2010 Archived oncology news:
Revised January 2011 ASP Pricing File from CMS
The Centers for Medicare & Medicaid Services (CMS) has posted a revised January 2011 ASP Pricing file, which is available for download on their site. See the menu to the left for year-specific links.
FDA Approves Gardasil to Prevent Anal Cancer
On Dec. 22, 2010, the U.S. Food and Drug Administration (FDA) approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.
Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females. It is also approved for the prevention of genital warts caused by types 6 and 11 in both males and females.
NCI to Consolidate Clinical Trials Cooperative Group Program
On Dec. 23, 2010, the National Cancer Institute (NCI) announced major changes to be made in the long-established Clinical Trials Cooperative Group Program that conducts many of the nationwide trials of new cancer therapies. In a major transformation, NCI intends to consolidate the nine groups that currently conduct trials in adult cancer patients into four state-of-the-art entities that will design and perform improved trials of cancer therapies. These changes are designed to provide greater benefits for cancer patients and more information for researchers. These moves come in response to an NCI-requested April 2010 report from the Institute of Medicine (IOM), which called for a series of changes to the cooperative groups program, including restructuring.
The NCI Cooperative Group program, founded over 50 years ago, involves more than 3,100 institutions and 14,000 investigators, and the program enrolls over 25,000 patients in clinical trials each year. Four pediatric groups were consolidated into one group a number of years ago, and that sole pediatric group will not be consolidated with other groups.
Consolidation is intended to improve the efficiencies of operations centers, data management centers, and tumor banks, and the changes will take into consideration an assessment of all currently active cooperative groups. The current groups will also be given opportunities to comment on the proposed changes and to explore specific aspects of the reorganization plans in consultation with NCI leadership.
Registration for CMS's EHR Incentive Programs Starts Jan. 3, 2011
Dec. 22, 2010, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) announced availability of registration for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs.
Beginning Jan. 3, 2011, registration will be available for eligible healthcare professionals and eligible hospitals that want to participate in the Medicare Electronic Health Record (EHR) Incentive Program.
On Jan. 3, 2011, registration in the Medicaid EHR Incentive Program will also be available in Alaska, Iowa, Kentucky, Louisiana, Oklahoma, Michigan, Mississippi, North Carolina, South Carolina, Tennessee, and Texas. In February, registration will open in California, Missouri, and North Dakota. Other states likely will launch their Medicaid EHR Incentive Programs during the spring and summer of 2011.
CMS and ONC outlined online and in-person resources in place to assist eligible professionals and eligible hospitals that want to participate. Eligible professionals and eligible hospitals must register to participate in the Medicare and Medicaid EHR incentive programs.
To prepare for registration, providers should first familiarize themselves with the incentive programs' requirements by visiting CMS's Official Web Site for the Medicare and Medicaid EHR Incentive Programs at www.cms.gov/ehrincentiveprograms.
Under the EHR incentive programs, eligible professionals can receive as much as $44,000 over a five-year period through Medicare. For Medicaid, eligible professionals can receive as much as $63,750 over six years. Under both Medicare and Medicaid, eligible hospitals may receive millions of dollars for implementing and meaningfully using certified EHR technology.
FDA Drug Safety Communication: Abnormal heart rhythms associated with use of Anzemet (dolasetron mesylate)
Dec. 17, 2010, The U.S. Food and Drug Administration (FDA) released a safety communication informing patients and healthcare professionals that the injection form of Anzemet (dolasetron mesylate) should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy (CINV) in pediatric and adult patients. New data demonstrate that Anzemet injection can increase the risk of developing an abnormal heart rhythm (torsade de pointes), which in some cases can be fatal. Patients at particular risk are those with underlying heart conditions or those who have existing heart rate or rhythm problems. Anzemet causes a dose-dependant prolongation in the QT, PR, and QRS intervals on an electrocardiogram (ECG).
A contraindication against this use (CINV) is being added to the product label for Anzemet injection. Anzemet injection may still be used for the prevention and treatment of postoperative nausea and vomiting (PONV) because the lower doses used for PONV are less likely to affect the electrical activity of the heart and result in abnormal heart rhythms.
Anzemet tablets may still be used to prevent CINV because the risk of developing an abnormal heart rhythm with the oral form of this drug is less than that seen with the injection form. However, a stronger warning about this potential risk is being added to the Warnings and Precautions sections of the Anzemet tablet label. Anzemet tablets may also still be used for prevention of PONV.
Nausea and vomiting are common side effects of chemotherapy and general anesthesia used in surgery.
Read the FDA Safety Communication here: www.fda.gov/Drugs/DrugSafety/ucm237081.htm.
January 2011 ASP Files Now Available
The Centers for Medicare & Medicaid Services (CMS) has posted the January 2011 Average Sales Price (ASP) and NOC pricing files and crosswalks, and updated pricing files for October 2010 and July 2010.
These are available for download at: http://www.cms.hhs.gov/McrPartBDrugAvgSalesPrice. See left menus for year-specific links.
Tell your Senators to Support S. 3775, the PROSTATE Act
S. 3775, the Prostate Research, Outreach, Screening, Testing, Access, and Treatment Effectiveness (PROSTATE) Act of 2010 was introduced in the Senate. The PROSTATE Act will help foster an integrated and coordinated focus on effective prevention, diagnosis and treatment of this disease. Take action now and request that your Senator support this important legislation.
New Folotyn HCPCS Code
The Centers for Medicare and Medicaid Services (CMS) has issued J9307, a new national permanent Healthcare Common Procedure Coding System (HCPCS) J-code for Allos Therapeutics Inc.'s FOLOTYN® (pralatrexate injection). Healthcare professionals and patients may call the Allos Support for Assisting Patients (ASAP) program for questions about the new HCPCS code, or any other coverage, coding, or payment issues related to FOLOTYN at 1-877-ASAP102.
Click here for more information.
House Approves One-Year Medicare Physician Pay Fix; Obama Expected to Sign
By a 409-2 vote, the House approved legislation (H.R. 4994) delaying a 25 percent cut in Medicare reimbursement for physicians for a year, reports the BNA Health Care Daily Report. The bill was sent to President Obama, who is expected to sign it. The $19 billion Medicare and Medicaid Extenders Act of 2010 would freeze physicians' reimbursement for all of 2011, replacing the 25 percent cut scheduled to be implemented Jan. 1, 2011. It also makes changes in other Medicare payment policy affecting several other provider groups. The measure was passed by the Senate late Dec. 8 by unanimous consent. The bill is paid for by modifying policy in the healthcare affordability tax credit in the healthcare reform law.
ACCC Submits Comments to CMS on Accountable Care Organizations
On December 3, 2010, ACCC submitted comments on the Centers for Medicare & Medicaid Services' (CMS) request for information regarding accountable care organizations (ACOs) and the Medicare Shared Savings Program. ACCC supports CMS's efforts to improve the quality of care and believes that any effort to develop new healthcare delivery systems and payment models to achieve this goal must allow community cancer centers and physician practices to participate. Still, ACCC expressed concerns that many ACCC members will not have the opportunity to participate in the Shared Savings Program or the models tested because they are small practices or facilities.
"Many of our members are located in rural areas that do not have a sufficient concentration of patients or other providers that might be necessary to form an ACO on their own. . . These providers are concerned that they will be able to participate only if they cease to be independent entities and are acquired or employed by larger hospitals."
ACCC asks CMS to encourage ACOs to form that include networks of solo and small practice providers and recommends that CMS establish standards to ensure that patients have access to providers in their communities.
ARIAD's Ponatinib Shows Clinical Evidence of Improving Anti-Leukemic Activity in Patients with Drug-Resistant CML
ARIAD Pharmaceuticals, Inc. recently announced updated clinical data from a fully enrolled and ongoing Phase 1 study of its investigational pan-BCR-ABL inhibitor, ponatinib, in patients with resistant and refractory chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL). The study demonstrates that in chronic-phase CML patients treated with ponatinib, 66 percent of patients in the trial achieved a major cytogenetic response, including 100 percent of patients who also had a T315I mutation.
"The updated findings from this study confirm ongoing clinical evidence of anti-leukemic activity of ponatinib in a larger number of patients. The response rates are both impressive and, until now, have not been seen in either such heavily pretreated patients who have failed multiple prior therapies for CML, or those with the T315I mutation for which there are no currently available treatments," stated Jorge Cortes, M.D., professor and deputy chair, Department of Leukemia, The University of Texas M.D. Anderson Cancer Center. "We are very encouraged by the evidence of efficacy of ponatinib at the molecular level and the anti-leukemic activity that looks to be durable."
Click here for more information.
Longer-term Phase III data show Novartis drug Tasigna® continues to surpass Glivec® in slowing disease progression in patients with newly diagnosed CML
Novartis announced on December 6, 2010 24-month data showing that Tasigna® (nilotinib) continues to surpass Glivec® (imatinib) in the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. These new data, from the first Phase III comparison of the two oral therapies as initial treatment for this blood cancer, were presented at the 52nd Annual Meeting and Exposition of the American Society of Hematology (ASH) in Orlando, Florida.
Click here for the full press release.
President Obama Signs Temporary SGR Fix
President Obama signed a one-month Medicare physician payment extension that will temporarily postpone a 23 percent reduction in the payment rate. The Senate passed the one-month payment extension, H.R. 5712 on Nov. 18, and the House followed on Nov. 29 after returning from its Thanksgiving recess. The patch extends the current Medicare payment rate until Dec. 30, thereby postponing the 23 percent reduction called for by the sustainable growth rate, or SGR, formula that was scheduled to take effect Dec. 1. Without further congressional intervention, however, the payment cut will deepen to 25 percent on Jan. 1.
Emend 150 mg Now Available; Emend 115 mg Discontinued
On November 15, Merck announced the availability of Emend (fosaprepitant dimeglumine) for Injection 150 mg. Emend 115 mg vial has been discontinued. Options now are the 150 mg vial (injection) and the oral tripack (there is a 125 hospital dose and a bi-pack to accompany that. Both are oral).
The Emend 150 mg vial J-code stays the same as the Emend 115 mg vial, J1453, 1 mg. Note: Because the J code will be the same for the 150-mg vial as for the 115-mg, the average sale price (ASP) will remain the same for the 150-mg vial as for the 115-mg vial on a per-mg basis.
If you have additional questions regarding reimbursement for Emend for Injection, please contact the ACT Program at 866-363-6379.
