2012 Archived oncology news:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
ACCC Comments on Proposed OPPS Rule, Physician Fee Schedule
The Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the proposed Hospital Outpatient Prospective Payment System (OPPS) rule and the proposed Physician Fee Schedule (PFS) rule for 2013.
Comments to proposed OPPS rule. ACCC noted that CMS has made significant adjustments to its rate-setting methodology, which ACCC believes will provide for more appropriate and stable reimbursement levels for drugs and pharmacy-related services. In 2013 the agency proposes to reimburse separately payable drugs at ASP +6 percent.
Comments to proposed PFS. ACCC urged Congress to develop a long-term fix to the Sustainable Growth Rate (SGR) formula and avert a 27.4 percent reduction to the conversation factor in 2013. Among other recommendations, ACCC also advised that CMS should not implement the proposed changes to the time inputs for CPT codes 77418 (intensity modulated treatment delivery) and 77373 (stereotactic body radiation therapy).
It's Official: ICD-10 Implementation Delayed Until 2014
Department of Health and Human Services (HHS) Secretary Kathleen Sebelius announced a one-year delay in the compliance deadline for the nationwide conversion to ICD-10 code sets. The delay, first proposed in April, will move the compliance deadline to Oct. 1, 2014. HHS said the extra time would allow healthcare organizations—small organizations in particular—adequate time to get ready for the changeover.
"By delaying the compliance date of ICD-10 from October 1, 2013, to October 1, 2014, we are allowing more time for covered entities to prepare for the transition to ICD-10 and to conduct thorough testing," HHS said in the rule. "By allowing more time to prepare, covered entities may be able to avoid costly obstacles that would otherwise emerge while in production."
Campath Distribution Program to Begin September 4
Effective September 4, 2012, Campath (alemtuzumab) will no longer be available commercially, but will be provided through the Campath Distribution Program free of charge, according to Sanofi Oncology. In order to receive Campath, healthcare providers must document and comply with certain requirements.
To learn more, contact the Campath Distribution Program at 1.877.422.6728, or visit www.campath.com.
ACCC Submits Comments to CMS About Non-Coverage Language of the PET National Coverage Determination
The Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding reconsideration of the National Coverage Determination (NCD) for the use of positron emission tomography (PET). ACCC strongly supports the request for reconsideration and urges CMS to remove the current blanket non-coverage language of the PET NCD as applied to new PET radiopharmaceuticals approved by the Food and Drug Administration (FDA). This revision will allow new and improved tracers to reach patients battling cancer much sooner than would be possible under the current language that requires CMS to reopen the NCD in order to cover each new PET radiopharmaceutical approved by the FDA.
According to ACCC's comments, "Our patients cannot afford to wait so long for technologies that, under the FDA's rigorous approval process, already have demonstrated meaningful clinical benefit."
FDA Approves Ziv-Aflibercept Injection
On August 3, 2012, the U. S. Food and Drug Administration approved ziv-aflibercept injection (Zaltrap, Sanofi U.S., Inc.) for use in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI) for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.
New Website Launched About Doxil Supply
Janssen Products, LP, has launched a new website for updates about Doxil supply, www.doxilsupply.com, and a Twitter account, @SupplyUpdate. With the deployment, Janssen also announced it will provide Doxil from its allocation program supply to two clinical trials – Endocyte's PROCEED trial and another trial sponsored by VentiRx.
FDA Approves Kyprolis™ (carfilzomib) for Injection for Some Patients with Multiple Myeloma
The U.S. Food and Drug Administration approved Kyprolis™ (carfilzomib) for Injection to treat patients with multiple myeloma who have received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory therapy. In 2012, an estimated 21,700 people will be diagnosed with multiple myeloma and 10,710 will die from the disease, according to the American Cancer Society.
"The approval of Kyprolis provides a treatment option to patients with multiple myeloma whose disease has progressed despite use of available therapies," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research. "We are encouraged by the continued progress in the development of drugs for multiple myeloma over the past decade, offering improved treatment of this disease."
The safety and effectiveness of Kyprolis, which is administered directly into a patient's vein (intravenously), was evaluated in a study of 266 patients with relapsed multiple myeloma who had received at least two prior therapies, including Velcade and Thalomid (thalidomide).
