Oncology Newsfeed

FDA Approves Xofigo (Radium Ra 223) for Advanced Prostate Cancer

On May 15, 2013, the U. S. Food and Drug Administration (FDA) approved radium Ra 223 dichloride (Xofigo Injection, Bayer HealthCare Pharmaceuticals Inc.) for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is an alpha-particle emitting radiotherapeutic drug which mimics calcium and forms complexes with hydroxyapatite at areas of increased bone turnover, such as bone metastases.

Learn more here.

Posted 5/15/2013

FDA Approves Frontline Erlotinib with Companion Diagnostic Test for Metastatic NSCLC

On May 14, 2013, the U. S. Food and Drug Administration (FDA) approved erlotinib (Tarceva, Astellas Pharma Inc.) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. This indication for erlotinib is being approved concurrently with the cobas EGFR Mutation Test, a companion diagnostic test for patient selection.

Learn more here.

Coding and specialty pharmacy information available here.

Posted 5/15/2013

CMS Issues Proposed Rule on DSH Reductions

On May 13, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule on Medicaid payment reductions for safety-net hospitals required under the Affordable Care Act. The proposed rule will be published in May 15 Federal Register. Comments on the proposed rule are due July 12.

Read a CMS fact sheet on the proposed rule here.

Read the proposed rule here.

Posted 5/14/2013

Genomic Health Announces Medicare Expanded Coverage Policy for OncotypeDX Breast Cancer Test to Include DCIS Diagnosis

On May 10, Genomic Health, Inc., announced that effective, May 8, 2013, Palmetto GBA, the designated national contractor for the company's OncotypeDX breast cancer test, has expanded its coverage policy for all qualified Medicare patients to include patients with ductal carcinoma in situ (DCIS) following the recent publication of the breast cancer test's DCIS Score in the Journal of the National Cancer Institute. Press release available here.

Posted 5/14/2013

Archived April 30 Call on Lung Cancer Screening Programs

On April 30, ACCC hosted a members-only conference call that explored reasons for and challenges to establishing a low-dose CT lung cancer screening program. Both presenters' slides and the audio archive of the call are available to ACCC members on ACCC's MyNetwork site here. Login required.

Posted 5/1/2013

ACCC Joins in Letter Urging Congress to Protect Part D

Medicare Access for Patients RX (MAPRx) brings together national beneficiary, patient advocacy, family caregiver, and health professional organizations committed to ensuring and improving access to prescription medications and safeguarding the well-being of beneficiaries with chronic diseases and disabilities under the Medicare prescription drug benefit (Part D). ACCC joined in an April 26 MAPRx letter urging Congress to protect the Part D program as it examines ways to reduce the federal deficit and resist any changes that unduly shift costs to beneficiaries. Read letter here.

Posted 4/30/2013

ACCC April 30 Conference Call: Lung Cancer Screening Programs

On April 30, ACCC will host a members-only conference call that will delve into reasons for and challenges to establishing a low-dose CT lung cancer screening program. The conference call is scheduled for Tuesday, April 30, 2013, from 12:00 pm to 1:00 pm ET.

The call will be facilitated by:

• Dr. Andrea McKee, Chairman, Department of Radiation Oncology, Sophia Gordon Cancer Center, Lahey Clinic
• Dr. Robert Smith, Senior Director, Cancer Screening, American Cancer Society.

Call participants will be able to ask questions and discuss the issues. ACCC members can access call-in information here.

Posted 4/25/2013

CMS Updates EHR FAQs: Information on Sequestration and Attestation

CMS had posted two updated FAQs related to the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. FAQs include information on how EHR incentive payments will be affected by sequestration, as well as guidance on how to successfully attest following an EHR vendor transition.

Question 1: Will incentive payments earned in the Medicare and Medicaid Electronic Health Records Incentive programs be affected by sequestration?

Answer: Incentive payments made through the Medicare EHR Incentive Program are subject to the mandatory reductions in federal spending known as sequestration, required by the Budget Control Act of 2011. The American Taxpayer Relief Act of 2012 postponed sequestration for 2 months. As required by law, President Obama issued a sequestration order on March 1, 2013... Read the full answer here.

