Renaissance American Management, Inc. & Beard Group

The Fourth Annual Physician Agreements & Ventures

Paul R. DeMuroPartnerLatham & Watkins LLPSan Francisco and Los Angeles, California(415) 395-8180(213) 891-7330email:paul.demuro@lw.com

John S. HowardVP and General CounselSt. John’s Mercy Health Care12800 Corporate Hill DriveSt. Louis, MO 63131(314) 364-3382email: howajs@stlo.mercy.net

Daryl P. JohnsonPrincipalHealthCare Appraisers, Inc.75 NW 1st Avenue, Ste. 201Delray Beach, FL 33444(561) 330-3488email: DJohnson@hcfmv.com

Chicago, IllinoisNovember 1, 2007

JOINT VENTURES IN CANCER CENTERS(including Stereotactic Radiosurgery)

■ Radiation Therapy

■ Surgery and Radiation Therapy

■ Stereotactic Radiosurgery and Radiotherapy

The Types of Technology Which May Be The Types of Technology Which May Be Employed in Cancer Center Joint VenturesEmployed in Cancer Center Joint Ventures

￭ Exposes all tissue in the general region of the tumor

Treats tumor seen and not seen (treatment plus prophylaxis)

￭ Toxicity (complications)

Conventional Radiation TreatmentConventional Radiation Treatment

How to Avoid ToxicityHow to Avoid Toxicity

￭ Avoid exposure

▪ Shield

· Change the shape of the beam

￭ Fractionate

▪ Divide the treatment into multiple sessions

What is radiosurgery?What is radiosurgery?

￭ Radiation

▪ Tissue destruction▪ High metabolic activity, higher sensitivity

▪ Eg. cancer

￭ Radiation limited only to the target

Advantages of stereotactic radiosurgeryAdvantages of stereotactic radiosurgery

￭ Avoid critical structures

￭ Higher dose to the target

￭ Treatment of previously radiated region

￭ Avoid open surgery

￭ Outpatient

Types of Radiosurgery/RadiotherapyTypes of Radiosurgery/Radiotherapy

￭ Stereotactic Radiosurgery (SRS)

▪ Usually with fixed cobalt source (i.e. gamma knife)

￭ Image Guided Radiotherapy (IGRT)

▪ IMRT with image guidance

￭ Image Guided Radiosurgery (IGRS)

▪ < 5 fractions (hypofractionation)

Types of Radiosurgery/Radiotherapy (Cont.)Types of Radiosurgery/Radiotherapy (Cont.)

￭ Intensity Modulated Radiotheraphy (IMRT)

▪ Standard radiation with shaped beam

▪ 20 to 40 fractions

￭ Image Guided Robotic Radiosurgery (IGRRS)

Radiosurgery Procedures and EquipmentRadiosurgery Procedures and Equipment

￭ SRS▪ Multiple fixed source

▪ Gamma Knife – frame and intercranial only

￭ Image Guided▪ Use of images to guide the treatment▪ Cyberknife, Trilogy, and Synergy

Radiosurgery Procedures and Equipment Radiosurgery Procedures and Equipment (con’t.)(con’t.)

￭ Robotic

▪ Use of Equipment that moves (adjusts) for positioning the target with remote control from different room

￭ Beam Focusing Methods

▪ Multiple beams

▪ Shaped beam

■ Cyberknife

￭ Linear Accelerator

￭ Robot arm

￭ Robot table￭ Xray with reconstructed 2D Image with fiducials

■ Synergy and Trilogy￭ Image Guided Treatment￭ Robotic table￭ Robotic extension of on board

imaging (Trilogy)￭ CT Image

Images in Image GuidedImages in Image Guided

■ Magnetic Resonance Imaging (MRI)￭ Good for imaging soft tissue and detecting small lesions (because of its

high resolution)

￭ Distorted with any metal in vicinity

■ Computed Tomography (CT)￭ Good for bone anatomy, and work with soft tissue￭ Artifacts with metal

Images in Image Guided (con’t.)Images in Image Guided (con’t.)

