FDA Approves Ofatumumab in Combination with Chlorambucil, for Previously Untreated CLL
On April 17, 2014, the U. S. Food and Drug Administration approved ofatumumab (Arzerra Injection, for intravenous infusion; GlaxoSmithKline) in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate.Read the FDA announcement here.
FDA Grants Orphan Drug Designation to Volasertib for AML
On April 17, 2014, Boehringer Ingelheim Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to volasertib for acute myeloid leukemia (AML). Volasertib is currently being evaluated in a Phase III clinical trial for the treatment of patients aged 65 or older, with previously untreated AML, who are ineligible for intensive remission induction therapy. Volasertib has not been approved by the FDA; its safety and efficacy have not been established.
In the U.S. Orphan Drug Designation is a status given to investigational compounds intended to treat a rare disease or condition that has limited treatment options. To qualify for FDA’s Orphan Drug Designation, the drug must, among other requirements, address a disease that affects fewer than 200,000 total people in the U.S.Read company press release here.
NCI GEM Initiative Webinar on April 17
The National Cancer Institute's Grid Enabled Measures (GEM) initiative is presenting a webinar on GEM Care Planning: Advancing Survivorship Care Planning Through Community Engagement on Thursday, April 17, 2014, 2-3PM EST.
NCI's Carly Perry, PhD, MA, MSW, and University of Pittsburgh's Ellen Beckjord, PhD, MPH, will present on the GEM-Care planning (GEM-CP) initiative and related science. They will share insights into the GEM-CP platform and movement to develop consensus on measures to evaluate survivorship care planning as well as discuss results of the initiative. Learn more about GEM here: www.gem-measures.org.
To access the webinar online, go to https://webmeeting.nih.gov/gems and log in as a Guest at 1:45 pm. When the login screen appears, select the option to Enter as a Guest, enter your full name and click on the Enter Room button. Once you have entered the Adobe Connect Webmeeting, call the teleconference call number and follow the prompts:
Teleconference Number: 1-866-398-2885
Teleconference Passcode: 6381864930
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.
NCI Statement Outlines Changes in Clinical Trials Programs
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.
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:
- Participation in the PQRS program grew by 36 percent from 2011. Approximately 36 percent of the 1,201,363 professionals who were eligible to participate in 2012 participated in PQRS. The 2012 PQRS incentive payments totaled $167,815,193.
- PSQRS participation is highest among eligible professionals who see the most Medicare patients. While the overall PQRS participation rate is 36%, participation is at 53% among those who treat more than 200 Medicare beneficiaries a year.
- Participation in the eRx program increased by 22 percent from 2011. Approximately 44 percent of the 778,904 professionals who were eligible to participate in 2012 participated in the eRx program. The 2012 eRx incentive payments totaled $335,331,216.
Read the CMS press release and access the full report here.
Senate Passes 1-Year SGR Extension
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 is expected to sign the bill, Bloomberg BNA reports.
The legislation would also delay implementation of ICD-10 until Oct. 1, 2015.
Update on Doxil Supply
In a March 24, 2014, Dear Healthcare Professional letter, Janssen Products, LP, provides an update on the doxil supply.
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.
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.”
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.
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.
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:
- Increase premiums under Part B and Part D for higher income beneficiaries
- Reduce reimbursements for Part B drugs from 106 percent of average sales price to 103 percent
- Align Medicare drug payment policies with Medicaid policies for low-income beneficiaries
- Prohibit critical access hospital designation for facilities that are less than 10 miles from the nearest hospital
- Strengthen the Independent Payment Advisory Board (IPAB) for Medicare by lowering the target rate for triggering IPAB recommendations to Congress.
Read the Health and Human Services FY 2015 Budget in Brief here.
FDA Grants Accelerated Approval to Ibrutinib for CLL
On Feb. 12, 2014, the U. S. Food and Drug Administration (FDA) granted accelerated approval to ibrutinib (IMBRUVICA, Pharmacyclics, Inc.) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.
Ibrutinib previously received accelerated approval on November 13, 2013, for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
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.
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.
Zaltrap Issued Permanent J Code
The Centers for Medicare & Medicaid Services (CMS) has granted Zaltrap® (ziv-aflibercept) Injection for Intravenous Infusion a permanent J Code: J9400. This new HCPCS code is effective for dates of service on or after January 1, 2014.
HHS Agency Suspends New Medicare Appeals for 2 Years, Due to Backlog
A 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.
HHS Report Provides Demographic Information on Insurance Marketplace Enrollees
From Oct. 1 to Dec. 28, 2013, almost 2.2 million people selected plans through the Affordable Care Act’s state and federal insurance Marketplaces, according to a report released Jan. 13, by the U.S. Department and Health and Human Services’ Office of the Assistant Secretary for Planning and Evaluation (ASPE). The report presents a “snapshot” of Marketplace enrollment-related activity during the initial open-enrollment period, based on available data. Highlights from the report include:
Marketplace Plan Selection by Age
- 24% of those who have selected a Marketplace plan are between the ages of 18 and 34.
- 30% of those who have selected a Marketplace plan are between the ages of 0 and 34.
Marketplace Plan Selection by Metal Level
- 60% of those selecting a Marketplace plan opted for a “Silver” tier plan.
- 20% have selected a Bronze tier plan.
- 13% have selected a Gold tier plan.
- 7% have selected a Platinum tier plan.
- 1% have selected a Catastrophic plan.
Marketplace Plan Selection by Financial Assistance
- 79% of those who have selected a Marketplace plan have selected a plan with financial assistance.
The report includes state-by-state information.
FDA Approves Mekinist in Combination with Tafinlar for Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has approved Mekinist® (trametinib) for use in combination with Tafinlar® (dabrafenib) for the treatment of patients with unresectable melanoma or metastatic melanoma with BRAF V600E or V600K mutations. These mutations must be detected by an FDA-approved test. Tafinlar is not indicated for treatment of patients with wild-type BRAF melanoma.
The FDA approved the combination of Mekinist and Tafinlar under the agency’s accelerated approval program.
USPSTF Releases Final Recommendation on Screening for Those at High Risk of Lung Cancer
On Dec. 30, 2013, the U.S. Preventive Services Task Force (USPSTF) released its final recommendation on screening those at high risk of lung cancer, grading annual low-dose CT screening for individuals at high risk for lung cancer with a B grade.
The USPSTF recommends annual screening for lung cancer with low-dose computed tomography (LDCT) in adults aged 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years. Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery.