Final 2011 Medicare Rules: Analysis and Conference Call Archive Available to ACCC Members
Last week, more than 200 ACCC members listed to a conference call sponsored by ACCC about the final 2011 Medicare rules. The Hospital Outpatient Prospective Payment System (HOPPS) and CY 2011 Payment Rates and the 2011 Physician Fee Schedule were released by the Centers for Medicare & Medicaid Services (CMS) in early November.
ACCC Members can listen to an archived conference call about the Final 2011 HOPPS Rule and Physician Fee Schedule. There's also a detailed summary available about both rules. You'll need to log in to the Members-only section of this website.
FDA Approves Amgen's Xgeva (Denosumab) for the Prevention of Skeletal-Related Events in Patients with Bone Metastases from Solid Tumors
Amgen Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Xgeva (denosumab), the first and only RANK Ligand inhibitorfor the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. Xgeva was approved following a 6 month priority review by the FDA, a designation reserved for drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists. Xgeva is not indicated for the prevention of SREs in patients with multiple myeloma.
Click here to read more.
FDA Approves Eisai's Halaven (Eribulin Mesylate) Injection for Treatment of Metastatic Breast Cancer
Eisai Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Halaven (eribulin mesylate) Injection for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included two common chemotherapy treatments, an anthracycline and a taxane, for early or advanced breast cancer. Discovered and developed by Eisai, Halaven is a non-taxane, microtubule dynamics inhibitor that is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai.
The FDA approval of Halaven is based on results from the pivotal Phase III clinical study EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus Eribulin), which showed that patients treated with Halaven survived a median of 2.5 months longer than patients who received a single-agent therapy chosen by their physician (Treatment of Physician's Choice). Overall survival was 13.12 months with Halaven versus 10.65 months with TPC (p=0.041). In an updated survival analysis, conducted when 77 percent of events had been observed, the result was consistent with the primary analysis.
Click here to read more.
Changes to the Way Taxotere® (docetaxel) Injection Concentrate Vials Are Provided
Sanofi-aventis U.S. has announced two important changes to the way that Taxotere® (docetaxel) Injection Concentrate vials are being provided:
1. New single vial formulation: The new 1-vial Taxotere at a doubled concentration is now replacing the current 2-vial Taxotere packaging. The new 1-vial concentration is 20 mg/mL in comparison to the previous 2-vial preparation, which was 10 mg/mL.
2. No reconstitution needed: The new 1-vial Taxotere no longer requires reconstitution. Taxotere can now be withdrawn from the new 1-vial formulation and injected directly into the IV infusion solution without further dilution.
Click here to read more.
Participate in a Test Market for Totect® Urgent Treatment Kit
Effective October 4, 2010, Topotarget is offering oncology infusion centers the opportunity to participate in a test market for Totect® Urgent Treatment Kit. The test market participants will be eligible to purchase Totect from an authorized distributor at $6,500 and receive one replacement kit, should the kit expire before use. Totect has a shelf life of 24 months from the date of manufacturing. Product at authorized distributors currently has a shelf life of 16 to 19 months.
Totect (dexrazoxane for injection) is packaged in an Urgent Treatment Kit for single patient use and includes 10 vials of Totect powder 500mg each and 10 vials of Totect diluent 50mL each. Totect is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy. Totect demonstrated 98.2 percent efficacy based on two biopsy-confirmed clinical trials and should be proactively stocked onsite and infused as soon as possible and within six hours of an anthracycline extravasation.
Click here to read more.
Enroll Today in ESA Apprise Oncology Program
The enrollment deadline is approaching for the ESA APPRISE Oncology Program. Failure to enroll in the ESA APPRISE Oncology Program by February 16, 2011 will result in suspension of access to ESAs (for healthcare providers who prescribe and hospitals that dispense ESAs for patients with cancer).
Click here to enroll.
Lung Cancer Screening Trial Results Show Mortality Benefit with Low-dose CT
Twenty percent fewer lung cancer deaths seen among those who were screened with low-dose spiral CT than with chest X-ray
The National Cancer Institute (NCI) released initial results from a large-scale test of screening methods to reduce deaths from lung cancer by detecting cancers at relatively early stages.
"This is the first time that we have seen clear evidence of a significant reduction in lung cancer mortality with a screening test in a randomized controlled trial. The fact that low-dose helical CT provides a decided benefit is a result that will have implications for the screening and management of lung cancer for many years to come," said Christine Berg, MD, National Lung Screening Trial (NLST) project officer for the Lung Screening Study at NCI.
The NLST, a randomized national trial involving more than 53,000 current and former heavy smokers ages 55 to 74, compared the effects of two screening procedures for lung cancer -- low-dose helical computed tomography (CT) and standard chest X-ray–on lung cancer mortality and found 20 percent fewer lung cancer deaths among trial participants screened with low-dose helical CT. The NLST was sponsored by NCI, a part of the National Institutes of Health, and conducted by the American College of Radiology Imaging Network (ACRIN) and the Lung Screening Study group. A paper describing the design and protocol of the NLST, "The National Lung Screening Trial: Overview and Study Design" by the NLST research team, was published by the journal Radiology.
CMS Issues Final 2011 MPFS Rule
On November 2, the Centers for Medicare & Medicaid Services (CMS) released the final 2011 Payment Policies Under the Physician Fee Schedule rule.
The final rule will appear in the Nov. 29, Federal Register. Except as otherwise specified, the policies and payment rates adopted in the final rule with comment period will be effective for services furnished on or after Jan. 1, 2011. CMS will accept comments on certain aspects of the final rule with comment period until Jan. 2, 2011.
ACCC members should look for an analysis of the rule to come.
CMS has posted fact sheets on the rule at www.cms.gov/apps/media/fact_sheets.asp.
CMS Issues Final 2011 HOPPS Rule and Payment Rates
On November 2, the final 2011 Medicare rule, Hospital Outpatient Prospective Payment System (HOPPS) and CY 2011 Payment Rates, was released by the Centers for Medicare & Medicaid Services (CMS). The new rule sets payment for the acquisition and pharmacy overhead costs of separately payable drugs and biologicals without pass-through status at average sales price (ASP) +5 percent (105 percent of the manufacturers' average sales prices). In meetings with CMS staff and in testimony before the APC Panel, ACCC has stated that hospitals should be reimbursed at least ASP+6 percent, if not higher, for drugs and their associated pharmacy costs.
The new rule modifies a number of the supervision requirements for outpatient therapeutic services, including redefining direct supervision for all hospital outpatient services to require "immediate availability" without reference to the boundaries of a physical location. The rule also expands the set of quality measures that must be reported by hospital outpatient departments to qualify for the full annual payment update factor.
Medicare payments for services in outpatient hospitals will increase approximately 2.5 percent—$3.2 billion—during calendar year 2011.
The rule is slated to be published in the Nov. 24 Federal Register. Comments on the final rule are due by Jan. 3. The changes in the final outpatient prospective payment system rule are for services provided on or after Jan. 1, 2011.
ACCC members should look for an analysis of the rule to come soon.
Click here to download the new rule.
FDA Approves Additional Medical Indication for Sprycel
October 28, 2010 — The U.S. Food and Drug Administration (FDA) approved a new indication for Sprycel® (dasatinib) for the treatment of Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML) when it is first diagnosed.
In June 2006, the FDA granted accelerated approval for Sprycel to treat adults with CP-CML with resistant disease or who were intolerant to prior therapy, including Gleevec (imatinib). The agency converted Sprycel to regular approval in May 2009, after 24-month follow-up data from earlier clinical studies confirmed the treatment's safety and effectiveness.
The FDA granted Sprycel a priority review for PH+ CP-CML.
Sprycel, an oral kinase inhibitor, is believed to inhibit the activity of certain proteins responsible for the growth of cancer cells. The action allows bone marrow to begin reproducing normal red and white blood cells.
The FDA news release is available at
A New Patient Resource for Patients with CML
Bristol-Myers Squibb has announced a new resource – My SPRYCEL® Support – that offers round-the-clock assistance to patients with chronic myeloid leukemia (CML). As part of the My SPRYCEL Support program, patients are granted access 24 hours a day, seven days a week to SPRYCEL Care Counselors – who are all registered nurses – to help respond to questions about SPRYCEL and offer general health and lifestyle tips. Patients will also receive helpful information, including: a patient brochure that provides an in-depth review of SPRYCEL and tips on having productive and meaningful discussions with members of a healthcare team; as well as a daily journal to help track activities and personal thoughts throughout the treatment process.
Learn more about My SPRYCEL Support, such as co-pay assistance during treatment, by visiting www.SPRYCEL.com or calling 1-877-526-7334.
Centocor Ortho Biotech Products, L.P. Announces Voluntary Recall of Certain Lots of PROCRIT® (Epoetin alfa)
Centocor Ortho Biotech Products, L.P. is conducting a voluntary recall of the lots of PROCRIT® (Epoetin alfa) on the attached list due to the presence of extremely thin glass flakes (lamellae), that are extremely difficult to see, in a limited number of PROCRIT® vials. PROCRIT® is manufactured and licensed by Amgen, Inc. With patient safety as a top priority, this voluntary recall is being initiated as a precautionary measure. To date, no trends have been identified in complaints or adverse event reporting that are directly attributable to glass lamellae from any lot of PROCRIT®. This recall is being conducted in coordination with the Food and Drug Administration.
ACCC Submits Comments to CMS on 2011 Proposed Hospital Outpatient Prospective Payment System Rule
On August 31, 2010, the Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare and Medicaid Services (CMS) about its proposed rule regarding revisions to the hospital outpatient prospective payment system (OPPS), published in the Federal Register on August 3, 2010.
Although ACCC was encouraged to see that CMS has proposed to reimburse separately payable drugs without pass-through status at average sales price (ASP) plus 6 percent in 2011, ACCC remains concerned that the methodology to determine this rate remains flawed, and that the final payment rates may not be sufficient to cover the cost of drug acquisition and related pharmacy overhead services costs.
"It is imperative to continued patient access in this crucial setting that the OPPS rates in 2011 and beyond adequately reimburse hospitals for the costs of providing advanced cancer therapies."
