2014 Archived oncology news:
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.
CMS Proposes New Risk Model under Medicare Shared Savings Program
On Dec. 1, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would make changes to the Medicare Shared Savings Program (MSSP), including proposing a new risk model for use by participating accountable care organizations (ACOs). In a press release, CMS said that the proposed adjustments would strengthen the shared savings program for ACOs “through a greater emphasis on primary care services and promoting transitions to performance-based risk arrangements.”
CMS is seeking comments on a number of adjustments to improve the Medicare Shared Savings Program, including:
- Providing more flexibility for ACOs seeking to renew their participation in the MSSP. CMS is proposing to give ACOs the option of a longer lead time to transition to a two-sided performance risk model (sharing savings and losses) after their first agreement period. ACOs would have the opportunity to renew under the one-sided model for one additional agreement period.
- Encouraging ACOs to take on greater performance-based risk and reward. CMS is proposing to create a new two-sided risk model, called “track 3,” which integrates some elements from the Pioneer ACO model, such as higher rates of shared savings and prospective attribution of beneficiaries.
CMS is also seeking comments on a number of care coordination tools that would make two-sided performance-risk models more attractive to ACOs such as expanded use of telehealth, beneficiary attestation, and more flexibility around post-acute care referrals to help ACOs better coordinate care for beneficiaries, the press release said.
The proposed rule is scheduled for publication in the Dec. 8 Federal Register. Comments are due by Feb. 6, 2015.
Webinar on Xofigo Coding and Billing
Bayer HealthCare announces an education webinar on Changes in Coding, Purchasing, and Reimbursement for Xofigo® (radium Ra 223 dichloride) Injection Effective January 1, 2015. The webinar will provide information on the new permanent Xofigo HCPCS code and changes in billing and reimbursement for Xofigo.
The webinar will be offered on the following dates at 12 pm (ET, CT, and PT):
- December 9, 2014
- December 11, 2014
- December 17, 2014
- January 7, 2015
- January 14, 2015
- January 28, 2015
Gazyva Issued Permanent J Code
The Centers for Medicare & Medicaid Services (CMS) has granted a permanent J-code for Gazyva® (obinutuzumab) that goes into effect January 1, 2015. The J-code for GAZYVA is J9301 (injection, obinutuzumab, 10 mg).
Gazyva® (obinutuzumab), in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).
CBO Puts Cost of “Doc Fix” Legislation at $144B Over 10 Years
According to the latest estimate from the Congressional Budget Office (CBO), the cost of “doc fix” legislation to replace the sustainable growth rate (SGR) payment system would be $144 billion from 2015 to 2024. CBO’s most recent cost estimate is a $6 billion increase from last February’s estimated cost for the same legislation. Freezing the rates through 2024 would cost $119 billion, the CBO report said.
The CBO’s new cost estimates were made following the release of the final 2015 Medicare Physician Fee Schedule.
HHS Withdraws Proposed 340B "Mega-Rule"
On Nov. 14, 2014, the U.S. Department of Health and Human Services’ (HHS) Health Resources and Services Administration (HRSA) withdrew the proposed 340B Drug Discount Program “mega-rule” (RIN 0906-AB04) from the White House Office of Management and Budget (OMB). The proposed rule had been under review at the OMB since April.
Instead, in 2015 the agency plans to issue guidance on “key policy issues raised by various stakeholders committed to the integrity of the 340B program.”
“HRSA places the highest priority on the integrity of the 340B Program and continually works to strengthen the oversight of this program. In 2015, HRSA plans to issue a proposed guidance for notice and comment that will address key policy issues raised by various stakeholders committed to the integrity of the 340B program. HRSA is also planning to issue proposed rules pertaining to civil monetary penalties for manufacturers, calculation of the 340B ceiling price, and administrative dispute resolution.”
FDA Approves Bevacizumab Plus Chemotherapy to Treat Platinum-Resistant Recurrent Ovarian Cancer
On November 14, 2014, the U.S. Food and Drug Administration (FDA) approved bevacizumab solution for intravenous infusion (Avastin, Genentech, Inc.) in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for the treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
U.S. Xofigo Production Resumes
On Nov. 3, 2014, Bayer HealthCare Pharmaceuticals announced that the company has resumed production of Xofigo (radium Ra 223 dicholoride).
Read the company's "Dear Healthcare Professional" letter here.
Update From Dendreon
Dendreon, the prostate cancer vaccine company, announced Monday, Nov. 10, that the company has reached agreements on terms of financial restructuring and has commenced voluntary Chapter 11 proceedings to implement restructuring agreements.
Dendreon said that company’s operations will continue without interruption and that Provenge (sipuleucel-T) is and will continue to be available for patients.
Read company press release here.
CMS Proposes Coverage for LDCT Lung Screening for High-Risk Individuals
On Nov. 10, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a draft decision memo that would add a lung cancer screening counseling and shared decision-making visit, and for appropriate beneficiaries, screening for lung cancer with low-dose computed tomography (LDCT), once per year, as an additional preventive service benefit under the Medicare program.
Read Proposed Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N) here.
The proposal is open for public comment for 30 days.
FDA Approves Ramucirumab in Combination with Paclitaxel for Advanced Gastric or GEJ Cancers After Prior Chemotherapy
On Nov. 5, 2014, Eli Lilly and Company announced that the U. S. Food and Drug Administration (FDA) has approved ramucirumab (Cyramza) for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
In April 2014, ramucirumab was approved as a single agent for the treatment of patients with advanced gastric or GEJ adenocarcinoma refractory to or progressive following first-line therapy with platinum or fluoropyrimidine chemotherapy.
CMS Issues Final 2015 OPPS Rule
On Oct. 31, 2014, the Centers for Medicare & Medicaid Services (CMS) issued the final 2015 Hospital Outpatient Prospective Payment System (OPPS) rule. Under the final rule, overall OPPS payments are estimated to increase by 2.3 percent for CY 2015.
The rule is slated for publication in the Nov. 10 Federal Register.
Read the CMS fact sheet here.
View the final 2015 OPPS rule here.
ACCC is currently analyzing the rule and will provide in-depth analysis to membership shortly.
ACCC will also schedule a conference call for membership on both the 2015 OPPS rule and the 2015 Physician Fee Schedule rule.
