Musings of an ASCO Curmudgeon

Association of Northern California Oncologists2005 Annual Meeting

Fish CAMPOctober 14-16, 2005

John V. Cox DO FACP

Chair, Clinical Practice

Committee

Overview

Strategic Plan of ASCO Clinical practice is central to the mission of ASCO Grassroots Come Alive - State Affiliate Program Clinical Practice Committee

MMA (passed 2003) How does / will it affect Cancer Care? Payments for chemotherapy 2005 - 06

ASP; CAP; Drug Admin; Demo Project; etc…..

Fee Schedule – Annual ritual SGR fix

Other Policy Issues

ASCO Strategic Plan

Goal 1: Cancer Care and Clinical Practice Management

Goal 2: Multidisciplinary Member NeedsGoal 3: EducationGoal 4: ResearchGoal 5: Early Career DevelopmentGoal 6: Cancer Prevention and ControlGoal 7: Authoritative ResourceGoal 8: Governance and Operations

Goal 1: Cancer Care and Clinical Practice

Management

In order to minimize the cancer burden in society and enhance the well being and survival of cancer patients, ASCO will

improve the quality of and access to the full spectrum of cancer care services.

Achieving Goal 1: New Initiatives

ASCO/AOHA Service Line Study to lay foundation for new codes and reimbursementPractice Management Workshop / Enhanced Support

State Affiliate Leadership Developing strong regional leadership Broadening grassroots networks

Add to existing lobbying and policy powerPractice based quality assessment / ASCO preparing members for “pay for quality”New publication focusing on practice management -- JOPWorkforce Study

History & Background of the Program

Created in 1993Most state societies had already been establishedFormalized relationship between ASCO & AffiliatesMembership on ASCO’s Clinical Practice Committee (CPC)Toll-free coding/reimbursement hotline

Policy/legislative analysis & advocacy assistanceEducational sessions at Annual Meeting & Fall Conference“Practical Tips for the Practicing Oncologist”

Program AssessmentNeeds Assessment & Benchmarking

In 2005: 5-year update of 1999-00

Needs Assessment Survey

Collect demographic data on State Affiliates

Measure progress and identify benchmarks for success

Vision…. (strength)

State Affiliates… More than an “affiliate”??!!To provide tools to strengthen the organizations in the states to increase the voice of our members To do so strengthens ASCO. We “deepen” the “grassroots” of the organization.Recognize that all affiliates don’t look alike

Clinical Practice Committee

The CPC addresses the interests of practicing oncologists, with particular emphasis on reimbursement for, access to, and quality of oncology services through advocacy and direct assistance to members

of ASCO and its State/Regional Affiliates.

The Committee provides a forum where practicing oncologists - via the State/Regional Affiliates - may address national, state or regional issues affecting cancer care and research.

Clinical Practice Committee

Membership

Increasing Influence Increasing liaison role

A “house” of leaders …. And ideas A portal of communication

Monthly Conference Calls

Increasing commitment to State Affiliates Development of a “deep” grassroots organization

Past Chairs… Dr. Jack Keech & Dean GesmeChair-elect…. Dr. Peter Yu

OverviewStrategic Plan of ASCO Clinical practice is central to the mission of ASCO Grassroots Come Alive - State Affiliate Program Clinical Practice Committee

MMA (passed 2003) How does / will it affect Cancer Care? Payments for chemotherapy 2005 - 06

ASP; CAP; Drug Admin; Demo Project; etc….. Fee Schedule –

Annual ritual SGR fix ASCO Principles and Policy

Other Policy Issues

MMAPayment for Chemotherapy

Drugs: (Payment in 2004 based on 85% of AWP) Payment in 2005 based on 106% of ASP ?? 2006 ?? a physician may obtain drugs though a Medicare contractor

(CAP)

Services – Drug Admin & Practice Expense: (2004 – Physician work, & approx 32% transitional add on) Transitional add on to + 3% in 2005 and to 0% in 2006 “New” Drug Admin Codes – (G-codes to CPT Jan 1, 2006) (Demo Project -- continuing in 2006???) (P4P – proposals … the future??)

