1. Reimbursement Overview
Calendar Year 2008

2. Outline for Today Overview of Benign Prostatic Hyperplasia (BPH)
PROSTIVA® RF Therapy
Coverage and Coding for PROSTIVA
Physician Reimbursement
Hospital Outpatient Reimbursement
Ambulatory Surgery Center (ASC) Reimbursement

3. Symptomatic BPH Population
Overview of BPH
Symptomatic BPH Population
US Prevalence: 14.9 Million
US Incidence: 500,000
Translates to: 50% of men over 50
60% of men over 60
70% of men over 70
80% of men over 80
US Census; Millennium Research, 2006; A.G. Edwards & Son, 2006.

4. Overview of BPH Prostate Enlargement
The prostate goes through two periods of growth. The first occurs early in puberty when the prostate doubles in size.
At around age 25, the prostate begins to grow again and often results, years later, in a condition called an enlarged prostate.
The medical term for this condition is called Benign Prostatic Hyperplasia (BPH).

5. Overview of BPH BPH Defined
BPH is the most common nonmalignant disorder of the prostate and is characterized by prostatic enlargement, obstruction of the bladder outlet, and voiding symptoms.
BPH is also referred to as Benign Prostatic Hypertrophy
Hyperplasia describes the process where cells increase in numbers
Hypertrophy describes the increase in cell size
Hyperplasia is the predominant process

6. How Does BPH Affect Urination?
Overview of BPH
How Does BPH Affect Urination?
BPH is a non-cancerous enlargement of the prostate
As the prostate enlarges, it presses against the urethra like a clamp on a garden hose
This can obstruct the flow of urine through the urethra
The prostate goes through two periods of growth. The first occurs early in puberty, when the prostate doubles in size.
At around age 25, the prostate begins the second phase of growth and often results years later in a condition called an enlarged prostate.
The medical term for this condition is called Benign Prostatic Hyperplasia - BPH.
As the prostate grows it presses against the urethra like a clamp on a garden hose.

7. How Does BPH Affect Urination?
Overview of BPH
How Does BPH Affect Urination?
The bladder wall becomes thicker and irritable and begins to contract even when it contains a small amount of urine.
These contractions cause the bladder to weaken so it does not completely empty.
If BPH is not treated it can cause the bladder wall to become thicker and irritable. It can begin to contract even when it contains a small amount of urine.
These contractions cause the bladder to weaken, so it does not completely empty.

8. Overview of BPH Why Treat BPH?
BPH is not cancer but it can lead to unwanted complications if not corrected
Urine retention and strain on the bladder can lead to
Urinary tract infections
Bladder or kidney damage
Bladder stones
Incontinence
When BPH is diagnosed and treated early, there is a lower risk of developing such complications

9. PROSTIVA® RF Therapy Safe and effective
A single office visit, treatment of less than one hour
Fewer side effects and adverse events when compared to traditional surgical treatments
Covered by Medicare and Medicaid in all 50 states and many private insurance companies
In-office procedure
If your patient decides that he no longer wants to take daily medication, but does not want to expose himself to the risks of invasive surgery such as TURP, an in-office procedure such as PROSTIVA RF Therapy may provide a safe and effective solution.
PROSTIVA RF Therapy can provide effective long-term clinical improvement
PROSTIVA allows treatment in a single office visit with treatment time of less than 1 hour
PROSTIVA RF Therapy is covered by Medicare and Medicaid in all 50 states and many private insurance companies

10. PROSTIVA® RF Therapy
Delivers low-level radio frequency energy into the middle of the prostate and relieves obstruction without causing damage to the urethra
Can be performed with a sedative and local anesthetic in a urologist’s office
Procedure takes less than one hour
Catheterization, if required, is zero-two days on average
Intended for men over age 50

11. PROSTIVA® RF Therapy
Indication for Use
PROSTIVA® radio frequency therapy is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.
PROSTIVA® RF Therapy System User Guide.

12. Disclaimer
Medtronic has compiled this coding information for your convenience. It is always the provider’s responsibility to determine coverage and submit appropriate codes, modifiers, and charges for the services that were rendered. Contact your local carrier/payor for interpretation of appropriate coverage and coding policies. For unapproved uses, consult with your local carrier/payor before seeking reimbursement for use of a product that may be inconsistent with or not expressly specified in the FDA cleared or approved labeling (manual). Some payors may have policies that make it inappropriate to submit claims for such items or related services.

13. Providers should refer to the applicable coverage policy!
Coverage and Coding
Coverage for PROSTIVA – Applicable Policies
There is currently no National Coverage Determination (NCD) for PROSTIVA/TUNA*; however many states have local policies.
The CPT code for PROSTIVA (53852) is on the Medicare Fee Schedules for 2008 (Physician, Hospital Outpatient, and ASC).
Many commercial payors have written coverage policy for PROSTIVA/TUNA*
Providers should refer to the applicable coverage policy!
*Note: Most policies for PROSTIVA will be listed under “TUNA.”