If you require any additional information or have specific questions, please contact the Onyx Pharmaceuticals 360™ program at 855-ONYX-360 (855-669-9360).
FDA Approves New Indication for Afinitor (everolimus)
On July 20, 2012, the U.S. Food and Drug Administration approved everolimus tablets (Afinitor, Novartis Pharmaceuticals Corporation) for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole. The approval was based on a randomized, double-blind, multicenter trial conducted in 724 postmenopausal women with estrogen receptor-positive, HER2-negative, advanced breast cancer with recurrence or progression following prior therapy with letrozole or anastrozole.
New Standards of Practice Released by Association of Oncology Social Work
The Association of Oncology Social Work has released its 2012 "Standards of Practice in Oncology Social Work." Its standards include qualifications, services to patients and families, services to institutions and agencies, services to the community, and services to the profession.
According to the new document, available on the AOSW website, "oncology social work services are available to patients and families throughout all phases of the cancer continuum, including prevention, diagnosis, treatment, survivorship, palliative care, end-of-life care, and bereavement. Services are delivered in a wide variety of settings including specialty cancer centers, community hospitals and health systems, ambulatory centers, home health and hospice programs, community-based agencies, and private practice settings.
Oncology social workers are an integral part of the health care team and contribute to the development and coordination of the overall treatment plan. In collaboration with the patient and family and other health care disciplines, oncology social workers provide counseling, education, discharge planning, case management and navigation, linking patients with a variety of services necessary to meet the person's multiple needs."
CMS Releases Proposed 2013 HOPD Rule
On July 6, 2012, the Centers for Medicare & Medicaid Services (CMS) released the 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, 2013.
Significant proposals for CY 2013 include:
- Projected hospital outpatient payment rate increase due to the market basket update and required adjustments. CMS is proposing to increase HOPD payment rates by 2.1 percent. CMS proposes to continue the statutory 2.0 percentage point reduction in payments for hospitals failing to meet the hospital outpatient quality reporting requirements.
- Change in payment methodology from median costs to geometric mean costs. CMS is proposing to use the geometric mean costs of services within an APC to determine the relative payment weights of services, rather than the median costs that have been used since the inception of the outpatient prospective payment system (OPPS). The agency believes geometric mean costs better reflect average sales costs of services than the median. CMS's analysis shows that the proposed change would have a limited payment impact on most providers.
- Drugs and pharmacy overhead. For CY 2013, CMS is proposing to pay for the acquisition and pharmacy overhead costs of separately payable drugs and biologicals without pass-through status at the statutory default of average sales price (ASP) plus 6.0 percent.
- Inpatient/Outpatient Status. The proposed rule provides an update on the Part A to Part B Rebilling Demonstration.
For the Hospital Outpatient Quality Reporting Program, CMS is not proposing to add any new measures to those previously finalized for the CY 2014 and CY 2015 payment determinations.
CMS proposes to extend the 2012 Medicare EHR Incentive Program Electronic Reporting Pilot for Eligible Hospitals and CAHs through 2013 without changes.
CMS Issues Proposed MPFS Rule for 2013
On July 6, 2012, the Centers for Medicare & Medicaid Services (CMS) issued the proposed 2013 Medicare Physician Fee Schedule (MPFS) rule that would update payment policies and payment rates for services provided under the MPFS on or after Jan. 1, 2013.
For 2013, CMS projects a 27 percent reduction in MPFS payments rates under the Sustainable Growth Rate (SGR) methodology due to the expiration of the adjustment made for CY 2012 in the statute.
Under the 2013 proposed MPFS rule, radiation oncology will face significant payment reductions due in part to changes in reimbursement for IMRT and SBRT, as well as an expansion of the Multiple Payment Procedure Rate (MPPR). In 2013 under the proposed MPFS, medical oncology rates will see roughly a 1 percent decrease, assuming Congress eliminates the SGR and not taking sequestration into account.
The proposed rule continues implementation of the physician value-based payment modifier (Value Modifier) included in the Affordable Care Act by providing choices to physicians regarding how to participate.
CMS proposes changes to two quality reporting programs associated with the MPFS—the Physician Quality Reporting Systems (PQRS) and the Electronic Prescribing (eRx) Incentive Program, as well as changes to the Medicare EHR Incentive Pilot and to the Physician Compare tool on the Medicare.gov website.
