Mod 6 Steps:
INSTRUCTIONS:
1.
Read Chapter 2 (p. 89-90) in our textbook, Legal and Ethical Issues for Health Professionals by George D. Pozgar (5th Edition).
2.
Experience the Simulation and Complete Your Role by Answering the Questions in a Word Document: Watch the Jones & Bartlett LearnScapes for Health Care Ethics episode: “
Confidentiality”
You do not need to answer the questions asked at the end of the simulation or submit your recommendation in an email. You will need to answer the questions I give you (see Step 3 instructions below).
3.
Read the Assignment and Instructions for the Mock CON Application and Presentation Project and be prepared to discuss and ask questions in preparation for completing the assignment.
4.
Complete Written Assignment #6: Mock CON Application and Presentation. This written assignment is your ticket to participate in class. See the instructions, forms, and resource links for this project in the link below. You cannot participate in class if you do not complete it and turn it in by the due date and time and earn at least a passing grade.
After class, your written assignment (both the CON application and Power Point slides) is considered together with your class presentation for your Final Advocacy Project grade.
This module is dedicated to the final simulation and essay exam. If you have any questions, contact me directly.
At the conclusion of this module, you should be able to:
· Experience the simulation and appraise the ethical dilemma.
· Demonstrate understanding of knowledge gained throughout the course from readings, discussions, and activities.
· Formulate your own recommendation to resolve the dilemma synthesizing multiple stakeholder perspectives, legal concerns, guiding values and fair process principles.
· Apply original, critical thinking and research skills to identify and document a need for health care services and/or facilities in the community, within the parameters of the certificate of need program in Tennessee.
· Prepare an abbreviated mock CON application using the official forms and applying the official criteria and standards of the Tennessee Health Services and Development Agency.
· Prepare a PowerPoint slide deck and make a presentation of the CON application you have prepared, advocating for the approval of the CON. Persuasively articulate your project to our class in a mock CON presentation and explain how the project meets the State’s criteria for CON approval.
These outcomes correspond to the following course objectives as stated in your syllabus:
· Identify a variety of key legal responsibilities, civil and criminal liability, perspectives and rights of major stakeholders, including selected healthcare organizations, providers, and patients, in the U.S. healthcare system.
· Evaluate and debate resolutions to current healthcare legal issues and ethical dilemmas by applying ethical and legal frameworks and reasoning.
· Creatively formulate and persuasively communicate your strategic recommendations to solve pressing health care problems with ethical and legal solutions.
Book: https://books.google.com/books?hl=en&lr=&id=j7J5DwAAQBAJ&oi=fnd&pg=PP1&dq=Legal+and+Ethical+Issues+for+Health+Professionals&ots=vMqsTnjhzu&sig=v_eGtmtjpSj1LUQwkxVISxwC79U#v=onepage&q=Legal%20and%20Ethical%20Issues%20for%20Health%20Professionals&f=false
BLAW 6500 MOCK CON APPLICIATON AND PRESENTATION
I. SCOPE OF THE ASSIGNMENT
1. Choose one of the following types of heath care facilities, the establishment of which requires a CON under Tennessee law, to be the subject of your CON application:
· Hospital
· Nursing Home
· Ambulatory Surgical Treatment Center (“ASTC”)
· Outpatient Diagnostic Center (“ODC”)
2. Choose one of the following counties in which you will propose to locate the new facility:
· Davidson County
· Rutherford County
· Williamson County
· Wilson County
Your choice of county might be influenced by the number of that type of facility already existing in the county. Please see the References and Resources document for sources you can check to determine that.
3. Prepare a Mock CON Application for your chosen facility and county in accordance with the instructions below, using the Mock CON Application form provided. You are not expected to know all the nuances of the law and regulations, and all of the many data sources needed to accurately and fully prepare a CON application. I am looking for you to demonstrate to me you are thinking logically about a balance of (a) allocation of limited health care resources and (b) consumer needs — within the context and parameters of the Tennessee CON program.
4. Your CON application must cite data or information you obtained from at least 3 of the sources identified in the References and Resources document.
5. Prepare a Power Point presentation of your CON application (please see the instructions below).
II. INSTRUCTIONS FOR THE MOCK CON APPLICATION:
1. This is a very abbreviated version of the full CON application form. Many questions have been left out, and those questions which are included retain their original numbering as they are in the full application (thus the gaps in question numbers). If you are interested you can take a look at the complete official CON application form on the HSDA website (a link is included on the References and Resources document for this assignment).
2. Some of the questions on the abbreviated form are marked “N/A.” This means you
do not have to respond to those questions. These questions are left in the form because they are important in getting a better understanding of the scope and goals of the CON process, but the responses called for are beyond the scope of your assignment.
3. A few of the “N/A” questions are followed by a
Question in italics
. These are questions I have inserted into the application form, and a response from you is required.
4. The applicant for your mock CON application should be a hypothetical provider. Please do not use the name of an actual hospital or other provider. As far as addresses and those types of
non-substantive things – just make something up.
5. The References and Resources document has the links to publicly available data sources which should be useful to you. Data or other information from at least three of these sources must be used and cited in your Mock CON Application You are free to use other resources and authorities, but you need to cite the source in the document after the data is used.
6. You may look at other CON applications which have been filed and are on the HSDA website, but keep in mind that any application filed before October 1, 2021 was governed by a since-replaced law, and those pre-October 1 applications utilized an application form different from the one in use today. If you use language from an existing application you must appropriately cite it – no plagiarism!
III. INSTRUCTIONS FOR THE POWER POINT PRESNTATION
1. You must use Microsoft Power Point to create the slides for your presentation.
2. Your presentation must not exceed 5 minutes in duration. You should not include anything in the slides that is not at least referenced in your CON application.
3. Assume you are making this presentation to members of the Tennessee Heath Services and Development Agency (“HSDA”), who know all about the CON program. Don’t waste time talking about what CON covers and doesn’t cover, the reasons for CON, or that kind of thing. Concentrate on your project and why it should be approved.
4. In an actual application situation, the HSDA would have a copy of your full application so you don’t have to put everything that is in the application in the slide deck. Choose a few points you think are the strongest and concentrate on them in the slides and in your presentaion.
The purpose of this assignment is to learn something regarding government regulation and “allotment” of health care resources, and to help you develop advocacy skills. I hope you can also have some fun with this! Good luck!
Adjunct Professor Taylor
State of Tennessee
Health Facilities Commission
Andrew Jackson Building, 9th Floor, 50
2
Deaderick Street, Nashville, TN
3
72
4
3
www.tn.gov/hsda Phone: 6
1
5-741-2364 Email: hsda.staff@tn.gov
CERTIFICATE OF NEED APPLICATION
1
A.
Name of Facility, Agency, or Institution
(Students – put the name of your hypothetical health care facility or service)
Name |
||||||||
Street or Route |
County |
|||||||
City |
State |
Zip |
||||||
Website Address |
Note: The facility’s name and address
must be
the name and address of the project and
must be
consistent with the Publication of Intent.
2A.
Contact Person Available for Responses to Questions
(Students – your name goes here).
Title |
||
Company Name |
Email Address |
|
Association with Owner |
Phone Number |
3A.
Proof of Publication – N/A
Attach the full page of newspaper in which the notice of intent appeared with the mast and dateline intact or submit a publication affidavit from the newspaper that includes a copy of the publication as proof of the publication of the letter of intent. (Attachment 3A)
Date LOI was Submitted:
Date LOI was Published:
4A.
Purpose of Review
(Check appropriate box(es) – more than one response may apply)
Establish New Health Care Institution
Addition of a Specialty to an Ambulatory Surgical Treatment Center (ASTC)
Change in Bed Complement
Initiation of Health Care Service as Defined in §TCA 68-11-1607(3) Specify: _____
Relocation
Initiation of MRI Service
MRI Unit Increase
Satellite Emergency Department
Addition of ASTC Specialty
Initiation of Cardiac Catheterization
Addition of Therapeutic Catheterization
Establishment of a Non-Residential Substitution Based Opioid Treatment Center
Linear Accelerator Service
Positron Emission Tomography (PET) Service
Please answer all questions on letter size, white paper, clearly typed and spaced, single sided, in order and sequentially numbered. In answering, please type the question and the response. All questions must be answered. If an item does not apply, please indicate “N/A” (not applicable). Attach appropriate documentation as an Appendix at the end of the application and reference the applicable item Number on the attachment, i.e. Attachment 1A, 2A, etc. The last page of the application should be a completed signed and notarized affidavit.
5A.
Type of Institution
(Check all appropriate boxes – more than one response may apply)
Hospital (Specify):
Ambulatory Surgical Treatment Center (ASTC) – Multi-Specialty
Ambulatory Surgical Treatment Center (ASTC) – Single Specialty
Home Health
Hospice
Intellectual Disability Institutional Habilitation Facility (ICF/IID)
Nursing Home
Outpatient Diagnostic Center
Rehabilitation Facility
Residential Hospice
Nonresidential Substitution Based Treatment Center of Opiate Addiction
Other (Specify):
6A.
Name of Owner of the Facility, Agency, or Institution – N/A
EXECUTIVE SUMMARY
1
E.
Overview
Please provide an overview not to exceed
ONE PAGE (for 1E only) in total explaining each item point below.
·
Description: Address the establishment of a health care institution, initiation of health services, and/or bed complement changes.
RESPONSE:
·
Ownership structure – N/A
·
Service Area (Counties in which you expect most of the patients will reside). N/A
RESPONSE:
·
Existing similar service providers in the county you propose to serve
RESPONSE:
·
Project Cost — N/A
·
Staffing – N/A
2E.
Rationale for Approval
A Certificate of Need can only be granted when a project is necessary to provide needed health care in the area to be served, will provide health care that meets appropriate quality standards, and the effects attributed to competition or duplication would be positive for consumers
Provide a brief description not to exceed
ONE PAGE (for 2E only)
of how the project meets the criteria necessary for granting a CON using the data and information points provided in criteria sections that follow.
·
Need
RESPONSE:
·
Quality Standards
RESPONSE:
·
Consumer Advantage
·
Choice
·
Improved access/availability to health care service(s)
·
Affordability
RESPONSE:
3E.
Consent Calendar Justification – N/A
Consent Calendar Requested (Attach rationale)
If Consent Calendar is requested, please attach the rationale for an expedited review in terms of Need, Quality Standards, and Consumer Advantage as a written communication to the Agency’s Executive Director at the time the application is filed.
Consent Calendar
NOT
Requested
4E.
PROJECT COST CHART — N/A
A. |
Construction and equipment acquired by purchase: |
|||||||||||||||||||||||
1. |
Architectural and Engineering Fees |
________
__________ |
||||||||||||||||||||||
2. |
Legal, Administrative (Excluding CON Filing Fee ), Consultant Fees |
|||||||||||||||||||||||
3. |
Acquisition of Site |
|||||||||||||||||||||||
4. |
Preparation of Site |
|||||||||||||||||||||||
5. |
Total Construction Costs |
|||||||||||||||||||||||
6. |
Contingency Fund |
|||||||||||||||||||||||
7. |
Fixed Equipment (Not included in Construction Contract) |
|||||||||||||||||||||||
8. |
Moveable Equipment (List all equipment over $50,000 as separate attachments) |
|||||||||||||||||||||||
9. |
Other (Specify) __________________________ _ |
|||||||||||||||||||||||
B. |
Acquisition by gift, donation, or lease: |
|||||||||||||||||||||||
Facility (inclusive of building and land) |
||||||||||||||||||||||||
Building only |
||||||||||||||||||||||||
Land only |
||||||||||||||||||||||||
Equipment (Specify)______________________ |
||||||||||||||||||||||||
Other (Specify) __________________________ | ||||||||||||||||||||||||
C. |
Financing Costs and Fees: |
|||||||||||||||||||||||
Interim Financing |
||||||||||||||||||||||||
Underwriting Costs |
||||||||||||||||||||||||
Reserve for One Year’s Debt Service |
||||||||||||||||||||||||
D. |
Estimated Project Cost (A+B+C) |
__________________ |
||||||||||||||||||||||
E. | CON Filing Fee | |||||||||||||||||||||||
F. |
Total Estimated Project Cost (D+E) |
__________________ |
GENERAL CRITERIA FOR CERTIFICATE OF NEED
In accordance with TCA §68-11-1609(b), “no Certificate of Need shall be granted unless the action proposed in the application for such Certificate is necessary to provide needed health care in the area to be served, will provide health care that meets appropriate quality standards, and the effect attributed to completion or duplication would be positive for consumers.” In making determinations, the Agency uses as guidelines the goals, objectives, criteria, and standards adopted to guide the agency in issuing certificates of need. Until the agency adopts its own criteria and standards by rule, those in the state health plan apply. Link to Criteria and Standards: Standards:
https://www.tn.gov/hsda/hsda-criteria-and-standards.html
Additional criteria for review are prescribed in Chapter 11 of the Agency Rules, Tennessee Rules and Regulations 01730-11.
