How to Develop a Clinical Study Site Budget

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "How to Develop a Clinical Study Site Budget"

Transcription

1 How to Develop a Clinical Study Site Budget Mary Fautsch Dale Klous White Paper 6/23/2011 Abstract Summary In today s dynamic environment, there is a need like never before for clinical data. In addition to IDE s, companies are finding themselves doing clinical studies for 510(k) products as well as market approved products. Once the protocol is written and the sites are being selected, the next big task is developing a site budget that is comprehensive and defensible. This can be an overwhelming task, especially if you are a not an accountant and are uncomfortable with developing budgets. This paper will provide an overview of clinical study site budgets, describe the importance of creating a defensible study budget, provide a process for building a site budget and discuss tips for negotiating the budget. Overview Changing economic conditions, a difficult reimbursement climate, and an unpredictable FDA are creating a variety of challenges across the industry. The FDA and payors are increasingly requiring convincing clinical evidence which generally requires sponsors to conduct large clinical trials. For many companies, such as those who have primarily followed a 510(k) path to market, launching a large clinical research project is a new venture. The process of building a study site budget for these sponsored trials can be an added challenge for those who have never previously created site budgets. This paper will describe some of the key elements surrounding budget development and budget negotiation. What is a Site Budget? A site budget includes both the direct and indirect costs associated with the tasks and activities described within a study protocol (Table 1). In other words, the site budget is full compensation for the cost of conducting a study at a research site. Typical direct costs include procedure fees (i.e. radiographic images, ECGs, MRIs) and various patient assessments (i.e. medical history, physical exam, quality of life survey). Direct costs outside of defined procedures or assessments often exist. For instance, when conducting an FDA regulated trial, the agency requires direct oversight by the principal investigator; naturally, this oversight translates into time and cost. The study coordinator will also spend time recruiting patients, working with site monitors, filing regulatory documents, and consulting with the principal investigator regarding the status of the study. The cost of these activities is more difficult to estimate, but time is a direct cost and research sites will expect compensation for investigator and coordinator salaries. RCRI is a leader in providing integrated CRO services to the medical device, IVD, biologic, and combination product industries.

2 The indirect costs associated with a study are sometimes referred to by study sites as the hidden costs. Typical indirect fees include facility overhead; such as, electricity, phone charges, space, and use of copy machines. Institutions will also realize indirect administrative expenses such as the time and effort associated with providing trained staff to support the trial. The site may also incur legal and financial service fees associated with contract review and maintenance. Research sites often feel that sponsors do not adequately recognize the indirect costs associated with conducting a clinical study. Therefore, it is especially important to be cognizant of the indirect costs. Table 1. Examples of Direct and Indirect Costs Direct Costs Study Defined Procedures (-rays, ECGs, diagnostic procedures) Study Assessments (Patient reported outcomes, Medical History) Investigator and Coordinator Fees IRB Fees Patient Stipend Advertising Indirect Costs Facility Overhead (electricity, space, phone charges) Administrative Fees (Staffing, Legal, Financial) Record Storage Implications For most medical device companies, clinical trials are the largest single area of R&D operating expense, and within a clinical trial, site budgets typically represent the majority of these costs. In addition to the cost implications, site budgets can have an effect on study success. Research sites do not take on clinical studies to lose money. Study site budgets need to represent a fair market value. A site budget that is below the fair market value will lead to limited attention by the study staff and a lackluster rate of subject enrollment. While a low budget can have a negative impact on study success, it is important to point out that excessive budgets can also have negative consequences. Namely, over recent years, there has been growing public scrutiny concerning industry payments to physicians. Sponsors need to avoid the appearance that a study budget is an attempt to influence investigator behavior. Across the industry, the process of establishing acceptable levels of payment is becoming more transparent. For instance, many institutions, professional organizations, and sponsor companies have developed physician payment guidelines to avoid the appearance of any impropriety. When developing a site budget it is necessary to walk a fine line the budget needs to be fair, but not excessive. How to Develop a Clinical Study Site Budget 2

3 Building the Budget Ideally, the study sponsor should drive the budget development process. Budgets are then presented to research sites by the study sponsor or a designee (i.e. CRO). It is generally best to present a draft budget to candidate sites at an early stage of site recruitment. The process of qualifying a site and the effort required to execute a site contract can be lengthy and time consuming. Therefore, it is best to know early in the process if the site feels that your study budget is in the ballpark. The budget is ultimately tied to a contract or clinical trial agreement which legally describes what is expected from the investigator and institution. The contract will also include details of how and when the site will receive payments for study related activities. To build a budget the following information is required: Schedule of Events (Table 2). The schedule of events describes all of the study related procedures and assessments to be performed per the protocol across a defined visit schedule. Staff Salary Estimate (principal investigator, study coordinator). Facility billing codes and payment rates for tests and procedures occurring in a facility. Physician billing codes and associated payment rates for tests and procedures performed by the physician. Estimated Overhead (e.g. typically, 12%-30%). Table 2. Sample Schedule of Events STUDY PROCEDURE Informed Consent Demographics Medical History STUDY VISITS Baseline Discharge Follow-up Time Period from Surgery 1 Wk 1 Mo 3 Mo 6 Mo 12 Mo Physical Exam Vital Signs Neurological Exam MRI VAS (Back and Leg) Quality of Life (SF-36) Hematology (WBC, Hgb,) Adverse Events With the study related tasks organized across a defined visit schedule, the first step in creating the actual budget numbers is to identify the procedures that have established billing codes. For these procedures (i.e. MRI, WBC, etc.) document the average payment level that corresponds with the code that describes the procedure or service (Table 3). Because Medicare is the only payor which provides their fee schedule, regulations and policies as public information, the Medicare National Average Payment is frequently used as a baseline to establish the estimated payment levels. The elements to calculate the Medicare payment levels are published annually in the Federal Register and can also be found at the Centers for Medicare and Medicaid Services website (cms.gov). The rules and regulations are organized by site of service (Hospital Inpatient, How to Develop a Clinical Study Site Budget 3