Question 2: For the Medicare and Medicaid EHR Incentive Programs, how should an EP, eligible hospital, or critical access hospital (CAH) attest if the certified EHR vendor being used is switched to another certified EHR vendor in the middle of the program year?

Answer: If an EP, eligible hospital or CAH switches from one certified EHR vendor to another during the program year, the data collected for the selected menu objectives and quality measures should be combined from both of the EHR systems for attestation. The count of unique patients does not need to be reconciled when combining from the two EHR systems... Read the full answer here.

For more information about the EHR Incentive Programs, visit the Medicare and Medicaid EHR Incentive Programs website for the latest news on the EHR Incentive Programs.

Posted 4/25/2013

April 30 Webinar on New Molecular Testing Guidelines and NSCLC

On Tuesday, April 30, there will be a webinar on the new College of American Pathologists (CAP) guidelines for molecular testing, and the impact these guidelines may have on non-small cell lung cancer diagnosis and treatment. The webinar is scheduled for 2:00 pm ET. Key opinion leaders will share insights and best practices for personalized diagnosis and treatment, and provide individual perspectives on the new CAP molecular testing guidelines.

For more information, click here.

Posted 4/18/2013

Bill Proposes to Exempt Cancer Drugs from the Sequester

On April 9, 2013, Congresswoman Renee Ellmers (R-NC) introduced a bill that would eliminate the sequester on chemotherapy drugs that must be administered in the physician office setting (HR 1416). It would also direct Medicare to repay providers for any reduced payment since the cuts began on April 1.

To send a letter to your Congressional representatives in support of HR 1416, the "Cancer Patient Protection Act,"enter your zip code to access the HR 1416 support letter template. There is also a petition to the President urging him to exempt cancer drugs from the sequester. In addition to sending a letter, you can also sign the petition. 

ACCC will keep its members updated.

Posted 4/18/2013

Sequestration Coming April 1

Starting on April 1, all Medicare payments will be reduced by 2%. This reduction applies to all services that are billed to Medicare, including E&M codes, chemotherapy administration, hydration, and drugs and their overhead costs. The reduction to drug reimbursement will be felt even more, as the impact of sequestration will reduce reimbursement to ASP+4.3% from ASP+6%.

Why is drug reimbursement being reduced by this amount?

For example, consider a drug with an average sales price (ASP) of $100.

At ASP+6%, reimbursement = $106. The beneficiary pays 20% = $21.20 and Medicare normally pays 80% = $84.80.

After sequestration, Medicare will pay $83.10 (98% of $84.80). Medicare’s share plus the beneficiary’s share after sequestration = $83.10 + $21.20 = $104.30, or ASP+4.3%.

With this change going into effect on April 1, practices and hospitals will begin to see these reductions by mid-April, when they start to get payments for services provided at the beginning of the month (CMS claims can often take 10 days to process). Cancer programs and practices need to be prepared for these reductions.

ACCC is working diligently with Congress and other advocacy organizations to try and roll these cuts back, but at least for now, the 2% reduction will remain on the books.

ACCC will keep its members updated.

Posted 3/29/2013

Webinars on Employer Obligations Under the ACA

On April 2 and April 11, from 1:30 pm – 3:00 pm EDT, the law firm of Hogan Lovells will present webinars on employer obligations under the Affordable Care Act (ACA). These complimentary webinars will include a Q&A session.

The webinars will focus on the “shared responsibility” or “employer mandate” provisions of the ACA, which will go into effect in 2014 but will require considerable advance planning in 2013. A high-level but comprehensive overview of other ACA provisions affecting employers already in effect or scheduled to go into effect soon will be provided.

The webinars will take a practical approach, with an emphasis on helping employers make the decisions about plan design changes and compliance strategies that will be critical in limiting the cost and burden of the new obligations.

The April 2 webinar will focus on issues of greater interest to larger employers and employers with significant numbers of high-wage workers, including the application of the controlled group rules and new nondiscrimination requirements.

