Transcript Slides - Clinicians Channel

Medicare 2007 and Beyond –
Impact on AMD
William T. Koch, COA, COE, CPC
Associate Consultant
Corcoran Consulting Group
San Bernadino, California
History of AMD Treatment

Focal laser treatment
– “Hot” laser
– Photocoagulation

Ocular photodynamic therapy
– Intravenous injection of verteporfin
– “Cold” laser used to activate drug

Anti-VEGF agents
– Intravitreal injection
– Antiangiogenic therapy
Challenges

Genesis of new treatments
– Ocular photodynamic therapy
– Intravitreal antiangiogenic therapies

Coding and reimbursement challenges
Ocular Photodynamic Therapy
Coding

CPT: 67221 Unilateral treatment

CPT: 67225 Second eye, single session

HCPCS: J3396 (verteporfin)

Description of drug in comment field
(box 19)
Intravitreal Injections for Wet AMD
Anti-VEGF Agents
Antiangiogenic therapy

Pegaptanib sodium injection
– On-label

Ranibizumab injection
– On-label
Pegaptanib Sodium Injection

Received FDA approval in December of
2004

Launched in January of 2005

Treatment of wet AMD (362.52)

Payment based on Average Selling
Price + 6%
HOPD: Use C9128
Pegaptanib Sodium Injection
Coding

CPT: 67028 – Intravitreal injection

HCPCS : J2503 – Injection, pegaptanib
sodium

Description of drug in comment field
(box 19)
Ranibizumab Injection

FDA approval June 30, 20061

Treatment of wet AMD (362.52)

Payment based on Average Selling
Price + 6%
1. http://www.fda.gov/bbs/topics/NEWS/2006/NEW01405.html
Ranibizumab Injection
Coding

CPT: 67028 – Intravitreal injection

HCPCS: J3590 – Unclassified biologics

Description of drug in comment field
(box 19)
Intravitreal Injections for Wet AMD
Anti-VEGF Agents

Antiangiogenic therapy
– Bevacizumab

Off-label
Intravitreal Injection of Bevacizumab
Treatment of Wet AMD

Carriers without published guidelines for wet
AMD
– Wheatlands (KS, NE, MO, West)
– NHIC (CA, ME, MA, NH, VT)

Proceed with caution
– Carrier may reimburse for wet AMD (362.52)
– Carrier may follow “unlabeled use of drug” policy

Monitor carrier website
Unlabeled Use of Drug
“If a medication is determined not to be reasonable
and necessary for diagnosis or treatment of an
illness or injury according to these guidelines, the
carrier excludes the entire charge (ie, for both the
drug and its administration). Also, carriers exclude
from payment any charges for other services (such
as office visits) which were primarily for the
purpose of administering a noncovered injection
(i.e., an injection that is not reasonable and
necessary for the diagnosis or treatment of an
illness or injury). . . ”
Source: MBPM Chapter 15, §50.4.2
Intravitreal Injection of Bevacizumab

Off-label use when injected in the eye
– Wet age-related macular degeneration
– Clinically significant diabetic macular edema
– Macular edema from central retinal vein
occlusion (CRVO) or branch retinal vein
occlusion (BRVO)

Vigorous informed consent needed
– Off-label status
– Absence of clinical studies for ophthalmic use
Intravitreal Injection of Bevacizumab

Utilize an Advance Beneficiary Notice (ABN)

Coding
– CPT: 67028 GA – Intravitreal injection*
– HCPCS: J3490 GA – Unclassified drugs
– HCPCS: J3590 GA – Unclassified biologics
– HCPCS: J9035 GA – Injection, bevacizumab
– Description of drug in comment field (box 19)
*Some Medicare carriers require 67299-GA
Minor or Major Procedure?