USPSTF Finds Benefit in Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-related Cancer for Small Group of High-Risk Women
On Dec. 24, 2013, the U.S. Preventive Services Task Force (USPSTF) issued its final recommendation on risk assessment, genetic counseling, and genetic testing for BRCA-related cancer in women. The USPSTF recommends that women with family members who have had breast, ovarian, tubal, or peritoneal cancer talk with a healthcare professional to learn if their history might put them at risk for carrying a BRCA mutation. Women who screen positive should receive genetic counseling and, if indicated after counseling, BRCA testing. Additionally, for the vast majority of American women (90 percent), who do not have a family history associated with an increased risk for the inherited mutations, the USPSTF continues to recommend against genetic counseling and testing.
CMS Announces 123 New Provider Groups to Participate in MSSP as ACOs
On December 23, 2013, the Centers for Medicare & Medicaid Services (CMS) announced 123 new provider groups that will be participating in the Medicare Shared Savings Program (MSSP) in 2014 as accountable care organizations (ACOs), Bloomberg BNA reports.
The agency said that the new ACOs represent a diverse cross-section of healthcare providers, including those providing care in underserved areas. According to CMS, the new ACOs will deliver care for about 1.5 million more Medicare beneficiaries. The performance period for the new ACOs starts Jan. 1, 2014.
Annual Report to the Nation Shows Lung Cancer Deaths Continue to Decline
The Annual Report to the Nation on the Status of Cancer, covering the period 1975–2010, showed death rates for lung cancer, which accounts for more than one in four cancer deaths, dropping at a faster pace than in previous years. The recent larger drop in lung cancer deaths is likely the result of decreased cigarette smoking prevalence over many years, and is now being reflected in mortality trends. The report showed, however, that death rates increased for some cancers, including cancers of the liver and pancreas for both sexes, cancers of the uterus in women, and, in men only, melanoma of the skin and cancers of the soft tissue in this 10 year period.
The Report, produced annually since 1998, is co-authored by researchers from the National Cancer Institute (NCI); the American Cancer Society (ACS); the Centers for Disease Control and Prevention (CDC); and the North American Association of Central Cancer Registries (NAACCR). The Report appeared online in the journal Cancer on Dec. 16, 2013.
The Annual Report to the Nation on the Status of Cancer, 1975-2010, Featuring Prevalence of Comorbidity and Impact on Survival Among Persons With Lung, Colorectal, Breast, or Prostate Cancer is available here.
Federal Pre-Existing Condition Insurance Plan Extended One Month
The federal government’s Pre-Existing Condition Insurance Plan (PCIP), which was set to expire on Dec. 31, 2013, will be extended for one month while the government works to fix the Affordable Care Act health exchange that is intended to serve as an alternative, according to Bloomberg BNA Health Care Daily Report (Dec. 13, 2013). Individuals in the program who have not obtained coverage will be able to stay through the end of January, Aaron Albright, a CMS spokesperson said in a Dec. 12 email, BNA reports.
The extension does not affect high-risk insurance pools for sick people independently run by 35 states. Expiration dates for those plans vary and, in some states, will extend beyond Jan. 1, BNA reports.
CMS Delays Start of Stage 3 Meaningful Use
On Dec. 6, 2013, the Centers for Medicare & Medicaid Services (CMS) announced it will delay the start of Stage 3 Meaningful Use for one year, according to Bloomberg BNA Health Care Daily Report. Under the revised timeline, Stage 2 will be extended through 2016 and Stage 3 will begin in 2017 for those providers that have completed at least two years in Stage 2.
Hospitals and providers who have received incentive payments for at least two years under Stage 1 of the Meaningful Use program will still be required to move into Stage 2 in 2014. But the delay will provide an additional year of reporting under Stage 2 before they must move to Stage 3.
The revised timeline will not affect the 2016 Medicare payment penalties scheduled for providers and hospitals that do not meet meaningful use requirements, a CMS spokesperson told BNA.
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 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.
ACCC is continuing to review the final 2014 PFS rule and will have a more complete summary available later this week. ACCC will also host a members-only conference call on the 2014 OPPS and PFS final rules on Thursday, December 12.
The 2014 PFS final rule will appear in the December 10 Federal Register.
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 Prospective 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.
ACCC is continuing to review the final 2014 OPPS rule and will have a more complete summary available later this week. ACCC will also host a members-only conference call on the 2014 OPPS and PFS final rules on Thursday, December 12.
The 2014 OPPS final rule will appear in the December 10 Federal Register, and can be viewed here.
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.
Commission on Cancer to Modify Standard 1.3
The Accreditation Committee of the American College of Surgeons Commission on Cancer (CoC) has approved a motion to modify Standard 1.3, Cancer Committee Attendance. The modification will allow for an appointed individual and one designated alternate for both physician and non-physician members of the Cancer Committee. The individual appointment and alternate designation would be set at the beginning of the year when membership is confirmed. The revision to the standard would allow for the attendance of the appointed individual and the designated alternate to be combined to meet the percentage attendance requirement.
The CoC’s Standards Advisory Group of Excellence (SAGE) recommended that the Accreditation Committee approve the changes which will be implemented Jan. 1, 2014.
PCORI Board Approves More than $1 Billion in Funding for CER
The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors recently approved a two-year commitment to spend more than $1 billion in funding for comparative effective research (CER) projects in fiscal years 2014 and 2015, Bloomberg BNA Health Care Daily reports. At a November 18 meeting, the PCORI board also accepted the revised version of its methodology report that sets the groundwork for standards and types of research methods that can be used to develop CER.
PCORI has also adopted a new strategic plan that outlines three goals to advance patient-centered outcomes research: These are:
- To substantially increase the quantity, quality, and timeliness of useful, reliable evidence to improve healthcare decision making;
- To speed the implementation and use of findings from patient-centered outcomes research; and
- To influence clinical and healthcare research funded by others to be more patient-centered.
FDA Grants Crizotinib Regular Approval for Metastatic NSCLC
On November 20, 2013, the U. S. Food and Drug Administration (FDA) granted regular approval for crizotinib (Xalkori) capsules for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The approval was based on demonstration of superior progression-free survival (PFS) and overall response rate (ORR) for crizotinib-treated patients compared to chemotherapy in patients with ALK-positive NSCLC with disease progression after platinum-based doublet chemotherapy.