The April 11 webinar will focus on issues of greater interest to smaller employers and employers with significant numbers of temporary, part-time, seasonal or low-wage workers, including using Exchanges to provide coverage

To register click here.

Posted 3/28/2013

ACCC Joins in Comment Letter to CMS on 2014 Advance Notice and Call Letter

The Association of Community Cancer Centers (ACCC), along with the American Society of Clinical Oncology (ASCO), the American Association for Cancer Research (AACR), the Association of American Cancer Institutes (AACI), the National Coalition for Cancer Research (NCCR), the National Coalition for Cancer Survivorship (NCCS), the National Comprehensive Cancer Network (NCCN), the Oncology Nursing Society (ONS), the Ovarian Cancer National Alliance (OCNA), and the Susan G. Komen for the Cure, provided comments to the Centers for Medicare & Medicaid Services (CMS) on the recently released 2014 Advance Notice and Call Letter.

The letter urges CMS to correct a long-standing inequity in Medicare coverage by requiring that the final 2014 plan document that Medicare Advantage (MA) plans provide coverage for cancer clinical trials.

Read the comment letter.

Posted 3/21/2013

ACCC Joins in Letter Urging Congress to Stop Sequestration Cuts

On March 13, ACCC along with 19 organizations in the cancer community sent a letter to Senate and House leadership urging Congress to stop the sequestration cuts. The letter asks Congress to help protect cost-effective, high-quality community cancer care for Medicare beneficiaries fighting cancer.

Read the coalition letter.

Posted 3/21/2013

CMS OPPS Transmittal Lists New SRS Payment Changes

The March 1, Centers for Medicare & Medicaid Services (CMS) Transmittal 2664, April 2013 Update of the Hospital Outpatient Prospective Payment System (OPPS), lists the updated payments for stereotactic radiosurgery (SRS) under the Outpatient Prospective Payments Systems (OPPS) as mandated by the American Taxpayer Relief Act (ATRA) of 2012. These changes are effective April 1, 2013.

Attachment A, Table 2 OPPS APC and Payment Rate for 77371 and G0173 states:

CPT/HCPCS Code 77371—Radiation treatment delivery, stereotactic radiosurgery (SRS), complete course of treatment of cranial lesion(s) consisting of 1 session; multi-source Cobalt 60 based

April 2013 Payment Rate for rural hospitals and other excepted hospitals = $7,911

April 2013 Payment Rate for all other hospitals = $3,301

CPT/HCPCS Code G0173—Linear accelerator based stereotactic radiosurgery, complete course of therapy in one session

April 2013 Payment Rate: $3,301

Read the CMS transmittal here.

Posted 3/20/2013

CMS Proposes Expanding PET Scan Coverage; Removal of CED Requirement

On March 13, the Centers for Medicare & Medicaid Services (CMS) proposed ending the Coverage with Evidence Development (CED) requirement for FDG PET scans for oncologic indication.

In its proposed decision memo, the agency proposed coverage of one FDG PET to guide subsequent physician management of anti-tumor treatment strategy after completion of initial anti-cancer therapy. Local Medicare Administrative Contractors (MACs) would decide coverage of any additional FDG PET scans.

However, CMS said FDG PET for subsequent anti-tumor treatment for beneficiaries with prostate cancer is not reasonable and necessary and therefore is not covered by Medicare, Bloomberg BNA reported.

The proposed coverage expansion would remove the current requirement for prospective data collection by the National Oncologic PET Registry (NOPR), the agency said.

Read the proposed decision memo here.

Posted 3/18/2013

MedPAC Releases 2013 Report to Congress

On March 15, the Medicare Payment Advisory Commission (MedPAC) released its annual report to Congress. The Report to Congress: Medicare Payment Policy includes the Commission’s analyses of payment adequacy in fee-for-service (FFS) Medicare; Medicare Advantage (MA), including MA special needs plans; and Part D.

For 2014 MedPAC recommends no update for five fee-for-service payment systems and a 1 percent update for the hospital inpatient and outpatient payment systems.