Toward this end, ACCC recommends that CMS:
- Reimburse the acquisition cost of separately payable drugs at no less than ASP plus six Percent
- Reallocate a larger share of costs for pharmacy overhead from packaged drugs to separately payable drugs
- Use an ASP file that better reflects the time period of the claims and cost report data used to calculate drug payment rates
- Remove 340B hospital data from calculation of drug payment rates and continue to pay 340B hospitals at the same rate as non-340B hospitals
- Make separate payment for all drugs with Healthcare Common Procedure Coding System (HCPCS) codes, or, at a minimum, not increase the packaging threshold for drugs
- Reinstate separate payment for diagnostic radiopharmaceuticals and contrast agents
- Implement the new payment rates for brachytherapy sources
- Continue to apply the current policy for establishing payment for new brachytherapy sources
- Reinstate separate payment for radiation oncology guidance services
- Implement the proposal to waive beneficiary cost-sharing for certain preventive services
- Implement the adjustment to payments for PPS-exempt cancer hospitals in a truly budget neutral manner
- Work with providers and specialty societies to determine which new measures to add to the quality reporting requirement.
CMS Offers National Provider Call on ICD-10 Implementation in a 5010 Environment
On Monday, September 13, 12 pm to 1:30 pm ET, the Centers for Medicare & Medicaid Services (CMS) will host a follow-up national provider conference call on "ICD-10 Implementation in a 5010 Environment." The call is designed for medical coders, physician office staff, provider billing staff, health records staff, vendors, educators, system maintainers, and all Medicare fee-for-service (FFS) providers. Among the topics will be ICD-10 implementation for services provided on and after October 1, 2013; differences between ICD-10 and ICD-9-CM codes; and HIPAA Version 5010: What you need to be doing to prepare.
For more information and to register, click here. Registration will close at 12 pm ET on September 10, 2010, or when available space has been filled.
New Section Page Added to the Physician Quality Reporting Initiative (PQRI) Web Page
The Centers for Medicare & Medicaid Services (CMS) announced a new section on "How to Get Started" in participating with the Electronic Prescribing Incentive (eRx) program, which is available on eRx web page.
Click here to learn more.
ACCC Submits Comments to CMS on Proposed 2011 Physician Fee Schedule
On August 24 the Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding the proposed payment policies under the Medicare physician fee schedule (PFS). ACCC remains concerned over the proposed cut to the conversion factor due to the Sustainable Growth Rate (SGR) formula and encourages CMS to continue to work with Congress to develop a stable update formula for the future. ACCC also recommended that CMS halt the cuts to chemotherapy administration, and continue to only apply the increase in the assumed utilization rate to certain diagnostic equipment priced at more than $1 million.
CMS Reconsiders Limitation on FDG PET
After "careful review," the Centers for Medicare and Medicaid Services (CMS) has issued a decision memo for "Positron Emission Tomography for Initial Treatment Strategy in Solid Tumors and Myeloma" (CAG-00181R3). CMS was asked to reconsider the April 3, 2009, NCD provision at Section 220.6.17 of the National Coverage Determinations (NCD) Manual, described below, that established an absolute frequency limitation of only one FDG PET study for the noted purposes.
"CMS will cover only one FDG PET study for beneficiaries who have solid tumors that are biopsy proven or strongly suspected based on other diagnostic testing when the beneficiary's treating physician determines that the FDG PET study is needed to determine the location and/or extent of the tumor for the following therapeutic purposes related to the initial treatment strategy:
- To determine whether or not the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or
- To determine the optimal anatomic location for an invasive procedure; or
- To determine the anatomic extent of tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor."
In its recent decision memo, CMS believes that the current absolute restriction is not supported by the available evidence and, therefore, will amend 220.6.17 of the National Coverage Determinations Manual:
- The NCD will be changed to remove the current absolute restriction of coverage to 'only one' FDG PET scan to determine the location and/or extent of the tumor for the therapeutic purposes related to the initial treatment strategy as described above.
- CMS will continue to nationally cover one FDG PET scan to determine the location and/or extent of the tumor for the therapeutic purposes related to the initial treatment strategy as described above.
- Local Medicare administrative contractors will have discretion to cover (or not cover) within their jurisdictions any additional FDG PET scan for the therapeutic purposes related to the initial treatment strategy as described above.
"For any individual beneficiary the usefulness of any additional FDG PET scan for initial treatment planning might be affected by the beneficiary's specific medical problem, the availability of results of other diagnostic tests and the expertise of the interpreting physician. We believe in such situations that our local administrative contractors, who may more readily obtain this information, can make these determinations about any additional FDG PET scan for initial treatment planning within their jurisdictions. We do not believe that a national coverage determination is the most appropriate way to address coverage for any additional FDG PET scans for the therapeutic purposes related to the initial treatment strategy at this time."
Expanded Enrollment for 340B Opens
Expanded enrollment in the 340B discount drug program opened Aug. 2 for thousands of providers who are newly eligible to participate under the health reform law. The expansion of the 340B Drug Pricing Program included in the Patient Protection and Affordable Care Act (Pub. L. No. 111-148) makes discounted drugs available to free-standing cancer centers, as well as children's hospitals, critical access hospitals, rural referral centers, and sole community hospitals. The newly eligible facilities will save an average of 20 percent to 50 percent on covered outpatient medications, according to the Health Resources and Services Administration, the division of the Health and Human Services Department that administers the program.
As reported in the August 3 BNA Health Care Daily, under the expansion the number of facilities participating in the 340B program is expected to increase from 14,000 to nearly 20,000, including 1,500 newly eligible hospitals. Enrollment in the expansion will take place using a rolling, online admissions process that ends Sept. 30. All forms must be submitted by Sept. 27.
CMS Posts "Tip Sheets" on EHR Incentive Programs
The Centers for Medicare & Medicaid Services (CMS) has posted "Tip Sheets" on its EHR Incentive Programs.
- Medicare EHR Incentive Payments for Eligible Professionals. This tip sheet describes which types of individual practitioners can participate in the Medicare EHR incentive program. It provides user-friendly information about incentive payment amounts and describes how they are calculated for fee for service and Medicare advantage providers. It also describes payment adjustments beginning in 2015 for EPs who are not meaningful users of certified EHR technology.
- Medicare EHR Incentive Program, PQRI and E-Prescribing Comparison. Learn what opportunities are available to Medicare Eligible Professionals to receive incentive payments for participating in important Medicare initiatives. This fact sheet provides information on eligibility, timeframes, and maximum payments for each program.
Click here to visit the CMS website. Select the Medicare Eligible Professional tab on the left, and then scroll to "Downloads."
ACCC Comments on National Coverage Analysis Tracking Sheet for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer
On July 27, 2010, the Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services' (CMS) about the opening of a national coverage analysis (NCA) for autologous cellular immunotherapy of treatment of metastatic prostate cancer. ACCC is deeply concerned that CMS has opened this NCA regarding an autologous cellular immunotherapeutic agent for its Food and Drug Administration (FDA)-approved indication to treat certain forms of prostate cancer. "Not only is CMS's action contrary to Congress' intent to ensure beneficiary access to drugs and biologicals used in an anticancer chemotherapeutic regimen, but it threatens to stifle future innovation and cancer research for years to come." Accordingly, ACCC urges CMS to withdraw this NCA immediately.
ACCC also is concerned that CMS's decision to initiate this NCA will be "detrimental to cancer research for years to come. Cancer is a deadly disease, and patients often require treatment with the most innovative and cutting-edge therapies to win their battles against it. Bringing new therapies to market is costly, however, and investors will be more hesitant to fund new research if CMS threatens to restrict coverage for medically accepted indications of cancer drugs."
CMS Seeks Participants for Medicare Imaging Demonstration
The Centers for Medicare & Medicaid Services (CMS) announced July 22 that it is soliciting proposals for participation in the Medicare Imaging Demonstration (MID). The MID was authorized by section 135(b) of the Medicare Improvements for Patients and Providers Act of 2008 and will test whether the use of decision support systems (DSSs) can improve quality of care and reduce unnecessary radiation exposure and utilization by promoting appropriate ordering of advanced imaging services. The two-year demonstration will assess the impact that DSSs used by physician practices have on the appropriateness and utilization of advanced medical imaging services ordered for the Medicare fee-for-service population. A DSS provides immediate feedback based on current medical specialty guidelines to the physician on the appropriateness of the test ordered for the patient.
Eleven advanced imaging procedures—Spect MPI, MRI lumbar spine, CT lumbar spine, MRI brain, CT brain, CT sinus, CT thorax, CT abdomen, CT pelvis, MRI Knee, and MRI shoulder—will be included in the demonstration.
CMS said it is seeking participation of some 2,500 to 3,000 physicians from at least 500 practices. Interested parties have 60 days to apply to participate.
ACCC Summary and Analysis of Proposed 2011 Medicare HOPPS Rule and Physician Fee Schedule Available
On July 21 more than 200 ACCC members listened to a discussion of the proposed HOPPS rule and Physician Fee Schedule.
ACCC members can view a detailed summary of the proposed 2011 HOPPS rule and Physician Fee Schedule. After you log on to the Members-Only section, select MEMBER CONTENT from the menu at left.
ACCC Releases 2010 Survey on Cancer Care Trends
The Association of Community Cancer Centers (ACCC) has released its "Cancer Care Trends in Community Cancer Centers" survey, a joint project between ACCC and Eli Lilly. Research and analysis were conducted by Kantar Health. This is the second year in which the survey has been conducted.
Results suggest that many of the nation's cancer programs are delaying construction projects, information technology improvements, and some radiation technology equipment purchases, as well as freezing hiring as a result of the current economic recession.
"This year's survey of ACCC-members provides insight into the effects of the recession on cancer programs and organizational strategies that may help the cancer care team adapt to the changes in the healthcare marketplace," said Al B. Benson III, MD, FACP, ACCC President.
Survey results show that many hospitals are adapting to the recession by initiating cost-cutting efforts and affiliating with other local providers. The recession is also affecting patients with cancer: Hospitals are seeing an increasing number of patients with growing financial needs.
"ACCC has great concerns about the ability of cancer patients to afford the medication they need and the quality care they deserve," said Dr. Benson. "In addition, ACCC is concerned that more oncologists are closing their practices as they move to full-time employment with the hospital. ACCC will closely observe this trend of alternative employment arrangements between oncology practices and hospital cancer programs."
Final Rules Released on Meaningful Use of EHR
U.S. Department of Health and Human Services Secretary Kathleen Sebelius announced two final rules to support "meaningful use" of electronic health records. One regulation, issued by CMS, defines the minimum requirements that providers must meet through their use of certified EHR technology to qualify for the payments. The other rule, issued by the Office of the National Coordinator for Health Information Technology (ONC), identifies the standards and certification criteria for the certification of EHR technology, so eligible professionals and hospitals may be assured that the systems they adopt are capable of performing the required functions.