14. Coverage and Coding Coverage for PROSTIVA – Diagnosis Coding
CMS requires 5 digit ICD-9 Diagnosis Codes
See our PROSTIVA reimbursement guide for common diagnosis codes.
Providers should refer to the applicable coverage policy for diagnosis coding!

15. Coverage and Coding Coverage for PROSTIVA - Typical LCD Language
Indications must be documented (vary by state)
BPH of Significant Degree to Cause
An AUA symptom score of 11 or higher
Urine flow rate of 15 cc/sec. or less on a voided volume of 125 cc or more
Volume of the prostate less than 65 gms on a transrectal ultrasound of the prostate
Failed trial of voiding with an alpha-blocker medication, or tolerance to alpha- blocker

16. Coverage and Coding Coverage for PROSTIVA - Typical LCD Language
Common contraindications may include:
Prostate or Bladder Cancer
Neurogenic, decompensated or atonic bladder
Prior non-drug treatment (eg TURP, Laser, TUMT)
Presence of other device that could interfere, eg penile implant, pacemaker, ICD, neurostimulator
Prostate size less than 34 mm or greater than 80 mm tranverse diameter
Active cystolithiasis, gross hematuria, urethral stricture acute prostatitis, diabetes mellitis affecting bladder function
Active urinary tract infection
ASA class group V patients
Providers should refer to the applicable coverage policy for medical necessity criteria!

17. The CPT Code for PROSTIVA is:
Coverage and Coding
Coding for PROSTIVA
The CPT Code for PROSTIVA is:
53852
CPT® is a registered trademark of the American Medical Association. Current Procedural Terminology (CPT) is copyright 2005 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use.

18. Coverage and Coding
Coding for PROSTIVA
Transurethral destruction of prostate tissue; by radio frequency thermotherapy
CPT® is a registered trademark of the American Medical Association. Current Procedural Terminology (CPT) is copyright 2005 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use.

19. Coverage and Coding Coding for PROSTIVA
“Workup” codes for PROSTIVA commonly include:
Office Visit (CPT Codes or )
Electro-Uroflowmetry (CPT Code 51741)
Cystoscopy (CPT Code 52000)
PSA (CPT Code 84153)
Urinalysis (CPT Code 81000–81003)
Office or Other Outpatient Consultation (New or Established Patient) (CPT Codes )
CPT® is a registered trademark of the American Medical Association. Current Procedural Terminology (CPT) is copyright 2005 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use.

20. Physician Reimbursement
Physician Reimbursement: January – June 2008
53852 Non-Facility (Office) Rate: $2,959*
53852 Facility (Hospital or ASC) Rate: $595*
The Non-Facility Rate is designed to cover the cost of the physician’s time, the disposable cartridge and any additional indirect expense (rent, nursing staff, etc.)
This code has a 90-day global period.
*Indicates national average payment amount from Medicare – commercial payor reimbursement will be based on the provider’s individual contract with that payor.

21. Physician Reimbursement
Physician Reimbursement: January – June A Note on Global Periods:
The global period describes the time interval for all related services and care included in a surgical procedure
PROSTIVA Therapy – CPT – has a global period of 90 days
The global period for PROSTIVA Therapy is inclusive of anesthetics, whether lidocaine or the use of a prostatic block
Examples:
PROSTIVA patient returns to office after three days for catheter removal – can the physician bill for an office visit? NO
PROSTIVA patient sees the physician within the 90 days for continued concerns about their BPH, or for questions about the PROSTIVA procedure – can the physician bill for an office visit? NO

22. Hospital Outpatient Reimbursement
In 2008, CPT code maps to APC 0429 in the Medicare Outpatient Prospective Payment System (OPPS).
APC 0429 has a national average payment rate of $2,879*
There is no separate device code for the disposable PROSTIVA cartridge.
*Indicates national average payment amount from Medicare – commercial payor reimbursement will be based on the provider’s individual contract with that payor.

23. ASC Reimbursement Ambulatory Surgery Center (ASC) Reimbursement: 2008
In 2008, CPT code maps to APC 0429 in the Medicare’s ASC Payment System.
APC 0429 has a national average payment rate of $1,872* in an ASC setting
There is no separate device code for the disposable PROSTIVA cartridge.
*Indicates national average payment amount from Medicare – commercial payor reimbursement will be based on the provider’s individual contract with that payor.

24. PROSTIVA Reimbursement
What is a modifier?
A modifier is used with CPT codes to denote special consideration on the code
PROSTIVA CPT Code is 53852
Two modifiers that are commonly associated with PROSTIVA are:
-53 Discontinued Procedure
Example: PROSTIVA procedure was aborted partial way through
-59 Distinct Procedural Service
Example: TRUS was performed on the same day as PROSTIVA

25. PROSTIVA Reimbursement
Questions????

26. PROSTIVA® RF Therapy
Indications: PROSTIVA RF Therapy is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.
Adverse Events: Side effects may include obstruction, urinary retention, bleeding, pain/discomfort, urgency, frequency and urinary tract infection.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions and warnings, please refer to the System User Guide.