On Nov. 27, 2013, the Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2014 Physician Fee Schedule (PFS) final rule. Among the provisions included in the 2014 PFS final rule are the following:
Primary Care and Chronic Care Management. Medicare will begin making a separate payment for chronic care management services beginning in 2015. The rule indicates that CMS intends to establish practice standards necessary to support payment for furnishing care management services through future notice-and-comment rulemaking.
Misvalued Codes. Consistent with amendments made by the Affordable Care Act, CMS has been engaged in a vigorous effort over the past several years to identify and review potentially misvalued codes, and make adjustments where appropriate. The agency is continuing this effort as the values for around 200 codes were finalized and approximately 200 additional codes had their work relative value units changed on an interim basis for 2014.
CMS is not finalizing its proposal to adjust relative values under the PFS to effectively cap the physician practice expense payment for procedures furnished in a non-facility setting at the total payment rate for the service when furnished in an ambulatory surgical center or hospital outpatient setting. Instead, CMS will take additional time to consider issues raised by the public commenters and plans to address this issue in future rulemaking.
Compliance with State Law for “Incident To” Services. CMS is requiring as a condition of Medicare payment that “incident to” services be furnished in compliance with applicable state law. CMS also eliminated redundant regulations for each type of practitioner by consolidating the “incident to” requirements for all practitioners that are permitted to bill Medicare directly for their services, reducing the regulatory burden and making it less difficult for practitioners to determine what is required in order to bill Medicare for “incident to” services.
On Nov. 27, 2013, the Centers for Medicare & Medicaid Services (CMS) released the final calendar year (CY) 2014 Hospital Outpatient Payment System (OPPS) rule. The final rule updates the OPPS market basket by 1.7 percent for CY 2014.
Under the final rule, changes to hospitals OPPS payments and policies include:
Items and Services to be “Packaged” or Included in Payment for a Primary Service. For 2014, CMS finalizes five new categories of supporting items and services rather than the seven proposed. For certain cases, a separate payment would be made if the item or service is furnished on a different date of service as the primary service. The five final categories are:
1) Drugs, biologicals, and radiopharmaceuticals that function as supplies when used in a diagnostic test or procedure;
2) Drugs and biologicals that function as supplies; when used in a surgical procedure, including skin substitutes. Skin substitutes will be classified as either high cost or low cost and will be packaged into the associated surgical procedures with other skin substitutes of the same class;
3) Certain clinical diagnostic laboratory tests;
4) Certain procedures described by add-on codes;
5) Device removal procedures.
In addition to packaging these five categories, CMS finalizes its proposal to create 29 comprehensive APCs to replace 29 existing device-dependent APCs, but with a modification to apply a complexity adjustment for the most complex multiple device claims. CMS is delaying the implementation of these comprehensive APCs until CY 2015.
Collapsing Five Levels of Visits to One. The final rule streamlines the current five levels of outpatient clinic visit codes, replacing them with a single Healthcare Common Procedure Coding System (HCPCS) code describing all clinic visits.
The final rule does not finalize the proposal to replace the current five levels of codes for each type of emergency department visits. CMS intends to consider options to improve the codes for these services in future rulemaking.
Part B Drugs in the Outpatient Department. The rule finalizes the proposal to continue paying at ASP+6 percent for non-pass-through drugs and biologicals that are payable separately under the OPPS.
On Nov. 22, 2013, the U.S. Food and Drug Administration (FDA) expanded the approved uses of Nexavar (sorafenib) to treat late-stage (metastatic) differentiated thyroid cancer. Differentiated thyroid cancer is the most common type of thyroid cancer.
Nexavar works by inhibiting multiple proteins in cancer cells, limiting cancer cell growth and division. The drug’s new use is intended for patients with locally recurrent or metastatic, progressive differentiated thyroid cancer that no longer responds to radioactive iodine treatment.
The FDA approved Nexavar to treat advanced kidney cancer in 2005. In 2007, the agency expanded the drug’s label to treat liver cancer that cannot be surgically removed.
On November 1, 2013, the U.S. Food and Drug Administration (FDA) approved obinutuzumab (Gazyva™ injection, for intravenous use, previously known as GA101) for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).
Obinutuzumab is approved with a BOXED WARNING regarding Hepatitis B virus reactivation and Progressive Multifocal Leukoencephalopathy. Patients should be advised of these risks and assessed for Hepatitis B virus and reactivation risk. Infusion reactions are included in the WARNING and PRECAUTIONS section of the label.
As a condition of payment for hospital inpatient services under Medicare Part A, section 1814(a) of the
Social Security Act requires physician certification of the medical necessity that such services be
provided on an inpatient basis. The order to admit as an inpatient (“practitioner order”) is a critical
element of the physician certification, and is therefore also required for hospital inpatient coverage and
payment under Part A. The physician certification, which includes the practitioner order, is considered
along with other documentation in the medical record as evidence that hospital inpatient service(s)
were reasonable and necessary.