Studies: OIG – to assess ASP / ability to buy drugs– 10/1/05 --- ASCO comments Sec of HHS / CMS – to assess ASP methodology / big purchasers – due

1/1/06 MedPAC – to assess affects on oncologists due 1/1/06 & to assess effects on

other specialties 1/1/07

Impact on Oncology

In 2004 …… “…virtually no net change in total Medicare payments

for oncologists.“ Page 1108, fee schedule notice for 2004 published on Jan. 7,

2004

In 2005 …. Impact of change blunted by Demo Project…

“..change manageable”

In 2006….. ?????

2005 Medicare Payments for Office-Administered Drugs

Payments for drugs in 2005 are based on 106% of manufacturer’s average sales price (ASP)

Manufacturers report the ASPs for their drugs to the Centers for Medicare & Medicaid Services (CMS) within 30 days after the end of each calendar quarter

Payment amounts for multiple-source drugs are determined by weighting each drug’s ASP by its sales volume

2005 Medicare Payments for Office-Administered Drugs (2)

Payments are adjusted quarterly with 2-quarter lag E.g., payment amounts for July-September

quarter are based on ASPs for January-March quarter

New drugs are paid at 106% of wholesale acquisition cost (WAC) until ASP data are collected

Principal Problems with ASP System

“Underwater” drugs Some drugs are not available to some physicians

at the Medicare payment amount No exceptions process for particular drugs

2-quarter delay in adjusting payment amounts to reflect price increases may cause payment amount to be less than the

current drug price reduces any margin that might otherwise be

available

Competitive Acquisition Program

Under CAP, physicians may annually elect to obtain all Medicare drugs from a Medicare vendor instead of purchasing them and seeking reimbursement.

Entire group practice must make same enrollment decision.

Implementation of CAP delayed by CMS until July 2006.

CAP – General Process

Physician will order drugs from vendor for a specific patient and date of administration. Physician could order entire course of therapy at once but vendor may ship in segments.Vendor will ship drugs with an identifying order number within 2 business days for standard shipments and 1 business day for emergency shipmentsPhysician will file claim with Medicare for drug administration services, list the drugs administered, and include the vendor order numberWhen physician files claim, carrier will notify vendor that the drugs had been administered, and vendor could then bill Medicare for the drug and patient for the coinsurance

Principal CAP Issues

Administrative work associated with ordering and tracking of drugs is significant.Process for handling unused drug is vague negotiation between vendor and physician Vendors must offer assistance with coinsurance issues in the form of referral to independent charities, a payment plan, or waiver of coinsuranceVendor may cease shipment of drugs for beneficiaries with balance outstanding 45 days after billing date

Drug Administration Payments

Payments for drug administration services were generally increased substantially between 2003 and 2004

In addition, a 32% transitional add-on payment applied in 2004

Transitional add-on was reduced to 3% for 2005 and is eliminated for 2006 and later years

Revamped Drug Administration Codes

In response to MMA, AMA CPT Editorial Panel extensively revised drug administration codes, and the AMA Relative Value Update Committee assigned relative values

CMS made the new codes effective for Medicare in 2005 by adopting them as temporary G-codes

AMA’s action is effective for the 2006 CPT book

Revised codes will be mandatory for all payers in 2006 when they are issued as CPT codes

2005 Demonstration Project

Centers for Medicare & Medicaid Services (CMS) adopted a demonstration project for 2005

$130 payment for each chemotherapy encounter (push or infusion) for reporting on claim form patient’s assessment of nausea/vomiting, pain, and fatigue

Intended to increase payments related to drug administration so that overall payment reductions would be in line with 2003 congressional estimates

2005 Demonstration Project (2)

CMS released preliminary data from demonstration: minority of patients suffer significant symptoms –

2% with substantial nausea/vomiting, 8% with substantial pain, 26% of substantial fatigue

CMS plans to look at relationships between reported symptoms and hospitalizations and ED visits

CMS does not have evidence that MMA changes are affecting access to care.

