Insurance Coverage of INTRABEAM® Procedures Cracking the Mystery of Cancer-related Reimbursement

William Hrushesky, MD Oncology Analytics, Florida

The statements of the healthcare professional giving this presentation reflect only their personal opinions and experiences and do not necessarily reflect the opinions of any institution with whom they are affiliated.

The healthcare professional giving this presentation has a contractual relationship with Carl Zeiss Meditec, Inc., and has received financial compensation.

The following presentation may include discussion of device features and applications that are not FDA cleared in the United States.

Cracking the Mystery of Cancer-re la ted Re im bursem ent

Will iam Hrushesky, MD, FACP Chief Scient i f ic Of f icer & VP for Innovat ion & New Product Developm ent Oncology Analyt ics (OA) Mobile No. 803-429-2184 First U.S. INTRABEAM (Zeiss) User Meet ing Feb 19-20, 2016 Las Vegas, NV

What We Do...Cancer Care Decision Suppor t Through a Rigorous and Dat a Based Pre-Approval Process

Why We Do This

Mission: Assure each cancer patient receives the highest quality & value cancer care possible “The right care at the right cost for the right reasons”

Vision : To be recogn ized na tiona lly as the source of the m ost accura te , use fu l, and re liab le source for non-conflicted cance r ca re m anagem ent gu idance

Oncology Analytics Corp .

Who decides which cancer treatments should be re im bursed am ong the 325 m illion Am ericans?

Com plex -- NO ONE? Everyone? No NICE.

• FDA approves based upon e fficacy and sa fe ty. No va lue conside ra tion .

• CMS decides which se rvices, p roducts, and devices will be re im bursed for the 50 m illion Medicare recip ien ts.

• NCCN com pendium guide lines, a long with ind ividua l insurance carrie rs, la rge ly de te rm ine whe the r re im bursem ent occurs am ong the m illions of com m ercia l m em bers for cance r ca re .

Insurance Reimbursement Policy for Cancer Care

Insurance reimbursement policy for cancer care is heavily in fluenced by:

1. CMS Medicare policy / federa l regu la tions 1. NCCN com pendium policy

1. Sta te regu la tions, gu ide lines, and loca l coverage

de te rm inations (LCD)

How may these be inf luenced?

NCCN: Nature and Quality • NCCN is a se lf-appoin ted group of for-profit academ ic cancer cen te rs,

each of which survive econom ica lly based upon re im bursem ent for cancer care .

• NCCN decision-m aking com m ittee m em bers and cha irs a re p racticing cancer doctors whose sa la rie s depend upon re im bursem ent.

• NCCN disease -specific cha irs and m em bers virtua lly a ll participa te in com m ercia l clin ica l tria ls .

• Most NCCN chairs and com m ittee m em bers speak for and are pa id by various and m any pharm aceutica l com panies who sponsor these tria ls.

• Som e NCCN com m ittee m em bers and cha irs hold pa ten ts for the rap ies be ing conside red by NCCN for re im bursem ent recom m endations.

OA Guidance • OA takes no funds from drug or m edica l device

com panies. • No OA em ployee consu lts for any pharm aceutica l or

device firm . • OA does not accep t shared savings in paym ent for

se rvices rendered , free ing decision support from paym ent for d irect savings.

• OA value in savings for choosing h ighest va lue the rap ies exceeds two-fold the cost of OA se rvices.

• OA guidance is updated da ily in rea l-tim e . • OA advice is p rovided to cancer doctors collegia lly,

accom panied by a ll re levan t da ta . • All conflicts of in te rest a re avoided .

OA Assistance in Creating High-va lue Ne tworks

• OA assesses ind ividual cancer doctor/p ractice va lue and he lps payers bu ild and m ain ta in h igh-va lue cancer ne tworks.

• OA provides incen tives and assists p rovide rs in ge tting clear, ce rta in and qu ick pre -approvals for the rap ies of the h ighest va lue .

• When lower va lue the rap ies a re requested , OA provides com ple te da ta , d iscusses a lte rna tives, and arrives collegia lly a t a m utua lly accep tab le consensus decision .

• All OA m edica l d irectors a re board-ce rtified in the specia lty for which they are in te racting with p roviders.

• All clin ica l consu lta tions a re deep and sub tle , and of benefit to the trea ting physician and pa tien t.

Dirty Little Secrets • FDA approval stud ies a re frequently flawed

or gam ed by sponsors • OA analyzes and poin ts ou t these gam es

and flaws to payers, p rovide rs, CMS and NCCN.

• Many NCCN approvals a re given without da ta , poor qua lity or incom ple te da ta , or without conside ra tion for superior and /or new da ta .

• OA m akes these da ta ava ilab le to p rovide rs, payers, NCCN, and CMS.

NCCN Accepts Petitions to Alter Com pendium Guidance • >200 pe titions have been filed

• >193 have origina ted from drug com panies asking for approval of

re im bursem ent for the ir the rap ies.

