Part B Drug Payment Part B Drug Payment ReformReform Experience and ExpectationsExperience and Expectations

August 11, 2005August 11, 2005

AgendaAgenda

• Coding developments• Medicare payment

– Physician office

– Hospital outpatient

• Private insurance and ASP• Medicaid reform• Conclusions • Pricing implications

• U.S. reimbursement planning and problem solving

• Payer research; strategic planning

• Reimbursement forecasting

• Competitive analysis

• Advocacy with major payers

Industries ServedIndustries Served

Devices/ Diagnostics

15%

Ad/ PR/ PA Agencies

10%

Investors/ Advisors

15%

Biotech/ Biologicals

40%

Pharmaceuti-cals20%

Coding DevelopmentsCoding Developments

New HCPCS ProcessNew HCPCS Process

• Open, interactive

• January 2 application deadline

• No waiting for 6 months marketing data

• Every application given public hearing

Recipe for Good Recipe for Good PresentationPresentation

• Show why existing HCPCS categories do not adequately describe product

– Dissimilar function or– Significant therapeutic distinction

• No sales pitches, no testimonials

Good Presentation Good Presentation – (Cont’d)

• Data, data, data

• Discuss efficacy and safety in the context of who will benefit by the use of the product

• OK to supplement written application with new, additional info

CMS Decision MakingCMS Decision Making

• Contractors, SADMERC, regional office involvement continues behind the scenes

• Private insurer involvement minimal

But Does It Matter?But Does It Matter?

• Time will tell; I expect ‘Yes’

• Sometimes they just don’t get it from written application

• Opportunity to level playing field when coding change creates competitive disadvantage

• Coding and coverage decisions are linked; improving coding process will improve coverage

Medicare Physician OfficeMedicare Physician Office

ASP ReimbursementASP Reimbursement

• CMS and Congress are of one mind on ASP: Relevant, reliable, worth the time and money to manage

• HHS OIG findings: ASP is 26% lower than AWP for single source; 30% lower for multisource; 68% lower for generics OIG Report No. OEI-03-05-00200, June 2005

ASP’s WeaknessASP’s Weakness

• It presumes rational, predictable wholesaler markup and small, infrequent manufacturer price changes

• Some would argue that is exactly what’s good about ASP – it forces that conduct

ASP’s Weakness ASP’s Weakness – (Cont’d)

• But what happens when market forces overwhelm the formula?

– What happens when ASP is $40/unit and physician’s AAC is $60 or more?

The Case of IGIVThe Case of IGIV

• Demand for intravenous immune globulin (IGIV) exceeds supply

• ‘Secondary’ distributors purchase from wholesalers and apply 20%+ markups

The Case of IGIV The Case of IGIV – (Cont’d)

• Physicians who are under water at ASP + 6% refuse to treat, refer to hospital OPD

• When hospitals are paid ASP + 8%, will they take the referral?

Implications of IGIV Implications of IGIV ExperienceExperience

• ASP+ not a good long term choice if too many other situations like IGIV create access uncertainty for patients and providers

IGIV ExperienceIGIV Experience – (Cont’d)

• But if CAP is successful, ASP+ will be sustainable for long haul (validates access with ASP formula)

• Additional fine tuning needed for CAP-exempt products

CAP Exempt Drugs CAP Exempt Drugs (Interim Final (Interim Final Rule)Rule)

• Contrast agents• Controlled substances• Certain vaccines• Drugs used with DME• Leuprolide• Orphan drugs w/o non-orphan use• Clotting factor• IGIV and other immune globulins• Drugs w/o J code

Emergency AuthorityEmergency Authority

• HHS Sec. can modify reimbursement in case of “public health emergency … where there is a documented inability to access drugs and biologicals, and a concomitant increase in the price … which is not reflected in the manufacturer’s average sales price …” Medicare Prescription Drug, Improvement, and Modernization Act of 2003, sec. 303(e)

Refocus on PreventionRefocus on Prevention

• Waiting for a public health emergency is the wrong standard – should be amended to prevent an emergency, esp. for CAP exempt drugs

Procedure PaymentsProcedure Payments

• Cancer quality demo

• New infusion payments

Infusion Payments ImprovedInfusion Payments Improved

• New payments created for – Hydration

– Admin of non-chemo drugs during chemo session

– Severe reaction management

– Chemo treatment planning and

– Supervision of chemo drug preparation

Payments Improved Payments Improved – (Cont’d)

• Chemo drugs and biologic response modifiers billable under chemo infusion codes

• Infusion of 15-30 min. can be billed as infusion of up to 1 hour

Cancer Quality DemoCancer Quality Demo

• Oncologist receives additional $130 for reporting patient info about

– Nausea/vomiting– Pain– Fatigue

Cancer Quality DemoCancer Quality Demo – (Cont’d)

• Sunsets in December unless extended by Congress

• CMS estimates that demo is responsible for 15% of 2005 hem-onc revenue from Medicare fees Proposed 2006 Physician Fee Schedule at p.341

Medicare Hospital O/PMedicare Hospital O/P

HOPPS: GAO SurveyHOPPS: GAO Survey

• Average purchase prices were – Significantly lower than

reimbursement– Usually lower than ASP even before

taking rebates into account

GAO-05-581R Medicare Hospital Outpatient Drug Prices, June 30, 2005

2006 HOPPS Changes 2006 HOPPS Changes

• ASP + 8% replaces previous payments (typically 83% AWP)

– ASP + 6% for drug component

– 2% for pharmacy overhead in 2006 and 2007

– Orphan drugs included

– 2008: Adjust based on 2 year study of actual cost

2006 Changes 2006 Changes – (Cont’d)

• Out: “Pass-through drugs”