4 Hospital Outpatient, Physician, etc.). If the majority of the participants in your study will be under 65 years of age and thus eligible for commercial insurance, inflating the Medicare fee schedule by 20%-40% would be appropriate. Table 3. Sample Schedule of Events with Estimated Costs per Medicare Fee Schedule STUDY VISITS Follow-up Time Period from Surgery STUDY PROCEDURE Baseline Discharge 1 Wk 1 Mo 3 Mo 6 Mo 12 Mo Informed Consent Demographics Medical History Physical Exam $102 $97 $102 $102 $102 $102 $102 Vital Signs Neurological Exam MRI $129 VAS (Back and Leg) Quality of Life (SF-36) Hematology (WBC, Hgb,) $9 Adverse Events Some study-related tasks will not have a corresponding Medicare fee schedule (i.e. informed consent, adverse event review, etc.). For these procedures, you should develop the cost estimate based on the resource(s) expected to perform the task (i.e. physician and/or coordinator) and the anticipated amount of time required to complete the task. Next you need to decide on an hourly rate for the assigned resource (Note: Several national organizations publish annual salary surveys for research professionals). For example, the process of obtaining informed consent requires time from both the research coordinator and the principal investigator. Let s assume that the consent process requires 30 minutes of the study coordinator s time at an hourly rate of $60 and 10 minutes of the principal investigator s time at an hourly rate of $300. Therefore, $80 would be budgeted for the cost of the informed consent. (Table 4) Table 4. Example of Cost Calculation for Informed Consent Resource Hourly Salary Time Assumption Cost Principal Investigator $ minutes $50 Study Coordinator $60 30 minutes $30 $80 It is important to document all of your assumptions so you can easily reference them if needed during conversations with research sites (Table 5). How to Develop a Clinical Study Site Budget 4

5 Table 5. Sample Documentation Description CPT-4 Code CPT-4 Description 2011 National Average Medicare Payment Market Assumption Medical/Surgical Office or other outpatient visit for the History evaluation and management of an $102 established patient, which requires at least Physical Exam 2 of these 3 key components: A detailed history; A detailed examination; Medical decision making of moderate complexity. Vital Signs Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) Neurological Exams and the patient s and/or family s needs. Usually, the presenting problem(s) are of moderate to high severity. Physicians typically spend 25 minutes face-to-face with the patient and/or family. MRI Magnetic resonance (e.g., proton) imaging, spinal canal and contents, without contrast $129 material, followed by contrast material(s) and further sequences; thoracic Magnetic resonance (e.g., proton) imaging, MRI TC spinal canal and contents, without contrast $556 material, followed by contrast material(s) and further sequences; thoracic. Informed Consent Research Time $80 It is also necessary to differentiate procedures and services which are considered standard of care and those which are not. Procedures and services routinely performed as a part of the treatment or care plan are considered standard of care; those that that are done solely to support the research objective are not. The costs associated with the procedures and services which are a direct result of the research are the responsibility of the sponsor; those that are considered standard of care are billed to the payor (Table 6). The interpretation of what is standard of care during a clinical study may vary by payor. How to Develop a Clinical Study Site Budget 5

6 Table 6. Example of Completed Budget Worksheet STUDY PROCEDURE Baseline Discharge STUDY VISITS Follow-up Time Period from Surgery 1 Wk 1 Mo 3 Mo 6 Mo 12 Mo TOTAL Informed Consent $80 $80 Demographics $50 $50 Medical/Surgical History Physical Exam Vital Signs Neurological Exam $102 $97 $102 $102 $102 $102 $102 $709 MRI $129 $129 VAS (Back and Leg) $40 $40 $40 $40 $40 $40 $240 Quality of Life (SF-36) $76 $76 $76 $76 $76 $375 Hematology (WBC, Hgb,) $9 $9 Adverse Events $25 $25 $25 $25 $25 $25 $150 SUBTOTAL OTHER COSTS Insitutional Overhead (12%-30%) Clinical Sudy Coordinator Fee ($80/hour) Principal Investigator Fee ($300/hour) Patient Reimbursement Facility Payments (Radiology) TC $556 $556 Patient Reimbursement TOTAL Assumptions Standard of Care $xx $xx Medicare Fee Schedule Market Assumptions Once the study induced costs, salaries, and overhead have been consolidated into one worksheet, the overall cost per patient can be calculated with and without an overhead assumption (Table 7). Prior to talking with the research sites, it is also important to plan for the implementation of the payment terms. Will the payment schedule be monthly, quarterly, or based on completed and monitored case report forms? Will an invoice from the site be required? It is important to plan payment schedules in advance so sites know what to expect. How to Develop a Clinical Study Site Budget 6

7 Table 7. Payment Schedule Per Patient Services and Timeline Baseline Discharge Budget Estimate Per Patient $1041 $122 1 Week Follow-Up $167 1 Month Follow-Up 3 Month Follow-Up 6 Month Follow-Up 12 Month Follow-Up $242 $242 $242 $242 Subtotal $2,298 Total with 25% Overhead $2,873 Site Budget Negotiations Each site will have different needs, requests and perspectives, so plan to negotiate. A significant component of a negotiation is mental preparation. If you plan for it to be challenging, difficult and tense it will be. Try to view budget negotiations as a dialogue or a discussion an exchange of information. Expect it to be a discussion with an exchange of information and perspectives and that you will listen as much, if not more, than you speak. Also, consider that the research sites you are speaking with are most likely potential or current customers who you will likely wish to maintain a relationship with. It is also helpful to anticipate variables or objectives from the perspective of the research site and have a plan for how you will respond. The best way to prepare is to identify the potential variables in advance of your conversation and have a prepared response outlining your position and rationale. This should be succinct and defendable. It should also be documented to ensure a consistent message to sites. Finally, if there are any limits or guidelines that you are expected to stay within; know them in advance. (Table 8). As you start having the conversation with the site consider it a conversation. Ask questions and seek to understand the site s position. The long term goal of the conversation is to have a solid, respectful relationship no matter the outcome of the negotiation. There will always be questions from sites that you are not prepared for, no matter how much you plan. Rather than trying to create an answer on the spot, it is appropriate to state that you need to do some additional research and will get back to the site in a defined amount of time. As you proceed through the negotiations, document your decisions, agreements, and areas of difference so you have a record of what has been agreed to and what is still open. How to Develop a Clinical Study Site Budget 7

8 Table 8. Sample Negotiation Worksheet Negotiation Variable or Objection Position Rational Limits Outcome In today s economic environment, sites are sensitive to the costs of clinical research. The additional time to prepare and plan for your budget negotiations will increase your confidence, allow you to defend your assumptions and position, anticipate alternative perspectives, obtain better results and increase the efficiency of the process. The medical community, research staff and industry sponsors must all work together to ensure a mutually beneficial economic arrangement in which everyone benefits. Regulatory and Clinical Research Institute, Inc. The premier integrated Contract Research Organization (CRO) for Medical Devices, IVDs & Biologics. RCRI is a world leader in providing superior CRO services. How to Develop a Clinical Study Site Budget 8

NEGOTIATING CLINICAL TRIAL BUDGETS. Debbie Williams R.N., C.C.R.C., C.R.A., A.B.N.