The proposed 2013 MPFS rule will appear in the July 30, 2012, Federal Register. More information is available at www.cms.gov.
Supreme Court Upholds Constitutionality of Healthcare Reform Law
The Supreme Court upheld the central component of the Patient Protection and Affordable Care Act agreeing that the requirement for nearly all Americans to secure health insurance is permissible. The vote came down to a 5-4 decision, with Chief Justice John Roberts providing the swing vote for the majority.
Although the primary argument for the upholding of the individual mandate rested in Congress's power to regulate commerce between the states to require everyone to buy health insurance (Commerce Clause), there were not five votes to uphold it on this ground. However, five Justices (Roberts, Breyer, Sotomayor, Ginsberg, and Kagan) did agree that the penalty a citizen must pay if he or she refuses to buy insurance is a kind of tax that Congress can impose using its taxing power. In other words, Congress does not have the power to require individuals to buy health insurance, but it does hold the power to tax them if they do not.
Because the mandate survives, the Court did not need to decide what other parts of the statute were constitutional, except for a provision that required states to comply with new eligibility requirements for Medicaid or risk losing their funding. On that question, the Court held that the provision is constitutional as long as states would only lose new funds if they didn't comply with the new requirements, rather than lose all of their funding.
ACCC continues to parse the Supreme Court's decision and will keep you updated on additional information as it becomes available. For any questions, please contact Sydney Abbott at email@example.com.
Doxil Receives New, Temporary HCPCS Code
Beginning July 1, 2012, healthcare providers administering Doxil and billing Medicare should begin using the temporary Healthcare Common Procedure Coding System (HCPCS) code that the Centers for Medicare & Medicaid Services (CMS) have assigned specific to Doxil (Q2048), and discontinue use of the code J9001.
The Doxil HCPCS Fact Sheet is available on the DOXILine website. Click here.
FDA Approves Perjeta (Pertuzumab) for Treatment of HER2-Positive Metastatic Breast Cancer
Genentech announced that the U.S. Food and Drug Administration (FDA) has approved Perjeta (pertuzumab). Perjeta is approved in combination with Herceptin® (trastuzumab) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
This approval is based on data from a Phase III study, which showed that people with previously untreated HER2-positive mBC who received the combination of Perjeta, Herceptin, and docetaxel chemotherapy lived a median of 6.1 months longer without their cancer getting worse (progression-free survival, or PFS) compared to Herceptin plus docetaxel chemotherapy (median PFS 18.5 vs. 12.4 months). Read more.
Rare Cell Technology Educational Seminars
WEBCONFERENCE SERIES: WEDNESDAY, MAY 30, 2012
10:00 am US/EDT; 14:00 GMT
Rare Cell Technology Educational Seminars brought to you by Veridex, LLC
Abstract: In the management of metastatic prostate cancer patients, use of a validated assay for the enumeration of circulating tumor cells provides additional insight. We will review the prognostic value of CTCs and their clinical value in comparison to PSA.
Speaker: Nancy A. Dawson, MD
Lombardi Comprehensive Cancer Center,
Georgetown University Hospital, Washington, DC
To register, visit: www.medconference.net/vrx
Follow instructions to register for this program. Once registered, you will receive an email confirmation that includes instructions for participating. Speaker and date are subject to change. If you are registered for an event and there is a change, you will receive an e-mail notification. Please be advised that by registering for this event, we will use your Personally Identifiable Information as your confirmation to participate in this WebEx. This information may be shared with Veridex, LLC, its affiliates and a third party vendor for the sole purpose of fulfilling your registration and meeting logistics. This promotional educational activity is brought to you by Veridex, LLC and is not certified for continuing medical education. The speaker(s) will be presenting information on behalf of Veridex, LLC and must present information in compliance with FDA requirements.
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Call or Email Your Senators Today: Urge Passage of PDUFA
Important language in the Prescription Drug User Fee Act (PDUFA) would help eliminate some of the drug shortage crisis by shifting shortage reporting requirements from physicians to manufacturers and giving the Food and Drug Administration (FDA) increased capability to more quickly authorize manufacturers to produce drugs in short supply. However, there is a potential delay in passing PDUFA. Because of this delay, we are asking ACCC members to call their Senators to urge passage before the Memorial Day recess.