The following questions are listed according to the three criteria: (1) Need, (2) the effects attributed to competition or duplication would be positive for consumers (Consumer Advantage), and (3) Quality Standards.
NEED
The responses to this section of the application will help determine whether the project will provide needed health care facilities or services in the area to be served.
1N. Provide responses as an attachment to the applicable criteria and standards for the
type of institution or service requested. A word version and pdf version for each reviewable type of institution or service are located at the following website.
https://www.tn.gov/hsda/hsda-criteria-and-standards.html.
RESPONSE:
[Students – You do not have to respond to the Criteria and Standards. However, you must attach a copy of the Criteria and Standards which would be applicable to your type of project (hospital, nursing home, etc. from the website – link is provided in the paragraph above) to show me you went to the website and chose the correct set of criteria.
]
2N. Identify the proposed service area and provide justification for its reasonableness. Submit a county level map for the Tennessee portion and counties boarding the state of the service area using the supplemental map, clearly marked, and shaded to reflect the service area as it relates to meeting the requirements for CON criteria and standards that may apply to the project. Please include a discussion of the inclusion of counties in the border states, if applicable. (Attachment 2N). N/A
Complete the following utilization tables for each county in the service area, if applicable. N/A
Service Area Counties |
Projected Utilization-County Residents to be Served – Year 1 (Year=__________) |
% of Total |
||
County #1 |
||||
County #2 |
||||
County #3 |
||||
Etc. |
||||
Total |
100% |
4N. Describe the special needs of the service area population, including health disparities, the accessibility to consumers, particularly those who are uninsured or underinsured, the elderly, women, racial and ethnic minorities, TennCare or Medicaid recipients, and low income groups. Document how the business plans of the facility will take into consideration the special needs of the service area population.
RESPONSE:
CONSUMER ADVANTAGE ATTRIBUTED TO COMPETITION
The responses to this section of the application helps determine whether the effects attributed to competition or duplication would be positive for consumers within the service area.
1C. List all transfer agreements relevant to the proposed project. N/A
2C. List all commercial private insurance plans contracted or plan to be contracted by the applicant. N/A
3C. Describe the effects of competition and/or duplication of the proposal on the health care system, including the impact upon consumer charges and consumer choice of services.
RESPONSE:
6C. See
INSTRUCTIONS to assist in completing the following tables. N/A
HISTORICAL DATA CHART — N/A |
□ Project Only □ Total Facility |
||||||||||||||||||
Give information for the last |
|||||||||||||||||||
Year___ _ _ |
|||||||||||||||||||
Utilization Data Specify Unit of Measure _______________ |
________ |
________ |
|||||||||||||||||
Revenue from Services to Patients |
|||||||||||||||||||
Inpatient Services |
$________ |
||||||||||||||||||
Outpatient Services |
|||||||||||||||||||
Emergency Services |
|||||||||||||||||||
Other Operating Revenue (Specify)_____________ _______ |
|||||||||||||||||||
Gross Operating Revenue |
|||||||||||||||||||
Deductions from Gross Operating Revenue |
|||||||||||||||||||
Contractual Adjustments |
|||||||||||||||||||
Provision for Charity Care |
|||||||||||||||||||
Provisions for Bad Debt |
|||||||||||||||||||
Total Deductions |
|||||||||||||||||||
NET OPERATING REVENUE |
PROJECTED DATA CHART — N/A |
|||||||||||
Give information for the two (2) years following the completion of this proposal. |
|||||||||||
Year______ |
|||||||||||
__________ | |||||||||||
1 |
$__________ |
||||||||||
2 | |||||||||||
3 | |||||||||||
4 | Other Operating Revenue (Specify)_____________ | ||||||||||
$__________ |
|||||||||||
7C. Please identify the project’s average gross charge, average deduction from operating revenue, and average net charge using information from the Historical and Projected Data Charts of the proposed project. N/A
Project Only Chart N/A
Previous Year to Most Recent Year Year ____ |
Most Recent Year Year____ |
Year One Year___ |
Year Two Year____ |
% Change (Current Year to Year 2) |
Gross Charge |
||||
Deduction from Revenue |
||||
Average Net Charge |
8C. Provide the proposed charges for the project and discuss any adjustment to current charges that will result from the implementation of the proposal. Additionally, describe the anticipated revenue from the project and the impact on existing patient charges.
N/A
9C. Compare the proposed project charges to those of similar facilities/services in the service area/adjoining services areas, or to proposed charges of recently approved Certificates of Need. If applicable, compare the proposed charges of the project to the current Medicare allowable fee schedule by common procedure terminology (CPT) code(s).
N/A
Question:
Questions 6C-9C examine charges to consumers. Please explain why you think health care providers “charges” are important, in light of the fact insurance companies pay much of those charges.
RESPONSE:
10C. Discuss the project’s participation in state and federal revenue programs, including a description of the extent to which Medicare,
TennCare/Medicaid
, and medically indigent patients will be served by the project. Report the estimated gross operating revenue dollar amount and percentage of project gross operating revenue anticipated by payor classification for the first year of the project by completing the table below.
N/A
Applicant’s Projected Payor Mix N/A
Payor Source |
Year 1 |
Year 2 |
Medicare/Medicare Managed Care |
||
TennCare/Medicaid | ||
Commercial/Other Managed Care |
||
Self-Pay |
||
Other (Specify)________________ |
||
Total* |
||
Charity Care |
*Needs to match Gross Operating Revenue Year One and Year Two on Projected Data Chart
Question:
Why is the Payor Mix important? What state interests are at stake here?
RESPONSE:
QUALITY STANDARDS
1Q. Per PC 1043, Acts of 2016, any receiving a CON after July 1, 2016, must report annually using forms prescribed by the Agency concerning appropriate quality measures. Please attest that the applicant will submit an annual Quality Measure report when due. –
N/A
RESPONSE:
2Q. The proposal shall provide health care that meets appropriate quality standards. Please address each of the following questions. – All of the following questions are
N/A
· Does the applicant commit to maintaining the staffing comparable to the staffing chart presented in its CON application?
· Does the applicant commit to obtaining and maintaining all applicable state licenses in good standing?
· Does the applicant commit to obtaining and maintaining TennCare and Medicare certification(s), if participation in such programs are indicated in the application?
RESPONSE:
7Q. Respond to all of the following and for such occurrences, identify, explain, and provide documentation if occurred in last five (5) years. – All the following questions are
N/A
Has any of the following:
· Any person(s) or entity with more than 5% ownership (direct or indirect) in the applicant (to include any entity in the chain of ownership for applicant);
· Any entity in which any person(s) or entity with more than 5% ownership (direct or indirect) in the applicant (to include any entity in the chain of ownership for applicant) has an ownership interest of more than 5%; and/or
Been subject to any of the following:
· Final Order or Judgement in a state licensure action;
· Criminal fines in cases involving a Federal or State health care offense;
· Civil monetary penalties in cases involving a Federal or State health care offense;
· Administrative monetary penalties in cases involving a Federal or State health care offense;
· Agreement to pay civil or administrative monetary penalties to the federal government or any state in cases involving claims related to the provision of health care items and services;
· Suspension or termination of participation in Medicare or TennCare/Medicaid programs; and/or
· Is presently subject of/to an investigation, or party in any regulatory or criminal action of which you are aware.
Question:
Assuming all the sanctions or disciplinary actions listed above are under the authority of a federal agency and/or a state agency
other than HFC (which is the case), why is this question included in the CON application?
RESPONSE:
DEVELOPMENT SCHEDULE – N/A
TCA §68-11-1609(c) provides that activity authorized by a Certificate of Need is valid for a period not to exceed three (3) years (for hospital and nursing home projects) or two (2) years (for all other projects) from the date of its issuance and after such time authorization expires; provided, that the Agency may, in granting the Certificate of Need, allow longer periods of validity for Certificate of Need for good cause shown. Subsequent to granting the Certificate of Need, the Agency may extend a Certificate of Need for a period upon application and good cause shown, accompanied by a non-refundable reasonable filing fee, as prescribed by rule. A certificate of Need authorization which has been extended shall expire at the end of the extended time period. The decision whether to grant an extension is within the sole discretion of the Agency, and is not subject to review, reconsideration, or appeal.
· Complete the Project Completion Forecast Chart below. If the project will be completed in multiple phases, please identify the anticipated completion date for each phase.
· If the CON is granted and the project cannot be completed within the standard completion time period (3 years for hospital and nursing home projects and 2 years for all others), please document why an extended period should be approved and document the “good cause” for such an extension.
PROJECT COMPLETION FORECAST CHART – N/A
Assuming the Certificate of Need (CON) approval becomes the final HSDA action on the date listed in Item 1 below, indicate the number of days from the HSDA decision date to each phase of the completion forecast. N/A
Phase |
Days Required |
Anticipated Date (Month/Year) |
1. Initial HSDA Decision Date |
||
2. Building Construction Commenced |
||
3. Construction 100% Complete (Approval for Occupancy) |
||
4. Issuance of License |
||
5. Issuance of Service |
||
6. Final Project Report Form Submitted (Form HR0055) |
image1
REFERENCE AND RESOURCE MATERIALS FOR MOCK CON APPLICATION
BLAW 6500
Health Services and Development Agency Home Page:
https://www.tn.gov/hsda.html
Complete official CON Application form (HSDA):
https://www.tn.gov/hsda/con-forms.html
.
· For this assignment use the abbreviated form I have provided.
· Do not use the complete, official form on the website.
CON Criteria and Standards for Health Care Facilities and Services:
https://www.tn.gov/hsda/hsda-criteria-and-standards.html
.
· You are not required to respond to each of the criteria for whatever type of service or facility that is the subject of your CON application, but you must attach a copy of the applicable set of criteria.
· You will need to download it and convert it to Word format and include the copy as an attachment to your application (as explained in the application form).
Joint Annual Reports from health care providers – Tennessee Department of Health:
https://apps.health.tn.gov/publicjars/default.aspx-
.
· These mandated annual reports from hospitals, ambulatory surgical treatment facilities, nursing homes, and outpatient diagnostic centers include utilization data for the reporting year.
· They are normally a year or two behind the current date, but you may rely on the data in these reports.
*(Note: this is a very “clunky” site. Each time you make a change from a drop-down menu, wait for the page to “refresh” before continuing. If it goes down, you are usually able to exit the site and re-enter it and it will function properly again).
Licensed health care facilities by county of location and type of service:
https://dhlrapps.health.tn.gov/FacilityListings
· This will show you the existing inventory of licensed facilities in any given county.
· The “Current Search” function should be all that is needed for this assignment.
US Census Bureau – Quick Facts:
https://www.census.gov/quickfacts/fact/table/US/PST045219
.
· This is searchable by state and county and shows certain demographic information which may be helpful (e.g., population, median income, and poverty rates).
· You may wat to consult this when responding to questions about “special needs” of the population you are proposing to serve.
TennCare Enrollment Data:
https://www.tn.gov/tenncare/information-statistics/enrollment-data.html
.