For two sectors, skilled nursing facilities and home health agencies, it reiterates previous recommendations calling for an array of reforms including rebasing (lowering the base rate), creating incentives to improve quality, and increasing program integrity.

For the physician and other health professional payment system it calls for making the system fairer and for repeal of the sustainable growth rate system (SGR), which governs physician fee schedule payments.

Read the full report here.

Read a fact sheet on the report here.

Posted 3/15/2013

Doxil Supply Update

Janssen Products, LP, is updating healthcare professionals (HCPs), patient organizations, and others in the healthcare community about the release of DOXIL® (doxorubicin HCl liposome injection) utilizing an alternate manufacturing approach.

Read Dear Healthcare Professional letter here.

Learn more here.

Posted 3/12/2013

CMS Issues PET Final Coverage Decision

The Centers for Medicare & Medicaid Services (CMS) says it will allow Medicare Administrative Contractors (MACs) decide coverage for PET imaging scans for oncology.

In a final decision, issued on March 7, CMS changes the national coverage determination so that new PET radiopharmaceuticals will be decided by local contractors, rather than automatically not covered, Bloomberg BNA reports.

Read the decision memo here.

Posted 3/12/2013

Feb. 28 is Last Day to Complete Attestation for 2012 Medicare EHR Incentive Program

Eligible professionals (EPs) who participated in the Medicare Electronic Health Record (EHR) Incentive Program in 2012 must complete attestation for the 2012 program year by today, February 28, 2013.

CMS has several resources located on the Educational Resources page of the EHR Incentive Programs website to help you properly meet meaningful use and attest.

Today is also the deadline for EPs to submit any pending Medicare Part B claims from calendar year (CY) 2012, as CMS allows 60 days after December 31, 2012, for all pending claims to be processed.

Visit the EHR Incentive Programs website for the latest updates and news on EHR Incentive Programs.

Posted 2/28/2013

FDA Approves Stivarga for Advanced Gastrointestinal Stromal Tumors

On Feb. 25, 2013, the U.S. Food and Drug Administration (FDA) expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease.

GIST is a tumor in which cancerous cells form in the tissues of the gastrointestinal tract, part of the body's digestive system. According to the National Cancer Institute, an estimated 3,300 to 6,000 new cases of GIST occur yearly in the United States, most often in older adults.

Read FDA press release here.

FDA Approves Kadcyla for HER2-Positive, Late-Stage Breast Cancer

On Feb. 22, 2013, the U.S. Food and Drug Administration (FDA) approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.

Kadcyla is intended for patients who were previously treated with trastuzumab, another anti-HER2 therapy, and taxanes, a class of chemotherapy drugs commonly used for the treatment of breast cancer.

Referred to as T-DM1 during clinical research, Kadcyla was reviewed under the FDA’s priority review program, which provides for an expedited six-month review of drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products.

Kadcyla is being approved with a Boxed Warning alerting patients and health care professionals that the drug can cause liver toxicity, heart toxicity and death. The drug can also cause severe life-threatening birth defects, and pregnancy status should be verified prior to starting Kadcyla treatment.

Read FDA press release here.

FDA Approves Pomalyst for Advanced Multiple Myeloma

On Feb. 8, the U.S. Food and Drug Administration (FDA) approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs.

Pomalyst is a pill that modulates the body’s immune system to destroy cancerous cells and inhibit their growth. It is intended for patients who have received at least two prior therapies, including lenalidomide and bortezomib, and whose disease did not respond to treatment and progressed within 60 days of the last treatment (relapsed and refractory).

Pomalyst’s safety and effectiveness was evaluated in a clinical trial of 221 patients with relapsed or refractory multiple myeloma. The trial was designed to measure the number of patients whose cancer completely or partially disappeared after treatment (objective response rate, or ORR). Patients were randomly assigned to receive Pomalyst alone or Pomalyst with low-dose dexamethasone, a corticosteroid. Results showed 7.4 percent of patients treated with Pomalyst alone achieved ORR. The median duration of response has not yet been reached in these patients. In patients treated with Pomalyst plus low-dose dexamethasone, 29.2 percent achieved ORR with a 7.4-month median duration of response.