An open-label, active-controlled, multinational, randomized trial enrolled 347 patients with ALK-positive, metastatic NSCLC. Patients were required to have progressed following platinum-based chemotherapy and to have ALK expression in tumor specimens detected by fluorescence in situ hybridization on central laboratory testing. Patients were randomized to receive either crizotinib 250 mg orally twice daily (n=173) or chemotherapy (n=174). Patients randomized to chemotherapy received pemetrexed (58%) or docetaxel (42%) if they had received prior pemetrexed. Approximately 64% of patients on the chemotherapy arm subsequently received crizotinib.
The trial demonstrated significantly prolonged progression-free survival (PFS) for crizotinib treatment compared to chemotherapy [HR=0.49, (95% CI: 0.37, 0.64), p<0.0001].
Crizotinib was previously granted accelerated approval in August 2011, based on durable, objective response rates (ORR) of 50% and 61% in two single-arm, open-label studies.
FDA Approves Imbruvica for Mantle Cell Lymphoma (MCL)
On Nov. 13, 2013, the U.S. Food and Drug Administration approved Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer.
MCL is a rare form of non-Hodgkin lymphoma and represents about 6 percent of all non-Hodgkin lymphoma cases in the U.S. By the time MCL is diagnosed, it usually has already spread to the lymph nodes, bone marrow, and other organs.
Imbruvica is intended for patients with MCL who have received at least one prior therapy. It works by inhibiting the enzyme needed by the cancer to multiply and spread. Imbruvica is the third drug approved to treat MCL. Velcade (2006) and Revlimid (2013) are also approved to treat the disease.
Imbruvica is the second drug with breakthrough therapy designation to receive FDA approval. The Food and Drug Administration Safety and Innovation Act, passed in July 2012, gave the FDA the ability to designate a drug a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases.
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.
ACCC Issues Position Statement on 340B Drug Program
The Association of Community Cancer Centers (ACCC) has released a position paper regarding the 340B Drug Discount Program. In 1992, Congress created the 340B Drug Discount Program to reduce outpatient drug costs for certain types of healthcare facilities that treated a high proportion of uninsured or underinsured patients. The law requires pharmaceutical manufacturers to give discounted rates on drugs to qualifying hospitals or clinics, otherwise known as qualified entities. In 2010, as part of the Affordable Care Act, Congress expanded the program, allowing more healthcare facilities to qualify.
ACCC's position paper calls for clearer regulations to be promulgated to ensure the long-term viability of the 340B Program.
Read the position paper here.
CMS Says Final 2014 OPPS & PFS Rules Likely Delayed
As reported in the Oct. 24, Bloomberg BNA Health Care Daily Report, an Oct. 23, 2013, memorandum to providers from Robert Fritter, Director of the Centers for Medicare & Medicaid Services (CMS) Division of Provider Relations and Outreach, states that four 2014 Medicare rules, including the 2014 Physician Fee Schedule (PFS) and the Hospital Outpatient Prospective Payment Systems (OPPS) rules, may not be released until the end of November, possibly not until November 27. The likely delay is stemming from the impact of the recent government shutdown on regulatory work.
CMS states that the rules will be effective Jan. 1, 2014.
LDCT Lung Screening Seminar
Rescue Lung, Rescue Life is a multidisciplinary movement founded by physicians, administrators, and staff from the departments of internal medicine, pulmonary and critical care, radiation and medical oncology, cardio thoracic surgery, laboratory medicine and radiology at the Lahey Hospital & Medical Center (LHMC) in Massachusetts. On Friday, November, 22, 2013, the multidisciplinary lung cancer screening team will present a seminar on:
Low-Dose CT Lung Cancer Screening: Creating and Managing an Effective LDCT Screening Program
Friday, November 22, 2013
8 am to 5 pm
Lahey Hospital & Medical Center
41 Mall Rd, Burlington, MA
The seminar will focus on designing and implementing a high-volume, cost-efficient, responsible low-dose CT lung cancer screening program based on best practices.
The program agenda and registration information is available here.
ASHP Foundation Offers Oncology Patient Care Traineeship
The ASHP Foundation of the American Society of Health-System Pharmacists (ASHP) is offering an Oncology Patient Care Traineeship. The four-month, ACPE-accredited educational program is designed to train pharmacists to develop and maintain specialized services for the management of patients with cancer. Trainees will receive intensive distance and experiential training that prepares them to participate on inter-professional patient care teams as the health professional who is responsible and accountable for patients’ medication-related outcomes.
The Oncology Patient Care Traineeship Program is designed for pharmacists in acute, ambulatory, and home care settings who have not completed a specialized residency in oncology and are developing or expanding specialized oncology services and care to patients with cancer. The traineeship prepares health-system pharmacists to assume responsibility for the management of the complex medication regimens often required by patients with cancer. The ultimate goal of the program is to train pharmacists to practice in the oncology setting where they have the ability to positively impact and improve patient outcomes.
More information about the program, qualification requirements, how to apply, and the application deadline is available here.
Update On Doxil Drug Supply Shortages
On Oct. 14, 2013, Janssen Products, LP, provided an update regarding Doxil drug supply shortages. In a Dear Healthcare Provider letter, the company states that it is beginning to experience supply outages of Doxil at the distributor level.
The letter states that, in conjunction with the U.S. Food and Drug Administration, the company is continuing to explore options to keep Doxil accessible in both the short- and long-term. The company is continuing to take steps needed for its long-term transition to new suppliers of Doxil.
Read the Dear Healthcare Provider letter here.
Learn more here.
ACCC Updates Survey on Off-Label Utilization in Cancer Care
ACCC and PhRMA recently released results of a joint survey on off-label therapy in cancer care. This was a follow-up to a survey first conducted in 2008 to study the importance of off-label therapies in cancer care. The new survey, conducted in August and September 2013, polled ACCC members not only to understand the utilization of off-label therapy in cancer care, but also to determine the impact of payer coverage policies on prescribing.
One of the main drivers of the 2008 survey was the change in policy for drug compendia; in 2008 CMS increased the number of approved compendia. While there was no such change in 2013, the survey attempted to determine how significant changes in payment reform may be impacting compendia and off-label utilization.
The 2013 survey respondents, comprised mostly of medical oncologists and practice and cancer service line administrators, overwhelmingly stated that off-label therapy remains important in their facilities; 64% of oncology practices described off-label use as somewhat important and 27% described it as extremely important. However, the level of importance did decrease from an average of 4.1 to 3.6 on a 1-5 scale where 5 indicates “extremely important.”