As much as $27 billion may be expended in incentive payments over ten years. Eligible professionals may receive as much as $44,000 under Medicare and $63,750 under Medicaid, and hospitals may receive millions of dollars for implementation and meaningful use of certified EHRs under both Medicare and Medicaid. There will also be greater flexibility with respect to eligible professionals and hospitals in meeting and reporting certain objectives for demonstrating meaningful use. The final rule divides the objectives into a "core" group of required objectives and a "menu set" of procedures from which providers may choose any five to defer in 2011-2012. This gives providers latitude to pick their own path toward full EHR implementation and meaningful use.
An objective of providing condition-specific patient education resources for both EPs and eligible hospitals and the objective of recording advance directives for eligible hospitals are in line with recommendations from the Health Information Technology Policy Committee.
Berwick Sworn in as CMS Administrator
Donald M. Berwick was sworn in July 12 as administrator of the Centers for Medicare & Medicaid Services. President Obama bypassed the Senate confirmation process and appointed Berwick CMS administrator July 7. The agency had been without a permanent administrator since 2006.
Berwick, a pediatrician, is a clinical professor of pediatrics and health care policy at the Harvard Medical School and the Harvard School of Public Health. He also is president and chief executive officer of the Institute for Healthcare Improvement, a Cambridge, Mass.-based not-for-profit organization that promotes the improvement of healthcare.
House Members Send Letter Urging CMS to Stop Inpatient Hospital Pay Cuts
In a July 12 letter, 242 House members urged the Centers for Medicare & Medicaid Services to re-examine its proposal to reduce Medicare payments to inpatient hospitals due to changes in documentation and coding practices that were included in the agency's fiscal year 2011 hospital inpatient prospective payment system (IPPS) proposed rule.
In the letter to CMS Administrator Donald Berwick, the lawmakers wrote that "the coding 'offset' assumes that hospital payments have increased solely due to changes in coding, or classification of patients, as opposed to hospitals' treatment of more complex and more severely ill patients. We believe that this assertion fails to take into consideration that hospital patients are indeed sicker."
As reported in the July 13 BNA "Healthcare Daily Report," the draft rule for FY 2011, issued April 19, set out a large proposed cut to adjust for additional payments that CMS estimates were made due to changes in documentation and coding following CMS's changes to Medicare-Severity Diagnosis-Related Groups (MS-DRGs) for determining inpatient PPS payment amounts. CMS in the rule proposed a 2.9 percent cut—$3.7 billion—to recoup one-half of the payments that the agency said were made in FY 2008 and FY 2009 due to documentation and coding changes that did not reflect increases in patients' severity of illness. The agency is expected to issue a final rule by Aug. 1.
The lawmakers' letter states that the Medicare Payment Advisory Commission has projected a negative 5.9 percent overall Medicare margin for hospitals in FY 2010 and recommended a full inflation update for hospital payments in FY 2011. "If the proposed rule is enacted, the projected inflationary increase for next year, 2.4 percent, would be more than eliminated," the lawmakers wrote.
ACCC Efforts Pay Off: Drug Reimbursement in Hospital Outpatient Departments Set to Increase in 2011
The proposed 2011 Hospital Outpatient Prospective Payment System rule has been put on public display by the Centers for Medicare & Medicaid Services (CMS). In the 2011 proposed rule, CMS announced that reimbursement for drugs and pharmacy services will increase to ASP+6 percent from the current level of ASP+4 percent. ACCC has advocated for this change for the past three years, ever since reimbursement began to decrease in 2007.
In meetings with CMS staff and in testimony before the APC Panel, ACCC has stated that hospitals should be reimbursed at least ASP+6 percent, if not higher, for drugs and their associated pharmacy costs. ACCC data have shown that pharmacy overhead costs are higher than CMS allows for, and, therefore, the ASP+ number should be higher. Each year, CMS listened, but continued to decrease the reimbursement. ACCC continued to push for its position, and it appears that all of that effort has finally paid off.
While ACCC does not agree with every aspect of the proposed rule and will be submitting comments to CMS about those issues, ACCC is pleased that CMS has finally recognized our efforts and our data.
The comment period for this rule closes on August 31. ACCC will submit comments during that period. We anticipate the final rule by Nov. 1, 2010.
Click here to read payment allowance limits for Medicare Part B drugs effective July 1.
CMS Posts Proposed 2011 Physician Fee Schedule
The proposed 2011 rule relating to the Medicare physician fee schedule and other Part B issues has been put on public display by the Centers for Medicare & Medicaid Services (CMS). ACCC is analyzing the proposed rule and will report details soon.
CMS proposes a 6.1 percent cut for physician services that would take effect Jan. 1, 2011. However, due to other formulaic changes in how payments are determined, including a rebasing of the Medicare Economic Index, the impact on medical and radiation oncology services will be much less, ranging from a 1 percent reduction to a 1 percent increase in payments.
The proposed rule was published the same day that President Obama signed the Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act of 2010 (H.R. 3962). The measure replaced the 21.3 percent reduction in physician payment rates required by the sustainable growth rate formula for 2010 with a 2.2 percent increase in effect through Nov. 30. It makes the conversion factor $36.8729.
The rule also would institute changes in the Physician Quality Reporting Initiative that offers an incentive payment to doctors and other professionals covered by the fee schedule and would extend the payments through 2014.
Beginning in 2011, 20 more PQRI measures would be added, including those for reporting through registries and electronic health records. It would also add a group practice reporting option that would allow those with fewer than 200 professionals to participate.
Click here to read the proposed Medicare physician fee schedule.
CMS Posts Corrections to Third Quarter Medicare Drug Payments
The Centers for Medicare & Medicaid Services (CMS) has corrected an error in the Q3 2010 Medicare reimbursement allowable for Abraxane (J9264). CMS has posted the revised file that shows the updated Medicare Q3 2010 ASP + 6 percent allowable for Abraxane as $9.399 per 1 mg.
Click here to read payment allowance limits for Medicare Part B drugs effective July 1.
President Obama Signs Physician-Fix Legislation
On June 25, 2010, President Obama signed into law The Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act of 2010, passed by the House on June 24 and the Senate on June 18. Included in the law is a six-month physician pay patch that will block a 21.3 percent cut in Medicare physician payments, replacing it with a 2.2 percent increase costing $6 billion. The legislation is retroactive to June 1 and runs through Nov. 30.
The cuts are the result of a sustainable growth rate (SGR) formula established by Congress in 1997 to control spending. The SGR reduces physician payments when Medicare expenditures on physician services exceed a predetermined target.
The provision to block the cuts, known on Capital Hill as the 'Doc Fix,' was originally included in the tax extenders bill held up in the Senate. With the extenders bill lacking the votes for passage, pressure from the medical community forced the Senate to take the Doc Fix out of the bill and passed it as a stand-alone measure. The measure, originally a 19-month extension passed by the House, was changed because that measure lacked funding.
The cuts officially became law on June 1 but the Center for Medicare and Medicaid Services (CMS) asked contractors to hold claims until Congress discussed a solution. That hold was lifted on June 18 when the Senate sent the new bill back to the House for approval and CMS began processing claims with the cuts.
The law does not include funding to reprocess claims filed since June 18 but experts suggests CMS already has the funds necessary for reprocessing. In addition, CMS has stated it expects to begin processing claims with the new increase no later than July 1.
Members of the medical community expressed support of the extension but added that a long series of short-term Medicare patches will not solve the problem that Congress has created in the last decade.
The SGR formula links physician reimbursement rates to increases in the gross domestic product (GDP). Because spending on physician services has outpaced increases in the GDP, the formula has called for cuts in reimbursements each year over most of the past decade, and Congress has always voted to push those cuts down the road, granting small rate increases instead. Both ACCC and the American Society of Clinical Oncology have called for a long-term solution.
2010 Physician Quality Reporting Initiative (PQRI) Program Reminder
It is not too late to start participating in the 2010 Physician Quality Reporting Initiative (PQRI) and potentially qualify to receive incentive payments. A new six month reporting period begins on July 1, 2010. The 2010 Physician Quality Reporting Initiative (PQRI) has two reporting periods: 12-months (January 1-December 31, 2010) and 6-months (July 1-December 31, 2010). For 2010, eligible professionals (EPs) who satisfactorily report PQRI measures for the 6-month reporting period will become eligible to receive a PQRI incentive equal to 2.0 percent of their total Medicare Part B allowed charges for services performed during the reporting period.
If you have not participated in the PQRI program, you can begin by reporting PQRI data for July 1-December 31, 2010, using any of the following four options:
- Claims-based reporting of individual measures for 80% or more of applicable patients on at least 3 individual measures or on each measure if less than 3 measures apply
- Claims-based reporting of one measures group for 80 percent or more of applicable Medicare Part B FFS patients of each EP (with a minimum of 8 patients)
- Registry-based reporting of at least 3 individual PQRI measures for 80% or more of applicable Medicare Part B FFS patients of each EP
- Registry-based reporting of one measures group for 80 percent or more of applicable Medicare Part B FFS patients of each EP (with a minimum of 8 patients).
ONC Issues Final Rule to Establish the Temporary Certification Program for EHR Technology
The Office of the National Coordinator for Health Information Technology (ONC) issued a final rule to establish a temporary certification program for electronic health record (EHR) technology. The temporary certification program establishes processes that organizations will need to follow in order to be authorized by the National Coordinator to test and certify EHR technology.
Use of "certified EHR technology" is a core requirement for providers who seek to qualify to receive incentive payments under the Medicare and Medicaid Electronic Health Record Incentive Programs provisions authorized in the Health Information Technology for Economic and Clinical Health (HITECH) Act. HITECH was enacted as part of the American Recovery and Reinvestment Act (ARRA) of 2009. The Centers for Medicare & Medicaid Services will soon issue final regulations to implement the EHR incentive programs.
July 2010 Average Sales Price (ASP) Files Are Now Available
The Centers for Medicare and Medicaid Services (CMS) has posted the July 2010 ASP and NOC pricing files and crosswalks. The ASP pricing files for April 2010, January 2010, October 2009, and July 2009 have also been updated. All are available for download.
FDA Approves Jevtana® (cabazitaxel) Injection
Sanofi-aventis announced June 17 that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for Jevtana® (cabazitaxel) Injection in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing treatment regimen.