· This shows the number of TennCare enrollees in any given county, and the percentage of the total population of the county TennCare enrollees represent.
· You may wat to consult this when responding to questions about “special needs” of the population you are proposing to serve.
Mod 6 Steps:
INSTRUCTIONS:
1.
Read Chapter 2 (p. 89-90) in our textbook, Legal and Ethical Issues for Health Professionals by George D. Pozgar (5th Edition).
2.
Experience the Simulation and Complete Your Role by Answering the Questions in a Word Document: Watch the Jones & Bartlett LearnScapes for Health Care Ethics episode: “
Confidentiality”
You do not need to answer the questions asked at the end of the simulation or submit your recommendation in an email. You will need to answer the questions I give you (see Step 3 instructions below).
3.
Read the Assignment and Instructions for the Mock CON Application and Presentation Project and be prepared to discuss and ask questions in preparation for completing the assignment.
4.
Complete Written Assignment #6: Mock CON Application and Presentation. This written assignment is your ticket to participate in class. See the instructions, forms, and resource links for this project in the link below. You cannot participate in class if you do not complete it and turn it in by the due date and time and earn at least a passing grade.
After class, your written assignment (both the CON application and Power Point slides) is considered together with your class presentation for your Final Advocacy Project grade.
This module is dedicated to the final simulation and essay exam. If you have any questions, contact me directly.
At the conclusion of this module, you should be able to:
· Experience the simulation and appraise the ethical dilemma.
· Demonstrate understanding of knowledge gained throughout the course from readings, discussions, and activities.
· Formulate your own recommendation to resolve the dilemma synthesizing multiple stakeholder perspectives, legal concerns, guiding values and fair process principles.
· Apply original, critical thinking and research skills to identify and document a need for health care services and/or facilities in the community, within the parameters of the certificate of need program in Tennessee.
· Prepare an abbreviated mock CON application using the official forms and applying the official criteria and standards of the Tennessee Health Services and Development Agency.
· Prepare a PowerPoint slide deck and make a presentation of the CON application you have prepared, advocating for the approval of the CON. Persuasively articulate your project to our class in a mock CON presentation and explain how the project meets the State’s criteria for CON approval.
These outcomes correspond to the following course objectives as stated in your syllabus:
· Identify a variety of key legal responsibilities, civil and criminal liability, perspectives and rights of major stakeholders, including selected healthcare organizations, providers, and patients, in the U.S. healthcare system.
· Evaluate and debate resolutions to current healthcare legal issues and ethical dilemmas by applying ethical and legal frameworks and reasoning.
· Creatively formulate and persuasively communicate your strategic recommendations to solve pressing health care problems with ethical and legal solutions.
Book: https://books.google.com/books?hl=en&lr=&id=j7J5DwAAQBAJ&oi=fnd&pg=PP1&dq=Legal+and+Ethical+Issues+for+Health+Professionals&ots=vMqsTnjhzu&sig=v_eGtmtjpSj1LUQwkxVISxwC79U#v=onepage&q=Legal%20and%20Ethical%20Issues%20for%20Health%20Professionals&f=false
BLAW 6500 MOCK CON APPLICIATON AND PRESENTATION
I. SCOPE OF THE ASSIGNMENT
1. Choose one of the following types of heath care facilities, the establishment of which requires a CON under Tennessee law, to be the subject of your CON application:
· Hospital
· Nursing Home
· Ambulatory Surgical Treatment Center (“ASTC”)
· Outpatient Diagnostic Center (“ODC”)
2. Choose one of the following counties in which you will propose to locate the new facility:
· Davidson County
· Rutherford County
· Williamson County
· Wilson County
Your choice of county might be influenced by the number of that type of facility already existing in the county. Please see the References and Resources document for sources you can check to determine that.
3. Prepare a Mock CON Application for your chosen facility and county in accordance with the instructions below, using the Mock CON Application form provided. You are not expected to know all the nuances of the law and regulations, and all of the many data sources needed to accurately and fully prepare a CON application. I am looking for you to demonstrate to me you are thinking logically about a balance of (a) allocation of limited health care resources and (b) consumer needs — within the context and parameters of the Tennessee CON program.
4. Your CON application must cite data or information you obtained from at least 3 of the sources identified in the References and Resources document.
5. Prepare a Power Point presentation of your CON application (please see the instructions below).
II. INSTRUCTIONS FOR THE MOCK CON APPLICATION:
1. This is a very abbreviated version of the full CON application form. Many questions have been left out, and those questions which are included retain their original numbering as they are in the full application (thus the gaps in question numbers). If you are interested you can take a look at the complete official CON application form on the HSDA website (a link is included on the References and Resources document for this assignment).
2. Some of the questions on the abbreviated form are marked “N/A.” This means you
do not have to respond to those questions. These questions are left in the form because they are important in getting a better understanding of the scope and goals of the CON process, but the responses called for are beyond the scope of your assignment.
3. A few of the “N/A” questions are followed by a
Question in italics
. These are questions I have inserted into the application form, and a response from you is required.
4. The applicant for your mock CON application should be a hypothetical provider. Please do not use the name of an actual hospital or other provider. As far as addresses and those types of
non-substantive things – just make something up.
5. The References and Resources document has the links to publicly available data sources which should be useful to you. Data or other information from at least three of these sources must be used and cited in your Mock CON Application You are free to use other resources and authorities, but you need to cite the source in the document after the data is used.
6. You may look at other CON applications which have been filed and are on the HSDA website, but keep in mind that any application filed before October 1, 2021 was governed by a since-replaced law, and those pre-October 1 applications utilized an application form different from the one in use today. If you use language from an existing application you must appropriately cite it – no plagiarism!
III. INSTRUCTIONS FOR THE POWER POINT PRESNTATION
1. You must use Microsoft Power Point to create the slides for your presentation.
2. Your presentation must not exceed 5 minutes in duration. You should not include anything in the slides that is not at least referenced in your CON application.
3. Assume you are making this presentation to members of the Tennessee Heath Services and Development Agency (“HSDA”), who know all about the CON program. Don’t waste time talking about what CON covers and doesn’t cover, the reasons for CON, or that kind of thing. Concentrate on your project and why it should be approved.
4. In an actual application situation, the HSDA would have a copy of your full application so you don’t have to put everything that is in the application in the slide deck. Choose a few points you think are the strongest and concentrate on them in the slides and in your presentaion.
The purpose of this assignment is to learn something regarding government regulation and “allotment” of health care resources, and to help you develop advocacy skills. I hope you can also have some fun with this! Good luck!
Adjunct Professor Taylor
State of Tennessee
Health Facilities Commission
Andrew Jackson Building, 9th Floor, 50
2
Deaderick Street, Nashville, TN
3
72
4
3
www.tn.gov/hsda Phone: 6
1
5-741-2364 Email: hsda.staff@tn.gov
CERTIFICATE OF NEED APPLICATION
1
A.
Name of Facility, Agency, or Institution
(Students – put the name of your hypothetical health care facility or service)
Name |
||||||||
Street or Route |
County |
|||||||
City |
State |
Zip |
||||||
Website Address |
Note: The facility’s name and address
must be
the name and address of the project and
must be
consistent with the Publication of Intent.
2A.
Contact Person Available for Responses to Questions
(Students – your name goes here).
Title |
||
Company Name |
Email Address |
|
Association with Owner |
Phone Number |
3A.
Proof of Publication – N/A
Attach the full page of newspaper in which the notice of intent appeared with the mast and dateline intact or submit a publication affidavit from the newspaper that includes a copy of the publication as proof of the publication of the letter of intent. (Attachment 3A)
Date LOI was Submitted:
Date LOI was Published:
4A.
Purpose of Review
(Check appropriate box(es) – more than one response may apply)
Establish New Health Care Institution
Addition of a Specialty to an Ambulatory Surgical Treatment Center (ASTC)
Change in Bed Complement
Initiation of Health Care Service as Defined in §TCA 68-11-1607(3) Specify: _____
Relocation
Initiation of MRI Service
MRI Unit Increase
Satellite Emergency Department
Addition of ASTC Specialty
Initiation of Cardiac Catheterization
Addition of Therapeutic Catheterization
Establishment of a Non-Residential Substitution Based Opioid Treatment Center
Linear Accelerator Service
Positron Emission Tomography (PET) Service
Please answer all questions on letter size, white paper, clearly typed and spaced, single sided, in order and sequentially numbered. In answering, please type the question and the response. All questions must be answered. If an item does not apply, please indicate “N/A” (not applicable). Attach appropriate documentation as an Appendix at the end of the application and reference the applicable item Number on the attachment, i.e. Attachment 1A, 2A, etc. The last page of the application should be a completed signed and notarized affidavit.
5A.
Type of Institution
(Check all appropriate boxes – more than one response may apply)
Hospital (Specify):
Ambulatory Surgical Treatment Center (ASTC) – Multi-Specialty
Ambulatory Surgical Treatment Center (ASTC) – Single Specialty
Home Health
Hospice
Intellectual Disability Institutional Habilitation Facility (ICF/IID)
Nursing Home
Outpatient Diagnostic Center
Rehabilitation Facility
Residential Hospice
Nonresidential Substitution Based Treatment Center of Opiate Addiction
Other (Specify):
6A.
Name of Owner of the Facility, Agency, or Institution – N/A
EXECUTIVE SUMMARY
1
E.
Overview
Please provide an overview not to exceed
ONE PAGE (for 1E only) in total explaining each item point below.
·
Description: Address the establishment of a health care institution, initiation of health services, and/or bed complement changes.
RESPONSE:
·
Ownership structure – N/A
·
Service Area (Counties in which you expect most of the patients will reside). N/A
RESPONSE:
·
Existing similar service providers in the county you propose to serve
RESPONSE:
·
Project Cost — N/A
·
Staffing – N/A
2E.
Rationale for Approval
A Certificate of Need can only be granted when a project is necessary to provide needed health care in the area to be served, will provide health care that meets appropriate quality standards, and the effects attributed to competition or duplication would be positive for consumers
Provide a brief description not to exceed
ONE PAGE (for 2E only)
of how the project meets the criteria necessary for granting a CON using the data and information points provided in criteria sections that follow.
·
Need
RESPONSE:
·
Quality Standards
RESPONSE:
·
Consumer Advantage
·
Choice
·
Improved access/availability to health care service(s)
·
Affordability
RESPONSE:
3E.
Consent Calendar Justification – N/A
Consent Calendar Requested (Attach rationale)
If Consent Calendar is requested, please attach the rationale for an expedited review in terms of Need, Quality Standards, and Consumer Advantage as a written communication to the Agency’s Executive Director at the time the application is filed.
Consent Calendar
NOT
Requested
4E.