NEGOTIATING CLINICAL TRIAL BUDGETS. Debbie Williams R.N., C.C.R.C., C.R.A., A.B.N. NEGOTIATING CLINICAL TRIAL BUDGETS Debbie Williams R.N., C.C.R.C., C.R.A., A.B.N. A.B.N. Amateur Budget Negotiator OVERVIEW Budget Types Analyzing the Protocol Negotiating the Contract Discussion / Tips

More information

HIRING A QUALIFIED OFFICE STAFF

HIRING A QUALIFIED OFFICE STAFF Tinsley, Reed. Streamlining Medical Practice Reimbursements. Career Pulse December 1994: 38-41. Streamlining Medical Practice Reimbursements Physicians must actively manage their medical practices for

More information

Clinical Trials Budgeting and Billing

Clinical Trials Budgeting and Billing Clinical Trials Budgeting and Billing Presented by: Ellen N. Jamieson, MS, MBA Director, Grants Administration Alexandria Hui, BA Manager, Clinical Trial Financial Analyst Rules and Regulations Medicare

More information

Cheryl K. Bernstein RN, BSN, CCRC Director Bernstein Clinical Research Center, LLC Cincinnati, Ohio Cherylkb@fuse.net

Cheryl K. Bernstein RN, BSN, CCRC Director Bernstein Clinical Research Center, LLC Cincinnati, Ohio Cherylkb@fuse.net Cheryl K. Bernstein RN, BSN, CCRC Director Bernstein Clinical Research Center, LLC Cincinnati, Ohio Cherylkb@fuse.net Identify and discuss the language used in reciprocal or crossed indemnification and

More information

Coverage Analysis: The Cornerstone of Clinical Research Billing Presented by: Mary L. Veazie, CPA, MBA, CHC, CHRC Executive Director, Clinical

Coverage Analysis: The Cornerstone of Clinical Research Billing Presented by: Mary L. Veazie, CPA, MBA, CHC, CHRC Executive Director, Clinical Coverage Analysis: The Cornerstone of Clinical Research Billing Presented by: Mary L. Veazie, CPA, MBA, CHC, CHRC Executive Director, Clinical Research Finance The University of Texas MD Anderson Cancer

More information

2. For all clinical trials, the coverage analysis will also be audited to ensure compliance with the Medicare National Coverage Determination.

2. For all clinical trials, the coverage analysis will also be audited to ensure compliance with the Medicare National Coverage Determination. COMPLIANCE PROGRAM POLICY: Clinical Research Billing Audit Policy Effective Date: August 1, 2014 Last Updated: Page 1 of 8 I. POLICY All UC Irvine Health departments engaged in clinical research may be

More information

Objectives. Project Management Overview. Successful Project Fundamentals. Additional Training Resources

Objectives. Project Management Overview. Successful Project Fundamentals. Additional Training Resources Project Management for Small Business Moderator: Maria Mancha Frontline Systems, Inc. Objectives Project Management Overview Successful Project Fundamentals Additional Training Resources Project Management

More information

BSM Connection elearning Course

BSM Connection elearning Course BSM Connection elearning Course Basics of Medical Practice Finance: Part 1 2009, BSM Consulting All rights reserved. Table of Contents OVERVIEW... 1 FORMS OF DOING BUSINESS... 1 BUSINESS FORMATS AT A GLANCE...

More information

CLINICAL RESEARCH ROLES CLINICAL RESEARCH ROLESCLINICAL RESEARCH ROLES

CLINICAL RESEARCH ROLES CLINICAL RESEARCH ROLESCLINICAL RESEARCH ROLES CLINICAL RESEARCH ROLESCLINICAL RESEARCH ROLES 1. Clinical Study Team Principal Investigator Co Principal Investigator (Co PI) Research Coordinator Study Monitor Data manage Sponsor Post Doctoral Scholar

More information

How to Run Clinical Trials in Private Practice

How to Run Clinical Trials in Private Practice How to Run Clinical Trials in Private Practice Thomas M. Siler, MD Midwest Chest Consultants, PC Saint Charles, MO DISCLOSURE Dr. Siler has received research grants from GlaxoSmithKline, Forest, Boehringer

More information

6. MEASURING EFFECTS OVERVIEW CHOOSE APPROPRIATE METRICS

6. MEASURING EFFECTS OVERVIEW CHOOSE APPROPRIATE METRICS 45 6. MEASURING EFFECTS OVERVIEW In Section 4, we provided an overview of how to select metrics for monitoring implementation progress. This section provides additional detail on metric selection and offers

More information

Split Billing Overview

Split Billing Overview Split Billing Overview June 2, 2008 Doug McGregor Partner, Healthcare Services Feeley & Driscoll, P.C. (617) 742-7788 DougM@fdcpa.com Definitions Split Billing reimbursement A structure under which two

More information

Radiology Prior Authorization Program Frequently Asked Questions (FAQ) For AmeriChoice by UnitedHealthcare, Tennessee

Radiology Prior Authorization Program Frequently Asked Questions (FAQ) For AmeriChoice by UnitedHealthcare, Tennessee Radiology Prior Authorization Program Frequently Asked Questions (FAQ) For AmeriChoice by UnitedHealthcare, Tennessee 1. What is the AmeriChoice Radiology Prior Authorization Program? Acting on behalf