Minor procedure
– Postoperative period of 0 or 10 days

Major Procedure
– Postoperative period of 90 days
Intravitreal Injection

Minor procedure
– CPT Code 67028
– Postoperative period = 0 days
Minor Procedure

Included in surgery package
– Same-day exam usually bundled
– Includes supplies
Source: MCPM, Chapter 12, §40.1C
Billing Office Visit
with Minor Procedure
“CPT Modifier 25 – Significant Evaluation
and Management Service By Same Physician
On Date of Global Procedure
Pay for an evaluation and management service
provided on the day of a procedure with a global fee
period if the physician indicates that the service is
for a significant, separately identifiable evaluation
and management service that is above and beyond
the pre- and post-operative work of the procedure.”
Source: MCPM, Chapter 12, §40.2.A8
Billing Office Visit
with Minor Procedure
“Evaluation and Management Service
Resulting in the Initial Decision to Perform
Surgery
…..where the decision to perform the minor
procedure is typically done immediately before the
service, it is considered a routine preoperative
service and a visit or consultation is not billed in
addition to the procedure.”
Source: MCPM, Chapter 12, §40.2A4
Modifier -25
Significant separate E/M services on
the day of a minor surgery, ie, new
patient to practice
99243-25
362.52 wet AMD
67028
362.52 wet AMD
Office Visit—Established
Wet AMD

CC: S/P intravitreal
injection x 4 wk OD;
recheck wet AMD OD,
patient states vision
still poor

Dx: wet AMD OD
unresolved

Tx: intravitreal injection
OD today

Hx: healthy

Exam: VA, SLE, DFE
CPT = 67028 RT
S/P = status post; OD = right eye; VA = visual acuity; SLE = slit lamp examination; DFE = dilated fundus
examination.
Modifier -25
Significant separate E/M services on
the day of a minor surgery, ie, to cope
with bilateral disease
92012-25
362.51 dry AMD RT
67028
362.52 wet AMD LT
National Correct Coding Initiative
(NCCI)

NCCI
– Bundles
– Mutually exclusive
– Quarterly publication

Published at
www.cms.gov/physicians/cciedits/
NCCI Edits
Procedure
67028
Bundles
36000 36410 37202 62318 62319 64415
64416 64417 64450 64470 64475 67500
69990 90760 90765 90772 90774 90775
J2001
67500 Retrobulbar injection; medication
Paracentesis

Some ophthalmologists remove aqueous
humor from the anterior chamber prior to an
intravitreal injection

Paracentesis (CPT 65800 or 65805) is
performed as a prophylactic measure to
avoid elevating intraocular pressure

Since both of these CPT codes carry the
“separate procedure” designation, and the
paracentesis is only performed as prelude to
the intravitreal injection, the paracentesis is
considered to be an incidental part of the
total service and no additional claim is
merited
Injection for Complication
Performed during postoperative period of another surgery

Performed in office
– Included in global surgery package

Performed in the OR
– Covered
– Modifier 78 (return to the OR)

Staged (preplanned)
– Covered
– Modifier 58 (staged or related)
Source: MCPM, Chapter 12, §40.1A
Wet AMD

Dx: submacular hemorrhage AMD OD

Tx: pars plana vitrectomy (PPV)

Plan: intravitreal injection following PPV
in office

Can you be reimbursed?

For what?
Wet AMD

Dx: submacular hemorrhage AMD OD

Tx: pars plana vitrectomy

Plan: intravitreal injection following PPV
in office

Claim: 67038 for surgery

Claim: 67028 58RT (intravitreal injection)
pegaptanib/ranibizumab/bevacizumab

Modifier 58: staged or related procedure
during the postoperative period
Wet AMD

Dx: wet AMD OD

Tx: intravitreal injection

Can you be reimbursed?

For what?
Wet AMD

Dx: wet AMD OD

Tx: intravitreal injection

Claim: 67028 RT (intravitreal injection)
J2503 (pegaptanib)
J3590 (ranibizumab)
J3490/J3590/J9035 (bevacizumab)
Wet AMD

Hx: S/P intravitreal injection OD x 5 weeks

Dx: wet AMD OD, unresolved

Tx: intravitreal injection OD

Can you be reimbursed?

For what?

Why?
Wet AMD

Hx: S/P intravitreal injection OD x 5 weeks

Dx: wet AMD OD, unresolved

Tx: intravitreal injection OD

Claim: 67028 RT (intravitreal injection)
J2503 (pegaptanib)
J3590 (ranibizumab)
J3490/J3590/J9035 (bevacizumab)

67028 = 0 days postoperative period
Wet AMD

Dx: wet AMD OS

Tx: intravitreal injection OS, return
1 wk for PDT OS

Can you be reimbursed?

