Download Oncology Outlook for 2009

Oncology Outlook for 2009
Joseph S. Bailes, MD
Chair, ASCO Government Relations
Council
Disclosure Information:
– Employment or Leadership Position: Texas Oncology
– Consultant or Advisory Role: Cell Genesys, ImClone, Telik
– Stock Ownership: Briston-Meyers Squibb, Telik
– Honoraria: NOC
– Research Funding: No relevant relationship to disclose
– Expert Testimony: No relevant relationship to disclose
– Other Remuneration: No relevant relationship to disclose
Overview
n
n
n
n
n
n
n
n
n
n
n
Physician Reimbursement
Medicare Quality Initiatives
Competitive Acquisition Program
Off-Label Drug Coverage
Coverage of Clinical Trials
Hospital Outpatient Payments
Medicare Coverage of ESAs
Recovery Audit/Medicare Administrative Contractors
Workforce
Food and Drug Administration
Appropriations for National Institutes of Health
1
Medicare Physician Fee Schedule
n
Annual Update
– 10.6% decrease in conversion factor (CF) was set to
go into effect on July 1, 2008
– Congressional action instead continued 2008
increase of 0.5% for July – December. In 2009 there
will be a 1.1% increase
– Brief time where 10.6 cut was in effect. Legislation
was retroactive
– CMS should be automatically reprocessing claims
that had the 10.6% reduction
Ongoing Issues with SGR
n
n
n
Sustainable growth rate methodology (“SGR”) will
reduce physician fee schedule conversion factor by
about 5% each year for several years unless Congress
fixes it permanently.
– SGR compares actual expenditures to target amount
and penalizes or rewards any difference
Congress keeps passing short term fixes which makes
the subsequent cut larger
Issues impeding SGR fix include:
– Very expensive to fix permanently.
– What is the appropriate formula?
Legislative Outlook - SGR
n
Congress now has until the end of 2009 to fix SGR
n
Leadership discussing various options but cost still an
issue
2
Oncology Reimbursement
n
n
n
n
Quality Measurement
Payments for chemotherapy and supportive
care drugs
Imaging
Legislative Outlook
Quality Measurement
n
ASCO has been on forefront of developing and
implementing measures (e.g., NICCQ, QOPI,
ASCO/NCCN Quality Measures)
n
Tax Relief and Health Care Act 2006 requires that
measures be developed by specialty societies and put
through a consensus organization.
–
–
–
–
National Quality Forum
AMA Physician Consortium for Practice Improvement
Ambulatory Quality Alliance
Others?
Quality Measurement – PQRI 2008
n
n
n
n
CMS will continue the Physician Quality Reporting
Initiative (PQRI) with minor modifications
PQRI establishes a financial incentive for eligible
professionals to participate in a voluntary quality
reporting program
– Payment bonus for 2008 is ~ 1.5%
– Payment bonus for 2009 & 2010 ~ 2.0%
Program applies only to Medicare FFS and not Medicare
Advantage
PQRI measures may be reported by non-physician
practitioners
3
Quality Measurement – PQRI 2008
(continued)
n
n
119 PQRI quality measures available in 2008
2007 oncology -related measures to be used in 2008,
with some coding and specification changes
– NOTE: Coding and specifications for breast cancer
hormonal therapy (#71), colon cancer chemotherapy
(#72) and chemotherapy planning (#73) measures
have been changed
– 2007 G codes cannot be submitted for these
measures in 2008
Quality Measurement – PQRI 2008
(continued)
n
NOTE: Reporting for measures 71 (breast
cancer hormonal therapy) and 72 (colon cancer
chemotherapy) is more burdensome in 2008
– New CPT II staging codes require use of instructions
for interpretation and reporting
– ASCO requested changes to CPT II codes but AMA
declined to make changes for 2008 because of time
constraints
Quality Measurement – PQRI 2009
(continued)
n
n
CMS proposes to adopt several new cancer specific measures for
2009 including:
– Medical and radiation: plan of care for pain
– Pain intensity quantified
– Radiation dose limits to normal tissues
– Recording of clinical stage for esophageal & lung cancer
Measures to be deleted in 2009:
– #74: Radiation recommended for invasive breast cancer
– #104: Review of treatment options in patients with localized
prostate cancer
4
Reporting on Hematocrit/Hemoglobin
n
n
n
Effective January 1, 2008, physicians must report
hematocrit or hemoglobin levels on any claim for
treatment of anemia in connection with cancer
treatment.