Tell your Senators that you are urging them to pass the FDA User Fee Bill, S. 3187, before the Memorial Day recess. This bill contains a critical provision that will help address the worst drug shortage crisis in our nation's history. Ask your Senators to pass this bill now.
Visit ACCC's Legislative Action Center to find your Senators' contact information.
Get an Inside Look at Oncology Medical Home: Podcast Interview and ACCC Survey in Oncology Times
Read an Oncology Times article about medical home and listen as ACCC Immediate Past President Thomas L. Whittaker, MD, discusses the Association of Community Cancer Centers' survey results on an iPad podcast.
ACCC's survey on the medical home model for oncology care finds that the majority of respondents expect they will be practicing as an oncology medical home or part of an accountable care organization within five years. Most respondents think the medical home model will work for oncology care—but many are worried about the transition from their current practice to the care delivery model of the future.
ACCC Submits Comments on Medication Non-Adherence and on EHR Meaningful Use Criteria
On May 7, 2012, the Association of Community Cancer Centers (ACCC) submitted comments to the Office of the Surgeon General regarding the causes, impact, and potential solutions for prescription medication non-adherence, which can increase costs to the patient, health plans, and society.
ACCC members identified several potential solutions for non-adherence:
- Physicians or other members of a patient's healthcare team should contact the patient within 72 hours after prescribing a medication to ensure that the patient fills the prescription, understands how to take the medication, and understands potential side effects.
- Pharmacists and/or insurers should educate patients and physicians about therapeutic substitutions and how they affect the dosing regimen prescribed by the physician.
- Policymakers should develop an "electronic pill box" that explains the differences between medications and helps patients understand when to take their medications.
- The Centers for Medicare & Medicaid Services (CMS) and other payers should continue to implement programs that help to reduce patients' out-of-pocket costs for medications, such as the provisions in the Patient Protection and Affordable Care Act that close the Medicare Part D "donut hole."
On a separate issue, ACCC submitted comments to CMS regarding the proposed rule specifying Stage 2 electronic health record (EHR) meaningful use criteria and related matters for eligible professionals (EPs), eligible hospitals (EHs) and critical access hospitals (CAHs).
Doxil C.A.R.E.S. Physician Access Program Initiates Open Enrollment
As part of its ongoing commitment to providing available medication to patients, Janssen Products, LP, has announced the initiation of an open enrollment process for the Doxil® C.A.R.E.S. Physician Access Program, starting 12:00 noon Eastern Time on Friday, May 11, 2012.
In a May 9, 2012, letter Rob Bazemore, President, Janssen Products, LP, announced that, "Returning a reliable supply of Doxil to the marketplace remains our top priority. We are able to re-open enrollment at this time because some physician allocation requests have changed and freed up product for reallocation. Other physicians indicated Doxil earmarked for patients in the program is no longer needed, or they opted patients out of the program. We've met the needs of all physicians who submitted enrollment forms for their patients during the recent Doxil C.A.R.E.S. Physician Access Program re-enrollment process and this latest assessment has allowed us to re-open enrollment for the Doxil C.A.R.E.S. Physician Access Program for patients not currently enrolled."
For more information, call 1-866-298-5774. Read more.
FDA Approves Pazopanib Tablets for Soft Tissue Sarcoma
On April 26, 2012, the U. S. Food and Drug Administration approved pazopanib tablets (Votrient, a registered trademark of GlaxoSmithKline) for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The efficacy of pazopanib for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors (GIST) has not been demonstrated. The approval is based on a randomized, double-blind, placebo-controlled, multicenter trial in patients with metastatic STS who had received prior chemotherapy, including an anthracycline.
For more information, click here.
ACCC Calls for Revision of the 2014 Proposed Essential Health Benefits Prescription Drug Coverage Standard
The Association of Community Cancer Centers (ACCC) joined with 103 other medical organizations to urge revision of the 2014 proposed Essential Health Benefits (EHB) prescription drug coverage standard, as put forth in the December 2011 "Essential Health Benefits Bulletin." The April 11, 2012, letter to Kathleen Sebelius, Secretary, U.S. Department of Health and Human Services, urged her to address critical aspects not mentioned in the bulletin, including strong federal oversight mechanisms and patient protections involving medical necessity and anti-discrimination.
