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HEALTH FACILITIES COMMISSION JANUARY 25, 2023 APPLICATION REVIEW

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SERVICE SPECIFIC CRITERIA AND STANDARD REVIEW Home Health Services: All applicable criteria and standards were met except for the following:  Did not meet the standard of #1. Determination of Need “In a given county, 1.5 percent of the total population will be considered as the need estimate for home health services in that county. This 1.5 percent formula will be applied as a general guideline, as a means of comparison within the proposed Service Area.” This project proposes to initiate home health services in a twelve-county service area, which cumulatively show a surplus of (9,776) home health admissions according to the standard of (1.5%) of the total population of the counties included in the project service area. The three counties included in the service area which show the largest surplus are the following: Davidson County (2,844), Sumner County (1,512), and Wilson County (1,432). See Attachment 1.N.3, Home Health Services Standards and Criteria, Pages 1 -4. Note to Commission Members: The applicant cites multiple concerns with the existing home health service need formula including the following: • The need formula is not specific to the type of home health service being proposed by the applicant – home infusion therapy services, which are more complex and specialized than traditional home health services, and is therefore not accurately representative of need for the project in the service area. • The applicant states that (1.5%) rate for the service area population prescribed by the need standard is exceeded by the actual use rate if the services area in 2021 (1.9%). Please see attached for a full listing of the criteria and standards and the applicant’s responses. Service Area Demographics • The proposed service area includes Cheatham, Davidson, Dickson, Macon, Maury, Montgomery, Robertson, Rutherford, Sumner, Trousdale, Williamson, and Wilson Counties. (see Attachment 2N for a county level map). • The target population is the adult population age 65 and younger. (See Attachment 3NR for more demographic details.) 2022 Population 2026 Population % Change TennCare % Total Under 65 Total Under 65 Total Under 65 Service Area 2,215,104 1,642,287 2,346,478 1,989,983 5.9% 21.2% 19.3% Tennessee Total 6,997,493 5,743,164 7,203,404 5,826,949 2.9% 1.4% 24.4% Source: The University of Tennessee Center for Business and Economic Research Population Projection Data Files, Reassembled by the Tennessee Department of Health, Division of Policy, Planning and Assessment, Office of Health Statistics. • The proposed service area projects a 4-year growth rate () among residents aged 65 and under of (21.2%) which is higher than the statewide rate of (1.4%). The latest 2022 percentage of (19.3%) of service area residents enrolled in the TennCare program is above the (24.4%) statewide average. • The applicant identifies patients requiring anti-infectives, patients on special cardiac medications, patients who need nutritional support, patients receiving immunoglobulin (IG) therapy and patients who require specialty medication infusions as special populations that will be served by this project. See Section 4N, Pages 15-16. Note to Commission members: The applicant provides the following detail regarding the percentage of Medicare and TennCare enrolled patients who are currently served through its pharmacy and infusion centers in Tennessee: “TennCare patients are eligible for infusion therapy services, both through the pharmacy and in the infusion center, and Paragon’s existing pharmacies and infusion centers in Tennessee accept and serve TennCare patients. To date in 2022, 37.1 percent and 28.6 percent of Paragon’s patients in Tennessee were Medicare and TennCare, respectively. The balance of patients were commercial, other managed care, pharmacy benefit manager (PBM), out of network, or self-pay.” See Supplemental #1, Item 3, Page 3. • The applicant provides two (2) letters of support from area providers. Service Area- Historical Utilization (Home Health Agencies) • Utilization of all service area home health providers for the past three years () is provided by the applicant in Attachment 1N-5R. The following table is a summary of the service area home health utilization from 2019 to 2021: Total Patients 2019 2020 2021 % Change 19-21 51 Home Health Agencies Serving Patients in 12 CON Reviewable Service Area Counties 32,485 33,299 33,641 -3.56% Source: CN2210-040, Supplemental #1, Attachment 1N5R • From , the (51) combined home health agencies operating in the 12 CON reviewable service area counties reported a decrease of (-3.56%) in total home health visits (not limited to home infusion home visits) from 32,485 in 2019 to 33,641 in 2021. • The three highest volume providers in 2021 were Vanderbilt Home Care Services, LLC – ID # 19314 (4,419 visits); Adoration Home Health, LLC – ID # 19714 (4,422 visits); and Home Health Care of Middle Tennessee, LLC – ID # 19584 (2,422 visits); and Suncrest Home Health – ID #19324 (2,251 visits). • The applicant provided the following utilization data for the (12) licensed home health agencies in the twelve-county service area that provided home infusion services: Statewide Utilization of Specialty Home Infusion Providers Serving the Proposed Service Area 2021 2019 2020 2021 *CAGR ‘19-‘21 Facility Name State ID Licensed County Visits Hours Visits Hours Visits Hours Visits Hours Accredo Health Group, Inc. 79456 Shelby 79 0 174 0 586 0 95.02% NA Advanced Nursing Solutions 19754 Davidson NA NA 201 789 857 3,036 NA NA Amedisys Home Health 33103 Hamilton 0 0 0 0 1,994 0 NA NA Amedisys Home Health Care 75064 Rutherford 6 0 0 0 234 0 239.12% NA Clinch River Home Health 01032 Anderson 0 0 0 0 11 0 NA NA Coram CVS Specialty Infusion Services 19734 Davidson 662 1,563 779 2,361 1,055 2,173 16.81% 11.61% Coram CVS/Specialty Infusion Services 47442 Knox 907 1,987 997 4,677 1,163 2,540 8.64% 8.53% Covenant Homecare 47402 Knox 0 0 0 0 52 0 NA NA Implanted Pump Management, LLC 47452 Knox 278 278 315 315 218 218 -7.78% -7.78% Optum Infusion Services 79856 Shelby 247 1,235 764 6,504 1,116 2,859 65.32% 32.29% Vanderbilt HC/Option Care IV Services 19994 Davidson 881 2,328 1,337 3,877 1,243 3,662 12.16% 16.3% Maxim Healthcare Services 33433 Hamilton 23 36 0 115 17 116 -9.59% 47.7% Total 3,083 7,427 4,567 18,638 8,546 14,604 40.47% 25.28% Source: CN2210-040, Supplemental #1, Attachment 1N-9-2R *Compound Annual Growth Rate • In 2021 (12) home health agencies reported 14,604 home infusion therapy visits for either pain management or other types of infusion services. • From , the total number of infusion hours reported by home health agencies licensed in the service area increased by (96.6%) from 7,427 in 2019 to 14,604 in 2021. The reported hours are not specific to each of the 12 counties in the project service area as they are only reported on a statewide basis.