PROJECT COST CHART — N/A
A. |
Construction and equipment acquired by purchase: |
|||||||||||||||||||||||
1. |
Architectural and Engineering Fees |
________
__________ |
||||||||||||||||||||||
2. |
Legal, Administrative (Excluding CON Filing Fee ), Consultant Fees |
|||||||||||||||||||||||
3. |
Acquisition of Site |
|||||||||||||||||||||||
4. |
Preparation of Site |
|||||||||||||||||||||||
5. |
Total Construction Costs |
|||||||||||||||||||||||
6. |
Contingency Fund |
|||||||||||||||||||||||
7. |
Fixed Equipment (Not included in Construction Contract) |
|||||||||||||||||||||||
8. |
Moveable Equipment (List all equipment over $50,000 as separate attachments) |
|||||||||||||||||||||||
9. |
Other (Specify) __________________________ _ |
|||||||||||||||||||||||
B. |
Acquisition by gift, donation, or lease: |
|||||||||||||||||||||||
Facility (inclusive of building and land) |
||||||||||||||||||||||||
Building only |
||||||||||||||||||||||||
Land only |
||||||||||||||||||||||||
Equipment (Specify)______________________ |
||||||||||||||||||||||||
Other (Specify) __________________________ | ||||||||||||||||||||||||
C. |
Financing Costs and Fees: |
|||||||||||||||||||||||
Interim Financing |
||||||||||||||||||||||||
Underwriting Costs |
||||||||||||||||||||||||
Reserve for One Year’s Debt Service |
||||||||||||||||||||||||
D. |
Estimated Project Cost (A+B+C) |
__________________ |
||||||||||||||||||||||
E. | CON Filing Fee | |||||||||||||||||||||||
F. |
Total Estimated Project Cost (D+E) |
__________________ |
GENERAL CRITERIA FOR CERTIFICATE OF NEED
In accordance with TCA §68-11-1609(b), “no Certificate of Need shall be granted unless the action proposed in the application for such Certificate is necessary to provide needed health care in the area to be served, will provide health care that meets appropriate quality standards, and the effect attributed to completion or duplication would be positive for consumers.” In making determinations, the Agency uses as guidelines the goals, objectives, criteria, and standards adopted to guide the agency in issuing certificates of need. Until the agency adopts its own criteria and standards by rule, those in the state health plan apply. Link to Criteria and Standards: Standards:
https://www.tn.gov/hsda/hsda-criteria-and-standards.html
Additional criteria for review are prescribed in Chapter 11 of the Agency Rules, Tennessee Rules and Regulations 01730-11.
The following questions are listed according to the three criteria: (1) Need, (2) the effects attributed to competition or duplication would be positive for consumers (Consumer Advantage), and (3) Quality Standards.
NEED
The responses to this section of the application will help determine whether the project will provide needed health care facilities or services in the area to be served.
1N. Provide responses as an attachment to the applicable criteria and standards for the
type of institution or service requested. A word version and pdf version for each reviewable type of institution or service are located at the following website.
https://www.tn.gov/hsda/hsda-criteria-and-standards.html.
RESPONSE:
[Students – You do not have to respond to the Criteria and Standards. However, you must attach a copy of the Criteria and Standards which would be applicable to your type of project (hospital, nursing home, etc. from the website – link is provided in the paragraph above) to show me you went to the website and chose the correct set of criteria.
]
2N. Identify the proposed service area and provide justification for its reasonableness. Submit a county level map for the Tennessee portion and counties boarding the state of the service area using the supplemental map, clearly marked, and shaded to reflect the service area as it relates to meeting the requirements for CON criteria and standards that may apply to the project. Please include a discussion of the inclusion of counties in the border states, if applicable. (Attachment 2N). N/A
Complete the following utilization tables for each county in the service area, if applicable. N/A
Service Area Counties |
Projected Utilization-County Residents to be Served – Year 1 (Year=__________) |
% of Total |
||
County #1 |
||||
County #2 |
||||
County #3 |
||||
Etc. |
||||
Total |
100% |
4N. Describe the special needs of the service area population, including health disparities, the accessibility to consumers, particularly those who are uninsured or underinsured, the elderly, women, racial and ethnic minorities, TennCare or Medicaid recipients, and low income groups. Document how the business plans of the facility will take into consideration the special needs of the service area population.
RESPONSE:
CONSUMER ADVANTAGE ATTRIBUTED TO COMPETITION
The responses to this section of the application helps determine whether the effects attributed to competition or duplication would be positive for consumers within the service area.
1C. List all transfer agreements relevant to the proposed project. N/A
2C. List all commercial private insurance plans contracted or plan to be contracted by the applicant. N/A
3C. Describe the effects of competition and/or duplication of the proposal on the health care system, including the impact upon consumer charges and consumer choice of services.
RESPONSE:
6C. See
INSTRUCTIONS to assist in completing the following tables. N/A
HISTORICAL DATA CHART — N/A |
□ Project Only □ Total Facility |
||||||||||||||||||
Give information for the last |
|||||||||||||||||||
Year___ _ _ |
|||||||||||||||||||
Utilization Data Specify Unit of Measure _______________ |
________ |
________ |
|||||||||||||||||
Revenue from Services to Patients |
|||||||||||||||||||
Inpatient Services |
$________ |
||||||||||||||||||
Outpatient Services |
|||||||||||||||||||
Emergency Services |
|||||||||||||||||||
Other Operating Revenue (Specify)_____________ _______ |
|||||||||||||||||||
Gross Operating Revenue |
|||||||||||||||||||
Deductions from Gross Operating Revenue |
|||||||||||||||||||
Contractual Adjustments |
|||||||||||||||||||
Provision for Charity Care |
|||||||||||||||||||
Provisions for Bad Debt |
|||||||||||||||||||
Total Deductions |
|||||||||||||||||||
NET OPERATING REVENUE |
PROJECTED DATA CHART — N/A |
|||||||||||
Give information for the two (2) years following the completion of this proposal. |
|||||||||||
Year______ |
|||||||||||
__________ | |||||||||||
1 |
$__________ |
||||||||||
2 | |||||||||||
3 | |||||||||||
4 | Other Operating Revenue (Specify)_____________ | ||||||||||
$__________ |
|||||||||||
7C. Please identify the project’s average gross charge, average deduction from operating revenue, and average net charge using information from the Historical and Projected Data Charts of the proposed project. N/A
Project Only Chart N/A
Previous Year to Most Recent Year Year ____ |
Most Recent Year Year____ |
Year One Year___ |
Year Two Year____ |
% Change (Current Year to Year 2) |
Gross Charge |
||||
Deduction from Revenue |
||||
Average Net Charge |
8C. Provide the proposed charges for the project and discuss any adjustment to current charges that will result from the implementation of the proposal. Additionally, describe the anticipated revenue from the project and the impact on existing patient charges.
N/A
9C. Compare the proposed project charges to those of similar facilities/services in the service area/adjoining services areas, or to proposed charges of recently approved Certificates of Need. If applicable, compare the proposed charges of the project to the current Medicare allowable fee schedule by common procedure terminology (CPT) code(s).
N/A
Question:
Questions 6C-9C examine charges to consumers. Please explain why you think health care providers “charges” are important, in light of the fact insurance companies pay much of those charges.
RESPONSE:
10C. Discuss the project’s participation in state and federal revenue programs, including a description of the extent to which Medicare,
TennCare/Medicaid
, and medically indigent patients will be served by the project. Report the estimated gross operating revenue dollar amount and percentage of project gross operating revenue anticipated by payor classification for the first year of the project by completing the table below.
N/A
Applicant’s Projected Payor Mix N/A
Payor Source |
Year 1 |
Year 2 |
Medicare/Medicare Managed Care |
||
TennCare/Medicaid | ||
Commercial/Other Managed Care |
||
Self-Pay |
||
Other (Specify)________________ |
||
Total* |
||
Charity Care |
*Needs to match Gross Operating Revenue Year One and Year Two on Projected Data Chart
Question:
Why is the Payor Mix important? What state interests are at stake here?
RESPONSE:
QUALITY STANDARDS
1Q. Per PC 1043, Acts of 2016, any receiving a CON after July 1, 2016, must report annually using forms prescribed by the Agency concerning appropriate quality measures. Please attest that the applicant will submit an annual Quality Measure report when due. –
N/A
RESPONSE:
2Q. The proposal shall provide health care that meets appropriate quality standards. Please address each of the following questions. – All of the following questions are
N/A
· Does the applicant commit to maintaining the staffing comparable to the staffing chart presented in its CON application?
· Does the applicant commit to obtaining and maintaining all applicable state licenses in good standing?
· Does the applicant commit to obtaining and maintaining TennCare and Medicare certification(s), if participation in such programs are indicated in the application?
RESPONSE:
7Q. Respond to all of the following and for such occurrences, identify, explain, and provide documentation if occurred in last five (5) years. – All the following questions are
N/A
Has any of the following:
· Any person(s) or entity with more than 5% ownership (direct or indirect) in the applicant (to include any entity in the chain of ownership for applicant);
· Any entity in which any person(s) or entity with more than 5% ownership (direct or indirect) in the applicant (to include any entity in the chain of ownership for applicant) has an ownership interest of more than 5%; and/or
Been subject to any of the following:
· Final Order or Judgement in a state licensure action;
· Criminal fines in cases involving a Federal or State health care offense;
· Civil monetary penalties in cases involving a Federal or State health care offense;
· Administrative monetary penalties in cases involving a Federal or State health care offense;
· Agreement to pay civil or administrative monetary penalties to the federal government or any state in cases involving claims related to the provision of health care items and services;
· Suspension or termination of participation in Medicare or TennCare/Medicaid programs; and/or
· Is presently subject of/to an investigation, or party in any regulatory or criminal action of which you are aware.
Question:
Assuming all the sanctions or disciplinary actions listed above are under the authority of a federal agency and/or a state agency
other than HFC (which is the case), why is this question included in the CON application?
RESPONSE:
DEVELOPMENT SCHEDULE – N/A
TCA §68-11-1609(c) provides that activity authorized by a Certificate of Need is valid for a period not to exceed three (3) years (for hospital and nursing home projects) or two (2) years (for all other projects) from the date of its issuance and after such time authorization expires; provided, that the Agency may, in granting the Certificate of Need, allow longer periods of validity for Certificate of Need for good cause shown. Subsequent to granting the Certificate of Need, the Agency may extend a Certificate of Need for a period upon application and good cause shown, accompanied by a non-refundable reasonable filing fee, as prescribed by rule. A certificate of Need authorization which has been extended shall expire at the end of the extended time period. The decision whether to grant an extension is within the sole discretion of the Agency, and is not subject to review, reconsideration, or appeal.
· Complete the Project Completion Forecast Chart below. If the project will be completed in multiple phases, please identify the anticipated completion date for each phase.
· If the CON is granted and the project cannot be completed within the standard completion time period (3 years for hospital and nursing home projects and 2 years for all others), please document why an extended period should be approved and document the “good cause” for such an extension.
PROJECT COMPLETION FORECAST CHART – N/A
Assuming the Certificate of Need (CON) approval becomes the final HSDA action on the date listed in Item 1 below, indicate the number of days from the HSDA decision date to each phase of the completion forecast. N/A
Phase |
Days Required |
Anticipated Date (Month/Year) |
1. Initial HSDA Decision Date |
||
2. Building Construction Commenced |
||
3. Construction 100% Complete (Approval for Occupancy) |
||
4. Issuance of License |
||
5. Issuance of Service |
||
6. Final Project Report Form Submitted (Form HR0055) |
image1
REFERENCE AND RESOURCE MATERIALS FOR MOCK CON APPLICATION
BLAW 6500
Health Services and Development Agency Home Page:
https://www.tn.gov/hsda.html
Complete official CON Application form (HSDA):
https://www.tn.gov/hsda/con-forms.html
.
· For this assignment use the abbreviated form I have provided.
· Do not use the complete, official form on the website.
CON Criteria and Standards for Health Care Facilities and Services:
https://www.tn.gov/hsda/hsda-criteria-and-standards.html
.
· You are not required to respond to each of the criteria for whatever type of service or facility that is the subject of your CON application, but you must attach a copy of the applicable set of criteria.
· You will need to download it and convert it to Word format and include the copy as an attachment to your application (as explained in the application form).
Joint Annual Reports from health care providers – Tennessee Department of Health:
https://apps.health.tn.gov/publicjars/default.aspx-
.
· These mandated annual reports from hospitals, ambulatory surgical treatment facilities, nursing homes, and outpatient diagnostic centers include utilization data for the reporting year.
· They are normally a year or two behind the current date, but you may rely on the data in these reports.
*(Note: this is a very “clunky” site. Each time you make a change from a drop-down menu, wait for the page to “refresh” before continuing. If it goes down, you are usually able to exit the site and re-enter it and it will function properly again).
Licensed health care facilities by county of location and type of service:
https://dhlrapps.health.tn.gov/FacilityListings
· This will show you the existing inventory of licensed facilities in any given county.
· The “Current Search” function should be all that is needed for this assignment.
US Census Bureau – Quick Facts:
https://www.census.gov/quickfacts/fact/table/US/PST045219
.
