Kara Daniel; Stephanie Brammer-Barnes

This administrative regulation incorporates by reference the current State Health Plan as defined by KRS 216B.015(28) and as required by KRS 216B.040(2)(a).

This administrative regulation is necessary to comply with the content of the authorizing statutes, specifically KRS 216B.010, 216B.015(28), and 216B.040(2)(a)2.a.

This administrative regulation conforms to the content of the authorizing statutes, KRS 216B.010, 216B.015(28), and 216B.040(2)(a)2.a., by establishing the State Health Plan’s review criteria used for determinations regarding the issuance and denial of certificates of need.

This administrative regulation assists in the effective administration of the statutes by establishing the review criteria for certificate of need determinations.

In response to suggestions and comments submitted to the cabinet by interested groups, the amendment to this administrative regulation makes the following changes to the State Health Plan (SHP): 1. Updates the title and edition date of the SHP on page i of the Plan; 2. Updates the Table of Contents on page ii to show deletions and revised page numbers; 3. Updates the title of the SHP on page iii of the Plan under the heading "Purpose"; 4. Adds new language to the review criteria on pages 23 and 24 to allow acute care hospitals to convert existing acute care beds to psychiatric beds for adult patients under the following conditions: a. The occupancy of acute care beds in the applicant's facility is less than seventy (70) percent according to the most recent edition of the Kentucky Annual Hospital Utilization and Services Report; i. All of the proposed psychiatric beds are being converted from licensed acute care beds; and ii. No more than twenty-five (25) acute care beds will be converted to psychiatric beds; b. All of the psychiatric beds will be implemented on-site at the applicant's existing licensed facility; and c. All of the psychiatric beds shall be dedicated exclusively to the treatment of adult patients, aged eighteen (18) to sixty-four (64); 5. Deletes outdated language on page 24 referring to tuberculosis beds. That is no longer a bed category in Kentucky 6. Adds language on page 33 to allow a long-term care pediatric facility to add fifty (50) or fewer beds if: a. It is certified under Title XVIII and XIX of the Social Security Act; b. It provides high and low intensity nursing facility services to children, including resident admitted to the facility prior to age twenty-one (21) and remain in the facility after reaching age twenty-one (21); 7. Amends language on page 35 to allow an acute care hospital, a critical access hospital, or a nursing facility to establish or expand a home health service to provide services exclusively to their patients who require home health services at the time of discharge; 8. Deletes the criteria on page 47 for megavoltage radiation, thereby making it subject to nonsubstantive review; 9. Deletes the criteria on page 52 for magnetic resonance imaging, thereby making it subject to nonsubstantive review; and 10. Amends the criteria on page 55 for ophthalmological ambulatory surgical centers to: a. Allow joint ownership by ophthalmologists with optometrists; b. Decrease the time required that the group has been practicing from 10 years to 5 years; c. Delete the requirement for a $300,000 investment in laser technology; and d. Allow the facility to be located in any county in which one of the owners is located. These changes align with the proposed amendment of 900 KAR 6:075, Section 2(3)(h) – (l), filed concurrently with this administrative regulation to grant nonsubstantive review status to certificate of need applications for: 1. Applications by licensed hospitals to convert existing acute care beds to psychiatric beds for adult patients if certain criteria are met; 2. Applications by a licensed hospital to provide megavoltage radiation therapy; 3. Applications to provide positron emission tomography services; 4. Applications to provide magnetic resonance imaging services; and 5. Applications by a licensed acute care hospital, critical access hospital, or nursing facility proposing to establish or expand a home health service to serve patients discharged from its facility.

This amendment is needed to expand health services throughout the state, including rural areas, to enhance immediate access to resources.

This amendment conforms to the content of the authorizing statutes because it incorporates by reference the State Health Plan.

This amendment assists in the effective administration of the statutes by establishing the review criteria for certificate of need determinations.

This administrative regulation affects entities that submit certificate of need applications and affected persons as defined by KRS 216B.015(3). A total of 81 applications were submitted to the cabinet in calendar year 2022; 70 certificate of need applications were submitted in calendar year 2021; and 60 certificate of need applications were submitted in calendar year 2020.

Entities that submit a certificate of need application are subject to the criteria set forth in the State Health Plan.

. The certificate of need application filing fee for nonsubstantive review and formal review is established in a separate administrative regulation, 900 KAR 6:020.

Entities subject to certificate of need approval must demonstrate that their proposal is consistent with the State Health Plan pursuant to KRS 216B.040(2)(a)2.a.

There are no additional costs to the Office of Inspector General for implementation of this amendment.

There are no additional costs to the Office of Inspector General for implementation of this amendment on a continuing basis.

State general funds and agency monies are used to implement and enforce this administrative regulation.

No increase in fees or funding is necessary to implement this amendment.

This amendment does not establish or increase any fees.

Yes, tiering is used as there are different certificate of need review criteria for each licensure category addressed in the State Health Plan.

This administrative regulation impacts the Cabinet for Health and Family Services, Office of Inspector General, and may impact any government owned or controlled health care facility.

KRS 216B.010, 216B.015(28), and 216B.040(2)(a)2.a.

This amendment will not generate additional revenue for state or local government.

This amendment will not generate additional revenue for state or local government during subsequent years.

This amendment imposes no additional costs on the administrative body.

This amendment imposes no additional costs on the administrative body during subsequent years.

See response above.

This administrative regulation is anticipated to have minimal fiscal impact to the cabinet.

This administrative regulation will not generate cost savings for regulated entities during the first year.

This administrative regulation will not generate cost savings for regulated entities during subsequent years.

This administrative regulation imposes no additional costs on regulated entities.

This administrative regulation imposes no additional costs on regulated entities during subsequent years.

"Major economic impact" means an overall negative or adverse economic impact from an administrative regulation of five hundred thousand dollars ($500,000) or more on state or local government or regulated entities, in aggregate, as determined by the promulgating administrative bodies. [KRS 13A.010(13)]. This new administrative regulation is not expected to have a major economic impact on the regulated entities.