Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

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 health plans, and expanding Medicaid coverage;
• Improving health care quality and patient safety, including implementing value-based purchasing programs for hospitals and other health care providers and promoting health information technology adoption and electronic health records;
• Improving response to adverse events, including establish a unique identification system to track medical devices
• Advancing scientific research by revising ethical rules governing research on human subjects; and
• Streamlining regulations to reduce regulatory burdens, including Food and Drug Administration (FDA) rules designed to reduce reporting and data submission requirements for drug and medical device manufacturers, and streamlined Medicare conditions of participation for hospitals and other providers.

A listing of specific HHS rules under consideration (including a variety of Medicare payment update rules) also is available.

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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 to children’s hospitals for pediatric medical residency programs). The Senate Health, Education, Labor and Pensions Committee approved the Senate versions of these bills earlier in the month (S. 958, the Children’s Hospital GME Support Reauthorization Act of 2011, and S. 1094, the Combating Autism Reauthorization Act).

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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, and partnership. The target audience for the summit includes health care professionals, patient advocates, entrepreneurs, policymakers, researchers, investors, and health information technology innovators.  The event is free, but space is limited and registration is required.

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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 in informed consent of exculpatory language (that is, language which has the general effect of freeing or appearing to free an individual or an entity from malpractice, negligence, blame, fault, or guilt);
• Includes examples of language that OHRP and FDA consider acceptable as well as examples of language that the agencies would consider exculpatory; and
• Clarifies that OHRP and FDA have concluded that language in informed consent is not exculpatory if it informs subjects that, by agreeing to allow the use of their biospecimens for research purposes, they are giving up any legal right to be compensated for the use of the biospecimens. This represents a change from OHRP's November 15, 1996 guidance on point, "Exculpatory Language in Informed Consent," which identified as "exculpatory" certain informed consent statements in which subjects gave up any rights they might have in their biospecimens. OHRP and FDA now consider these statements to be acceptable for inclusion in informed consent, and they are restated as examples of acceptable language in the draft guidance. Thus, for example, it would now be acceptable to include language in a consent form such as "I give up any property rights I may have" in biospecimens, or "I voluntarily and freely donate" the biospecimens to a particular institution.

When finalized, the draft document will supersede OHRP's November 15, 1996 guidance entitled, "Exculpatory Language in Informed Consent" and question number 52 in FDA's January 1998 guidance entitled "Institutional Review Boards Frequently Asked Questions - Information Sheet Guidance for Institutional Review Boards and Clinical Investigators." FDA is accepting comments on the draft until November 7, 2011. A September 7, 2011 Federal Register notice of availability of the guidance, the joint draft guidance document, and instructions for submitting comments can be accessed on the OHRP website. 

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This post was written by Erin Janssen and Areta Kupchyk.

On September 23, 2011, FDA released guidance entitled “Reproductive and Developmental Toxicities--Integrating Study Results to Assess Concerns.” The guidance describes an approach to estimating possible human developmental or reproductive risks associated with drug or biological product exposure when a finding of toxicity has been identified, but definitive human data are unavailable. The guidance is intended for drug developers intending to submit NDAs and BLAs, and who are assessing nonclinical toxicity information. The recommendations included will also help to ensure a consistent review of reproductive and developmental toxicity data among Center for Drug Evaluation and Research review staff.

The guidance does not: (1) give detailed advice about labeling or placement of toxicity information in product labeling (for information on labeling, see 21 CFR 201.57); or (2) discuss clinical data, the integration of nonclinical and clinical data, or the clinical implications of these data. The approach presented in the guidance for assessing nonclinical reproductive and developmental toxicity data involves the integration and careful consideration of a variety of different types of nonclinical information: Reproductive toxicology; general toxicology; and toxicokinetic and pharmacokinetic information, including absorption, distribution, metabolism, and elimination findings. The approach is used when there is a toxicity finding and focuses on assessing the likelihood that a drug will increase the risk of adverse human developmental or reproductive outcomes. The approach includes noting when studies were not conducted or when they were not performed using relevant model systems or at appropriate dose ranges.

FDA released a prior draft of this guidance in 2001, however, one important change has been made. The description of a process that involved assignment of values of +1, -1 or 0 to the various factors was removed from the guidance. Comments on the guidance may be submitted at any time.