For what?

Why?
OS = left eye; PDT = photodynamic therapy.
Wet AMD

Dx: wet AMD OS

Tx: intravitreal injection OS, return
1 wk for PDT OS

Claim: 67028 LT (intravitreal injection)
J2503 (pegaptanib)
J3590 (ranibizumab)
J3490/J3590/J9035 (bevacizumab)
Wet AMD

Hx: S/P intravitreal injection 1 week OS

Dx: wet AMD OS

Tx: photodynamic therapy OS

Can you be reimbursed?

For what?

Why?
Wet AMD

Hx: S/P intravitreal injection 1 week OS

Dx: wet AMD OS

Tx: photodynamic therapy (PDT) OS

Claim: 67221 LT (PDT)
J3396 (verteporfin)
Operative Reports

Pre- and postoperative diagnoses

Indications for surgery

Description of surgery

Discharge instructions
Conclusion

Laser treatments
– Focal laser

CPT: 67220
– Photodynamic therapy

CPT: 67221/67225

HCPCS: J3396 (verteporfin)
Conclusion

Antiangiogenic therapies
– Pegaptanib sodium

CPT: 67028 (intravitreal injection)

HCPCS: J2503 (pegaptanib sodium)
– Ranibizumab

CPT: 67028 (intravitreal injection)

HCPCS: J3590 (ranibizumab)
– Bevacizumab

CPT: 67028 (intravitreal injection)

HCPCS: J3490/J3590/J9035

Bevacizumab/carrier specific
Conclusion

Future of AMD treatment

Clinical research ongoing
– Private sector
– NEI/NIH

Improvement of existing therapies

Combination therapies using current
methods
Overview of AMD Therapy
Sharam Danesh, MD
Vitreoretinal Surgeon
Associated Retina Consultants, Ltd.
Associate Professor
Department of Ophthalmology Retina Services
University of Arizona
Phoenix, Arizona
Introduction
Definition of age-related macular
degeneration (AMD)

A constellation of degenerative macular
abnormalities, strongly associated with
age

These degenerative abnormalities are
along a spectrum of changes from normal
aging to severe AMD
Classifications

Dry AMD
– Non-neovascular changes


Drusen

Abnormalities of the retinal pigment
epithelium
Wet AMD
– Neovascular changes

Choroidal neovascularization
Dry AMD


Dry AMD is more common
– Dry AMD
85%
– Wet AMD
15%
Severe visual loss
– Dry AMD
15%
– Wet AMD
85%
Drusen

Round and yellow lesions

Located in the outer retina of the posterior pole

Accumulation of material in Bruch’s membrane

Failure of the debris from the retinal pigment
epithelium cells to cross the Bruch’s membrane into
the choriocapillaris
Courtesy of Dr. S. Danesh.
Dry AMD
Geographic atrophy

The end result of the atrophic form of AMD

Round oval area of hypopigmentation and
apparent absence of the retinal pigment
epithelium

Choroidal vessels are more visible
Courtesy of Dr. S. Danesh.
Neovascular AMD

Choroidal neovascular membrane
is the hallmark of wet AMD

Neovascular vessels grow
through the Bruch’s membrane
into the sub–retinal pigment
epithelium and sub–retinal space

The fibrovascular complex can
destroy the normal structure of
the RPE and retina

Secondary exudation or
hemorrhage from neovascular
vessels may occur
Available at: http://health.yahoo.com/media/mayoclinic/images/image_popup/r7_wetmacdegen.jpg.
Accessed June 26, 2007.
Mayo Foundation for Medical Education and Research. All rights reserved.
Reprinted with permission.
Neovascular AMD
Clinical finding of choroidal neovascular membrane

A grey subretinal membrane

Subretinal hemorrhage

Subretinal fluid
Courtesy of Dr. S. Danesh.
Neovascular AMD
Symptoms of choroidal neovascular membrane

Blurred central vision

Central scotoma

Metamorphopsia (distortion)
Courtesy of Dr. S. Danesh.
Neovascular AMD
Disciform scar

