Oncology Newsfeed

CMS Posts 2012 PQRS Educational Products

The Centers for Medicare & Medicaid Services (CMS) announced the posting of 2012 Physician Quality Reporting System educational products on the CMS website:

• 2012 Physician Quality Reporting System Measures List. This document identifies and explains the measures used in Physician Quality Reporting, including information on the reporting options/methods, measure developers and their contact. Note that this document was updated and re-posted on 1/05/2012.
• 2012 Physician Quality Reporting System Quality-Data Code (QDC) Categories – a table that outlines, for each measure, each QDC that should be reported for a corresponding quality action performed by the individual eligible professional as noted in the measures specification. This determines how each code will be used when calculating performance rates. This also clarifies those measures that require two or more QDCs to report satisfactorily. Insufficiently reporting the QDCs (as specified in the 2012 Physician Quality Reporting System Measure Specifications Manual) will result in invalid reporting.
• 2012 Physician Quality Reporting System Single Source Code Master. This file includes a numerical listing of all codes included in 2012 Physician Quality Reporting for incorporation into billing software.
• 2012 Physician Quality Reporting System Measure Specifications Manual for Claims and Registry Reporting of Individual Measures – the 2012 measure specifications include codes and reporting instructions for the 210 Physician Quality Reporting System measures for claims and/or registry-based reporting. Note that this document was revised and re-posted on 1/05/2012.
• 2012 Physician Quality Reporting System Measure Specification Release Notes – outlines changes from the 2011 Physician Quality Reporting System Measure Specifications Manual in the form of Release Notes. Note that this document was revised and re-posted on 1/05/2012.
• 2012 Physician Quality Reporting System Implementation Guide – provides guidance about how to select measures for reporting, how to read and understand a measure, and outlines the reporting options available for 2012 Physician Quality Reporting System. The Implementation Guide also details how to implement claims-based reporting of measures to facilitate satisfactory reporting of quality-data codes by eligible professionals.
• 2012 Physician Quality Reporting System Measures Groups Specifications Manual – measures group specifications are different from those of the individual measures that form the group. Therefore, the specifications and instructions for measures group reporting are provided in a separate manual. The 2012 measures groups specifications include codes and reporting instructions for the 22 Physician quality Reporting System measures groups for claims or registry-based reporting.
• 2012 Physician Quality Reporting Measures Groups Release Notes. This document outlines changes from the 2011 Physician Quality Reporting System Measures Groups Specifications Manual in the form of release notes.
• Getting Started with 2012 Physician Quality Reporting System of Measures Groups – provides guidance on implementing the 2012 Physician Quality Reporting System measures groups.
• 2012 Physician Quality Reporting Measures Groups Single Source Code Master. This file includes a numerical listing of all codes included in 2012 Physician Quality Reporting System Measures Groups for incorporation into billing software.
• 2012 Physician Quality Reporting System Measure-Applicability Validation Process for Claims-Based Reporting of Individual Measures – provides guidance for those eligible professionals who satisfactorily submit quality-data codes for fewer than three Physician Quality Reporting measures, and how the measure-applicability validation process will determine whether they should have submitted QDCs for additional measures.
• 2012 Physician Quality Reporting Measure-Applicability Validation Process Release Notes – the release notes for the changes occurring for the 2015 Physician Quality Reporting Measure-Applicability Validation Process (MAV).
• 2012 Physician Quality Reporting System Measure-Applicability Validation Process Flow – a chart that depicts the Measure-Applicability Validation Process (MAV).
• Group Practice Reporting Option (GPRO) Requirements for Submission of 2012 Physician Quality Reporting System Data – provides guidance on how a group practice of over 25 eligible professionals can self-nominate to participate in GPRO for 2012 data submission.
• 2012 Physician Quality Reporting System Group Practice Reporting Option (GPRO) Measures List – a document containing a list of the 2012 Physician Quality Reporting GPRO Measures.
• 2012 Physician Quality Reporting GPRO Narrative Measure Specifications and Release Notes. This document contains descriptions of the 2012 Physician Quality Reporting GPRO measures and changes in the program since the 2011 reporting year.
• 2012 EHR Direct Vendor Qualification Requirements – provides guidance on how EHR Direct Vendors can self-nominate and qualify to submit Physician Quality Reporting System measures data for 2012.
• 2012 EHR Data Submission Vendor Qualification Requirements – provides guidance on how EHR Data Submission Vendors can self-nominate and qualify to submit Physician Quality Reporting System measures data for 2012.
• 2012 EHR Documents for Eligible Professionals. This zipped file contains the following: 1) 2012 Physician Quality Reporting System EHR Measure Specifications – the detailed description of data element names and codes related to each of 51 2012 Physician Quality Reporting System quality measures available for electronic submission; 2) 2012 Physician Quality Reporting System Physician Quality Reporting System EHR Measure Specifications; 2012 EHR Downloadable Resource Table; and 2012 EHR Downloadable Resource Table - Release Notes.

Posted 1/10/2012

National Provider Call on Physician Quality Reporting System & Electronic Prescribing Incentive Program

On Tuesday, January 17, 1:30 pm - 3:00 pm EST, the Centers for Medicare & Medicaid Services (CMS) will host a national provider call on the Physician Quality Reporting System & Electronic Prescribing Incentive Program. Experts will provide an overview on how the 2012 electronic prescribing (eRx) payment adjustment will appear on remittance advice, as well as, an overview of the self-nomination process. A question and answer session will follow the presentation. This call is designed for Medicare fee-for-service (FFS) providers, medical coders, physician office staff, and provider billing staff.

Click here to register.

Posted 12/30/2011

Technical Component of Advanced Diagnostic Imaging Accreditation Requirements Effective Sunday, January 1, 2012

Suppliers of the technical component of Advanced Diagnostic Imaging that are billing with a service date on or after Sunday, January 1, 2012, must evidence an active accreditation date for diagnostic imaging of CPT codes attached to an MRI, CT, and Nuclear Medicine claim. The professional component claims are not affected by the accreditation requirements and must be processed as usual. Refer to Transmittal #380, or MLN Matters 7177, for further information on claims processing.