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On September 7, 2011, the Senate Health, Education, Labor and Pensions (HELP) Committee is scheduled to vote on S. 958, the Children's Hospital GME Support Reauthorization Act, and S.1094, the Combating Autism Reauthorization Act.

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This post was written by Erin Janssen.

On September 1, 2011, HHS published a notice extending the comment period for the advance notice of proposed rulemaking (ANPRM) on how current regulations for protecting human subjects might be modernized and revised to be more effective. That ANPRM, entitled "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators," was published in the Federal Register on July 26, 2011, with a comment deadline of September 26, 2011. Since the ANPRM was published, HHS has received requests to extend the comment period to allow sufficient time for a full review of the ANPRM. In response to these requests, the comment period will be extended by 30 days to October 26, 2011.

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This post was written by Erin Janssen.

On August 17, 2011, the FDA released its “Strategic Plan for Regulatory Science,” calling for a sweeping modernization of the science used in developing and evaluating products critical to the nation’s health, economy, and security. The plan addresses regulatory science, the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. Eight priority areas of regulatory science are identified where new or enhanced engagement is essential to the continued success of FDA’s public health and regulatory mission. The priority areas are: (1) Modernize Toxicology to Enhance Product Safety; (2) Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcomes; (3) Support New Approaches to Improve Product Manufacturing and Quality; (4) Ensure FDA Readiness to Evaluate Innovative Emerging Technologies; (5) Harness Diverse Data through Information Sciences to Improve Health Outcomes; (6) Implement a New Prevention-Focused Food Safety System to Protect Public Health; (7) Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security; and (8) Strengthen Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions about Regulated Products.

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On August 25, 2011, HHS published a final rule on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding is Sought and Responsible Prospective Contractors. The final rule revises 1995 standards on this subject in order to “update enhance the objectivity and integrity of the research process” and provide “a framework for identifying, managing, and ultimately avoiding investigators’ financial conflicts of interest.“ Among other thing, the rule revises: the definition of significant financial interest (SFI); modifies the extent of investigator disclosure (including lowering the monetary threshold at which SFI requires disclosure, generally from $10,000 to $5,000, and requiring investigators to disclose to their institutions all of their significant financial interests related to their institutional responsibilities); changes the information reported to the PHS awarding component and made accessible to the public; and updates investigator training requirements. An institution applying for or receiving PHS funding covered by the rule must be in full compliance with the regulatory requirements no later than August 24, 2012; and immediately upon making its Institutional Financial Conflict of Interest policy publicly accessible, as described in the rule.  Additional information about the rule is available at the National Institutes of Health website.

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On July 21, 2011, the Senate Judiciary Committee approved S. 27, the Preserve Access to Affordable Generics Act, which would prohibit certain so-called “pay-for-delay” agreements in patent litigation settlements in which a brand-name pharmaceutical company compensates a generic pharmaceutical company for delays in generic entry. On July 28, 2011, the House Energy and Commerce Committee approved H.R. 2405, the Pandemic and All-Hazards Preparedness Reauthorization Act (which reauthorizes certain provisions of the Project Bioshield Act of 2004 and Pandemic and All-Hazards Preparedness Act of 2006); H.R. 1254, the Synthetic Drug Control Act (which would make illegal synthetic drugs that imitate the effect of drugs like marijuana, cocaine, and methamphetamines); and H.R. 1852, the Children's Hospital GME Support Reauthorization Act (which provides support to children’s hospitals for pediatric medical residency programs). On August 3, the Senate Health, Education, Labor and Pensions Committee Committee is scheduled to vote on S. 958, the Children's Hospital GME Support Reauthorization Act, and S.1094, the Combating Autism Reauthorization Act.

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HHS is seeking comments on proposed data collection standards for race, ethnicity, sex, primary language, and disability status in population health surveys, as required by Section 4302 of the ACA.  Comments will be accepted until August 1, 2011. HHS also announced plans to begin collecting health data on lesbian, gay, bisexual and transgender populations. According to HHS, both of these initiatives “aim to help researchers, policy makers, health providers and advocates to identify and address health disparities afflicting these communities.”