Pomalyst carries a Boxed Warning alerting patients and health care professionals that the drug should not be used in pregnant women because it can cause severe life-threatening birth defects, and that the drug can cause blood clots.

Read FDA press release here.

CMS Issues Final 'Sunshine' Rule

On Feb. 1, the Centers for Medicare & Medicaid Services (CMS) released a final rule, commonly know as the 'Sunshine' rule, that will require manufacturers of drugs, devices, and other medical supplies to report certain payments provided to physicians or teaching hospitals. The final rule also requires manufacturers and group purchasing organizations (GPOs) to disclose to CMS physician ownership or investment interests.

To give applicable manufacturers and applicable GPOs sufficient time to prepare, CMS said data collection will begin August 1, and the reporting period will run through December. Data are due to be reported to CMS by March 31, 2014, and CMS said it will release the data on a public website by September 30, 2014.

View final rule here.

View CMS fact sheet here.

CMS Proposed Rule Aims to Reduce Regulatory Burden on Providers

On Feb. 4, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule designed to help healthcare providers operate more efficiently by eliminating or reducing regulations that are out of date or no longer needed. Many of the rule’s provisions streamline the standards providers must meet in order to participate in the Medicare and Medicaid programs without jeopardizing beneficiary safety.

A key provision reduces the burden on very small critical access hospitals, as well as rural health clinics, and federally qualified health centers, by eliminating the requirement that a physician be held to an excessively prescriptive schedule for being onsite once every two weeks. This provision seeks to address the geographic barriers and remoteness of many rural facilities, and recognize telemedicine improvements and expansions that allow physicians to provide many types of care at lower costs, while maintaining high-quality care.

Another provision would reduce the requirements ambulatory surgical centers must meet in order to provide radiological services that are an integral part of their surgical procedures, permitting them greater flexibility for physician supervision requirements.

CMS also proposes to permit trained nuclear medicine technicians in hospitals to prepare radiopharmaceuticals for nuclear medicine without the supervising physician or pharmacist constantly being present, which helps speed services to patients, particularly during off hours.

The proposal would also eliminate a redundant data submission requirement and an unnecessary survey process for transplant centers while maintaining strong federal oversight.

CMS estimates the proposed reductions in regulatory burdens could save $676 million annually, and $3.4 billion over five years.

The proposed rule will be published in the Feb. 7 Federal Register. The comment period ends April 8.

View the proposed rule here.

Posted 2/6/2013

FDA Approves Generic Version of Doxil

On Feb. 4, 2013, the U.S. Food and Drug Administration (FDA) approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection).

Doxorubicin hydrochloride liposome injection is currently on the FDA’s drug shortage list. For products on the shortage list, the FDA’s Office of Generic Drugs is using a priority review system to expedite the review of generic applications to help alleviate shortages.

“The agency is committed to doing everything we can to address drug shortages so that patients can get the medicines they need when they need them,” said Capt. Valerie Jensen, RPh, director, Drug Shortage Staff, Center for Drug Evaluation and Research, FDA. “For the past year, the FDA has been working to ensure that supplies of doxorubicin HCl liposome injection were not interrupted.”

The generic is made by Sun Pharma Global FZE (Sun). Sun’s generic will be available in 20 milligram and 50 milligram vials.

Learn more here.

Posted 2/5/2013

FDA Approves New Use for Avastin

On January 23, 2013, the U. S. Food and Drug Administration approved bevacizumab (Avastin, Genentech U.S., Inc.) for use in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed on a first-line bevacizumab-containing regimen. Bevacizumab is a recombinant humanized monoclonal IgG1 antibody that binds to human vascular endothelial growth factor (VEGF), preventing the interaction of VEGF to its receptors on the surface of endothelial cells. This approval is based on the results of a randomized, open-label, multinational trial enrolling patients with mCRC that progressed during or within 3 months of discontinuation of bevacizumab-based combination chemotherapy with fluoropyrimidine-oxaliplatin or fluoropyrimidine-irinotecan in the first line.

Learn more here.

