FDA Approves Ramucirumab as Second-Line Therapy for mCRC
On April 24, 2015, the U. S. Food and Drug Administration (FDA) approved ramucirumab (CYRAMZA®, Eli Lilly and Company) for use in combination with FOLFIRI for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed on a first line bevacizumab-, oxaliplatin- and fluoropyrimidine-containing regimen.
Free ASCO April 28 Webinar on Medicare Oncology Payment Model
The American Society of Clinical Oncology (ASCO) will hold a free webinar on CMMI's Oncology Care Model (OCM) on Tuesday, April 28, 2015 at 4:00 p.m. ET. Attendees will learn about OCM's purpose and key features, payment methodology, six practice requirements, quality and performance measures, practice implications, and navigating the application process.This ASCO webinar, moderated by Elaine L. Towle, CMPE, director of ASCO’s Analysis and Consulting Services, will feature:
- Kavita K. Patel, MD, MSHS, managing director for clinical transformation and delivery at the Engelberg Center for Health Care Reform of the Brookings Institution.
- Ronald Kline, MD, Medical Officer, CMMI, part of the program team directing CMS’s Oncology Care Model.
- Ronald Barkley, MS, JD, president of the Cancer Center Business Development Group, and Co-Founder and National Co-Chair of the Cancer Center Business Summit, and an expert in alternate payment initiatives in oncology.
Registration for the ASCO webinar is now open.
CMS OCM Webinar Today: FAQs & Application Overview
The Oncology Care Model team will host a webinar on CMMI’s Oncology Care Model (OCM) Frequently Asked Questions and Application Overview on Wednesday, April 22, 2015, at 12:00 pm EDT. No password is required for the webinar.
How to Join:
Webinar presentation materials will be available here
No password required
Telephone Call-In Information (US/Canada):
Access code: 665 947 599
President Obama Signs H.R. 2 into Law
On April 16, 2015, President Barack Obama signed into law H.R. 2., the Medicare Access and CHIP Reauthorization Act (MACRA), legislation that permanently replaces Medicare's sustainable growth rate (SGR) formula for physician reimbursement with new value-based systems for establishing annual reimbursement updates for physician services.
The law went into effect on signing.
For more on what MACRA will mean for Medicare physician reimbursement, read our ACCCBuzz blog post, SGR is Over: What Does it Mean for Providers?
Senate Passes SGR Repeal!
Late on April 14, 2015, the U.S. Senate overwhelmingly by a 92-8 vote passed H.R. 2, legislation that permanently repeals Medicare’s sustainable growth rate (SGR) for physician reimbursements. The vote came just hours before a scheduled cut to physician' payments would have gone into effect.
The bill now goes to President Barack Obama, who has said he will sign it.
H.R. 2 would replace the current SGR formula with new value-based systems for setting the annual updates to payment rates for physician services provided to Medicare beneficiaries.
CMS to Host April 15 Call for Providers on Open Payments
CMS is hosting a MLN Connects National Provider Call on April 15 that will provide a brief overview of the Open Payments program and highlight the parts of the program timeline when it is most critical for physicians and teaching hospitals to be aware and get involved. The call aligns with the beginning of the program phase when physicians and teaching hospitals are able to enter the Open Payments system and review the accuracy of data submitted about them, prior to the publication of this data on the CMS website.
Open Payments (Sunshine Act) 2015—Prepare to Review Reported Data
Wednesday, April 15, 2015
2:00 PM - 3:30 PM ET
Registration information is available here.
The Open Payments website has important information about the program, including educational materials. CMS encourages all physicians and teaching hospitals, plus physician office staff members to visit this resource and become familiar with the Open Payments program.
This MLN Connects Call is being evaluated by CMS for CME and CEU continuing education credit (CE). More information is available on the call detail page.