CMS Issues Final 2015 Physician Fee Schedule Rule
On Oct. 31, 2014, the Centers for Medicare & Medicaid Services (CMS) issued the final 2015 Physician Fee Schedule (PFS) rule. Under the rule, Medicare physician payment rates will be cut by 21.2 percent after March 2015, unless Congress intervenes once again with a short-term "doc fix" to the sustainable growth rate (SGR) formula.
The rule is slated for publication in the Nov. 13 Federal Register.
Read the CMS fact sheet here.
View the final rule here. This link will change once the rule is published in the Federal Register on Nov. 13.
ACCC is currently analyzing the rule and will provide in-depth analysis to membership shortly. However, we do know that CMS did not finalize a proposal related to vaults used in radiation oncology that would have led to significant cuts in 2015. ACCC had asked CMS not to finalize this proposal in comments, and CMS listened, averting the cuts.
ACCC will also schedule a conference call for membership on both the 2015 OPPS rule and the 2015 Physician Fee Schedule rule.
CMS Launches $840 Million Transforming Clinical Practice Initiative
On Oct. 23, 2014, the Centers for Medicare & Medicaid Services (CMS) announced the launch of its $840 million Transforming Clinical Practice Initiative. Through this initiative, the agency will invest in the creation of evidence-based, peer-led collaboratives and practice transformation networks to support clinicians and their practices as they move towards and navigate a value-based health care system that rewards value and high-quality care.
CMS will award cooperative agreement funding for two network systems under this initiative: Practice Transformation Networks and Support and Alignment Networks.
Applications will be accepted for both cooperative agreement funding opportunities starting Oct. 23, 2014. Applicants are encouraged, but not required, to submit a letter of intent by Nov. 20, 2014. Applications are due to CMS no later than Jan. 6, 2015.
A series of informational session webinars for potential applications will be held on November 6, 2014, and November 20, 2014. Potential applicants may submit questions during these webinars and responses will be posted to CMS website after the respective webinars conclude.
CMS expect to announce awards in Spring/Summer 2015.
Update on Xofigo Shortage
Bayer HealthCare Pharmaceuticals issued a Dear Healthcare Professional letter on Oct. 21, 2014, stating that the company is currently experiencing a drug shortage for Xofigo® (radium Ra 223 dichloride) Injection due to a production issue. Bayer is currently coordinating with the U.S.Food and Drug Administration (FDA) to increase the availability of the drug.
CMS Awards Medicare Coverage for Breast Cancer Index Molecular Test
On Oct. 15, 2014, bioTheranostics, Inc., announced that the company’s Breast Cancer IndexSM
test has been awarded Medicare coverage. The Centers for Medicare & Medicaid Services (CMS) posted a positive coverage and reimbursement policy after evaluation by Palmetto GBA, the Medicare administrator responsible for the MolDx molecular diagnostic technology assessment program.
FDA Approves Bortezomib (Velcade) for Previously Untreated MCL
On Oct. 9, 2014, the U.S. Food and Drug Administration (FDA) approved bortezomib (Velcade) for injection for use in previously untreated patients with mantle cell lymphoma (MCL).
FDA Approves Akynzeo to Prevent CINV
On Oct. 10, 2014, the U.S. Food and Drug Administration (FDA) approved Akynzeo (netupitant and palonosetron) to treat chemotherapy-induced nausea and vomiting (CINV).
Akynzeo is a fixed combination capsule comprised of two drugs. Oral palonosetron, approved in 2008, prevents nausea and vomiting during the acute phase (within the first 24 hours) after the start of cancer chemotherapy. Netupitant, a new drug, prevents nausea and vomiting during both the acute phase and delayed phase (from 25 to 120 hours) after the start of cancer chemotherapy.
CMS Reopens Hardship Exception Deadline for EHRs
The Centers for Medicare & Medicaid Services (CMS) announced on Oct. 7, the agency has reopened the submission period for hardship exception applications for eligible professionals (EPs) and eligible hospitals to avoid the 2015 Medicare payment adjustments for not demonstrating meaningful use (MU) of Certified Electronic Health Record Technology (CEHRT). The new deadline is 11:59 PM EST November 30, 2014.
ASCO Releases Policy Statement on Obesity and Cancer
On Oct. 1, 2014, the American Society of Clinical Oncology (ASCO) released a new policy statement on obesity and cancer. The statement calls for increased education, research, and advocacy to reduce the impact of obesity—both as a leading cause of cancer and a complication in the care of cancer patients.
The policy statement was published online in the Journal of Clinical Oncology.
Open Payments Data Released by CMS
On Sept. 30, 2014, the Centers for Medicare & Medicaid Services (CMS) released the first round of Open Payments data to the public. The data, which contains 4.4 million payments valued at nearly $3.5 billion, covered financial transactions between drug and device manufacturers and physicians and teaching hospitals during the last five months of 2013.
The data release is part of the Open Payments program created under the Affordable Care Act (ACA).
Future reports will be published annually and will include a full 12 months of payment data, beginning in June 2015.
More Insurers for 2015 ACA Marketplaces, HHS Reports
According to a U.S. Department of Health & Human Services (HHS) report issued Sept 23, 2014, there will be a 25% increase in the number of health insurance issuers participating in the Affordable Care Act insurance marketplaces in 2015.
The report, “Health Insurance Issuer Participation and New Entrants in the Health Insurance Marketplace in 2015,” is available here.
NCI Launches Exceptional Responders to Cancer Therapy Study
On Wednesday, Sept. 24, 2014, the National Cancer Institute (NCI) announced the launch of the Exceptional Responders Initiative, a study to investigate the molecular factors of tumors associated with exceptional treatment responses of cancer patients to drug therapies. Scientists will attempt to identify the molecular features of tumors that predict whether or not a particular drug or class of drugs will be beneficial. Investigators will examine tumor specimens from patients in clinical trials who achieved an exceptional response relative to other trial participants, or other patients who achieved an exceptional and unexpected response to a non-investigational therapy.
IOM Issues Report on End of Life Care
On Sept. 17, 2014, the Institute of Medicine (IOM) issued a new report, “Dying in America: Improving Quality and Honoring Individual Preferences Near the End of Life.” The report calls for a “reorientation and restructuring of Medicare, Medicaid and other health care delivery programs” so that the healthcare system can better address the needs of people nearing the end of life.
The consensus report finds that “improving the quality and availability of medical and social services for patients and their families could not only enhance quality of life through the end of life, but may also contribute to a more sustainable care system.”