The bulletin states that EHB plans must only cover one drug per therapeutic category or class covered by a selected state benchmark plan to meet the EHB standard. ACCC joined the other organizations in expressing the belief that "this is wholly inadequate to meet the complex needs of patients with chronic diseases and disabilities, and runs counter to the government's existing minimum prescription drug coverage standards, including under the Medicare Part D program."
CMS Announces One-Year Delay in ICD-10 Compliance Deadline
On April 9, 2012, the Centers for Medicare & Medicaid Services (CMS) revealed plans to set the new ICD-10 compliance date at Oct. 1, 2014, a one-year delay from the planned Oct. 1, 2013, deadline, which physician groups had complained was not viable for many physicians. The agency in February agreed to delay the compliance date for the new procedure codes in response to physicians' concerns, but at the time didn't specify what the new date would be.
For more information, click here.
Two Compelling Patient Programs Worth Checking Out
Patient Education. Last year, Pfizer Oncology launched "Cancer: It's Personal," a program designed to educate people with cancer, their caregivers, and healthcare professionals about the role personalized medicine may play in oncology. Since its launch, the "Cancer: It's Personal" website has reached more than 75,000 unique visitors to help them better understand the role biomarkers play in the diagnosis, prognosis and clinical treatment of cancer. Recently updated with new content, The Patient Education Center on the "Cancer: Its' Personal" website includes links to the following downloadable materials: "Personalized Medicine in Cancer: What I Need to Know," a video featuring Diane Blum, chief executive officer of the Lymphoma Research Foundation; "Biomarker by Tumor Type" interactive chart; "Myths and Facts about Personalized Medicine;" a biomarker testing process chart; and more. (When you visit the website, click on the Resources tab in the top menu and then on the Education Center on the dropdown menu.)
Patient Inspiration. CALL FOR ENTRIES. More than 3,600 individuals have shared their cancer journeys through art and narrative in the "Lilly Oncology On Canvas: Expressions of a Cancer Journey Art Competition and Exhibition." Lilly's Oncology On Canvas, a biennial art compilation, honors the journey of those whose lives have been affected by cancer. The deadline for submission to the 2012 competition is June 29, 2012; the competition registration deadline is June 29, 2012. Winners will be selected by an independent panel of judges, typically including the art competition director, past winners, cancer survivors, and representatives from patient advocacy groups. Winners will be announced during October 2012. The end result of the competition will be a compelling art collection that can provide insights into the wide range of emotions experienced by those touched by cancer. Artwork and narratives from the 2012 competition will tour during 2013 and 2014. For further information about Oncology On Canvas, click here.
ACCC Comments on PCORI Priorities and Agenda
The Association of Community Cancer Centers (ACCC) submitted comments on the Patient-Centered Outcomes Research Institute's (PCORI's) Draft National Priorities and Research Agenda. ACCC strongly supports PCORI's mission "to fund research that offers patients and caregivers the information they need to make important healthcare decisions," and is hopeful that PCORI will fulfill this purpose.
ACCC noted that high-quality cancer care involves "not only appropriate use of drugs, devices, and medical procedures, but also effective coordination among caregivers. Prevention and screening are vital to sparing patients the pain of cancer or allowing treatment at earlier stages of the disease. Further research into all of these aspects of cancer and its diagnosis and treatment is essential to improving patients' outcomes."
The Draft National Priorities and Research Agenda have the potential to promote important research that could change the lives of cancer patients. PCORI proposes five broad priority areas of research:
- Assessment of Prevention, Diagnosis, and Treatment Options
- Improving Healthcare Systems
- Communication and Dissemination
- Addressing Disparities
- Accelerating Patient-Centered and Methodological Research.
ACCC Urges Faster Congressional Action to Confront Drug Shortage Crisis
The Association of Community Cancer Centers (ACCC) joined 31 other medical organizations in urging House Energy and Commerce Committee Chairman Fred Upton to move forward with legislation to combat the drug shortage crisis. While acknowledging that drug shortages cannot be solved by Congressional action alone, ACCC and the other organizations urged Representative Upton in a letter to take action now.