CMS to Host Call on 2016 MSSP Application Process
CMS will hold a call on April 7, 2015, at 1:30 pm EST to provide information on what you can do to prepare for the Medicare Shared Savings Program (Shared Savings Program) application process for the January 1, 2016, start date. Register here.
CMS Deadline for ICD-10 End-to-End Testing Volunteer Forms
During the week of July 20 through 24, 2015, a third sample group of providers will have the opportunity to participate in ICD-10 end-to-end testing with Medicare Administrative Contractors (MACs) and the Common Electronic Data Interchange (CEDI) contractor. Volunteer forms are due April 17, and are available on MAC websites.
CMS to Hold Provider Claims until April 15
The current "doc fix" patch to Medicare's sustainable growth rate (SGR) formula expired on March 31, 2015. In an April 1 notice, the Centers for Medicare & Medicaid Services (CMS) told providers that the agency is holding physicians' claims until April 15. CMS said the agency will notify providers on or before April 11 with more information.
CMS has also announced that the agency is delaying enforcement of the "two midnight" payment policy for short hospital stays until the end of April. This delay gives Congress time to pass the SGR repeal legislation when it reconvenes on April 13. The SGR repeal bill includes a six-month delay in enforcement of this payment rule. Source: Modern Healthcare
No Senate Vote on SGR Until After Its Recess
The U.S. Senate recessed on Friday, March 27, without voting on SGR repeal legislation.
The Senate is recessed for two weeks, but is still expected to act on the permanent SGR repeal bill when it reconvenes on April 13.
Modern Healthcare reports that despite the fact that the current SGR “patch” will expire on April 1, physicians will not face a 21% pay cut as CMS “has indicated that it can delay processing claims for a period of time to keep the cut from being implemented.”
House Passes H.R. 2, SGR Repeal Legislation
On March 26, by a vote of 392-37 the U.S. House of Representatives overwhelmingly passed H.R. 2, the Medicare Access and CHIP Reauthorization Act of 2015, legislation to permanently repeal and replace Medicare’s sustainable growth rate (SGR) formula for physician reimbursement. Read a summary of the legislation here.
Rep. Michael C. Burgess, MD, (R-Texas), the bill’s primary sponsor, said in a statement, “This is the work of a collaborative body. . . .It is time to end the SGR. Let us never speak of this issue again.”
The White House has expressed support for the bill.
The Senate is expected to vote on the bill March 27.
According to analysis by the Congressional Budget Office (CBO), the bill would increase the federal deficit by $141 billion through 2025.
FDA: Don’t Use Treanda Injection (Solution) With Certain CSTDs
The U.S. Food and Drug Administration (FDA) is warning healthcare professionals not to use Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution) with closed system transfer devices (CSTD), adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS). CSTDs are devices that are used to prepare and administer hazardous drugs for intravenous infusion, such as chemotherapy drugs. Most marketed CSTDs contain either polycarbonate or ABS and are not compatible with Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution).
Treanda (bendamustine hydrochloride), manufactured by Teva, is used to treat patients with chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkins lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
Treanda is available in two formulations:
- a solution, Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution); and
- a lyophilized powder, Treanda for Injection (25mg/vial or 100 mg/vial lyophilized powder).
The FDA is recommending healthcare professionals use Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution) only with polypropylene syringes containing a metal needle and a polypropylene hub. If a CSTD would be used with Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution), the FDA advises healthcare professionals to verify with the CSTD manufacturer or Teva U.S. Medical Information (1-800-896-5855) that the CSTD is compatible with Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution) prior to preparing the drug. Alternatively, healthcare professionals can use Treanda for Injection (25mg/vial or 100 mg/vial lyophilized powder) with a CSTD.
Read FDA notice here.
Read Teva Pharmaceuticals' Dear Health Care Provider letter here.
HHS Issues Stage 3 EHR Incentive Programs Proposed Rule
On Mar. 20, 2015, the U.S. Department of Health and Human Services (HHS) released a Stage 3 Medicare and Medicaid EHR Incentive Programs proposed rule.
