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Home > Mediaroom > Archived Oncology News - 2011

2011 Archived oncology news:

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

FDA Approves New Drug for Patients with Metastatic Castration-resistant Prostate Cancer

On April 28, 2011, the U.S. Food and Drug Administration approved abiraterone acetate (Zytiga Tablets, Centocor Ortho Biotech, Inc.) for use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have received prior chemotherapy containing docetaxel.

The approval is based on the results of a randomized, placebo-controlled, multicenter trial in 1195 patients with mCRPC previously treated with docetaxel-containing regimens. Patients were randomly allocated (2:1) to receive either abiraterone acetate orally at a dose of 1000 mg once daily (N=797) or placebo once daily (N=398). Patients in both arms (abiraterone acetate and placebo) received prednisone 5 mg orally twice daily. Treatment continued until disease progression (defined as a 25% increase in PSA over the patient's baseline/nadir together with protocol-defined radiographic progression and symptomatic or clinical progression), unacceptable toxicity, initiation of new treatment, or withdrawal. Patients with prior ketoconazole treatment for prostate cancer and a history of adrenal gland or pituitary disorders were excluded.

Posted 4/29/2011

Attestation for the Medicare EHR Incentive Program Begins April 18

Attestation for the Medicare Electronic Health Record (EHR) Incentive Program begins April 18, which means that eligible professionals, eligible hospitals, and critical access hospitals can attest through the CMS web-based attestation system and be on their way to receiving Medicare EHR incentive payments.

A new attestation page on the CMS EHR website helps participants in the Medicare EHR Incentive Program find important information on attestation.

Posted 4/18/2011

Accountable Care Organizations: Great Interest Among ACCC Members

Three-hundred and fifty callers tuned in on Tuesday, April 12, 2011, to hear legal experts summarize and discuss the key points of the proposed Accountable Care Organizations (ACOs) rule, including answering critical questions about the impact ACOs may have on the oncology community.

The conference call will be archived in the Members-only section of ACCC's website. (Log-in required.)

Why would your organization want to join (or become) an ACO? Two words: shared savings. ACOs will be eligible to receive a percentage of their shared savings for meeting specific targets—CMS anticipates seeing about $960 million in savings over the first three years of the program.

The opportunity to receive a share of these savings is not without risk, however. Since ACOs will be scored in three-year cycles, the proposed rule suggests two routes for the first cycle. Option 1 is designed for cautious ACOs. It's a delayed-risk option where the ACOs report data all three years—the first two without fear of penalty for failure to achieve benchmarks and in the final year they have the opportunity to receive a small percent of savings for below-benchmark costs and a small penalty for above-benchmark costs. Option 2 is better suited for well-integrated organizations that are "ready made" ACOs. It offers a two-sided risk model for all three years of the cycle with the potential to receive significantly higher percentage of savings payments. These options form a sort of entrance ramp into ACOs for organizations strained from high start-up costs. Starting with the second three-year cycle in 2015, all ACOs will be required to enroll in the two-sided risk model.

How likely will community cancer centers find the prospect of creating an ACO in light of the shared risk? For most, not too likely.

It may be difficult for anyone other than a well-established, vertically integrated healthcare delivery system to participate in the first round of the project. Start-up costs are estimated to be at least $1.75 million per ACO. And this estimate might be too low in light of the significant investments required in health information technology, according to the conference call presenters.

As written the proposed rule doesn't seem to be conducive for oncology-centered ACOs, but it is subject to influence and change through the 60-day comment period, which ends June 6.

Visit the CMS website to read more about the proposed rule on ACOs.

Posted 4/13/2011

FDA Approves Vandetanib for Advanced Thyroid Cancer

AstraZeneca announced that its orphan drug vandetanib was approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced medullary thyroid cancer. The FDA approval is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with non-operable locally advanced or metastatic disease. For indolent or slowly progressing disease, vandetanib is required to be evaluated because of the treatment-related risks.

In a phase III study, patients who received Vandetanib demonstrated a 65 percent reduction in risk for disease progression in comparison with those who received placebo. Median progression-free survival or PFS was at least 22.6 months in the vandetanib arm, compared with 16.4 months in the placebo arm. At the primary PFS analysis, no significant overall survival difference was noted. The objective response rate, all of which were partial, was 44 percent for vandetanib and 1 percent for patients who received placebo. QT prolongation was reported in 14 percent of patients in the vandetanib arm and 1 percent of patients in the placebo arm.

A risk evaluation and mitigation strategy is required for vandetanib.

Vandetanib will be dispensed exclusively through the pharmacy business unit of Biologics, Inc

Posted 4/7/2011

National Provider Call on 2011 Physician Quality Reporting System & eRx Incentive Program

On Tuesday, April 19, 2011 1:30 - 3:00 pm EDT, the Centers for Medicare & Medicaid Services' Provider Communications Group will host a national provider conference call on the 2011 Physician Quality Reporting System and Electronic Prescribing (eRx) Incentive Program.

Click here to register for the call. To receive the call-in information, you must register. Registration will close at 1:30 pm EDT on Monday, April 18, 2011, or when available space has been filled; no exceptions will be made, so please register early.

A PowerPoint slide presentation will be posted to the Physician Quality Reporting System webpage for you to download prior to the call so that you can follow along with the presenter. Educational products are available on the Physician Quality Reporting System and the eRx Incentive Program websites.

The Physician Quality Reporting System is voluntary quality reporting program that provides an incentive payment to identified individual eligible professionals (EPs) and group practices that satisfactorily report data on quality measures for covered Physician Fee Schedule services furnished to Medicare Part-B Fee-For-Service beneficiaries; the Physician Quality Reporting System (formerly known as PQRI) was first implemented in 2007 as a result of section 101 of the Tax Relief and Health Care Act of 2006 (TRHCA) and further expanded as a result of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA), and the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The eRx Incentive Program is an incentive program for eligible professionals initially implemented in 2009 as a result of section 132(b) of MIPPA; the eRx Incentive Program promotes the adoption and use of eRx systems by individual eligible professionals and group practices.