More information

ROLE OF THE RESEARCH COORDINATOR Study Start-up Best Practices

ROLE OF THE RESEARCH COORDINATOR Study Start-up Best Practices Clinical and Translational Science Institute / CTSI at the University of California, San Francisco Welcome to Online Training for Clinical Research Coordinators ROLE OF THE RESEARCH COORDINATOR Study Start-up

More information

NEGOTIATING STRATEGIES

NEGOTIATING STRATEGIES NEGOTIATING STRATEGIES Career Services GSU 309 768-4287 www.hartford.edu/career An aspect of the job search process that people tend to have the most questions about is negotiating; how does one go about

More information

Principal Investigator and Sub Investigator Responsibilities

Principal Investigator and Sub Investigator Responsibilities Principal Investigator and Sub Investigator Responsibilities I. Purpose To define the roles and responsibilities of Principal Investigators conducting research at GRU. II. Definition The term Principal

More information

Radiology Prior Authorization Program Frequently Asked Questions for the UnitedHealthcare Community Plan

Radiology Prior Authorization Program Frequently Asked Questions for the UnitedHealthcare Community Plan Radiology Prior Authorization Program Frequently Asked Questions for the UnitedHealthcare Community Plan 1. What is the UnitedHealthcare Radiology Prior Authorization Program? Acting on behalf of our Medicaid

More information

Review current regulatory climate Budget development Coverage analysis Charge reconciliation / 3 rd party billing Lessons learned

Review current regulatory climate Budget development Coverage analysis Charge reconciliation / 3 rd party billing Lessons learned Meeting the Challenge of Compliant Clinical Research Billing Kathy Hammerhofer, BSN, RN Kelly Nottingham, MPH, CHES Objectives Review current regulatory climate Budget development Coverage analysis Charge

More information

Comprehensive Study Documents List (Biomedical Studies)

Comprehensive Study Documents List (Biomedical Studies) Comprehensive Study Documents List (Biomedical Studies) Investigators conducting human subjects research must maintain study documents in adherence to federal and state regulations, USC policies, and good

More information

Orientation Manual for Clinical Research Coordinators

Orientation Manual for Clinical Research Coordinators Orientation Manual for Clinical Research Coordinators Maine Medical Center Research Institute Page 1 of 19 Version 1 (2009) MAINE MEDICAL CENTER RESEARCH INSTITUTE Statement of Mission, Vision, Goals and

More information

Coverage Analysis. Purpose

Coverage Analysis. Purpose Coverage Analysis Purpose The purpose of this policy is to provide a method for researchers to perform a Coverage Analysis (CA) for clinical research conducted at Mission Hospital, Inc., Memorial and St.

More information

Application for Research

Application for Research Application for Research All research conducted within the Brooks Rehabilitation system or any entity or facility bearing the Brooks name, including the Brooks Rehabilitation Clinical Research Center,

More information

Report of Independent Auditors and Consolidated Financial Statements. Kaweah Delta Health Care District

Report of Independent Auditors and Consolidated Financial Statements. Kaweah Delta Health Care District Report of Independent Auditors and Consolidated Financial Statements Kaweah Delta Health Care District June 30, 2014 and 2013 CONTENTS MANAGEMENT S DISCUSSION AND ANALYSIS 1 16 PAGE REPORT OF INDEPENDENT

More information

VIEW FROM WASHINGTON. Judi Lund Person, MPH Vice President, Compliance and Regulatory Leadership, NHPCO

VIEW FROM WASHINGTON. Judi Lund Person, MPH Vice President, Compliance and Regulatory Leadership, NHPCO 1 VIEW FROM WASHINGTON Judi Lund Person, MPH Vice President, Compliance and Regulatory Leadership, NHPCO Today we will discuss 2 Sequestration what s the latest New research on hospice cost savings Basic

More information

Part D Drugs & Medicare Coverage Rules

Part D Drugs & Medicare Coverage Rules Part D Drugs & Medicare Coverage Rules Ryan Meade, JD Meade & Roach, LLP RMeade@MeadeRoach.com 312.498.7004 Kristin H. West, JD Assoc. V.P. & Director, Office of Research Compliance Emory University kwest02@emory.edu

More information

Retiree Drug Coverage under the MMA: Issues for Public Comment to Maximize Enhancement in Drug Coverage and Reductions in Drug Costs for Retirees

Retiree Drug Coverage under the MMA: Issues for Public Comment to Maximize Enhancement in Drug Coverage and Reductions in Drug Costs for Retirees Retiree Drug Coverage under the MMA: Issues for Public Comment to Maximize Enhancement in Drug Coverage and Reductions in Drug Costs for Retirees Discussion Paper: CMS Employer Open Door Forum I. Summary:

More information

Not FDIC Insured May Lose Value Not Bank Guaranteed RETIREMENT FIDUCIARY FOCUS

Not FDIC Insured May Lose Value Not Bank Guaranteed RETIREMENT FIDUCIARY FOCUS USING ERISA ACCOUNTS TO HELP MANAGE FEE- RELATED FIDUCIARY RESPONSIBILITIES Not FDIC Insured May Lose Value Not Bank Guaranteed RETIREMENT FIDUCIARY FOCUS TABLE OF CONTENTS 1 Employer Fee Responsibilities

More information

INTERIM SITE MONITORING PROCEDURE

INTERIM SITE MONITORING PROCEDURE INTERIM SITE MONITORING PROCEDURE 1. PURPOSE The purpose of this SOP is to describe the interim monitoring procedures conducted at Institution, according to GCP and other applicable local regulations.

More information

HMI. Provide health care services with a cashless access (may include some cost sharing)

HMI. Provide health care services with a cashless access (may include some cost sharing) briefing note 11 Microinsurance Innovation Facility Third-party payment mechanisms in health microinsurance: practical tips and solutions Some health microinsurance (HMI) schemes require that patients

More information

A guide for the patient

A guide for the patient Understanding series LUNG CANCER CLINICAL TRIALS 1-800-298-2436 LungCancerAlliance.org A guide for the patient TABLE OF CONTENTS The Basics What is a Clinical Trial?...3 Types of Clinical Trials... 3 Phases

More information

Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com

Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com SAMPLE CRA CV Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com Education: Masters of Science, Healthcare Administration, Capital City University,

More information

Workflow and Process Analysis for CCC

Workflow and Process Analysis for CCC Section 3.6 Design Workflow and Process Analysis for CCC This tool introduces the importance of workflow and process improvement in a community-based care coordination (CCC) program, describes the value

More information

Reimbursement for Physician- Administered Drugs:

Reimbursement for Physician- Administered Drugs: Reimbursement for Physician- Purchased and Physician- Administered Drugs: Understanding the Buy and Bill Process 60889-R5-V1 This information is provided d for your background education and is not intended

More information

Explore New Roads Gap Medical. May Insurance Broker Meeting September 2015

Explore New Roads Gap Medical. May Insurance Broker Meeting September 2015 Explore New Roads Gap Medical May Insurance Broker Meeting September 2015 1 Why Explore New Roads? The New Road Marketplace changes Broker opportunities Customer needs Timely solutions ACA unfolding Shrinking

More information

(2) The neurological surgeon shall not participate in any activity, which is not in the best interest of the patient.

