled hearing. Individuals interested in attending this virtual hearing shall notify this agency in writing by December 16, 2024, five (5) workdays prior to the hearing, of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who attends virtually will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on this proposed administrative regulation until December 31, 2024. Send written notification of intent to attend the public hearing or written comments on the proposed administrative regulation to the contact person. Pursuant to KRS 13A.280(8), copies of the statement of consideration and, if applicable, the amended after comments version of the administrative regulation shall be made available upon request.
CONTACT PERSON: Krista Quarles, Policy Analyst, Office of Legislative and Regulatory Affairs, 275 East Main Street 5 W-A, Frankfort, Kentucky 40621; Phone: 502-564-7476; Fax: 502-564-7091; CHFSregs@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Jonathan Scott and Krista Quarles
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation establishes the provisions relating to the coverage of and reimbursement for independent laboratory and radiological services.
(b) The necessity of this administrative regulation:
This administrative regulation is necessary to establish the provisions relating to the coverage of and reimbursement for independent laboratory and radiological services.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
This administrative regulation conforms to the content of the authorizing statutes by establishing the provisions relating to the coverage of and reimbursement for independent laboratory and radiological services.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation assists with the effective administration of the statutes by establishing the provisions relating to the coverage of and reimbursement for independent laboratory and radiological services.
(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing administrative regulation:
The amendments contain various changes to comply with 907 KAR. In addition, references to CPT codes and CPT code ranges have been removed to reflect updated capacity of the Department’s information technology systems to better assess provider eligibility to provide a service.
(b) The necessity of the amendment to this administrative regulation:
This amendment is necessary to reflect current practice and reimbursement in this healthcare area.
(c) How the amendment conforms to the content of the authorizing statutes:
This amendment conforms to the content of the authorizing statutes by establishing a more updated system of provider reimbursement for independent laboratories.
(d) How the amendment will assist in the effective administration of the statutes:
This amendment assists with the affective administration of the statutes by establishing a more updated system of provider reimbursement for independent laboratories.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
There are currently 360 independent laboratory providers in the Medicaid program.
(4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:
(a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment:
Regulated entities will not need to take any new action to comply with this amendment.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
Regulated entities will experience no new costs in complying with this administrative regulation.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
Recipients will be able to participate or continue to participate in the Medicaid program. Providers will be able to more easily bill and seek reimbursement for services rendered to Medicaid-covered individuals.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
The Department anticipates no additional costs in implementing this administrative regulation.
(b) On a continuing basis:
The Department anticipates no additional costs in implementing this administrative regulation.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
Sources of funding to be used for the implementation and enforcement of this administrative regulation are federal funds authorized under Title XIX and Title XXI of the Social Security Act, and state matching funds of general and agency appropriations.
(7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment:
Neither an increase in fees nor funding will be necessary to implement the amendments.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
The amendment does not establish or increase any fees.
(9) TIERING: Is tiering applied?
(Explain why or why not) Tiering was not appropriate in this administrative regulation because the administrative regulation applies equally to all those individuals or entities regulated by it.
FISCAL IMPACT STATEMENT
(1) Identify each state statute, federal statute, or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS 205.520, 42 C.F.R. Part 493
(2) Identify the promulgating agency and any other affected state units, parts, or divisions:
Department for Medicaid Services is the promulgating agency, other agencies have not been identified.
(a) Estimate the following for the first year:
Expenditures:
No additional expenditures beyond those allocated to the Department pursuant to 2024 House Bill 6.
Revenues:
The Department does not anticipate revenues as a result of this administrative regulation.
Cost Savings:
The Department does not anticipate cost savings as a result of this administrative regulation.
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
DMS does not expect a change to expenditures, revenues, or cost savings in subsequent years.
(3) Identify affected local entities (for example: cities, counties, fire departments, school districts):
None known.
(a) Estimate the following for the first year:
Expenditures:
n/a The Department does not anticipate additional expenditures.
Revenues:
n/a The Department does not anticipate additional revenues.
Cost Savings:
n/a The Department does not anticipate cost savings.
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
DMS does not expect additional expenditures, revenues, or cost savings for local entities as a result of this regulation.
(4) Identify additional regulated entities not listed in questions (2) or (3):
Independent laboratory providers.
(a) Estimate the following for the first year:
Expenditures:
n/a The Department does not anticipate additional expenditures.
Revenues:
n/a The Department does not anticipate additional revenues.
Cost Savings:
The Department anticipates some cost savings due to decreased administrative burden for the providers who are billing.
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
DMS expects cost savings due to decreased administrative burden on an ongoing basis.
(5) Provide a narrative to explain the:
(a) Fiscal impact of this administrative regulation:
The administrative regulation does not contain an additional fiscal impact.