Posted 1/25/2013

Synribo Approved by FDA for CML

The U.S. FDA has approved Synribo (omacetaxine mepesuccinate) for Injection, for subcutaneous use, for the treatment of adult patients with chronic or acclerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs).

Learn more here.

Posted 1/25/2013

Update on Doxil Supply

Janssen Products, LP, is updating healthcare professionals (HCPs), patient organizations, and others in the healthcare community about the release of DOXIL® (doxorubicin HCl liposome injection) utilizing an alternate manufacturing approach.

Read Dear Healthcare Professional letter here.

Learn more here.

Posted 1/25/2013

CMS Issues Update on Processing Claims through 2013 MPFS

On Dec. 19 the Centers for Medicare & Medicaid Services (CMS) issued an update on processing claims through the 2013 Medicare Physician Schedule. If Congress does not step in with a “doc fix” to prevent the reimbursement cut due to the sustainable growth rate (SGR), physicians providing coverage to Medicare beneficiaries will face a 27% reimbursement cut effective Jan. 1, 2013.

In the notice, CMS states that Medicare Physician Fee Schedule claims for services rendered on or before December 31, 2012, are unaffected by the 2013 payment cut and will be processed and paid under normal procedures and time frames.

However, the agency states that it must take steps to implement the negative update in the event that Congress is unable to pass legislation preventing the cuts. CMS states that under current law, clean electronic claims are not paid sooner than 14 calendar days (29 days for paper claims) after the date of receipt. CMS will notify providers on or before January 11, 2013, with more information about the status of Congressional action to avert the negative update and next steps.

The Association of Community Cancer Centers (ACCC) anticipates Congressional action, either before Jan. 1 or soon thereafter, to patch the SGR for a short-term fix.

Read the CMS notice here.

Posted 12/21/2012

FDA approves Iclusig (ponatinib) to Treat Two Rare Types of Leukemia

On December 14, 2012, the U.S. Food and Drug Administration approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases.

Iclusig is being approved more than three months ahead of the product’s prescription user fee goal date of March 27, 2013, the date the agency was scheduled to complete review of the drug application. The FDA reviewed the Iclusig drug application under the agency’s priority review program, which provides for an expedited six-month review for drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products.

Iclusig blocks certain proteins that promote the development of cancerous cells. The drug is taken once a day to treat patients with chronic, accelerated, and blast phases of CML and Ph+ ALL whose leukemia is resistant or intolerant to a class of drugs called tyrosine kinase inhibitors (TKIs). Iclusig targets CML cells that have a particular mutation, known as T315I, which makes these cells resistant to currently approved TKIs.

Iclusig is marketed by ARIAD Pharmaceuticals, based in Cambridge, Mass.

Learn more here.

Posted 12/14/2012

Adcetris Granted New J-Code, Effective Jan. 1, 2013

Seattle Genetics, Inc., has announced that Adcetris® (brentuximab vedotin) has been granted a new J-code. HCPCS code J9042 per 1 mg will be effective for dates of service beginning January 1, 2013. This new J-code should be used to bill Adcetris to most payers in all settings and will replace J9999/J3490 and C9287 per 1 mg.*

Seattle Genetics, Inc. will inform government and commercial payers of the new code to facilitate claims processing.

Updated Adcetris Sample Claim Forms will be available at www.SeaGenSecure.com

*In some rare cases a payer may want another HCPCS code on a temporary basis.

Posted 12/13/2012

FDA Approves Expanded Indication for Abiraterone Acetate

On December 10, 2012, the U. S. Food and Drug Administration approved an expanded indication for abiraterone acetate (Zytiga Tablets, Janssen Biotech, Inc.) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.

Learn more here.

Posted 12/11/2012

FDA Approves Cometriq to Treat Rare Type of Thyroid Cancer

The U.S. Food and Drug Administration (FDA) has approved Cometriq (cabozantinib) to treat medullary thyroid cancer that has metastasized to other parts of the body.

The National Cancer Institute (NCI) estimates that 56,460 Americans will be diagnosed with thyroid cancer and 1,780 will die from the disease in 2012. About 4 percent of thyroid cancers are medullary thyroid cancer, making it one of the rarer types of thyroid cancers.