– Not limited to erythropoiesis stimulating agents
(ESAs) but also applies if other anti-anemia drugs are
used
CMS has issued carrier instructions on how to report.
CMS will accept “most recent” hematocrit or hemoglobin
and will recognize that multiple claims may be submitted
with the same hematocrit or hemoglobin.
Reporting on Hematocrit/Hemoglobin
(continued)
n
CMS has released new modifiers for use in 2008; these
need to be reported on claim form along with actual
hematocrit/hemoglobin.
– EA – ESA, anemia, chemo-induced
– EB – ESA, anemia, radio-induced
– EC – ESA, anemia, non-chemo/radio
Payments for Chemotherapy and
Supportive Care Drugs
n
n
n
Payments for drugs based on 106% of manufacturer’s
average sales price (ASP)
– Manufacturers report ASPs for their drugs to CMS
within 30 days after the end of each calendar quarter
– Payments for multiple-source drugs determined by
weighting each drug’s ASP by its sales volume
Payments are adjusted quarterly with 2-quarter lag
New drugs are paid at 106% of wholesale acquisition
cost (WAC) until ASP data are collected
5
Principal Problems with ASP System
n
n
n
“Underwater” drugs
– Some drugs are not available to some physicians at
the Medicare payment amount.
– Prompt pay discounts included in calculation but not
passed on to the physician.
– No exceptions process for particular drugs.
2-quarter delay in adjusting payment amounts to reflect
price increases
IVIG continues to be underwater but CMS has proposed
to discontinue preadministration payment of $71 in 2008.
Competitive Acquisition Program
n
n
CAP program for drugs and biologicals is
on hold for 2009
CMS does not have a vendor
– Previous vendor BioScrip has not reapplied
– Fate of the CAP program is unclear
Imaging Services
n
Payments for technical component of imaging services
provided in the office capped at HOPPS level (includes
CT, PET, MRI, etc. but not mammography)
n
Reduction of 25% for multiple imaging services in same
“family” continuing. Savings will not be transferred to
other services as CMS had planned
n
For services affected by both provisions, CMS will first
apply the multiple imaging adjustment and then apply
the HOPPS cap
6
Legislation Outlook – Towns Bill
n
n
n
H.R. 3011
Sponsored by Reps. Towns (D-NY), Hall (R-TX) and
Whitfield (R-KY)
Bill addresses “underwater” drugs:
– Would establish a floor on Medicare payment for Part
B drugs at the “widely available market price”
(WAMP)
– WAMP is defined in current law as the price that a
prudent physician would pay for the drug
– CMS would increase payment above 106% of ASP as
necessary to reach WAMP
Legislation Outlook – Towns Bill
(Continued)
n
Bill would also increase payment amounts in general
– Manufacturers would no longer consider prompt pay
discounts to wholesalers and distributors in reporting
their average sales price (ASP)
– These discounts do not go to physicians and
therefore artificially lower ASP for purposes of
calculating Medicare payments
– Change would parallel 2005 change to calculation of
average manufacturer price in Medicaid rebate
program, which eliminated prompt pay discounts to
wholesalers from the calculation
Legislation Outlook for 2008 –
Capps/Landrieu Bill
n
n
n
n
n
H.R. 1078/S. 2790: Reps. Capps (D-CA) and Davis (R-VA)/Senator
Landrieu (D-LA) developed in coordination with NCCS.
114 Cosponsors
Adds new Medicare benefit for comprehensive cancer care planning
services
– Detailed plan of care furnished in person to cancer patient soon
after diagnosis
– Revised plan of care if substantial change in condition
– Follow-up plan after completion of primary treatment
– Revised follow-up plan if substantial change
Payment for plan of care or revision equal to payment for Level 5
new patient consult plus home health certification ($298 in 2006)
Service could be provided by physician or hospital
7
Oncology Treatment Plan and Summary
n
n
n
n
ASCO is developing a series of customizable, disease-specific
chemotherapy treatment plans and summaries.