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HEALTH FACILITIES COMMISSION
JANUARY 25, 2023
APPLICATION REVIEW
NAME OF PROJECT: CareMax Pharmacy of Loudon, Inc. (Middle)

PROJECT NUMBER: CN2210-040

ADDRESS: 601 Grassmere Park, Suite 19A
Nashville (Davidson County), TN 37211

LEGAL OWNER: CareMax Pharmacy of Loudon, Inc.
601 Grassmere Park, Suite 19A
Nashville (Davidson County), TN 37211

OPERATING ENTITY: N/A

CONTACT PERSON: Daniel Carter, Ascendient Healthcare Advisors
(919) 226-1705

DATE FILED: October 31, 2022

PROJECT COST: $155,000

PURPOSE FOR FILING: Establishment of a home care organization and the initiation of
home health services.



Staff Review

Note to Commission members: This staff review is an analysis of the statutory criteria
of Need, Consumer Advantage Attributed to Competition, and Quality Standards,
including data verification of the original application and, if applicable, supplemental
responses submitted by the applicant. Any Health Facilities Commission Staff
comments will be presented as a "Note to Commission members" in bold italic.

PROJECT DESCRIPTION:



CAREMAX PHARMACY OF LOUDON, INC. (MIDDLE) CN2210-040
JANUARY 25, 2023
PAGE | 1

, 2
This application is for the establishment of a home care organization to initiate and
provide home health services limited to infusion services. The 12-county service area
counties include Cheatham, Davidson, Dickson, Macon, Maury, Montgomery, Robertson,
Rutherford, Sumner, Trousdale, Williamson and Wilson Counties. The new home health
organization’s office will be located at 601 Grassmere Park, Suite 19A, Nashville
(Davidson County), Tennessee 37211.
Executive Summary
• If approved, the applicant projects the proposed project will open for service in
March 2023.
• The applicant is proposing to establish a home health agency limited to home
infusion services in Middle Tennessee to serve patients of its existing pharmacy
and infusion center businesses based in Nashville (Davidson County) and
Hendersonville (Sumner County) Tennessee.
• The applicant’s affiliates currently provide pharmacy-related services, including
outpatient infusion centers, specialty pharmacy, and home infusion therapy in 9
states including Tennessee. The applicant states that its affiliated entities have
experienced difficulty in meeting the in-home infusion therapy needs of patients in
the service area for specific types of infusion services including anti-infectives,
cardiac medications, nutritional support, immunoglobulin (IG), and specialty
medications. This is due to the inability of existing home health providers to
deliver these type of services because of limitations related to staff availability and
payer source considerations. The applicant will not provide
oncology/chemotherapy infusions in the home.
• Please see application Item 1E. on page 7 for the applicant’s executive summary
overview that includes project description, ownership, service area, existing similar
service providers, project cost, and staffing.

Note to Commission Members: The applicant has also filed a pending home health
infusion therapy companion application, CareMax of Pharmacy of Loudon, Inc. (East),
CN2210-039 which will also be heard at the January 25, 2023 Commission Meeting. The
applicant’s home office will be located will be located at 418 South Gay Street, Suite 203,
Knoxville (Knox County), TN 37902. The proposed service area includes Anderson,
Bledsoe, Blount, Bradley, Campbell, Claiborne, Cocke, Cumberland, Fentress, Grainger,
Hamblen, Hamilton, Jefferson, Knox, Loudon, Marion, McMinn, Meigs, Monroe, Rhea,
Roane, Sequatchie, Sevier and Union Counties.