Posted 12/30/2011

2012 Medicare Physician Fee Schedule: End of Year Update

The negative update under current law for the 2012 Medicare Physician Fee Schedule is scheduled to take effect on January 1, 2012. Consequently, as on numerous occasions in the past, the Centers for Medicare & Medicaid Services (CMS) will instruct its Medicare claims administration contractors to hold claims containing 2012 services paid under the Medicare Physician Fee Schedule for the first 10 business days of January (i.e., January 1, 2012, through January 17, 2012). The hold should have minimal impact on provider cash flow because, under current law, clean electronic claims are not paid sooner than 14 calendar days (29 days for paper claims) after the date of receipt.

Medicare Physician Fee Schedule claims for services rendered on or before December 31, 2011, are unaffected by the 2012 claims hold and will be processed and paid under normal procedures and time frames.

ACCC will keep members apprised of any changes.

Posted 12/19/2011

New J-Codes/C-Code in 2012

The Centers for Medicare and Medicaid Services (CMS) has established a product-specific Healthcare Common Procedures Coding System (HCPCS) J–code, or permanent code, for a number of oncology drugs, effective for dates of service on or after January 1, 2012.

• J0897 injection, denosumab, 1 mg
• J9043 injection, cabazitaxel, 1 mg
• J9179 injection, eribulin mesylate, 0.1 mg

A new C-code has been assigned to brentuximab vedotin, injection, 1 mg, C9287.

A complete list of drugs and biologicals can be found within ACCC's analysis (page 2) of selected provisions of the Hospital Outpatient Prospective Payment System Final Rule for 2012.

Posted 12/19/2011

Surveys Reveal Wide Gaps in Knowledge of Genetic Mutation Testing Exist Between Oncologists, Nurses, and Cancer Patients

Three new surveys reveal a disconnect in understanding of and communication about genetic mutation testing among healthcare professionals and cancer patients. Results of the surveys were announced by Boehringer Ingelheim Pharmaceuticals, Inc., who sponsored the surveys in partnership with the Association of Community Cancer Centers (ACCC), ONS:Edge, and the National Lung Cancer Partnership (NLCP).

Surveys of 95 community oncologists, 522 oncology nurses, and 436 lung cancer patients across the U.S. were collected in October 2011 to measure perceptions and knowledge of genetic mutation testing and to identify unmet needs and gaps in education. The surveys found that while 94 percent of physicians responded that they discuss genetic mutation testing with their patients, only 17 percent of lung cancer patients surveyed were aware of genetic mutation testing. Nearly half of oncology nurses (44 percent) did not discuss genetic mutation testing with patients, primarily because they felt that they lacked the knowledge to discuss it (56 percent) or didn't have the proper resources to share with their patients (33 percent). These findings highlight the need for a greater understanding of genetic mutation testing.

Posted 12/5/2011

HHS Changes ‘Meaningful Use’ Timeline for Providers Attesting in 2011

Providers and hospitals that attest to Stage 1 of the "meaningful use" incentive program in 2011 will not have to meet Stage 2 criteria until 2014, allowing extra time for early adopters of electronic health records, Department of Health and Human Services Secretary Kathleen Sebelius announced Nov. 30. By allowing more time for early adopters to reach Stage 2 of meaningful use, HHS hopes to make it easier to adopt health IT, and to encourage faster adoption, the agency said in a press release.

Under the current requirements, eligible doctors and hospitals that participate in the Medicare electronic health record incentive programs in 2011 would have to meet new criteria for the program in 2013. However, if they did not participate in the program until 2012, they could wait to meet these new criteria until 2014 and still be eligible for the same incentive payments.

Eligible hospitals and providers must meet meaningful use criteria using certified electronic health record systems to receive incentive payments from the Centers for Medicare & Medicaid Services under the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act (ARRA).

Posted 12/1/2011

Medicare Shared Savings Program Application Webpage Updated with Notice of Intent to Apply and Complete Application Package

The Medicare Shared Savings Program Application webpage is now updated with the Notice of Intent to Apply (NOI) and the complete Shared Savings Program application package. You will find links to the NOI and application in the Downloads section of the webpage. The complete application includes the following documents:

• Medicare Shared Savings Program Application 2012
• Appendix A-Electronic Funds Transfer (EFT) Authorization Agreement (CMS Form 588)
• Appendix B-Participant List
• Appendix C-Data Use Agreement (DUA)
• Appendix D-Application Reference Guide.

Submitting the NOI is the first step in the application process. The second step is submitting the application and the accompanying required documents.

Posted 11/28/2011

FDA Approves Updates to Prescribing Information for Velcade

Millennium: The Takeda Oncology Company announced that the U.S. Food and Drug Administration (FDA) has approved updates to the Velcade prescribing information that include additional long-term (median follow-up 60.1 months) overall survival data from the VISTA trial. The landmark VISTA trial examined the use of Velcade with melphalan+prednisone (MP) vs MP in patients with previously untreated multiple myeloma. Velcade is the first and only FDA-approved agent to deliver an overall survival advantage in combination with MP in patients with previously untreated MM. The 5-year follow-up data demonstrated that patients treated with Velcade+MP continued to have a significantly longer overall survival (median 56.4 months vs 43.1 months, P<0.05) than those treated with MP alone, a recognized standard of care. These results translated into a 43.9% improvement in overall survival when patients received the Velcade-containing regimen.

The prescribing information is also being updated to provide the information that the concomitant use of strong CYP3A4 inducers with Velcade is not recommended.