Posted 4/4/2011

Take Action Now: Two Legislative Bills You Should Support

  • Support the bill to remove the prompt pay discount from average sales price. The Association of Community Cancer Centers (ACCC) supports HR 905, a bill that would remove the prompt pay discount from the calculation of average sales price (ASP). This bill was introduced by Representatives Gene Green (D-TX) & Ed Whitfield (R-KY). The bill would remove the prompt pay discount from the ASP calculation, thus giving physicians a more accurate reimbursement for drugs, closer to the ASP+6 percent they should be getting based on the 2003 Medicare Modernization Act (MMA).
  • Support the bill to shift drug shortage reporting responsibility to manufacturers. ACCC also supports S 296, a bill that shifts the responsibility of reporting drug shortages from physicians to manufacturers. This bill was introduced by Senators Amy Klobuchar (D-MN) and Robert Casey (D-PA). The bill requires drug manufacturers to notify the FDA of impending shortages, creating an incentive to avoid unnecessary production stoppages.

Click here to visit ACCC's Legislative Action Center. We'll help you compose your letter to Congress.

Posted 4/1/2011

FDA Approves Peginterferon Alfa-2b (Sylatron) for Adjuvant Melanoma

On March 29, 2011, the U. S. Food and Drug Administration approved peginterferon alfa-2b (Sylatron), for the treatment of patients with melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. The approval was based on a single trial, EORTC 18991, an open label, multi-center trial enrolling 1256 patients. Patients who had been adequately surgically resected for their primary cutaneous melanoma and affected regional lymph nodes were randomized (1:1) to receive either Sylatron or observation for a 5-year period. Patients were assessed for local and regional recurrence or distant metastases every three months for the first two years of treatment and subsequently every six months through the end of the trial. An independent review committee, blinded to randomization assignment and to information that would break the treatment blind, reviewed the case report form data to determine the occurrence, and the date of loco-regional recurrence, or distant metastasis.

The primary efficacy endpoint, relapse-free survival (RFS), was defined as the time to the earliest of local or regional recurrence, distant metastases, or death. Based on 696 RFS events, an improvement in RFS for Sylatron-treated patients [hazard ratio 0.82 (95% CI: 0.71, 0.96); unstratified log-rank p = 0.011] was observed. The estimated median RFS was 34.8 months (95% CI: 26.1, 47.4) and 25.5 months (95% CI: 19.6, 30.8) in the Sylatron and observation arms, respectively. Following 525 deaths on study, there was no difference in overall survival between the Sylatron and the observation arms [hazard ratio 0.98 (95% CI: 0.82, 1.16)].

Read more.

Posted 4/1/2011

Medicare to Cover Prostate Cancer Immunotherapy

Medicare plans to pay for sipuleucel-T (Provenge), the autologous immunotherapy for prostate cancer, following a determination that it is genuinely effective in metastatic hormone-refractory disease, according to the Centers for Medicare & Medicaid Services (CMS).

"The evidence is adequate to conclude that the use of ... sipuleucel-T 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," the agency said in a proposed decision memo.

CMS declined to either endorse or prohibit off-label coverage nationwide. Instead, the agency will allow its individual local contractors to cover Provenge for certain off-label uses at their discretion. A final decision is scheduled to be issued by June 30 after CMS evaluates public comments on the memo.

Many ACCC Member Institutions Make Thomson Reuters Top Hospitals List

Thomson Reuters has released its annual study identifying the 100 top U.S. hospitals based on their overall organizational performance in 10 key areas. The hospitals on Reuters' list show that it's possible to boost patient care and cut down on costs – a tough balance in this economy. The Thomson Reuters 100 Top Hospitals study evaluates performance in mortality, medical complications, patient safety, average patient stay, expenses, profitability, patient satisfaction, adherence to clinical standards of care, post-discharge mortality and readmission rates for acute myocardial infarction, heart failure, and pneumonia.

Congratulations to these ACCC members:

  • Advocate Good Samaritan Hospital, Downers Grove, Ill.
  • Advocate Illinois Masonic Medical Center, Chicago, Ill.
  • August Health, Fisherville, Va.
  • Aultman Hospital, Canton, Ohio
  • Beaumont Hospital-Troy, Troy, Mich.
  • Bryn Mawr Hospital, Bryn Mawr, Pa.
  • Carle Foundation Hospital, Urbana, Ill.
  • CHRISTUS St. Michael Health System, Texarkana, Tex.
  • Columbus Regional Hospital, Columbus, Ohio
  • Decatur Memorial Hospital, Decatur, Ill.
  • Edward Hospital, Naperville, Ill.
  • Fairview Hospital, Cleveland, Ohio
  • Geisinger Medical Center, Danville, Pa.
  • Gundersen Lutheran Health System, La Crosse, Wis.
  • Kettering Medical Center, Kettering, Ohio
  • Martin Memorial Medical Center, Stuart, Fla.
  • Memorial Health Care System, Chattanooga, Tenn.
  • Memorial Hermann Hospital System, Houston, Tex.
  • Memorial Hermann Katy Hospital, Katy, Tex.
  • Memorial Hospital & Health System, South Bend, Ind.
  • Mercy Hospital, Coon Rapids, Minn.
  • Mercy Medical Center North Iowa, Mason City, Iowa
  • Middlesex Hospital, Middletown, Conn.
  • Missouri Baptist Medical Center, St. Louis, Mo.
  • Munson Medical Center, Traverse City, Mich.
  • NorthShore University HealthSystem, Evanston, Ill.
  • Oschner Medical Center, New Orleans, La.
  • Paoli Hospital, Paoli, Pa.
  • Reid Hospital & Health Care Services, Richmond, Ind.
  • Riverside Medical Center, Kankakee, Ill.
  • Riverside Methodist Hospital, Columbus, Ohio
  • Robert Packer Hospital, Sayre, Pa.
  • Spectrum Health Hospital Group, Grand Rapids, Mich.
  • Saint Joseph East, Lexington, Ky.
  • St. Elizabeth Healthcare, Edgewood, Ky.
  • St. Vincent Indianapolis Hospital, Indianapolis, Ind.
  • Trinity Rock Island, Rock Island, Ill.
  • Winchester Hospital, Winchester, Mass.