· This is searchable by state and county and shows certain demographic information which may be helpful (e.g., population, median income, and poverty rates).
· You may wat to consult this when responding to questions about “special needs” of the population you are proposing to serve.
TennCare Enrollment Data:
https://www.tn.gov/tenncare/information-statistics/enrollment-data.html
.
· This shows the number of TennCare enrollees in any given county, and the percentage of the total population of the county TennCare enrollees represent.
· You may wat to consult this when responding to questions about “special needs” of the population you are proposing to serve.
Mod 6 Steps:
INSTRUCTIONS:
1.
Read Chapter 2 (p. 89-90) in our textbook, Legal and Ethical Issues for Health Professionals by George D. Pozgar (5th Edition).
2.
Experience the Simulation and Complete Your Role by Answering the Questions in a Word Document: Watch the Jones & Bartlett LearnScapes for Health Care Ethics episode: “
Confidentiality”
You do not need to answer the questions asked at the end of the simulation or submit your recommendation in an email. You will need to answer the questions I give you (see Step 3 instructions below).
3.
Read the Assignment and Instructions for the Mock CON Application and Presentation Project and be prepared to discuss and ask questions in preparation for completing the assignment.
4.
Complete Written Assignment #6: Mock CON Application and Presentation. This written assignment is your ticket to participate in class. See the instructions, forms, and resource links for this project in the link below. You cannot participate in class if you do not complete it and turn it in by the due date and time and earn at least a passing grade.
After class, your written assignment (both the CON application and Power Point slides) is considered together with your class presentation for your Final Advocacy Project grade.
This module is dedicated to the final simulation and essay exam. If you have any questions, contact me directly.
At the conclusion of this module, you should be able to:
· Experience the simulation and appraise the ethical dilemma.
· Demonstrate understanding of knowledge gained throughout the course from readings, discussions, and activities.
· Formulate your own recommendation to resolve the dilemma synthesizing multiple stakeholder perspectives, legal concerns, guiding values and fair process principles.
· Apply original, critical thinking and research skills to identify and document a need for health care services and/or facilities in the community, within the parameters of the certificate of need program in Tennessee.
· Prepare an abbreviated mock CON application using the official forms and applying the official criteria and standards of the Tennessee Health Services and Development Agency.
· Prepare a PowerPoint slide deck and make a presentation of the CON application you have prepared, advocating for the approval of the CON. Persuasively articulate your project to our class in a mock CON presentation and explain how the project meets the State’s criteria for CON approval.
These outcomes correspond to the following course objectives as stated in your syllabus:
· Identify a variety of key legal responsibilities, civil and criminal liability, perspectives and rights of major stakeholders, including selected healthcare organizations, providers, and patients, in the U.S. healthcare system.
· Evaluate and debate resolutions to current healthcare legal issues and ethical dilemmas by applying ethical and legal frameworks and reasoning.
· Creatively formulate and persuasively communicate your strategic recommendations to solve pressing health care problems with ethical and legal solutions.
Book: https://books.google.com/books?hl=en&lr=&id=j7J5DwAAQBAJ&oi=fnd&pg=PP1&dq=Legal+and+Ethical+Issues+for+Health+Professionals&ots=vMqsTnjhzu&sig=v_eGtmtjpSj1LUQwkxVISxwC79U#v=onepage&q=Legal%20and%20Ethical%20Issues%20for%20Health%20Professionals&f=false
BLAW 6500 MOCK CON APPLICIATON AND PRESENTATION
I. SCOPE OF THE ASSIGNMENT
1. Choose one of the following types of heath care facilities, the establishment of which requires a CON under Tennessee law, to be the subject of your CON application:
· Hospital
· Nursing Home
· Ambulatory Surgical Treatment Center (“ASTC”)
· Outpatient Diagnostic Center (“ODC”)
2. Choose one of the following counties in which you will propose to locate the new facility:
· Davidson County
· Rutherford County
· Williamson County
· Wilson County
Your choice of county might be influenced by the number of that type of facility already existing in the county. Please see the References and Resources document for sources you can check to determine that.
3. Prepare a Mock CON Application for your chosen facility and county in accordance with the instructions below, using the Mock CON Application form provided. You are not expected to know all the nuances of the law and regulations, and all of the many data sources needed to accurately and fully prepare a CON application. I am looking for you to demonstrate to me you are thinking logically about a balance of (a) allocation of limited health care resources and (b) consumer needs — within the context and parameters of the Tennessee CON program.
4. Your CON application must cite data or information you obtained from at least 3 of the sources identified in the References and Resources document.
5. Prepare a Power Point presentation of your CON application (please see the instructions below).
II. INSTRUCTIONS FOR THE MOCK CON APPLICATION:
1. This is a very abbreviated version of the full CON application form. Many questions have been left out, and those questions which are included retain their original numbering as they are in the full application (thus the gaps in question numbers). If you are interested you can take a look at the complete official CON application form on the HSDA website (a link is included on the References and Resources document for this assignment).
2. Some of the questions on the abbreviated form are marked “N/A.” This means you
do not have to respond to those questions. These questions are left in the form because they are important in getting a better understanding of the scope and goals of the CON process, but the responses called for are beyond the scope of your assignment.
3. A few of the “N/A” questions are followed by a
Question in italics
. These are questions I have inserted into the application form, and a response from you is required.
4. The applicant for your mock CON application should be a hypothetical provider. Please do not use the name of an actual hospital or other provider. As far as addresses and those types of
non-substantive things – just make something up.
5. The References and Resources document has the links to publicly available data sources which should be useful to you. Data or other information from at least three of these sources must be used and cited in your Mock CON Application You are free to use other resources and authorities, but you need to cite the source in the document after the data is used.
6. You may look at other CON applications which have been filed and are on the HSDA website, but keep in mind that any application filed before October 1, 2021 was governed by a since-replaced law, and those pre-October 1 applications utilized an application form different from the one in use today. If you use language from an existing application you must appropriately cite it – no plagiarism!
III. INSTRUCTIONS FOR THE POWER POINT PRESNTATION
1. You must use Microsoft Power Point to create the slides for your presentation.
2. Your presentation must not exceed 5 minutes in duration. You should not include anything in the slides that is not at least referenced in your CON application.
3. Assume you are making this presentation to members of the Tennessee Heath Services and Development Agency (“HSDA”), who know all about the CON program. Don’t waste time talking about what CON covers and doesn’t cover, the reasons for CON, or that kind of thing. Concentrate on your project and why it should be approved.
4. In an actual application situation, the HSDA would have a copy of your full application so you don’t have to put everything that is in the application in the slide deck. Choose a few points you think are the strongest and concentrate on them in the slides and in your presentaion.
The purpose of this assignment is to learn something regarding government regulation and “allotment” of health care resources, and to help you develop advocacy skills. I hope you can also have some fun with this! Good luck!
Adjunct Professor Taylor
State of Tennessee
Health Facilities Commission
Andrew Jackson Building, 9th Floor, 50
2
Deaderick Street, Nashville, TN
3
72
4
3
www.tn.gov/hsda Phone: 6
1
5-741-2364 Email: hsda.staff@tn.gov
CERTIFICATE OF NEED APPLICATION
1
A.
Name of Facility, Agency, or Institution
(Students – put the name of your hypothetical health care facility or service)
Name |
||||||||
Street or Route |
County |
|||||||
City |
State |
Zip |
||||||
Website Address |
Note: The facility’s name and address
must be
the name and address of the project and
must be
consistent with the Publication of Intent.
2A.
Contact Person Available for Responses to Questions
(Students – your name goes here).
Title |
||
Company Name |
Email Address |
|
Association with Owner |
Phone Number |
3A.
Proof of Publication – N/A
Attach the full page of newspaper in which the notice of intent appeared with the mast and dateline intact or submit a publication affidavit from the newspaper that includes a copy of the publication as proof of the publication of the letter of intent. (Attachment 3A)
Date LOI was Submitted:
Date LOI was Published:
4A.
Purpose of Review
(Check appropriate box(es) – more than one response may apply)
Establish New Health Care Institution
Addition of a Specialty to an Ambulatory Surgical Treatment Center (ASTC)
Change in Bed Complement
Initiation of Health Care Service as Defined in §TCA 68-11-1607(3) Specify: _____
Relocation
Initiation of MRI Service
MRI Unit Increase
Satellite Emergency Department
Addition of ASTC Specialty
Initiation of Cardiac Catheterization
Addition of Therapeutic Catheterization
Establishment of a Non-Residential Substitution Based Opioid Treatment Center
Linear Accelerator Service
Positron Emission Tomography (PET) Service
Please answer all questions on letter size, white paper, clearly typed and spaced, single sided, in order and sequentially numbered. In answering, please type the question and the response. All questions must be answered. If an item does not apply, please indicate “N/A” (not applicable). Attach appropriate documentation as an Appendix at the end of the application and reference the applicable item Number on the attachment, i.e. Attachment 1A, 2A, etc. The last page of the application should be a completed signed and notarized affidavit.
5A.
Type of Institution
(Check all appropriate boxes – more than one response may apply)
Hospital (Specify):
Ambulatory Surgical Treatment Center (ASTC) – Multi-Specialty
Ambulatory Surgical Treatment Center (ASTC) – Single Specialty
Home Health
Hospice
Intellectual Disability Institutional Habilitation Facility (ICF/IID)
Nursing Home
Outpatient Diagnostic Center
Rehabilitation Facility
Residential Hospice
Nonresidential Substitution Based Treatment Center of Opiate Addiction
Other (Specify):
6A.
Name of Owner of the Facility, Agency, or Institution – N/A
EXECUTIVE SUMMARY
1
E.
Overview
Please provide an overview not to exceed
ONE PAGE (for 1E only) in total explaining each item point below.
·
Description: Address the establishment of a health care institution, initiation of health services, and/or bed complement changes.
RESPONSE:
·
Ownership structure – N/A
·
Service Area (Counties in which you expect most of the patients will reside). N/A
RESPONSE:
·
Existing similar service providers in the county you propose to serve
RESPONSE:
·
Project Cost — N/A
·
Staffing – N/A
2E.
Rationale for Approval
A Certificate of Need can only be granted when a project is necessary to provide needed health care in the area to be served, will provide health care that meets appropriate quality standards, and the effects attributed to competition or duplication would be positive for consumers
Provide a brief description not to exceed
ONE PAGE (for 2E only)
of how the project meets the criteria necessary for granting a CON using the data and information points provided in criteria sections that follow.
·
Need
RESPONSE:
·
Quality Standards
RESPONSE:
·
Consumer Advantage
·
Choice
·
Improved access/availability to health care service(s)
·
Affordability
RESPONSE:
3E.
Consent Calendar Justification – N/A
Consent Calendar Requested (Attach rationale)
If Consent Calendar is requested, please attach the rationale for an expedited review in terms of Need, Quality Standards, and Consumer Advantage as a written communication to the Agency’s Executive Director at the time the application is filed.
Consent Calendar
NOT
Requested
4E.