Jevtana, a microtubule inhibitor, in combination with prednisone was approved based on results from the Phase 3 TROPIC clinical study involving 755 patients with mHRPC previously treated with a docetaxel-containing treatment regimen. Results from this trial demonstrated a statistically significant 30 percent [HR=0.70 (95 percent CI: 0.59-0.83); P<0.0001] reduction in risk of death from mHRPC among patients taking Jevtana in combination with prednisone compared with an active chemotherapy regimen consisting of a standard dose of mitoxantrone and prednisone. Investigator-assessed tumor response rates using Response Evaluation Criteria in Solid Tumors (RECIST) were 14.4 percent and 4.4 percent for cabazitaxel-treated and mitoxantrone-treated patients respectively, p=0.0005. No complete responses were observed on either arm.
FDA approves Tasigna® for Newly Diagnosed CML Patients
On June 17, following a priority review, the U.S. Food and Drug Administration (FDA) approved Tasigna® (nilotinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. With this approval, Tasigna becomes the first new therapeutic option for newly diagnosed patients since the introduction of Gleevec® (imatinib). The U.S. approval was based on results of the ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients) Phase III clinical trial, which were published in The New England Journal of Medicine (NEJM).
Tasigna is a potent and selective inhibitor of the Bcr-Abl protein that causes production of cancer cells in Ph+ CML2,3. It is also active against a broad spectrum of Bcr-Abl mutations associated with resistance to Gleevec. The first clinical trials of Tasigna began only 21 months after its discovery, with the drug receiving its first regulatory approval as a second-line treatment in 2007.
New HCPCS Code for Oforta (Fludarabine Phosphate Tablets)
The Centers for Medicare & Medicaid Services (CMS) has assigned a new Healthcare Common Procedure Coding System (HCPCS) billing code to Oforta™ (fludarabine phosphate tablets): Q2025 (fludarabine phosphate, oral, 1 mg).
Q2025 (fludarabine phosphate, oral, 1 mg) should replace code J8999 (Prescription drug, oral, chemotherapeutic, not otherwise specified) when submitting Medicare claims for OFORTA™ for dates of services on or after July 1, 2010.
Correct billing for OFORTA™ must be billed to reflect a 1 mg billing unit. Example: One 10 mg tablet = 10 billing units of Q2025.
Other payers, including private payers and Medicaid programs, may update their claims processing systems with this new code on an alternate schedule. Many payers will continue to require the NDC, rather than Q2025, when billing for OFORTA™.
DME MACs still require providers to list the 11-digit NDC code (00024-5820-20), manufacturer's name (sanofi-aventis), drug name (OFORTA™), and the number of tablets reported as units in the narrative field of the CMS-1500 claim form.
For any questions regarding billing and reimbursement of OFORTA™, contact the PACT+® Program at 1-800-996-6626, www.pactplusonline.com, Monday–Friday, 9 am–8 pm ET.
CMS Issues Another Clarification to Physician Supervision Requirements for Hospital Outpatients
The Centers for Medicare & Medicaid Services (CMS) issued a transmittal on May 28 clarifying its policies requiring physician supervision of diagnostic and therapeutic services provided to hospital outpatients. According to the transmittal, "physician assistants, nurse practitioners, clinical nurse specialists, and certified nurse midwives who operate within the scope of practice under state law may order and perform diagnostic tests" outlined in the Medicare manual and previous guidance. However, they "are not permitted to function as supervisory 'physicians' for the purposes of other hospital staff performing diagnostic tests."
The transmittal stated that physician assistants, nurse practitioners, clinical nurse specialists, and certified nurse midwives only require physician supervision "included in any collaboration or supervision requirements particular to that type of practitioner when they personally perform a diagnostic test."
ACCC is analyzing the language and will post analysis soon on its website.
FDA Public Health Alert: Healthcare Professionals Warned Not To Use Certain Intravenous Ondansetron and Ciprofloxacin Due To Potential Contamination
On May 29, 2010, the U.S. Food and Drug Administration (FDA) alerted healthcare professionals not to use certain intravenous bags of ondansetron, ciprofloxacin, and metronidazole because of potential contamination. FDA has received reports of floating matter in IV bags manufactured by Claris Lifesciences Limited.
Peripheral T-Cell Lymphoma Registry Gets Underway
If your center sees at least one newly diagnosed patient with peripheral T-cell lymphoma (PTCL) each year, you may be able to participate in COMPLETE (Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment), a new international registry of patients with PTCL. The Registry is an observational study and is designed to complement clinical studies in PTCL.
Email email@example.com, or call 215.801.4017 for more information.
Update: Holding of June 2010 Claims for Services Paid under the 2010 Medicare Physician Fee Schedule
The Continuing Extension Act of 2010, enacted on April 15, 2010, extended the zero percent (0%) update to the 2010 Medicare Physician Fee Schedule (MPFS) through May 31, 2010. The Centers for Medicare & Medicaid Services (CMS) believes Congress is working to avert the negative update scheduled to take effect June 1, 2010. To avoid disruption in the delivery of healthcare services to beneficiaries and payment of claims for physicians, non-physician practitioners, and other providers of services paid under the MPFS, CMS has instructed its contractors to hold claims containing services paid under the MPFS (including anesthesia services) for the first 10 business days of June. This hold will only affect MPFS claims with dates of service June 1, 2010, and later. This hold should have minimum impact on provider cash flow because, under the current law, clean electronic claims are not paid any sooner than 14 calendar days (29 for paper claims) after the date of receipt.
Be on the alert for more information about the 2010 Medicare Physician Fee Schedule Update.
NCI Community Cancer Centers Program (NCCCP) Releases Request for Information
The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) has released a Request for Information (RFI) to those cancer programs interested in participating in the NCCCP network and receiving the complete Request for Proposal (RFP). The RFI provides an opportunity for NCI to obtain comments related to the potential future RFP's statement of work, requirements, and deliverables. Comments are due by June 30, 2010.
The NCCCP began as a pilot program in 2007 as a network of community hospital cancer centers that is working to provide the most current, research-based cancer care spanning the full cancer continuum – from prevention, screening, diagnosis, treatment and survivorship through end-of-life care, with an emphasis on minority and underserved populations. NCCCP centers are studying ways to reduce healthcare disparities, improve access to clinical trials, improve overall quality of care, promote an infrastructure to collect high-quality biospecimens such as blood and tissue samples for research, and to link with national computer networks that support research. The centers also work to improve survivorship, palliative care services, and patient advocacy.
Palmetto Re-Tapped as J11 MAC Contractor, to Process Claims For 18 States
A disputed, five-year federal contract worth $304.5 million to process Part A, Part B, home health, and hospice claims in 18 states was re-awarded Friday to Palmetto GBA, the Centers for Medicare & Medicaid Services (CMS) said in a memo to congressional staff. Palmetto initially won the contract in January 2009, but it was blocked by a protest to the Government Accountability Office and remained in limbo for 15 months. The agency told health staffers in an e-mail Monday that it had "conducted a thorough review of revised final proposal revisions and determined Palmetto GBA represented the best value to the Government."
The J11 Medicare Administrative Contractor processes Part A/Part B claims in North Carolina, South Carolina, Virginia, and West Virginia, as well as home health and hospice claims for 16 states (that include North Carolina and South Carolina).
Palmetto also serves as the J1 MAC, which serves California and Nevada. That award was also protested, but the GAO upheld CMS' decision to issue the contract to Palmetto, despite efforts by the former California carrier, National Heritage Insurance Co. Palmetto also holds the DME MAC contract for 15 states, Puerto Rico and the Virgin Islands.
In documents sent to Capitol Hill today, CMS said that MACs now conduct "65 percent of claims administrative services ... and expects to complete the implementation of the remaining contracts by October 2011."
Stemming from the Medicare Modernization Act, the MAC program was envisioned as a way to streamline Medicare claims processing and reduce the number of contractors that act as middle men from about 45 down to 15. The effort to merge Part A and Part B claims processing activities, as well as DME, home health and hospice claims, has, however, faced hurdles.
A Call to Action! Review and Comment on Proposed Changes to CoC Standards
Representing ACCC, Immediate Past-President, Luana R. Lamkin, RN, MPH, attended a recent meeting of the American College of Surgeons (ACoS) Commission on Cancer (CoC), which proposed several key changes to its current standards. A number of the new standards focus on patient support and quality measurement. While final review will take place this summer, ACCC members are encouraged to review the current draft standards and submit comments through June 30 at: http://www.facs.org/cancer/coc/cps2011.html. The May 2010 meeting marked the culmination of two years of work, including the Cancer Program Standards revision project and two National Cancer Data Base (NCDB) programs.
While all standards, revisions, deletions, and additions are available on the CoC website, ACCC members may want to look specifically at the following proposed additions, deletions, and changes.
Proposed Additional Standards
- Seventy-five percent of the appointed physician and non-physician members, respectively, attend each meeting of the cancer committee, or other appropriate leadership body, annually.
- Palliative care services are available onsite or by referral.
- Cancer risk assessment, genetic counseling, and testing services are provided onsite or by referral.
- The cancer committee, or other appropriate leadership body, develops a policy and procedure to provide a clear scope of activities, roles, and responsibilities of patient navigation services within the healthcare team. The policy is reviewed at least annually.
- The cancer committee, or other appropriate leadership body, develops a process to monitor screening of cancer patients for psychosocial distress.
- The cancer committee, or other appropriate leadership body, works with the psychosocial representative to monitor the effectiveness of psychosocial activities on an annual basis. The activities and findings are documented in a Psychosocial Services Annual Summary Report presented to the cancer committee annually.
- The cancer committee, or other appropriate leadership body, develops a process to implement and monitor dissemination of a comprehensive care summary and follow-up plan to cancer patients completing cancer treatment. The process is monitored, evaluated, and presented at least annually to the cancer committee, or other appropriate leadership body, and documented in minutes.
- A Cancer Liaison Physician serves in a leadership role within the cancer program and is responsible for evaluating and interpreting the facility's performance using the National Cancer Data Base (NCDB) data and reporting to the cancer committee at least every three months.
- It is recommended that each program develop a Cancer Program Activities Manual that describes the activities of the cancer program. The description of this manual should be included in the introduction section of the Cancer Program Standards Manual.
- It is recommended that that each program develop a Cancer Registry Policy and Procedure Manual that describes the activities of the cancer registry.
Proposed Deleted Standards
- Standard 2.3: Based on category requirements, one coordinator is designated for each of the specified areas of cancer program activity.
- Standard 2.6: The cancer committee, or other appropriate leadership body, establishes the cancer conference frequency and format on an annual basis.
- Standard 2.11: Each year, the cancer committee, or other appropriate leadership body, analyzes patient outcomes and disseminates the results of the analysis.
- Standard 4.5: Nursing provides leadership for oncology patient care.