"Look no further than the recent methotrexate shortage as evidence that this issue can no longer be ignored, as children with otherwise treatable cancer face being without treatment options…the time to take action is now as our patients simply cannot wait any longer."
The communication from the drug shortage stakeholders requested that the Committee move forward with legislation that includes: developing an early warning system for production disruption or discontinuation, requiring manufacturers to have contingency plans for raw materials suppliers, encouraging redundancies in manufacturing, requiring collaboration between the Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) to offer flexibility for product development and raw material quotas and establishing incentives for manufacturers.
In addition to ACCC, the American College of Surgeons, the American Hospital Association, the American Medical Association, the American Society of Clinical Oncology, and the American Academy of Pediatrics, among others, were all signatories to the letter.
ACCC Submits Comments to CMS on Sunshine Act
The Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the Physician Payment Sunshine Act, which requires drug, biologic, and medical device manufacturers to report certain gifts and payments made to physicians. ACCC believes that careful implementation of the Sunshine Act is essential to encourage clinical research and promote accurate public understanding about the benefits of collaboration among physicians, teaching hospitals, and manufacturers. That said, ACCC expressed concerns that the approach proposed by CMS will confuse the public about the amount of payments physicians and hospitals receive from manufacturers.
Short Term "Doc Fix" Passes Congress
Physicians can breathe a short, 10 month, sigh of relief. Congress recently approved yet another "doc fix" for the sustainable growth rate (SGR) that will take us through the end of 2012. H.R. 3630 is a 10 month patch to cancel a Medicare reimbursement cut of 27 percent for physicians that otherwise would have gone into effect on March 1. The measure passed the House 293-132 and passed the Senate 60-36. It is expected to be signed by President Obama by the weekend.
Though ACCC urged Congress to find monies in other places, H.R. 3630 will be offset by $6.9 billion in cuts to Medicare bad debt payments along with $2.7 billion cuts to clinical lab payments. The health care reform law will also be trimmed by $11.6 billion to help pay for the physician pay fix. If Congress were to pass a permanent fix for the SGR, it is estimated to cost $300 million over 10 years.
ACCC will continue to fight for a permanent solution for the sustainable growth rate. We will keep our members updated during this process.
Conferees Approve Agreement Canceling Physician Pay Cut for 2012
According to BNA Health Care Daily Report, members of a House and Senate conference committee approved an agreement Feb. 16 that would cancel a Medicare reimbursement cut for physicians for the rest of 2012. The agreement would replace the cut with a payment freeze for 2012.
BNA reports that votes on the measure could come as early as Feb. 17.
Counterfeit Version of Avastin in U.S. Distribution
The U.S. Food and Drug Administration (FDA) is warning healthcare professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. The counterfeit version of Avastin does not contain the medicine's active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy. Read the FDA notice.
CMS to "Re-Examine" ICD-10 Implementation Schedule
Acting Centers for Medicare & Medicaid Services (CMS) Administrator Marilyn Tavenner said Feb. 14 that CMS will likely delay implementation of the ICD-10 coding system. According to BNA Health Care Daily Report, Tavenner told the American Medical Association's National Federal Advocacy Conference, "I'm committed to re-examining the pace of implementation." Tavenner did not reveal a new implementation time line, but she said a notice will be forthcoming in the next few days to start the process.
FDA Approves New Treatment for Basal Cell Carcinoma
Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration for the treatment of adults with metastatic basal cell carcinoma or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. Erivedge is a pill taken once a day and works by inhibiting the Hedgehog pathway, a pathway that is active in most basal cell cancers and only a few normal tissues, such as hair follicles.
CMS Posts 2012 PQRS Educational Products
The Centers for Medicare & Medicaid Services (CMS) announced the posting of 2012 Physician Quality Reporting System educational products on the CMS website:
- 2012 Physician Quality Reporting System Measures List. This document identifies and explains the measures used in Physician Quality Reporting, including information on the reporting options/methods, measure developers and their contact. Note that this document was updated and re-posted on 1/05/2012.
- 2012 Physician Quality Reporting System Quality-Data Code (QDC) Categories – a table that outlines, for each measure, each QDC that should be reported for a corresponding quality action performed by the individual eligible professional as noted in the measures specification. This determines how each code will be used when calculating performance rates. This also clarifies those measures that require two or more QDCs to report satisfactorily. Insufficiently reporting the QDCs (as specified in the 2012 Physician Quality Reporting System Measure Specifications Manual) will result in invalid reporting.