The report makes five recommendations for steps that government programs, clinicians, private insurers, professional societies and other stakeholders can take to improve the quality and availability of end-of-life care:
- "Government health insurers and care delivery programs, as well as private health insurers, should cover the provision of comprehensive care for individuals with advanced serious illness who are nearing the end of life."
- "Professional societies and other organizations that establish quality standards should develop standards for clinician–patient communication and advance care planning that are measurable, actionable, and evidence based."
- "Educational institutions, credentialing bodies, accrediting boards, state regulatory agencies, and healthcare delivery organizations should establish the appropriate training, certification, and/or licensure requirements to strengthen the palliative care knowledge and skills of all clinicians who care for individuals with advanced serious illness who are nearing the end of life."
- "Federal, state, and private insurance and health care delivery programs should integrate the financing of medical and social services to support the provision of quality care consistent with the values, goals, and informed preferences of people with advanced serious illness nearing the end of life."
- "Civic leaders, public health and other governmental agencies, community-based organizations, faith-based organizations, consumer groups, health care delivery organizations, payers, employers, and professional societies should engage their constituents and provide fact-based information about care of people with advanced serious illness to encourage advance care planning and informed choice based on the needs and values of individuals."
FDA Approves New Indication for Xtandi for Metastatic Castration-Resistant Prostate Cancer
On Sept. 10, 2014, the U.S. Food and Drug Administration (FDA) approved a new indication for the use of Xtandi® (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC). This new approved use follows a priority review of the supplemental New Drug Application (sNDA) that was based on results of the Phase 3 PREVAIL trial.
ASCO & CCO Issue New Guideline on Treating Metastatic Castration-Resistant Prostate Cancer
On Sept. 8, 2014, the American Society of Clinical Oncology (ASCO) and Cancer Care Ontario (CCO) released a joint clinical practice guideline on treating men with metastatic castration-resistant prostate cancer. The guideline includes recommendations on systemic therapies that are indicated for use alongside androgen deprivation, addressing survival and quality of life benefits, side effects, and cost considerations for each.
The guideline, Systemic Therapy in Men with Metastatic Castration-Resistant Prostate Cancer (CRPC): American Society of Clinical Oncology and Cancer Care Ontario Clinical Practice Guideline, was published in the Journal of Clinical Oncology.
CMS Report Projects Decrease in Uninsured; Faster Health Expenditure Growth as Coverage Expands & Economy Improves
The number of uninsured is expected to decline by nearly half—from 45 million in 2012 to 23 million by 2023—as a result of the coverage expansions associated with the Affordable Care Act, according to a report from the Centers for Medicare & Medicaid Services (CMS) Office of the Actuary. The report was published Sept. 4, 2014, in the journal, Health Affairs.
For 2014, the health spending growth rate is expected to be 5.6 percent, as 9 million Americans are projected to gain health insurance coverage, predominantly through Medicaid or the Health Insurance Marketplaces.
FDA Approves Keytruda for Advanced Melanoma
The U.S. Food and Drug Administration (FDA) Sept. 4, 2014, granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.
Keytruda is the first approved drug that blocks a cellular pathway known as PD-1, which restricts the body’s immune system from attacking melanoma cells. Keytruda is intended for use following treatment with ipilimumab, a type of immunotherapy. For melanoma patients whose tumors express a gene mutation called BRAF V600, Keytruda is intended for use after treatment with ipilimumab and a BRAF inhibitor, a therapy that blocks activity of BRAF gene mutations.
CMS Announces ICD-10 Testing Weeks
In preparation for the Oct. 1, 2015, compliance deadline, the Centers Medicare & Medicaid Services (CMS) has announced three ICD-10 testing weeks:
- November 17-21, 2014
- March 2-6, 2015
- June 1-5, 2015
ASCO Issues New Guideline for HER2-Negative Breast Cancer
The American Society of Clinical Oncology (ASCO) has released a new clinical practice guideline to help identify optimal chemo- and targeted therapy for women with HER2-negative (or unknown) advanced breast cancer.
The guideline was published online Sept. 2, 2014, in the Journal of Clinical Oncology.
CMS Final Rule Permits Automatic Re-Enrollment in 2015 Health Plans
The Centers for Medicare & Medicaid Services (CMS) issued a final rule Sept. 2, 2014, that will allow consumers in the federal Affordable Care Act (ACA) health insurance Marketplace to automatically re-enroll in plans for 2015.
Consumers in the federally-facilitated Marketplace will receive notices from the Marketplace shortly before open enrollment begins explaining the auto-enrollment process and how they can return to the Marketplace to see if they qualify for additional financial assistance and shop for plans.
CMS Final EHR Rule Provides Some Flexibility on MU Requirements
On Aug. 29, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a final rule allowing healthcare providers more flexibility in how they use certified electronic health record (EHR) technology (CEHRT) to meet meaningful use for an EHR Incentive Program reporting period for 2014. The final rule allows providers and hospitals unable to obtain an electronic health record system certified as meeting the latest federal standards for use in the meaningful use program to continue participation in the program. The rule also delays the start of Stage 3 until 2017.
The final rule will be published in the Sept. 4 Federal Register. The rule goes into effect Oct. 1, 2014.
More information on the EHR Incentive Programs is available here.
More information on CEHRT is available here.
CMS Extends Deadline for Open Payments Review and Dispute
The Centers for Medicare & Medicaid Services (CMS) has extended the deadline for review and dispute of payment information on the Open Payments system until Sept. 10, 2014, according to an Aug. 28 announcement.
In an emailed statement, CMS said that access to the Open Payment system “will be unavailable for approximately two days due to the upcoming maintenance updates at the CMS Data Center.” In the email, the agency said the scheduled maintenance upgrades at the CMS Data Center would take place between Aug. 30 and Sept. 5.
Following the new Sept. 10 deadline, the 15-day correction period will last from Sept. 11 through Sept. 25, the agency said. The date that the public website will be available is still Sept. 30, 2014.
Source: Bloomberg BNA.
NIH Issues Final Policy on Genomic Data Sharing
The National Institutes of Health (NIH) has issued a final NIH Genomic Data Sharing (GDS) policy to promote data sharing as a way to speed the translation of data into knowledge, products and procedures that improve health while protecting the privacy of research participants. The final policy was posted in the Federal Register August 26, 2014, and published in the NIH Guide for Grants and Contracts August 27, 2014.Learn more here.