■ Xray/fluoroscopy

￭ Can only see bones with reliability▪ e.g. rarely see tumor in lung

￭ No reconstruction￭ Depends on visible markers such as

bone or fiducials

Neurosurgeons

Radiation Oncologists

Radiologists

Nonradiologists

Cardiothoracic Surgeons

Neurologists

Urologists

Referring Physicians

Physicists

Hospitals

Health Plans

Equipment Manufacturers

Wholesalers

Salespersons

Lenders/Financing Companies

3rd Party Management Companies

Consultants

Valuation Consultants

Others

Who Are the Potential Parties?

General Legal ConsiderationsGeneral Legal Considerations

Stark Laws

Anti-kickback Statute

State Anti-Self-Referral Laws

Certificate of Need and Licensure

Tax-Exemption Issues

Antitrust

Reimbursement Issues

Securities Laws

Practical Planning for Hospital and Practical Planning for Hospital and PhysiciansPhysicians

■ Understanding the Hospital’s Interests– Accretive to current business

– Expansion of current therapies and modalities

– Context of therapies in cancer centers

– Equipment options IGRT IGRS Gamma Knife Cyber Knife

– Physician leadership to enhance clinical services and treatment alternatives

Practical Planning for Hospital and Practical Planning for Hospital and Physicians (continued)Physicians (continued)

■ Understanding the Physicians’ Interests– Complement to professional fees– Clinical leadership possibilities– Alternatives to other options within practice

specialties (e.g., neurosurgery, general surgery, thoracic, radiation oncology)

– Passive income consistent with value of services– Control of service line– Forging relationship of trust with hospital partner

Creating Physician Interest

■ Clinical Opportunities– Genuine service to patients– Expansion of services– Consistent with reimbursement– Changing lives through salvage care– Gamma knife example– 3 year continuation of care

after terminal diagnosis

Creating Physician Interest

■ Financial Opportunities– Professional fees– Investment opportunity for passive income– Meeting the four R’s for physician engagement

Recruitment Retention Redirection Redeplyoment

Sample Relationship involving Hospital Sample Relationship involving Hospital and Physician Companyand Physician Company

■ General Principles and Description– Physician and hospital investment opportunity to

expand services and provide stereotactic radiosurgery (SRS) services to patients

– The new company (Newco) would be responsible for purchasing equipment and potentially the shielding and/or building improvements and to provide services in support of the SRS care model at the Hospital.

Sample RelationshipSample Relationship

SRS, LLC Hospital

SRS EquipmentLease

ServicesAgreement

PhysicianInvestor

PhysicianInvestor Hospital

Ownership Interests

Payment for Services

Lease Payments

Planning Considerations for Services and Physician Involvement

■ Credentialing for new and expanded services (e.g., unique SRS services)

■ Equipment options all require unique training– Sufficient current staff– Specialized treatment– Incentive for specialized training– Proctoring new physicians– Maintaining local proficiency (Joint Commission)

Planning Considerations for Relationship

■ Governance of company– Hospital and physician shared governance model

Creates necessary alignment of clinical delivery– Hospital’s control of services and departmental

relationships (e.g., neurosurgery, radiation oncology)

■ Understanding lease and service agreements for hospital-physician company

Sample Lease and Services Agreements

■ Company will lease the SRS Equipment and related improvements to the hospital.

■ Company, through its physician members, will provide medical/ administrative services to the hospital to support the SRS service line.

Sample Lease AgreementSample Lease Agreement

■ Determining method for payment under the lease:– Per click payments (every use)– Fee Schedule per click (fees based on type of click)– Per patient fee (shared risk)

■ Newco will pay for improvements and the SRS Equipment

■ Lease will have a term consistent with expected life of equipment.– Lease may be renewed on mutually agreeable

terms.

■ Hospital agrees that if it wants to acquire additional equipment to perform SRS that Newco will be granted a right of first refusal to provide such equipment.

