Oncology News in Brief

FDA Approves Keytruda for Advanced Melanoma

On Sept. 4, 2014, the U.S. Food and Drug Administration (FDA), granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.

Keytruda is the first approved drug that blocks a cellular pathway known as PD-1, which restricts the body’s immune system from attacking melanoma cells. Keytruda is intended for use following treatment with ipilimumab, a type of immunotherapy. For melanoma patients whose tumors express a gene mutation called BRAF V600, Keytruda is intended for use after treatment with ipilimumab and a BRAF inhibitor, a therapy that blocks activity of BRAF gene mutations.

Keytruda is marketed by Merck & Co., based in Whitehouse Station, New Jersey.

Read FDA press release here.

Posted 9/11/2014

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CMS Extends Deadline for Open Payments Review and Dispute

The Centers for Medicare & Medicaid Services (CMS) has extended the deadline for review and dispute of payment information on the Open Payments system until Sept. 10, 2014, according to an Aug. 28 announcement.

In an emailed statement, CMS said that access to the Open Payment system “will be unavailable for approximately two days due to the upcoming maintenance updates at the CMS Data Center.” In the email, the agency said the scheduled maintenance upgrades at the CMS Data Center would take place between Aug. 30 and Sept. 5.

Following the new Sept. 10 deadline, the 15-day correction period will last from Sept. 11 through Sept. 25, the agency said. The date that the public website will be available is still Sept. 30, 2014.

For more information, go to CMS's Open Payments web section.

Posted 8/29/2014

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Open Payments System Reopens, CMS Extends Physician Registration & Review Period

The Centers for Medicare & Medicaid Services (CMS) announced Aug. 15, 2014, that the Open Payments system is reopened so that physicians and teaching hospitals can register, review and, as needed, dispute financial payment information received from healthcare manufacturers, under the Sunshine Act Open Payments program. The system was taken offline on August 3 to resolve a technical issue, the agency said in a statement. To account for system down time, CMS is extending the time for physicians and teaching hospitals to review their records to Sept. 8, 2014. The public website will be available on Sept. 30, 2014.

Read CMS announcement here.

Posted 8/27/2014

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FDA Approves Avastin for Late-stage Cervical Cancer

On August 14, 2014, the U. S. Food and Drug Administration (FDA) approved bevacizumab solution for intravenous infusion (Avastin, Genentech, Inc.) for the treatment of persistent, recurrent or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.

Read FDA announcement here.

Coding and additional information available here.

Posted 8/20/2014

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CMS Issues Rule Finalizing Oct. 1, 2015 as ICD-10 Compliance Date

On July 31, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a rule (CMS-0043-F) making Oct. 1, 2015, the new compliance date for healthcare providers, health plans, and healthcare clearinghouses to transition to ICD-10. “This deadline allows providers, insurance companies and others in the health care industry time to ramp up their operations to ensure their systems and business processes are ready to go on Oct. 1, 2015,” the agency said in a statement.

Read the CMS press release here.

Posted 8/1/2014

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Be Counted in This Year’s ASCO National Oncology Census!

The 2014 ASCO National Oncology Census results will be used to identify continuing and emerging oncology clinical care trends across the entire oncology community. The survey is divided into two parts. The basic list of questions will take 10-12 minutes to complete and will ask you to provide information regarding your practice/institution and workforce characteristics and patient payment methodologies. We also encourage you to complete the second section, which asks about issues facing your practice and will take another 8 minutes.

Whether you are a new or returning participant, 2014 is a new opportunity to be counted!

New This Year: The 2014 survey tool does not require user IDs or passwords so you can click on the below link and be counted immediately.

Please go to www.asco.org/census to complete the census.