(2) The neurological surgeon shall not participate in any activity, which is not in the best interest of the patient. AANS Code of Ethics a) General Statement of Purpose The American Association of Neurological Surgeons has established a Code of Ethics for neurological surgeons as guidelines in medical, social, and professional

More information

Table of Contents NON-QUANTITATIVE TREATMENTS LIMITATIONS INCLUDED IN THIS SUMMARY:

Table of Contents NON-QUANTITATIVE TREATMENTS LIMITATIONS INCLUDED IN THIS SUMMARY: Answers to Key Questions This summary describes the general non-quantitative treatment limitations (NQTLs) that are applied to the behavioral benefits provided by United Behavioral Health ( Optum ). A

More information

How to Increase Site Productivity with a CTMS. Manage financials, meet timelines, increase compliance, and more...

How to Increase Site Productivity with a CTMS. Manage financials, meet timelines, increase compliance, and more... How to Increase Site Productivity with a CTMS Manage financials, meet timelines, increase compliance, and more... By Introduction Clinical trials are essential to the development and safety of new drugs

More information

RESEARCH STUDY PROTOCOL. Study Title. Name of the Principal Investigator

RESEARCH STUDY PROTOCOL. Study Title. Name of the Principal Investigator RESEARCH STUDY PROTOCOL Study Title Name of the Principal Investigator For research involving human subjects, certain elements must be included with each new IRB submission to ensure an effective review

More information

WHAT YOU SHOULD KNOW ABOUT MERGING YOUR PRACTICE

WHAT YOU SHOULD KNOW ABOUT MERGING YOUR PRACTICE WHAT YOU SHOULD KNOW ABOUT MERGING YOUR PRACTICE One night at dinner with his friend and colleague John, Bruce looks at him and says, we are both successful, good friends, cover for each other and trust

More information

Academic health centers play an essential

Academic health centers play an essential of Current Ryan D. Brutger, MA Together, academic and community health centers can treat patients, perform research, and expand clinical trials in ways that neither would be able to do on their own. Academic

More information

PRACTICE ANALYSIS. Strategic Planning and Market Analysis

PRACTICE ANALYSIS. Strategic Planning and Market Analysis PRACTICE ANALYSIS Developing a specific plan, communicating it clearly, and gaining support are essential steps in any business venture. Putting together a strategic plan, including analyzing your market,

More information

How B2B Customer Self-Service Impacts the Customer and Your Bottom Line. zedsuite

How B2B Customer Self-Service Impacts the Customer and Your Bottom Line. zedsuite How B2B Customer Self-Service Impacts the Customer and Your Bottom Line Introduction For small to mid-sized businesses trying to grow and compete with their larger counterparts, having close relationships

More information

Sponsor-CRO Collaboration Study. Executive Summary

Sponsor-CRO Collaboration Study. Executive Summary Sponsor-CRO Collaboration Study Executive Summary 2013 About Vantage Partners Vantage Partners, LLC is a global strategy and management consulting firm that specializes in helping companies achieve breakthrough

More information

National Bill Audit Services, LLC

National Bill Audit Services, LLC Founded in 2000, (NBAS) is an independent full service medical bill review and auditing firm specializing in the commercial payor market. Our experienced team of professionals works with health plans,

More information

GrantSpace - Collaboration Hub. Access to Healthcare Network. Participating Organizations. Primary Contact. Formation

GrantSpace - Collaboration Hub. Access to Healthcare Network. Participating Organizations. Primary Contact. Formation GrantSpace - Collaboration Hub Access to Healthcare Network Participating Organizations Saint Mary's Regional Hospital, Reno, NV Primary Contact Name:Mike Johnson Title:CEO Email:mike.johnson@chw.edu Please

More information

Grant Monitoring. Curriculum developed by the Office of Grants Management and Nonprofits Assistance Fund

Grant Monitoring. Curriculum developed by the Office of Grants Management and Nonprofits Assistance Fund Grant Monitoring Curriculum developed by the Office of Grants Management and Nonprofits Assistance Fund Who We Are The mission of Admin's Office of Grants Management is to standardize, streamline and improve

More information

Department of Mental Health

Department of Mental Health 332401 Forensic Services $4,319,519 $4,328,547 $4,371,610 $4,323,287 $3,089,969 $3,244,251 0.2% 1.0% -1.1% -28.5% 5.0% Section 335.10.10 of Am. Sub. H.B. 1 of the 128th G.A. (originally established by

More information

IDAHO STATE UNIVERSITY POLICIES AND PROCEDURES (ISUPP) HIPAA Privacy - Minimum Necessary Standard for Use and Disclosure of PHI 10190

IDAHO STATE UNIVERSITY POLICIES AND PROCEDURES (ISUPP) HIPAA Privacy - Minimum Necessary Standard for Use and Disclosure of PHI 10190 IDAHO STATE UNIVERSITY POLICIES AND PROCEDURES (ISUPP) HIPAA Privacy - Minimum Necessary Standard for Use and Disclosure of PHI 10190 POLICY INFORMATION Major Functional Area (MFA): MFA X - Office of General

More information

THE 2013 GENENTECH ONCOLOGY TREND REPORT

THE 2013 GENENTECH ONCOLOGY TREND REPORT THE 2013 GENENTECH ONCOLOGY TREND REPORT Perspectives From Managed Care, Specialty Pharmacy Providers, Oncologists, Practice Managers, and Employers 2013 Genentech, South San Francisco, CA December 2013