Consent Calendar: □ Yes √ No
• Executive Director’s Consent Memo Attached: □ Yes √ Not applicable

Facility Information


CAREMAX PHARMACY OF LOUDON, INC. (MIDDLE) CN2210-040
JANUARY 25, 2023
PAGE | 2

, 3
• The 184 square foot project office site will be a home health nursing office colocated
with the Paragon Healthcare Nashville pharmacy office. The property is being sub-
leased to the applicant, CareMax Pharmacy of Loudon, Inc., through its owner,
Paragon Healthcare, Inc. through the landlord, EP Grassmere LLC, for an initial
seven-year term beginning July 1, 2021. See Attachment 9.A. Lease Agreement and
Sub-Lease Agreement.
• The applicant is not proposing to establish any branch offices.
Ownership
• The applicant, is owned by Pathwrite, Inc., which is owned by Paragon Healthcare,
Inc., which is owned by PHI Parent, LLC, which is ultimately owned by PHI Topco,
LLC.

Project Cost Chart
• The total project cost is $155,000. Of this amount, the highest line-item costs of the
project are Legal, Administrative, Consultant Fees Costs ($125,000), and Facility
Lease Costs ($23,000).
• Please see the Project Cost Chart on page 11 of the application.

NEED
The applicant provided the following supporting the need for the proposed project:
• The inability of the applicant to service its patient base through referrals to
traditional home health agencies to serve home infusion therapy patients due to
limitations with staff experience and training.
• The existing patient base of the applicant includes individuals who have recently
been discharged from an acute care setting and are unable to receive home based
infusion services in a timely fashion.
• The availability of home infusion services will reduce or eliminate travel time and
expenses for patients who require infusion services.
• The applicant cites the fact that traditional home health agencies are often not
reimbursed for the nursing services associated with home infusion services at a
level that covers the cost of care and are therefore not willing to deliver these types
of specialized services.

(For applicant discussion, see the Original Application, Page 9)

SERVICE SPECIFIC CRITERIA AND STANDARD REVIEW

Home Health Services:
All applicable criteria and standards were met except for the following:



CAREMAX PHARMACY OF LOUDON, INC. (MIDDLE) CN2210-040
JANUARY 25, 2023
PAGE | 3

, 4
 Did not meet the standard of #1. Determination of Need “In a given county, 1.5
percent of the total population will be considered as the need estimate for home
health services in that county. This 1.5 percent formula will be applied as a
general guideline, as a means of comparison within the proposed Service Area.”
This project proposes to initiate home health services in a twelve-county service area, which
cumulatively show a surplus of (9,776) home health admissions according to the standard of
(1.5%) of the total population of the counties included in the project service area. The three
counties included in the service area which show the largest surplus are the following:
Davidson County (2,844), Sumner County (1,512), and Wilson County (1,432). See
Attachment 1.N.3, Home Health Services Standards and Criteria, Pages 1 -4.

Note to Commission Members: The applicant cites multiple concerns with the existing
home health service need formula including the following:
• The need formula is not specific to the type of home health service being proposed
by the applicant – home infusion therapy services, which are more complex and
specialized than traditional home health services, and is therefore not accurately
representative of need for the project in the service area.
• The applicant states that (1.5%) rate for the service area population prescribed by
the need standard is exceeded by the actual use rate if the services area in 2021
(1.9%).

Please see attached for a full listing of the criteria and standards and the applicant’s
responses.

Service Area Demographics
• The proposed service area includes Cheatham, Davidson, Dickson, Macon, Maury,
Montgomery, Robertson, Rutherford, Sumner, Trousdale, Williamson, and Wilson
Counties. (see Attachment 2N for a county level map).
• The target population is the adult population age 65 and younger. (See Attachment
3NR for more demographic details.)

2022 Population 2026 Population % Change TennCare
Total Under 65 Total Under 65 Total Under %
65
Service Area 2,215,104 1,642,287 2,346,478 1,989,983 5.9% 21.2% 19.3%
Tennessee Total 6,997,493 5,743,164 7,203,404 5,826,949 2.9% 1.4% 24.4%
Source: The University of Tennessee Center for Business and Economic Research Population Projection Data Files, Reassembled by the Tennessee
Department of Health, Division of Policy, Planning and Assessment, Office of Health Statistics.



• The proposed service area projects a 4-year growth rate (2022-2026) among
residents aged 65 and under of (21.2%) which is higher than the statewide rate of


CAREMAX PHARMACY OF LOUDON, INC. (MIDDLE) CN2210-040
JANUARY 25, 2023
PAGE | 4

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