NIH Announces Launch of 3 Integrated Precision-Medicine Lung Cancer Trials
The National Institutes of Health (NIH) Aug. 18 announced the launch of the Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials, or ALCHEMIST, which comprises 3 integrated precision medicine trials. ALCHEMIST aims to identify early-stage lung cancer patients with tumors that harbor certain uncommon genetic changes and evaluate whether drug treatments targeted against those changes can lead to improved survival.
ALCHEMIST is supported by the National Cancer Institute (NCI) with coordination of the component trials by the Alliance for Clinical Trials in Oncology and the ECOG-ACRIN Cancer Research Group. All of the NCI-supported National Clinical Trials Network (NCTN) groups collaborated in the development of ALCHEMIST and are participating in the component trials.
The three component trials of ALCHEMIST are:
ALCHEMIST - Screening component (A151216) – Coordinated by the Alliance for Clinical Trials in Oncology; Principal Investigators: Pasi A. Janne, MD, PhD, and Geoffrey Oxnard, MD, Dana-Farber Cancer Institute, Boston. http://www.cancer.gov/clinicaltrials/NCT02194738
ALCHEMIST - EGFR Treatment component (A081105) – Coordinated by the Alliance for Clinical Trials in Oncology; Principal Investigator: Ramaswamy Govindan, MD, Washington University, St. Louis. http://www.cancer.gov/clinicaltrials/NCT02193282
ALCHEMIST - ALK Treatment component (E4512) – Coordinated by ECOG-ACRIN; Principal Investigator: David E. Gerber, MD, University of Texas Southwestern Medical Center at Dallas. http://www.cancer.gov/clinicaltrials/NCT02201992
FDA Approves Velcade for Retreatment in Patients with Multiple Myeloma
Millennium: The Takeda Oncology Company announced Aug. 10, 2014, that the U.S. Food and Drug Administration (FDA) has approved Velcade® (bortezomib) for the retreatment of adult patients with multiple myeloma who had previously responded to Velcade therapy and relapsed at least six months following completion of prior Velcade treatment. The labeling update includes dosing guidelines as well as safety and efficacy findings for the use of Velcade as a single agent or Velcade in combination with dexamethasone in patients previously treated with Velcade.
Open Payments System Reopens, CMS Extends Physician Registration & Review Period
The Centers for Medicare & Medicaid Services (CMS) announced Aug. 15, 2014, that the Open Payments system is reopened so that physicians and teaching hospitals can register, review and, as needed, dispute financial payment information received from healthcare manufacturers, under the Sunshine Act Open Payments program. The system was taken offline on August 3 to resolve a technical issue, the agency said in a statement. To account for system down time, CMS is extending the time for physicians and teaching hospitals to review their records to Sept. 8, 2014. The public website will be available on Sept. 30, 2014.
FDA Approves Avastin for Late-stage Cervical Cancer
On August 14, 2014, the U. S. Food and Drug Administration (FDA) approved bevacizumab solution for intravenous infusion (Avastin, Genentech, Inc.) for the treatment of persistent, recurrent or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
Posted 8/15/14, updated 8/19/14
CMS Needs Better Oversight Tools to Reduce Duplicate Post-Payment Claims Reviews, GAO Report Finds
A Government Accountability Office (GAO) report on Medicare contractors issued August 13, 2014, calls for the Centers for Medicare & Medicaid Services (CMS) to improve oversight tools of its contractors’ post-payment review of claims to reduce duplication.
The report, Medicare Program Integrity: Increased Oversight and Guidance Could Improve Effectiveness and Efficiency of Postpayment Claims Reviews, finds that “…[CMS] has taken steps to prevent its contractors from conducting certain duplicative post-payment claims reviews—reviews of the same claims that are not permitted by the agency—but CMS neither has reliable data nor provides sufficient oversight and guidance to measure and fully prevent duplication.
For the report, the GAO looked at four types of contractors that examine providers’ documentation to determine whether Medicare’s payment are proper:
- Medicare Administrative Contractors (MACs);
- Zone Program Integrity Contractors (ZPICs);
- Recovery Audit Contractors (RACs); and
- Comprehensive Error Rate Testing Contractors (CERTs).
The GAO report recommends that CMS should:
- Monitor the Recovery Audit Data Warehouse to ensure all post-payment review contractors are submitting required data and that the data within the database are accurate and complete;
- Develop complete guidance to define contractors’ responsibilities for duplicative claims reviews, including specifying if and when MACs and ZPICs can duplicate other contractors’ reviews;
- Regularly assess whether contractors are complying with CMS requirements for content of correspondence to providers regarding claims review;
- Clarify current requirements for content of contractors’ additional documentation requests (ADRs) and results letters and standardize the requirements and contents as much as possible to ensure greater consistency among post-payment claims review contractors’ correspondence.
FDA Approves First Non-invasive DNA Screening Test for Colorectal Cancer
The U.S. Food and Drug Administration (FDA) Aug. 11, 2014, approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer.
Using a stool sample, Cologuard detects hemoglobin, a protein molecule that is a component of blood. Cologuard also detects certain mutations associated with colorectal cancer in the DNA of cells shed by advanced adenomas as stool moves through the large intestine and rectum. Patients with positive test results are advised to undergo a diagnostic colonoscopy.
The FDA's approval of the Cologuard does not change current practice guidelines for colorectal cancer screening. Stool DNA testing (also called “fecal DNA testing”) is not currently recommended as a method to screen for colorectal cancer by the United States Preventive Services Task Force (USPSTF).
Also on Aug. 11, the Centers for Medicare & Medicaid Services (CMS) issued a proposed national coverage determination (NCD) for Cologuard. Cologuard is the first product reviewed through a joint FDA-CMS pilot parallel review program where the agencies concurrently review medical devices to help reduce the time between the FDA’s approval of a device and Medicare coverage.
President Obama Signs $16.3 Billion VA Reform Bill
On Aug. 7, 2014, President Obama signed into law a $16.3 billion bill to improve healthcare for veterans.
The law establishes a $10 billion Veterans Choice Fund that will enable veterans who have experienced long wait times for medical care (about 30 days) or who live a significant distance from VA facilities (more than 40 miles) to access care outside the VA health system—if certain conditions are met.
The administration has 90 days to issue regulations on implementing the law.
Source: Bloomberg, BNA.
