STATEMENT OF EMERGENCY

907 KAR 3:206E

 

      This emergency administrative regulation is being promulgated to repeal 907 KAR 3:205, Hemophilia Treatment Reimbursement and Coverage Via the 340B Drug Pricing Program, because its provisions are being established in a new chapter, 907 KAR Chapter 23. This emergency repealer is needed to avoid confusion that would result from having multiple administrative regulations covering the same subject matter in effect simultaneously. The new administrative regulations in 907 KAR Chapter 23 are being promulgated as emergency administrative regulations pursuant to KRS 13A.190(1)(a)2. and 3., to prevent a loss of federal funds and to meet a deadline for promulgation established by federal law. By extension, those same justifications apply to this emergency repealer. This emergency administrative regulation will not be replaced by an ordinary administrative regulation because, pursuant to KRS 13A.190(2), it will be effective upon filing with the regulations compiler. Once 907 KAR 3:205 is repealed by this emergency administrative regulation, it will no longer exist and, therefore, cannot be repealed by a subsequent ordinary administrative regulation.

 

MATTHEW G. BEVIN, Governor

VICKIE YATES BROWN GLISSON, Secretary

 

CABINET FOR HEALTH AND FAMILY SERVICES

Department for Medicaid Services

Division of Policy and Operations

(Emergency Repealer)

 

      907 KAR 3:206E. Repeal of 907 KAR 3:205.

 

      RELATES TO: 42 U.S.C. 256b; 42 U.S.C. 701(a)(2)

      STATUTORY AUTHORITY: KRS 194A.030(2), 194A.050(1), 205.520(3)

      EFFECTIVE: March 31, 2017

      NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Health and Family Services, Department for Medicaid Services has responsibility to administer the Medicaid Program. KRS 205.520(3) authorizes the cabinet, by administrative regulation, to comply with any requirement that may be imposed or opportunity presented by federal law to qualify for federal Medicaid funds. This administrative regulations repeals 907 KAR 3:205 because its subject matter is now covered by 907 KAR Chapter 23.

 

      Section 1. 907 KAR 3:205, Hemophilia Treatment Reimbursement and Coverage Via the 340B Drug Pricing Program, is hereby repealed.

 

STEPHEN P. MILLER, Commissioner

VICKIE YATES BROWN GLISSON, Secretary

      APPROVED BY AGENCY: March 28, 2017

      FILED WITH LRC: March 31, 2017 at 2 p.m.

      PUBLIC HEARING AND PUBLIC COMMENT PERIOD: A public hearing on this administrative regulation shall, if requested, be held on May 22, 2017 at 9:00 a.m. in Suites A & B of the Health Services Auditorium, Health Services Building, First Floor, 275 East Main Street, Frankfort, Kentucky 40621. Individuals interested in attending this hearing shall notify this agency in writing May 15, 2017, 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. The hearing is open to the public. Any person who attends 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 attend the public hearing, you may submit written comments on the proposed administrative regulation. You may submit written comments regarding this proposed administrative regulation until May 31, 2017. Send written notification of intent to attend the public hearing or written comments on the proposed administrative regulation to:

      CONTACT PERSON: Tricia Orme, Administrative Specialist, Office of Legal Services, 275 East Main Street 5 W-B, Frankfort, Kentucky 40601, phone (502) 564-7905, fax (502) 564-7573, email tricia.orme@ky.gov.

 

REGULATORY IMPACT ANALYSIS And Tiering Statement

 

Contact Person: Donna Little, (502) 564-4321, extension 2015; donna.little@ky.gov, or Tricia Orme

      (1) Provide a brief summary of:

      (a) What this administrative regulation does: This emergency administrative regulation repeals 907 KAR 3:205, Hemophilia Treatment Reimbursement and Coverage Via the 340B Drug Pricing Program, because its provisions are being established in a new chapter, 907 KAR Chapter 23. This emergency repealer is needed to avoid confusion that would result from having multiple administrative regulations covering the same subject matter in effect simultaneously.

      (b) The necessity of this administrative regulation: This administrative regulation is necessary to repeal an existing administrative regulation because its provisions are being established in a new chapter, 907 KAR Chapter 23. The repeal is necessary to avoid confusion from having multiple administrative regulations covering the same subject matter in effect simultaneously.

      (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 repealing an administrative regulation in accordance with KRS 13A.310.

      (d) How this administrative regulation currently assists or will assist in the effective administration of the statutes: The repeal of the administrative regulation will avoid confusion that would result from having multiple administrative regulations covering the same subject matter in effect simultaneously.

      (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: This is a new administrative regulation.

      (b) The necessity of the amendment to this administrative regulation: This is a new administrative regulation.