Survey respondents also reported a decrease in the importance of drug compendia, from an average of 4.2 to 3.7 on the same 1-5 scale. Even though there was a decrease in level of importance, compendia still play a large role in off-label utilization, with an average of 64% of off-label indications being supported by compendia.
Even though the compendia landscape has been relatively stable for the past 5 years, there are still concerns over denials of compendia-listed indications. Eighty percent of respondents reported being denied coverage of medicines supported by compendia, and 84% reported denials for medicines listed in peer-reviewed journals. As a result, nearly all respondents (95%) report that coverage and reimbursement policies cause clinicians to alter their decision-making process.
In 2013, pathways and guidelines utilization has increased, and are playing a larger role in off-label treatment. Overall, off-label therapy continues to be a common practice in oncology, and while compendia and journals still play a large role, practices are turning to guidelines more often to inform their decision making.
FDA Provides Information on Availability of Doxorubicin Hydrochloride Liposome Injection
On Oct. 8, 2013, the U.S. Food and Drug Administration (FDA) provided information on the availability of doxorubicin hydrochloride liposome injection to supply the U.S. market.
Doxil® (doxorubicin hydrochloride liposome injection) is distributed by Janssen Products, LP and has been manufactured under contract by Ben Venue Laboratories, Inc. On September 25, 2013, Janssen notified healthcare professionals of an interruption of supply of Doxil resulting from manufacturing issues at Ben Venue Laboratories. On October 3, 2013, Ben Venue Laboratories announced their plans to cease all manufacturing by the end of 2013.
Sun Pharma Global has confirmed to FDA that there are sufficient supplies of its doxorubicin hydrochloride liposome injection, a generic product that is therapeutically equivalent to Janssen’s Doxil, to cover the U.S. market.
Please contact your wholesaler or the following customer service numbers to obtain product:
|Sun Pharma Global FZE
(Caraco Pharmaceutical, U.S. distributor)
2 mg/mL; 10 mL vial
|Janssen Products, LP
|Doxil 2 mg/mL, Janssen Products, LP
2 mg/mL, 10 mL (20 mg) vial (NDC 59676-0960-01)
Training in Psychosocial Distress Screening Program Development
The American Psychosocial Oncology Society (APOS) in partnership with Yale School of Nursing is offering training for cancer care professionals on how to develop, implement, and maintain psychosocial screening programs. The Screening for Psychosocial Distress Program is a two-year course, funded by the National Cancer Institute, that will enroll up to 18 cancer centers each year. The course will train two cancer care professionals from each center.
The first year of the program begins with a one-day workshop at the annual American Psychosocial Oncology Society conference and continues with videoconferences with experts every three months.
The second year includes an advanced one-day workshop at the annual APOS conference with two videoconferences during the year.
The first cohort of trainees will begin the course in February 2014.
The deadline to submit an application is November 15, 2013.More information is available here.
FDA Approves Perjeta for Neoadjuvant Breast Cancer Treatment
On September 30, 2013, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Perjeta (pertuzumab) as part of a complete treatment regimen for patients with early stage breast cancer before surgery (neoadjuvant setting). Perjeta is the first FDA-approved drug for the neoadjuvant treatment of breast cancer.
Perjeta was approved in 2012 for the treatment of patients with advanced or late-stage (metastatic) HER2-positive breast cancer.
Perjeta’s new use is intended for patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer (tumor greater than 2 cm in diameter or with positive lymph nodes) who are at high risk of having their cancer return or spread (metastasize) or of dying from the disease. It is to be used in combination with trastuzumab and other chemotherapy prior to surgery and, depending upon the treatment regimen used, may be followed by chemotherapy after surgery. Following surgery, patients should continue to receive trastuzumab to complete one year of treatment.
Cancer Insurance Checklist: New Tool to Help Navigate Insurance Marketplaces
On October 1, 2013, state-based health insurance marketplaces (also known as insurance exchanges) open for enrollment. The exchanges are designed for the uninsured, people who buy their own coverage, and those whose employer-provided coverage is too expensive or lacks needed benefits.
For people with cancer, a history of cancer, or a risk for cancer, understanding the coverage for cancer-related health services is crucial for making educated decisions based on their healthcare needs and budgets.
A new tool, the Cancer Insurance Checklist, developed by the Cancer Support Community in partnership with the Association of Community Cancer Centers and 17 other cancer and patient advocacy organizations, is designed to help. The checklist is designed to use while evaluating insurance plans and when discussing them with a navigator or healthcare provider. It offers a checklist, a glossary, and additional resources to help with insurance-related decisions.
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.
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.
The rule is available here.
ACCC Submits Comments to CMS on Proposed 2014 OPPS and PFS Rules
On Sept. 6, 2013, the Association of Community Cancer Centers (ACCC) submitted comment letters to the Centers for Medicare & Medicaid Services (CMS) on the proposed 2014 Hospital Outpatient Prospective Payment System (OPPS) Rule and the proposed 2014 Physician Fee Schedule (PFS) Rule.
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:
- engaged patients;
- an adequately staffed, trained, and coordinated workforce;
- evidence-based care;
- learning healthcare information technology (IT);
- translation of evidence into clinical practice, quality measurement, and performance improvement; and
- accessible and affordable care.
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.
Sept. 19 Webinar on Evidence-Based Psychosocial Interventions
On Thursday, September 19, 2013, the American Psychosocial Oncology Society (APOS) is hosting a 90-minute webinar on “Evidence-Based Psychosocial Interventions: Accessing and Developing Research-Tested Intervention Programs (RTIPs) for Real World Implementation.”
The webinar will provide an overview on evidence-based programs for health professionals seeking interventions for implementation in clinical and community settings and provide an introduction to the online and freely accessible Research-tested Intervention Programs (RTIPs) registry, sponsored by the National Cancer Institute (NCI) and the Substance Abuse and Mental Health Services Administration (SAMHSA).
FDA Issues Label Change for Adcetris
On Aug 19, 2013, the FDA issued a label change for Adcetris® (brentuximab vedotin). Key label changes include:
- Dosage and Administration Section 1: 16 cycle limitation has been removed from the label. New label states “Continue treatment until disease progression or unacceptable toxicity”
- Warnings and Precautions Section 5: Growth factor support added for consistency with Dose Modification in section 2.