(b) Methodology and resources used to determine the fiscal impact:
The policies impacting providers and facilities have not changed, as a result no fiscal impact is expected.
(6) Explain:
(a) Whether this administrative regulation will have an overall negative or adverse major economic impact to the entities identified in questions (2) - (4). ($500,000 or more, in aggregate)
: The administrative regulation will not have a major economic impact – as defined by KRS 13A.010 – on regulated entities.
(b) The methodology and resources used to reach this conclusion:
The policies impacting providers and facilities have not changed, as a result no fiscal impact is expected.
FEDERAL MANDATE ANALYSIS COMPARISON
(1) Federal statute or regulation constituting the federal mandate.
42 C.F.R. Part 493 establishes policies relating to independent laboratories in the Medicaid program.
(2) State compliance standards.
KRS 194A.030(2) requires the Department for Medicaid Services to "serve as the single state agency in the commonwealth to administer Title XIX of the Federal Social Security Act."
(3) Minimum or uniform standards contained in the federal mandate.
42 C.F.R. Part 493 establishes a comprehensive scheme of federal requirements for state Medicaid agencies related to independent laboratory services.
(4) Will this administrative regulation impose stricter requirements, or additional or different responsibilities or requirements, than those required by the federal mandate?
The amendment will not impose stricter than federal requirements.
(5) Justification for the imposition of the stricter standard, or additional or different responsibilities or requirements.
The amendment will not impose stricter than federal requirements.
CABINET FOR HEALTH AND FAMILY SERVICES
Department for Medicaid Services
Division of Healthcare Policy
(Amendment)
907 KAR 1:028.Independent laboratory and radiological service coverage and reimbursement.
Section 1.
Definitions.(1)
"CLIA" means the Clinical Laboratory Improvement Amendments, 42 C.F.R. Part 493.(2)
"CMS" means the Centers for Medicare and Medicaid Services.(3)
"Covered benefit" or "covered service" means an independent laboratory or radiological service for which the department shall reimburse.(4)
"CPT" means the current procedural terminology coding system.(5)
"Department" means the Department for Medicaid Services or its designee.(6)
"Incidental" means a medical procedure or service which:(a)
1.
Is performed at the same time as a more complex primary procedure or service; and2.
Requires little additional resources; or(b)
Is clinically integral to the performance of the primary procedure or service.(7)
"Independent laboratory" means a laboratory which:(a)
Is certified by CMS under the CLIA to perform laboratory services;(b)
Is independent of an institutional setting;(c)
Is a Medicare-participating facility;(d)
Meets the requirements established in 42 C.F.R. Part 493 regarding laboratory certification, registration, or other accreditation as appropriate; and(e)
Is a Medicaid-enrolled provider.(8)
"Laboratory director" means an individual meeting the director of laboratory qualifications established in KRS 333.090(1), (2), or (3).(9)
"Medicaid-enrolled provider" means a provider participating in the Kentucky Medicaid Program in accordance with 907 KAR 1:671 and 1:672.(10)
"Medically necessary" or "medical necessity" means a covered benefit determined to be needed in accordance with 907 KAR 3:130.(11)
"Medicare-participating" means certified by CMS and accepting reimbursement from Medicare.(12)
"Mutually exclusive" means two (2) laboratory or radiological services:(a)
Not reasonably provided in conjunction with one (1) another during the same patient encounter on the same date of service; or(b)
Representing:1.
Duplicate or very similar items; or2.
Medically inappropriate use of CPT codes.(13)
"Prescriber" means a physician, podiatrist, optometrist, dentist, oral surgeon, advanced registered nurse practitioner, or physician's assistant who:(a)
Is acting within the legal scope of clinical practice under the licensing laws of the state in which the health care provider's medical practice is located;(b)
Is in good standing with:1.
The licensure board of jurisdiction for the provider's practice; and2.
CMS;(c)
Has the legal authority to write an order for a medically necessary service for the recipient; and(d)
If enrolled as a Kentucky Medicaid provider, is in compliance with all requirements of 907 KAR 1:671 and 1:672.(14)
"Radiological service" means a service in which X-rays or rays from radioactive substances are used for diagnostic or therapeutic purposes.(15)
"Recipient" is defined in KRS 205.8451(9).(16)
"Usual and customary" means the uniform amount which a provider charges the general public for a specific procedure or service.Section 2.
Coverage.(1)
The department shall reimburse for a procedure provided by an independent laboratory if the procedure:(a)
Is one that the laboratory is certified to provide by Medicare and in accordance with 907 KAR 1:575;(b)
Is prescribed in writing or by electronic request by a physician, podiatrist, dentist, oral surgeon, advanced registered nurse practitioner, or optometrist; and(c)
Is supervised by a laboratory director.(2)
The department shall reimburse for a radiological service if the service:(a)
Is provided by a facility that:1.