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A number of Congressional panels have held hearings on health policy issues this month, and more are scheduled, including the following:

• The House Energy and Commerce Committee has held hearings on: reauthorization of the Prescription Drug User Fee Act (PDUFA); the ACA’s Independent Payment Advisory Board (IPAB), which is charged with helping to contain Medicare costs; and legislation addressing children's hospital graduate medical education (GME) costs (H.R. 1852) and autism research (H.R. 2005). On July 20, the panel will hold a hearing on “FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs." On July 21, the Committee will hold a legislative hearing to review H.R. 1254, the Synthetic Drug Control Act, H.R. 2405, a bill to reauthorize certain provisions of the Public Health Services Act and the Federal Food, Drug, and Cosmetic Act relating to public health preparedness and countermeasure development; and draft legislation entitled the Enhancing Disease Coordination Activities Act.  
• The House Budget Committee held hearings on the IPAB and the sustainability of the Medicare program.
• The House Oversight and Government Reform Committee held a hearing on "Fulfilling A Legal Duty: Triggering A Medicare Plan From The Administration." 
• The Senate Finance Committee held a hearing on “Governors’ Perspectives on Medicaid.” 
• The Senate Homeland Security and Governmental Affairs Committee held a hearing entitled "Harnessing Technology and Innovation to Cut Waste and Curb Fraud in Federal Health Programs." 
• On July 21, the Senate Special Committee on Aging will hold a hearing on reducing Medicare drug costs.
• On July 21, the Senate Judiciary Committee is scheduled to vote on S. 27, the Preserve Access to Affordable Generics Act.
• On August 3, 2011, the Senate Health, Education, Labor and Pensions Committee is scheduled to vote on S. 958, the Children's Hospital GME Support Reauthorization Act, and S.1094, the Combating Autism Reauthorization Act. 

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The Government Accountability Office (GAO) has issued a report entitled "HHS Research Awards: Use of Recovery Act and Patient Protection and Affordable Care Act Funds for Comparative Effectiveness Research." The report includes a more than 40-page listing of all comparative effectiveness research grants issued under the Recovery Act, including the entities that have received funding and the general purpose of the funding (no funding had been obligated under the ACA's comparative effectiveness provision as of April 25, 2011).

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Recent Congressional health policy hearings have included: a House Ways and Means Health Subcommittee hearing on the Medicare program’s financial status; a Senate Finance Committee hearing on “Health Care Entitlements: The Road Forward"; a House Energy and Commerce Committee hearings examining the Medicare/Medicaid dual eligible population and the Medicare Secondary Payer program; and a Senate Homeland Security and Governmental Affairs Committee hearing entitled “Transforming Lives Through Diabetes Research.” Looking ahead, on July 13 the Energy and Commerce Health Subcommittee is holding a hearing entitled “IPAB: The Controversial Consequences for Medicare and Seniors.” Under the ACA, the new Independent Payment Advisory Board (IPAB) is charged with submitting detailed proposals to Congress and the President to reduce Medicare per-capita spending if projected spending growth exceeds a target. IPAB's proposals will go into effect automatically unless Congress enacts alternative legislation to achieve the required savings (with certain exceptions). 

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On June 29, 2011, the Senate Health, Education, Labor and Pensions Committee is scheduled to vote on S. 958, the Children's Hospital Graduate Medical Education (GME) Support Reauthorization Act.  The panel also will consider S.1094, the Combating Autism Reauthorization Act. 

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HHS has launched the “Health Indicators Warehouse,” a collection of health indicators (e.g., population characteristics, determinants of health, and health care access, cost, quality, and use data) from HHS data sources that are maintained to support researchers, technology developers, and policymakers. 

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CMS is soliciting studies, policy analyses, and program evaluations for its Medicare & Medicaid Research Review. In particular, CMS is interested in papers using rigorous, scientific research methods that address: coverage, quality, access, organization, and delivery of health services; payment for health services; and innovative methods. 

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On January 4, 2011, President Obama signed into law S. 3036, the National Alzheimer's Project Act, which establishes a National Alzheimer’s Project within HHS and an advisory council on Alzheimer’s research, care, and services to coordinate related research, health care, and treatment efforts.

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The Office for Human Research Protections (OHRP) within the Department of Health and Human Services (HHS) has released “Guidance on IRB Approval of Research with Conditions,” which is OHRP’s first formal guidance on this topic. OHRP also released related “Guidance on Continuing Review.” Both documents are intended primarily for IRBs, investigators, HHS funding agencies, and others that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS.