PCORI Announces $76 Million Available for New CER Grants
The Patient-Centered Outcomes Research Institute (PCORI) August 6, 2014, made a series of funding announcements that offer up to $76 million in support for patient-centered comparative clinical effectiveness research (CER) projects under PCORI’s five broad National Priorities for Research.
The funding available is for opportunities related to the assessment of prevention, diagnosis, and treatment options; improving health-care systems; communication and dissemination of research; addressing disparities; and improving methods for conducting patient-centered outcomes research.
In a press release, PCORI states that its grant application process has been streamlined based on applicant feedback, offering more guidance on research areas and topics of greatest interest.
Physician Groups Ask CMS to Delay Release of Sunshine Act Data
On Aug. 6, 2014, the American Medical Association and 112 specialty and state medical societies sent a letter to the Centers for Medicare & Medicaid Services (CMS) asking that the agency postpone the public release of Sunshine Act Open Payments data from Sept. 30, 2014, to March 31, 2015.
The letter highlights a number of concerns with the roll-out of the Physician Payments Sunshine Act, including a complex and cumbersome registration process for physician review of submitted data.
CAP Publishes Recommendations for Prostate Cancer Active Surveillance
On August 5, 2014, the College of American Pathologists (CAP) announced that a multi-specialty team has published recommendations for prostate cancer active surveillance in a special online posting from the Archives of Pathology & Laboratory Medicine.
“Active surveillance is an important management option for men with low-risk prostate cancer,” said lead author Mahul Amin, MD, FCAP, Chair, Department of Pathology & Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles, Calif., in a statement. “Vital to this process is the critical role pathologic parameters play in identifying appropriate candidates for active surveillance.”
Dr. Amin headed up the team that highlighted the pathologic parameters key for the successful identification of patients likely to succeed with active surveillance. These key parameters, at a general level, address:
- Sampling, submission, and processing issues in needle biopsies used to diagnose prostate cancer
- Tumor extent in needle biopsies
- Biopsy reporting for all and special cases
- Gleason scores, the system for grading prostate cancer tissue based on how it looks under a microscope
- Precision medicine markers
- Other pathologic considerations.
The recommendations appear in the Archives article: The Critical Role of the Pathologist in Determining Eligibility for Active Surveillance as a Management Option in Patients with Prostate Cancer: Consensus Statement with Recommendations Supported by the College of American Pathologists, International Society Of Urological Pathology, Association of Directors of Anatomic and Surgical Pathology, the New Zealand Society of Pathologists, and the Prostate Cancer Foundation.
PCORI Awards $54.8 Million to Support 33 New CER Projects; Upcoming PCORI Opportunities
On July 29, 2014, the Patient-Centered Outcomes Research Institute (PCORI) Board of Governors approved $54.8 million in funding to support 33 new patient-centered comparative clinical effectiveness research (CER) projects.
The approved proposals include studies of ways to improve outcomes for people experiencing cardiovascular disease, diabetes, chronic pain, mental health conditions, nervous system disorders, kidney disease, multiple chronic conditions, and cancer. The approved projects resulted from PCORI Funding Accouncements (PFAs) issued in Sept. 2013.
All the awards were approved pending completion of a business programmatic review by PCORI staff and issuance of a formal award contract.
For details about the newly approved studies click here.
Starting Wednesday, Aug. 6, 2014, PCORI is opening up its Web portal for new applications. Researchers can submit letters for upcoming opportunities in five priority areas Aug. 6 through Friday Sept. 5. Learn more here.
CMS to Resume RAC Audits on Limited Basis
On Aug. 4, 2014, in a notification sent to the House and Senate, the Centers for Medicare & Medicaid Services (CMS) announced a limited restart of Recovery Audit Contractor (RAC) reviews, BNA Bloomberg reports.
According to the CMS website “Most reviews will be done on an automated basis, but a limited number will be complex reviews of topics selected by CMS.”
ACCC Provides Comments to Proposed USP Chapter 800
On July 31, the Association of Community Cancers’ Oncology Pharmacy Education Network (OPEN) sent a comment letter to the US Pharmacopeial Convention (USP) on proposed new USP General Chapter <800> “Hazardous Drugs—Handling in Healthcare Settings.”
While OPEN supports USP’s dedication to ensuring the highest standards for personnel safety, the guidelines set forth in Chapter 800 would be unduly burdensome to undertake and could cause some facilities to discontinue compounding drugs for their patients. The letter encourages USP to reconsider these guidelines.
ACCC’s Oncology Pharmacy Education Network (OPEN) also joined in group letter with organizations representing cancer care providers on both the state and national level that expressed common concerns regarding proposed USP Chapter <800>.
Read ACCC’s Oncology Pharmacy Education Network (OPEN) comment letter here.
Read the joint comment letter here.
Learn more about proposed new USP General Chapter <800> here.
NCI Announces Official Launch of NCORP
On August 1, 2014, the National Cancer Institute (NCI) announced the official launch of the new NCI Community Oncology Research Program (NCORP). NCORP is a national network of investigators, cancer care providers, academic institutions, and other organizations that provide care to diverse populations in community-based healthcare practices across the U.S. This effort is a collaboration between NCI's Divisions of Cancer Prevention, Cancer Control and Population Sciences, Cancer Treatment and Diagnosis, and Center to Reduce Cancer Health Disparities.
NCORP will design and conduct trials to improve cancer prevention, cancer control, screening, and post-treatment management. Additionally, a new focus for NCI community-based research will be care delivery and comparative effectiveness research that will focus on the factors that affect access to and quality of care in the community.
NCORP replaces two previous NCI community-based clinical research programs: the NCI Community Clinical Oncology Program (CCOP), made up of the Community Clinical Oncology Programs, Minority-Based Clinical Oncology Programs, and Research Bases, and the NCI Community Cancer Centers Program (NCCCP).
Read NCI news note about NCORP here.
To learn more about NCORP here.
FDA to Issue Guidance on Companion Diagnostics; Agency Plans to Publish Proposed Oversight Framework for LDTs
On July 31, 2014, the U.S. Food and Drug Administration (FDA) announced the agency is issuing a final guidance on the development, review, and approval or clearance of companion diagnostics, which are tests used to identify patients who will benefit from or be harmed by treatment with a certain drug. Companion diagnostic tests are intended to aid physicians in selecting appropriate therapies for individual patients. These tests are commonly used to detect certain types of gene-based cancers.