2005 Demonstration Project/CMS Fact Sheet

CMS has not yet committed to extending the demonstration project. Issues under consideration are: More effective time frame for inquiring about patient

quality of life and symptoms More effective alternatives to collecting data on

quality of life than cancer patients receiving IV chemotherapy

More effective measures related to quality of care (evidence-based practice guidelines)

Looking at the oncology demonstration program in the context of physician payments.

House Resolution 261

On May 4, Rep. Ralph Hall (R-TX) introduced H. Res. 261 Commends CMS for 2005 demonstration project Expresses sense of House of Representatives that

CMS should continue the demonstration project at least through 2006, subject to any appropriate modifications

Bipartisan cosponsors and support of Energy and Commerce Committee

Passed the House October 6th Can see video of floor speeches …. www.asco.org

Prospects for 2006 Medicare Payments

In the absence of any action:

Demonstration project ($130/encounter) terminates 12/31/05

3% add-on to drug administration codes ends

Prospects for 2006 Medicare Payments (2)

CMS appears interested in continuing some form of a demonstration project

May not be as broad as the current demonstration

May not add as much funding to the system as the current demonstration

Private Payers

Some private payers are moving to the Medicare ASP-based payment rates

But they may not be offering increased payments for drug administration services

Many payers will index Medicare Payment rates… read contracts well, be aware of “index year” - dramatic differences between Medicare year 2004 and 2005

Physician Fee Schedule Changes

2006 proposed rule published on August 1, 2005. (final rule approx early November )

Annual Conversion Factor Update Change to conversion factor is based in part on

compliance with “sustainable growth rate.” Projected 4.3% reduction for 2006. Estimation of annual approximate 5% reductions

each year from 2006 through 2012. CMS requesting comments.

Physician Fee Schedule Changes (2)

Practice expense methodology CMS proposing change from top-down to bottom-up

methodology for direct practice expense. Would be transitioned in over 4 years. Oncologists would experience slight increase in

payments under new system (1.4% increase by 2009).

Payments for multiple imaging procedures in same family of procedures on same day would be reduced (also in HOPD).

ASCO Projects

ASCO contractor worked with practices to identify the complete range of services for which there is no explicit Medicare (or other) payment

Further work will seek to refine study to support new codes and payment amounts

ASCO/AOHA Service Line Study

Develop common definitions for supportive care

Lay foundation for new codes and reimbursement

Pending MedPAC Report

Medicare Payment Advisory Commission is required to review and report on changes in payments for drugs and drug administration services Effect on quality of care and patient satisfaction Adequacy of reimbursement Impact on physician practices

CMS is authorized to revise payments for 2007 taking into account the MedPAC reportReport due 1/1/2006 On 10/6th Prelim Report

Interim MedPAC DiscussionOctober 2005

Volume of beneficiaries continue to riseAre some / limited problems with shift to OPD of beneficiaries without supplemental coverage / dual eligiblesOverall no significant change in patterns of careAll interviews pointed to the presence of the Demo project as major reason for lack of significant changeDiscussion concerning the validity of any “bottom line” in light of the Demo project / 2005 surveyNext meeting November 2005 to take up quality / P4P

OIG Report

HHS Office of Inspector General required to study the ability of hematology and oncology practices to obtain drugs at 106% of ASP

OIG visited practices to look at invoices of the prices that oncologists and hematologists pay for drugs, compared to the Medicare reimbursement amounts.

Reported to Congress October 1, 2005

The report presents results in a manner suggesting that the new payment system is working well "Physician practices...could generally purchase drugs...at

less than the MMA-established reimbursement rates." 

…….links in Oct 13 ASCO M&QCU

OIG Report

Of the 39 drugs surveyed by the OIG, only three could be purchased by all physicians for less than the Medicare reimbursement amount.