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The House and Senate have approved S. 3199, the Early Hearing Detection and Intervention Act, and S. 3036, the National Alzheimer's Project Act, clearing the measures for the President. On December 1, 2010, the Senate Health, Education, Labor and Pensions Committee approved, with amendments, H.R. 2941, to reauthorize and enhance Johanna's Law to increase public awareness and knowledge with respect to gynecologic cancers. The Senate version of the bill now must be reconciled with an earlier version of the measure approved by the House in September.

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On December 9, 2010, the House Energy and Commerce Committee held a hearing on "Alzheimer's Disease: The Ongoing Challenges." On December 1, the House Judiciary Subcommittee on Courts and Competition Policy held a hearing on “Antitrust Laws and Their Effects on Healthcare Providers, Insurers and Patients.”

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On November 30, 2010, the Senate Judiciary Crime and Drugs Subcommittee is holding a hearing on "Examining Enforcement of the Foreign Corrupt Practices Act." On December 1, the Senate Commerce, Science and Transportation Committee is holding a hearing entitled "Are Mini Med Policies Really Health Insurance?" Also on December 1, the Senate Health, Education, Labor and Pensions Committee is scheduled to vote on a number of health policy bills, including: H.R. 2941, to reauthorize and enhance Johanna's Law to increase public awareness and knowledge with respect to gynecologic cancers; S. 3199, the Early Hearing Detection and Intervention Act; and S. 3036, the National Alzheimer's Project Act. This markup previously was scheduled for November 17.

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The Obama Administration has made a much-anticipated announcement of the recipients of the $1 billion in new ACA therapeutic discovery project tax credits, which are designed to support research with significant potential to produce new therapies, address unmet medical needs, reduce the long-term growth of health care costs, or advance the goal of curing cancer within the next 30 years. The credit covers up to 50% of the cost of qualifying biomedical research, and is limited to firms with fewer than 250 employees. Almost 3,000 small biotechnology companies were awarded funds for a total of 4,606 projects.

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On November 17, 2010, the Senate Finance Committee is holding a hearing on "Strengthening Medicare and Medicaid: Taking Steps to Modernize America’s Health Care System," at which CMS Administrator Donald Berwick, M.D. is scheduled to testify.  Also on November 17, the Senate Health, Education, Labor and Pensions Committee is scheduled to consider a number of health policy and other bills, including the following: H.R. 5710, the National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010; H.R. 2941, to reauthorize and enhance Johanna's Law to increase public awareness and knowledge with respect to gynecologic cancers; S. 3199, the Early Hearing Detection and Intervention Act of 2010; S. 3036, the National Alzheimer's Project Act; and S. 259, the Vision Care for Kids Act.

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On October 5, 2010, President Obama signed into law S. 1674, the Improving Access to Clinical Trials Act. The law provides for an exclusion under the Supplemental Security Income program and Medicaid for certain compensation of individuals who participate in clinical trials for rare diseases or conditions. In addition, on October 10, President Obama signed S. 3751, the Stem Cell Therapeutic and Research Reauthorization Act, which reauthorizes and makes changes to the National Cord Blood Inventory Program and the C.W. Bill Young Transplantation Program. 

