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.