Proposed Changes to Existing Standards
- Under Eligibility Requirements, that language of "Board Certified or Board eligible" revised to: "Board Certified or in the process of being Board Certified."
- Standard 2.10: The standard and definition have been changed to specify that the cancer committee, or appropriate leadership body, will address data inequities identified by the quality control review.
- Standard 2.5: The definition has been changed to indicate that only a clinical and programmatic goal is required. All programs will set an annual goal in each of these areas. The status of each goal is evaluated and documented at least twice annually. Goals can carry over from one year to the next as long as new goals are also established each year.
- Standard 2.8: The standard and documentation have been changed to increase the percentage of cases presented annually at cancer conference (from 10 percent to 15 percent), to specify that 80 percent of the cases discussed involve planning the first course of treatment, and to include the discussion of site-specific prognostic indicators. A Commendation rating is given if 25 percent or more of the annual analytic caseload is discussed at conference annually.
- Standard 3.1: The standard has been changed to require abstracting by a CTR. The standard will be phased-in over three years. After that time, abstracting by non CTRs is not permitted.
- Standard 4.4: The definition has been changed to indicate that the nursing service or department verifies the credentials of the nurses and reports this finding to the cancer committee at least annually.
- Standard 5.2: The standard has been changed to increase the required clinical trial accrual rate and the commendation clinical trial accrual rate for most categories. The increased rates will be phased-in over three years. Proposed minimum accrual would be as follows: Integrated (network) programs, 6 percent; NCI-designated programs, 15 percent; Teaching (Academic) programs, 6 percent; VA Programs, 2 percent; Pediatric Programs, 30 percent; community programs (> 500 cases) 4 percent; community programs (< 500 cases), 2 percent; and freestanding programs, 2 percent.
- Standard 6.2: The standard has been changed to focus on annual development of a screening or early detection program by the cancer committee and includes a process to follow up on positive findings identified during the program.
- Standard 6.3: The standard has been changed to focus on the cancer committee's monitoring of community outreach activities through the preparation of a community outreach annual summary report, which is prepared by the community outreach coordinator and presented to the committee at least annually. The standard will be moved to the quality improvement chapter.
- Standard 7.2: The commendation rating has been changed to include CTR attendance at a national, regional, or state cancer-related meeting once during the three year survey cycle.
- Standard 8.2: The standard has been changed to strengthen the role of the quality improvement coordinator in quality improvement activities and to focus on the implementation of improvements that are directly related to completed studies of quality. The existing commendation for this standard has been deleted.
Congratulations to ACCC Secretary and Board Member Virginia T. Vaitones, MSW, OSW-C
Virginia T. Vaitones, MSW, OSW-C, received the prestigious Association of Oncology Social Work (AOSW) Leadership in Oncology Social Work Award at the recent AOSW meeting in Phoenix, Ariz.
Ginny is an oncology social worker at the Penobscot Bay Medical Center, Cancer Care Center, in Rockport, Maine. She has served on ACCC's Board of Trustees since March 2008 and served on various committees, including the Guidelines Committee, the Program Committee, and the Patient Advocacy Committee. She currently is ACCC Secretary and chairs the Patient Advocacy Subcommittee of the Governmental Affairs Committee. (She was co-chair, 2006-2007.) She has provided a strong voice to the ACCC's advocacy efforts. In January 2010, for example, Ginny participated in an educational briefing on Capitol Hill, where she helped raise awareness among legislators and their staffs about new oral anti-cancer agents, how they may change oncology care, and the difficulties cancer programs have in securing these medications for patients. In addition, she has advocated for proper reimbursement for pharmacy overhead services in the hospital outpatient department. Over the years, she has worked with ACCC to support such legislation as Senator Kennedy's Comprehensive Cancer Care bill, as well as legislation to eliminate the Medicare waiting period.
Since 2005, Ginny has been a driving force within ACCC's Guidelines Committee. As a long-time Committee member, Ginny helped craft the ACCC guideline on patient navigation within ACCC's Cancer Program Guidelines. She detailed the components that a model patient navigation program should have. The guideline helps define patient navigation within the context of cancer care and outlines key elements needed to provide comprehensive patient navigation services.
ACCC congratulates her for work well done!
CMS Issues Change on Payment Reduction to Certain Diagnostic Imaging Procedures
The Centers for Medicare & Medicaid Services (CMS) issued a one-time change notification regarding the multiple procedure payment reduction on the technical component of certain diagnostic imaging procedures. Effective July 1, 2010, for implementation on July 6, CMS will increase the technical component from 25 percent to 50 percent.
Click here to view the transmittal. Go to page 2 to view current payment, and payment as of July 1.
Cancer Costs Double in Less than 20 Years
Over a period of nearly two decades, the medical costs of cancer care almost doubled in constant dollars, but remained proportional to other medical costs, according to a study published in the recent Cancer journal. (Tangka FJ et al. "Cancer treatment cost in the United States: Has the burden shifted over time?" Cancer 2010; 116: DOI: 10.1002/cncr.25150.) Over the same time—from 1987 to 2005—cancer costs shifted away from inpatient care, according to Florence Tangka, PhD, of the CDC, and colleagues.
Across payers, cancer inpatient costs fell from 64.4 percent of total costs in 1987 to 27.5 percent during 2001-2005. In real terms, total inpatient spending on cancer dropped from $15.9 billion to $13.2 billion, essentially because the probability of receiving inpatient cancer treatment decreased markedly for every payer, the researchers said. At the same time, outpatient costs attributable to cancer increased nearly fourfold, from $7.5 billion to $30.3 billion.
New England Journal of Medicine Tackles Solutions to Medicare Physician Payment System
The May 5, 2010, New England Journal of Medicine explores problems with the Medicare physician payment system, "an arbitrary, if elegantly conceived, formula for total payments to physicians—the sustainable growth rate (SGR)." The SGR will reduce Medicare's physician payments, which already trail those from private insurers, as far into the future as the eye can see, according to the article. Moreover, there is widespread consensus that the relative fees in the current system are a significant cause of the growing imbalance in supply and utilization between primary care and specialty services in the U.S. health care system. That imbalance, in turn, is widely perceived as a major cause of both excessive costs and inadequate quality of care.
FDA Approves Provenge, Plans Underway to Treat 2,000 Patients
The U.S. Food and Drug Administration (FDA) approved Provenge (Sipuleucel-T) for use in treating metastisized prostate cancer as of April 29. Provenge is an immune therapy created by harvesting immune cells from a patient, genetically engineering them to fight prostate cancer, and then infusing them back into the patient. Provenge is the first treatment of its kind to win FDA approval. The FDA decision comes almost exactly one year after encouraging evidence from Phase III clinical trials showed that the therapy would extend life a median 4.1 months over placebo—about half of patients were below that amount and half were above. But some of the patients remain alive years after the treatment. In the most recent trial, 32 percent of Provenge-treated patients remained alive three years after treatment. Only 23 percent of placebo-treated patients survived that long.
Dendreon had already begun developing three manufacturing plants for Provenge before FDA approval (as early as 2006). In the next year, Dendreon will complete construction and secure licensure for these plants. With the facilities they already have the company is looking to provide full treatments for about 2,000 patients in the months ahead. Those patients will be treated in about 50 oncology clinics around the U.S. and Canada, all (or most) of which were involved in Provenge/Sipuleucel-T clinical trials. A Dendreon spokesmen said that Provenge will be priced around $31,000 per infusion, with three infusions necessary for a full treatment ($93,000 total). They anticipate that most insurance carriers will cover the treatment, and they have set up a patient financial assistance program. The "Dendreon On-Call" service will be available to provide oncology support for patients as well as guide them in accessing the treatment.
13 ACCC-Member Cancer Programs Added to NCCCP
The National Cancer Institute Community Cancer Centers Program (NCCCP) will add 14 new hospitals to its current network. Of these, 13 are ACCC-member cancer programs. Congratulations to:
- Albert Einstein Medical Center, Philadelphia, Pa. (Einstein Cancer Center and Einstein Center One)
- Geisinger Medical Center, Danville, Pa. (Geisinger Medical Center Cancer Institute)
- Gundersen Lutheran Medical Center, La Crosse, Wisc. (Gundersen Lutheran Center for Cancer & Blood Disorders)
- Lehigh Valley Hospital, Allentown, Pa. (John and Dorothy Morgan Cancer Center)
- Maine Medical Center, Portland, Maine (Maine Medical Center Cancer Institute)
- Mercy Medical Center, Des Moines, Iowa (Mercy Cancer Center)
- Northside Hospital, Atlanta, Ga. (Northside Hospital Cancer Care Program)
- Norton Suburban Hospital, Louisville, Ky. (Norton Cancer Institute)
- Providence Portland Medical Center, Portland, Ore. (Providence Cancer Center)
- The Queen's Medical Center, Honolulu, Hawaii (The Queen's Cancer Center)
- St. Joseph Mercy Hospital, Ann Arbor, Mich. (St. Joseph Mercy Cancer Care Center)
- St. Luke's Regional Medical Center, Boise, Idaho (Mountain State Tumor Institute)
- Saint Mary's Health Care, Grand Rapids, Mich. (The Lacks Cancer Center)
NCI, part of the National Institutes of Health (NIH), is using $80 million from the American Recovery and Reinvestment Act (ARRA) to expand research benefitting patients at the 16 member hospitals of the NCCCP and to add 14 new hospitals to the current network. The expansion uses approximately $40 million of ARRA funds to support additional research opportunities within the original network of 16 NCCCP sites and another $40 million of ARRA funds to expand the network to include 14 new community cancer centers, for a total of 30 sites in 22 states.
The NCCCP began as a pilot program in 2007 as a network of community hospital cancer centers that is working to provide the most current, research-based cancer care spanning the full cancer continuum – from prevention, screening, diagnosis, treatment and survivorship through end-of-life care, with an emphasis on minority and underserved populations. The program is designed as a community-based platform to support basic, clinical, and population-based initiatives that are working to produce effective new prevention strategies and treatments for cancer patients.
NCCCP centers are studying ways to reduce healthcare disparities, improve access to clinical trials, improve overall quality of care, promote an infrastructure to collect high-quality biospecimens such as blood and tissue samples for research, and to link with national computer networks that support research. The centers also work to improve survivorship, palliative care services, and patient advocacy.
For more information about the program, visit http://ncccp.cancer.gov.
Neulasta Co-Pay Support Program Updated
Amgen Inc. announced an update to its Neulasta FIRST STEP™ Program, a co-pay support program that assists eligible, commercially insured patients receiving Neulasta®. The program now covers deductibles as outlined in a letter mailed to business directors of hospitals and oncology office practice managers in community oncology clinics.
