Oncology Newsfeed

CMS Issues Proposed Hospital Outpatient Department Rule for 2010

On July 1, 2009, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would update payment policies and rates for services provided in hospital outpatient departments for 2010 under the Outpatient Prospective Payment System (OPPS). The proposed rule also clarifies “physician supervision” as it relates to hospital outpatient therapeutic services, and seeks to promote higher quality, efficient services for Medicare beneficiaries by proposing improvements to the Hospital Outpatient Quality Data Reporting Program.

The Association of Community Cancer Centers (ACCC) is analyzing the CMS proposed OPPS rule and will report to membership soon, as well as submit comments to CMS. CMS will accept comments on the proposed rule until August 31, 2009, and will respond to comments in a final rule to be issued by November 1, 2009.

Physician supervision requirements. CMS is proposing to revise or further define several current policies for the physician supervision of outpatient services. First, CMS is proposing that nonphysician practitioners, specifically physician assistants, nurse practitioners, certified nurse specialists, and certified nurse-midwives, may directly supervise all hospital outpatient therapeutic services that they are able to personally perform within their state scope of practice and hospital-granted privileges. Under current policy, only physicians may provide the direct supervision of these services.

In addition, CMS is proposing to define “direct supervision” for on-campus hospital outpatient services to mean that the physician or nonphysician practitioner must be present in the hospital or on-campus provider-based department of the hospital and immediately available to furnish assistance and direction throughout the performance of the procedure, in contrast to the current definition which requires the physician to be present in the on-campus provider-based department. For services furnished in an off-campus provider-based department, “direct supervision” would continue to mean that the physician or nonphysician practitioner must be present in the off-campus provider-based department and immediately available to furnish assistance and direction throughout the performance of the procedure.

CMS is also proposing to require that all hospital outpatient diagnostic services furnished directly or under arrangement, whether provided in the hospital, in a provider-based department, or at a nonhospital location, follow the Medicare Physician Fee Schedule physician supervision requirements for individual tests.

Drugs and pharmacy overhead. CMS is proposing to pay for the acquisition and pharmacy overhead costs of separately payable drugs and biologicals without pass-through status at the average sales price (ASP) plus 4 percent in 2010. The proposed payment rate of ASP plus 4 percent is based upon the cost of separately payable drugs and biologicals calculated from hospital claims and cost reports (ASP minus 2 percent), with an adjustment for pharmacy overhead cost that reflects the redistribution of $150 million of the pharmacy overhead cost currently attributed to packaged drugs and biologicals to separately payable drugs and biologicals without pass-through status.

Therapeutic radiopharmaceuticals. CMS is proposing to provide payment for separately payable therapeutic radiopharmaceuticals that have ASP information submitted through the existing ASP process at ASP plus 4 percent. If ASP information is not available, CMS is proposing that payment would be based upon mean unit cost from hospital claims data.

Brachytherapy sources. CMS is proposing to pay for brachytherapy sources based on median unit costs, as calculated from claims data according to the standard OPPS rate setting methodology. In 2009, the payment methodology for brachytherapy sources was based on each hospital’s charges adjusted to cost through January 1, 2010.

Proposals to strengthen ties between payment and quality: Payment reduction for failure to report quality measures. As required by law, the proposed rule includes a reduction to the projected CY 2010 annual payment update factor of two percentage points for most services furnished by hospitals that failed to meet the requirements of the Hospital Outpatient Quality Data Reporting Program for the 2010 payment update. The reduction would not apply to payments for separately payable pass-through drugs and biologicals and devices, separately payable non-pass-through drugs and non-implantable biologicals, separately payable therapeutic radiopharmaceuticals, and services assigned to New Technology APCs.