More information

The Ontario Cancer Research Ethics Board Overview

The Ontario Cancer Research Ethics Board Overview The Ontario Cancer Research Ethics Board Overview Research Ethics Research ethics review is vital to the advancement of ethically sound research. Before individuals can be enrolled in a research study,

More information

Position Title: Management Info Chief. Working Title: Technical Project Management Section Chief

Position Title: Management Info Chief. Working Title: Technical Project Management Section Chief Position Title: Management Info Chief Working Title: Technical Project Management Section Chief This management position directs the operational activities of the Project Management Office whose mission

More information

Do I Have Epilepsy? Diagnosing Epilepsy and Seizures. Epilepsy & Seizures: Diagnosis

Do I Have Epilepsy? Diagnosing Epilepsy and Seizures. Epilepsy & Seizures: Diagnosis Epilepsy & Seizures: Diagnosis Do I Have Epilepsy? Diagnosing Epilepsy and Seizures Artwork by Studio E participant Ashley N. (details on inside cover) About the Cover: Cover artwork was created by Ashley

More information

e-media Kit GET CONNECTED TO THE INDUSTRY'S MOST HIGHLY-DESIRED AUDIENCE www.actmagazine.com

e-media Kit GET CONNECTED TO THE INDUSTRY'S MOST HIGHLY-DESIRED AUDIENCE www.actmagazine.com e-media Kit GET CONNECTED TO THE INDUSTRY'S MOST HIGHLY-DESIRED AUDIENCE www.actmagazine.com Contents Electronic Suite of Opportunities Usage Profile Website Advertising vlink: Web Video Ads e-issue Alert

More information

National Council for Behavioral Health

National Council for Behavioral Health National Council for Behavioral Health Preparing your Organization for ICD-10 Implementation Presented by: Michael D. Flora, MBA, M.A.Ed, LCPC, LSW Senior Operations and Management Consultant David R.

More information

The Sunshine Act and Clinical Research

The Sunshine Act and Clinical Research ISR whitepaper The Sunshine Act and Clinical Research Views from Principal Investigators and Primary Cary Physicians Info@ISRreports.com 2013 Industry Standard Research www.isrreports.com Finally! After

More information

PROMISING PRACTICES IN HOME AND COMMUNITY-BASED SERVICES

PROMISING PRACTICES IN HOME AND COMMUNITY-BASED SERVICES PROMISING PRACTICES IN HOME AND COMMUNITY-BASED SERVICES Lessons Learned from Using a Health Information Technology Program that Combines Claims-Level Data with Service-Level Data Outcome data in the treatment

More information

Bundled Episodes of Care Payments

Bundled Episodes of Care Payments Index: How do Bundled Payments Differ from Capitation Payments? Steps to Implementing Bundled Payments Case Studies of Bundled Payments in California How Do I Implement Bundled Payments? Benefits and Risk

More information

To learn the fundamentals of preparing a clinical trial budget:

To learn the fundamentals of preparing a clinical trial budget: Learning Objectives: To learn the fundamentals of preparing a clinical trial budget: Identifying Potential Members of a Budgeting Team Identifying reasonable / hidden costs in budgeting Understanding the

More information

Physician, Health Care Professional, Facility and Ancillary Provider Administrative Guide for American Medical Security Life Insurance Company

Physician, Health Care Professional, Facility and Ancillary Provider Administrative Guide for American Medical Security Life Insurance Company Physician, Health Care Professional, Facility and Ancillary Provider Administrative Guide for American Medical Security Life Insurance Company Insureds 2009 Contents How to contact us... 2 Our claims process...

More information

BEACON HEALTH STRATEGIES, LLC TELEHEALTH PROGRAM SPECIFICATION

BEACON HEALTH STRATEGIES, LLC TELEHEALTH PROGRAM SPECIFICATION BEACON HEALTH STRATEGIES, LLC TELEHEALTH PROGRAM SPECIFICATION Providers contracted for the telehealth service will be expected to comply with all requirements of the performance specifications. Additionally,

More information

Procedure: Guidelines for a Breastfeeding Peer Counselor Program

Procedure: Guidelines for a Breastfeeding Peer Counselor Program Procedure: Volume: Nutrition Services/Breastfeeding Section: Breastfeeding Approval Date: 11.2012 Citation: Loving Support Model for Peer Counseling Revised Date: Purpose Definition of a Breastfeeding

More information

Patient Handbook on Stem Cell Therapies

Patient Handbook on Stem Cell Therapies Patient Handbook on Stem Cell Therapies Appendix I of the Guidelines for the Clinical Translation of Stem Cells www.isscr.org 2008, International Society for Stem Cell Research 2 Introduction We have all

More information

Independent Contracting

Independent Contracting Independent Contracting USED BY PERMISSION From AAPA: 950 North Washington Street, Alexandria, VA 22314 www.aapa.org Deciding to practice as an independent contractor requires consideration of many factors.

More information

Children's Hospital, Boston (Draft Edition)

Children's Hospital, Boston (Draft Edition) Children's Hospital, Boston (Draft Edition) The Researcher's Guide to HIPAA Evervthing You Alwavs Wanted to Know About HIPAA But Were Afraid to Ask 1. What is HIPAA? 2. What is the Privacy Rule? 3. What

More information

Chronic Care Management (CCM) from a Physician Practice Administrator s Perspective

Chronic Care Management (CCM) from a Physician Practice Administrator s Perspective Chronic Care Management (CCM) from a Physician Practice Administrator s Perspective Chronic Care Management (CCM) from a Physician Practice Administrator s Perspective 1 ABOUT THE AUTHOR Dennis Breslin

More information

Attachment B HIPAA-P03 Instructions for Completing IU s Authorization for Research Purposes

Attachment B HIPAA-P03 Instructions for Completing IU s Authorization for Research Purposes Attachment B HIPAA-P03 Instructions for Completing IU s Authorization for Research Purposes The HIPAA Privacy Rule generally prohibits health care providers from using or releasing protected health information

More information

September 20, 2012. Kelly Willenberg, MBA, BSN, CHC, CHRC. Kelly Willenberg, LLC

September 20, 2012. Kelly Willenberg, MBA, BSN, CHC, CHRC. Kelly Willenberg, LLC September 20, 2012 Kelly Willenberg, MBA, BSN, CHC, CHRC 1 1 Understand the importance of research billing compliance and how that impacts the hospital and your practice Understand how billing can advance