More than 20% of physicians could not obtain 17 of the 39 drugs without taking an out-of-pocket loss. More that 90% practices had at least 2 drugs that were underwater.

No pattern – consistent with ASCO data last year

ASCO has long advocated that the Medicare payment for drugs allow all physicians, regardless of practice size, to purchase the chemotherapy drugs their patients need.

Pending Sec HHS / CMS Report

CMS is required to study prices paid by large purchasers (e.g., HMOs, PBMs) compared to prices paid by physicians

Issue is whether prices paid by large purchasers should be excluded from ASP calculation

Study is being conducted by contractor, Abt Associates

Report and recommendations are due January 1, 2006

Pay for Performance

Congress and the Administration are seeking to institute Medicare reforms that would link payments to improved quality of care

Hospital payments are now reduced by 0.4 percentage point for hospitals that do not report certain quality indicators

Pay for PerformanceSenator Chuck Grassley (R-IA) has introduced S. 1356, “Medicare Value Purchasing Act of 2005.” Grassley has indicated desire to link to SGR fix. Phase 1: Medicare updates tied to reporting

data on quality measures starting in 2006. Phase 2: Portion of total payments tied to

quality performance – providers rewarded for meeting threshold measures.

A portion of total payment phased in -- 1% in first year, scaling up to 2% over 5 year period

Would combine with health information technology legislation.

Pay for Performance

Nancy Johnson (R-CT) introducing legislation that would fix the annual SGR update and link the update to quality measures. Phase 1: Would become effective in 2007 with

reporting of quality measures. Phase 2: Move toward physician profiling based

on meeting quality measures/improvement measures in 2009.

Process outlined in legislation involves specialty groups for determining measures.

OverviewStrategic Plan of ASCO Clinical practice is central to the mission of ASCO Grassroots Come Alive - State Affiliate Program Clinical Practice Committee

MMA (passed 2003) How does / will it affect Cancer Care? Payments for chemotherapy 2005 - 06

ASP; CAP; Drug Admin; Demo Project; etc….. Fee Schedule –

Annual ritual SGR fix ASCO Principles and Policy

Other Policy Issues

Other Policy Issues• ASCO Quality Initiatives• Off Label Use ---- Use the CAC Rep• FDA Oversight of approved Drugs• Hospital Outpatient Department• PET Scans• Medicare Claims Appeals• Medicare Contractor Reform• Clinical Trials Registry• Publications of Clinical Trials Results• NIH Reauthorization

ASCO Quality Initiatives

QAG – Quality Advisory Group Chaired Patricia Ganz, MD

Cancer Quality Alliance ASCO / NCCS Bring together stakeholders (payers, academia, the

community, survivor groups, non-profits, etc..) Goal of leading the quality discussion

“defining what quality looks like in oncology”NICCQ - National Initiative on Cancer Care Quality QOPI - Quality Oncology Practice Initiative Treatment Plan /// Treatment Summary

Off-Label Drug Coverage

Medicare must cover off-label uses if accepted in: United States Pharmacopoeia Drug Information (USP

DI) American Hospital Formulary Service Drug Information

(AHFS DI) American Medical Association Drug Evaluations

(merged into USP DI)

USP DI changed hands from USP to Thomson Micromedex in spring 2004. Since then: Oncologic Drugs Advisory Board and expert review

process created with input from ASCO, ASH, and ACCC. Two new indications for oncology drugs have been

published.

Off-Label Drug Coverage (2)

Current activities: ASCO encouraging Thomson Micromedex to

conduct timely reviews and ensure rapid publication of accepted uses in USP DI.

AHFS interested in enhancing oncologic drugs section of AHFS DI.

National Comprehensive Cancer Network (NCCN) introducing new compendium and seeking recognition by Medicare for coverage purposes.