Learn more here.

Posted 11/30/2012

CMS Issues Proposed Rules Related to Pre-Existing Conditions and Essential Health Benefits

Moving forward on implementation of provisions under the Affordable Care Act, on Nov. 20, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that, beginning in 2014, would prohibit health insurance companies from discriminating against individuals because of a pre-existing or chronic condition.

The rule would ensure that people for whom coverage would otherwise be unaffordable, and young adults, have access to a catastrophic coverage plan in the individual market.

View a factsheet on the proposed rule here.

CMS also released a proposed rule outlining policies and standards for coverage of essential health benefits. Essential health benefits are a core set of benefits that would give consumers a consistent way to compare health plans in the individual and small group markets. A companion letter on the flexibility in implementing the essential health benefits in Medicaid was also sent to states.

View a factsheet on the proposed rule here.

View both proposed rules here.

Posted 11/20/2012

Nov. 28 CMS Provider Call on Implementation of Medicare Physician Value-Based Payment Modifier

CMS will provide an overview of its final plans for the physician value-based payment modifier as described in the final Physician Fee Schedule Rule published on November 16, 2012. This call also includes a question and answer session.

When: Wednesday, November 28, 2012

Time: 3-4:30 pm ET

Target Audience: Physicians, physician group practices, practice managers, medical and specialty societies, payers, insurers.

Registration: To receive call-in information, you must register. Please visit the CMS Upcoming National Provider Calls webpage to register. Registration closes at 12 pm on the day of the call or when full.

The presentation for this call will be posted on the FFS National Provider Calls webpage prior to the call, and a link to the slide presentation will be emailed to registrants on the day of the call.

For more information.

Posted 11/20/2012

CMS Releases 2013 PFS Final Rule

On Nov. 1, the Centers for Medicare & Medicaid Services (CMS) issued a final physician payment rule for 2013. The final rule includes a new policy to pay a patient’s physician or practitioner to coordinate the patient’s care in the 30 days following a hospital or skilled nursing facility stay. Changes in care coordination payment and other changes in the rule are expected to increase payments to family physicians by about 7 percent and payment to other primary care practitioners between 3 and 5 percent, according to a CMS fact sheet. The rule is scheduled for publication in the Nov. 16 Federal Register.

The final rule also includes a 26.5 percent across-the-board reduction to Medicare payment rates under the SGR. A CMS fact sheet notes that Congress has overridden the required cut every year since 2003, and states that: “The Administration is committed to fixing the SGR update methodology and ensuring these payment cuts do not take effect. Predictable, fiscally-responsible physician payments are essential for Medicare to sustain quality and lower health care costs over the long-term.”

ACCC is currently analyzing the rule.

View the 2013 PFS rule here.

View the CMS fact sheet here.

Posted 11/2/2012

CMS Releases 2013 HOPPS Final Rule

The Centers for Medicare & Medicaid Services (CMS) released the final 2013 Hospital Outpatient Prospective Payment System (HOPPS) and Ambulatory Surgical Center (ASC) rule on Nov. 1, 2012, updating Medicare payment policies and rates for hospital outpatient and ASC services beginning Jan. 1, 2013. The final rule is scheduled to be published in the Nov. 15 Federal Register. The 2013 HOPPS final rule will increase payment rates for hospital outpatient departments by 1.8 percent. The increase is based on the projected hospital market basket of 2.6 percent, minus 0.8 percent in statutory reductions, according to a CMS fact sheet. For 2013, the OPPS final rule:

• Included a significant change from prior policy: as proposed, it bases relative payment weights on geometric mean costs rather than median costs.
• Finalized payment for separately payable drugs in the OPPS at ASP+6%.
• Made several changes to the quality-reporting program for outpatient departments.

ACCC is currently analyzing the rule.

View the 2013 HOPPS rule here.

View the CMS fact sheet here.