Posted 6/6/2014

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QOPI Approved as Pathway to Meet CMS's Quality Reporting Requirements

The Centers for Medicare & Medicaid Services (CMS) has approved the American Society of Clinical Oncology’s (ASCO) Quality Oncology Practice Initiative (QOPI®) as a pathway for oncologists to meet the agency’s quality reporting requirements. Starting in the fall of 2014, oncology practices registered with QOPI will have the opportunity to fulfill CMS’s Physician Quality Reporting System (PQRS) or Qualified Clinical Data Registry (QCDR) reporting requirements through QOPI, according to an ASCO press release.

During the 2014 fall reporting round, practices will have the opportunity to submit their data electronically via eQOPI, a reporting pathway that accepts structured data elements output from their electronic health record.

Read ASCO press release here.

Posted 6/5/2014

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Sunshine Act Phase 2 Data Submissions to Start June 1

Sunshine Act Phase 2 data collection will begin June 1, 2014, according to a recent blog post from the Centers for Medicare & Medicaid Services (CMS).

From June 1 through June 30, applicable drug manufacturers and group purchasing organizations will be able to complete their registration in the Open Payments system and confirm the accuracy of any data submitted during Phase 1. All payment data must be submitted by June 30.

Also beginning June 1, physicians and teaching hospitals will be able to register in the CMS Enterprise Portal, and review data submitted about them by pharmaceutical manufacturers and GPOs.

The CMS blog post states:

"Physicians and teaching hospitals will be able to review data submitted by the manufacturers and GPOs, and if needed, they should report and dispute inaccuracies before the data is included in the public database. They can review the information submitted about them by registering in our Enterprise Portal starting June 1, 2014. Then, in July, physicians and teaching hospitals can begin to register in the Open Payments system. Those registered will be notified when data has been submitted about them, allowing them to review and dispute data submitted by health care manufacturing companies and GPOs prior to public data posting."

Read the full CMS blog post here.

Information on Phase 2 of the Sunshine Act is available here.

Posted 5/29/2014

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Submit 2014 PQRS Quality Measures Via GPRO Web Interface

If you are part of a group practice of 25 or more eligible professionals that is interested in submitting your PQRS quality data using the Web Interface method, resources for 2014 participation are now available to guide you through this reporting option.

Group practices choosing to take part in one of the PQRS Group Practice Reporting Option (GPRO) reporting methods, including the Web Interface, must register by September 30, 2014. Registration must be completed online through the Physician Value Modifier (PV) PQRS Registration System.

For more information from CMS, please click here or dowload GPRO Web Interface Reporting Made Simple.

Posted 5/21/2014

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FDA Approves Ramucirumab for Advanced Gastric or GEJ Cancer

On April 21, 2014, the U. S. Food and Drug Administration approved ramucirumab (Cyramza, Eli Lilly and Company) for use as a single agent for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior treatment with fluoropyrimidine- or platinum-containing chemotherapy. Ramucirumab is a recombinant monoclonal antibody of the IgG1 class that binds to vascular endothelial growth factor receptor-2 (VEGFR-2) and blocks the activation of the receptor.

Read the FDA announcement here.

Posted 4/30/2014

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ASCO Releases Three Guidelines on Survivorship Care

On April 14, the American Society of Clinical Oncology (ASCO) issued three evidence-based clinical practice guidelines on the prevention and management of symptoms that affect many cancer survivors—neuropathy, fatigue and depression, and anxiety. The guidelines are the first three in a planned series of guidelines on survivorship care.

Learn more here.

Posted 4/15/2014

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NCI Statement Outlines Changes in Clinical Trials Program

The National Cancer Institute (NCI) issued a statement on April 4 that briefly outlines the changes now being made in the enterprises that conduct clinical trials under the auspices of the NCI. This includes creation of the new National Clinical Trials Network (NCTN), and consolidation of NCI’s several existing community-based clinical trials programs into an NCI Community Oncology Research Program (NCORP).

Read the NCI statement here.

More information is available here.