CMS is proposing to implement a new Hospital Outpatient Quality Data Reporting Program (HOP QDRP) validation requirement to ensure that hospitals are accurately reporting measures using HOP QDRP chart-abstracted data. Under this requirement, CMS would take a sample of actual patient records, determine how the chart-abstracted measures should have been reported, and compare the results with the measures reported by the hospital. CMS will begin validating hospital submitted data for purposes of the 2011 update, but the validation results will not affect a hospital’s OPPS payment until 2012. This timeline will give hospitals sufficient advance notice to become familiar with the process.

Click here to read the proposed CMS rule. 

Posted 07/2/2009

Cancer Figures Prominently in IOM Comparative Effectiveness Research Report

The Institute of Medicine (IOM) provided a road map June 1, 2009, for a new U.S.-backed effort to compare medical treatments and give healthcare providers and patients better information to guide care. In its new report entitled “Initial National Priorities for Comparative Effectiveness Research,” IOM defines comparative effectiveness research and puts forth a portfolio of 100 high-priority research priorities from about 2,600 suggestions submitted from professional groups, policy makers, and the public.

Cancer figures prominently in the IOM report with four priority topics in the first quartile.

• Compare the effectiveness of management strategies for localized prostate cancer (e.g., active surveillance, radical prostatectomy [conventional, robotic, and laparoscopic], radiotherapy [conformal, brachytherapy, proton-beam, and intensity-modulated radiotherapy]) on survival, recurrence, side effects, quality of life, and costs.
• Compare the effectiveness of management strategies for ductal carcinoma in situ (DCIS).
• Compare the effectiveness of imaging technologies in diagnosing, staging, and monitoring patients with cancer including positron emission tomography (PET), magnetic resonance imaging (MRI), and computed tomography (CT).
• Compare the effectiveness of genetic and biomarker testing and usual care in preventing and treating breast, colorectal, prostate, lung, and ovarian cancer, and possibly other clinical conditions for which promising biomarkers exist.

In the second quartile, three priority topics relate to cancer.

• Compare the effectiveness of robotic assistance surgery and conventional surgery for common operations, such as prostatectomies.
• Compare the effectiveness of film-screen or digital mammography alone and mammography plus magnetic resonance imaging (MRI) in community practice-based screening for breast cancer in high-risk women of different ages, risk factors, and race or ethnicity.
• Compare the effectiveness of new screening technologies (such as fecal immunochemical tests and computed tomography [CT] colonography) and usual care (fecal occult blood tests and colonoscopy) in preventing colorectal cancer.

The Association of Community Cancer Centers (ACCC) welcomes the report and supports comparative effectiveness research. At the same time ACCC has expressed concerns that comparative effectiveness research may ultimately lead to treatment decisions based on price and has urged that any guidance on comparative effectiveness research include explicit language preventing cost from being considered. ACCC has also noted the importance of recognizing that all patients with the same disease may not benefit from the same treatment option, which is especially important in oncology, where the most effective treatment for one person may not be the same for another person with the same diagnosis. According to ACCC, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations. Click here for more information.

Congress, in the American Recovery and Reinvestment Act (ARRA) of 2009, appropriated $1.1 billion to jump-start the nation’s efforts to accelerate comparative effectiveness research.

Comparative effectiveness research as defined by IOM “is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of comparative effectiveness research is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels.”

The key elements of this definition are the direct comparison of effective interventions, the study of patients in typical day-to-day clinical care, and the aim of tailoring decisions to the needs of individual patients.

Posted 07/1/2009

CMS Proposes Payment, Policy Changes for Physicians' Services in 2010

The Centers for Medicare & Medicaid Services (CMS) announced July 1, 2009, proposed changes to policies and payment rates for services to be furnished during 2010) by over 1 million physicians and nonphysician practitioners who are paid under the Medicare Physician Fee Schedule (MPFS). The MPFS sets payment rates for more than 7,000 types of services in physician offices, hospitals, and other settings. the proposed rule includes a general 21.5 percent reduction to all physicians and elimination of consultation codes.

ACCC is analyzing the proposed changes and will report shortly to membership.