The new guidance applies to all inpatient hospital and critical access hospital (CAH) services unless otherwise specified. To read the certification guidance in full, please click here.
CMS has extended the deadline to register in Administrative Claims from Oct. 15 to Oct. 18.
The ACA requires CMS to apply a Value-Based Modifier (VBM) to all physicians’ Medicare payments by 2017 and to some physicians’ payment beginning in 2015. In response, CMS intends to apply a 1 percent VBM penalty to the Medicare payments of physicians in groups of 100 or more that did not engage in group participation in the Physician Quality Reporting System (PQRS) in 2013. This VBM penalty would be in addition to another 1.5 percent penalty that would apply to all physicians who did not participate in PQRS either as an individual or as part of a group.
To avoid these penalties, physicians in groups of 100 or more should ensure that their group is registered for one of the PQRS group participation options. Physicians who are not subject to VBM and are not yet participating in PQRS can still avoid the 2015 payment cut by registering for the CMS-calculated administrative claims reporting mechanism in 2013.
The PQRS registration system will close on Oct. 18, click here to access: https://portal.cms.gov. Use of the system requires an Individuals Authorized Access to the CMS Computer Services (IACS) number, which can be acquired here. Additional information regarding registration and obtaining or modifying an IACS account is available at the Self Nomination/Registration web page. Please note that due to the government shutdown, CMS is unable to update the October 15 date listed on their website.
Additionally, please note the help desk phone number listed in error messages on the PQRS registration portal is incorrect. Users should call the PV-PQRS Help Desk at 1-888-734-6433 Option 3 for questions about registration. They can also contact CMS’ QualityNet help desk at: 1-866-288-8912 (TTY 1-877-715-6222).
On Sept. 6, 2013, the U.S. Food and Drug Administration expanded the approved uses of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) to treat patients with late-stage (metastatic) pancreatic cancer.
Abraxane is a chemotherapy drug that can slow the growth of certain tumors. Abraxane is intended to be used with gemcitabine, another chemotherapy drug, in patients with pancreatic cancer that has spread to other parts of the body.
The FDA reviewed the new use for Abraxane under the agency’s priority review program, which provides for an expedited review of drugs. Abraxane was also granted orphan product designation for pancreatic cancer because it is intended to treat a rare disease or condition.
According to a Congressional Budget Office (CBO) cost estimate issued on Sept. 13, 2013, the House bill (H.R. 2810) to reform the Medicare physician payment system would cost about $175 billion over 10 years.
The House Energy and Commerce Committee unanimously passed the bill in July. However, the Senate Finance Committee, with jurisdiction over the issue in that chamber, has yet to put forward a proposal.
The price tag for the House bill is more costly than a freeze to avoid a pay cut under the sustainable growth rate (SGR) payment methodology, as reported in BNA Health Care Daily Report. The CBO had estimated that freezing physician reimbursement and stopping SGR-related cuts for 10 years would cost $139 billion.
On Sept. 13, 2013, the Centers for Medicare & Medicaid Services (CMS) released the final rule implementing funding reductions required by the Affordable Care Act (ACA) for the disproportionate share hospital (DSH) program. The rule is slated for publication in the Federal Register on Sept. 18, 2013. The rule will go into effect on Nov. 12, 2013.
The final rule includes a reduction methodology only for FY 2014 and FY 2015. CMS will revisit the methodology and promulgate new rules for DSH reductions in FYs 2016 and beyond, the agency said.
The rule is available here.
On Sept. 10, 2013, the Institute of Medicine released a new report, Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis. The report concludes that the U.S. cancer care delivery system is in crisis due to a growing demand for cancer care, increasing complexity of treatment, a shrinking workforce, and rising costs. While calling for "changes across the board" to improve the quality of cancer care, the report proposes a conceptual framework for improving the quality of cancer care comprising six interconnected components:
On June 13, 2013, the U. S. Food and Drug Administration (FDA) approved denosumab (Xgeva injection, for subcutaneous use, Amgen Inc.) for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity. Xgeva was approved following a priority review by the FDA.
On June 5, 2013, the U. S. Food and Drug Administration (FDA) approved lenalidomide capsules (REVLIMID, Celgene Corporation), for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
The approval was based a single-arm, multicenter clinical trial enrolling 134 patients with mantle cell lymphoma who have relapsed after or were refractory to bortezomib or a bortezomib-containing regimen. All 134 patients received prior treatment with bortezomib and 60% were documented to have disease refractory to bortezomib therapy. Patients received a median of 4 prior therapies for MCL. The median age was 67 years, 81% were male, 96% were Caucasian, and 61% had MCL for at least 3 years.