Posted 11/21/2011

Erbitux Now Approved for Five Indications Across Two Tumor Types

The U.S. Food and Drug Administration (FDA) has approved Erbitux® (cetuximab), in combination with platinum-based chemotherapy with 5-fluorouracil (CT), for the first-line treatment of recurrent locoregional or metastatic squamous cell carcinoma of the head and neck (SCCHN). The approval, which is based on data from the landmark EXTREME (ErbituX in first-line Treatment of REcurrent or MEtastatic head & neck cancer) trial, makes Erbitux plus CT the first treatment regimen approved in 30 years with extended overall survival in patients with recurrent locoregional or metastatic SCCHN. This is the fifth indication approved for Erbitux and the third indication demonstrating overall survival. Erbitux was previously approved for the initial treatment of locally or regionally advanced SCCHN in combination with radiation therapy. Erbitux, as a single agent, is indicated for the treatment of EGFR-expressing metastatic colorectal cancer after failure of both irinotecan- and oxaliplatin-based regimens, and, as a single agent, is also indicated for the treatment of EGFR-expressing metastatic colorectal cancer in patients who are intolerant to irinotecan-based regimens.

Read more.

Posted 11/9/2011

CMS Releases Final Changes to the Hospital Outpatient Prospective Payment System and 2012 Payment Rates

On Nov. 1, 2011, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that will update payment policies and payment rates for services furnished to Medicare beneficiaries in hospital outpatient departments and ambulatory surgical centers (ASCs) beginning Jan. 1, 2012. In addition to establishing payment rates for calendar year 2012, the final rule expands the measures to be reported under the Hospital Outpatient Quality Reporting Program, creates a new quality reporting program for ASCs, and strengthens the Hospital Value-based Purchasing (Hospital VBP) program that will affect payments to hospitals for inpatient stays beginning Oct. 1, 2012.

The final rule will:

• Pay for the acquisition and pharmacy overhead costs of separately payable drugs and biologicals, other than new drugs and biologicals that have pass-through status, at the average sales price (ASP) plus 4 percent.
• Increase the number of measures for reporting in 2012 and 2013 for purposes of the 2014 and 2015 payment determinations.

In the Association of Community Cancer Centers' August 29 comments to CMS, ACCC recommended that CMS reimburse hospitals for the acquisition cost of separately payable drugs at no less than ASP plus 6 percent. "Adequate OPPS payment rates for cancer drugs and the services required to prepare and administer them are critical to ensuring patient access to care," we noted in the comment letter.

ACCC will analyze the final rule and report to membership shortly.

In response to concerns that Medicare’s requirement for direct physician supervision of outpatient hospital therapeutic services could hinder access for beneficiaries specifically in rural areas, the final rule establishes an independent advisory review process to consider requests that specific outpatient services be subject to a level of supervision other than direct supervision. Under this process, CMS will seek recommendations from Ambulatory Payment Classification (APC) Advisory Panel about appropriate supervision requirements. This panel was created to provide technical advice and recommendations to CMS about assigning items and services furnished in hospital outpatient departments to appropriate payment classifications. CMS will add two small rural PPS hospital members and two CAH members to represent their interests to the Panel so that all hospitals subject to the supervision rules for payment of outpatient therapeutic services will be represented. Since CAHs are not paid under the OPPS, CAH representatives would not participate in deliberations about APC assignments.

The final rule will increase payment rates under the OPPS by 1.9 percent in CY 2012. This increase is based on the projected hospital inpatient market basket percentage increase of 3.0 percent for inpatient services paid under the Hospital Inpatient Prospective Payment System (IPPS) minus the multifactor productivity adjustment of 1.0 percentage points and minus a 0.1 percentage point adjustment, both of which are required by the Affordable Care Act.

Download CMS Final Hospital Outpatient Prospective Payment System Rule.

Posted 11/2/2011

CMS Announces Policy, Payment Rate Changes for the Physician Fee Schedule in 2012

On Nov. 1, 2011, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that updates payment policies and rates under the Medicare Physician Fee Schedule (MPFS) in 2012. The final rule makes changes to several of the incentive programs that are associated with MPFS payments – electronic health records (EHRs), and the Physician Quality Reporting System (PQRS).

With regard to the Sustainable Growth Rate (SGR), CMS Administrator Donald M. Berwick, M.D., noted: “We need a permanent SGR fix to solve this problem once and for all. That’s why the President’s Budget and his Plan for Economic Growth and Deficit Reduction call for permanent, fiscally responsible reform and why we are committed to working with the Congress to achieve a permanent and sustainable fix.” Under current law, providers will face steep across-the-board reductions in payment rates, based on the SGR formula.

In the 2012 final rule, CMS is expanding the potentially misvalued code initiative, an effort to ensure Medicare is paying accurately for physician services and more closely managing the payment system.

CMS is also making changes in how it adjusts payment for geographic variation in the cost of practice. The Affordable Care Act and the Medicare and Medicaid Extensions Act made some temporary adjustments that were in place for two years while CMS and the Institute of Medicine (IOM) began to comprehensively study these issues. As part of this initiative, CMS is replacing some of the data sources—such as using data from the American Community Survey (ACS) in place of the Department of Housing and Urban Development (HUD) rental data and also using ACS data in place of the data currently used for non-physician employee compensation. Consistent with IOM’s recommendation, CMS is also adjusting its payments for the full range of occupations employed in physicians’ office as well as making other adjustments called for in prior year public comments. Although these improvements result in very little change to the indices, they show that the data Medicare has used in the past and will be using in the future produce consistent results—suggesting past year adjustments have accurately reflected geographic variations in the cost of practice.

ACCC will analyze the final rule and report to membership shortly.

Download the 2012 Medicare Physician Fee Schedule (MPFS).

Posted 11/2/2011

Send a Message to Congress: Fight Cancer, Not Cancer Care

The debt "Super Committee" will consider cuts to Medicare, possibly including the reduction of drug reimbursement to ASP + 3%. If the Super Committee cannot find at least $1.2 trillion in cuts, or Congress does not act on the committee's recommendations, there will be an across-the-board 2 percent cut to all Medicare payments -- including oncology drugs and services.

Send a message to your representatives today at ACCC's Legislative Action Center. Tell them the proposed cuts to Medicare are unacceptable. ACCC will keep members informed of our progress and will notify you of any updates.

