Transcript No Slide Title

John V. Cox DO
FACP
Chair, Clinical
Practice Committee
Musings of an ASCO Curmudgeon
Association of Northern California Oncologists
2005 Annual Meeting
Fish CAMP
October 14-16, 2005
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 Needs
Goal 3: Education
Goal 4: Research
Goal 5: Early Career Development
Goal 6: Cancer Prevention and Control
Goal 7: Authoritative Resource
Goal 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 reimbursement
Practice Management Workshop / Enhanced Support
State Affiliate Leadership
 Developing strong regional leadership
 Broadening grassroots networks
Add to existing lobbying and policy power
Practice based quality assessment / ASCO preparing members for
“pay for quality”
New publication focusing on practice management -- JOP
Workforce Study
History & Background of the Program
Created in 1993
Most state societies had already been established
Formalized relationship between ASCO & Affiliates
Membership on ASCO’s Clinical Practice Committee (CPC)
Toll-free coding/reimbursement hotline
Policy/legislative analysis & advocacy assistance
Educational sessions at Annual Meeting & Fall
Conference
“Practical Tips for the Practicing Oncologist”
Program Assessment
Needs 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 Gesme
Chair-elect…. Dr. Peter Yu
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
 ASCO Principles and Policy
Other Policy Issues
MMA
Payment 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 shipments
Physician will file claim with Medicare for drug administration
services, list the drugs administered, and include the vendor order
number
When 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 coinsurance
Vendor 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 ASPbased 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 report
Report due 1/1/2006
 On 10/6th Prelim Report
Interim MedPAC Discussion
October 2005
Volume of beneficiaries continue to rise
Are some / limited problems with shift to OPD of
beneficiaries without supplemental coverage / dual
eligibles
Overall no significant change in patterns of care
All interviews pointed to the presence of the Demo
project as major reason for lack of significant change
Discussion concerning the validity of any “bottom line”
in light of the Demo project / 2005 survey
Next 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 Performance
Senator 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.
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
 ASCO Principles and Policy
Other Policy Issues
Other Policy Issues
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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 Issues
Evaluating 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 Issues
Administrative/Legislative Response
FDA’s response: Drug Safety Oversight Board, Drug Watch Web
Page, Health Professional and Patient Information Sheets
FDA 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, 2005
Conversion 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 Evidence
PET 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
QUESTIONS
??????
Contact ASCO’s
Cancer Policy
&
Clinical Affairs
Department
(703) 299-1050 / [email protected]