According to the agency, the proposed rule will support “efforts to increase simplicity and flexibility in the program while driving interoperability and a focus on patient outcomes in the meaningful use program.”
The comment period for proposed Stage 3 rule will close on May 29, 2015.
Also on Mar. 20, the Office of the National Coordinator (ONC) released a proposed rule covering 2015 Edition Health IT Certification Criteria for EHR products used by meaningful use program participants.
House Leaders Introduce Legislation to Permanently Repeal and Replace SGR
On Mar. 24, 2015, bipartisan leaders of the House Energy and Commerce and House Ways and Means Committees introduced H.R. 2 the Medicare Access and CHIP Reauthorization Act (MACRA) to permanently replace the Medicare Sustainable Growth Rate (SGR). H.R. 2 builds upon H.R. 1470, the SGR Repeal and Medicare Provider Payment Modernization Act, bipartisan legislation released March 19 that would replace the SGR with incentives for doctors to focus on value-driven care.
On Friday, Mar. 20, the bipartisan committee leaders released a working framework of these additional proposals, some of which will help to help offset the costs of this package. Read the complete bill online here.
The House is expected to vote on the legislation Mar. 26, Bloomberg BNA reported.
Read a statement from the House Energy and Commerce Committee.
OCM Letter of Intent Deadlines Extended
The Centers for Medicare & Medicaid Services (CMS) Innovation Center has extended the deadlines for physician practices and payers to submit letters of intent (LOIs) to participate in the Oncology Care Model (OCM). The new submission deadlines are:
- April 9, 2015 — Payer LOIs
- May 7, 2015 — Practice LOIs
- June 18, 2015 — ALL Applications (unchanged)
The Innovation Center will publicly post the list of payers who submit LOIs and agree to public posting on April 16, 2015, and will post the list of practices who submit LOIs and agree to public posting on May 14, 2015. These lists will appear on the OCM website to allow interested payers and practices to engage with one another and coordinate participation in the OCM.
House, Senate Leaders Introduce SGR Legislation
On Mar. 19, 2015, leaders in the U.S. Senate and House introduced bipartisan, bicameral legislation (HR 1470) to replace the broken Medicare Sustainable Growth Rate (SGR) formula with an improved payment system that rewards quality, efficiency, and innovation. The bipartisan, bicameral bill seeks to end the cycle of annual “doc fix” crises that have created uncertainty for millions of Medicare providers and beneficiaries for over a decade.
- Repeal the SGR, while instituting a 0.5% payment update each year for five years.
- Improve the fee-for-service system by streamlining Medicare’s existing web of quality programs into one value-based performance program. It increases payment accuracy and encourages physicians to adopt proven practices.
- Incentivize the use of alternative payment models to encourage doctors and providers to focus more on coordination and prevention to improve quality and reduce costs.
- Make Medicare more transparent by giving patients more access to information and supplying doctors with data they can use to improve care.
ACCC is analyzing the proposed legislation and will keep members updated.
NCCN Publishes New Guidelines for Smoking Cessation
On March 13, 2015, the National Comprehensive Cancer Network (NCCN) announced publication of new NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Smoking Cessation. The guidelines, which are written for the treatment of smokers diagnosed with cancer, recommend treatment plans that include evidence-based pharmacotherapy and behavior therapy.
CMS Announces Next Generation ACO Model
On March 10, 2015, the Centers for Medicare & Medicaid Services (CMS) announced the new Next Generation ACO Model. The new model “sets predictable financial targets, enables greater levels of financial risk so that providers have more opportunities to coordinate beneficiaries’ care,” the agency said in a press release.
The Next Generation ACO Model is for ACOs that are experienced in coordinating care for populations of patients. Under this model, provider groups will be allowed to assume higher levels of financial risk and reward than are available under the current Pioneer Model and Shared Savings Program (MSSP), the agency said.