Medicare requires CMS to adjust the MPFS payment rates annually based on an update formula which includes application of the Sustainable Growth Rate or SGR that was adopted in the Balanced Budget Act of 1997. This formula has yielded negative updates every year beginning in 2002, although CMS was able to take administrative steps to avert a reduction in 2003, and Congress has taken a series of legislative actions to prevent reductions in 2004-2009. Based on current data, CMS is projecting a rate reduction of -21.5 percent for 2010.

As part of healthcare reform, the Administration supports comprehensive, but fiscally responsible, reforms to the physician payment formula. Consistent with this goal, the Administration announced in the 2010 President’s Budget that it would explore the breadth of options available under current authority to facilitate such reforms, including an assessment of whether the cost of physician-administered drugs should continue to be included in the payment formula. Thus, while working with Congress to develop a more appropriate mechanism for updating physician payment rates, CMS is proposing to remove physician-administered drugs from the definition of “physician services” for purposes of computing the physician update formula in anticipation of enactment of legislation to provide fundamental reforms to Medicare physician payments. While the proposal will not change the projected update for services during 2010, CMS projects that it would reduce the number of years in which physicians are projected to experience a negative update.

CMS is also proposing to stop making payment for consultation codes, which are typically billed by specialists and are paid at a higher rate than equivalent evaluation and management (E/M) services. Practitioners will use existing E/M service codes when providing these services instead. Resulting savings would be redistributed to increase payments for the existing E/M services.

Imaging. CMS is proposing to implement a requirement that suppliers of the technical component of advanced imaging services be accredited beginning January 1, 2012, by designating accrediting organizations (AOs) for these suppliers and utilizing the imaging quality standards that have been developed by the AOs. The accreditation requirement would apply to mobile units, physicians’ offices, and independent diagnostic testing facilities that create the images, but would not apply to the physician who interprets them. According to the GAO, spending on advanced imaging services, such as computed tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography (PET), is growing almost twice as fast as spending on other types of imaging services, and is a significant contributor to the rapid growth in health care spending in recent years, but there is little administrative oversight to ensure the quality of care.

E-Prescribing and PQRI. The proposed rule contains a number of provisions to promote improvement in quality of care and patient outcomes through revisions to the Electronic Prescribing Incentive Program (e-Prescribing Program) and the Physician Quality Reporting Initiative (PQRI). Eligible professionals or group practices that meet the requirements of each program in CY 2010 will be eligible for incentive payments for each program equal to 2.0 percent of their total estimated allowed charges for the reporting periods. CMS is proposing to simplify the reporting requirements for the electronic prescribing measure and to provide eligible professionals with more reporting options. CMS is also proposing a new process for group practices to be considered successful electronic prescribers.

In addition, CMS is proposing to add more measures and more measures groups for eligible professionals to report under the PQRI, to provide a mechanism for participants to submit quality measure data from a qualified electronic health record and to create a process for group practices to use for reporting the quality measures.

Posted 07/1/2009

Non-Small Cell Lung Cancer Trial Seeks Study Sites

Accelerated Community Oncology Research Network, Inc. (ACORN) is seeking study sites to accrue patients to a multi-center randomized phase 2b study of Cetuximab (Erbitux®) in combination with platinum-based chemotherapy as first-line treatment of patients with recurrent or advanced non-small cell lung cancer (NSCLC). The primary objective is to evaluate overall survival with three different regimens of chemotherapy and cetuximab. Key eligibility: Stage IIIb, IV or recurrent NSCLC; all histologies allowed; ECOG PS 0-1; no prior chemotherapy for advanced NSCLC. Patients will be treated with combination chemotherapy/study drug for up to 6 cycles and then continue with maintenance study drug every other week until progression or unacceptable toxicity (estimated to be approximately 5 months).