Treatment plan captures:
– Planned chemotherapy regimen, dose, cycles and duration
– Major side effects of chemotherapy regimen
Treatment summary describes:
– Details of chemotherapy care delivered, major toxicities
experienced, follow-up plan of care
Colon Adjuvant Chemotherapy , Breast Adjuvant Chemotherapy,
and general Cancer Treatment Plan and Summary templates
available: www.asco.org/treatmentsummary
Legislation Outlook for 2008 – Imaging
n
Recently passed Medicare bill requires physicians and
other suppliers that furnish advanced diagnostic imaging
services like MRI, CT and PET to meet Medicare
accreditation criteria by 2012
n
ASCO member of Access to Medical Imaging Coalition
n
GAO Report recommending prior authorization to control
spending
Off-Label Drug Coverage
n
By statute, Medicare must cover off-label uses of drugs
used in anticancer chemotherapy regimens if the uses
are supported by citations in:
– U.S. Pharmacopoeia – Drug Information (and
successor publications)
n
n
– American Hospital Formulary Service
CMS has authority to recognize other authoritative
compendia as well.
Recent law harmonizes Part B and Part D off -label
coverage rules for anticancer chemotherapy.
8
Off-Label Drug Coverage (continued)
n
CMS has established an annual process to review
compendia.
n
CMS recently announced recognition of:
– NCCN Drugs & Biologics Compendium
– Clinical Pharmacology
– Thomson Micromedex DrugDex
n
Thomson Micromedex DrugPoints will not be
recognized.
n
AHFS will continue to be recognized.
Off-Label Uses Not in the Compendia
n
Medicare statute authorizes carriers to cover off-label
uses of cancer drugs not in the compendia based on
studies in peer-reviewed publications specified by CMS
n
CMS’s current list of 15 journals had not been updated
since legislation was passed in 1993
n
ASCO recommended that additional journals be added
to the CMS list.
CMS announced that an additional 11 journals would be
recognized effective October 22, 2007.
n
Recently Added Journals
n
n
n
n
n
n
Annals of Oncology
Biology of Blood and
Marrow Transplantation
Bone Marrow
Transplantation
Gynecologic Oncology
Clinical Cancer Research
n
n
Journal of NCCN
Radiation Oncology
n
Annals of Surgical
Oncology
n
Journal of Urology
Lancet Oncology
n
Int’l Journal of Radiation,
Oncology, Biology, and
Physics
9
Medicare Coverage of Clinical Trials
n
In 2000, CMS issued a National Coverage Decision
(NCD) announcing coverage for routine costs of clinical
trials.
n
July 2007, CMS issued proposed revisions that would:
– Eliminate automatic coverage for federally funded or
FDA-reviewed trials
– Instead, would require self -certification of trial with
CMS according to 13 standards
n
October, 2007 – CMS decided not to proceed with
proposed revisions but may revisit.
Hospital Outpatient Issues
n
Payment for drugs
– Separately billable drugs now paid at ASP + 5%
n
CMS proposes to further reduce payments to ASP
+ 4% in 2009.
– Medicare proposes to continue paying separately for
drugs costing more than $60 per day; drugs costing
less than $60 are not reimbursed separately
– Anti-emetics are reimbursed separately regardless of
their daily cost in 2008
Hospital Outpatient Issues (continued)
n
IVIG
– CMS is continuing payment for G0332, pre-administration
services for IVIG; payment is approximately $37 in 2008.
CMS has proposed eliminating payment in 2009.
n
Imaging
– New proposal for composite imaging APCs would provide
a single payment when two or more imaging procedures
using same modality are conducted in one session.
10
ESAs: What’s New
n
n
The CMS NCD still stands
FDA mandated changes to ESA labels (July 2008)
n
Two new reports of negative outcomes in ESA studies
(November/December 2007)
n
ODAC met March 13 to review ESA safety data and
make recommendations to FDA.
Label Changes
n
n
ESAs are no longer indicated for patients receiving
myelosuppressive chemotherapy if the anticipated treatment
outcome is cure. They remain indicated when myelosuppressive
chemotherapy is intended for palliation.