The Centers for Medicare & Medicaid Services on May 29, 2013, issued a final Decision Memo for Aprepitant for Chemotherapy-Induced Emesis (CAG-00248R) expanding coverage of anti-nausea and vomiting therapy for beneficiaries undergoing chemotherapy.
The decision memo states: "The three-drug regimen of oral aprepitant, an oral 5HT3 antagonist and oral dexamethasone is reasonable and necessary for beneficiaries receiving moderately emetogenic chemotherapy (MEC) immediately before and within 48 hours after the administration of the anticancer treatment."
The decision memo states that this all-oral regimen is covered when it is administered in that time frame with any of the following chemotherapeutic agents, administered either singularly or in combination: alemtuzumab, azacitidine, bendamustine, carboplatin, carmustine, cisplatin, clofarabine, cyclophosphamide, cytarabine, dacarbazine, daunorubicin, doxorubicin, epirubicin, idarubicin, ifosfamide, irinotecan, lomustine, mechlorethamine, oxaliplatin, and streptozocin.
Medicare Administrative Contractors (MACs) may determine coverage for other all-oral three-drug antiemesis regimens of aprepitant or any other FDA approved oral NK-1 antagonist in combination with an oral 5HT3 antagonist and oral dexamethasone with the chemotherapeutic agents listed above, or any other anticancer chemotherapeutic agents that are FDA approved and are defined as highly or moderately emetogenic.
CMS is defining highly emetogenic chemotherapy and moderately emetogenic chemotherapy as those anticancer agents so designated in at least two of three guidelines published by the National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), and European Society of Medical Oncology (ESMO)/Multinational Association of Supportive Care in Cancer (MASCC).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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 Bayer HealthCare/ONYX Pharmaceuticals press release.
Read highlights of Stivarga Prescribing Information.
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).
Click on the link below for the fourth quarter 2012 NCCN Flash UpdatesTM report. For ease of reading, this report includes all NCCN Flash Updates released between October 1, 2012, and December 31, 2012, beginning with the most recent updates first.
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.
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.
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.
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.
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:
ACCC is currently analyzing the rule.
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.
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.
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).
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.
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.
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.
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.
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.
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.
Millennium: The Takeda Oncology Company announced that Velcade (bortezomib) is now FDA-approved for subcutaneous administration in patients with multiple myeloma (MM) and relapsed mantle cell lymphoma (MCL).
The FDA warned 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 is labeled as Avastin, manufactured by Roche and does not contain the medicine's active ingredient, Bevacizumab, which may have resulted in patients not receiving needed therapy.
Nineteen medical practices in the United States purchased unapproved cancer medicines from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tenn., is a distributor of QSP's products.
Further information from the FDA regarding this warning can be found at: http://www.fda.gov/Drugs/DrugSafety/ucm291960.htm
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.
Read the FDA press release.
The Food and Drug Administration posted a notice on its website about the risks of purchasing unapproved injectable cancer medications from unlicensed sources.
“Current shortages of injectable cancer medications may present an opportunity for unscrupulous individuals to introduce non-FDA approved products into the drug supply, which could result in serious harm to patients. Health care providers are reminded to obtain and use only FDA-approved injectable cancer medications purchased directly from the manufacturer or from wholesale distributors licensed in the United States.”
“In certain circumstances, the FDA may authorize limited importation of medications that are in short supply. Such medications are imported from approved international sources and distributed in the U.S. through a controlled network, and would not be sold in direct-to-clinic solicitations.
Detailed information is posted on the FDA’s Drug Integrity and Supply Chain Security webpage under the "Outreach" header.
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.
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 the Association of Community Cancer Centers' analysis (page 2) of selected provisions of the Hospital Outpatient Prospective Payment System Final Rule for 2012.
Effective December 6, 2011, the Prescribing Information (PI) for Nplate (romiplostim) has changed. A summary of the changes in the Nplate PI are as follows:
The debt "Super Committee" will consider cuts to Medicare, possibly including the reduction of drug reimbursement to ASP + 3 percent. 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. Tell them the proposed cuts to Medicare are unacceptable. ACCC will keep members informed of our progress and will notify you of any updates.
Prolia (denosumab) has been approved by the U.S. Food and Drug Administration as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer and as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer.
Read the full press release here.
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.
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.
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.
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.
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.
Celgene has informed providers that the shortage of paclitaxel injection has NOT affected the supply of Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound). Abraxane remains fully available through established distribution channels.
Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
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:
An in-depth analysis is available at the Association of Community Cancer Centers' member-only website ACCC's Members-only web section. Log in required.