Posted 3/31/2011

CMS Releases Proposal on Accountable Care Organizations

The Centers for Medicare & Medicaid Services (CMS) released a proposed rule under the health reform law to help physicians, hospitals, and other healthcare providers better coordinate care for Medicare beneficiaries by establishing accountable care organizations (ACOs). Under the proposed rule, CMS would implement both a one-sided risk model (sharing savings only for the first two years and sharing savings and losses in the third year) and a two-sided risk model (sharing savings and losses for all three years), allowing the ACO to opt for one or the other model. CMS Administrator Donald Berwick said the choice allows entities to form ACOs that are not yet ready to take on shared risk.

ACOs that participate in the two-sided model would be able to obtain greater savings. However, the rule also proposed to establish a minimum sharing rate. ACOs in the one-sided risk program that have smaller populations (and have more variation in expenditures) would have a larger sharing rate, and ACOs with larger populations (and have less variation in expenditures) have a smaller rate. Under the two-sided approach, CMS proposed a flat 2 percent minimum sharing rate.

The proposed rule, which will be published in the April 7 Federal Register, calls for a 60-day public comment period. Under the Patient Protection and Affordable Care Act, the shared savings program will reward ACOs that lower costs while meeting quality standards. The program must be established by Jan. 1, 2012.

Posted 3/31/2011

Provider Attestation of EHR Systems for Medicare Incentive Starts April 18

Beginning April 18, providers will be able to attest that their electronic health records systems (EHRs) meet the necessary meaningful use criteria to qualify for Medicare incentive payments, according to an email notice from the Centers for Medicare & Medicaid Services (CMS), said BNA Health Care Daily Report.

CMS is providing a preview of the attestation system, but the agency notes that the preview is intended to give examples of what the attestation process will look like and that the final appearance and language may incorporate additional changes.

CMS will release additional information about the attestation process soon, including User Guides that will give step-by-step instructions for completing attestation and educational webinars that describe the attestation process in depth.

View CMS's Preview of the Attestation System for Medicare Electronic Health Record (EHR) Incentive Program here.

For more information on the Medicare and Medicaid EHR Incentive Program, go to cms.gov/EHRIncentivePrograms.

Posted 3/29/2011

ONC Releases New Federal Health IT Strategic Plan

The Office of the National Coordinator for Health Information Technology released the new Federal Health IT Strategic Plan March 25, BNA Health Care Daily Report said. The plan includes new initiatives and goals for 2015, outgoing Health IT National Coordinator David Blumenthal, MD, said in a blog post on the ONC website.

Read Dr. Blumenthal's blog.

ONC will accept public comment on the new Federal Health IT Strategic Plan through April 22.

More information is available here.

Posted 3/29/2011

FDA Approves New Treatment for Patients with Unresectable or Metastatic Melanoma

Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) approved YERVOY (ipilimumab) 3 mg/kg for the treatment of patients with unresectable or metastatic melanoma. Yervoy is a monoclonal antibody that blocks a molecule known as cytotoxic T-lymphocyte antigen or CTLA-4. CTLA-4 may play a role in slowing down or turning off the body's immune system, affecting its ability to fight off cancerous cells. Yervoy may work by allowing the body's immune system to recognize, target, and attack cells in melanoma tumors. The drug is administered intravenously.

Yervoy's safety and effectiveness were established in a single international study of 676 patients with melanoma. All patients in the study had stopped responding to other FDA-approved or commonly used treatments for melanoma. In addition, participants had disease that had spread or that could not be surgically removed. The study was designed to measure overall survival, the length of time from when this treatment started until a patient's death. The randomly assigned patients received Yervoy plus an experimental tumor vaccine called gp100, Yervoy alone, or the vaccine alone. Those who received the combination of Yervoy plus the vaccine or Yervoy alone lived an average of about 10 months, while those who received only the experimental vaccine lived an average of 6.5 months.

Due to the unusual and severe side effects associated with Yervoy, the therapy is being approved with a Risk Evaluation and Mitigation Strategy to inform healthcare professionals about these serious risks. A medication guide will also be provided to patients to inform them about the therapy's potential side effects.

Read more.

Posted 3/28/2011

Medicare Program Providers Must Start Paying $505 Application Fee as of March 25

The Centers for Medicare & Medicaid Services (CMS) officially announced March 22 that all institutional providers, excluding physicians and nonphysician practitioners, will have to pay a $505 application fee when enrolling or revalidating their participation in Medicare.

The application fee provisions were included in a Feb. 2 final rule from CMS that also covered enhanced provider enrollment screening. Beginning March 25, providers will have to submit the calendar year 2011 fee for all enrollment and revalidation applications through Dec. 31. The fee will also be required if a provider adds a new Medicare practice location. Newly enrolling and revalidating Medicaid and Children's Health Insurance Program providers will also have to submit the $505 fee, with the exception of individual physicians or nonphysician practitioners, and providers enrolled in Title XVIII programs of the Social Security Act or a state Title XIX or XXI plan who have already paid an application fee to a Medicare contractor or to another state.

Section 6401 of the Patient Protection and Affordable Care Act included a provision for imposing an application fee on all institutional providers, excluding physicians and nonphysicians practitioners. Institutional providers, according to PPACA, are defined as any providers submitting a paper Medicare enrollment application using the CMS-855A, CMS-855B (excluding physicians and nonphysician practitioners), or CMS-855S form, or using a web-based Provider Enrollment, Chain and Ownership System application.