Posted 11/2/2011

President Obama Addresses Drug Shortage Issue

President Obama will issue an executive order on October 31 that the administration hopes will help resolve a growing number of critical shortages of vital medicines used to treat life-threatening illnesses, among them cancer.

The order offers drug manufacturers and wholesalers both a helping hand and a gloved fist in efforts to prevent or resolve shortages that have worsened greatly in recent years, endangering thousands of lives. It instructs the U.S. Food and Drug Administration to do three things: 1) broaden reporting of potential shortages of certain prescription drugs; 2) speed reviews of applications to begin or alter production of these drugs; and 3) provide more information to the Justice Department about possible instances of collusion or price gouging. Such efforts are included in proposed legislation that has been pending in Congress since February despite bipartisan support for its provisions.

ACCC has been advocating on Capitol Hill to help remedy the oncology drug shortage crisis. Read ACCC's blog.

Posted 10/31/2011

Exceptional ACCC Conference Brightens Rainy Days in Seattle

Nearly 600 cancer care professionals gathered October 19-22, 2011, in Seattle at the Association of Community Cancer Centers' 28th National Oncology Conference to learn practical ideas to help make their programs more competitive, efficient, effective, and financially viable. Sessions on virtual communications, survivorship care, and leveraging information technology, for example, were designed to help attendees improve the quality and performance of their programs. Read highlights.

Posted 10/24/2011

New ACCC Meeting to Focus on Strategies for Integrating Cancer Guidelines and Pathways into Daily Practice

The Association of Community Cancer Centers (ACCC) will host a first-ever seminar December 8, 2011, at the Fox Chase Cancer Center in Philadelphia, Pa., for physicians, pharmacists, and cancer program executives. Entitled "Navigating the Changing Landscape of Payment Models in Community Oncology," the one-day seminar will explore new cancer management systems that integrate guidelines and pathways into each oncologist's workflow. Registration is complimentary for ACCC members!

Register Today. Find out if a cancer management system makes sense in your practice setting. Explore options in the selection of a cancer management system and how to achieve buy-in from key stakeholders. And hear directly from the nation's leaders in pathway and cancer management system development about their innovations aimed at improving quality care at lower costs.

Posted 10/17/2011

Make a Note: Two Important CMS Updates

The Centers for Medicare & Medicaid Services (CMS) wants to remind you of the key registration dates for the Electronic Health Record (EHR) Incentive Programs: Wednesday, Nov. 30, 2011, is the last day for eligible hospitals to register and attest to receive an incentive payment for FY 2011. Wednesday, Feb. 29, 2012, is the last day for eligible professionals to register and attest to receive an incentive payment for CY 2011.

The third and final Accountable Care Organization (ACO) Accelerated Development Learning Session (ADLS) will be held in Baltimore, Md., on Thursday, Nov. 17, 2011, and Friday, Nov. 18, 2011. Registration is free and open for teams of between two and four senior leaders from healthcare delivery organizations interested in forming an ACO or from an existing ACO. The ADLS is designed to help existing or emerging ACOs understand the steps they can take to improve care delivery and how to develop an action plan for moving toward providing better coordinated care.

Posted 10/17/2011

Palmetto Establishes Coverage Policy for Oncotype DX Assay

Palmetto GBA, the designated national contractor for its Oncotype DX colon cancer test, has established a formal coverage policy for all Medicare patients. The Oncotype DX colon cancer test has been clinically validated to predict risk of recurrence in patients with stage II colon cancer. The policy covers men and women with stage II colon cancer. Palmetto's decision is based on the two large QUASAR and CALGB clinical validation studies in addition to clinical utility information. Coverage for the Oncotype DX colon cancer test is posted on the Palmetto GBA website. The coverage is effective for claims for services performed on or after September 18, 2011.

Posted 10/10/2011

CMS Posts October 2011 ASP Pricing

The Centers for Medicare and Medicaid Services (CMS) has posted the October 2011 ASP and NOC pricing files and crosswalks. The ASP pricing files and crosswalks for July 2011, April 2011, January 2011, and October 2010 have also been updated. All are available for download on the CMS website (see left menu for year-specific links).

Posted 9/19/2011

Advanced Diagnostic Imaging Accreditation – Time is Running Out

As a reminder, beginning Sunday, Jan. 1, 2012, suppliers who furnish the technical component of Advanced Diagnostic Imaging (ADI) must be accredited in order to bill Medicare for these services. ADI procedures include MRI, CT, nuclear medicine imaging, and positron emission tomography; x-ray, ultrasound, fluoroscopy, and Hospital Outpatient procedures are excluded. The technical component of ADI services includes the performance of the imaging procedures, not the physician interpretation.

For dates of service on or after Jan. 1, 2011, Medicare Administrative Contractors (MACs) will begin denying claims for the technical component of ADI that are submitted under the Physician Fee Schedule by suppliers who have not yet been accredited. Once a provider becomes accredited, they can begin billing Medicare for these services again.

For more information about ADI Accreditation, including a list of accrediting organizations and details of the accreditation process, click here.

Posted 9/19/2011

New Commission on Cancer Accreditation Standards Released, Focus on Patient-Centered Approach

On August 31 the Commission on Cancer (CoC) of the American College of Surgeons (ACS) released new standards that include three key areas of patient-centered treatment:

• A patient navigation process to address health care disparities and barriers to care
• Screening patients for psychosocial distress
• A survivorship care plan that documents care received and seeks to improve cancer survivors’ quality of life.

Additionally, new patient-centered standards have been developed that require accredited programs to offer patients palliative care (either on site or by referral) and genetic services (either on site or by referral by a qualified genetics professional).

The Association of Community Cancer Centers (ACCC) will examine the new standards and their implementation challenges at its 28th National Oncology Conference in October 2011 (Friday, October 21 at 8:00 am – 9:15 am) in Seattle, Wash.