CMS & Health IT Coordinator Release Plan for HIE Acceleration
On August 7, 2013, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology released a plan for speeding up health data exchange among providers and health care organizations.
The plan, Principles and Strategy to Accelerate Health Information Exchange (HIE), highlights HHS policy goals and ways HHS hopes to further advance HIE beyond the current Medicare and Medicaid EHR Incentive Programs and ONC certification programs. Among the goals identified are the following:
- New HHS regulations and guidance on existing programs will enable a patient’s health information to follow them wherever they access care with appropriate privacy and security safeguards.
- HHS programs will advance HIE across providers including long-term and post-acute care, behavioral health, and laboratory providers.
- HHS will advance multi-stakeholder development of standards, including an interoperability and certification road map that will serve as a transparent planning tool to guide standards development, adoption, and HIT certification.
- HHS will build upon and move beyond the foundation of the Medicare and Medicaid EHR Incentive Programs and the ONC HIT Certification Program.
- HHS will work to align HIT standards for quality measurement and improvement across Medicare and Medicaid.
- HHS will implement policies that encourage electronic HIE incrementally and evolve from incentive and reward structures to electronic HIE as a standard business practice for providers.
GSK to Discontinue Manufacture and Sale of BEXXAR
GlaxoSmithKline (GSK) has announced that the company will discontinue the manufacture and sale of the BEXXAR® therapeutic regimen (tositumomab and iodine I 131 tositumomab) on February 20, 2014. BEXXAR is currently approved in the U.S. and Canada for the treatment of certain types of non-Hodgkin's lymphoma.
GSK is announcing its decision now to give treatment centers in the U.S. and Canada currently offering BEXXAR adequate time to consider and, if appropriate, transition to other therapies.
According to a company press release, the use of BEXXAR has been extremely limited and is projected to continue to decline.
Over the next six months, GSK will continue to provide support services for patients and treatment centers. Physicians and patients with questions can call the GSK Response Center (GRC) at 1-888-825-5249 (U.S.) or 1-800-387-7374 (Canada).
ACCC Aug. 5 Conference Call on 2014 PFS
ACCC held an additional conference call to review the 2014 Physician Fee Schedule (PFS) proposed rule in more depth on Monday, August 5.
More information is available at www.cms.gov.
Posted 8/1/2013. Updated 8/8/2013.
USPSTF Issues Draft Recommendation on CT Scans for Those at High Risk for Lung Cancer
On July 30, the U.S. Preventive Services Task Force (USPSTF) issued a draft recommendation for annual CT scans for those at high risk for lung cancer. The draft recommends screening for current and former smokers ages 55 through 79 with a smoking history the equivalent of smoking a pack a day for 30 years or two packs a day for 15 years. The recommendation for screening includes those who have quit within the past 15 years.
The USPSTF draft recommendation statement is available for comment from July 30 until August 26, 2013, at 5:00 PM ET.
MAPRx Coalition Report Highlights Flaws in Part D Specialty Tier Policy
On July 25, the Medicare Access for Patients Rx (MAPRx) Coalition released a white paper outlining ways to improve patient prescription drug access under Medicare Part D. The report, “Revising Specialty Tiers: Protecting Medicare Part D Beneficiaries from Burdensome Cost Shifting,” was introduced on the same day that U.S. Rep. Hank Johnson (D-GA) reintroduced H.R. 2827, The Part D Beneficiary Appeals Fairness Act, on the House floor. Senate Aging Committee Chairman Bill Nelson (D-FL) introduced the bill in the Senate as S. 1365.
The Association of Community Cancer Centers (ACCC) participates in the MAPRx Coalition, which includes beneficiary, patient advocacy, family caregiver and health professional organizations committed to safeguarding the well-being of patients with chronic diseases and disabilities under Medicare Prescription Drug Coverage.
APOS Announces Recommendations to Support Distress Screening
On July 16, the American Psychosocial Oncology Society (APOS) announced recommendations to support new American College of Surgeons (ACoS) Commission on Cancer (CoC) standard 3.2 on psychosocial distress screening. APOS, together with the Association of Oncology Social Work (AOSW) and the Oncology Nursing Society (ONS), has published a joint statement outlining eight key issues that must be addressed before cancer programs can adhere to the new distress screening guidelines and provide quality patient care. The joint statement emphasizes that referrals for the assessment and management of distress should be considered part of a patient’s routine medical care.
ACCC Conference Call on 2014 Proposed Rules
ACCC held a conference call on the proposed 2014 OPPS Rule and Physician Fee Schedule on Wednesday, July 24, 2013.
More information is available at www.cms.gov.
HHS Issues Final 340B Rule Clarifying Policy on Orphan Drugs
July 22 the U.S. Department of Health and Human Services (HHS) issued a final rule on "Exclusion of Orphan Drugs for Certain Covered Entities Under 340B Program" that clarifies the types of discounts available on orphan drugs purchased under the 340B Program. The rule will become effective Oct. 1.
While the Affordable Care Act (ACA) expanded the types of entities allowed to participate in the 340B Drug Program, for certain covered entities the ACA also carved out an exclusion from the 340B Program for orphan drugs.
As reported in BNA Health Care Daily Report, the final rule identifies the specific covered entities to which the orphan drug exclusion applies. They are:
- free-standing cancer hospitals qualifying under Section 340B(a)(4)(M) of the PHSA;
- critical access hospitals qualifying under Section 340B(a)(4)(N) of the PHSA; and
- rural referral centers and sole community hospitals qualifying under Section 340B(a)(4)(o) of the PHSA.
The exclusion for orphan drugs does not apply to other covered entities that meet the 340B Program eligibility requirements, according to the final rule.
Pioneer ACOs Yield Mixed Results on Lowering Costs, CMS Says
In a press release issued July 16, the Centers for Medicare & Medicaid Services (CMS) reported first-year results from Pioneer ACOs. All 32 Pioneer ACOs successfully reported quality measures and achieved the maximum reporting rate, earning incentive payments for their reporting accomplishments. However, only 13 out of 32 pioneer ACOs produced shared savings with CMS. They generated a gross savings of $87.6 million in 2012, saving nearly $33 million to the Medicare Trust Funds. Two Pioneer ACOs had shared losses totaling approximately $4 million.
CMS states that 7 Pioneer ACOs that did not produce savings have notified the agency that they intend to apply to the Medicare Shared Savings Program—another ACO model. Two Pioneer ACOs have indicated to CMS their intent to leave the program.