End-stage choroidal
neovascular
membrane

A fibrovascular scar is
formed in the
subretinal space

Associated with severe
loss of central vision

Not yet amenable to
any treatments
Courtesy of Dr. S. Danesh.
Severe Visual Loss in AMD

Geographic atrophy in
the center of macula

Choroidal neovascular
membrane
Courtesy of Dr. S. Danesh.
Risk Factors and Preventions

Excellent evidence
–
–
–
–
–
–

Age
Race/ethnicity
Family history
Smoking
Antioxidant vitamins: C, E, beta carotene
Zinc
Some evidence
– Lifelong exposure to blue light
– Lutein/zeaxanthin
– Omega 3 long chain fatty acids

No evidence
– Exposure to UV light
Current and Potential Treatments
Photodynamic Therapy

Treatment with a photosensitizing dye

Proposed mechanism of action:
Verteporfin is activated by light
Oxygen radicals
Endothelial damage and thrombus formation
Occlusion of neovascular vessels
Treatment of AMD with Photodynamic
Therapy (TAP) Study
Conclusions

Photodynamic therapy is clinically beneficial
for patients with choroidal neovascular
membrane with >50% classic component

This beneficial effect only slows visual loss at
best
TAP Study Group. Arch Ophthalmol.1999;117:1329.
Anti-VEGF Therapies in Eye Diseases

Pegaptanib*

Ranibizumab*

Bevacizumab

VEGF-trap

siRNAs
Pegaptani
b
Ranibizuma
b
oAvastin
Bevacizumap
oVEGF-trap
Squalaminelactate
lactate
Squalamine
Anecortave
*Approved by FDA for AMD
VEGF = vascular endothelial growth factor; siRNAs = small interfering RNAs; PDT = photodynamic
therapy; TTT = transpupillary thermotherapy; EBRT = external beam radiation.
The Eye Digest. http://www.agingeye.net/maculardegen/maculardegennewdevelopments.php
The Eye Digest. www.agingeye.net. University of Illinois Eye & Ear Infirmary.
Pegaptanib—VISION Results
In 2 combined randomized, doublemasked, sham-controlled trials,
pegaptanib

Significantly reduced the proportion of
patients who lost >15 letters

Reduced the progression to legal blindness
Chakravarthy U, et al. Ophthalmology. 2006;113:1508.
Ranibizumab* and Bevacizumab
Affinity
maturation
(140×)
RANIBIZUMAB
48 kDa
(rhu Fab v1)
Humanization
Construction
of full length
antibody
Mouse
Anti-VEGF-A mAb
(~150 kDa)
*FDA approved for AMD.
Courtesy of Dr. S. Danesh.
(Fab-12)
BEVACIZUMAB
149 kDa
Ranibizumab—MARINA Results
≥15-Letter Gain from Baseline
100
90
80
70
60
50
40
30
20
10
0
94.6*
90.0*
62.2
52.9
Sham Ranibizumab Sham Ranibizumab
0.5 mg
(n = 238) 0.5 mg
(n = 238)
(n = 240)
(n = 240)
Month 12
% of Subjects
% of Subjects
<15-Letter Loss from Baseline
100
90
80
70
60
50
40
30
20
10
0
Sham (n = 238)
Ranibizumab
0.5 mg (n = 240)
33.3
33.8
4.6
Month 12
3.8
Month 24
Month 24
MARINA = Minimally Classic/Occult Trial of Anti-VEGF Antibody Ranibizumab in the Treatment of
Neovascular Age-Related Macular Degeneration.
With permission from Rosenfeld PJ, et al. N Engl J Med. 2006;355:1419-1431. Copyright 2006.
Massachusetts Medical Society. All rights reserved.
Ranibizumab—MARINA Results
Mean Change in Visual Acuity Over Time Through Month 24
Sham (n = 238)
ETDRS Letters
10
Ranibizumab 0.5 mg (n = 240)
+7.2
+6.6
5
0
2 4 6 8 10 12 14 16 18 20 22 24
-5
-10
-15
-10.4
Month
-14.9
ETDRS = Early Treatment of Diabetic Retinopathy Study.
With permission from Rosenfeld PJ, et al. N Engl J Med. 2006;355:1419-1431. Copyright 2006.
Massachusetts Medical Society. All rights reserved.
Ranibizumab—ANCHOR Results
≥15-Letter Gain From
Baseline at Month 12
<15-Letter Loss From
Baseline at Month 12
96.4
100
90
90
80
80
70
% of Subjects
% of Subjects
100
64.3
60
50
40
30
70
60
50
40
30
20
20
10
10
0
0
PDT
(n = 143)
Ranibizumab
0.5 mg
(n = 139)
40.3
5.6
PDT
(n = 143)
Ranibizumab
0.5 mg
(n = 139)
PDT = photodynamic therapy.
With permission from Brown DM, et al. N Engl J Med. 2006;355:1432-1444. Copyright 2006.
Massachusetts Medical Society. All rights reserved.
Ranibizumab—ANCHOR Results
Mean Change in Visual Acuity
Over Time Through Month 12
PDT (n = 143)
Ranibizumab 0.5 mg (n = 139)
ETDRS Letters
15
+11.3
10
5
0
1
2
3
4
5
6
7
8
9
10 11 12
-5
-10
Month
–9.5
-15
PDT = photodynamic therapy; ETDRS = Early Treatment of Diabetic Retinopathy Study.
With permission from Brown DM, et al. N Engl J Med. 2006;355:1432-1444. Copyright 2006.
Massachusetts Medical Society. All rights reserved.
CATT
Comparison of AMD Treatments Trial
Multicentered
randomized
clinical trial
involving
40 centers
Group 1
Ranibizumab q 4 wk x
1y
then randomize to
bevacizumab PRN
or q 4 wk
Group 2
Bevacizumab q 4 wk x
1y
then randomize to
ranibizumab PRN
or q 4 wk
Group 3
Ranibizumab
PRN
Group 4
Bevacizumab
PRN
VEGF Trap