The agency also notified Congress of its intention to publish a proposed risk-based oversight framework for laboratory developed tests (LDTs), which are designed, manufactured and used within a single laboratory. They include some genetic tests and tests that are used by healthcare professionals to guide medical treatment for their patients.
The FDA already oversees direct-to-consumer tests regardless of whether they are LDTs or traditional diagnostics.
Read the FDA press release here.
CMS Issues Rule Finalizing Oct. 1, 2015 as ICD-10 Compliance Date
On July 31, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a rule (CMS-0043-F) making Oct. 1, 2015, the new compliance date for healthcare providers, health plans, and healthcare clearinghouses to transition to ICD-10. “This deadline allows providers, insurance companies and others in the health care industry time to ramp up their operations to ensure their systems and business processes are ready to go on Oct. 1, 2015,” the agency said in a statement.
Read the CMS press release here.
FDA Expands Approved Use of Imbruvica for CLL
On July 28, 2014, the U.S. Food and Drug Administration (FDA) expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use.
The FDA is also approving new labeling to reflect that Imbruvica’s clinical benefit in treating CLL has been verified. In February 2014, Imbruvica received accelerated approval to treat CLL based on its effect on overall response rate. New clinical trial results examining progression-free survival and overall survival have confirmed the drug’s clinical benefit.
Read the FDA press release here.
FDA Approves Zydelig for Three Types of Blood Cancers
On July 23, 2014, the U.S. Food and Drug Administration (FDA) approved Zydelig (idelalisib) to treat patients with three types of blood cancers.
Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic leukemia (CLL) has returned (relapsed). Used in combination with Rituxan (rituximab), Zydelig is to be used in patients for whom Rituxan alone would be considered appropriate therapy due to other existing medical conditions (co-morbidities). Zydelig is the fifth new drug with breakthrough therapy designation to be approved by the FDA and the third drug with this designation approved to treat CLL.
The FDA is also granting Zydelig accelerated approval to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL), another type of non-Hodgkin lymphoma. Zydelig is intended to be used in patients who have received at least two prior systemic therapies.
Read the FDA press release here.
Upcoming MLN Connects Call on Open Payments: Registration, Review, & Dispute
Phase 2 of the Open Payments (Sunshine Act) roll out allows providers to register in the Open Payments system, and then review and—if needed—dispute any of the data reported by the industry before public posting of the data. During an upcoming MLN Connects National Provider Call, CMS experts will give a brief overview about Open Payments and provide a step-by-step review of the registration, review, and dispute process.
Open Payments (Sunshine Act): Registration, Review, and Dispute
Tuesday, July 22
2:30 pm – 4:00 pm ET
To register: Visit MLN Connects™ Upcoming Calls. Space may be limited, register early.
More information is available here.
CMS Announces New Prospective Health Care Innovation Awardees
July 9, 2014, U.S. Department of Health and Human Services Secretary Sylvia Mathews Burwell announced new prospective awardees to test innovative care models under the Health Care Innovations Awards program. This brings the total amount of funding to as much as $360 million for 39 recipients spanning 27 states and the District of Columbia. These models are designed to deliver better health care and lower costs under the Health Care Innovation Awards program.
The new prospective (not yet final) awards range from an expected $2 million to $23.8 million over a three-year period. These awards, made possible by the Affordable Care Act, round out the anticipated recipients for round two of the Health Care Innovation Awards program.
Read HHS press release here.
Learn more about Health Care Innovation Awards Round Two here.
CMS Releases 2015 Medicare PFS Proposed Rule
On July 3, 2014, the Centers for Medicare & Medicaid Services (CMS) released the 2015 Medicare Physician Fee Schedule (PFS) Proposed Rule. In a fact sheet, CMS states that the agency is proposing a new process for establishing PFS payment rates that will be more transparent and allow for greater public input prior to payment rates being set. Under the proposed new process, beginning in 2016, payment changes would go through notice and comment rulemaking before being adopted.
The proposed rule is scheduled for publication in the July 11, 2014 Federal Register. CMS will accept comments on the proposed rule until Sept. 2, 2014.
More information is available here.
ACCC is currently analyzing the proposed rule and will be provide more in-depth information to members shortly.
View additional fact sheets on the Value-Based Payment Modifier (Value Modifier) and quality provisions in the 2015 PFS proposed rule here.
CMS Releases 2015 OPPS Proposed Rule
On July 3, 2014, the Centers for Medicare & Medicaid Services (CMS) released the 2015 Outpatient Prospective Payment System (OPPS) Proposed Rule. Under the proposal payments for outpatient hospitals would increase 2.1 percent in 2015.
The proposed rule is scheduled for publication in the July 14, 2014 Federal Register and can be downloaded from the Federal Register here.
CMS will accept comments on the proposed rule until Sept. 2, 2014, and will respond to comments in a final rule scheduled for release on or around Nov. 1, 2014.
ACCC is currently analyzing the proposed rule and will be provide more in-depth information to members shortly.
Read a separate CMS fact sheet on quality provisions in the proposed rule here.
FDA Approves Beleodaq to Treat Rare Form of non-Hodgkin Lymphoma
On July 3, 2014, the U. S. Food and Drug Administration (FDA) granted accelerated approval to belinostat (BELEODAQ, Spectrum Pharmaceuticals, Inc.) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
As a condition of this accelerated approval, FDA requires the sponsor to conduct a dose-finding trial of belinostat when combined with CHOP (cyclophosphamide, vincristine, doxorubicin and prednisone) and a subsequent phase 3 trial to characterize the comparative efficacy and safety of belinostat in combination with CHOP versus CHOP alone.
Read the FDA announcement here.
Read FDA press release here.
Navigator Grants Opportunity in Federally-Facilitated and State Partnership Marketplaces Announced by CMS
The Centers for Medicare & Medicaid Services (CMS) has announced a total of $60 million in available funding to support Navigators in federally-facilitated and state partnership Marketplaces in 2014-2015. Navigators provide unbiased information to consumers about health insurance, the Health Insurance Marketplace, qualified health plans, and public programs including Medicaid and the Children’s Health Insurance Program.
The funding opportunity for navigator grants is open to eligible individuals, as well as private and public entities, applying to serve as Navigators in states with a Federally-facilitated or State Partnership Marketplace. It is open to new and returning Navigator applicants. Applications are due by July 10, 2014.
Last month, CMS finalized regulations that update the requirements applicable to Navigators. The final rule is available here.
The CMS funding opportunity announcement is available here, search for CFDA # 93.332.