Is licensed to provide radiological services;2.
Meets the requirements established in 42 C.F.R. 440.30;3.
Is certified by Medicare to provide the given service;4.
Is a Medicare-participating facility;5.
Meets the requirements established in 42 C.F.R. Part 493 regarding laboratory certification, registration, or other accreditation as appropriate; and6.
Is a Medicaid-enrolled provider;(b)
Is prescribed in writing or by electronic request by a physician, oral surgeon, dentist, podiatrist, optometrist, advanced registered nurse practitioner, or a physician's assistant;(c)
Is provided under the direction or supervision of a licensed physician.Section 3.
Exclusions. The department shall not reimburse for an independent laboratory or radiological service under this administrative regulation for the following services or procedures:(1)
A service provided to a resident of a nursing facility or an intermediate care facility for individuals with an intellectual disability; or(2)
A court-ordered laboratory or toxicology test.Section 4.
Reimbursement.(1)
The department shall reimburse an independent laboratory the current Medicare rate established by CMS:(a)
For Kentucky;(b)
For the covered service or procedure; and(c)
In accordance with 42 U.S.C. 1395l(h)(1)(A).(2)
Reimbursement for a service provided by an independent laboratory shall not exceed the limit established in 42 U.S.C. 1396b(i)(7).(3)
The department shall reimburse a Medicaid-enrolled provider licensed to provide radiological services:(a)
The provider's usual and customary charge for the service; and(b)
Not to exceed sixty (60) percent of the upper payment limit established for the procedure in the Medicaid physician fee schedule pursuant to 907 KAR 3:010.Section 5.
Provider Participation Conditions.(1)
To be reimbursed by the department for a service provided in accordance with this administrative regulation, a provider of independent laboratory services or radiological services shall:(a)
Be a Medicaid-enrolled provider;(b)
Comply with all relevant provisions of KAR Title 907;(c)
Comply with the requirements regarding the confidentiality of personal records pursuant to 42 U.S.C. 1320d-8 and 45 C.F.R. parts 160 and 164; and(d)
Annually submit documentation of:1.
Current CLIA certification to the department if the provider is an independent laboratory; and2.
A current radiological license to the department if the provider provides radiological services.(2)
A provider may bill a recipient for a service not covered by the department if the provider informed the recipient of noncoverage prior to providing the service.Section 6.
Appeal Rights.(1)
An appeal of a department decision regarding a recipient based upon an application of this administrative regulation shall be in accordance with 907 KAR 1:563.(2)
An appeal of a department decision regarding Medicaid eligibility of an individual shall be in accordance with 907 KAR 1:560.(3)
An appeal of a department decision regarding a Medicaid provider based upon an application of this administrative regulation shall be in accordance with 907 KAR 1:671.LISA D. LEE, Commissioner
ERIC C. FRIEDLANDER, Secretary
APPROVED BY AGENCY: September 30, 2024
FILED WITH LRC: October 9, 2024 at 1:30 p.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall, if requested, be held on December 23, 2024, at 9:00 a.m. using the CHFS Office of Legislative and Regulatory Affairs Zoom meeting room. The Zoom invitation will be emailed to each requestor the week prior to the scheduled hearing. Individuals interested in attending this virtual hearing shall notify this agency in writing by December 16, 2024, five (5) workdays prior to the hearing, of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who attends virtually will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on this proposed administrative regulation until December 31, 2024. Send written notification of intent to attend the public hearing or written comments on the proposed administrative regulation to the contact person. Pursuant to KRS 13A.280(8), copies of the statement of consideration and, if applicable, the amended after comments version of the administrative regulation shall be made available upon request.
CONTACT PERSON: Krista Quarles, Policy Analyst, Office of Legislative and Regulatory Affairs, 275 East Main Street 5 W-A, Frankfort, Kentucky 40621; Phone: 502-564-7476; Fax: 502-564-7091; CHFSregs@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Jonathan Scott and Krista Quarles
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation establishes the provisions relating to the coverage of and reimbursement for independent laboratory and radiological services.
(b) The necessity of this administrative regulation:
This administrative regulation is necessary to establish the provisions relating to the coverage of and reimbursement for independent laboratory and radiological services.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
This administrative regulation conforms to the content of the authorizing statutes by establishing the provisions relating to the coverage of and reimbursement for independent laboratory and radiological services.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation assists with the effective administration of the statutes by establishing the provisions relating to the coverage of and reimbursement for independent laboratory and radiological services.
(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing administrative regulation:
The amendments contain various changes to comply with 907 KAR. In addition, references to CPT codes and CPT code ranges have been removed to reflect updated capacity of the Department’s information technology systems to better assess provider eligibility to provide a service.