PROJECT COST CHART — N/A
A. |
Construction and equipment acquired by purchase: |
|||||||||||||||||||||||
1. |
Architectural and Engineering Fees |
________
__________ |
||||||||||||||||||||||
2. |
Legal, Administrative (Excluding CON Filing Fee ), Consultant Fees |
|||||||||||||||||||||||
3. |
Acquisition of Site |
|||||||||||||||||||||||
4. |
Preparation of Site |
|||||||||||||||||||||||
5. |
Total Construction Costs |
|||||||||||||||||||||||
6. |
Contingency Fund |
|||||||||||||||||||||||
7. |
Fixed Equipment (Not included in Construction Contract) |
|||||||||||||||||||||||
8. |
Moveable Equipment (List all equipment over $50,000 as separate attachments) |
|||||||||||||||||||||||
9. |
Other (Specify) __________________________ _ |
|||||||||||||||||||||||
B. |
Acquisition by gift, donation, or lease: |
|||||||||||||||||||||||
Facility (inclusive of building and land) |
||||||||||||||||||||||||
Building only |
||||||||||||||||||||||||
Land only |
||||||||||||||||||||||||
Equipment (Specify)______________________ |
||||||||||||||||||||||||
Other (Specify) __________________________ | ||||||||||||||||||||||||
C. |
Financing Costs and Fees: |
|||||||||||||||||||||||
Interim Financing |
||||||||||||||||||||||||
Underwriting Costs |
||||||||||||||||||||||||
Reserve for One Year’s Debt Service |
||||||||||||||||||||||||
D. |
Estimated Project Cost (A+B+C) |
__________________ |
||||||||||||||||||||||
E. | CON Filing Fee | |||||||||||||||||||||||
F. |
Total Estimated Project Cost (D+E) |
__________________ |
GENERAL CRITERIA FOR CERTIFICATE OF NEED
In accordance with TCA §68-11-1609(b), “no Certificate of Need shall be granted unless the action proposed in the application for such Certificate is necessary to provide needed health care in the area to be served, will provide health care that meets appropriate quality standards, and the effect attributed to completion or duplication would be positive for consumers.” In making determinations, the Agency uses as guidelines the goals, objectives, criteria, and standards adopted to guide the agency in issuing certificates of need. Until the agency adopts its own criteria and standards by rule, those in the state health plan apply. Link to Criteria and Standards: Standards:
https://www.tn.gov/hsda/hsda-criteria-and-standards.html
Additional criteria for review are prescribed in Chapter 11 of the Agency Rules, Tennessee Rules and Regulations 01730-11.
The following questions are listed according to the three criteria: (1) Need, (2) the effects attributed to competition or duplication would be positive for consumers (Consumer Advantage), and (3) Quality Standards.
NEED
The responses to this section of the application will help determine whether the project will provide needed health care facilities or services in the area to be served.
1N. Provide responses as an attachment to the applicable criteria and standards for the
type of institution or service requested. A word version and pdf version for each reviewable type of institution or service are located at the following website.
https://www.tn.gov/hsda/hsda-criteria-and-standards.html.
RESPONSE:
[Students – You do not have to respond to the Criteria and Standards. However, you must attach a copy of the Criteria and Standards which would be applicable to your type of project (hospital, nursing home, etc. from the website – link is provided in the paragraph above) to show me you went to the website and chose the correct set of criteria.
]
2N. Identify the proposed service area and provide justification for its reasonableness. Submit a county level map for the Tennessee portion and counties boarding the state of the service area using the supplemental map, clearly marked, and shaded to reflect the service area as it relates to meeting the requirements for CON criteria and standards that may apply to the project. Please include a discussion of the inclusion of counties in the border states, if applicable. (Attachment 2N). N/A
Complete the following utilization tables for each county in the service area, if applicable. N/A
Service Area Counties |
Projected Utilization-County Residents to be Served – Year 1 (Year=__________) |
% of Total |
||
County #1 |
||||
County #2 |
||||
County #3 |
||||
Etc. |
||||
Total |
100% |
4N. Describe the special needs of the service area population, including health disparities, the accessibility to consumers, particularly those who are uninsured or underinsured, the elderly, women, racial and ethnic minorities, TennCare or Medicaid recipients, and low income groups. Document how the business plans of the facility will take into consideration the special needs of the service area population.
RESPONSE:
CONSUMER ADVANTAGE ATTRIBUTED TO COMPETITION
The responses to this section of the application helps determine whether the effects attributed to competition or duplication would be positive for consumers within the service area.
1C. List all transfer agreements relevant to the proposed project. N/A
2C. List all commercial private insurance plans contracted or plan to be contracted by the applicant. N/A
3C. Describe the effects of competition and/or duplication of the proposal on the health care system, including the impact upon consumer charges and consumer choice of services.
RESPONSE:
6C. See
INSTRUCTIONS to assist in completing the following tables. N/A
HISTORICAL DATA CHART — N/A |
□ Project Only □ Total Facility |
||||||||||||||||||
Give information for the last |
|||||||||||||||||||
Year___ _ _ |
|||||||||||||||||||
Utilization Data Specify Unit of Measure _______________ |
________ |
________ |
|||||||||||||||||
Revenue from Services to Patients |
|||||||||||||||||||
Inpatient Services |
$________ |
||||||||||||||||||
Outpatient Services |
|||||||||||||||||||
Emergency Services |
|||||||||||||||||||
Other Operating Revenue (Specify)_____________ _______ |
|||||||||||||||||||
Gross Operating Revenue |
|||||||||||||||||||
Deductions from Gross Operating Revenue |
|||||||||||||||||||
Contractual Adjustments |
|||||||||||||||||||
Provision for Charity Care |
|||||||||||||||||||
Provisions for Bad Debt |
|||||||||||||||||||
Total Deductions |
|||||||||||||||||||
NET OPERATING REVENUE |
PROJECTED DATA CHART — N/A |
|||||||||||
Give information for the two (2) years following the completion of this proposal. |
|||||||||||
Year______ |
|||||||||||
__________ | |||||||||||
1 |
$__________ |
||||||||||
2 | |||||||||||
3 | |||||||||||
4 | Other Operating Revenue (Specify)_____________ | ||||||||||
$__________ |
|||||||||||
7C. Please identify the project’s average gross charge, average deduction from operating revenue, and average net charge using information from the Historical and Projected Data Charts of the proposed project. N/A
Project Only Chart N/A
Previous Year to Most Recent Year Year ____ |
Most Recent Year Year____ |
Year One Year___ |
Year Two Year____ |
% Change (Current Year to Year 2) |
Gross Charge |
||||
Deduction from Revenue |
||||
Average Net Charge |
8C. Provide the proposed charges for the project and discuss any adjustment to current charges that will result from the implementation of the proposal. Additionally, describe the anticipated revenue from the project and the impact on existing patient charges.
N/A
9C. Compare the proposed project charges to those of similar facilities/services in the service area/adjoining services areas, or to proposed charges of recently approved Certificates of Need. If applicable, compare the proposed charges of the project to the current Medicare allowable fee schedule by common procedure terminology (CPT) code(s).
N/A
Question:
Questions 6C-9C examine charges to consumers. Please explain why you think health care providers “charges” are important, in light of the fact insurance companies pay much of those charges.
RESPONSE:
10C. Discuss the project’s participation in state and federal revenue programs, including a description of the extent to which Medicare,
TennCare/Medicaid
, and medically indigent patients will be served by the project. Report the estimated gross operating revenue dollar amount and percentage of project gross operating revenue anticipated by payor classification for the first year of the project by completing the table below.
N/A
Applicant’s Projected Payor Mix N/A
Payor Source |
Year 1 |
Year 2 |
Medicare/Medicare Managed Care |
||
TennCare/Medicaid | ||
Commercial/Other Managed Care |
||
Self-Pay |
||
Other (Specify)________________ |
||
Total* |
||
Charity Care |
*Needs to match Gross Operating Revenue Year One and Year Two on Projected Data Chart
Question:
Why is the Payor Mix important? What state interests are at stake here?
RESPONSE:
QUALITY STANDARDS
1Q. Per PC 1043, Acts of 2016, any receiving a CON after July 1, 2016, must report annually using forms prescribed by the Agency concerning appropriate quality measures. Please attest that the applicant will submit an annual Quality Measure report when due. –
N/A
RESPONSE:
2Q. The proposal shall provide health care that meets appropriate quality standards. Please address each of the following questions. – All of the following questions are
N/A
· Does the applicant commit to maintaining the staffing comparable to the staffing chart presented in its CON application?
· Does the applicant commit to obtaining and maintaining all applicable state licenses in good standing?
· Does the applicant commit to obtaining and maintaining TennCare and Medicare certification(s), if participation in such programs are indicated in the application?
RESPONSE:
7Q. Respond to all of the following and for such occurrences, identify, explain, and provide documentation if occurred in last five (5) years. – All the following questions are
N/A
Has any of the following:
· Any person(s) or entity with more than 5% ownership (direct or indirect) in the applicant (to include any entity in the chain of ownership for applicant);
· Any entity in which any person(s) or entity with more than 5% ownership (direct or indirect) in the applicant (to include any entity in the chain of ownership for applicant) has an ownership interest of more than 5%; and/or
Been subject to any of the following:
· Final Order or Judgement in a state licensure action;
· Criminal fines in cases involving a Federal or State health care offense;
· Civil monetary penalties in cases involving a Federal or State health care offense;
· Administrative monetary penalties in cases involving a Federal or State health care offense;
· Agreement to pay civil or administrative monetary penalties to the federal government or any state in cases involving claims related to the provision of health care items and services;
· Suspension or termination of participation in Medicare or TennCare/Medicaid programs; and/or
· Is presently subject of/to an investigation, or party in any regulatory or criminal action of which you are aware.
Question:
Assuming all the sanctions or disciplinary actions listed above are under the authority of a federal agency and/or a state agency
other than HFC (which is the case), why is this question included in the CON application?
RESPONSE:
DEVELOPMENT SCHEDULE – N/A
TCA §68-11-1609(c) provides that activity authorized by a Certificate of Need is valid for a period not to exceed three (3) years (for hospital and nursing home projects) or two (2) years (for all other projects) from the date of its issuance and after such time authorization expires; provided, that the Agency may, in granting the Certificate of Need, allow longer periods of validity for Certificate of Need for good cause shown. Subsequent to granting the Certificate of Need, the Agency may extend a Certificate of Need for a period upon application and good cause shown, accompanied by a non-refundable reasonable filing fee, as prescribed by rule. A certificate of Need authorization which has been extended shall expire at the end of the extended time period. The decision whether to grant an extension is within the sole discretion of the Agency, and is not subject to review, reconsideration, or appeal.
· Complete the Project Completion Forecast Chart below. If the project will be completed in multiple phases, please identify the anticipated completion date for each phase.
· If the CON is granted and the project cannot be completed within the standard completion time period (3 years for hospital and nursing home projects and 2 years for all others), please document why an extended period should be approved and document the “good cause” for such an extension.
PROJECT COMPLETION FORECAST CHART – N/A
Assuming the Certificate of Need (CON) approval becomes the final HSDA action on the date listed in Item 1 below, indicate the number of days from the HSDA decision date to each phase of the completion forecast. N/A
Phase |
Days Required |
Anticipated Date (Month/Year) |
1. Initial HSDA Decision Date |
||
2. Building Construction Commenced |
||
3. Construction 100% Complete (Approval for Occupancy) |
||
4. Issuance of License |
||
5. Issuance of Service |
||
6. Final Project Report Form Submitted (Form HR0055) |
image1
REFERENCE AND RESOURCE MATERIALS FOR MOCK CON APPLICATION
BLAW 6500
Health Services and Development Agency Home Page:
https://www.tn.gov/hsda.html
Complete official CON Application form (HSDA):
https://www.tn.gov/hsda/con-forms.html
.
· For this assignment use the abbreviated form I have provided.
· Do not use the complete, official form on the website.
CON Criteria and Standards for Health Care Facilities and Services:
https://www.tn.gov/hsda/hsda-criteria-and-standards.html
.
· You are not required to respond to each of the criteria for whatever type of service or facility that is the subject of your CON application, but you must attach a copy of the applicable set of criteria.
· You will need to download it and convert it to Word format and include the copy as an attachment to your application (as explained in the application form).
Joint Annual Reports from health care providers – Tennessee Department of Health:
https://apps.health.tn.gov/publicjars/default.aspx-
.
· These mandated annual reports from hospitals, ambulatory surgical treatment facilities, nursing homes, and outpatient diagnostic centers include utilization data for the reporting year.
· They are normally a year or two behind the current date, but you may rely on the data in these reports.
*(Note: this is a very “clunky” site. Each time you make a change from a drop-down menu, wait for the page to “refresh” before continuing. If it goes down, you are usually able to exit the site and re-enter it and it will function properly again).
Licensed health care facilities by county of location and type of service:
https://dhlrapps.health.tn.gov/FacilityListings
· This will show you the existing inventory of licensed facilities in any given county.