CMS expects approximately 15 to 20 ACOs to participate in the Next Generation ACO Model with representation from a variety of provider organization types and geographic regions. The Model will consist of three initial performance years and two optional one-year extensions.
Details and specific eligibility criteria are available on the Next Generation ACO Model webpage.
Read CMS fact sheet on the Next Generation ACO Model here.
FDA Approves New Antifungal Drug Cresemba
On March 6, 2105, the U.S. Food and Drug Administration (FDA) approved Cresemba (isavuconazonium sulfate), a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections.
Aspergillosis is a fungal infection caused by Aspergillus species, and mucormycosis is caused by the Mucorales fungi. These infections occur most often in people with weakened immune systems.
Cresemba belongs to a class of drugs called azole antifungal agents, which target the cell membrane of a fungus. Cresemba is available in oral and intravenous formulations.
FDA Approves First Biosimilar Zarxio (filgratim-sndz)
On March 6, 2015, the U.S. Food and Drug Administration (FDA) approved filgrastim-sndz (Zarxio Injection, Sandoz Inc.), as a biosimilar to US-licensed Neupogen for the five indications for which US-licensed Neupogen is approved. The formulation of Zarxio differs from that of US-licensed Neupogen in one inactive component, according to the FDA press release.
The approval of Zarxio was based on review of evidence that included comparative structural and functional characterization, animal studies, human pharmacokinetic (PK) and pharmacodynamics (PD), and clinical immunogenicity data, and other clinical safety and effectiveness data which demonstrate Zarxio is highly similar to US-licensed Neupogen notwithstanding minor differences in clinically inactive components and that there are no clinically meaningful differences between Zarxio and US-licensed Neupogen, the FDA press release said.
FDA Launches Drug Shortages Mobile App
On March 4, 2015, the U.S. Food and Drug Administration (FDA) launched the agency’s first mobile application (app) designed to speed public access to valuable information about drug shortages.The app identifies current drug shortages, resolved shortages and discontinuations of drug products. The app is available for free download via iTunes (for Apple devices) and the Google Play store (for Android devices) by searching “FDA Drug Shortages.”
FDA Approval Opdivo for Patients with Previously Treated Metastatic Squamous NSCLC
On March 4, 2015, the U. S. Food and Drug Administration (FDA) granted approval to nivolumab (Opdivo, Bristol-Myers Squibb Company) for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
Nivolumab was previously approved in December 2014, for the treatment of previously treated unresectable or metastatic melanoma. Nivolumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, thereby releasing PD-1 pathway-mediated inhibition of the immune response, including anti-tumor immune response.
CMS Update on Health Care Payment Learning and Action Network
On Feb. 27, 2015, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet on the newly created Health Care Payment Learning and Action Network (the "Network"). The Network will serve as a forum where payers, providers, employers, purchasers, state partners, consumer groups, individual consumers, and others can discuss how to transition towards alternative payment models that emphasize value.
According to the fact sheet, the Network will be supported by an independent contractor that will act as convener and facilitator for the Network.
The fact sheet describes the structure, management, and activities of the Network, and outlines the following Network functions:
- Serve as a convening body to facilitate joint implementation of new models of payment and care delivery,
- Identify areas of agreement around movement toward alternative payment models and define how best to report on these new payment models,
- Collaborate to generate evidence, share approaches, and remove barriers,
- Develop common approaches to core issues such as beneficiary attribution, financial models, benchmarking, quality and performance measurement, risk adjustment, and other topics raised for discussion, and
- Create implementation guides for payers, purchasers, providers, and consumers.
Invitation to Participate
According to the fact sheet, all payers, providers, employers, purchasers, states, consumer groups, individual consumers, and others can participate in the Health Care Payment Learning and Action Network. All interested individuals and organizations are invited to register at innovation.cms.gov/initiatives/Health-Care-Payment-Learning-and-Action-Network/.
View the Health Care Payment Learning and Action Network webpage here.