Read more.

Posted 3/23/2011

Revised April 2011 ASP Files Available

The Centers for Medicare & Medicaid Services (CMS) has posted revised average sales price (ASP) files for April 2011 and restated files for prior quarters. All are available for download.

Posted 3/21/2011

CMS Updates Physician Compare Initiative Web Page

The Centers for Medicare & Medicaid Services (CMS) announced that the Physician Compare Initiative web page is now available with links to the Physician Compare website. Individuals can search for a physician or other healthcare professional by specialty, type of professional, and location.

Posted 3/18/2011

CMS Updates Advanced Diagnostic Imaging Accreditation Enrollment Procedures

The Centers for Medicare & Medicaid Services (CMS) approved three national accreditation organizations – the American College of Radiology, the Intersocietal Accreditation Commission, and The Joint Commission - to provide accreditation services for suppliers of the technical component (TC) of advanced diagnostic imaging procedures. The accreditation will apply only to the suppliers of the images themselves, and not to the physician's interpretation of the image. This accreditation only applies to those who are paid under the Physician Fee Schedule. A provider submitting claims for the TC must be accredited by January 1, 2012, to be reimbursed for the claim if the service is performed on or after that date.

Click here to read more about the enrollment procedures.

Posted 3/18/2011

UnitedHealthcare, Other Insurers Remove KRAS Pathology Report Requirement

KRAS pathology report submission to obtain coverage for Erbitux (cetuximab) and Vectibix (panitumumab):

  • UnitedHealthcare is removing the requirement to submit a pathology report. The change is effective February 25, 2011.
  • The Oxford Health Plan will eliminate the requirement for a pathology report submission beginning April 1, 2011.
  • The River Valley health plans will eliminate the requirement for pathology reports submission beginning April 1, 2011.

UnitedHealthcare's medical policy has not changed: the use of Erbitux and Vectibix for treatment of individuals with colorectal cancer should be limited to those individuals with the wild type gene. "Our recent audit demonstrates that coompliance has been superb and we are committed to removing these quality checks when they are no longer needed," states UnitedHealthcare.

At this time, the process for Erbitux and Vectibix claims for benefits issued or administered by AmeriChoice, Evercare, Neighborhood Health Partnership Inc., Pacificare, and SecureHorizons have not been changed. Any changes will be announced here.

Posted 3/15/2011

New Education/Support Program Available for Ovarian Cancer Patients Receiving Doxil

Centocor Ortho Biotech Products, LP, has launched DOXIL C.A.R.E.S., a program specifically created to help patients who are starting treatment with DOXIL. The program is intended to complement the efforts of the healthcare team by providing education and treatment follow-up. After enrolling in DOXIL C.A.R.E.S., the patient will receive 1) regularly scheduled telephone calls from oncology nurses to review tips on living with side effects such as hand-foot syndrome and stomatitis, and 2) patient education materials. Patients are eligible to enroll in DOXIL C.A.R.E.S. if they are receiving or are about to start DOXIL treatment for recurrent ovarian cancer.

Patients can enroll in DOXIL C.A.R.E.S. by calling 1-877-CARES-49 (1-877-227-3749) Monday to Friday, 9:30 am to 10:00 pm ET.

Learn more.

Posted 3/11/2011

AHA Study Finds Hospital Revenues Closely Linked to Costs, Not Market Power

A new study by the American Hospital Association (AHA) concludes that increased hospital revenues are the result of increased costs and that market power has little impact on hospital revenues overall. "Assessment of Cost Trends and Price Differences for U.S. Hospitals" provides an in-depth examination of the costs hospitals incur in providing patient care and why those costs may differ among various types of hospitals, as well as the relationship of costs to prices. The key findings demonstrate that hospital prices are directly related to the costs of providing services to patients and their communities, including wages, capital investment, and the level and specialization of services. According to the AHA report, this study should dispel un- or poorly supported claims that differences in hospital prices are attributable automatically to market power. Perhaps more importantly, the research demonstrates a link between improving care coordination, cost reduction, and lower prices.

Other findings:

  • Labor costs now make up more than half of all hospital expenses. Labor costs incurred by hospitals grew at a rate of between 5 percent to 8 percent from 2002 to 2009.
  • The growth in the number of patients covered by Medicare or Medicaid is an increasingly significant issue for hospitals. These patients now constitute more than 60 percent of all admissions and neither program covers the full cost of care.
  • Uncompensated care for patients unable to pay accounts for 6 percent of total hospital expenses.
  • A large percentage—up to 72 percent—of differences among hospitals in non-Medicare prices is attributable to factors such as case mix, regional costs, hospital investments in capital, and other improvements.

Posted 3/9/2011

ACCC Submits Comments on Advance Notice from CMS

The Association of Community Cancer Centers (ACCC), as well as the American Society of Clinical Oncology (ASCO), the Association of American Cancer Institutes (AACI), the National Comprehensive Cancer Network (NCCN) and the Oncology Nursing Society (ONS), provided comments on the 2012 Advance Notice and Call Letter that the Centers for Medicare & Medicaid Services (CMS) recently released. In the 2011 Advance Notice, CMS addressed a long‐standing inequity in the Clinical Trial Policy for Medicare Advantage (MA) enrollees. 2011 MA plans are required to reimburse enrollees for the difference between fee‐for‐service cost sharing incurred for clinical trial items and services and the MA plan's in‐network cost sharing for the same category of service. This change is very important, however, it places a significant burden on MA enrollees to provide paperwork to document their out‐of‐pocket costs associated with their trial participation.

ACCC urges CMS to revisit this issue in the final 2012 plan document by requiring MA plans to directly cover the routine costs associated with clinical trial participation. "The Clinical Trial Policy has been in place for over a decade, and MA plans should be required to provide coverage for clinical trial services in the same way as other Medicare‐covered services," according to the comments.