According to a CoC press release, the new standards require a coordination of care among many medical disciplines including physicians ranging from primary care providers to specialists in all oncology disciplines. Clinical and allied-health professionals including nursing, social work, genetics, nutrition, rehabilitation, and others also help to ensure that patient needs are addressed. This complex system of care can be a challenge for many cancer patients and their families, prompting the CoC to work with the American Cancer Society to develop a patient navigation standard. Specifically, the CoC will require that its accredited cancer programs perform an assessment of their community and develop programs to address barriers to access and cancer care.

The CoC recognizes that the revised standards require "concerted effort."

"Certainly there is some cost associated with this effort. . . the majority of the cost will be in the commitment of the providers and staff in developing the systems by which they will implement these key processes of care."

The CoC revises its standards every five to seven years.

Posted 9/6/2011

CMS Releases Information on Accessing 2010 PQRI and eRx Incentive Program Feedback Reports

On Sept. 1, the Centers for Medicare & Medicaid Services (CMS) provided information on accessing 2010 feedback reports for eligible professionals who participated in the 2010 Physician Quality Reporting Initiative (PQRI) and/or the 2010 Electronic Prescribing (eRx) Incentive Program. (The PQRI program name changed to the Physician Quality Reporting System, or PQRS.)

Feedback reports for the 2010 eRx Incentive Program are now available. Feedback reports for the 2010 PQRI will be available in late September or early October 2011.

Read the full post, including information on “Creating an IACS Account”, “Information on Updating IACS User Accounts and Passwords,” and CMS resources related to IACS Accounts here.

Posted 9/2/2011

ACCC Submits Comments to CMS on 2012 OPPS Proposed Rule

On Aug. 29, 2011, the Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding the proposed 2012 hospital outpatient prospective payment system (OPPS) rule. ACCC urged CMS to pay at least ASP plus 6 percent for the acquisition cost of separately payable drugs and to make an appropriate adjustment for pharmacy overhead. In addition, ACCC urged the agency to implement the adjustment to payments to PPS-exempt cancer hospitals in a truly budget neutral manner that will reduce the payment reduction to other hospitals as much as possible.

In its comments, ACCC stated that, "It is imperative to continued patient access in this crucial setting that the OPPS rates in 2012 and beyond adequately reimburse hospitals for the costs of providing advanced cancer therapies."

Toward this end, ACCC recommended that CMS:

• Reallocate a larger portion of pharmacy overhead costs from packaged drugs to separately payable drugs
• Remove data for drugs purchased under the 340B program from the calculation of drug payment rates while continuing to reimburse all hospitals at the same rate
• 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
• Not implement an “equitable adjustment” to cap payment for any outpatient procedures at the rates calculated under the inpatient prospective payment system (IPPS)
• Implement the proposed payment rates for low dose rate prostate brachytherapy
• Continue to apply the current policy for establishing payment for new brachytherapy Sources
• Reinstate separate payment for radiation oncology guidance services and monitor access to these services
• Implement the proposed new Ambulatory Payment Classification (APC) assignments for combined Computed Tomography (CT) of the abdomen and pelvis
• Implement the proposal to allow the Advisory Panel on APC Groups (APC Panel) to make suggestions to CMS on the correct level of supervision for selected procedures
• Implement the adjustment to payments for cancer hospitals exempt from the OPPS in a truly budget neutral manner.

Read more.

Posted 8/30/2011

ACCC Submits Comments to CMS on 2012 Physician Fee Schedule Proposed Rule

On Aug. 26, 2011, the Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding the proposed changes to payment policies under the Medicare physician fee schedule (PFS). In its comments, ACCC recommended that CMS:

• Work with Congress to develop a fix to the Sustainable Growth Rate (SGR) formula and avert a 29.5 percent reduction to the conversation factor
• Halt the cuts to chemotherapy administration services
• Exercise caution as it evaluates potentially misvalued services and ensure that the review of drug administration codes includes the substantial time and practice expenses searching for and making accommodations for drugs in short supply and for complying with rapidly increasing Risk Evaluation and Mitigation Strategy (REMS) requirements
• Not expand the Multiple Procedure Payment Reduction (MPPR) policy to the professional component of advanced imaging services
• Implement the provisions related to the Physician Quality Reporting System (PQRS), the Electronic Prescribing (eRx) Incentive Program, and the Electronic Health Records (EHR) Incentive Program
• Work with ACCC and other specialty societies on the implementation of the Value-Based Payment Modifier
• Consult the ACCC report on patient transitions from hospital to community setting in order to improve hospital discharge care coordination
• Implement reimbursement for patient education about cancer therapy by physicians and nurses.

ACCC believes that CMS should provide reimbursement for the time and resources physicians and nurses spend educating patients and their caregivers about the symptoms and side effects associated with cancer treatment, including surgery, chemotherapy (both oral and injectable therapies), and radiation therapy. Currently, there is no dedicated payment for a period of treatment education for people with cancer and their caregivers, prior to the onset of treatment. Medicare’s payment for infused chemotherapy includes the costs of only 48 minutes, amortized over an average of six cycles, of patient education during the infusion, and recognizes some costs for post procedure education. However, the time and payment allocated for this education does not cover its cost and is not sufficient to cover the requisite initial and ongoing teaching. In addition, the cost of education is factored into payment for administration of infusion therapies but not into payment for surgery, radiation therapy, or oral chemotherapy.

By providing distinct reimbursement under the PFS for a one-hour cancer patient treatment education session delivered by a physician or a registered nurse under the supervision of a physician, CMS can help address this disparity in access to care and ensure that all patients, irrespective of treatment modality or treatment setting, have access to the information they need to minimize adverse events and maximize their quality of life and outcomes.

ACCC urged CMS to reimburse physicians and nurses for these important patient education services accordingly.

Read more.