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The House and Senate have approved the following health policy bills, which now await the President’s signature: H.R. 2923, the Combat Methamphetamine Enhancement Act; S. 1674, the Improving Access to Clinical Trials Act (to provide for an exclusion under the Supplemental Security Income program and Medicaid for compensation of individuals who participate in clinical trials for rare diseases or conditions); and S. 3751, the Stem Cell Therapeutic and Research Reauthorization Act. In addition, the House recently approved the following bills, which still await Senate action: H.R. 3470, Nationally Enhancing the Wellbeing of Babies through Outreach and Research Now (NEWBORN) Act (which would authorize funding for infant mortality pilot programs in areas with high rates of infant mortality); H.R. 5809, the Safe Drug Disposal Act (which would provide for takeback disposal of controlled substances in certain instances); H.R. 5756, the Training and Research for Autism Improvements Nationwide Act; H.R. 3199, the Emergency Medic Transition Act (to provide grants to state emergency medical service departments to provide expedited training of veterans with prior medical training); H.R. 1745, the Family Health Care Accessibility Act (to provide liability protections for volunteer practitioners at health centers); H.R. 5710, the National All Schedules Prescription Electronic Reporting Reauthorization Act; H.R. 6012, to direct the HHS Secretary to review utilization of diabetes screening benefits and establish a related outreach program; H.R. 1362, the National MS and Parkinson's Disease Registries Act; H.R. 1995, the Diabetes in Minority Populations Evaluation Act; H.R. 5986, the Neglected Infections of Impoverished Americans Act; H.R. 758, the Pediatric Research Consortia Establishment Act; H.R. 5354, the Gestational Diabetes Act; H.R. 1347, the Concussion Treatment and Care Tools Act; H.R. 2408, the Scleroderma Research and Awareness Act; H.R. 2818, the Methamphetamine Education, Treatment, and Hope Act; H.R. 1032, the Heart Disease Education, Analysis Research, and Treatment for Women Act; H.R. 1230, the Acquired Bone Marrow Failure Disease Research and Treatment Act; H.R. 2941, to reauthorize and enhance Johanna’s Law to increase public awareness and knowledge with respect to gynecologic cancers; H.R. 5462, the Birth Defects Prevention, Risk Reduction, and Awareness Act; and H.R. 1210, the Arthritis Prevention, Control, and Cure Act. Note that Congress has adjourned until November 15, 2010 (after the mid-term elections).

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Congressional panels have held several health policy hearings recently, including the following: 

• A House Science and Technology Subcommittee on Technology and Innovation Committee hearing on "Standards for Health IT: Meaningful Use and Beyond"; 
• A House Energy and Commerce Subcommittee on Health hearing on “Cutting Waste, Fraud, and Abuse in Medicare and Medicaid”; 
• A House Veterans Affairs Subcommittee hearing on “Veterans Health Administration Contracting and Procurement Practices”; 
• A Senate Appropriations Committee hearing on "Defending Against Public Health Threats"; and 
• A House Oversight and Government Reform Committee hearing entitled "From Molecules to Minds: The Future of Neuroscience Research and Development."

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On September 16, 2010, the House Energy and Commerce Subcommittee on Health approved with amendments the following bills: H.R. 758, the Pediatric Research Consortia Establishment Act; H.R. 1032, the Heart Disease Education, Analysis Research, and Treatment for Women Act; H.R. 1210, the Arthritis Prevention, Control, and Cure Act of 2009; H.R. 1230, the Bone Marrow Failure Disease Research and Treatment Act of 2009; H.R. 1347, the Concussion Treatment and Care Tools Act of 2009; H.R. 1362, the National MS and Parkinson's Disease Registries Act; H.R. 1995, the Eliminating Disparities in Diabetes Prevention Access and Care Act of 2009; H.R. 2408, the Scleroderma Research and Awareness Act; H.R. 2818, the Methamphetamine Education, Treatment, and Hope Act of 2009; H.R. 2941, Johanna’s Law Reauthorization (to educate women and healthcare providers about gynecologic cancers); H.R. 2999, the Veterinary Public Health Workforce and Education Act; H.R. 5354, the Gestational Diabetes Act of 2009; H.R. 5462, the Birth Defects Prevention, Risk Reduction, and Awareness Act of 2010; H.R. 5986, the Neglected Infections of Impoverished Americans Act of 2010; H.R. 6012, To direct the HHS Secretary to review uptake and utilization of diabetes screening benefits and establish an outreach program with respect to such benefits, and for other purpose; H.R. 6081, the Stem Cell Therapeutic and Research Reauthorization Act of 2010; and H.R. 6109, the Health Data Collection Improvement Act. The legislation now awaits full Committee consideration.

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On July 28, 2010, the House Energy and Commerce Committee approved a variety of health policy bills, including the following: H.R. 903, the “Dental Emergency Responder Act of 2010” (amended); H.R. 1745, the “Family Health Care Accessibility Act of 2010” (amended); H.R. 2923, the “Combat Methamphetamine Enhancement Act of 2010”, H.R. 3199, the “Emergency Medic Transition Act of 2010” (amended); H.R. 3470, the “Nationally Enhancing the Wellbeing of Babies through Outreach and Research Now Act of 2010” (amended); H.R. 5710, the “National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010” (amended); H.R. 5756, the “Training and Research for Autism Improvement Nationwide Act of 2010” (amended); and H.R. 5809, the “Safe Drug Disposal Act of 2010” (amended). The legislation now awaits action by the full House.  

