Tag Archives: Health Research

Roundup of Recent Congressional Health Policy Hearings

A number of Congressional committees have recently held hearings on health policy issues, including the following: House Energy and Commerce Committee hearings on “Cybersecurity in the Heath Care Sector: Strengthening Public-Private Partnerships” and Food and Drug Administration (FDA) medical device user fees. A House Oversight and Government Reform Committee hearing on “Federally Funded Cancer Research: … Continue Reading

Senate HELP Committee Completes Work on Bipartisan “Cures”/Medical Innovation Legislation

The Senate Health, Education, Labor and Pensions (HELP) Committee has approved the last of its biomedical innovation bills that form its counterpart to the House 21st Century Cures Act.  Together with the bills cleared by the HELP committee in February and March 2016, the panel has now passed 19 bipartisan medical innovation bills.  The five … Continue Reading

Senate HELP Committee Clears Bipartisan Biomedical Innovation, Health IT Bills

The Senate Health, Education, Labor and Pensions (HELP) Committee has approved several bipartisan health policy bills, including health information technology (HIT) legislation and bills aimed at spurring biomedical innovation to complement the “House 21st Century Cures” initiative. Specifically, on February 9, 2016, the Committee approved:… Continue Reading

President Obama Establishes “White House Cancer Moonshot Task Force” Led by VP Biden, Calls for $1 Billion Investment in Cancer Research

President Obama recently signed a memorandum formally establishing a White House Cancer Moonshot Task Force to coordinate and strengthen federal and private efforts to support cancer research and treatment.  The Task Force, which is chaired by Vice President Biden, is charged with developing recommendations to: accelerate understanding of cancer and its prevention, early detection, treatment, … Continue Reading

Bipartisan Health Policy Bills Advance

On September 8, 2015, the House of Representatives approved the following bipartisan bills by voice vote:  H.R. 1344, the Early Hearing Detection and Intervention Act of 2015 – to reauthorize a program for early detection, diagnosis and treatment regarding deaf and hard-of-hearing newborns, infants, and young children. H.R. 1725, the National All Schedules Prescription Electronic … Continue Reading

White House Releases Proposed Precision Medicine Initiative Privacy Framework

Earlier this year, President Obama launched a high-profile “Precision Medicine Initiative” (PMI) to develop treatments, diagnostics, and prevention strategies tailored to the individual genetic characteristics of each patient.  On July 8, 2015 the White House released for public comment a draft document entitled “Precision Medicine Initiative: Proposed Privacy and Trust Principles,” which provides broad guidance … Continue Reading

President Obama Signs Post-Acute Care Transformation Act and Other Health Policy Bills

On October 6, 2014, President Obama signed into law H.R. 4994, the Improving Medicare Post-Acute Care Transformation Act of 2014 (the “IMPACT Act”). The IMPACT Act’s provisions will affect a broad range of post-acute care (PAC) providers: home health agencies (HHAs), skilled nursing facilities (SNFs), inpatient rehabilitation facilities (IRFs), and long-term acute care hospitals (LTCHs). … Continue Reading

July Congressional Health Policy Hearings

Congressional panels have held numerous hearings on health policy issues this month, including the following: The House Energy and Commerce Committee held a series of hearings on its “21st Century Cures” initiative, focusing on personalized medicine, barriers to evidence development and communication, technological innovations, the patient perspective, and modernizing clinical trials. A separate hearing focused on … Continue Reading

Congressional Hearings Examine Medicare Fraud, ACA, Digital Health, MedPAC Report, Brain Injuries

Recent Congressional hearings on health policy issues include the following: A House Energy and Commerce Health Subcommittee “21st Century Cures Roundtable” discussed steps Congress can take to bridge the gap between medical advances and the regulatory policies that govern them, and ultimately advance digital and personalized health care. The panel also released a related white … Continue Reading

Congressional Committees to Consider HHS Secretary Nomination, HHS Budget, ACA Implementation, Cancer Research

The Senate Appropriations Committee has scheduled a May 7, 2014 hearing to review the Administration’s FY 2015 budget request for the Department of Health and Human Services (HHS). Also on May 7, the House Energy and Commerce Oversight Subcommittee will examine the status of health insurance enrollment under the ACA, and the Senate Aging Committee will … Continue Reading

HIV Organ Policy Equity, PREEMIE Reauthorization Acts Signed into Law

President Obama recently signed into law S. 330, the HIV Organ Policy Equity Act, which eliminates the restriction on acquiring HIV-positive organs in order to permit research on transplants involving HIV-positive individuals. In addition, the President has signed S. 252, the "Prematurity Research Expansion and Education for Mothers who deliver Infants Early Reauthorization Act" which … Continue Reading