Fusion protein of key domains
from human VEGF receptors 1
and 2 with human IgG1 Fc

High affinity: binds VEGF
more tightly than native
receptors or monoclonal
antibodies

Blocks all VEGF-A isoforms
and placental growth factor
(PIGF)

Smaller than an antibody
Kd 10–30 pM
Kd 100–300 pM
Kaiser PK. Presented at: 2006 Retinal Physician Symposium. Paradise Island, Bahamas, May 31, 2006.
http://www.retinalphysician.com/article.aspx?article=100264
Courtesy of Dr. S. Danesh.
VEGF Trap
0.5 mg
q 4 wk
Phase II study
of intravitreous
VEGF trap in
patient with
neovascular AMD
0.5 mg
q 12 wk
Initial
12 weeks
2 mg
q 4 wk
2 mg
q 12 wk
4 mg
q 4 wk
Followed by
9 months of
PRN dosing
Small Interfering RNAs
Natural pathway
Pegaptani
b
Ranibizumab
Squalamine
Anecortave
lactate

Cand5: VEGF SiRNA

Sirna-027: VEGF receptor siRNA
The Eye Digest. http://agingeye.net/maculardegen/maculardegennewdevelopments.php
The Eye Digest. www.agingeye.net. University of Illinois Eye & Ear Infirmary.
Sarnow P, et al. Nat Rev Microbiol. 2006;4:651.
Future Directions—Combination/Triple
Therapies
Early trial of photodynamic therapy
with verteporfin + bevacizumab +
dexamethasone

Visual acuity improved in most of the 59
patients treated

1 cycle only required, with occasional
supplementation with intravitreal injections
of bevacizumab
Augustin AJ, et al. Presented at: Joint Meeting of AAO and APAO. Las Vegas, Nevada;
November 11-14, 2006.
Conclusions

Photodynamic therapy is beneficial for
patients with choroidal neovascular
membrane with >50% classic component,
but only slows visual loss at best

Pegaptanib maintains visual acuity

Ranibizumab maintains and improves
visual acuity

Potential future therapies for AMD include
bevacizumab, VEGF trap, siRNAs, and
combination/triple regimens
AMD Best Practice for Best
Patient Care:
Improving Patient Processes
Angela M. Chambers, RN, MBA
Executive Director
Associated Retina Consultants, Ltd.
Phoenix, Arizona
Improving Patient Flow