Posted 3/4/2011

ACCC Submits Comments on Medicare Managed Care Manual Update

The Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services' (CMS) draft update to Chapter 4 of the Medicare Managed Care Manual. ACCC urged CMS to not implement the proposed update to section 10.2 because it would deny beneficiaries access to medically necessary drugs and biologicals and because it is inconsistent with the Medicare statute, regulations, and manual guidance.

While MA plans must pay for all Part B drug or DME items covered under original Medicare, they may restrict access – for each covered Part B drug or DME item – to certain manufacturers' drugs and/or DME items, provided these drugs and/or DME items are accessible to plan enrollees through all contracted network providers. If implemented, this provision would allow MA plans to deny coverage of medically necessary cancer therapies based not on clinical data, but on other, possibly financial considerations, such as the availability of discounts from the manufacturer.

According to the comment letter, "This would be simply unacceptable not only morally, but also as a clinical and legal matter."

ACCC is committed to ensuring that patients have access to the most appropriate treatments and diagnostic tools needed to prevent, diagnose, and treat cancer.

Posted 3/4/2011

Over Three-Quarters of Hospitals Report RAC Activity, AHA Survey Shows

More than three-quarters of hospitals (79%) have experienced some Recovery Audit Contractor (RAC) activity through the fourth quarter of 2010, the American Hospital Association's (AHA's) latest RACTrac survey reveals, according to Mar. 1 BNA's Health Care Daily Report. The AHA survey was released Feb. 24.

Of the 1,800 hospitals responding to the survey, 1,500 reported some RAC activity, BNA said. Only 400 reported no RAC activity.

The fourth quarter RACTrac survey is available at www.aha.org/aha/content/2011/pdf/Q4ractracresults.pdf.

Posted 3/1/2011

2011 eRx Incentive Program—How to Avoid the Adjustment

A reminder from the Centers for Medicare & Medicaid Services (CMS) that beginning in calendar year 2012, eligible professionals (EPs) who are not successful electronic prescribers based on claims submitted between January 1, 2011—June 30, 2011, may be subject to a payment adjustment on their Medicare Part B Physician Fee Schedule (PFS) covered professional services.

From 2012 through 2014, the payment adjustment will increase each calendar year. In 2012, the payment adjustment for not being a successful electronic prescriber will result in an EP or group practice receiving 99 percent of their Medicare Part B PFS amount that would otherwise apply to such services. In 2013, an EP or group practice will receive 98.5 percent of their Medicare Part B PFS covered professional services for not being a successful electronic prescriber in 2011 or as defined in a future regulation. In 2014, the payment adjustment for not being a successful electronic prescriber is 2 percent, resulting in an EP or group practice receiving 98 percent of their Medicare Part B PFS covered professional services.

The payment adjustment does not apply if <10 percent of an eligible professional's (or group practice's) allowed charges for the January 1, 2011 through June 30, 2011 reporting period are comprised of codes in the denominator of the 2011 eRx measure.

Earning an eRx incentive for 2011 will NOT necessarily exempt an EP or group practice from the payment adjustment in 2012.

How to Avoid the 2012 eRx Payment Adjustment

  • Eligible professionals—EPs can avoid the 2012 eRx Payment Adjustment if they:
    • Are not a physician (MD, DO, or podiatrist), nurse practitioner, or physician assistant as of June 30, 2011, based on primary taxonomy code in NPPES;
    • Do not have prescribing privileges. Note: They must report (G8644) at least one time on an eligible claim prior to June 30, 2011;
    • Do not have at least 100 cases containing an encounter code in the measure denominator;
    • Become a successful e-prescriber; and
    • Report the eRx measure for at least 10 unique eRx events for patients in the denominator of the measure.
  • Group Practices—For group practices that are participating in eRx GPRO I or GPRO II during 2011, the group practice MUST become a successful e-prescriber.
  • Depending on the group's size, the group practice must report the eRx measure for 75-2,500 unique eRx events for patients in the denominator of the measure.

For additional information, visit the "Getting Started" webpage at www.cms.gov/erxincentive; or download Medicare's Practical Guide to the Electronic Prescribing (eRx) Incentive Program under Educational Resources.

Posted 3/1/2011

Oncology Leaders Gather for ACCC's Presidents' Retreat

Oncology state society presidents and leaders discussed major hurdles to data collection and utilization at ACCC's 19th Annual Presidents' Retreat, held in Alexandria, Va., Feb. 17-18, 2011. Their concern was how cancer programs and practices will handle a constant and increasing level of submission and regulation, how they can support the personnel to meet the data acquisition demands, and how to best define quality reporting in oncology.

"Community-based oncology must have a voice on these issues," said ACCC President Al B. Benson III, MD, FACP. "We're all in this together. . . and it's more important than ever we are a unified force at the local as well as the national levels."

Read Dr. Benson's comments on the "Data Deluge."

Read our blog about the meeting.

Posted 2/22/2011

Kudos to Two ACCC Members: NSCLC Initiative Successes

ACCC is pleased to acknowledge the significant contribution of two of our member centers, Mount Carmel Health System in Columbus, Ohio and Baptist Hospital East in Louisville, Kentucky. As part of the on-going community clinical perspectives educational initiative between ACCC and Medscape Oncology, each site recently hosted Live Regional Meetings as part of the Case Challenges Studies in NSCLC: Identifying and Overcoming the Barriers program. These initiatives paired a nationally recognized authority on NSCLC with a local community oncologist with expertise in lung cancer to discuss clinical issues of concern to local healthcare professionals.

On February 4, 2011, Dr. Dennis Tishko of Mount Carmel Health System co-presented with Dr. Jeffrey Crawford of Duke University.