• 1 arose from an academ ic cen te r

• 6 were subm itted by OA; 4 of which successfu lly a lte red NCCN recom m endations.

There is hope!

Strategies to enhance the success of re im bursem ent for h igh va lue the rap ies

• Sta te -based cam paigns to dem onstra te va lue to LCD com m ittees.

• Papers which appear in one of the 26 key cance r journa ls listed by CMS supporting h igh va lue cance r the rap ies.

• NCCN pe titions to m ake h igh va lue the rap ies (recom m ended).

• Working with OA to recom m end h igh-va lue the rap ies as “pre fe rred” choices.

The Future As I See It

Today

Tom orrow

Soon

IORT in Breast Cancer • IORT is an OA pre fe rred m odality for early stage breast cancer • Medicare Re im bursem ent

– CMS National Policy has approved for IORT for Medicare recip ien ts • Multip le sta tes have LCDs for IMRT, SRS, and /or SBRT • Without an LCD, le ss hoops for coverage crite ria • Although if frequent den ia ls, IORT LCD can be deve loped

• Com m ercia l Re im bursem ent – Priva te payers can take d iffe ren t positions on IORT

• RT type for com m ercia l pa tien ts m ay be d icta ted by payer • OA provides advice on na tiona l payer policies

• OA Is recognized as a trusted non-conflicted Source of Data based Cancer Care Guidance .

• OA recognizes the equal e fficacy and h igh VALUE of IORT com pared to standard post re section Breast Cancer whole b reast XRT.

• The cost of WBXRT is som e TEN fold grea te r for standard the rapy than IORT.

• 30 to 35 week day trea tm ents requ ire m any weeks and d isrup t the lives of wom en undergoing exte rna l WBXRT for m onths .

• IORT is done concurren t with loca l re section im m edia te ly fo llowing tha t re section add ing virtua lly no add itiona l d isrup tion of these wom en 's lives.

IORT in Breast Cancer

How Oncology Analytics Might Help • OA prepares white papers summarizing relevant world literature. • OA publishes these findings in the peer review literature among the 26 CMS approved journals. • OA supports the approval of high value therapies providing medical directors with convincing evidence. • OA Radiation Therapy pre-approval process list high value therapeutics including IORT as a preferred choice. • OA petitions NCCN for appropriate compendium changes. • OA petitions CMS for appropriate policy changes. • OA petitions LCD committees for appropriate changes.

Will Medical Directors listen and respond to new clin ica l evidence?

In gene ra l, Medica l Directors fo llow CMS, guide lines, as we ll as com pendia . Medica l Directors m odula te the ir decision m aking accord ing to qua lifying m edica l lite ra ture as new evidence becom es ava ilab le with in one of the 26 key CMS approved journa ls. This lite ra ture m ust be com piled and presen ted to them in com pe lling form at dem onstra ting e fficacy, sa fe ty and hopefu lly enhanced va lue .

How often are LCDs reviewed? LCDs for CMS are reviewed at least annually • LCDs for CMS are reviewed a t least annua lly.

• LCDs by sta te a re a lso pe riod ica lly reviewed.

• Oncology Analytics reviews re levant da ta continuously and m odula te s its recom m endations based upon new find ings in rea l tim e .

How do Medical Directors Generally Handle Appea ls?

• They subm it the re levan t evidence and appeal to an independent expert review board (usua lly by sta te ) for fina l ad jud ica tion .

• Ultim ate resu lts depend upon the com ple teness and pe rsuasiveness of the subm itted docum enta tion .

• Oncology Analytics recom m ends den ia l of le ss than 2% of requested the rap ies a fte r p resen ting the requestor with com pelling evidence for a be tte r a lte rna tive choice .

• OA decisions a re uphe ld in excess of 99% of the tim e .

LCD Process 1. Com m ent pe riod (m in im um 45 days - pub lic m ay add com m ents on

the LCD)

2. Com m ent Review Period , with Deve lopm ent of Responses. (Contractor m edica l d irectors review a ll com m ents, deve lop responses, updated LCD)

3. Notice Period (LCD posted to CMS website bu t not active ye t. Providers have 45 days from posting to im plem ent b illing changes and educate sta ff be fore LCD im plem enta tion)

4. Active Period (LCD is in Effect)

Ask Me About... • OA’s new, com prehensive , th ree -tie red Radia tion Oncology Guidance

Product

• IORT is a p re fe rred m odality for early-stage breast cancer

• Other innovations foste ring va lue , d im in ish ing waste , and e lim ina ting fraud and abuse a re key to th is p roduct su ite .

Contact Info Will iam Hrushesky, MD, FACP Chie f Scien tific Office r & VP for Innovation & New Product Deve lopm ent Oncology Analytics (OA) Mobile : No. 803-429-2184 Em ail: whrushesky@oncologyanalytics.com Website : www.OncologyAnalytics.com

The 2016 U.S. INTRABEAM® User Meeting has been sponsored by ZEISS.

Not all products, services or offers referenced in this presentation are approved or offered in every market and approved labeling and instructions may vary from one country to another.

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