Contact Heidi Vosseler at 215.801.4017, or email: heidi.vosseler@actsolutions.org

Posted 06/17/2009

Support the Bill to Remove the Prompt Pay Discount from ASP

Senators Arlen Specter (D-PA) and Pat Roberts (R-KS) introduced a bill (S. 1221) June 11, 2009, in the Senate to address the Average Sales Price (ASP) issue with Part B drugs by removing prompt pay discounts extended to wholesalers from the ASP calculation. Including prompt pay discounts in the ASP calculation threatens community oncology practices by artificially lowering the reimbursement rate for chemotherapy treatments.

The Association of Community Cancer Centers (ACCC) strongly endorses S. 1221 and looks forward to working with Senators Specter and Roberts, the other Congressional champions of community cancer care and the broader community oncology and specialty distribution coalition, to move this important legislation forward in Congress.

This bill is a companion to H.R. 1392, introduced in the House of Representatives earlier this year, which ACCC also supports. H.R. 1392 was introduced by Reps. Gene Green (D-TX), Ed Whitfield (R-KY), Diana DeGette (D-CO), Mike Ross (D-AR), Edolphus Towns (D-NY), Mike Rogers (R-MI), Betty Sutton (D-OH), Bart Gordon (D-TN), Lee Terry (R-NE), and Ralph Hall (R-TX) and currently has 46 co-sponsors. That bill would also change the ASP methodology used by Medicare to set prices for Part B drugs and biologicals to better align drug reimbursement with actual cost.

Drug manufacturers are currently required to net out prompt pay discounts paid to wholesale distributors before reporting ASP figures to the Centers for Medicare and Medicaid Services (CMS), even though the wholesaler prompt pay discount is not passed along to physicians. Physician drug reimbursements are lowered by approximately two percent by this provision in the ASP calculation, which is the customary amount of the wholesale distributor prompt pay discount.

  Click here to send an email to your Congressman in support of S. 1221 and H.R. 1392.

Posted 06/15/2009

CMS Issues Clarification for Billing Part B versus Part D for the Anti-emetic Aprepitant (Emend)

The Centers for Medicare & Medicaid Services (CMS) has issued a clarification of policy distinguishing Part B versus Part D billing for the anti-emetic medication aprepitant (Emend®) for chemotherapy induced nausea-vomiting (CINV). Be sure your billing staff is aware of this information.

Medicare Part B covers Emend when used as part of the following regimen:

• IV Emend provided on day 1 would be covered under B. (Payment for Oral Emend on days 2 and 3 would not be made under Part B but should be billed under Part D.)
• Days 1-3 of the oral anti-emetic 3-drug combination of Emend, a 5-HT3 antagonist, and dexamethasone. This regimen acts as a full replacement for IV anti-emetic therapy for patients receiving one or more of the following anti-cancer chemotherapeutic agents: Carmustine, Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubicin, Epirubicin, Lomustine, Mechlorethamine, Streptozocin.

Coverage of Emend Under the Part D Program
The Part D program will generally cover Emend when it is not prescribed in accordance with the above Medicare Part B coverage guidelines. If Emend IV is given on Day 1, then oral Emend is given on days 2-3, the oral Emend must be billed to Part D. To assist in billing of Emend, CMS recommends physicians indicate on a prescription that the Emend is being used as part of a CINV chemotherapeutic drug regimen, what day of treatment the patient is on (e.g. Post chemo Day 2) and whether the IV or oral form of the drug was given on Day 1.

  Click here to learn more.

Posted 06/15/2009

ACCC Submits Comments About Comparative Effectiveness Research

The Association of Community Cancer Centers (ACCC) submitted comments on June 9, 2009, to the Federal Coordinating Council (Council) about its Draft Definition of Comparative Effectiveness Research (CER), Draft Prioritization Criteria, and Draft Strategic Framework. ACCC expressed agreement with the Threshold Minimal Criteria and also with the Prioritization Criteria in the draft document. ACCC also agreed with the basic framework and cross-cutting priorities, such as cancer, announced by Council, and appreciated the Council’s transparency and willingness to seek stakeholder input to this important process.