• In: SCODs – specified covered outpatient drugs

ImplicationsImplications

• Generics and brands have same formula

• Payment adjusted quarterly rather than annually

• No significant (2%) difference in payment among treatment settings

• Net impact on hospitals: significant decrease for 11 of top 20 SCODs

Comparison of 2005 HOPPS Payment to 2006 Comparison of 2005 HOPPS Payment to 2006 Formula for Top 70% of Medicare Spending on Formula for Top 70% of Medicare Spending on

SCODsSCODs

Drug/BiologicalApril 2005 HOPPS ($)

April 2005 ASP ($)

108% ASP ($) % Change

EPO per 1,000 units 11.09 9.25 9.99 -10.00

Rituxan® 100 mg 437.83 414.92 448.11 2.00

Neulasta® 6 mg 2448.50 2017.55 2178.95 -11.00

IGIV Lyoph 1g 80.68 36.54 39.46 -51.00

IGIV Non-Lyoph 1g

80.68 53.04 57.28 -29.00

Remicade® 10 mg 57.40 50.20 54.22 -6.00

Aranesp® 1 mcg 3.66 3.04 3.28 -10.00

Taxotere® 20 mg 312.69 278.95 301.27 -4.00

Carboplatin 50 mg 129.96 71.46 77.18 -41.00

EloxatinTM per 5 mg 82.53 77.86 84.10 2.00

Comparison of 2005 HOPPS PaymentComparison of 2005 HOPPS Payment - (Cont’d)- (Cont’d)

Drug/BiologicalApril 2005 HOPPS ($)

April 2005 ASP ($)

108% ASP ($) % Change

Zometa® 1 mg 197.87 187.47 202.47 2.00

Gemzar ® 200 mg 105.73 108.79 117.49 11.00

Camptosar® 20 mg 127.33 119.59 129.16 1.00

Natrecor® 0.25 mg 66.23 69.64 75.21 14.00

Paclitaxel 30 mg 79.04 17.70 19.12 -76.00

Herceptin® 10 mg 50.79 49.99 53.99 6.00

Eligard &Lupron Depot 7.5 MG

543.72 213.83 230.94 -58.00

Alpha 1 PI 10 mg 3.72 3.06 3.30 -11.00

AvastinTM 10 mg 57.11 53.88 58.19 2.00

Neupogen® 480 mcg 274.40 261.46 282.38 3.00

Functional Equivalence Dies Functional Equivalence Dies (Again)(Again)

• “Functional equivalence” applied by CMS in 2002 to stretch LCA concept to Aranesp

• Banned by MMA, so CMS applied an “equitable adjustment” to Aranesp based on Procrit cost for equivalent dosage

• Equitable adjustment ends in 2006 – replaced by ASP + 8%

Treatment Setting Treatment Setting Shift?Shift?

• Some anecdotal reports of physicians sending patients to hospital OPDs for infusions, but we see no evidence of trend– Published reports about IGIV, for

example, do not represent what’s happening with other categories of drugs

Private InsurersPrivate Insurers

Heading Toward ASPHeading Toward ASP

• Feb 2005 survey

• 15 private insurers/PBMs

• ~100 mil covered lives

Survey FindingsSurvey Findings

• AWP – 15% most prevalent payment

• 3 plans moving to ASP by 2006

• 4 plans expect payment to be reduced even if they remain with AWP

• 6 plans evaluating

• 2 plans staying with AWP

• Only 3 use NDCs

MedicaidMedicaid

Rx Payment Reform in 2006Rx Payment Reform in 2006

• Reform is high priority for fall Congress

• 3 proposals

– Administration

– National Governors Assn.

– HHS OIG

AdministrationAdministration

• ASP + 6%

• Replace best price calculation with flat rebate higher than existing 15.1% basic rebate

GovernorsGovernors

• Unclear endorsement of switch to ASP

• Dispensing fee not linked to Rx price• Increase rebate• Substitute front-end discount for

rebate payment• Include authorized generics in rebate• Keep Best Price

HHS OIGHHS OIG

• ASP or AMP based formula

ConclusionsConclusions

ConclusionsConclusions

• Coding for new product requires more planning and prep but has better/quicker chance for success

• New coding process allows you to use competitor’s application to shed light on your issues

Conclusions Conclusions – (Cont’d)

• Congress and CMS like ASP results

• ASP reduces provider profit by 25%+ on brand products

• ASP endurance depends in part on CAP success

Conclusions Conclusions – (Cont’d)

• Because ASP does not account for middleman markup, HHS Sec. “emergency powers” should be expanded to prevent rather than only react

Conclusions Conclusions – (Cont’d)

• Hospital pharmacy revenue will see major declines in 2006 (Medicare & Medicaid) and 2007 (private insurers)

• ASP will be widely adopted by private insurers and Medicaid

Conclusions Conclusions – (Cont’d)

• Drug profit becoming less significant to provider; procedure profit is the improving opportunity

• CAP delay will slow but not diminish specialty pharmacy’s march to become the power customers

Part B Pricing ImplicationsPart B Pricing Implications

Pricing ImplicationsPricing Implications

1. Greater pricing flexibility in Part B than Part D

– Part B ASPs cap price at the provider, not the manufacturer level

– Part D managed market formularies cap price at the manufacturer

Unless …

Pricing Implications Pricing Implications – (Cont’d)

• Drug will be in a multi-product HCPCS code

• Or subject to LCA– Selected LHRH agonists

Pricing ImplicationsPricing Implications – (Cont’d)

2. Shift in profit focus from drug to procedure creates different pricing opportunity for drug that maximize procedure profit

3. In selected situations, a new drug can still grab share because of reimbursement • AWP vs. ASP

• Higher ASP

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