Posted 4/7/2014

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PQRS and eRx Incentive Program Participation Grows, CMS Says

The Centers for Medicare & Medicaid Services (CMS) reports increased participation in the Medicare Physician Quality Reporting System (PQRS) and the Electronic Prescribing Incentive (eRx) Program between 2011 and 2012. On April 3, CMS released “The 2012 Physician Quality Reporting System (PQRS) and Electronic Prescribing (eRx) Incentive Program Experience Report.” The report finds:

Read the CMS press release and access the full report here.

Posted 4/4/2014

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SGR "Fix" Extends Current Physician Payment Rates, Delays ICD-10 Implementation

On March 31 the U.S. Senate approved sustainable growth rate (SGR) "patch" legislation to extend current Medicare physician payment rates through March 15, 2015. The House had approved the legislation on March 27. President Obama signed the bill on Tuesday, April 1.

The legislation also delays implementation of ICD-10 until at least Oct. 1, 2015.

This is the 17th time Congress has stepped in with a "doc fix," since the SGR went into effect in 2002.

Read more here.

Posted 4/4/2014

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CMS Issues Meaningful Use 2014 CEHRT Hardship Exception Guidance

On March 10, the Centers for Medicare & Medicaid Services (CMS) issued hardship exception guidance for Medicare-participating eligible providers (EPs) and eligible hospitals unable to implement the 2014 Edition of Certified Electronic Health Record (EHR) Technology in time to successfully demonstrate meaningful use for the 2014 reporting year.

The guidance is to help EPs and hospitals who participated in Stage 1 of the meaningful use program but have been unable to update their EHR systems this year to comply with the 2014 Edition EHR certification criteria from the Office of the National Coordinator of Health IT.

Payment adjustments based on the 2014 reporting period will go into effect in 2016. CMS notes that the payment adjustments only apply to the Medicare EHR Incentive Program.

CMS issued separate one-page guidance for Medicare-participating EPs and Medicare-participating hospitals.

Read the guidance for eligible professionals here.

Read the guidance for eligible hospitals and critical access hospitals here.

In additional guidance for eligible professionals and eligible hospitals updated in March, CMS indicated that additional exceptions may be granted for other reasons such as being  newly practicing EPs, practice at multiple locations, and “unforeseen circumstances.”

Posted 3/12/2014

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CMS Will Not Finalize Several Provisions of Part D Proposal

In a March 10 letter, the Centers for Medicare & Medicaid Services (CMS) Administrator Marilyn Tavenner told Congress the agency will not move ahead with four provisions of a Part D proposed rule, including the proposal to lift the "protected class" definition of three drug classes.

In the letter, Tavenner said: “Give the complexities of these issues and stakeholder input, we do not plan to finalize these proposals at this time.”

Read the letter here.

Posted 3/11/2014

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CMS Seeks Comments on Transforming Physician Payment Models

The Centers for Medicare & Medicaid Services (CMS) is seeking comments on the best methods for assisting physician practices in the move from a fee-for-service reimbursement model to alternative payment models. On March 5, CMS issued a request for information (RFI) on delivery system reform. The agency is asking for input on policy considerations about large scale transformation of clinical practices with the aim of better care and better health at lower costs. CMS may use the information collected from this RFI to test new payment and service delivery models.

The deadline for comments is April 8, 2014.

Posted 3/7/2014

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Administration’s Proposed FY 2015 Budget Includes $1 Trillion in Health Spending

On March 4 the Obama administration proposed a fiscal year (FY) 2015 budget that includes nearly $1 trillion for federal health programs administered by the Department of Health and Human Services (HHS). Included are legislative proposals for Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP) that the administration says will save more than $400 billion through 2024.

However, it is unlikely that the administration’s proposals in their current form will be passed by Congress. Many of the proposals have been included in previous budgets proposed by the administration and have not been acted upon.

The proposed FY 2015 budget includes the following Medicare-specific proposals:

Read the Health and Human Services FY 2015 Budget in Brief here.