Still, ACCC expressed concerns that cost effectiveness may be included in future CER. “Although the Draft Definition does not refer to cost effectiveness, there still could be opportunities for cost effectiveness to be taken into account in CER.” ACCC requested that any guidance on CER include explicit language preventing cost from being considered.

In addition, ACCC was concerned that the Draft Definition’s reference to “decision-makers,” along with patients and providers, as the users of CER could be construed as support for the use of CER in payers’ coverage decisions. “This would be contrary to the American Reinvestment and Recovery Act’s (ARRA) express prohibition against the Council mandating coverage, reimbursement, or other policies for any public or private payer. The ARRA conference report also notes that Congress did not intend for CER funding to be used for such purposes.”

ACCC asked that the definition of CER include explicit language preventing coverage decisions from being based on CER. “The Council should clarify that ‘decision-makers’ refers to patients’ advocates, including a patient’s parents, guardians, and family members who may be involved in making health care decisions.”

ACCC was pleased that the Draft Definition appeared to recognize that all patients with the same disease may not benefit from the same treatment option, which is especially important in oncology, where the most effective treatment for one person, may not be the same for another person with the same diagnosis. To further clarify that CER “must assess a comprehensive array of health-related outcomes for diverse patient populations,” ACCC suggested that the word “subpopulations” be added to the end of this sentence.

ACCC also expressed concerns with some of the aspects of comparative effectiveness that were not included in the Draft Definition, Prioritization Criteria, or Strategic Framework. ACCC remains concerned that there is still some confusion as to where this research will take place. The Agency for Healthcare Research and Quality (AHRQ) already is conducting some CER, and the National Institutes of Health (NIH) is also in line to conduct research. ACCC asked the Council to clarify whether other agencies will be involved in CER. “We also ask for clarification about the application of the Draft Definition, Prioritization Criteria, and Strategic Framework. Will these terms and structures apply to research already underway, or will they apply only to new research?”

Posted 06/9/2009

Policy Change on Supervising Physicians Makes Hospitals Vulnerable, Groups Tell CMS; ACCC Agrees

In a June 1, 2009, letter to the Centers for Medicare & Medicaid Services (CMS), a number of hospital groups, including the American Hospital Association, encouraged the agency to withdraw the 2009 policy clarification that imposes physician supervision of outpatient therapeutic services.

"Our members remain very concerned about certain CMS statements from the 2009 OPPS rulemaking that have the potential to subject hospitals to substantially heightened and unwarranted enforcement scrutiny," the groups said in the letter. "As the agency considers next steps related to its policy, we strongly urge CMS to take immediate steps to mitigate the new and inappropriate enforcement risks that the troubling CMS statements have created."

As reported in the BNA Healthcare Daily, the hospital groups said that a policy clarification in the 2009 Outpatient Prospective Payment System (OPPS) final rule actually was a policy change that now requires physicians that supervise therapeutic outpatient services to be present physically, even if the services are rendered in an on-campus hospital department.

Furthermore, the groups said that CMS's clarification in the 2009 OPPS was different from the policy on supervising physicians articulated in the 2001 OPPS, which stated that physicians supervising outpatient therapeutic services in an on-campus hospital outpatient department were not required to be present physically. The hospital organizations said they understood the policy as of 2001 to require that supervising doctors be present physically only for services provided in off-campus departments.

The Association of Community Cancer Centers supports the statement. On February 25, 2009, Matt Farber, ACCC Manager, Provider Economics and Public Policy, met with CMS representatives to discuss the policy and express concerns.

  Click here to learn more.

Posted 06/8/2009

ACCC Launches Cancer Care Patient Navigation Website

The Association of Community Cancer Centers is pleased to announce the launch of its new Cancer Care Patient Navigation resource. You'll find:

• Model patient navigation efforts underway at ACCC member programs and articles from a supplement published in Oncology Issues
• Sample forms, including pre-assessment forms, intake summaries, referrals forms, patient satisfaction surveys, and outcomes measures
• An update to ACCC's "Cancer Program Guidelines" to include patient navigation services
• A full array of tools, including navigator job descriptions, tracking forms, and discharge tools.