On February 18, 2011, Dr. Khalid Ghosheh of Baptist Hospital East co-presented with Dr. Suresh Ramalingam of Emory University. These events provided CME credit to participant's in attendance.

ACCC wishes to thank all of the staff at each of these member centers who contributed their time and resources to making these events a success.

Posted 2/22/2011

Commission on Cancer Posts 2012 Working Draft of Cancer Program Standards

The American College of Surgeons Commission on Cancer has posted the 2012 working draft of its "Cancer Program Standards 2012: Ensuring Patient-Centered Care." Eligibility criteria, as well as program management, clinical services, continuum of care services, outcomes, and data quality categories, are reviewed.

Read ACCC blogs about the working draft.

Posted 2/16/2011

President Obama's 2012 Budget Includes Money for Physician Pay Fix

Feb. 13 senior administration officials said that President Obama's fiscal year 2012 budget will propose to cut the deficit by $1.1 trillion over ten years, according to BNA's Health Care Daily Report. The budget, which is slated to be released Feb. 14, proposes to pay for two years of reimbursements to Medicare physicians at current levels, reports BNA. Without legislation, physicians would face a 30 percent reduction in Medicare reimbursement.

Posted 2/14/2011

CMS to Reprocess Claims Affected by ACA & 2010 MPFS Changes

Over the next several weeks, CMS will begin reprocessing claims affected by provisions in the Affordable Care Act (ACA) and corrections to the 2010 Medicare Physician Fee Schedule (MPFS). ACA was signed into law on March 23, 2010. Various provisions in ACA were implemented some time after their effective date. Corrections to the 2010 MFPS were implemented concurrently with ACA and had an effective date retroactive to Jan. 1, 2010.

Due to the retroactive effective dates of these provisions and the MPFS corrections, a large volume of Medicare fee-for-schedule claims will be reprocessed. In a post to the agency's Physicians Listserve, CMS states:

We expect that this reprocessing effort will take some time and will vary depending upon the claim-type, the volume, and each individual Medicare claims administration contractor.

In the majority of cases, you will not have to request adjustments because your Medicare claims administration contractor will automatically reprocess your claims. Please do not resubmit claims because they will be denied as duplicate claims and slow the retroactive adjustment process. However, any claim that contains services with submitted charges lower than the revised 2010 fee schedule amount (MPFS and ambulance fee schedule) cannot be automatically reprocessed at the higher rates. In such cases, you will need to request a manual reopening/adjustment from your Medicare contractor. While there is normally a one-year time limit for physicians and other providers and suppliers to request the reopening of claims, we believe that these circumstances fall under the "good cause" criteria described in the Claims Processing Manual, Publication 100-04, Chapter 34, Section 10.11 (http://www.cms.gov/manuals/downloads/clm104c34.pdf ). CMS is, therefore, extending the time period to request adjustment of these claims, as necessary.

Medicare claims administration contactors will follow the normal process for handling any applicable underpayments or overpayments that occur while reprocessing your claims. Underpayments will be included in your next regularly scheduled remittance after the adjustment. Overpayments resulting from institutional provider (e.g., hospitals, inpatient rehabilitation facilities, etc.) claim adjustments will be offset immediately, regardless of the amount, unless there are insufficient funds to make the offset. When these overpayments cannot be offset, the amounts will accumulate until a $25 threshold is reached. At that time, a demand letter will be sent to the institutional provider. When a claim adjustment for a non-institutional provider (e.g., physician, other practitioner, supplier, etc.) results in an overpayment, the Medicare contractor will send a request for repayment. If this overpayment is less than $10, your contractor will not request repayment until the total amount owed accrues to at least $10. See the Financial Management Manual, Publication 100-06, Chapter 4, Section 70.16 or Section 90.2 (www.cms.gov/manuals/downloads/fin106c04.pdf) for more information.

CMS reminds physicians, practitioners, suppliers, and other providers affected by the retroactive increases in payment rates for claims affected by ACA and the 2010 MPFS changes of the OIG's policy related to waiving beneficiary cost-sharing amounts attributable to retroactive increases in payment rates resulting from the operation of new Federal statutes or regulations. Available at
oig.hhs.gov/ Contact your Medicare claims administration contractor with any questions.

Posted 2/10/2011

Update on Fulvestrant Claim Denials

The Association of Community Cancer Centers (ACCC) and American Society of Clinical Oncology (ASCO) report that in January some members experienced denials of claims for fulvestrant at a dose of 500 mg based on a "medically unlikely edit" (MUE) for fulvestrant.

ASCO reports that the CMS contractor responsible for the National Correct Coding Initiative and MUEs has a workaround for fulvestrant claims, as follows: In this instance only, providers may submit their claims prior to April 1 by reporting J9395 on two lines of a claim utilizing modifier 59 with the code on one claim line and be paid for the 500 mg dose of fulvestrant. On each claim line the provider may report 10 units of service.

Providers may also delay submission of their claims until April 1, 2011, which is when CMS will modify the MUE value for this code in its next regularly scheduled update.

If providers have already had claims denied due to this MUE value, they may resubmit their claims or appeal them after April 1, 2011, to their local claims processing contractor.

Posted 2/10/2011

Update on EP Registration for EHR Incentive

Can a third-party be designated to register eligible professionals (EPs) for the EHR Incentive? The answer from the Centers for Medicare & Medicaid Services (CMS) is no—not currently. "At this time, there is no method available for a third-party to register multiple eligible professionals (EPs) for the Medicare and Medicaid EHR Incentive Programs."

However, in May, the agency plans to implement functionality that will allow an EP to designate a third-party to register and attest on his or her behalf. CMS will release detailed information about that process when it is available.

CMS states that currently, EPs are NOT permitted to allow a practice manager or any other person to register in their place. Sharing your National Plan and Provider Enumeration System (NPPES) user ID and password with third-parties can place your information at risk. Until CMS implements new functionality in May, each EP should register himself or herself separately for the Medicare and Medicaid EHR Incentive Programs.