Posted 3/7/2014

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Sunshine Act Data Collection to Begin Feb. 18, CMS Says

The Centers for Medicare & Medicaid Services (CMS) has announced the agency will start the first phase of Sunshine Act data collection on Feb. 18, 2014. During the initial phase, some manufacturers and group purchasing organizations will start submitting data to CMS on payments made to healthcare providers, including gifts, consulting fees, and research activities. Phase two, which will begin in May, will include industry registration in the CMS Open Payments system, submission of detailed 2013 payment data, and legal attestation to the accuracy of the data, Bloomberg BNA reports.

Posted 2/12/2014

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CMS Extends Medicare EHR Attestation Deadline for EPs; Offers Hospitals Attestation Help

On Feb. 7, the Centers for Medicare & Medicaid Services (CMS) announced a one-month extension—from 11:59 pm on February 28 to 11:59 pm on March 31, 2014—of the deadline for physicians and other eligible professionals (EPs) to meet the requirements of Medicare Meaningful Use program in 2013.

The hospital deadline was Dec. 1, 2013. However, the agency said that hospitals that experienced problems in attesting in 2013 can retroactively submit their attestation data in 2014. Hospitals that want to retroactively submit 2013 data must contact CMS by March 15, 2014.

The one-month deadline extension applies only to the Medicare EHR Incentive Program and not to the Medicaid EHR Incentive Program or the Physician Quality Reporting System EHR Incentive Program, the agency said.

Posted 2/12/2014

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HHS Agency Suspends New Medicare Appeals for 2 Years, Due to Backlog

memorandum from the Department of Health and Human Services (HHS) Office of Medicare Hearings and Appeals (OMHA) states that it is suspending the assignment of new Medicare appeals to administrative law judges for at least two years in order to work through an increasing backlog of appeals, according to Bloomberg BNA Health Care Daily Report (01/16, 2014). However, new beneficiary-initiated appeals will not be suspended.

The memorandum, authored by OMHA’s Chief Administrative Law Judge Nancy J. Griswold, said the suspension was effective as of July 15, 2013, and will affect most Medicare appeals at the ALJ appeal level. Griswold said the suspension applied to “Medicare providers and suppliers, and Medicaid state agencies,” BNA reports.

However, the letter stated that appeals filed directly by Medicare beneficiaries will continue to be assigned and processed “to ensure [beneficiaries’] health and safety is protected.”

OMHA will hold an Medicare Appellant Forum in Washington on February 12 to address the impact of the appeals suspension.

Posted 1/16/2014

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New J-code for Carfilzomib

The Centers for Medicare & Medicaid Services (CMS) have granted Kyprolis® (carfilzomib) for Injection a permanent Healthcare Common Procedure Coding System (HCPCS) J-code. The new code, J9047, is defined as “Injection, carfilzomib, 1mg.” This code is effective January 1, 2014.

Posted 12/27/2013

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New J-codes from Genentech

The Centers for Medicare & Medicaid Services (CMS) have granted KADCYLA® (ado-trastuzumab emtansine) and PERJETA® (pertuzumab) permanent J-codes that go into effect January 1, 2014. The J-code for KADCYLA is J9354 (injection, ado-trastuzumab emtansine, 1 mg) and the J-code for PERJETA is J9306 (injection, pertuzumab, 1 mg).

Please be sure to prepare your systems for the introduction of these 2 new codes. For additional assistance, you can contact one of the dedicated Specialists at Genentech BioOncology™ Access Solutions at 888.249.4918, or visit Genentech‐Access.com/BioOncology for more information.

Posted 12/9/2013

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CMS Releases 2014 PFS Final Rule

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 CodesConsistent 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.

View the 2014 PFS final rule here.

View CMS Fact Sheet on 2014 PFS final rule here.

Posted 12/2/2013

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CMS Releases 2014 OPPS Final Rule

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.   

View the 2014 OPPS final rule.