      (c) How the amendment conforms to the content of the authorizing statutes: This is a new administrative regulation.

      (d) How the amendment will assist in the effective administration of the statutes: This is a new administrative regulation.

      (3) List the type and number of individuals, businesses, organizations, or state and local government affected by this administrative regulation: All participating pharmacy providers dispensing covered drugs (approximately 1,500) and all participating medical providers administering covered drugs (approximately 43,400) will be affected by the administrative regulation.

      (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: In order to be reimbursed by the DMS, participating providers will have to submit pharmacy or medical claims for covered outpatient drugs in accordance with the new administrative regulations promulgated in 907 KAR Chapter 23, rather than by using the administrative regulation being repealed by this repealer administrative regulation.

      (b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3): There will be no additional costs experienced by affected providers.

      (c) As a result of compliance, what benefits will accrue to the entities identified in question (3): By complying with the new administrative regulations promulgated in 907 KAR Chapter 23, applicable providers will benefit by receiving a true drug ingredient cost based reimbursement along with a professional dispensing fee from DMS for dispensing covered outpatient drugs to Medicaid recipients who are not enrolled with a managed care organization. The benefit to this repealer administrative regulation is that there will not be multiple administrative regulations covering the same subject matter simultaneously.

      (5) Provide an estimate of how much it will cost to implement this administrative regulation:

      (a) Initially: There are no costs to this repeal.

      (b) On a continuing basis: Please see (5)(a) above

      (6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation: There is no source of funding needed to implement this repeal.

      (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 is necessary to implement this repeal.

      (8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees: This administrative regulation neither establishes nor increases any fees.

      (9) Tiering: Is tiering applied? Tiering was not appropriate in this administrative regulation because the administration regulation simply repeals an administrative regulation.

 

FISCAL NOTE ON STATE OR LOCAL GOVERNMENT

 

      1. What units, parts or divisions of state or local government (including cities, counties, fire departments, or school districts) will be impacted by this administrative regulation? DMS will be affected by this administrative regulation.

      2. Identify each state or federal regulation that requires or authorizes the action taken by the administrative regulation. 42 U.S.C. 256b; 42 U.S.C. 701(a)(2)

      3. Estimate the effect of this administrative regulation on the expenditures and revenues of a state or local government agency (including cities, counties, fire departments, or school districts) for the first full year the administrative regulation is to be in effect.

      (a) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for the first year? This administrative regulation is not expected to generate revenue for state or local government.

      (b) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for subsequent years? This administrative regulation is not expected to generate revenue for state or local government.

      (c) How much will it cost to administer this program for the first year? This administrative regulation is not expected to have any costs for its administration.

      (d) How much will it cost to administer this program for subsequent years? Please see 3.(c) above.

      Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.

      Revenues (+/-):

      Expenditures (+/-):

      Other Explanation:

 

FEDERAL MANDATE ANALYSIS COMPARISON

 

      1. Federal statute or regulation constituting the federal mandate. Medicaid Program; Covered Outpatient Drugs; Final Rule (CMS-2345-FC) amending 42 C.F.R. Part 447 (the CMS COD Final Rule).

      2. State compliance standards. KRS 205.520(3) states: "Further, it is the policy of the Commonwealth to take advantage of all federal funds that may be available for medical assistance. To qualify for federal funds the secretary for health and family services may by regulation comply with any requirement that may be imposed or opportunity that may be presented by federal law. Nothing in KRS 205.510 to 205.630 is intended to limit the secretary's power in this respect." The CMS COD Final Rule mandates that the Medicaid Program revise its reimbursement methodology for outpatient drugs dispensed or administered to Medicaid recipients who are not enrolled with a managed care organization. Those revisions have been promulgated in 907 KAR Chapter 23, at the same time as this emergency repealer. To avoid having multiple administrative regulations covering the same subject matter simultaneously, this administrative regulation repeals 907 KAR 3:205.

      3. Minimum or uniform standards contained in the federal mandate. 42 U.S.C. 1396a(a)(10)(B) requires the Medicaid Program to ensure that services are available to Medicaid recipients in the same amount, duration, and scope as available to other individuals (non-Medicaid). Revising reimbursement methodology for outpatient drugs (in 907 KAR Chapter 23) dispensed or administered to Medicaid recipients who are not enrolled with a managed care organization will not change compliance standards.

      4. Will this administrative regulation impose stricter requirements, or additional or different responsibilities or requirements, than those required by the federal mandate? This administrative regulation does not impose stricter or different responsibilities than the federal requirements.

      5. Justification for the imposition of the stricter standard, or additional or different responsibilities or requirements. The administrative regulation does not impose stricter or different responsibilities than the federal requirements.