More information about Navigators is available here.
FDA Warns Docetaxel May Cause Symptoms of Alcohol Intoxication After Treatment
In a June 20, 2014, drug safety communication, the U.S. Food and Drug Administration (FDA) warns that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. The FDA is revising the labels of all docetaxel drug products to warn about this risk. The FDA announcement states that healthcare professionals should consider the alcohol content of docetaxel when prescribing or administering the drug to patients, particularly in those whom alcohol intake should be avoided or minimized and when using it in conjunction with other medications.
View the FDA drug safety communication on docetaxel here.
MedPAC Makes Short- and Long-Term Recommendations for Strengthening ACOs
On June 16, the Medicare Payment Advisory Commission (MedPAC) provided comments to the Centers for Medicare & Medicaid Services (CMS) that raise five key issues regarding the Pioneer ACOs.
In the short-term, MedPAC said that CMS needs to improve beneficiary assignment and simplify the quality measurement and evaluation process. Among the longer term issues that need to be addressed is the necessity to move toward a program in which ACOs share risks as well as savings. The MedPAC comment letter states that: "Almost all MSSP ACOs have chosen to be one-sided (bonus only) rather than two-sided risk. However, incentives for improvement are much stronger in a two-sided model."
The 18-page comment letter addresses "...issues essential to the success of the program that will require changes in either regulation or legislation to be resolved...."
Read the MedPAC comment letter here.
Lung-MAP Collaborative Clinical Trial Launched
On June 16, 2014, the launch of a unique public-private collaborative clinical trial, the Lung Cancer Master Protocol (Lung-MAP) trial was announced. The trial represents a collaborative effort among the National Cancer Institute (NCI), SWOG Cancer Research, Friends of Cancer Research, the Foundation for the National Institutes of Health (FNIH), five pharmaceutical companies (Amgen, Genentech, Pfizer, AstraZeneca, and AstraZeneca’s global biologics R&D arm, MedImmune), and Foundation Medicine.
Lung-MAP is a multi-drug, multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer. The trial will use genomic profiling to match patients to one of several different investigational treatments that are designed to target the genomic alterations found to be driving the growth of their cancer.
“Lung-MAP represents the first of several planned large, genomically-driven treatment trials that will be conducted by NCI’s newly formed National Clinical Trials Network (NCTN),” said Jeff Abrams, MD, Associate Director of NCI’s Cancer Therapy Evaluation Program in a press release. “The restructuring and consolidation of NCI’s large trial treatment program, resulting in the formation of the NCTN, is quite timely, as it now can offer an ideal platform for bringing the benefits of more precise molecular diagnostics to cancer patients in communities large and small.”
Initially, the trial will test five experimental drugs—four targeted therapies and an anti-PD-L1 immunotherapy. Estimates are that between 500 and 1000 patients will be screened per year for over 200 cancer-related genes for genomic alterations. The results of this test will be used to assign each patient to the trial arm that is best matched to his or her tumor’s genomic profile.
Read the press release here.
Learn more about the Lung-MAP trial here.
American Cancer Society Releases New Prostate Survivorship Guidelines
New Prostate Cancer Survivorship Care guidelines from the American Cancer Society (ACS), released on June 10, outline post-treatment clinical follow-up care for the long-term and late effects that the estimated 2.8 million prostate cancer survivors in the U.S. may face. The guidelines report is published early online in the ACS journal, CA: A Cancer Journal for Clinicians.
The guidelines are designed to promote optimal health and quality of life for post-treatment prostate cancer survivors by facilitating the delivery of comprehensive post-treatment care by primary care clinicians, the ACS said. The new guidelines are based on recommendations from an expert panel convened through the National Cancer Survivorship Resource Center, a collaboration between ACS and The George Washington University Cancer Institute, which is funded by a 5-year cooperative agreement from the Centers for Disease Control and Prevention (CDC).
Read the ACS press release here.
ONC Releases 10-Year Plan for Health IT Interoperability
The Office of the National Coordinator (ONC) for Health Information Technology has issued a 10-year general plan for achieving an interoperable health IT infrastructure. The plan focuses on the need to resolve interoperability issues in order to realize the promise of health IT to improve care, create efficiencies, and save money. The 13-page plan outlines three-, six- and 10-year agendas for interoperability and data sharing.
Read “A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure” here.
QOPI Approved as Pathway to Meet CMS's Quality Reporting Requirements
The Centers for Medicare & Medicaid Services (CMS) has approved the American Society of Clinical Oncology’s (ASCO) Quality Oncology Practice Initiative (QOPI®) as a pathway for oncologists to meet the agency’s quality reporting requirements. Starting in the fall of 2014, oncology practices registered with QOPI will have the opportunity to fulfill CMS’s Physician Quality Reporting System (PQRS) or Qualified Clinical Data Registry (QCDR) reporting requirements through QOPI, according to an ASCO press release.
FDA Approves Aloxi for Pediatric Patients
On May 28, Eisai Inc. and Helsinn Group announced U.S. Food and Drug Administration (FDA) approval of Aloxi® (palonosetron HCl) injection for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy, in children aged 1 month to less than 17 years.
Sunshine Act Phase 2 Data Submissions to Start June 1
Sunshine Act Phase 2 data collection will begin June 1, 2014, according to a recent blog post from the Centers for Medicare & Medicaid Services (CMS).
From June 1 through June 30, applicable drug manufacturers and group purchasing organizations will be able to complete their registration in the Open Payments system and confirm the accuracy of any data submitted during Phase 1. All payment data must be submitted by June 30.
Also beginning June 1, physicians and teaching hospitals will be able to register in the CMS Enterprise Portal, and review data submitted about them by pharmaceutical manufacturers and GPOs.
The CMS blog post states:
"Physicians and teaching hospitals will be able to review data submitted by the manufacturers and GPOs, and if needed, they should report and dispute inaccuracies before the data is included in the public database. They can review the information submitted about them by registering in our Enterprise Portal starting June 1, 2014. Then, in July, physicians and teaching hospitals can begin to register in the Open Payments system. Those registered will be notified when data has been submitted about them, allowing them to review and dispute data submitted by health care manufacturing companies and GPOs prior to public data posting."
FDA Approves Panitumumab for Use with FOLFOX in Wild-Type KRAS mCRC
On May 23, 2014, Amgen announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Vectibix® (panitumumab) specifically for use in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, as first-line treatment in patients with wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC).