Regarding registration for the Medicaid program, CMS states that eligible professionals must select between the Medicare and Medicaid EHR Incentive Programs. If you register for the Medicaid EHR Incentive Program, when you select "Medicaid" on the registration screen, you will be asked to select a state from the drop-down menu. Only states with launched programs (i.e., states that are prepared to confirm your eligibility and make payments) are listed in that drop-down menu. Each month, CMS will add new states as they launch programs.

If you have questions about when your state will launch, visit Medicaid State Information.

You may also contact your State Medicaid Agency for more information about the program; visit State EHR Incentive Program Launch Dates and HIT Websites for the Medicaid EHR Incentive Program links for each State Medicaid Agency.

For more on the Medicare & Medicaid EHR Incentive Programs and to register, go to www.CMS.gov/EHRIncentivePrograms.

Posted 2/7/2011

PCORI Methodology Committee Appointees Named

The Government Accountability Office (GAO) announced Jan. 21 the appointment of 15 members to the Methodology Committee of the Patient-Centered Outcomes Research Institute (PCORI).

"The Methodology Committee has the responsibility of helping PCORI develop and update methodological standards and guidance for comparative clinical effectiveness research. The men and women named today bring impressive credentials and experience to this important task," said Comptroller General Gene L. Dorado, in a press release.

PCORI was authorized under the Patient Protection and Affordable Care Act (PPACA) as a nonprofit corporation to assist patients, clinicians, purchasers, and policymakers in making informed health decisions by providing quality, relevant evidence on how best to prevent, diagnose, treat, and monitor diseases and other health conditions.

In addition to the 15 members named to the Methodology Committee, the Director of the Agency for Healthcare Research and Quality and the Director of the National Institutes of Health, or their designees, will serve on the Committee.

More information and the list of appointees is available here.

Posted 1/25/2011

House Votes to Repeal PPACA

January 19, the U.S. House of Representatives voted 245-189 to approve legislation (H.R. 2) to repeal the Patient Protection and Affordable Care Act (PPACA), initiating the first step toward fulfilling campaign promises made by many Republicans last November. However, the measure must still pass the Senate before going to the President for signature, two hurdles which will not be overcome. Senate Democrats have already vowed to not take up the measure, effectively killing the legislation.

However, House Republicans may still try to limit implementation through other avenues, such as the appropriations process or oversight hearings.

On January 20, the House will consider a resolution instructing committees with healthcare jurisdiction to begin developing legislative alternatives to the healthcare law, BNA Health Care Daily Report said.

ACCC will continue to monitor this issue and will inform members of any updates.

Posted 1/20/2011

New Coverage Option for Uninsured—Federal Pre-Existing Condition Plan

If you are providing care to uninsured patients who have pre-existing conditions and cannot find health insurance coverage, a federal program—the Pre-Existing Condition Insurance Plan—may be an option.

The Pre-Existing Condition Insurance Plan (PCIP) was created under the Affordable Care Act. The federally administered PCIP and is administered by either your state or the U.S. Department of Health and Human Services.

The program does not base eligibility on income and enrollees receive comprehensive health coverage at the same price that healthy people pay.

To qualify for the program, applicants must:

  • Be a citizen of the United States or residing here legally;
  • Have been uninsured for at least 6 months; and
  • Have a pre-existing condition or have been denied coverage because of a medical condition.

The Pre-Existing Condition Insurance Plan covers physician and hospital services and prescription drugs. All insurance benefits are available to enrollees—even to treat a pre-existing condition. Premiums vary by state and annual out-of-pocket expenses for enrollees are capped.

Each state may use different methods to determine whether a person applying for the Pre-Existing Condition Insurance Plan has a pre-existing condition or whether he or she has been denied health coverage. As such, people need to check on how to establish eligibility in their state. For more information about the Pre-Existing Condition Insurance Plan and how to apply, visit www.PCIP.gov or, between the hours of 8am and 11pm EST, call 866-717-5826 (TTY: 866-561-1604).

Posted 1/18/2011

Study Predicts Cancer Costs to Reach $158 Billion in 2020

Based on growth and aging of the U.S. population, medical expenditures for cancer in the year 2020 are projected to reach at least $158 billion (in 2010 dollars)—an increase of 27 percent over 2010, according to a National Institutes of Health analysis. The study appeared online, Jan. 12, 2011, in the Journal of the National Cancer Institute.

The projections were based on the most recent data available on cancer incidence, survival, and costs of care. In 2010, medical costs associated with cancer were projected to reach $127.6 billion, with the highest costs associated with breast cancer ($16.5 billion), followed by colorectal cancer ($14 billion), lymphoma ($12 billion), lung cancer ($12 billion), and prostate cancer ($12 billion).

If cancer incidence and survival rates and costs remain stable and the U.S. population ages at the rate predicted by the U.S. Census Bureau, direct cancer care expenditures would reach $158 billion in 2020, the report said.

However, the researchers also did additional analyses to account for changes in cancer incidence and survival rates and for the likelihood that cancer care costs will increase as new technologies and treatments are developed. Assuming a 2 percent annual increase in medical costs in the initial and final phases of care—which mirrors recent trends—the projected 2020 costs increased to $173 billion. Estimating a 5 percent annual increase in these costs raised the projection to $207 billion. These figures do not include other types of costs, such as lost productivity, which add to the overall financial burden of cancer.

"The rising costs of cancer care illustrate how important it is for us to advance the science of cancer prevention and treatment to ensure that we're using the most effective approaches," said Robert Croyle, PhD, director, Division of Cancer Control and Population Sciences, NCI, in a statement. "This is especially important for elderly cancer patients with other complex health problems."

Read full NCI press release www.cancer.gov/newscenter/pressreleases/CostCancer2020.

More information about these cost projections is available at: costprojections.cancer.gov.