During the first cycle of a new chemotherapy regimen, Amgen will pay an eligible patient's entire Neulasta® deductible, co-insurance, and/or co-payment requirements. For all subsequent chemotherapy cycles, Amgen will pay the Neulasta® out-of-pocket amount in excess of an eligible patient's required portion of $50 per cycle.
Click here to read the letter and learn more.
Donald M.Berwick Nominated to CMS Administrator Post
On April 19 President Obama nominated Harvard professor Donald M. Berwick, MD, MPP, to be administrator of the Centers for Medicare & Medicaid Services (CMS). The top CMS post has been vacant since late 2006. Dr. Berwick must be approved by the Senate Finance Committee and the full Senate before beginning his position, according to BNA Health Care Daily Report.
Dr. Berwick is president and chief executive officer of the Institute for Healthcare Improvement (IHI), a not-for-profit organization promoting the improvement of health care. He is also a clinical professor of pediatrics and healthcare policy at the Harvard Medical School and professor of health policy and management at the Harvard School of Public Health. Dr. Berwick is a pediatrician on the adjunct staff in the Department of Medicine at Boston Children's Hospital and a consultant in pediatrics at Massachusetts General Hospital.
Among other positions, Dr. Berwick served as chair of the National Advisory Council of the Agency for Healthcare Research and Quality (1999-2001) and is an elected member of the Institute of Medicine (IOM). He was vice chair of the U.S. Preventative Services Task Force (1990-1996). From 1987 through 1991, Dr. Berwick was co-founder and co-principal investigator for the National Demonstration Project on Quality Improvement in Health Care (NDP). He was appointed by President Clinton to serve on the Advisory Commission on Consumer Protection and Quality in the Healthcare Industry in 1997 and 1998.
He has published more than 130 scientific articles in numerous professional journals on topics related to healthcare policy, decision analysis, technology assessment, and healthcare quality management.
Physician Pay Cut Delayed through May 31
On April 15, President Obama signed the Continuing Extension Act of 2010, delaying the 21 percent Medicare payment reimbursement cut for physicians through May 31, reports BNA Daily Health Care Report.
Late on April 15, the House passed the bill by a 289-112 vote. The bill passed the Senate earlier by a 59-38 vote. With passage of the legislation (H.R. 4851), physicians will not face a reduction in reimbursement.
The Centers for Medicare & Medicaid Services (CMS) has been holding claims, waiting for congress to act on the bill. In a statement, the agency said that it "has instructed Medicare contractors to begin processing claims under the new law for services provided by physicians, non-physician practitioners (NPPs) and others paid under the MPFS [Medicare Physician Fee Schedule]. Most claims with dates of service April 1 and later were held by Medicare in anticipation of congressional action."
The bill also includes a provision that would allow certain hospital-based physicians to be eligible for health IT "meaningful use" incentives under the American Recovery and Reinvestment Act (ARRA).
Healthcare Reform and Oncology: More than 350 ACCC Members Listen In To Conference Call Analysis
On April 13, 2010, more than 350 ACCC members listened to a conference call about healthcare reform and its effects on cancer care. The complete slide show and phone call recording are available to ACCC members.
Oncology Nursing and Social Work Professional Associations Release Position on Patient Navigation
The Oncology Nursing Society (ONS), the Association of Oncology Social Work (AOSW), and the National Association of Social Workers (NASW) worked together to develop a joint position statement on the role of oncology nursing and oncology social work in patient navigation. The joint position is a direct result of a think tank that convened in Pittsburgh, PA, in June 2009, during which representatives from ONS and AOSW worked collaboratively, along with representation from NASW, to discuss the role of patient navigation and identify needs of the healthcare professional in this emerging new role for oncology nurses and social workers as they care for patients from pre-diagnosis through all phases of the cancer experience.
The Association of Community Cancer Centers' Center for Provider Education provides ACCC members with an extensive online resource about Cancer Care Patient Navigation.
Healthcare Reform Establishes New Requirements for Tax-Exempt Hospitals
The recently enacted healthcare reform legislation includes important new requirements for tax-exempt hospitals. The Patient Protection and Affordable Care Act of 2010 (the "Act") was signed into law by President Obama on March 23, 2010. Most of the provisions in the Act applicable to tax-exempt hospitals are effective for tax years beginning after March 23, 2010. Tax-exempt hospitals will want to review existing policies and procedures prior to the start of the next tax year to ensure compliance.
The new requirements apply to any Section 501(c)(3) organization that operates a facility which is required by a state to be "licensed, registered or similarly recognized as a hospital," and to any other organization that has the principal function or purpose of providing hospital care as the basis for its tax-exempt status. If an organization operates more than one hospital facility, requirements apply separately to each hospital.
New Exemption Requirements: New Section 501(r) of the Internal Revenue Code imposes four requirements on hospitals seeking to qualify for and maintain tax-exempt status.
Read more about the exemption requirements in a document prepared by the law firm of Hogan & Hartson.
ACCC to Study Challenges in Treating Small-Population Cancers in the Community Setting
The Association of Community Cancer Centers (ACCC) has launched a ground-breaking program to provide community-based cancer care providers the tools they need to improve the quality of care for patients with small-population cancers, such as chronic myeloid leukemia (CML).
"Caring for patients with less common cancers presents unique challenges for community-based cancer care providers," said ACCC President Al B. Benson III, MD, FACP. "Physicians treating small-population cancers have limited time and resources to incorporate emerging clinical data into practice. Other health professionals, including nurses, social workers, and pharmacists, see these diseases less frequently and need information to better support the physician and the patient."
The project is made possible by an educational grant from Novartis Oncology and will take about two years to complete.
ACCC surveys revealed that many community-based cancer care providers see a relatively high number of patients with breast, lung, colon, or prostate cancer. Practice patterns are relatively well-established for these cancers and resources are available for both providers and patients. Patients with a small-population cancer, however, usually are underserved or elderly and may not have the resources or desire to be treated far away from their homes.
ACCC's first objective will be to raise awareness among the public and healthcare providers about the challenges presented by small-population cancers, and the need to assess barriers to treatment and best practices within the community setting. Barriers include limited physician and cancer team knowledge of emerging data, difficulties in incorporating new clinical information into practice, and inadequate managerial and administrative processes in treating small-population cancers like CML.
Medicare Will Cover PET Scans to Detect Bone Metastasis of Cancer Under CED Only
On March 29, affirming an earlier proposed coverage decision, the Centers for Medicare & Medicaid Services (CMS) announced that Medicare will cover positron emission tomography (PET) scans to identify bone metastasis of cancer only under Coverage With Evidence Development (CED).
ACCC submitted comments to CMS on December 30, 2009, in which it agreed that NaF-18, or sodium fluoride-18 (a radioactive tracer), PET is promising. ACCC believes that the evidence is sufficient to cover the test as prescribed by physicians, however, without CED.
In a final decision memo dated Feb. 26, CMS said it will cover NaF-18 PET imaging only when the beneficiary's treating physician determines that an NaF-18 PET study is needed to "inform the initial antitumor treatment strategy or to guide subsequent antitumor treatment strategy after the completion of initial treatment." CMS also said it would cover the imaging procedure when the beneficiary is enrolled in, and the NaF-18 PET provider is participating in, a specific type of prospective clinical study.
In ACCC's comments, we noted that, "Rather than limiting coverage to beneficiaries who participate in a study, we recommend that CMS encourage beneficiaries and providers to participate in studies but not require participation for coverage of NaF-18 PET."
In a Nov. 30, 2009, proposed decision memo, CMS said that the available evidence is not sufficient to determine that the results of NaF-18 PET imaging improve health outcomes of beneficiaries with cancer (229 HCDR, 12/2/09).
According to the final memo, NaF-18 PET has been recognized as "an excellent technique for imaging areas of altered osteogenic activity in bone."
CMS said the new coverage policy will be implemented July 6.
ACCC Submits Comments to CMS About Radiation Therapy for Localized Prostate Cancer
On March 22, 2010, the Association of Community Cancer Centers (ACCC) provided comments to the Centers for Medicare & Medicaid Services (CMS) regarding the Medicare Development & Coverage Advisory Committee (MEDCAC) meeting on radiation therapy for localized prostate cancer. ACCC believes that each cancer patient should have access to the most appropriate treatment options for his condition, including various forms of radiation therapy for localized cancer.
On April 21, 2010, MEDCAC will consider the currently available evidence regarding the risks, benefits, and outcomes of radiation therapy, inclusive of external beam radiotherapy and brachytherapy, for the treatment of localized prostate cancer.
ACCC urged the agency "to recognize that each form of radiation therapy presents unique benefits and risks for patients with prostate cancer. . . Medicare's coverage policies must continue to allow beneficiaries access to the full range of treatment options so that each patient diagnosed with cancer has the best chance of survival."
ACCC also urged CMS to consider the effect of its coverage policies on access to future improvements in care. "Unduly restrictive Medicare coverage and uncertainty about Medicare coverage could discourage such investment, restrict treatment options, and deny patients the benefits of emerging technology."
Historic HealthCare Bill Passes House of Representatives: How Will Oncology Care Fare?
On March 21, the House of Representatives passed a landmark healthcare bill that seeks to extend health coverage to most Americans. An estimated 24 million people who lack access to affordable coverage through the workplace will be eligible for tax credits to buy insurance on new state-based exchanges. Medicaid, the federal-state program that provides health insurance to the poor and disabled, will be expanded to cover all adults earning less than 133 percent of the federal poverty level.
Bill sponsors predict that all but about 5 percent of non-elderly Americans will ultimately be covered. Half of those currently uninsured will receive coverage through the expansion of Medicaid and half through private insurance through the exchanges — often with subsidies that make up the bulk of the legislation's projected costs.
How will oncology care fare? Under the healthcare legislation, oncology comes out without cuts to its core businesses of medical oncology, radiation oncology, office administered drugs, or PET/PET-CT imaging.
Among the provisions that directly affect oncology care:
- Voluntary participation in accountable care organizations (ACOs). ACOs will manage and coordinate care across settings. Here, the concept is to improve value and control costs by aligning provider incentives toward integration, quality, and efficiency. Coordinating patient care across settings and using lower cost/equally effective regimens will be rewarded. ACOs can include physician groups, networks of physician groups, joint ventures between a hospital and physicians, hospitals with employed physicians, and integrated delivery systems.