The FDA also approved the therascreen® KRAS RGQ PCR Kit developed by QIAGEN (therascreen KRAS test) as a companion diagnostic for Vectibix. Vectibix is not indicated for the treatment of patients with KRAS-mutant mCRC or for whom KRAS mutation status is unknown.
ACR Launches Designated Lung Cancer Screening Center Program
On May 8, 2014, the American College of Radiology (ACR) announced that it is accepting applications for its new ACR Lung Cancer Screening Center program. The program recognizes facilities committed to providing quality screening care to patients at the highest risk for lung cancer.
To apply for the ACR Lung Cancer Screening Center designation, centers must have an active ACR CT accreditation in the chest module and meet specific equipment, personnel, and imaging protocol requirements.
FDA Approves Synribo for Injection for Home Administration
On May 5, 2014, Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Synribo® (omacetaxine mepesuccinate) for injection, for subcutaneous use, to include home administration, and also approved a related Medication Guide and Instructions for Use. With this approval, physicians who treat adults with chronic or accelerated phase CML who are no longer responding to, or who could not tolerate, two or more tyrosine kinase inhibitors will now have the option to allow their patients to administer Synribo® therapy at home.
Teva is working to finalize a comprehensive specialty pharmacy support program which will help facilitate successful home administration of Synribo for healthcare providers, their patients, and caregivers. This program is expected to “go live” as early as possible in the second quarter of 2014.
HHS Bulletin Mentions Special Enrollment Period for COBRA-Eligible People
On May 2, 2014, the U.S. Department of Health and Human Services (HHS) issued a guidance bulletin, titled “Special Enrollment Periods and Hardship Exemptions for Persons Meeting Certain Criteria” with information on three types of special enrollment periods for those seeking to enroll in qualified health plans (QHPs) through the Federally-facilitated Marketplace (FFM).
The guidance states that “special enrollment periods” will be allowed for people eligible for Consolidated Omnibus Budget Reconciliation Act (COBRA) coverage after losing or changing jobs. Those individuals will be able to select QHPs in the FFM 60 days from the date of the bulletin, through July 1, 2014, the bulletin said.
Altogether, the bulletin addresses three types of special enrollment periods for those seeking to enroll in QHPs through the FFM, and two hardship exemptions available for eligible consumers in FFM and state-based marketplaces.
MEDCAC Gives CT Lung Screening Low-Confidence Vote
On Wednesday, May 1, 2014, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) voted a mean of 2.2 on a 5.0 scale for confidence regarding annual low-dose CT lung cancer screening for high-risk individuals.
The panel’s vote does not align with the United States Preventive Services Task Force (USPSTF) December 2013 recommendation.
MEDCAC is slated to release its proposed decision in November, followed by a 30-day comment period, with a final determination 90 days later.
Read ACCC’s comment letter to CMS in support of low-dose CT screening as recommended by the USPSTF.
FDA Grants Orphan Drug Designation to Demcizumab for Pancreatic Cancer
On May 2, 2014, OncoMed Pharmaceuticals Inc., announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to demcizumab (anti-DLL4, OMP-21M18) for the treatment of pancreatic cancer. OncoMed is currently conducting a Phase 1b clinical trial of demcizumab in combination with Abraxane® (nab-paclitaxel) and gemcitabine in first-line Stage IV pancreatic cancer patients.
The FDA's Orphan Drug program provides orphan status to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S.
Read the company statement here.
CMS Releases Proposed Inpatient Hospital Payment Update
On April 30, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would update fiscal year (FY) 2015 Medicare payment policies and rates for inpatient stays at general acute care and long-term care hospitals. CMS states that the proposed rule would strengthen the tie between payment and quality improvement.
The agency projects that the payment rate update to general acute care hospitals will be 1.3 percent in FY 2015. However, under the proposed rule, aggregate payments (operating and capital) are expected to drop $241 million, the agency said, as reported by Bloomberg BNA.
The proposed rule will be published in the May 15 Federal Register. CMS will accept comments on the proposed rule until June 30, 2014, and will respond to comments in a final rule to be issued by August 1, 2014.
Read the CMS press release here.
CMS Issues Medicare PPS Rule for FQHCs
On April 29, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that establishes a Medicare Prospective Payment System for Federally Qualified Health Centers (FQHCs). The payment system could increase Medicare payments to FQHCs by as much as 32 percent, CMS said. FQHCs provide access to medical services to patients in or from medically underserved areas.
The Affordable Care Act requires that the new Medicare Prospective Payment System (PPS) for FQHCs account for a number of factors, including the type, intensity, and duration of services provided in this setting. The new payment system will be implemented beginning on October 1, 2014. FQHCs will be transitioned to the new payment system throughout 2015.
The final rule will be published in the May 2, 2014, Federal Register. CMS is seeking comments on modifications of a few proposals including: a simplified method for calculating coinsurance when a preventive and non-preventive service is on the same claim; the establishment of Medicare-specific payment codes to be used for Medicare encounter-based payment under the new PPS; and ways in which payment for chronic care management services could be adapted for FQHCs and rural health clinics. CMS will accept comments until July 1, 2014, and will respond to them in a final rule to be issued in 2014.
Read the CMS press release here.
FDA Approves Zykadia for Late-stage Lung Cancer
The U.S. Food and Drug Administration, on April 29, 2014, granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).
Zykadia is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients with metastatic ALK-positive NSCLC who were previously treated with crizotinib, the only other approved ALK tyrosine kinase inhibitor.
The FDA is approving Zykadia under the agency’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials.
Read the FDA press release here.
More information is available here.
FDA Approves Oral Suspension of Mercaptopurine
On April 28, 2014, the FDA approved an oral suspension of mercaptopurine (Purixan, NOVA Laboratories Limited). Mercaptopurine is a 20 mg/ml oral suspension. Purixan is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination regimen.
Read the FDA announcement here.
FDA Approves Ramucirumab for Advanced Gastric or GEJ Cancer
On April 21, 2014, the U. S. Food and Drug Administration approved ramucirumab (Cyramza, Eli Lilly and Company) for use as a single agent for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior treatment with fluoropyrimidine- or platinum-containing chemotherapy. Ramucirumab is a recombinant monoclonal antibody of the IgG1 class that binds to vascular endothelial growth factor receptor-2 (VEGFR-2) and blocks the activation of the receptor.
Read the FDA announcement here.
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.