More information

Welcome to the training on the TransCelerate approach to Risk-Based Monitoring. This course will take you through five modules of information to

Welcome to the training on the TransCelerate approach to Risk-Based Monitoring. This course will take you through five modules of information to Welcome to the training on the TransCelerate approach to Risk-Based Monitoring. This course will take you through five modules of information to introduce you to the concepts behind risk-based monitoring,

More information

Negotiating Clinical Trial Agreements: The Hospital s Perspective

Negotiating Clinical Trial Agreements: The Hospital s Perspective Negotiating Clinical Trial Agreements: The Hospital s Perspective P R E S E N T E D B Y: David Vukadinovich, JD, MPH Senior Counsel HCCA Research Compliance Conference October 20, 2009 Minneapolis Presentation

More information

Show your value, grow your business:

Show your value, grow your business: Show your value, grow your business: A SUPPLIER GUIDE TO MOVE FROM A TRANSACTIONAL PROVIDER TO A STRATEGIC PARTNER KAREN A. CALINSKI INTRODUCTION /02 At KellyOCG we take a holistic approach to talent sourcing

More information

Residential Treatment Center (RTC) Processes and Financial Information

Residential Treatment Center (RTC) Processes and Financial Information Residential Treatment Center (RTC) Processes and Financial Information This information is provided by Children's Help and Assistance for Residential Treatment (CHART), a program of The Adoption Exchange.

More information

Virginia. A guide for individuals and families. The health insurance benefits you want, at a cost you can afford

Virginia. A guide for individuals and families. The health insurance benefits you want, at a cost you can afford Virginia A guide for individuals and families CoventryOne is an individual product (for individuals and families) offered by Coventry Health Care, an Aetna company. The health insurance benefits you want,

More information

Healthy Michigan MEMBER HANDBOOK

Healthy Michigan MEMBER HANDBOOK Healthy Michigan MEMBER HANDBOOK 2015 The new name for Healthy 1 TABLE OF CONTENTS WELCOME TO HARBOR HEALTH PLAN.... 2 Who Is Harbor Health Plan?... 3 How Do I Reach Member Services?... 3 Is There A Website?....

More information

3. Outpatient services provided by non-participating non-georgia hospitals are reimbursed at 45% of covered charges.

3. Outpatient services provided by non-participating non-georgia hospitals are reimbursed at 45% of covered charges. Page 8.1 R. OUTPATIENT HOSPITAL SERVICES 1. Outpatient services by Georgia hospitals are reimbursed on a determination of allowable costs. The determination of allowable costs is made retrospectively and

More information

DIVISION OF HEALTH PLANNING AND RESOURCE DEVELOPMENT FEBRUARY 2013

DIVISION OF HEALTH PLANNING AND RESOURCE DEVELOPMENT FEBRUARY 2013 DIVISION OF HEALTH PLANNING AND RESOURCE DEVELOPMENT FEBRUARY 2013 CON REVIEW: KEMPER CAH, INC. D/B/A JOHN C. STENNIS MEMORIAL HOSPITAL ESTABLISHMENT OF MOBILE MAGNETIC RESONANCE IMAGING (MRI) SERVICES

More information

HEALTH INSURANCE ENROLLMENT FORM

HEALTH INSURANCE ENROLLMENT FORM HEALTH INSURANCE ENROLLMENT FORM Requirements You must complete the Enrollment Form as part of the New Hire Process. You must elect or decline coverage on the Enrollment Form. Return the Enrollment Form

More information

Core Training Outline

Core Training Outline Core Training Outline Modules: 1) Study Design 2) PI Oversight 3) Financial Management 4) Study Operations 5) Recruitment & Retention 6) Informed Consent 7) Investigational Products 8) Subject Safety 9)

More information

ACTION ITEM AMENDMENT TO FORMATION OF A CAPTIVE INSURANCE COMPANY EXECUTIVE SUMMARY

ACTION ITEM AMENDMENT TO FORMATION OF A CAPTIVE INSURANCE COMPANY EXECUTIVE SUMMARY F7 Office of the President TO MEMBERS OF THE COMMITTEE ON FINANCE: For Meeting of November 20, 2015 ACTION ITEM AMENDMENT TO FORMATION OF A CAPTIVE INSURANCE COMPANY EXECUTIVE SUMMARY In May 2012, the

More information

RE: CMS-3819-P; Medicare and Medicaid Programs; Conditions of Participation for Home Health Agencies

RE: CMS-3819-P; Medicare and Medicaid Programs; Conditions of Participation for Home Health Agencies January 6, 2015 Marilyn Tavenner Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Room 445 G Attention: CMS-3819-P Hubert H. Humphrey Building, 200 Independence

More information

Subtitle 09 WORKERS' COMPENSATION COMMISSION. 14.09.03 Guide of Medical and Surgical Fees

Subtitle 09 WORKERS' COMPENSATION COMMISSION. 14.09.03 Guide of Medical and Surgical Fees Subtitle 09 WORKERS' COMPENSATION COMMISSION 14.09.03 Guide of Medical and Surgical Fees Authority: Labor and Employment Article, 9-309, 9-663 and 9-731, Annotated Code of Maryland Notice of Proposed Action

More information

Benchmark Your Way to Financial Success

Benchmark Your Way to Financial Success Benchmark Your Way to Financial Success Thriving Radiology Practices Compare Financial Performance Introduction As payors continue to explore new ways to ratchet down reimbursement rates, running a radiology

More information

NJEMs Bill ID: This is a unique identification number created by the billing software to identify this particular invoice with the responsible party.