Posted 11/2/2012

Perjeta (pertuzumab) Assigned C-Code

Perjeta™ (pertuzumab), a first-in-class FDA-approved HER2 dimerization inhibitor, has been granted a unique C-code for infusions administered to Medicare patients in hospital outpatient facilities. The unique C-code for Perjeta – C9292 (injection, pertuzumab, 10 mg) – goes into effect on October 1, 2012. This C-code can be used until a permanent J-code is assigned in 2013.

Posted 10/23/2012

FDA Approves New Dosing and Administration for Rituximab

The U.S. Food and Drug Administration (FDA) has approved a 90-minute infusion for rituximab (Rituxan Injection, Genentech, Inc.) starting at Cycle 2 for patients with non-Hodgkin’s lymphoma (NHL) who did not experience a grade 3 or 4 infusion-related adverse reaction during Cycle 1. Patients with clinically significant cardiovascular disease and high circulating lymphocyte counts (>5000/mcL) are not recommended to receive the faster infusion.

Learn more.

Posted 10/23/2012

FDA Expands Labeling of Pemetrexed to Include Results of Additional Safety and Efficacy Trial

The U.S. Food and Drug Administration (FDA) has expanded labeling to include the results of an additional trial evaluating the safety and efficacy of pemetrexed (Alimta, Eli Lilly and Company) for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer followed by pemetrexed maintenance in patients whose disease has not progressed after four cycles of platinum and pemetrexed as first-line chemotherapy.

Learn more.

Posted 10/23/2012

Important Update on Availability of Doxil

Janssen Products, LP, announced that effective October 15, 2012, the company is restoring full access to Doxil®(doxorubicin HCl liposome injection) in the U.S. With this new full access, the company is suspending its DOXIL C.A.R.E.S. Physician Access Program. All healthcare professionals can order Doxil through authorized distributors beginning October 22, 2012, the company said.

Learn more.

Posted 10/16/2012

FDA Approves Abraxane for Metastatic NSCLC

The U.S. Food and Drug Administration (FDA) has approved paclitaxel protein-bound particles for injectable suspension, albumin-bound (Abraxane® for Injectable Suspension; Abraxis Bioscience a wholly owned subsidiary of Celgene Corporation) for use in combination with carboplatin for the initial treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not candidates for curative surgery or radiation therapy.

Learn more.

Posted 10/12/2012

FDA Approves Stivarga for Metastatic Colorectal Cancer

The U.S. Food and Drug Administration (FDA) approved regorafenib (Stivarga® tablets) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.

The approval of Stivarga is based on results from the pivotal Phase III study (CORRECT) that demonstrated improvement in overall survival (OS) and progression-free survival (PFS) compared to placebo in patients with mCRC whose disease had progressed after approved standard therapies.

Stivarga is marketed by Bayer HealthCare Pharmaceuticals.

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Posted 9/28/2012

FDA Approves Xtandi for Metastatic Castration-Resistant Prostate Cancer

The U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi capsules) for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.

The safety and effectiveness of Xtandi was evaluated in a study of 1,199 patients with metastatic castration-resistant prostate cancer who had received prior treatment with docetaxel. The study was designed to measure overall survival (the length of time before death) in men receiving Xtandi compared with men receiving a placebo (sugar pill). The median overall survival for patients receiving Xtandi was 18.4 months, compared with 13.6 months for the patients who received placebo.

Xtandi will be co-marketed by Astellas Pharma U.S., Inc., of Northbrook, Ill., and Medivation, Inc., of San Francisco, Calif.

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Posted 9/14/2012

FDA Approves Bosulif for Treatment of CML

Bosutinib, a tyrosine kinase inhibitor, has been approved by the Food and Drug Administration as a treatment for chronic myeloid leukemia, based on the results of a study of 546 patients, the agency announced on September 4. The approved indication is for the treatment of adults with chronic, accelerated, or blast-phase Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML) who are resistant to or cannot tolerate other treatments, including imatinib, according to the FDA and a statement issued by the manufacturer, Pfizer Inc.

Pfizer will be marketing bosutinib as Bosulif. The new agent inhibits the Abl and Src signaling pathways, and is taken once a day at a dose of 500 mg by mouth, according to the company.

Posted 9/13/2012