- CMS Innovation Center. The new legislation funds $10 billion to test new innovative payment models within the Medicare system. It specifies 13 models that CMS must consider. One model is specific to oncology: Align nationally recognized, evidence-based guidelines of cancer care with Medicare payment incentives in the areas of treatment planning and follow-up care planning for Medicare beneficiaries with cancer.
- Generic incentives. The healthcare reform legislation will pay biosimilars at the average sales price of the biosimilar plus 6 percent of the ASP of the reference/innovator biologic. The goal: to remove the incentive for using the higher cost drugs.
- Clinical trials. The legislation requires insurance company coverage of routine care costs associated with a patient's participation in a clinical trial. Bottom line: perhaps increased trial participation.
- New fees on medical device manufacturers. This will mean, for example, higher costs for such equipment as linear accelerators.
- Payment Advisory Board. The Senate version of the legislation creates an independent payment advisory board to make recommendations to Congress. The goal: reduce Medicare spending by $28 billion.
The legislation includes no provisions to 1) fix the SGR, 2) address advance care planning, or 3) provide prompt pay discount.
ACCC will update members about specific measures within the bill.
Although the bill has been passed by the House and will be signed into law by the President, most of the provisions do not take effect right away. The elimination of pre-existing conditions rules for adults does not take effect until 2014, as do some of the new taxes and fees. There are some provisions that will start this year, including the elimination of pre-existing conditions for children and the expansion of coverage of young adults on their parents' insurance until age 26.
Note that the healthcare debate is far from over. The Senate still needs to pass the reconciliation, or fixes, bill in order to implement some of the changes the President and members of the House of Representatives wanted in the final bill.
ACCC expects the Senate to take up the fixes bill soon, but it may be some time before it is passed. There continues to be strong opposition from the Republican Party, and there are a number of tactics at their disposal to slow the process.
Al B. Benson III, MD, FACP, Becomes President of the Association of Community Cancer Centers
Al B. Benson III, MD, FACP, became President of the Association of Community Cancer Centers at its 36th Annual Meeting on March 19, 2010. Dr. Benson is a professor of medicine in the Division of Hematology/Oncology at Northwestern University Feinberg School of Medicine in Chicago, Ill. He is also associate director for clinical investigations, Robert H. Lurie Comprehensive Cancer Center, at Northwestern.
"I am honored to serve as President of the Association of Community Cancer Centers," said Dr. Benson. "During my year as ACCC President, I hope to give voice to the importance of putting comparative effectiveness research and evidence-based medicine into practice. ACCC needs to be at the table with other oncology organizations. Oncology must have a definitive voice in the comparative effectiveness debate and how it evolves."
Dr. Benson has served on ACCC's Board of Directors since 2003 and has been active on ACCC's Strategic Planning Committee, Editorial Committee, New Technology Committee, Corporate Development Committee, Awards Committee, Bylaws Committee, Program Committee, and Membership Committee.
Dr. Benson was an assistant professor of medicine at the University of Illinois and co-medical director for the National Public Health Service in Champaign, Ill. He then served as a clinical oncology fellow at the University of Wisconsin Clinical Cancer Center, where he received an American Cancer Society Fellowship Award, prior to joining the faculty at Northwestern.
Dr. Benson's research is primarily in the areas of gastrointestinal cancer clinical trials, cancer clinical trials, biologic therapies, Phase I cancer clinical trials, and cancer guideline development. He has authored or co-authored numerous reports, reviews, and book chapters focusing on these topics. His research in biologics, cancer therapy, and cancer prevention has been awarded funding from a variety of sources including the NIH. Dr. Benson has been honored with a number of awards, including most recently the ASCO Statesman Award and the Woman's Board of Northwestern Memorial Hospital Compassionate Care Award.
Dr. Benson has served on a number of committees for the American Society of Clinical Oncology (ASCO) and is currently a member of the Task Force on Quality of Cancer Care, and the co-chair of ASCO's Colorectal Cancer Surveillance Guidelines Panel, the Stage II Colon Cancer Guidelines Panel and the RFA for colorectal cancer liver metastases panel. He is also the chair of the Eastern Cooperative Oncology Group Gastrointestinal and Data Monitoring Committees. In addition, he is a member of several medical societies, and serves as past-president of the Illinois Medical Oncology Society, past-president of the International Society of GI Oncology, and is a member and immediate past-chair of the board of directors of the National Comprehensive Cancer Network (NCCN). He was recently appointed as a Scientific Advisory Board member of both the Patient Advocacy Foundation and the National Patient Advocacy Foundation.
He earned his medical degree at the State University of New York at Buffalo, following which he completed an internal medicine residency at the University of Wisconsin Hospitals.
New 5-Day Dosing Regimen for Decitabine
Eisai Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a five-day dosing regimen for Dacogen® (decitabine) for Injection to treat patients with myelodysplastic syndromes (MDS). The new outpatient dosing option provides physicians and patients with the flexibility of a dosing regimen with a reduced infusion time. Dacogen is the only hypomethylating agent approved for a five-day dosing regimen. The new regimen will be administered at a dose of 20 mg/m2 continuous intravenous (IV) infusion over one hour repeated daily for five days per cycle. The cycle is repeated every four weeks.
The previously approved Dacogen three-day regimen is administered in an in-patient setting at a dose of 15 mg/m2 continuous IV infusion over three hours repeated every eight hours for three days per cycle and repeated every six weeks.
New C Codes Available
Effective April 1, 2010, for the Hospital Outpatient Prospective Payment System (HOPPS) only, new HCPCS codes are available for: Folotyn (pralatrexate injection), 1 mg, C9259; Arzerra (ofatumumab injection, 10 mg, C9260; Fludarabine phosphate, oral, 1 mg, C9262.
New Features on NCI Recovery Act Website
The National Cancer Institute (NCI) invites you to learn about the new services and research that are being funded through the Recovery Act. NCI's Recovery Act website has expanded to include new features on the people behind the science and videos from the field on navigators helping cancer patients. Recently added highlights include:
ACTNOW Trials At-A-Glance and In-Depth. Studies in the NCI's Accelerating Clinical Trials of Novel Oncologic PathWays (ACTNOW) initiative are high-priority early-phase clinical trials of new cancer treatments on an accelerated timeline, including a number of correlative studies. Researchers hope that this will help shorten the time between drug discovery and ultimately, approval and safe use of these treatments by cancer patients. A new ACTNOW table on the NCI Recovery Act Web site lists each ACTNOW trial by cancer type and contains links to descriptions of the trials, including trial objectives, patient enrollment criteria, and current trial locations.
Article on Recovery Funding of Comparative Effectiveness Research. Comparative Effectiveness Research (CER), also known as Patient-Centered Outcomes Research, is a key priority of the American Recovery and Reinvestment Act. A new article on the NCI Recovery Act website highlights Recovery Act-funded initiatives that are helping to improve patient outcomes while making cancer care more personalized, efficient, and cost-effective.
HHS Announces Proposed Rule On Temporary, Permanent EHR Certification
David Blumenthal, the national coordinator for health information technology, March 2 announced the release of a proposed rule from the Department of Health and Human Services (HHS) outlining processes for both temporary and permanent certification of electronic health record (EHR) technology.
Eligible professionals and eligible hospitals who seek to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs are required by statute to use Certified EHR Technology. Once certified, Complete EHRs and EHR Modules would be able to be used by eligible professionals and eligible hospitals, or be combined, to meet the statutory requirement for Certified EHR Technology.
Senate Approves 26-Day Delay in Physician Payment Cuts
The Senate voted late Tuesday, March 2, to stave off Medicare cuts to physicians until the end of March, finally overcoming a one-man blockade by Sen. Jim Bunning (R-Ky.). By a 78-19 vote, the Senate passed the $10 billion bill, which extends a number of programs, including federal programs for unemployment assistance, COBRA assistance, flood insurance, and highway funding. In particular, it offers physicians a temporary reprieve from 21 percent cuts to reimbursement under Medicare. The cuts will now go into effect March 28 unless Congress passes a longer-term fix.
After Congress failed to pass a bill last week to stave off the cuts mandated under the sustainable growth rate (SGR) formula, the reductions technically went into effect on March 1. But the Centers for Medicare & Medicaid Services (CMS) effectively postponed them by instructing contractors to hold claims until March 12, betting on Congressional action to stop the cuts before then.
ACCC Submits Comments to CMS about Meaningful Use Criteria of EHR Technology and EHR Incentive Program
On March 2, 2010, the Association of Community Cancer Centers submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding the interim final rule that specifies the initial set of standards, implementation specifications, and certification criteria for electronic health record (EHR) technology. ACCC voiced a number of concerns. Overall, ACCC believes that there are too many criteria proposed for Stage 1, that some of the proposed criteria are overly demanding, and that the proposed criteria may mean that relatively few eligible professionals and eligible hospitals would benefit from the Health information Technology (HIT) stimulus dollars approved under the American Recovery and Reinvestment Act.
ACCC noted that CMS has estimated that 47 to 79 percent of eligible professionals and an unspecified number of hospitals could face Medicare penalties in 2015 for failing to meet EHR meaningful use criteria. "We find this estimate troubling and we believe it suggests that the meaningful use criteria envisioned by CMS are overly ambitious," ACCC noted in its comments.
ACCC also urged the Office of the National Coordinator (ONC) to pay particular attention to the comments submitted by EHR vendors regarding the initial set of certification criteria. "Both ONC and CMS need to have reasonable expectations with respect to EHR vendor capabilities lest overly ambitious regulatory requirements significantly delay the availability of EHR technology," ACCC noted.
Further detailing its concerns, on March 2, 2010, ACCC also submitted comments to CMS about the Electronic Health Record Incentive Program.
CMS envisions a phased approach to defining meaningful use with three stages, but the proposed rule only addresses meaningful use criteria under Stage 1. CMS plans to propose the Stage 2 criteria by the end of 2011 (that is, in time for the 2013 payment year) and the Stage 3 criteria by the end of 2013 (in time for the 2015 payment year). For Stage 2 meaningful use criteria, CMS announces its intent to build up several functionality measures, including requiring: 1) the electronic transmission of CPOE-entered orders; 2) the incorporation of the full array of diagnostic test data into EHR as structured data, including radiology and nuclear medicine tests (rather than only clinical lab test results); 3) increased exchange of electronic and structured data (rather than unstructured data); and 4) actual electronic submission of data, such as syndromic surveillance data, to public health agencies (rather than only the performance of a capability test).
ACCC believes that the proposed meaningful use criteria for Stage 1 are far too ambitious and urged CMS to re-examine its plans for Stage 2 and Stage 3.