CMS Issues Proposed 2014 PFS and OPPS Rules
On July 8, the Centers for Medicare & Medicaid Services (CMS) released the 2014 Physician Fee Schedule (PFS) and the Hospital Outpatient Prospective Payment System (HOPPS) proposed rules. ACCC is currently reviewing the rules and preparing detailed summaries for its membership.
On Wednesday, July 24, from 2:00 – 3:00 pm ET, ACCC will host a conference call for members to review the rules and their potential impact on community oncology.
FDA Approves Gilotrif (afatinib) for Type of Late-Stage NSCLC
On July 12, 2013, the U.S. Food and Drug Administration (FDA) approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.
Gilotrif is a tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients whose tumors express the EGFR exon 19 deletions or exon 21 L858R substitution gene mutations. Gilotrif is being approved concurrently with the therascreen EGFR RGQ PCR Kit, a companion diagnostic that helps determine if a patient’s lung cancer cells express the EGFR mutations.
The FDA’s approval of the therascreen EGFR RGQ PCR Kit is based on data from the clinical study used to support Gilotrif’s approval. Tumor samples from NSCLC participants in the clinical trial helped to validate the test’s use for detecting EGFR mutations in this patient population.
ACCC Joins in Letter Asking the Administration to Provide ACA Guidance on Protecting Patient Access to Clinical Trials
The Association of Community Cancer Centers (ACCC) has joined with the American Society of Clinical Oncology, the American Association for Cancer Research, the American Cancer Society Cancer Action Network, the National Comprehensive Cancer Network, and more than 50 other organizations, in a June 18 letter urging the Administration to develop clear ACA guidance on coverage of routine medical costs for patients participating in approved clinical trials. Specifically, the letter asks the Department of Health and Human Services and the Department of Labor to issue regulations to address implementation of section 2709 of the Public Health Service Act, a provision of the Affordable Care Act (ACA) that will go into effect Jan. 1, 2014.
To ensure full implementation of the clinical trials provision of the ACA, the letter urges that federal rulemaking or guidance address the following four issues:
- Prevention, Detection, and Treatment of Complications: Inclusion of explicit safeguards to ensure that the prevention, detection, and treatment of complications arising from clinical trials are covered under the definition of “routine costs.”
- Meaningful Access to Clinical Trials: Regulations should prevent group health plans and insurance issuers from requiring patients to travel unreasonable distances to enroll in a clinical trial with an in-network provider.
- Prevention of Delays and Administrative Barriers: Explicit safeguards protecting patients from delays and administrative barriers that undermine access to clinical trials, including preventing financial incentives arising from new delivery models from inadvertently creating barriers for patients to participate in clinical trials.
- Determining a Life-Threatening Condition: Determination about whether an individual is an appropriate candidate for participation in a trial that qualifies for coverage should be made by that patient's healthcare professional.
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.
ACCC's Fact Sheet on Sunshine Act Final Rule & FAQs
The Centers for Medicare & Medicaid Services (CMS) issued a final rule to implement the Sunshine Act on Feb. 1, 2013. Under the final rule, manufacturers must report payments made from Aug. 1, 2013, onward, with the first report (covering payments made between Aug. 1 and Dec. 31, 2013) due to CMS by March 31, 2014.
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.
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).
FDA Approves Tafinlar (dabrafenib) and Mekinist (trametinib) for Unresectable or Metastatic Melanoma
On May 29, 2013, the U.S. Food and Drug Administration approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced (metastatic) or unresectable melanoma. Tafinlar, a BRAF inhibitor, is approved to treat patients with melanoma whose tumors express the BRAF V600E gene mutation. Mekinist, a MEK inhibitor, is approved to treat patients whose tumors express the BRAF V600E or V600K gene mutations. Approximately half of melanomas arising in the skin have a BRAF gene mutation.
Tafinlar and Mekinist are being approved as single agents, not as a combination treatment.
The FDA approved Tafinlar and Mekinist with a genetic test called the THxID BRAF test, a companion diagnostic that will help determine if a patient’s melanoma cells have the V600E or V600K mutation in the BRAF gene.
Living with Myeloma Webinar for Nurses and Social Workers
On June 3, 2013, the Leukemia & Lymphoma Society (LLS) is hosting a webinar on "Living with Myeloma: Treatment and Side Effects Management."
The free webinar features S. Vincent Rajkumar, MD, Professor of Medicine and Chair, Mayo Clinic Myeloma, Amyloidosis, Dysproteinemia Group. The program is designed for oncology nurses and social workers involved in the treatment of myeloma.
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.
FDA Approves Frontline Erlotinib with Companion Diagnostic Test for Metastatic NSCLC
On May 14, 2013, the U. S. Food and Drug Administration (FDA) approved erlotinib (Tarceva, Astellas Pharma Inc.) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. This indication for erlotinib is being approved concurrently with the cobas EGFR Mutation Test, a companion diagnostic test for patient selection.
Learn more here.
Coding and specialty pharmacy information available here.
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.
Genomic Health Announces Medicare Expanded Coverage Policy for OncotypeDX Breast Cancer Test to Include DCIS Diagnosis
On May 10, Genomic Health, Inc., announced that effective, May 8, 2013, Palmetto GBA, the designated national contractor for the company's OncotypeDX breast cancer test, has expanded its coverage policy for all qualified Medicare patients to include patients with ductal carcinoma in situ (DCIS) following the recent publication of the breast cancer test's DCIS Score in the Journal of the National Cancer Institute. Press release available here.
Archived April 30 Call on Lung Cancer Screening Programs
On April 30, ACCC hosted a members-only conference call that explored reasons for and challenges to establishing a low-dose CT lung cancer screening program. Both presenters' slides and the audio archive of the call are available to ACCC members on ACCC's MyNetwork site here. Login required.
ACCC Joins in Letter Urging Congress to Protect Part D
Medicare Access for Patients RX (MAPRx) brings together national beneficiary, patient advocacy, family caregiver, and health professional organizations committed to ensuring and improving access to prescription medications and safeguarding the well-being of beneficiaries with chronic diseases and disabilities under the Medicare prescription drug benefit (Part D). ACCC joined in an April 26 MAPRx letter urging Congress to protect the Part D program as it examines ways to reduce the federal deficit and resist any changes that unduly shift costs to beneficiaries. Read letter here.