FDA Approves Farydak for Treatment of Multiple Myeloma
On February 23, 2015, the U.S. Food and Drug Administration (FDA) today approved Farydak (panobinostat) for the treatment of patients with multiple myeloma.
Farydak is the first HDAC inhibitor approved to treat multiple myeloma. It is intended for patients who have received at least two prior standard therapies, including bortezomib and an immunomodulatory agent. Farydak is to be used in combination with bortezomib, a type of chemotherapy, and dexamethasone, an anti-inflammatory medication.
CMS Announces New ACA Enrollment Period for Tax Season
On Feb. 20, 2015, the Centers for Medicare & Medicaid Services (CMS) announced a special enrollment period for individuals and families who did not have health coverage in 2014 and are subject to the fee or “shared responsibility payment” when they file their 2014 taxes in states which use the Federally-facilitated Marketplaces (FFM). This special enrollment period, which will run from March 15 through April 30, will allow eligible consumers to enroll in 2015 health insurance coverage through the FFM.
Those eligible for this special enrollment period live in states with a Federally-facilitated Marketplace and:
- Currently are not enrolled in coverage through the FFM for 2015,
- Attest that when they filed their 2014 tax return they paid the fee for not having health coverage in 2014, and
- Attest that they first became aware of, or understood the implications of, the Shared Responsibility Payment after the end of open enrollment (February 15, 2015) in connection with preparing their 2014 taxes.
FDA Expands Indication for Revlimid Plus Dexamethasone to Include Patients Newly Diagnosed with Multiple Myeloma
On Feb. 18, 2015, Celgene Corporation announced that the U.S. Food and Drug Administration (FDA) has expanded the existing indication for Revlimid (lenalidomide) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma.
Read company press release here.
FDA Approves Lenvima for Differentiated Thyroid Cancer
On Feb. 13, 2015, the U. S. Food and Drug Administration (FDA) approved lenvatinib (Lenvima) for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.
CMS Innovation Center Announces Oncology Care Model
On Feb. 12, 2015, the Centers for Medicare & Medicaid Services (CMS) Innovation Center announced the Oncology Care Model, a new performance-based payment model that aims to provide higher quality, more highly coordinated oncology care at a lower cost. The Oncology Care Model (OCM) is a multi-payer model in which practices enter into payment arrangements that include financial and performance accountability for episodes of care surrounding chemotherapy administration to cancer patients. OCM is a five-year model that will begin in spring 2016.
According to an Innovation Center announcement, key facets of the model include:
- episode-based payment with a payment structure that targets chemotherapy and related care during a six-month period following the start of chemotherapy treatment
- emphasis on practice transformation, requiring physician practices to engage in practice transformation to improve quality and coordination of care
- multi-payer design with Medicare fee-for-service and other payers working in tandem to promote care redesign for oncology patients.
Physician group practices and solo practitioners that provide chemotherapy for cancer and are currently enrolled in Medicare may apply to participate. Other payers, including commercial insurers, Medicare Advantage plans, state programs, and Medicaid managed care plans, are also encouraged to apply.
Interested practices must submit letters of intent by 5:00 pm., EDT on April 23, 2015.
A webinar introducing the core concepts of OCM, including application instructions, will be available to the public from 12:00 – 1:00 pm EST on February 19, 2015. Advance registration is not required. Additional webinar information is available here.
More information is available on the Oncology Care Model webpage.
CMS Issues Final Rule on Medicare Advantage, Part D Changes for 2016
On Feb. 6, the Centers for Medicare & Medicaid Services (CMS) issued a rule that makes policy and technical changes to Medicare Advantage (MA) and the Medicare Part D prescription drug program for contract year 2016.
