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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