- 2012 Physician Quality Reporting System Single Source Code Master. This file includes a numerical listing of all codes included in 2012 Physician Quality Reporting for incorporation into billing software.
- 2012 Physician Quality Reporting System Measure Specifications Manual for Claims and Registry Reporting of Individual Measures – the 2012 measure specifications include codes and reporting instructions for the 210 Physician Quality Reporting System measures for claims and/or registry-based reporting. Note that this document was revised and re-posted on 1/05/2012.
- 2012 Physician Quality Reporting System Measure Specification Release Notes – outlines changes from the 2011 Physician Quality Reporting System Measure Specifications Manual in the form of Release Notes. Note that this document was revised and re-posted on 1/05/2012.
- 2012 Physician Quality Reporting System Implementation Guide – provides guidance about how to select measures for reporting, how to read and understand a measure, and outlines the reporting options available for 2012 Physician Quality Reporting System. The Implementation Guide also details how to implement claims-based reporting of measures to facilitate satisfactory reporting of quality-data codes by eligible professionals.
- 2012 Physician Quality Reporting System Measures Groups Specifications Manual – measures group specifications are different from those of the individual measures that form the group. Therefore, the specifications and instructions for measures group reporting are provided in a separate manual. The 2012 measures groups specifications include codes and reporting instructions for the 22 Physician quality Reporting System measures groups for claims or registry-based reporting.
- 2012 Physician Quality Reporting Measures Groups Release Notes. This document outlines changes from the 2011 Physician Quality Reporting System Measures Groups Specifications Manual in the form of release notes.
- Getting Started with 2012 Physician Quality Reporting System of Measures Groups – provides guidance on implementing the 2012 Physician Quality Reporting System measures groups.
- 2012 Physician Quality Reporting Measures Groups Single Source Code Master. This file includes a numerical listing of all codes included in 2012 Physician Quality Reporting System Measures Groups for incorporation into billing software.
- 2012 Physician Quality Reporting System Measure-Applicability Validation Process for Claims-Based Reporting of Individual Measures – provides guidance for those eligible professionals who satisfactorily submit quality-data codes for fewer than three Physician Quality Reporting measures, and how the measure-applicability validation process will determine whether they should have submitted QDCs for additional measures.
- 2012 Physician Quality Reporting Measure-Applicability Validation Process Release Notes – the release notes for the changes occurring for the 2015 Physician Quality Reporting Measure-Applicability Validation Process (MAV).
- 2012 Physician Quality Reporting System Measure-Applicability Validation Process Flow – a chart that depicts the Measure-Applicability Validation Process (MAV).
- Group Practice Reporting Option (GPRO) Requirements for Submission of 2012 Physician Quality Reporting System Data – provides guidance on how a group practice of over 25 eligible professionals can self-nominate to participate in GPRO for 2012 data submission.
- 2012 Physician Quality Reporting System Group Practice Reporting Option (GPRO) Measures List – a document containing a list of the 2012 Physician Quality Reporting GPRO Measures.
- 2012 Physician Quality Reporting GPRO Narrative Measure Specifications and Release Notes. This document contains descriptions of the 2012 Physician Quality Reporting GPRO measures and changes in the program since the 2011 reporting year.
- 2012 EHR Direct Vendor Qualification Requirements – provides guidance on how EHR Direct Vendors can self-nominate and qualify to submit Physician Quality Reporting System measures data for 2012.
- 2012 EHR Data Submission Vendor Qualification Requirements – provides guidance on how EHR Data Submission Vendors can self-nominate and qualify to submit Physician Quality Reporting System measures data for 2012.
- 2012 EHR Documents for Eligible Professionals. This zipped file contains the following: 1) 2012 Physician Quality Reporting System EHR Measure Specifications – the detailed description of data element names and codes related to each of 51 2012 Physician Quality Reporting System quality measures available for electronic submission; 2) 2012 Physician Quality Reporting System Physician Quality Reporting System EHR Measure Specifications; 2012 EHR Downloadable Resource Table; and 2012 EHR Downloadable Resource Table - Release Notes.