Posted 8/29/2011

FDA Approves Pfizer’s Xalkori (crizotinib) for Patients with Locally Advanced Or Metastatic ALK-Positive Non-Small Cell Lung Cancer

Pfizer, Inc,. announced that the U.S. Food and Drug Administration (FDA) has approved Xalkori (crizotinib) capsules, the first-ever therapy targeting anaplastic lymphoma kinase (ALK), for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ALK-positive as detected by an FDA-approved test. The effectiveness of Xalkori is based on objective response rates (ORR) and, as Xalkori received accelerated approval from the FDA, Pfizer is conducting post-marketing clinical trials to further evaluate its clinical benefit.

Aligned with the FDA’s latest guidance on targeted therapies and companion diagnostics, Pfizer worked closely with the FDA and partnered with Abbott Molecular’s business in Pfizer’s clinical studies to ensure the simultaneous review and approval of Xalkori along with a diagnostic test, Abbott Molecular's Vysis ALK Break Apart FISH Probe Kit, to identify presence of the ALK fusion gene.

Xalkori is available immediately through a number of specialty pharmacies.

Read more.

Posted 8/29/2011

FDA Approves Vemurafenib for Treatment of Metastatic Melanoma

The U.S. Food and Drug Administration (FDA) approved vemurafenib (Zelboraf) for the treatment of metastatic or unresectable melanoma. The new drug, also known as PLX4032, specifically targets patients whose tumors express the BRAF V600E gene mutation. Coinciding with the approval of vemurafenib is a companion diagnostic test, named the cobas 4800 BRAF V600 Mutation Test, which will determine if a patient's cells have the gene mutation.

Read more.

Posted 8/23/2011

Seattle Genetics Announces FDA Accelerated Approval of Adcetris (Brentuximab Vedotin) for Two Indications

Seattle Genetics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Adcetris (brentuximab vedotin) for two indications: 1) the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and 2) the treatment of patients with systemic anaplastic large cell lymphoma (ALCL) after failure of at least one prior multi-agent chemotherapy regimen. The indications for Adcetris are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with Adcetris.

Adcetris is the first drug approved by the FDA for Hodgkin lymphoma in more than 30 years, and provides a new therapeutic alternative for Hodgkin lymphoma and systemic ALCL in these settings. Adcetris is an antibody drug conjugate (ADC) directed to CD30.

Read more.

Posted 8/23/2011

FDA Clears Leukemia Genetic Test

Abbott Laboratories announced that the U.S. Food and Drug Administration (FDA) cleared a genetic test that can help determine the prognosis of patients with chronic lymphocytic leukemia. Abbott's Vysis CLL FISH Probe Kit detects genetic abnormalities in lymphocytes. CLL is the most common type of leukemia in the U.S., around 15,000 cases diagnosed per year.

Read more.

Posted 8/23/2011

Update Regarding the Availability of Doxil (doxorubicin HCl liposome injection)

Janssen Products, LP, has cautioned physicians not to begin treatment with Doxil (Doxorubicin Hcl liposome injection) because of shortages of the drug. Earlier this week, Janssen unit sent a letter to physicians informing them that a contract manufacturer is experiencing production delays.

"While exact timeframes are not yet confirmed, based on the latest estimates, initial replenishment supplies of Doxil should begin shipping in late August 2011. Supplies may be intermittently available in the weeks thereafter. Until then, Janssen advises that no new patients begin treatment with Doxil."

The letter notes that legislation introduced in Congress would require manufacturers to notify the Food and Drug Administration of problems that could result in drug shortages.

Read more.

Read about the Doxil C.A.R.E.S. Physician Access Program.

Posted 7/21/2011

Association of Community Cancer Centers Urges the President and Congress to Oppose $3 Billion Cut to Medicare Reimbursement

On July 14, 2011, the Association of Community Cancer Centers (ACCC) joined with nine other groups in the oncology community to urge lawmakers to oppose a $3 billion funding cut to Medicare reimbursement for cancer drugs and biologics. The measure is proposed as part of the ongoing deficit-reduction and debt-ceiling discussions taking place between Congress and the White House.

"The proposed cuts would be devastating to the nation’s hospital-based cancer programs"” said ACCC President Thomas Whittaker, MD, FACP. "The reduction would further strain community cancer care and threaten patient access to state-of-the-art services."

In a letter sent to Congressional leadership and the White House on July 14, ACCC joined others in the oncology community to ask that any cuts to Medicare reimbursement for cancer care be removed from the ongoing negotiations. The proposal would lower reimbursement for Part B drugs to Average Sales Price (ASP) plus 4 percent from the current ASP plus 6 percent.

As stated in the letter:

The cumulative effect of these cuts is compounded by the fact that chemotherapy agents are reimbursed at artificially low rates under Medicare because manufacturer-to-distributor prompt-pay discounts are included in the calculation of Average Sales Price (ASP). In recognition of the dire financial reality currently facing community oncology practices and the access impact to Medicare beneficiaries fighting cancer, more than 80 bipartisan Congressional leaders have co-sponsored HR 905 (Whitfield/Green) and S 733 (Stabenow/Roberts) to improve the viability of community cancer care. The cuts currently under consideration take the exact opposite direction from the changes these leaders recognize must be made to preserve the nation's cancer care delivery system.

ACCC supports legislation to remove the prompt-pay discount from Medicare reimbursement calculations and supports two bills currently in Congress: HR 905 and S 733. These bills are bi-partisan and were introduced by Representatives Green (D-TX) and Whitfield (R-KY) in the House and Senators Stabenow (D-MI) and Roberts (R-KS) in the Senate. The bills would remove the prompt-pay discount from the ASP calculation, thus giving physicians a more accurate reimbursement for drugs, closer to the ASP plus 6 percent they should be getting based on the 2003 Medicare Modernization Act (MMA).

In addition to ACCC, nine other oncology groups signed the letter: the American Society for Clinical Oncology, Community Oncology Alliance, The US Oncology Network, National Coalition for Cancer Survivorship, National Patient Advocate Foundation, Healthcare Distribution Management Association, UPMC Cancer Centers, AmerisourceBergen, and McKesson Corporation.

Read the letter sent to the President.

Read the letter sent to Congress.

Tell Congress to oppose the cuts to Medicare.