ACCC April 30 Conference Call: Lung Cancer Screening Programs
On April 30, ACCC will host a members-only conference call that will delve into reasons for and challenges to establishing a low-dose CT lung cancer screening program. The conference call is scheduled for Tuesday, April 30, 2013, from 12:00 pm to 1:00 pm ET.
The call will be facilitated by:
- Dr. Andrea McKee, Chairman, Department of Radiation Oncology, Sophia Gordon Cancer Center, Lahey Clinic
- Dr. Robert Smith, Senior Director, Cancer Screening, American Cancer Society.
Call participants will be able to ask questions and discuss the issues. ACCC members can access call-in information here.
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.
April 30 Webinar on New Molecular Testing Guidelines and NSCLC
On Tuesday, April 30, there will be a webinar on the new College of American Pathologists (CAP) guidelines for molecular testing, and the impact these guidelines may have on non-small cell lung cancer diagnosis and treatment. The webinar is scheduled for 2:00 pm ET. Key opinion leaders will share insights and best practices for personalized diagnosis and treatment, and provide individual perspectives on the new CAP molecular testing guidelines.
For more information, click here.
Bill Proposes to Exempt Cancer Drugs from the Sequester
On April 9, 2013, Congresswoman Renee Ellmers (R-NC) introduced a bill that would eliminate the sequester on chemotherapy drugs that must be administered in the physician office setting (HR 1416). It would also direct Medicare to repay providers for any reduced payment since the cuts began on April 1.
To send a letter to your Congressional representatives in support of HR 1416, the "Cancer Patient Protection Act,"enter your zip code to access the HR 1416 support letter template. There is also a petition to the President urging him to exempt cancer drugs from the sequester. In addition to sending a letter, you can also sign the petition.
ACCC will keep its members updated.
Sequestration Coming April 1
Starting on April 1, all Medicare payments will be reduced by 2%. This reduction applies to all services that are billed to Medicare, including E&M codes, chemotherapy administration, hydration, and drugs and their overhead costs. The reduction to drug reimbursement will be felt even more, as the impact of sequestration will reduce reimbursement to ASP+4.3% from ASP+6%.
Why is drug reimbursement being reduced by this amount?
For example, consider a drug with an average sales price (ASP) of $100.
At ASP+6%, reimbursement = $106. The beneficiary pays 20% = $21.20 and Medicare normally pays 80% = $84.80.
After sequestration, Medicare will pay $83.10 (98% of $84.80). Medicare’s share plus the beneficiary’s share after sequestration = $83.10 + $21.20 = $104.30, or ASP+4.3%.
With this change going into effect on April 1, practices and hospitals will begin to see these reductions by mid-April, when they start to get payments for services provided at the beginning of the month (CMS claims can often take 10 days to process). Cancer programs and practices need to be prepared for these reductions.
ACCC is working diligently with Congress and other advocacy organizations to try and roll these cuts back, but at least for now, the 2% reduction will remain on the books.
ACCC will keep its members updated.
Webinars on Employer Obligations Under the ACA
On April 2 and April 11, from 1:30 pm – 3:00 pm EDT, the law firm of Hogan Lovells will present webinars on employer obligations under the Affordable Care Act (ACA). These complimentary webinars will include a Q&A session.
The webinars will focus on the “shared responsibility” or “employer mandate” provisions of the ACA, which will go into effect in 2014 but will require considerable advance planning in 2013. A high-level but comprehensive overview of other ACA provisions affecting employers already in effect or scheduled to go into effect soon will be provided.
The webinars will take a practical approach, with an emphasis on helping employers make the decisions about plan design changes and compliance strategies that will be critical in limiting the cost and burden of the new obligations.
The April 2 webinar will focus on issues of greater interest to larger employers and employers with significant numbers of high-wage workers, including the application of the controlled group rules and new nondiscrimination requirements.
The April 11 webinar will focus on issues of greater interest to smaller employers and employers with significant numbers of temporary, part-time, seasonal or low-wage workers, including using Exchanges to provide coverage.
To register click here.
ACCC Joins in Comment Letter to CMS on 2014 Advance Notice and Call Letter
The Association of Community Cancer Centers (ACCC), along with the American Society of Clinical Oncology (ASCO), the American Association for Cancer Research (AACR), the Association of American Cancer Institutes (AACI), the National Coalition for Cancer Research (NCCR), the National Coalition for Cancer Survivorship (NCCS), the National Comprehensive Cancer Network (NCCN), the Oncology Nursing Society (ONS), the Ovarian Cancer National Alliance (OCNA), and the Susan G. Komen for the Cure, provided comments to the Centers for Medicare & Medicaid Services (CMS) on the recently released 2014 Advance Notice and Call Letter.
The letter urges CMS to correct a long-standing inequity in Medicare coverage by requiring that the final 2014 plan document that Medicare Advantage (MA) plans provide coverage for cancer clinical trials.
ACCC Joins in Letter Urging Congress to Stop Sequestration Cuts
On March 13, ACCC along with 19 organizations in the cancer community sent a letter to Senate and House leadership urging Congress to stop the sequestration cuts. The letter asks Congress to help protect cost-effective, high-quality community cancer care for Medicare beneficiaries fighting cancer.
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.
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.
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.
Doxil Supply Update
Janssen Products, LP, is updating healthcare professionals (HCPs), patient organizations, and others in the healthcare community about the release of DOXIL® (doxorubicin HCl liposome injection) utilizing an alternate manufacturing approach.
Read Dear Healthcare Professional letter here.
Learn more here.
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.
Feb. 28 is Last Day to Complete Attestation for 2012 Medicare EHR Incentive Program
Eligible professionals (EPs) who participated in the Medicare Electronic Health Record (EHR) Incentive Program in 2012 must complete attestation for the 2012 program year by today, February 28, 2013.
CMS has several resources located on the Educational Resources page of the EHR Incentive Programs website to help you properly meet meaningful use and attest.
Today is also the deadline for EPs to submit any pending Medicare Part B claims from calendar year (CY) 2012, as CMS allows 60 days after December 31, 2012, for all pending claims to be processed.
Visit the EHR Incentive Programs website for the latest updates and news on EHR Incentive Programs.
FDA Approves Stivarga for Advanced Gastrointestinal Stromal Tumors
On Feb. 25, 2013, the U.S. Food and Drug Administration (FDA) expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease.
GIST is a tumor in which cancerous cells form in the tissues of the gastrointestinal tract, part of the body's digestive system. According to the National Cancer Institute, an estimated 3,300 to 6,000 new cases of GIST occur yearly in the United States, most often in older adults.