According to the CMS fact sheet, the rule does not finalize any of the following provisions that appeared in a previous proposed rule:
- Lifting the protected class designation on three drug classes – antidepressants, antipsychotics and immunosuppressants for transplant rejection;
- Requiring Medicare Part D sponsors to include any pharmacy willing to accept the terms and conditions to participate in narrower pharmacy networks that offer preferred cost sharing to beneficiaries;
- Reducing the number of Part D plans a sponsor may offer; and
- Codifying CMS interpretation of the Part D non-interference provision.
Medicare to Cover Lung Cancer Screening with LDCT, CMS Issues Final NCD
On Feb. 5, the Centers for Medicare & Medicaid Services (CMS) issued a final national coverage determination (NCD) that provides for Medicare coverage of screening lung cancer with low dose computed tomography (LDCT). The coverage is effective immediately.
Medicare will now cover lung cancer screening with LDCT once per year for Medicare beneficiaries who meet all of the following criteria:
- they are age 55-77, and are either current smokers or have quit smoking within the last 15 years;
- they have a tobacco smoking history of at least 30“pack years”(an average of one pack a day for 30 years); and
- they receive a written order from a physician or qualified non-physician practitioner that meets certain requirements.
Medicare coverage includes a visit for counseling and shared decision-making on the benefits and risks of lung cancer screening. The NCD also includes required data collection and specific coverage eligibility criteria for radiologists and radiology imaging centers, consistent with the National Lung Screening Trial protocol, U.S. Preventive Services Task Force recommendation, and multi-society multidisciplinary stakeholder evidence-based guidelines.
FDA Approves Ibrance for Advanced Breast Cancer
On Feb. 3, 2015, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Ibrance (palbociclib) to treat advanced (metastatic) breast cancer in postmenopausal women.
Ibrance works by inhibiting molecules, known as cyclin-dependent kinases (CDKs) 4 and 6, involved in promoting the growth of cancer cells. Ibrance is intended for postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have not yet received an endocrine-based therapy. It is to be used in combination with letrozole, another FDA-approved product used to treat certain kinds of breast cancer in postmenopausal women.
Read the FDA press release here.
ONC Issues 10-Year Draft Plan; Sets 2017 Target for Health IT Interoperability
On Jan. 30, the Office of the National Coordinator for Health Information Technology (ONC) issued a draft plan that aims to ensure that a majority of healthcare providers across the care continuum will be able to “send, receive, find, and use a common set of electronic clinical information at the nationwide level by the end of 2017.”
The plan, "Connecting Health and Care for the Nation: A Shared Nationwide Interoperatiblity Roadmap," calls for the ONC to identify a set of technical standards to enable “core interoperability functions” in electronic health records and other health IT.
Comments on the plan are due by April 3.
Source: Bloomberg BNA
Obama Administration Unveils Details on Precision Medicine Initiative
On Jan. 30 the Obama Administration announced that the Precision Medicine Initiative referenced by President Obama in his State of the Union Address will be launched with a $215 million investment in the President’s 2016 Budget.
According to a White House fact sheet, the President’s 2016 budget will provide:
- $130 million to the National Institutes of Health (NIH) for development of a voluntary national research cohort of a million or more volunteers to propel understanding of health and disease and set the foundation for a new way of doing research through engaged participants and open, responsible data sharing.
- $70 million to the National Cancer Institute (NCI), part of NIH, to scale up efforts to identify genomic drivers in cancer and apply that knowledge in the development of more effective approaches to cancer treatment.
- $10 million to FDA to acquire additional expertise and advance the development of high quality, curated databases to support the regulatory structure needed to advance innovation in precision medicine and protect public health.
- $5 million to Office of the National Coordinator for Health Information Technology (ONC) to support the development of interoperability standards and requirements that address privacy and enable secure exchange of data across systems.
Read the White House fact sheet.
Read the White House blog post.
Read the NCI blog post on Precision Medicine Initiative and Cancer Research by Harold Varmus, MD.