Posted 7/14/2011

CMS Proposes Policy and Payment Changes for Outpatient Care in Hospitals

On July 1, 2011, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would update payment policies and payment rates for services furnished to Medicare beneficiaries in hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs) beginning Jan. 1, 2012. ACCC is analyzing the proposed rule and will report to membership soon.

Under the proposed rule, CMS would:

• Pay for the acquisition and pharmacy overhead costs of separately payable drugs and biologicals, other than new drugs and biologicals that have pass-through status, at the manufacturers’ average sales price (ASP) plus 4 percent
• Refer questions about supervision of specific services to the Ambulatory Payment Classification (APC) Panel, a panel initially created under the Federal Advisory Committee Act to provide technical advice and recommendations to CMS about assigning items and services furnished in HOPDs to appropriate APCs
• Change the Medicare Electronic Health Record Incentive Program that would allow eligible hospitals to report clinical quality measures for 2012 by participating in an electronic reporting pilot.

The proposed rule also contains proposals that would strengthen the Hospital Value-Based Purchasing (HVBP) Program. The HVBP Program, which was required by the Affordable Care Act of 2010, will tie a portion of a hospital's payment for inpatient stays under the Inpatient Prospective Payment System in fiscal year (FY) 2014 to its performance score on a set of quality measures. CMS issued a final rule establishing this program in April of this year.

CMS is proposing that the payment rates for 2012 will increase by 1.5 percent. This reflects a 2.8 percent increase in the hospital operating market basket, a -1.2 percent multifactor productivity (MFP) adjustment, and a 0.1 percentage point reduction required by the Affordable Care Act (ACA). Hospitals that fail to meet the quality data reporting requirements will receive an update that is reduced by 2.0 percentage points. CMS expects that total Medicare payments to hospital outpatient departments (HOPDs) will be approximately $41.9 billion and total payments to ambulatory surgical centers (ASCs) will be $3.61 billion in 2012.

Beginning with this rule, the addenda containing relative weights, payment rates, wage indices and other payment information no longer will be printed in the Federal Register. The addenda are available only on the CMS web site. Addenda relating to OPPS and addenda relating to the ASC payment system are available.

Read the proposed rule.

ACCC's in-depth analysis is available to ACCC members on ACCC's Members-only web section. Log in required.

Posted 7/5/2011

CMS Proposes Policy, Payment Rate Changes for the Physician Fee Schedule in 2012

On July 1, 2011, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would update payment policies and rates for physicians and nonphysician practitioners for services paid under the Medicare Physician Fee Schedule in 2012. In the 2012 proposed rule, CMS is significantly expanding the potentially misvalued code initiative, an effort to ensure Medicare is paying accurately for physician services and more closely managing the payment system. This year, CMS is focusing on the highest volume and dollar codes billed by physicians to determine whether these codes are overvalued and if evaluation and management codes are undervalued. In the past, CMS has targeted specific codes for review that may have affected a few procedural specialties like cardiology, radiology or nuclear medicine but not taken a look at the highest expenditure codes across all specialties.

CMS is also proposing some changes in how it adjusts payment for geographic variation in the cost of practice.

Highlights of the Proposed Rule:

• Projects a conversion factor of $23.9635, reducing physician payment rates in 2012 by 29.5 percent.
• Implements the third year of a four-year transition to practice expense (PE) relative value units (RVUs) calculated using Physician Practice Information Survey (PPIS) survey data.
• Identifies and revises potentially misvalued services under the PFS.
• Implements a new process for identifying misvalued codes.
• Expands the imaging multiple procedure payment reduction (MPPR) policy to the professional component of advanced imaging services.
• Implements provisions affecting the Physician Quality Reporting System (PQRS), Electronic Prescribing (eRx) Incentive Program, and Electronic Health Records (EHR) Incentive Program.
• Begins implementation of a value-based payment modifier.

ACCC's in-depth analysis is available to ACCC members on ACCC's Members-only web section. Log in required.

Read the proposed rule.

Posted 7/5/2011

Medicare Now Covers First FDA-Approved Immunotherapy for Prostate Cancer Treatment

The Centers for Medicare and Medicaid Services (CMS) has determined that the evidence is adequate to conclude that the use of autologous cellular immunotherapy treatment - sipuleucel-T (Provenge) improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer, and thus is reasonable and necessary for that indication. Under a final national coverage determination (NCD) issued June 30, 2011, Medicare patients with metastatic prostate cancer can get this first-of-its kind treatment recently approved by the Food and Drug Administration.

CMS internally initiated the NCD process for Provenge for multiple reasons, including: variations in local coverage; questions about the appropriate benefit category for Provenge; and inquiries from Congress. There was no prior NCD on this technology, and local contractors were generally making case by case determinations. CMS convened the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), a group of nationally recognized independent medical and scientific experts, on November 17, 2010 to make recommendations about the evidence. The MEDCAC votes supported coverage of Provenge for the FDA labeled indication and did not support coverage for unlabeled uses.

Read more.

Posted 7/1/2011

CMS Has a New FAQ on Payment for the Medicare EHR Incentive Program

The Centers for Medicare & Medicaid Services (CMS) wants to keep you updated with information on the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. Take a minute and review CMS' new FAQ on receiving an incentive payment in the Medicare EHR Incentive Program.

Click here to find answers to your questions about the incentive programs.

Visit the EHR Incentive Program home page.

Posted 6/27/2011

FDA Approves New Test to Help Determine If Breast Cancer Patients Are Candidates for Herceptin

The U.S. Food and Drug Administration approved a new genetic test that will help health care professionals determine if women with breast cancer are HER2-positive and, therefore, candidates for Herceptin (trastuzumab). The test, called Inform Dual ISH, allows for measurement of the number of copies of the HER2 gene in tumor tissue. The HER2 gene is located on chromosome 17 in human cells. An excessive amount of the protein produced by the gene is found in some types of cancer cells, including breast cancer cells.