The project is a joint effort by ACCC and the Meniscus Educational Institute in West Conshohocken, Pa. The project is made possible by an educational grant from sanofi-aventis U.S.

  Click here to learn more.

  Click here to register for ACCC's Cancer Care Patient Navigation: A Call to Action webinar. ACCC and the Meniscus Educational Institute have teamed up to present a free webinar about cancer care patient navigation. The live web presentation will take place on June 10, 2009, at 12:00 pm to 1:30 pm ET. Supported by an educational grant from sanofi-aventis U.S.

Can't attend? Come back later for the archived webinar on ACCC's Continuing Education Blackboard.

Posted 06/1/2009

FDA Grants Full Approval to Sprycel for CML

Bristol-Myers Squibb Company announced May 26, 2009, that the U.S. Food and Drug Administration (FDA) has granted full approval for Sprycel® (dasatinib) for the treatment of adults in all phases of chronic myeloid leukemia (CML) (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including Gleevec® (imatinib mesylate).

Sprycel, an oral tyrosine kinase inhibitor, was originally approved under the accelerated approval regulations of Subpart H for new drugs for serious or life-threatening illnesses of the Food, Drug and Cosmetic Act, based on its effectiveness on hematologic and cytogenetic response rates in CML. The full approval was based in part on results from a Phase 3 randomized, open-label dose optimization study that enrolled 670 chronic phase CML patients with resistance or intolerance to Gleevec. The primary endpoint of this study was major cytogenetic response (MCyR) (0-35 percent Ph+metaphases, which combines both complete and partial responses), in Gleevec-resistant patients. The data included a minimum of two years of follow up after the start of treatment with SPRYCEL 100 mg once daily, which is the recommended starting dose of SPRYCEL for chronic phase CML patients resistant or intolerant to Gleevec. A summary of results from the 167 patients who received Sprycel 100 mg once daily include:

• 80 percent progression-free survival (95% CI: 73%-87%) estimated rate at two years, based on Kaplan-Meier estimates
• 91 percent overall survival (95% CI: 86%-96%) estimated rate at two years, based on Kaplan-Meier estimates
• 63 percent of patients achieved MCyR (95% CI: 56%-71%; median duration of treatment was 22 months)
• 93 percent of patients who achieved MCyR maintained that response for 18 months (95% CI: 88%-98%), based on Kaplan-Meier estimates.

Posted 05/26/2009

ACCC's 2009 Cancer Program Administrator Survey, Salaries and Programmatic Challenges

In February and March 2009, ACCC sent email surveys to cancer program administrators employed at ACCC-Member Cancer Programs. Slightly more than 19 percent (130 programs) responded to ACCC’s survey. Survey results are now available to ACCC members.

  Click here to read survey results.

In this year of widespread economic distress, cancer program administrators, too, face a challenge: keeping their cancer service lines financially viable while still offering the best care to their patients. Sixty-four percent of respondents indicate that the economy is affecting their ability to access the capital needed to acquire new technologies or expand services. Of those respondents, 62 percent said upgrades to current radiation therapy equipment have been put on hold, including replacing outdated linear accelerators and HDRs or upgrading to IGRT, for example. Eight percent note that physical expansion plans have been put on hold.

All is not bad news, however. Although a majority of respondents report the economy is affecting their ability to access the capital needed to acquire new technologies or expand services, more than one in five (23 percent) report they are making upgrades to radiation oncology equipment and equipment for diagnostic imaging. A few report moving forward on building expansion.

The majority of the cancer program administrators remain happy in their positions. In fact, almost half report they are “very satisfied.” Just 3 percent express dissatisfaction, a sharp decline from 16 percent expressing dissatisfaction in 2006.

Posted 05/4/2009