Health Policy Bills Advance

On November 12, 2013, the House of Representatives approved S. 330, the HIV Organ Policy Equity Act, which would eliminate the restriction on acquiring HIV-positive organs in order to permit research on transplants involving HIV-positive individuals (the Senate approved the bill in June). The House also passed S. 252, the Prematurity Research Expansion and Education … Continue Reading

CMS Call on New Medicare Data Portal (May 16)

Beginning in July 2013, CMS will be posting downloadable data on from various Medicare.gov Compare websites (Dialysis Facility Compare, Home Health Compare, Hospital Compare, and Nursing Home Compare) at Data.Medicare.Gov. On May 16, 2013, CMS is hosting a webinar to provide an introduction to Data.Medicare.Gov and to demonstrate options for accessing the data. CMS notes … Continue Reading

House Approves GME, Pediatric Research, and EMT Bills

The full House of Representatives has passed three health policy bills recently cleared by the House Energy and Commerce Committee. On February 4, 2013, the House approved H.R. 297, the Children’s Hospital Graduate Medical Education (GME) Support Reauthorization Act of 2013 (which provides support to children’s hospitals for pediatric medical residency programs), and H.R. 225, … Continue Reading

February Congressional Health Policy Hearings & Markups

House Energy and Commerce subcommittees have held hearings on “Influenza: Perspective on Current Season and Update on Preparedness” and on “SGR: Data, Measures and Models; Building a Future Medicare Physician Payment System.” On the Senate side, the Senate Health, Education, Labor, and Pensions Committee voted to approve H.R. 307, the Pandemic and All-Hazards Preparedness Reauthorization Act … Continue Reading

House Energy and Commerce Committee Approves GME, Pediatric Research, and EMT Bills

The House Energy and Commerce Committee approved three health policy bills on January 22, 2013, versions of which were passed by the full House during the last Congress. Specifically, the panel voted to approve: H.R. 297, the Children’s Hospital Graduate Medical Education (GME) Support Reauthorization Act of 2013 (which provides support to children’s hospitals for … Continue Reading

House, Senate Committee Votes on Health Research Measures

Congress has recently voted on a number of health research bills. On September 19, 2012, the House of Representatives approved H.R. 733, the “Recalcitrant Cancer Research Act of 2012,” which directs the National Cancer Institute to develop a long-term strategic plan for addressing cancers with a high mortality rate. The Senate HELP Committee approved a … Continue Reading

PCORI Seeks Comments on Draft Outcomes Research Methodology Standards

The Patient-Centered Outcomes Research Institute (PCORI) is seeking comments on its draft Methodology Report, proposing standards for the conduct of patient-centered outcomes research.  The report covers, among other things, the rationale for standards for patient-centeredness, prioritizing topics for research; choosing a study design; and for designing, conducting, and reporting research (including standards for adaptive and … Continue Reading

Fall 2011 Regulatory Agenda (Belatedly) Released

On January 20, 2012, the Obama Administration posted its Fall 2011 Regulatory Agenda, outlining its planned regulatory initiatives in a number of policy areas. Priorities for the Department of Health and Human Services (HHS) include, among many others: Implementing Affordable Care Act (ACA) insurance reforms, including establishing Affordable Insurance Exchanges, establishing risk adjustment criteria for … Continue Reading

Autism, Pediatric GME Funding Bills Advance

On September 20, 2011, the House of Representatives approved H.R. 2005 and H.R. 1852.  H.R. 2005, the Combating Autism Reauthorization Act of 2011, provides funding for surveillance, education, early detection, intervention, and research related to autism, and operation of the Interagency Autism Coordinating Committee.  H.R. 1852, the Children’s Hospital GME Support Reauthorization Act, provides support … Continue Reading

CMS/ONC Care Innovations Summit (Jan. 26, 2012)

CMS and the HHS Office of the National Coordinator are hosting the first "Care Innovations Summit" in Washington, DC on January 26, 2012 to "showcase innovative work in care delivery and payment."  Presentations will be delivered by “national thought leaders, senior government officials and visionary innovators,” who will provide information on opportunities for collaboration, funding, … Continue Reading

Draft FDA Guidance on Exculpatory Language in Informed Consent

This post was written by Erin Janssen and Areta Kupchyk. The HHS Office for Human Subject Protections (OHRP) and the Food and Drug Administration (FDA) are seeking comments on a joint draft document entitled “Guidance on Exculpatory Language in Informed Consent.” Among other things, the draft document: Provides guidance on the regulatory prohibition on the inclusion … Continue Reading
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