Read FDA press release here.
FDA Approves Kadcyla for HER2-Positive, Late-Stage Breast Cancer
On Feb. 22, 2013, the U.S. Food and Drug Administration (FDA) approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.
Kadcyla is intended for patients who were previously treated with trastuzumab, another anti-HER2 therapy, and taxanes, a class of chemotherapy drugs commonly used for the treatment of breast cancer.
Referred to as T-DM1 during clinical research, Kadcyla was reviewed under the FDA’s priority review program, which provides for an expedited six-month review of drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products.
Kadcyla is being approved with a Boxed Warning alerting patients and health care professionals that the drug can cause liver toxicity, heart toxicity and death. The drug can also cause severe life-threatening birth defects, and pregnancy status should be verified prior to starting Kadcyla treatment.
Read FDA press release here.
FDA Approves Pomalyst for Advanced Multiple Myeloma
On Feb. 8, the U.S. Food and Drug Administration (FDA) approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs.
Pomalyst is a pill that modulates the body’s immune system to destroy cancerous cells and inhibit their growth. It is intended for patients who have received at least two prior therapies, including lenalidomide and bortezomib, and whose disease did not respond to treatment and progressed within 60 days of the last treatment (relapsed and refractory).
Pomalyst’s safety and effectiveness was evaluated in a clinical trial of 221 patients with relapsed or refractory multiple myeloma. The trial was designed to measure the number of patients whose cancer completely or partially disappeared after treatment (objective response rate, or ORR). Patients were randomly assigned to receive Pomalyst alone or Pomalyst with low-dose dexamethasone, a corticosteroid. Results showed 7.4 percent of patients treated with Pomalyst alone achieved ORR. The median duration of response has not yet been reached in these patients. In patients treated with Pomalyst plus low-dose dexamethasone, 29.2 percent achieved ORR with a 7.4-month median duration of response.
Pomalyst carries a Boxed Warning alerting patients and health care professionals that the drug should not be used in pregnant women because it can cause severe life-threatening birth defects, and that the drug can cause blood clots.
Read FDA press release here.
CMS Issues Final 'Sunshine' Rule
On Feb. 1, the Centers for Medicare & Medicaid Services (CMS) released a final rule, commonly know as the 'Sunshine' rule, that will require manufacturers of drugs, devices, and other medical supplies to report certain payments provided to physicians or teaching hospitals. The final rule also requires manufacturers and group purchasing organizations (GPOs) to disclose to CMS physician ownership or investment interests.
To give applicable manufacturers and applicable GPOs sufficient time to prepare, CMS said data collection will begin August 1, and the reporting period will run through December. Data are due to be reported to CMS by March 31, 2014, and CMS said it will release the data on a public website by September 30, 2014.
View final rule here.
View CMS fact sheet here.
CMS Proposed Rule Aims to Reduce Regulatory Burden on Providers
On Feb. 4, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule designed to help healthcare providers operate more efficiently by eliminating or reducing regulations that are out of date or no longer needed. Many of the rule’s provisions streamline the standards providers must meet in order to participate in the Medicare and Medicaid programs without jeopardizing beneficiary safety.
A key provision reduces the burden on very small critical access hospitals, as well as rural health clinics, and federally qualified health centers, by eliminating the requirement that a physician be held to an excessively prescriptive schedule for being onsite once every two weeks. This provision seeks to address the geographic barriers and remoteness of many rural facilities, and recognize telemedicine improvements and expansions that allow physicians to provide many types of care at lower costs, while maintaining high-quality care.
Another provision would reduce the requirements ambulatory surgical centers must meet in order to provide radiological services that are an integral part of their surgical procedures, permitting them greater flexibility for physician supervision requirements.
CMS also proposes to permit trained nuclear medicine technicians in hospitals to prepare radiopharmaceuticals for nuclear medicine without the supervising physician or pharmacist constantly being present, which helps speed services to patients, particularly during off hours.
The proposal would also eliminate a redundant data submission requirement and an unnecessary survey process for transplant centers while maintaining strong federal oversight.
CMS estimates the proposed reductions in regulatory burdens could save $676 million annually, and $3.4 billion over five years.
The proposed rule will be published in the Feb. 7 Federal Register. The comment period ends April 8.
View the proposed rule here.
FDA Approves Generic Version of Doxil
On Feb. 4, 2013, the U.S. Food and Drug Administration (FDA) approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection).
Doxorubicin hydrochloride liposome injection is currently on the FDA’s drug shortage list. For products on the shortage list, the FDA’s Office of Generic Drugs is using a priority review system to expedite the review of generic applications to help alleviate shortages.
“The agency is committed to doing everything we can to address drug shortages so that patients can get the medicines they need when they need them,” said Capt. Valerie Jensen, RPh, director, Drug Shortage Staff, Center for Drug Evaluation and Research, FDA. “For the past year, the FDA has been working to ensure that supplies of doxorubicin HCl liposome injection were not interrupted.”
The generic is made by Sun Pharma Global FZE (Sun). Sun’s generic will be available in 20 milligram and 50 milligram vials.
Learn more here.
FDA Approves New Use for Avastin
On January 23, 2013, the U. S. Food and Drug Administration approved bevacizumab (Avastin, Genentech U.S., Inc.) for use in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed on a first-line bevacizumab-containing regimen. Bevacizumab is a recombinant humanized monoclonal IgG1 antibody that binds to human vascular endothelial growth factor (VEGF), preventing the interaction of VEGF to its receptors on the surface of endothelial cells.
This approval is based on the results of a randomized, open-label, multinational trial enrolling patients with mCRC that progressed during or within 3 months of discontinuation of bevacizumab-based combination chemotherapy with fluoropyrimidine-oxaliplatin or fluoropyrimidine-irinotecan in the first line.
Learn more here.
Synribo Approved by FDA for CML
The U.S. FDA has approved Synribo (omacetaxine mepesuccinate) for Injection, for subcutaneous use, for the treatment of adult patients with chronic or acclerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs).
Learn more here.
Update on Doxil Supply
Janssen Products, LP, is updating healthcare professionals (HCPs), patient organizations, and others in the healthcare community about the release of DOXIL® (doxorubicin HCl liposome injection) utilizing an alternate manufacturing approach.
Read Dear Healthcare Professional letter here.
Learn more here.
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).