· The “Current Search” function should be all that is needed for this assignment.
US Census Bureau – Quick Facts:
https://www.census.gov/quickfacts/fact/table/US/PST045219
.
· This is searchable by state and county and shows certain demographic information which may be helpful (e.g., population, median income, and poverty rates).
· You may wat to consult this when responding to questions about “special needs” of the population you are proposing to serve.
TennCare Enrollment Data:
https://www.tn.gov/tenncare/information-statistics/enrollment-data.html
.
· This shows the number of TennCare enrollees in any given county, and the percentage of the total population of the county TennCare enrollees represent.
· You may wat to consult this when responding to questions about “special needs” of the population you are proposing to serve.
Mod 6 Steps:
INSTRUCTIONS:
1.
Read Chapter 2 (p. 89-90) in our textbook, Legal and Ethical Issues for Health Professionals by George D. Pozgar (5th Edition).
2.
Experience the Simulation and Complete Your Role by Answering the Questions in a Word Document: Watch the Jones & Bartlett LearnScapes for Health Care Ethics episode: “
Confidentiality”
You do not need to answer the questions asked at the end of the simulation or submit your recommendation in an email. You will need to answer the questions I give you (see Step 3 instructions below).
3.
Read the Assignment and Instructions for the Mock CON Application and Presentation Project and be prepared to discuss and ask questions in preparation for completing the assignment.
4.
Complete Written Assignment #6: Mock CON Application and Presentation. This written assignment is your ticket to participate in class. See the instructions, forms, and resource links for this project in the link below. You cannot participate in class if you do not complete it and turn it in by the due date and time and earn at least a passing grade.
After class, your written assignment (both the CON application and Power Point slides) is considered together with your class presentation for your Final Advocacy Project grade.
This module is dedicated to the final simulation and essay exam. If you have any questions, contact me directly.
At the conclusion of this module, you should be able to:
· Experience the simulation and appraise the ethical dilemma.
· Demonstrate understanding of knowledge gained throughout the course from readings, discussions, and activities.
· Formulate your own recommendation to resolve the dilemma synthesizing multiple stakeholder perspectives, legal concerns, guiding values and fair process principles.
· Apply original, critical thinking and research skills to identify and document a need for health care services and/or facilities in the community, within the parameters of the certificate of need program in Tennessee.
· Prepare an abbreviated mock CON application using the official forms and applying the official criteria and standards of the Tennessee Health Services and Development Agency.
· Prepare a PowerPoint slide deck and make a presentation of the CON application you have prepared, advocating for the approval of the CON. Persuasively articulate your project to our class in a mock CON presentation and explain how the project meets the State’s criteria for CON approval.
These outcomes correspond to the following course objectives as stated in your syllabus:
· Identify a variety of key legal responsibilities, civil and criminal liability, perspectives and rights of major stakeholders, including selected healthcare organizations, providers, and patients, in the U.S. healthcare system.
· Evaluate and debate resolutions to current healthcare legal issues and ethical dilemmas by applying ethical and legal frameworks and reasoning.
· Creatively formulate and persuasively communicate your strategic recommendations to solve pressing health care problems with ethical and legal solutions.
Book: https://books.google.com/books?hl=en&lr=&id=j7J5DwAAQBAJ&oi=fnd&pg=PP1&dq=Legal+and+Ethical+Issues+for+Health+Professionals&ots=vMqsTnjhzu&sig=v_eGtmtjpSj1LUQwkxVISxwC79U#v=onepage&q=Legal%20and%20Ethical%20Issues%20for%20Health%20Professionals&f=false
BLAW 6500 MOCK CON APPLICIATON AND PRESENTATION
I. SCOPE OF THE ASSIGNMENT
1. Choose one of the following types of heath care facilities, the establishment of which requires a CON under Tennessee law, to be the subject of your CON application:
· Hospital
· Nursing Home
· Ambulatory Surgical Treatment Center (“ASTC”)
· Outpatient Diagnostic Center (“ODC”)
2. Choose one of the following counties in which you will propose to locate the new facility:
· Davidson County
· Rutherford County
· Williamson County
· Wilson County
Your choice of county might be influenced by the number of that type of facility already existing in the county. Please see the References and Resources document for sources you can check to determine that.
3. Prepare a Mock CON Application for your chosen facility and county in accordance with the instructions below, using the Mock CON Application form provided. You are not expected to know all the nuances of the law and regulations, and all of the many data sources needed to accurately and fully prepare a CON application. I am looking for you to demonstrate to me you are thinking logically about a balance of (a) allocation of limited health care resources and (b) consumer needs — within the context and parameters of the Tennessee CON program.
4. Your CON application must cite data or information you obtained from at least 3 of the sources identified in the References and Resources document.
5. Prepare a Power Point presentation of your CON application (please see the instructions below).
II. INSTRUCTIONS FOR THE MOCK CON APPLICATION:
1. This is a very abbreviated version of the full CON application form. Many questions have been left out, and those questions which are included retain their original numbering as they are in the full application (thus the gaps in question numbers). If you are interested you can take a look at the complete official CON application form on the HSDA website (a link is included on the References and Resources document for this assignment).
2. Some of the questions on the abbreviated form are marked “N/A.” This means you
do not have to respond to those questions. These questions are left in the form because they are important in getting a better understanding of the scope and goals of the CON process, but the responses called for are beyond the scope of your assignment.
3. A few of the “N/A” questions are followed by a
Question in italics
. These are questions I have inserted into the application form, and a response from you is required.
4. The applicant for your mock CON application should be a hypothetical provider. Please do not use the name of an actual hospital or other provider. As far as addresses and those types of
non-substantive things – just make something up.
5. The References and Resources document has the links to publicly available data sources which should be useful to you. Data or other information from at least three of these sources must be used and cited in your Mock CON Application You are free to use other resources and authorities, but you need to cite the source in the document after the data is used.
6. You may look at other CON applications which have been filed and are on the HSDA website, but keep in mind that any application filed before October 1, 2021 was governed by a since-replaced law, and those pre-October 1 applications utilized an application form different from the one in use today. If you use language from an existing application you must appropriately cite it – no plagiarism!
III. INSTRUCTIONS FOR THE POWER POINT PRESNTATION
1. You must use Microsoft Power Point to create the slides for your presentation.
2. Your presentation must not exceed 5 minutes in duration. You should not include anything in the slides that is not at least referenced in your CON application.
3. Assume you are making this presentation to members of the Tennessee Heath Services and Development Agency (“HSDA”), who know all about the CON program. Don’t waste time talking about what CON covers and doesn’t cover, the reasons for CON, or that kind of thing. Concentrate on your project and why it should be approved.
4. In an actual application situation, the HSDA would have a copy of your full application so you don’t have to put everything that is in the application in the slide deck. Choose a few points you think are the strongest and concentrate on them in the slides and in your presentaion.
The purpose of this assignment is to learn something regarding government regulation and “allotment” of health care resources, and to help you develop advocacy skills. I hope you can also have some fun with this! Good luck!
Adjunct Professor Taylor
State of Tennessee
Health Facilities Commission
Andrew Jackson Building, 9th Floor, 50
2
Deaderick Street, Nashville, TN
3
72
4
3
www.tn.gov/hsda Phone: 6
1
5-741-2364 Email: hsda.staff@tn.gov
CERTIFICATE OF NEED APPLICATION
1
A.
Name of Facility, Agency, or Institution
(Students – put the name of your hypothetical health care facility or service)
Name |
||||||||
Street or Route |
County |
|||||||
City |
State |
Zip |
||||||
Website Address |
Note: The facility’s name and address
must be
the name and address of the project and
must be
consistent with the Publication of Intent.
2A.
Contact Person Available for Responses to Questions
(Students – your name goes here).
Title |
||
Company Name |
Email Address |
|
Association with Owner |
Phone Number |
3A.
Proof of Publication – N/A
Attach the full page of newspaper in which the notice of intent appeared with the mast and dateline intact or submit a publication affidavit from the newspaper that includes a copy of the publication as proof of the publication of the letter of intent. (Attachment 3A)
Date LOI was Submitted:
Date LOI was Published:
4A.
Purpose of Review
(Check appropriate box(es) – more than one response may apply)
Establish New Health Care Institution
Addition of a Specialty to an Ambulatory Surgical Treatment Center (ASTC)
Change in Bed Complement
Initiation of Health Care Service as Defined in §TCA 68-11-1607(3) Specify: _____
Relocation
Initiation of MRI Service
MRI Unit Increase
Satellite Emergency Department
Addition of ASTC Specialty
Initiation of Cardiac Catheterization
Addition of Therapeutic Catheterization
Establishment of a Non-Residential Substitution Based Opioid Treatment Center
Linear Accelerator Service
Positron Emission Tomography (PET) Service
Please answer all questions on letter size, white paper, clearly typed and spaced, single sided, in order and sequentially numbered. In answering, please type the question and the response. All questions must be answered. If an item does not apply, please indicate “N/A” (not applicable). Attach appropriate documentation as an Appendix at the end of the application and reference the applicable item Number on the attachment, i.e. Attachment 1A, 2A, etc. The last page of the application should be a completed signed and notarized affidavit.
5A.
Type of Institution
(Check all appropriate boxes – more than one response may apply)
Hospital (Specify):
Ambulatory Surgical Treatment Center (ASTC) – Multi-Specialty
Ambulatory Surgical Treatment Center (ASTC) – Single Specialty
Home Health
Hospice
Intellectual Disability Institutional Habilitation Facility (ICF/IID)
Nursing Home
Outpatient Diagnostic Center
Rehabilitation Facility
Residential Hospice
Nonresidential Substitution Based Treatment Center of Opiate Addiction
Other (Specify):
6A.
Name of Owner of the Facility, Agency, or Institution – N/A
EXECUTIVE SUMMARY
1
E.
Overview
Please provide an overview not to exceed
ONE PAGE (for 1E only) in total explaining each item point below.
·
Description: Address the establishment of a health care institution, initiation of health services, and/or bed complement changes.
RESPONSE:
·
Ownership structure – N/A
·
Service Area (Counties in which you expect most of the patients will reside). N/A
RESPONSE:
·
Existing similar service providers in the county you propose to serve
RESPONSE:
·
Project Cost — N/A
·
Staffing – N/A
2E.
Rationale for Approval
A Certificate of Need can only be granted when a project is necessary to provide needed health care in the area to be served, will provide health care that meets appropriate quality standards, and the effects attributed to competition or duplication would be positive for consumers
Provide a brief description not to exceed
ONE PAGE (for 2E only)
of how the project meets the criteria necessary for granting a CON using the data and information points provided in criteria sections that follow.
·
Need
RESPONSE:
·
Quality Standards
RESPONSE:
·
Consumer Advantage
·
Choice
·
Improved access/availability to health care service(s)
·
Affordability
RESPONSE:
3E.
Consent Calendar Justification – N/A
Consent Calendar Requested (Attach rationale)
If Consent Calendar is requested, please attach the rationale for an expedited review in terms of Need, Quality Standards, and Consumer Advantage as a written communication to the Agency’s Executive Director at the time the application is filed.
Consent Calendar
NOT
Requested
4E.