FDA IssuesEvaluating Drug Safety in Cancer Drugs

Unanticipated safety problems with FDA-approved drugs to treat chronic conditions (Vioxx) causing policymakers to call for increased monitoring and oversight of drug safety

Considerations of safety cannot be separate from overall risk/benefit analysis

Risk/benefit assessment is different for oncology drugs

Congress should devote new funding to increase ability to identify post-approval safety concerns

FDA IssuesAdministrative/Legislative Response

FDA’s response: Drug Safety Oversight Board, Drug Watch Web Page, Health Professional and Patient Information SheetsFDA Safety Act - S 930 – Sens. Grassley (R) & Dodd (D) Center for Postmarket Drug Evaluation & Research with

independent authority to remove drugs from market and to require post-market studies

Increased civil penalties and regulation of consumer drug ads

Senate HELP Committee Sen. Enzi opposed to separate center for drug safety because

it would weigh risks and benefits “on two separate scales”House Energy & Commerce Committee Focusing on investigations of FDA and drug company’s

handling of data on antidepressants and COX-2 inhibitors

Hospital Outpatient Department

2006 proposed rule published July 25, 2005Conversion factor to go up by forecast increase in market basket index: 3.2%Payments for drugs and drug administration: CMS will pay for drugs at ASP+6% with additional

2% to account for pharmacy overhead costs. Drugs with $50/day cost or lower continue to be

packaged into administration. Hospitals will use 2006 CPT codes for drug

administration.

Hospital Outpatient Department (2)

Payments for imaging procedures: CMS proposes to reduce the payment for second

and subsequent imaging procedures within the same family of procedures when performed in the same session.

Each additional procedure would be paid at 50% of full amount.

Payment reduction affects only technical component and not physician’s interpretation.

Overall effects of proposed changes: Estimated average increase to hospitals: 1.9%

Medicare Claims Appeals

Appeals process changes as of January 1, 2006 Carrier hearing replaced by appeal to

independent entity Deadlines imposed for action at each stage in

the appeals process

HHS administrative law judges will replace Social Security Administration ALJs for appeals filed beginning July 1, 2005

Medicare Contractor Reform

Carriers (Part B) and fiscal intermediaries (Part A) will be merged into one entity called Medicare Administrative Contractor (MAC) 15 primary Part A/B MACs 4 specialty MACs (home health and hospice) 4 specialty MACs (durable medical equipment)

Primary A/B MACs will serve newly defined geographical regions

Issue of medical directors in each state unresolved

Contracts to be awarded December ’05 through September ‘08.

Transition from existing contractor to MAC: 6-13 months

Coverage with EvidencePET Scans - Registry

Medicare will cover: Payment for PET scans for broad use in oncology

Though payment requires “hoops” Requires submission of data for payment Potential disconnect between the oncologist with

the information needed for documentation and PET provider – who, without the data being

submitted, will not be paid ASCO comments

Many interpretations of this by carrier….

Challenge of 2005 -06 (and beyond)

Need data…. Underwater drugs Need personal stories.. Impact of changes

Individual patient access Change in practice… research ? Outreach? Ceessation of

Services? Financial impact of “changeover”

Need information about Secondary Medigap’s Dual Eligibles Medicaid

Challenge of 2005 -06 (and beyond)

Continuation of Demo project…. ???

Look for legislative opportunity… Difficult political year

Always looking for long term resolution… Will require reformation of current “top down

methodology”…. Reformation of CPT coding process

Theme of Enthusiasm

Get involved and bring your colleagues Great time to be engaged…. Language of Quality

State affiliates are key to our voice

It is a good time to be an oncologist You make a difference daily in the lives of your

patients You make a difference in ASCO

QUESTIONQUESTIONSS

????????????Contact Contact

ASCO’s ASCO’s Cancer Cancer PolicyPolicy

& & Clinical Clinical Affairs Affairs

DepartmentDepartment (703) 299-1050 / (703) 299-1050 / publicpolicy@asco.orgpublicpolicy@asco.org