Implications of a DefaultImplications of a Default

■ Consider managing default obligations in relationship to:

– Equipment Limited portability Freestanding services may be prohibited by

state law Free standing services may not be

compensable in the market Free standing services may not be clinically

appropriate– Improvements and shielding

Not portable Problems of title for “improvements”

Services Agreement

■ The Company, through its physician members, will provide medical/administrative services in order to establish, develop and operate the hospital’s SRS Program. These services will include (but not be limited to):– Budgeting/Strategic Planning– Development and Implementation of clinical policies

and protocols– Research and clinical trial services– Utilization Review– Performance Improvement– Quality Assurance Processes– Peer Review services by specialty

Services Agreement (con’t.)

■ The Company may identify certain physicians members to provide the following services :

– Proctoring physicians seeking SRS privileges

– Marketing/Outreach for the Community

– Medical Director services if such are needed in terms

of clinical/administrative leadership

Change in Law for Change in Law for Lease or Services AgreementLease or Services Agreement

■ In the event of a “Change in Law” that affects the legality of the Lease or Service Agreement, the parties will attempt to negotiate an amendment to comply with such change in law.

■ If unable to agree on an amended agreement or lease, then Newco and the hospital will need to have prearranged for winding up the relationship.

Change in Law for Change in Law for Lease or Services Agreement (con’t.)Lease or Services Agreement (con’t.)

■ Consider the following:

– Ownership of equipment and improvements

– Pricing and value of equipment and improvements

(book/fmv)

– Continued administrative or clinical leadership

services

– Dissolution of non-competition provisions

Valuation ConsiderationsValuation Considerations

■ Overview of Topics -

■ FMV vs. Investment Value

■ Commercial Reasonableness

￭ FMV Attributes of “Per Click” Arrangements

￭ Valuation Approaches

■ “Top down” approaches

Investment Value vs. FMV

■ The fair market value standard is a hypothetical willing buyer/willing seller scenario. No consideration is given to any unique attributes or synergies of either party in reaching a determination of value.

■ The investment value standard takes into consideration the unique synergies or attributes that one or both parties may possess. – For example, if a hospital has more favorable

reimbursement that will enhance the profitability of a diagnostic cath lab being considered for purchase by the hospital, any valuation consideration of this benefit would reflect investment value, and not FMV.

Commercial Reasonableness

■ Commercial reasonableness and FMV must go hand in hand.

■ An independent valuator should opine with respect to FMV and commercial reasonableness

Examples of arrangements that may not be Examples of arrangements that may not be commercially reasonablecommercially reasonable

■ A physician group leases employees from a hospital so that the group can enter into a “turn key” service arrangement with the hospital.

■ A hospital enters into a one-year lease of physician-owned equipment at a “short-term rate premium,” but the lease continues to renew year after year.

■ The “flip” of an existing entity / service line into an “under-arrangement” structure where little changes (other than the physicians’ access to higher reimbursements).

■ A physician group leases to a hospital equipment which the hospital reasonably should own

FMV Attributes of “Per Click” ArrangementsFMV Attributes of “Per Click” Arrangements

■ Commercial reasonableness is paramount

■ Iffy “per click” arrangements may cast a shadow on all “per clicks” transactions

■ Uncertainty with respect to “normal” or projected volumes presents valuation challenges (particularly in the context of a new service)

■ Consider the possibility of (i) a descending payment structure; (ii) a fixed fee plus a per click; and/or (iii) a payment “cap” to avoid windfall payments should volume escalate.

■ Consider how FMV may be reassessed after the initial year(s)

Factors that Support the Commercial Factors that Support the Commercial Reasonableness of Stereotactic JVsReasonableness of Stereotactic JVs

■ The technology is relatively new, expensive and complex.

■ A limited number of procedures are expected to be performed each year.

■ The parties to the JV each bear substantial risk.

■ A hospital reasonably might be disinclined to offer these services without commitment from participating physicians.