NJEMs Bill ID: This is a unique identification number created by the billing software to identify this particular invoice with the responsible party. NJEMs Bill ID: This is a unique identification number created by the billing software to identify this particular invoice with the responsible party. Assessment Types SF (Oversight Spill Fund) or DF (Oversight

More information

Mapping the Work Flow and Coding. Alabama Early Screening Improvement Training. Commercial Interests Disclosure. Commercial Interests Disclosure

Mapping the Work Flow and Coding. Alabama Early Screening Improvement Training. Commercial Interests Disclosure. Commercial Interests Disclosure Alabama Early Screening Improvement Training Saturday, October 29, 2011 Tuscaloosa, Alabama Mapping the Work Flow and Coding Produced by the Alabama Department of Public Health Video Communications and

More information

A GUIDE TO EVALUATION & MANAGEMENT CODING AND DOCUMENTATION

A GUIDE TO EVALUATION & MANAGEMENT CODING AND DOCUMENTATION A GUIDE TO EVALUATION & MANAGEMENT CODING AND DOCUMENTATION Produced by ConnectiCare, Inc. in conjunction with its affiliate Group Health Incorporated TABLE OF CONTENTS Summary and Overview...Page 3 Part

More information

Research Ethics Review Committee (WHO ERC)

Research Ethics Review Committee (WHO ERC) Research Ethics Review Committee (WHO ERC) 20, AVENUE APPIA CH-1211 GENEVA 27 SWITZERLAND HTTP://INTRANET.WHO.INT/HOMES/RPC/ERC HTTP://WWW.WHO.INT/RPC/RESEARCH_ETHICS Informed Consent Template for Research

More information

RESEARCH PARTICIPANT INFORMED CONSENT AND PRIVACY AUTHORIZATION FORM

RESEARCH PARTICIPANT INFORMED CONSENT AND PRIVACY AUTHORIZATION FORM If you are using Epic for this study, fax a copy of the signed consent form to 410-367-7382. Patient I.D. Plate RESEARCH PARTICIPANT INFORMED CONSENT AND PRIVACY AUTHORIZATION FORM Protocol Title: Application

More information

Marshall Medical Center 1206(d) Clinics Case Study

Marshall Medical Center 1206(d) Clinics Case Study Marshall Medical Center 1206(d) Clinics Case Study Marshall Medical Center 105 Bed Community Hospital, located between Sacramento and South Lake Tahoe 12 Outpatient 1206(d) clinics, including a R.H.C.

More information

GEORGIA MEDICAID TELEMEDICINE HANDBOOK

GEORGIA MEDICAID TELEMEDICINE HANDBOOK GEORGIA MEDICAID TELEMEDICINE HANDBOOK CONNECTING GEORGIA OVERVIEW The Department of Community Health s (DCH) Telemedicine and Telehealth policies are slated to improve and increase access and efficiency

More information

Blue Assurance Medicare Supplement Rate Quote and Benefit Summary

Blue Assurance Medicare Supplement Rate Quote and Benefit Summary Blue Assurance Medicare Supplement Rate Quote and Benefit Summary This brochure is not a policy. Full information about the terms, exclusions and limitations of the policies advertised is found in the

More information

The Clinical Trial Accrual Challenges Facing Northern Michigan

The Clinical Trial Accrual Challenges Facing Northern Michigan The Clinical Trial Accrual Challenges Facing Northern Michigan PRESENTED BY ALICIA GARDNER, RN, BSN, MSA DIRECTOR OF HEALTH INITIATIVES - GREATER MICHIGAN, AMERICAN CANCER SOCIETY, INC. CO-AUTHORED BY

More information

A/E Joint Ventures: A Liability Challenge

A/E Joint Ventures: A Liability Challenge A/E Joint Ventures: A Liability Challenge Collaboration seems to be a key concept in today's design and construction environment. Integrated project delivery, design-build, and other alternative project

More information

Subject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure

Subject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure 703 1 of 11 POLICY The Beaumont Research Coordinating Center (BRCC) will provide advice to clinical trial investigators on protocol development, content and format. Upon request, the BRCC will review a

More information

Providing and Billing Medicare for Transitional Care Management

Providing and Billing Medicare for Transitional Care Management PYALeadership Briefing Providing and Billing Medicare for Transitional Care Management Updated November 2014 2014 Pershing Yoakley & Associates, PC (PYA). No portion of this white paper may be used or

More information

What is Home Care? Printed in USA Arcadia Home Care & Staffing www.arcadiahomecare.com

What is Home Care? Printed in USA Arcadia Home Care & Staffing www.arcadiahomecare.com Printed in USA Arcadia Home Care & Staffing www.arcadiahomecare.com Home Care: What does it mean to you? For some people it may mean having only occasional help with the laundry, grocery shopping, or simple

More information

Preparing and Evaluating A Request for Proposals: How to Select a Vendor Andrew Ness, Mercer Investment Consulting

Preparing and Evaluating A Request for Proposals: How to Select a Vendor Andrew Ness, Mercer Investment Consulting Preparing and Evaluating A Request for Proposals: How to Select a Vendor Andrew Ness, Mercer Investment Consulting Although sometimes thought of as a necessary evil for sponsors of defined contribution

More information

MRI TRAINING PROGRAM ONSITE CLINICAL PRACTICE

MRI TRAINING PROGRAM ONSITE CLINICAL PRACTICE MRI TRAINING PROGRAM ONSITE CLINICAL PRACTICE Neurologic & Orthopedic Imaging TRAINING POLICIES ABOUT THE PROGRAM MRI, Magnetic Resonance Imaging, is a method used by physicians to look inside the human

More information

CMS REGULATORY ACTION

CMS REGULATORY ACTION CMS REGULATORY ACTIONS CMS REGULATORY ACTION Government Provider Cost Limit Regulation Imposes new restrictions on payments to providers operated by units of government and clarifies that those entities

More information

Strategic time tracking

Strategic time tracking Strategic time tracking Manage your time and stay ahead! When time is money... Eliminate the guesswork and generate better results This whitepaper details how to fully optimise your business activities

More information

CSAT TA Package. Building a Business Plan for Provider Sustainability

CSAT TA Package. Building a Business Plan for Provider Sustainability Since the recent economic downturn, sustaining grant-funded treatment providers has become a major public health concern. This Technical Assistance (TA) Package was developed by the Center for Substance

More information

CLINICAL RESEARCH ORGANIZATION

CLINICAL RESEARCH ORGANIZATION CLINICAL RESEARCH ORGANIZATION SERVICES Project Management Study Monitoring Data Management Statistics Regulatory Reimbursement Quality Assurance & Manufacturing Healthcare Compliance 1 A FULLY INTEGRATED

More information