Read a CMS fact sheet on the 2014 OPPS final rule.

Posted 12/2/2013

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FDA Approves Nexavar to Treat Metastatic Differentiated Thyroid Cancer

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.

Read the FDA press release here.

Posted 11/27/2013

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FDA Approves Gazyva (obinutuzumab) for CLL

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.

Read the FDA press release here.

Posted 11/4/2013

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Update to Hospital Inpatient Admission Order and Certification from CMS

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.

Posted 10/16/2013

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CMS Extends PQRS Registration Deadline for Large Groups to October 18; Register Now to Avoid PQRS and VBM Payment Penalties

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).

Posted 10/15/2013

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FDA Approves Abraxane for Late-Stage Pancreatic Cancer

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.

Read the press release here.

Posted 9/17/2013

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CBO Puts Cost for SGR Fix at $175 Billion Over 10 Years

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.

Read the CBO cost estimate here.

Posted 9/17/2013

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CMS Issues Final Rule on DSH Cuts for Safety-Net Hospitals

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.

Read CMS fact sheet on the Medicaid State DSH Allotment Reductions Final Rule here.

The rule is available here.

Posted 9/16/2013

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IOM Releases Report on Delivering High-Quality Cancer Care

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:

  1. engaged patients;
  2. an adequately staffed, trained, and coordinated workforce;
  3. evidence-based care;
  4. learning healthcare information technology (IT);
  5. translation of evidence into clinical practice, quality measurement, and performance improvement; and
  6. accessible and affordable care.

Read the report brief here.

Access the full report here.

Posted 9/12/2013

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FDA Approves XGEVA (denosumab) for the Treatment of Giant Cell Tumor of Bone

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.

The FDA press release is available here.

Posted 6/28/2013

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FDA Approves Revlimid for Mantle Cell Lymphoma

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 FDA press release is available here.

Posted 6/20/2013

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CMS to Cover Anti-Nausea Regimen for Chemotherapy Patients

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).

The CMS Decision Memo is available here.

Posted 6/3/2013

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

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

Learn more here.

Posted 5/22/2013

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CMS Issues Proposed Rule on DSH Reductions

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

Read a CMS fact sheet on the proposed rule here.

Read the proposed rule here.

Posted 5/15/2013

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CMS Updates EHR FAQs: Information on Sequestration and Attestation

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

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

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

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

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

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

Posted 4/25/2013

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New Bill Proposes to Exempt Cancer Drugs from the Sequester

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

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

Posted 4/10/2013

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Sequestration Coming April 1

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

Why is drug reimbursement being reduced by this amount?

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

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

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

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

Posted 3/29/2013

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CMS OPPS Transmittal Lists New SRS Payment Changes

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

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

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

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

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

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

April 2013 Payment Rate: $3,301

Read the CMS transmittal here.

Posted 3/20/2013

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CMS Proposes Expanding PET Scan Coverage; Removal of CED Requirement

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

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

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

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

Read the proposed decision memo here.

Posted 3/18/2013

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MedPAC Releases 2013 Report to Congress

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

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

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

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

Read the full report here.

Read a fact sheet on the report here.

Posted 3/15/2013

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CMS Issues PET Final Coverage Decision

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

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

Read the decision memo here.

Posted 3/12/2013

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Synribo Approved by FDA for CML

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

Learn more.

Posted 3/14/2013

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FDA Approves Stivarga for Advanced Gastrointestinal Stromal Tumors

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

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

Read Bayer HealthCare/ONYX Pharmaceuticals press release.

Read highlights of Stivarga Prescribing Information.

Posted 2/28/2013

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FDA Approves Pomalyst for Advanced Multiple Myeloma

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

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

Read FDA press release.

Read letter from Celgene.

Prescribing Information.

Posted 2/28/2013

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NCCN Flash Reports for October through December 2012

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.

NCCN Quarterly Flash Report

Posted 1/4/2013

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