CMS Will Propose Changes to EHR Incentive Programs for 2015
The Centers for Medicare & Medicaid Services (CMS) announced that the agency intends to propose changes to update the Medicare and Medicaid EHR Incentive Programs in rulemaking this spring. In a Jan. 29 agency blog post, Patrick Conway, MD, CMS chief medical officer and deputy administrator for innovation and quality, said that the proposed rule would address provider concerns about software implementation and information exchange readiness.
Specifically, the agency is considering proposals to change the hospital reporting period for the meaningful use program from the fiscal year to the calendar year, and to shorten the EHR reporting period in 2015 from a full year to 90 days.
The blog post clarifies that the proposed rule would be separate from the Stage 3 meaningful use rule expected to be released in early March.
FDA Approves Imbruvica for Waldenstrom's Macroglobulinemia
On January 29, 2015, the U. S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica Capsules, Pharmacyclics, Inc.) for the treatment of patients with Waldenstrom’s macroglobulinemia.
Ibrutinib was initially approved in November 2013 for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Ibrutinib also received approval in February 2014 for the treatment of chronic lymphocytic leukemia (CLL) in patients who received at least one prior therapy and in July 2014 for the treatment of CLL with 17p deletion.
Read FDA press release here.
Read FDA announcement here.
HHS Announces Timeline for Expanding New Medicare Payment Models
U.S. Department of Health and Human Services (HHS) Secretary Sylvia M. Burwell has announced a timeline and measurable goals to shift Medicare, and the healthcare system at large, toward paying providers based on quality or value, rather the volume of care provided.
In a Jan. 26 meeting with leaders representing consumers, insurers, providers, and business leaders, Secretary Burwell announced that HHS has set a goal of tying 30 percent of traditional, or fee-for-service, Medicare payments to quality or value through alternative payments models, such as accountable care organizations (ACOs) or bundled payment arrangements, by the end of 2016, and tying 50 percent of payments to these models by the end of 2018. HHS also set a goal of tying 85 percent of all traditional Medicare payments to quality and value by 2016 and 90 percent by 2018 through programs such as the Hospital Value-Based Purchasing and Hospital Readmissions Reduction programs.
To help make these goals scalable beyond Medicare, HHS is creating the Health Care Payment Learning and Action Network, the agency said in a press release. Through this network, HHS will work with private payers, employers, consumers, providers, states, and state Medicaid programs, and other partners to expand alternative payment models into their programs. The Network’s first meeting is slated for March 2015, the press release said.
Read a "Perspective" article by Secretary Burwell in the New England Journal of Medicine here.
Read a blog post from Secretary Burwell here.
New IOM Report on Sharing Clinical Trial Data
A new report from the Institute of Medicine (IOM) Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk calls for professional standards for responsible sharing of clinical trial data.
The report calls for stakeholders in clinical trials to encourage a culture in which data sharing is the expected norm and commit to responsible strategies aimed at maximizing the benefits, minimizing the risks, and overcoming the challenges of sharing data. Included in the report are recommended guidelines about which data from a clinical trial should be shared and when. The report recommends data that supports results be shared no later than six months after publication.
The report’s recommendations for which specific data should be shared after key times in a clinical trial are:
- At the time of trial registration
- At the completion of a study
- After a publication reports the results of a clinical trial
- For studies of products or new indications that are approved
- For studies of new products or new indications for a marketed product that are abandoned.
CMS to Hold 2015 Date-of-Service Claims for Services Paid Under the MPFS for Two Weeks
In a Dec. 29, 2014, MLN Connects Provider eNews, the Centers for Medicare & Medicaid Services (CMS) states that in order to implement corrections to technical errors discovered after publication of the 2015 Medicare Physician Fee Schedule (MPFS) rule and process claims correctly, Medicare Administrative Contractors will hold claims containing 2015 services paid under the MPFS for the first 14 calendar days of January 2015 (i.e., Thursday Jan. 1 through Wednesday Jan. 14). According to CMS, the hold should have minimal impact on provider cash flow as, under current law, clean electronic claims are not paid sooner than 14 calendar days (29 days for paper claims) after the date of receipt.