PROJECT COST CHART — N/A
A. |
Construction and equipment acquired by purchase: |
|||||||||||||||||||||||
1. |
Architectural and Engineering Fees |
________
__________ |
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2. |
Legal, Administrative (Excluding CON Filing Fee ), Consultant Fees |
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3. |
Acquisition of Site |
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4. |
Preparation of Site |
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5. |
Total Construction Costs |
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6. |
Contingency Fund |
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7. |
Fixed Equipment (Not included in Construction Contract) |
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8. |
Moveable Equipment (List all equipment over $50,000 as separate attachments) |
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9. |
Other (Specify) __________________________ _ |
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B. |
Acquisition by gift, donation, or lease: |
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Facility (inclusive of building and land) |
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Building only |
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Land only |
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Equipment (Specify)______________________ |
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Other (Specify) __________________________ | ||||||||||||||||||||||||
C. |
Financing Costs and Fees: |
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Interim Financing |
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Underwriting Costs |
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Reserve for One Year’s Debt Service |
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D. |
Estimated Project Cost (A+B+C) |
__________________ |
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E. | CON Filing Fee | |||||||||||||||||||||||
F. |
Total Estimated Project Cost (D+E) |
__________________ |
GENERAL CRITERIA FOR CERTIFICATE OF NEED
In accordance with TCA §68-11-1609(b), “no Certificate of Need shall be granted unless the action proposed in the application for such Certificate is necessary to provide needed health care in the area to be served, will provide health care that meets appropriate quality standards, and the effect attributed to completion or duplication would be positive for consumers.” In making determinations, the Agency uses as guidelines the goals, objectives, criteria, and standards adopted to guide the agency in issuing certificates of need. Until the agency adopts its own criteria and standards by rule, those in the state health plan apply. Link to Criteria and Standards: Standards:
https://www.tn.gov/hsda/hsda-criteria-and-standards.html
Additional criteria for review are prescribed in Chapter 11 of the Agency Rules, Tennessee Rules and Regulations 01730-11.
The following questions are listed according to the three criteria: (1) Need, (2) the effects attributed to competition or duplication would be positive for consumers (Consumer Advantage), and (3) Quality Standards.
NEED
The responses to this section of the application will help determine whether the project will provide needed health care facilities or services in the area to be served.
1N. Provide responses as an attachment to the applicable criteria and standards for the
type of institution or service requested. A word version and pdf version for each reviewable type of institution or service are located at the following website.
https://www.tn.gov/hsda/hsda-criteria-and-standards.html.
RESPONSE:
[Students – You do not have to respond to the Criteria and Standards. However, you must attach a copy of the Criteria and Standards which would be applicable to your type of project (hospital, nursing home, etc. from the website – link is provided in the paragraph above) to show me you went to the website and chose the correct set of criteria.
]
2N. Identify the proposed service area and provide justification for its reasonableness. Submit a county level map for the Tennessee portion and counties boarding the state of the service area using the supplemental map, clearly marked, and shaded to reflect the service area as it relates to meeting the requirements for CON criteria and standards that may apply to the project. Please include a discussion of the inclusion of counties in the border states, if applicable. (Attachment 2N). N/A
Complete the following utilization tables for each county in the service area, if applicable. N/A
Service Area Counties |
Projected Utilization-County Residents to be Served – Year 1 (Year=__________) |
% of Total |
||
County #1 |
||||
County #2 |
||||
County #3 |
||||
Etc. |
||||
Total |
100% |
4N. Describe the special needs of the service area population, including health disparities, the accessibility to consumers, particularly those who are uninsured or underinsured, the elderly, women, racial and ethnic minorities, TennCare or Medicaid recipients, and low income groups. Document how the business plans of the facility will take into consideration the special needs of the service area population.
RESPONSE:
CONSUMER ADVANTAGE ATTRIBUTED TO COMPETITION
The responses to this section of the application helps determine whether the effects attributed to competition or duplication would be positive for consumers within the service area.
1C. List all transfer agreements relevant to the proposed project. N/A
2C. List all commercial private insurance plans contracted or plan to be contracted by the applicant. N/A
3C. Describe the effects of competition and/or duplication of the proposal on the health care system, including the impact upon consumer charges and consumer choice of services.
RESPONSE:
6C. See
INSTRUCTIONS to assist in completing the following tables. N/A
HISTORICAL DATA CHART — N/A |
□ Project Only □ Total Facility |
||||||||||||||||||
Give information for the last |
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Year___ _ _ |
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Utilization Data Specify Unit of Measure _______________ |
________ |
________ |
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Revenue from Services to Patients |
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Inpatient Services |
$________ |
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Outpatient Services |
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Emergency Services |
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Other Operating Revenue (Specify)_____________ _______ |
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Gross Operating Revenue |
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Deductions from Gross Operating Revenue |
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Contractual Adjustments |
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Provision for Charity Care |
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Provisions for Bad Debt |
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Total Deductions |
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NET OPERATING REVENUE |
PROJECTED DATA CHART — N/A |
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Give information for the two (2) years following the completion of this proposal. |
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Year______ |
|||||||||||
__________ | |||||||||||
1 |
$__________ |
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2 | |||||||||||
3 | |||||||||||
4 | Other Operating Revenue (Specify)_____________ | ||||||||||
$__________ |
|||||||||||
7C. Please identify the project’s average gross charge, average deduction from operating revenue, and average net charge using information from the Historical and Projected Data Charts of the proposed project. N/A
Project Only Chart N/A
Previous Year to Most Recent Year Year ____ |
Most Recent Year Year____ |
Year One Year___ |
Year Two Year____ |
% Change (Current Year to Year 2) |
Gross Charge |
||||
Deduction from Revenue |
||||
Average Net Charge |
8C. Provide the proposed charges for the project and discuss any adjustment to current charges that will result from the implementation of the proposal. Additionally, describe the anticipated revenue from the project and the impact on existing patient charges.
N/A
9C. Compare the proposed project charges to those of similar facilities/services in the service area/adjoining services areas, or to proposed charges of recently approved Certificates of Need. If applicable, compare the proposed charges of the project to the current Medicare allowable fee schedule by common procedure terminology (CPT) code(s).
N/A
Question:
Questions 6C-9C examine charges to consumers. Please explain why you think health care providers “charges” are important, in light of the fact insurance companies pay much of those charges.
RESPONSE:
10C. Discuss the project’s participation in state and federal revenue programs, including a description of the extent to which Medicare,
TennCare/Medicaid
, and medically indigent patients will be served by the project. Report the estimated gross operating revenue dollar amount and percentage of project gross operating revenue anticipated by payor classification for the first year of the project by completing the table below.
N/A
Applicant’s Projected Payor Mix N/A
Payor Source |
Year 1 |
Year 2 |
Medicare/Medicare Managed Care |
||
TennCare/Medicaid | ||
Commercial/Other Managed Care |
||
Self-Pay |
||
Other (Specify)________________ |
||
Total* |
||
Charity Care |
*Needs to match Gross Operating Revenue Year One and Year Two on Projected Data Chart
Question:
Why is the Payor Mix important? What state interests are at stake here?
RESPONSE:
QUALITY STANDARDS
1Q. Per PC 1043, Acts of 2016, any receiving a CON after July 1, 2016, must report annually using forms prescribed by the Agency concerning appropriate quality measures. Please attest that the applicant will submit an annual Quality Measure report when due. –
N/A
RESPONSE:
2Q. The proposal shall provide health care that meets appropriate quality standards. Please address each of the following questions. – All of the following questions are
N/A
· Does the applicant commit to maintaining the staffing comparable to the staffing chart presented in its CON application?
· Does the applicant commit to obtaining and maintaining all applicable state licenses in good standing?
· Does the applicant commit to obtaining and maintaining TennCare and Medicare certification(s), if participation in such programs are indicated in the application?
RESPONSE:
7Q. Respond to all of the following and for such occurrences, identify, explain, and provide documentation if occurred in last five (5) years. – All the following questions are
N/A
Has any of the following:
· Any person(s) or entity with more than 5% ownership (direct or indirect) in the applicant (to include any entity in the chain of ownership for applicant);
· Any entity in which any person(s) or entity with more than 5% ownership (direct or indirect) in the applicant (to include any entity in the chain of ownership for applicant) has an ownership interest of more than 5%; and/or
Been subject to any of the following:
· Final Order or Judgement in a state licensure action;
· Criminal fines in cases involving a Federal or State health care offense;
· Civil monetary penalties in cases involving a Federal or State health care offense;
· Administrative monetary penalties in cases involving a Federal or State health care offense;
· Agreement to pay civil or administrative monetary penalties to the federal government or any state in cases involving claims related to the provision of health care items and services;
· Suspension or termination of participation in Medicare or TennCare/Medicaid programs; and/or
· Is presently subject of/to an investigation, or party in any regulatory or criminal action of which you are aware.
Question:
Assuming all the sanctions or disciplinary actions listed above are under the authority of a federal agency and/or a state agency
other than HFC (which is the case), why is this question included in the CON application?
RESPONSE:
DEVELOPMENT SCHEDULE – N/A
TCA §68-11-1609(c) provides that activity authorized by a Certificate of Need is valid for a period not to exceed three (3) years (for hospital and nursing home projects) or two (2) years (for all other projects) from the date of its issuance and after such time authorization expires; provided, that the Agency may, in granting the Certificate of Need, allow longer periods of validity for Certificate of Need for good cause shown. Subsequent to granting the Certificate of Need, the Agency may extend a Certificate of Need for a period upon application and good cause shown, accompanied by a non-refundable reasonable filing fee, as prescribed by rule. A certificate of Need authorization which has been extended shall expire at the end of the extended time period. The decision whether to grant an extension is within the sole discretion of the Agency, and is not subject to review, reconsideration, or appeal.
· Complete the Project Completion Forecast Chart below. If the project will be completed in multiple phases, please identify the anticipated completion date for each phase.
· If the CON is granted and the project cannot be completed within the standard completion time period (3 years for hospital and nursing home projects and 2 years for all others), please document why an extended period should be approved and document the “good cause” for such an extension.
PROJECT COMPLETION FORECAST CHART – N/A
Assuming the Certificate of Need (CON) approval becomes the final HSDA action on the date listed in Item 1 below, indicate the number of days from the HSDA decision date to each phase of the completion forecast. N/A
Phase |
Days Required |
Anticipated Date (Month/Year) |
1. Initial HSDA Decision Date |
||
2. Building Construction Commenced |
||
3. Construction 100% Complete (Approval for Occupancy) |
||
4. Issuance of License |
||
5. Issuance of Service |
||
6. Final Project Report Form Submitted (Form HR0055) |
image1
REFERENCE AND RESOURCE MATERIALS FOR MOCK CON APPLICATION
BLAW 6500
Health Services and Development Agency Home Page:
https://www.tn.gov/hsda.html
Complete official CON Application form (HSDA):
https://www.tn.gov/hsda/con-forms.html
.
· For this assignment use the abbreviated form I have provided.
· Do not use the complete, official form on the website.
CON Criteria and Standards for Health Care Facilities and Services:
https://www.tn.gov/hsda/hsda-criteria-and-standards.html
.
· You are not required to respond to each of the criteria for whatever type of service or facility that is the subject of your CON application, but you must attach a copy of the applicable set of criteria.
· You will need to download it and convert it to Word format and include the copy as an attachment to your application (as explained in the application form).
Joint Annual Reports from health care providers – Tennessee Department of Health:
https://apps.health.tn.gov/publicjars/default.aspx-
.
· These mandated annual reports from hospitals, ambulatory surgical treatment facilities, nursing homes, and outpatient diagnostic centers include utilization data for the reporting year.
· They are normally a year or two behind the current date, but you may rely on the data in these reports.
*(Note: this is a very “clunky” site. Each time you make a change from a drop-down menu, wait for the page to “refresh” before continuing. If it goes down, you are usually able to exit the site and re-enter it and it will function properly again).
Licensed health care facilities by county of location and type of service:
https://dhlrapps.health.tn.gov/FacilityListings
· This will show you the existing inventory of licensed facilities in any given county.
· The “Current Search” function should be all that is needed for this assignment.
US Census Bureau – Quick Facts:
https://www.census.gov/quickfacts/fact/table/US/PST045219
.
· This is searchable by state and county and shows certain demographic information which may be helpful (e.g., population, median income, and poverty rates).
· You may wat to consult this when responding to questions about “special needs” of the population you are proposing to serve.
TennCare Enrollment Data:
https://www.tn.gov/tenncare/information-statistics/enrollment-data.html
.
· This shows the number of TennCare enrollees in any given county, and the percentage of the total population of the county TennCare enrollees represent.
· You may wat to consult this when responding to questions about “special needs” of the population you are proposing to serve.