Posted 1/13/2011

2011 eRx Incentive Update from CMS

A reminder from the Centers for Medicare & Medicaid Services (CMS) that beginning in 2012, eligible professionals who are not successful electronic prescribers may be subject to a payment adjustment on their Medicare Part B Physician Fee Schedule (PFS) covered professional services. Section 132 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) authorizes CMS to apply this payment adjustment whether or not the eligible professional is planning to participate in the eRx Incentive Program.

Note that earning an eRx incentive for 2011 will NOT necessarily exempt an eligible professional or group practice from the payment adjustment in 2012.

From 2012 through 2014, the payment adjustment will increase each calendar year. In 2012, the payment adjustment for not being a successful electronic prescriber will result in an eligible professional or group practice receiving 99% of their Medicare Part B PFS amount that would otherwise apply to such services. In 2013, an eligible professional or group practice will receive 98.5% of their Medicare Part B PFS covered professional services for not being a successful electronic prescriber in 2011 or as defined in a future regulation. In 2014, the payment adjustment for not being a successful electronic prescriber is 2%, resulting in an eligible professional or group practice receiving 98% of their Medicare Part B PFS covered professional services.

The payment adjustment does not apply if < 10% of an eligible professional's (or group practice's) allowed charges for the January 1, 2011 through June 30, 2011 reporting period are comprised of codes in the denominator of the 2011 eRx measure.

Tips for Avoiding the 2012 eRx Payment Adjustment

  • An eligible professional can avoid the 2012 eRx payment adjustment if he or she:
    • is not a physician (MD, DO, or podiatrist), nurse practitioner, or physician assistant as of June 30, 2011 based on primary taxonomy code in NPPES
    • does not have prescribing privileges. Note: He or she must report (G8644) at least one time on an eligible claim prior to June 30, 2011;
    • Does not have at least 100 cases containing an encounter code in the measure denominator;
    • Becomes a successful e-prescriber; and
    • Reports the eRx measure for at least 10 unique eRx events for patients in the denominator of the measure.
  • Group Practices that are participating in eRx GPRO I or GPRO II during 2011, the group practice MUST become a successful e-prescriber.
    • Depending on the group's size, the group practice must report the eRx measure for 75-2,500 unique eRx events for patients in the denominator of the measure.

For more information, go to http://www.cms.gov/erxincentive; read "How to Get Started" or download the Medicare's Practical Guide to the Electronic Prescribing (eRx) Incentive Program available at: http://www.cms.gov/partnerships/downloads/11399-P.pdf.

Posted 1/11/2011

ONC Issues Final Rule on Permanent Certification Program for HIT

Jan. 3, 2011, the Office of the National Coordinator for Health Information Technology (ONC) issued a final rule to establish the permanent certification program for health information technology (HIT). The permanent certification program provides new features that will enhance the certification of health information technology, including increasing the comprehensiveness, transparency, reliability, and efficiency of the current processes used for the certification of electronic health record (EHR) technology, according to an ONC news release. Meaningful use of "Certified EHR Technology" is a core requirement for eligible healthcare providers who seek to qualify to receive incentive payments under the Medicare and Medicaid Electronic Health Record Incentive Programs as authorized by the Health Information Technology for Economic and Clinical Health (HITECH) Act.

The temporary certification program, established through a final rule published on June 24, 2010, will continue to be in effect until it sunsets on December 31, 2011, or at a later date when the processes necessary for the permanent certification program to operate are completed. ONC expects to stand-up the programmatic activities necessary to implement the permanent certification program throughout 2011, the news release said.

Features of the permanent certification program include:

  • Organizations must first be accredited in order to test and/or certify health information technology;
  • Certification bodies authorized by the National Coordinator (ONC-Authorized Certification Bodies or ONC-ACBs) are required to conduct post-certification surveillance; and
  • ONC-ACBs are permitted to perform "gap certification."

Read the ONC news release.

For more information on the permanent certification program and the final rule, go to http://healthit.hhs.gov/certification.

Posted 1/4/2011

Upcoming CMS Teleconference: Preparing for ICD-10 Implementation in 2011

The Centers for Medicare & Medicaid Services (CMS) will host a national provider teleconference on "Preparing for ICD-10 Implementation in 2011," on Jan. 12, 2011, from 1:00 pm to 3:00 pm ET. Subject matter experts will review basic information on the transition to ICD-10 and discuss implementation planning and preparation strategies for this year. A question and answer session will follow the presentations.

The target audience for the call includes: medical coders, physician office staff, provider billing staff, health records staff, vendors, educators, system maintainers and all Medicare fee-for-service (FFS) providers.

In order to receive the call-in information, you must register for the call. If you are planning to sit in with a group, only one person needs to register to receive the call-in data. This registration is solely to reserve a phone line, NOT to allow participation. Registration will close at 1:00 p.m. ET on January 11, 2011, or when available space has been filled. No exceptions will be made. Please register early.

Click here for more information and to register.

The call will cover the following topics:

  • Planning for transition to ICD-10 – A call to action
  • ICD-10 implementation for services provided on and after October 1, 2013—No grace periods or delays
  • Date of service implementation requirements
  • Tools for converting codes – 2011 General Equivalence Mappings (GEMs)
  • Partial freeze of ICD-9-CM and ICD-10 code updates, except for new technologies and diseases
  • Use of unspecified codes in both ICD-9-CM and ICD-10
  • Updating payment and coverage policies for ICD-10
  • Differences between ICD-9-CM and ICD-10
  • Internal planning groups and organizational strategies
  • Awareness, educational strategies and assessing training needs
  • Implementation plan development and impact assessment
  • Determining vendor readiness
  • Coding gap analysis—What needs to be done for your coding staff
  • Assessing quality of medical record documentation
  • Developing an ICD-10 budget
  • Consequences of poor preparation

Posted 1/4/2011

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