(b) The necessity of the amendment to this administrative regulation:
This amendment is necessary to reflect current practice and reimbursement in this healthcare area.
(c) How the amendment conforms to the content of the authorizing statutes:
This amendment conforms to the content of the authorizing statutes by establishing a more updated system of provider reimbursement for independent laboratories.
(d) How the amendment will assist in the effective administration of the statutes:
This amendment assists with the affective administration of the statutes by establishing a more updated system of provider reimbursement for independent laboratories.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
There are currently 360 independent laboratory providers in the Medicaid program.
(4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:
(a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment:
Regulated entities will not need to take any new action to comply with this amendment.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
Regulated entities will experience no new costs in complying with this administrative regulation.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
Recipients will be able to participate or continue to participate in the Medicaid program. Providers will be able to more easily bill and seek reimbursement for services rendered to Medicaid-covered individuals.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
The Department anticipates no additional costs in implementing this administrative regulation.
(b) On a continuing basis:
The Department anticipates no additional costs in implementing this administrative regulation.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
Sources of funding to be used for the implementation and enforcement of this administrative regulation are federal funds authorized under Title XIX and Title XXI of the Social Security Act, and state matching funds of general and agency appropriations.
(7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment:
Neither an increase in fees nor funding will be necessary to implement the amendments.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
The amendment does not establish or increase any fees.
(9) TIERING: Is tiering applied?
(Explain why or why not) Tiering was not appropriate in this administrative regulation because the administrative regulation applies equally to all those individuals or entities regulated by it.
FISCAL IMPACT STATEMENT
(1) Identify each state statute, federal statute, or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS 205.520, 42 C.F.R. Part 493
(2) Identify the promulgating agency and any other affected state units, parts, or divisions:
Department for Medicaid Services is the promulgating agency, other agencies have not been identified.
(a) Estimate the following for the first year:
Expenditures:
No additional expenditures beyond those allocated to the Department pursuant to 2024 House Bill 6.
Revenues:
The Department does not anticipate revenues as a result of this administrative regulation.
Cost Savings:
The Department does not anticipate cost savings as a result of this administrative regulation.
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
DMS does not expect a change to expenditures, revenues, or cost savings in subsequent years.
(3) Identify affected local entities (for example: cities, counties, fire departments, school districts):
None known.
(a) Estimate the following for the first year:
Expenditures:
n/a The Department does not anticipate additional expenditures.
Revenues:
n/a The Department does not anticipate additional revenues.
Cost Savings:
n/a The Department does not anticipate cost savings.
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
DMS does not expect additional expenditures, revenues, or cost savings for local entities as a result of this regulation.
(4) Identify additional regulated entities not listed in questions (2) or (3):
Independent laboratory providers.
(a) Estimate the following for the first year:
Expenditures:
n/a The Department does not anticipate additional expenditures.
Revenues:
n/a The Department does not anticipate additional revenues.
Cost Savings:
The Department anticipates some cost savings due to decreased administrative burden for the providers who are billing.
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
DMS expects cost savings due to decreased administrative burden on an ongoing basis.
(5) Provide a narrative to explain the:
(a) Fiscal impact of this administrative regulation:
The administrative regulation does not contain an additional fiscal impact.
(b) Methodology and resources used to determine the fiscal impact:
The policies impacting providers and facilities have not changed, as a result no fiscal impact is expected.
(6) Explain:
(a) Whether this administrative regulation will have an overall negative or adverse major economic impact to the entities identified in questions (2) - (4). ($500,000 or more, in aggregate)
: The administrative regulation will not have a major economic impact – as defined by KRS 13A.010 – on regulated entities.
(b) The methodology and resources used to reach this conclusion:
The policies impacting providers and facilities have not changed, as a result no fiscal impact is expected.
FEDERAL MANDATE ANALYSIS COMPARISON
(1) Federal statute or regulation constituting the federal mandate.
42 C.F.R. Part 493 establishes policies relating to independent laboratories in the Medicaid program.
(2) State compliance standards.
KRS 194A.030(2) requires the Department for Medicaid Services to "serve as the single state agency in the commonwealth to administer Title XIX of the Federal Social Security Act."
(3) Minimum or uniform standards contained in the federal mandate.
42 C.F.R. Part 493 establishes a comprehensive scheme of federal requirements for state Medicaid agencies related to independent laboratory services.
(4) Will this administrative regulation impose stricter requirements, or additional or different responsibilities or requirements, than those required by the federal mandate?
The amendment will not impose stricter than federal requirements.
(5) Justification for the imposition of the stricter standard, or additional or different responsibilities or requirements.
The amendment will not impose stricter than federal requirements.