Generally Accepted Valuation Approaches

The following generally accepted valuation approaches can be used for valuing “per click” and other types of businesses/arrangements:

– Income Approach– Cost Approach– Market Approach

Income Approach

The use of an income approach in evaluating a “per click” arrangement may appear to give consideration to the value of possible referrals among the parties.

Market ApproachMarket Approach

A Market Approach is generally not suitable in valuing “per click” arrangements due to the lack of comparability from one arrangement to the next.

For example, the following may be different – – the type and cost of equipment involved – whether dosimetry and/or medical director services are

included– Procedure volume

Cost ApproachCost Approach

■ A Cost Approach can be used considering

- The exact services that will be provided by the JV

- A “target” operating margin derived from market sources

- Consideration should be given to the economic outcomes in relationship to the respective risks assumed

““Top Down” ApproachesTop Down” Approaches

■ “Non-traditional” agreements are emerging related to outpatient surgical departments, cath labs and other hospital services.

■ A “top down” approach “passes through” all of the hospital's reimbursement, less a portion retained by hospital related to billing, collections, and other hospital services.

■ This approach leaves open significant opportunity for challenge. – The actual services provided under the arrangement

must be FMV, and the valuation approach should primarily consider the value of such services

– The level of reimbursement received by a hospital may have no bearing on the FMV of the services

– Consider a “crosswalk” to non-healthcare scenarios

Preferred Structures For Joint VenturesPreferred Structures For Joint Ventures

1. Investor Contributions

2. Pro Rata Guarantees

3. Execute Debt Guarantees

4. Adding Joint Venture Parties After Formation

5. Expenses of the Joint Venture

6. Same Form of Contribution

7. Debt Guarantees for New Investors

8. Non-Physician Investors

9. Directorship Agreement

10. Earn-Ins

11. Modalities

12. Percentage Lease Agreements and Purchased Service Agreements

13. Management Fees

14. Retirement

Recommendations for New Joint Ventures in this Recommendations for New Joint Ventures in this Increasingly Hostile Regulatory ClimateIncreasingly Hostile Regulatory Climate

A. Capital Contributions

B. Distributions

C. Multiple Modalities

D. Selection of Investors

E. Marketing

F. Managed Care Plan Considerations

Overall OIG’S GuidelinesOverall OIG’S Guidelines

1. Is a healthcare provider in one line of business (owner) expanding into a related health care business by contracting with an existing provider of a related item or service (e.g. manager/supplier) to provide the new item or service to the providers existing patient population?

2. Does the owner operate the new line of business itself?

3. Does the owner commit substantial financial capital, or human resources to the venture? Or does it merely contract out substantially all the operations of the new business?

4. Are non-competition covenants involved?

5. Is the owner’s actual business risk minimal because of the owner’s ability to influence substantial referrals to the new business?

6. Is the manager/supplier an established provider of the same line of services as the owner’s new line of business?

7. Does the manager/supplier take its share in the form of payments under various contracts with the owner?

8. Do aggregate payments to the manager/supplier typically vary with the value of volume of business generated for the new business by the owner?

Special Regulatory Issues Found As A Result of Special Regulatory Issues Found As A Result of the Referral Issues Presented inthe Referral Issues Presented in

Cancer Joint VenturesCancer Joint Ventures

■ Distinguish from imaging and ASC joint ventures where a physician who refers to the joint venture refers for the test or surgical procedure

■ There may be a number of alternatives for treatment of cancer

▪ medication, surgical intervention, radiation therapy, different

types of stereotactic radiosurgery or radiotherapy

Special Regulatory Issues Found As A Result Special Regulatory Issues Found As A Result of the Referral Issues Presented in Cancer of the Referral Issues Presented in Cancer

Joint Ventures (con’t.)Joint Ventures (con’t.)

■ Need for double checks/quality indicators

■ Business and healthcare reasons for the physician joint venture partners

ConclusionsConclusions