MPFS claims for services rendered on or before Wednesday Dec. 31, 2014, are unaffected by the 2015 claims hold and will be processed and paid under normal procedures and time frames.
FDA Approves Opdivo for Advanced Melanoma
On Dec. 22, 2014, the U. S. Food and Drug Administration (FDA) granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable or metastatic (advanced) melanoma who no longer respond to other drugs.
Opdivo works by inhibiting the PD-1 protein on cells, which blocks the body’s immune system from attacking melanoma tumors. Opdivo is intended for patients who have been previously treated with ipilimumab and, for melanoma patients whose tumors express a gene mutation called BRAF V600, for use after treatment with ipilimumab and a BRAF inhibitor.
Opdivo is marketed by Princeton, New Jersey-based Bristol-Myers Squibb.
FDA Approves Lynparza to Treat Advanced Ovarian Cancer
On Dec. 19, 2014, the U. S. Food and Drug Administration (FDA) granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.
Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor that blocks enzymes involved in repairing damaged DNA. It is intended for women with heavily pretreated ovarian cancer that is associated with defective BRCA genes.
The FDA approved Lynparza with a genetic test called BRACAnalysis CDx, a companion diagnostic that will detect the presence of mutations in the BRCA genes (gBRCAm) in blood samples from patients with ovarian cancer.
Lynparza is marketed by AstraZeneca Pharmaceuticals, based in Wilmington, Delaware. BRACAnalysis CDx is manufactured by and performed at Salt Lake City, Utah-based Myriad Genetic Laboratories, Inc.
FDA Approves Lanreotide for Gastroenteropancreatic Neuroendocrine Tumors
On Dec. 16, 2014, the U. S. Food and Drug Administration (FDA) approved lanreotide (Somatuline Depot Injection, Ipsen Pharma) for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.
FDA Approves Cyramza to Treat Aggressive NSCLC
On Dec. 12, 2014, the U. S. Food and Drug Administration approved Cyramza Injection (ramucirumab) (Eli Lilly and Company) for use in combination with docetaxel for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving ramucirumab.Ramucirumab was previously approved as a single agent and for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma after disease progression on first line therapy.
FDA Approves Gardasil 9 Vaccine for Prevention of Certain Cancers Caused by 5 More Types of HPV
On Dec. 10, the U.S. Food and Drug Administration (FDA) approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers.
Gardasil 9 is a vaccine approved for use in females ages 9 through 26 and males ages 9 through 15. It is approved for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, and for the prevention of genital warts caused by HPV types 6 or 11. Gardasil 9 adds protection against five additional HPV types—31, 33, 45, 52 and 58—which cause approximately 20 percent of cervical cancers and are not covered by previously FDA-approved HPV vaccines.
FDA Approves Jakafi to Treat Polycythemia Vera
On Dec. 4, 2014, the U.S. Food and Drug Administration (FDA) approved a new use for Jakafi (ruxolitinib) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Jakafi is the first drug approved by the FDA for this condition.
FDA Grants Accelerated Approval for Blinatumomab for Philadelphia Chromosome-Negative Relapsed or Refractory B-cell Precursor ALL
On Dec. 3, 2014, the U. S. Food and Drug Administration (FDA) granted accelerated approval for blinatumomab (Blincyto, Amgen Inc.) for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (R/R ALL).
NCI Establishes Genomic Data Commons
The National Cancer Institute (NCI) is establishing the NCI Genomic Data Commons (GDC) to store, analyze and distribute cancer genomics data generated by NCI and other research organizations. The GDC will provide an interactive system for researchers to access data, with the goal of advancing the molecular diagnosis of cancer and suggest potential therapeutic targets based on genomic information.
The GDC is the first step toward the development of a knowledge system for cancer, as originally recommended in a 2011 Institute of Medicine (IOM) report, “Toward Precision Medicine,” the NCI said in a statement.