Establish a defined practice protocol for
treatment

Educate staff on protocol

Provide injections and therapies in a
defined room; removing this task from
clinic will improve regular clinic flow

Establish a separate schedule for this
procedure area that runs in conjunction
with the established clinic schedule

Schedule patients every 15 minutes
Improving Patient Flow

Schedule 1 person to handle the
procedure area

Define a protocol that addresses patient
education pre- and postprocedure

Make sure to provide written
educational information to the patient;
this will eliminate unnecessary phone
calls

Establish uniformity in set-up for
procedure to streamline cost
Improving Patient Flow

Call doctor to the
procedure room after
patient is prepped and
ready for the procedure

Follow defined protocol
for patient follow-up

Total time for patient
from check-in to check
out is 15–20 minutes

Have patient complete
satisfaction survey to
determine areas of
improvement
Processing of Claims and Collections

Verify patient eligibility

Collect co-pays and deductible
amounts at time of service

Educate all staff on proper coding
for AMD

Utilize pharmaceutical
reimbursement management team
for problems with specific carriers
regarding drug reimbursement

Identify proper Medicare Secondary
Payer (MSP) type prior to claim
submittal to avoid rejections
Drug Inventory

Establish a system to track drug
inventory

Have all drugs delivered to 1
central location; disburse to
other locations after labeling

Label each drug with a specific
identifier number that will
correspond to inventory log

Make 1 person in each office
responsible for drug inventory
received

Drug should not be dispensed till
payer source is identified
Reimbursement Strategies

Contact insurance carriers and request
a written response regarding payment
policy on drug and procedure

Establish a timeline for response, ie,
5 days

Outline in your request what your action
will be if you do not get a response in
identified timeframe, eg, collect from
patient prior to procedure etc.
Reimbursement Strategies

Patients not treated until payer source
is identified

Payment requested upfront for
noninsured patients

Billing department should check
appointment logs and verify eligibility at
least 24 hours prior to procedure
Reimbursement Strategies

Utilize your State Department of Insurance to
intercede in disputes with your insurance
carriers

Every insurance carrier has an appeals
process

Patient is required to initiate the process

The final stage of the appeals process
requires an outside review

The majority of the time when an outside
review is done they err on the side of the
provider
Reimbursement Strategies

Insurance carriers do not like having the
State Department of Insurance involved in the
claims process

Once they are called in to investigate a claims
issue they can expand their focus

The Department of Insurance notifies the
patient, provider, and carrier of the decision

If the carrier is found to be at fault, they
require the carrier to pay the claim with
interest within 5 days
Efficiencies that Ensure Optimal
Patient Care

Maximize your space to create better patient flow

Remove bottlenecks in the back office by
providing procedures in a separate area

Redefine scheduling scenarios to fast-track
patients and decrease wait times in clinic

Redefine the check-in process to assure an
efficient streamlined process

Mail, e-mail, or post on website, information
about required paperwork for patient check-in
process; on appointment day, patients arrive with
information in hand
Reminder Form Example
(Printed on Brightly Colored Paper)

You are scheduled for an intravitreal injection in
our Fast-Track Clinic

Date_______ Time______Location_____

Please do not wear any cosmetics on
appointment date

We advise that you arrange for a driver to
transport you home following injection

You have been given a prescription for an
antibiotic, which will need to be filled prior to the
injection date

If you have any questions, please telephone us at
602-242-4928
Conclusions

Look at all your clinic processes critically

Identify areas of the greatest bottleneck to
patient process and flow

Think outside of the box

Solicit suggestions and information from all
parties involved, ie, providers, staff, patients,
outside observers. Some of our best
solutions have come from this process
Conclusions

Streamline your work space and maximize
space that can be used for revenueproducing endeavors

Paperwork is the largest waste of labor. By
streamlining the paper process, efficiencies
improve and costs decrease

Develop instructional information for patients
regarding procedures and processes. This
will decrease questions and calls to the office
as well as labor costs
Conclusions

By restructuring work processes, you
will improve efficiency, increase
revenue, decrease cost, increase
productivity, and streamline workflow,
while improving the overall patient
experience in your practice