ESAs should not be initiated if the patient's hemoglobin is above 10
g/dL. Further, the label change
– specifies that ESA treatment should target the lowest
hemoglobin concentration that will avoid transfusion,
– removes "...or exceeds 12 g/dL" as an upper range for ESA use,
and
– removes language that allowed earlier initiation of ESAs, or
treatment to higher hemoglobin targets, if the patient cannot
tolerate anemia due to a co-morbid condition.
ASCO Actions on ESAs
n
n
Added language on FDA changes into recent
ASCO/ASH guideline
– Available online
Ongoing dialogue relating to the implementation
of the national coverage decision
11
Recovery Audit Contractors
n
n
CMS Recovery Audit Contractors (RACs) have identified
overpayments (and underpayments to a lesser extent) in
New York, Florida, and California as part of a
demonstration project.
Drugs and services are subject to review.
n
In response to complaints that audits are excessively
burdensome, ASCO has recommended measures to
CMS to make program less onerous on practices.
n
Recent legislation authorizes expansion of RAC program
to all 50 states by 2010.
Medicare Administrative Contractors
n
Under a competitive bidding process, Medicare is
replacing fiscal intermediaries and carriers with new
entities called MACs
n
Will be two types of MACs
– Part A/Part B MACs
– Specialty MACs (covering durable medical
equipment, home health, and hospice)
n
15 Part A/Part B MAC regions
Medicare Administrative Contractors
(continued)
12
Medicare Administrative Contractors
(continued)
Jurisdiction
Award Date
MAC
States
1
10/25/2007
Palmetto GBA
American Samoa, Guam, Northern
Mariana Islands, CA, HI, & NV
2
5/5/2008
National Heritage Ins. Co.
(NHIC)
AK, ID, OR, WA
3
7/31/2006
Noridian Administrative
Services
AZ, MT, ND, SD, UT, WY
4
8/3/2007
Trailblazer Health Enterprises
CO, NM, OK, TX
5
9/4/2007
Wisconsin Physician Services
(WPS)
IA, KS, MO, NE
7
6/11/2008
Pinnacle Business Solutions
12
10/24/2007
13
3/18/2008
Highmark Government
Services (HGS)
National Government Services
(NGS)
AR, LA, MS
DE, DC, MD, NJ, PA
CT, NY
Future Supply of and Demand for
Oncologists
n
n
n
n
ASCO-commissioned study on supply and demand for oncology
services
– Reported in March 2007 Journal of Oncology Practice
Demand expected to rise 48% between 2005 and 2020
– Based on population aging and growth and improvements in
cancer survival rates
Supply expected to rise 14%
– Based on oncologists’ current age distribution, practice patterns,
and number of oncology fellowships
ASCO Workforce Implementation Group to recommend steps to
meet the challenge of workforce shortage
FDA Reform and Drug Safety
n
n
Unanticipated safety problems with FDA-approved drugs
to treat chronic conditions (Vioxx) causing policymakers
to call for increased monitoring and oversight of drug
safety
Congress recently passed legislation with drug safety
provisions:
– Risk Evaluation and Mitigation Strategies establish post-market
safety procedures
– Limits FDA Conflict of Interest Waivers
– Requires sponsors to register trials in clinical trials database;
HHS examining results database
13
Biosimilars Legislation
n
HR 5629, the Pathway for Biosimilars Act, introduced by
Representatives Anna Eshoo (D-CA) and Joe Barton (RTX)
– Interchangeability: “can be expected to produce the
same clinical result”
– No determination of interchangeability may be made
without publication of a final guidance, following
notice public comment.
NIH Appropriations
n
ASCO and others in the cancer community had been
requesting a approximately 6% increase for FY 2009.
n
Instead, Congress has passed a Continuing Resolution
(CR) through March 6 to keep government running at
2008 levels.
n
Congress will have to pass appropriations bills or
another CR by March 6.
Questions
QUESTIONS
??????
Contact ASCO’s
Cancer Policy
&
Clinical Affairs
Department
n
(571) 483483- 1670 / [email protected]
14