The Inform Dual ISH test allows lab personnel to count the number of copies of HER2 genes on chromosome 17 in a small sample of the breast tumor. The sample is stained with chemicals that cause copies of HER2 genes and chromosome 17 to change color. Copies of the HER2 gene appear black and copies of chromosome 17 appear red. These color changes can be seen under a standard microscope.

Click here to read more.

Posted 6/15/2011

Affordable Care Act Provisions for Pre-Existing Conditions Kick In

Getting health coverage under the Pre-Existing Condition Insurance Plan (PCIP) is now easier and more affordable for those uninsured because of a pre-existing condition. New eligibility standards and lower premiums in some states, announced by the Department of Health and Human Services on May 31, will now make this program created by the Affordable Care Act available to many more Americans.

Premium prices were reduced up to 40 percent in some states effective July 1, 2011. To learn more, visit www.pcip.gov. Go to "State Plans" and click to see the current rates.

In addition, eligibility has been simplified. Starting July 1, 2011, people applying for coverage in the federally administered PCIP can demonstrate eligibility for PCIP simply by providing a letter from a doctor, physician assistant, or nurse practitioner dated within the past 12 months stating he or she has or, at any time in the past, had a medical condition, disability, or illness. This option became available to children under age 19 in February, and this pathway will be extended to all applicants regardless of age. A person applying for coverage must be a U.S. citizen or reside in the U.S. legally and have been without health coverage for at least 6 months.

Posted 6/7/2011

ACCC Submits Comments on Proposed Rule for ACOs

The Association of Community Cancer Centers (ACCC) recently submitted comments on the CMS proposed rule for accountable care organizations (ACOs). The comments expressed ACCC’s recommendations to protect beneficiary access to cancer care by requiring ACOs to include specialists in their leadership and management structures and by establishing additional protections for access to specialty care and clinical trials. ACCC asked CMS to consider the creation of oncology-centered ACOs under the Center for Medicare and Medicaid Innovation (CMMI) and reduce barriers to community cancer centers’ participation in ACOs by creating an option to participate under the one-sided risk model for all three years.

Click here to read ACCC's comments.

Posted 6/2/2011

Al B. Benson III receives the 2011 Rodger Winn Award

ACCC's Immediate Past-President Al B Benson III, MD, professor of Medicine at Northwestern University Feinberg School of Medicine and associate director for Clinical Investigations at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, received the 2011 Rodger Winn Award. Presented at the National Comprehensive Cancer Network (NCCN) Annual Meeting in March, the award is given to one NCCN Guidelines panel member each year who exemplifies Dr. Winn’s leadership, drive, and commitment to the development of evidence-based guidelines tempered by expert judgment. The award recognizes service in the development of clinical practice guidelines, promotion of collegiality in NCCN activities, commitment to excellence, and dedication to multidisciplinary care.

Posted 5/31/2011

CMS Announces Financial Resources, Flexibility to Help Providers Use Health IT Systems

On May 26, 2011, the Centers for Medicare & Medicaid Services (CMS) announced a proposed rule for eRX Incentive Program, which would give more flexibility to providers who are adopting electronic prescribing systems. The proposed rule would help providers phase in the use of e-prescribing technology. Specifically, the proposals provide exemptions from the payment adjustment for providers who plan to participate in the program but who face certain barriers to using electronic prescribing systems or meeting program requirements that may be beyond their control.

The eRX Incentive Program provides financial incentives, including payment adjustments beginning Jan. 1, 2012, for EPs to encourage e-prescribing.

Click here for more information about progress under the HITECH act to date.

Click here for detailed fact sheets on both the e-prescribing proposed rule and the EHR incentive payments.

Posted 5/27/2011

Three Senators Seek GAO Study of Drug Shortages, Potential Solutions

Three Senate Democrats have asked the Government Accountability Office to conduct a study of drug shortages in the United States, citing reports of frequent shortages of lifesaving pharmaceuticals at hospitals across the country.

In a May 4 letter, Sens. Bob Casey (D-Pa.), Tom Harkin (D-Iowa), and Richard Blumenthal (D-Conn.) asked GAO Comptroller General Gene L. Dodaro to examine how the Food and Drug Administration identifies and responds to drug shortages and to identify what steps FDA could take under its current authority to better identify and resolve drug shortages. Harkin is chairman of the Senate Health, Education, Labor, and Pensions Committee.

ACCC supports efforts to pass the “Preserving Access to Life-Saving Medications Act,” S. 296 introduced by Senator Amy Klobuchar (D-MN) and Robert Casey (D-PA). This bill shifts shortage reporting responsibility from providers to manufacturers; requires all manufacturers to report upcoming drug shortages to the FDA; increases manufacturer accountability by requiring them to anticipate and notify of future manufacturing stoppages, but does not impose fines or other sanctions for reporting; and allows providers to better anticipate impending shortages so both providers and patients can prepare for alterations in treatment regimens.

Read more on ACCCBuzz about the drug shortage issue and ACCC's advocacy efforts to address the issue.

Posted 5/9/2011

FDA Approves New Drug for Patients with Neuroendocrine Tumors of Pancreatic Origin

On May 5, 2011, the U. S. Food and Drug Administration approved everolimus (Afinitor Tablets, Novartis Pharmaceuticals Corporation), for the treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease. The safety and effectiveness of everolimus in the treatment of patients with carcinoid tumors have not been established.

The approval was based on a randomized, controlled trial of everolimus 10 mg/d (n=207) versus placebo (n=203) in patients with unresectable, locally advanced or metastatic pancreatic neuroendocrine tumors. Patients were stratified by prior cytotoxic chemotherapy and by WHO performance status. Treatment with somatostatin analogs was allowed as part of best supportive care. The primary endpoint was progression-free survival (PFS) as assessed by the investigator. After documented radiological progression, patients on the placebo arm could cross over to everolimus. Among the 203 patients randomized to placebo, 73% crossed over to everolimus. Secondary endpoints included overall survival, response rate, and response duration.

Posted 5/6/2011