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A House Ways and Means Health Subcommittee hearing examined efforts to promote the adoption of health information technology through Medicare incentives designed to encourage the meaningful use of electronic health records. Likewise, the House Energy and Commerce Health Subcommittee held a hearing on implementation of the Health Information Technology for Economic and Clinical Health (HITECH) Act, along with hearings on direct-to-consumer genetic testing, controlled substance monitoring, and prescription drug disposal. A Senate Health, Education, Labor and Pensions Committee hearing examined programs to promote treatments for rare and neglected pediatric diseases. The Senate Homeland Security and Governmental Affairs Committee held hearings on disaster medical preparedness and preventing and recovering Medicare payment errors.

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The Agency for Healthcare Research and Quality (AHRQ) is seeking nominees to fill upcoming vacancies on the National Advisory Council for Healthcare Research and Quality (the Council). The mission of the Council is to advise the HHS Secretary and AHRQ Director on such issues as priorities for health care research, related training needs, health quality research dissemination, and opportunities for public private partnerships. AHRQ is seeking nominees who are distinguished in areas such as, among others, health care research; the practice of medicine; health care economics; public policy; and representatives of patients and the private health care sector.

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The House Energy and Commerce Health Subcommittee has held hearings on MedPAC’s recent report to Congress on “Aligning Incentives in Medicare, and on "The Battle Against Diabetes: Progress Made, Challenges Unmet." In addition, the Senate Aging Committee held a hearing on prescription drug waste and disposal and the Senate Appropriations Agriculture Subcommittee examined the FDA’s review process for products to treat rare diseases and neglected tropical diseases. 

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On May 20, 2010, HHS published a proposed rule to amend the Department’s regulations regarding the responsibility of applicants to promote objectivity in research for which Public Health Service (PHS) funding is sought. The proposed revisions are intended to expand and add transparency to investigator disclosure of significant financial interests and enhance regulatory compliance and effective institutional oversight and management of investigators’ financial conflicts of interests. HHS is proposing these changes in light of the increasingly complex interactions among the government, research institutions, and private sector entities involved with biomedical and behavioral research. HHS will accept comments on the proposed rule until July 20, 2010.

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The Senate Special Committee on Aging held two recent hearings on prescription drug issues, one focusing on rising drug prices under the Medicare Part D program and the other addressing prescription drugs in the nursing home setting. In addition, the House Energy and Commerce Health Subcommittee held a hearing on National Cancer Institute’s progress on cancer research. The Energy and Commerce Health Subcommittee also has scheduled the first Congressional post-health reform hearing on April 21, 2010, focusing on the impact of health care reform law on large employers.

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President Obama has signed into law S. 1793, the Ryan White HIV/AIDS Extension Act of 2009 (P.L. 111-87). The law reauthorizes the Ryan White program for four years, increase authorizations, and makes other revisions to the program.   

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On November 5, 2009, the House of Representatives approved H.R. 3276, the American Medical Isotopes Production Act. The legislation is intended to provide the Department of Energy with new authority and funding to assist private sector projects to establish a steady domestic supply of the medical isotope molybdenum-99.  

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November 6, 2009, the Office for Human Research Protections (OHRP), Office of Public Health and Science published two notices announcing the availability of draft guidance on institutional review board (IRB) review of research. First, OHRP published a notice seeking comments on a draft policy entitled "Guidance on IRB Approval of Research with Conditions,” which would provide OHRP's first formal guidance on this issue. In particular, the document addresses such issues as: the circumstances that permit the IRB to approve research with conditions; how the IRB should handle changes to research that are proposed after initial IRB approval; how conditions on IRB approval affect ongoing research; and documentation of conditions of IRB approval of research. Comments will be accepted until January 5, 2010. The second draft document, "Guidance on IRB Continuing Review of Research," will supersede OHRP's January 15, 2007 document entitled "Guidance on Continuing Review." Among other things, the new draft guidance has been expanded to include a section on key IRB considerations when evaluating research undergoing continuing review and to provide more details regarding regulatory requirements and recommendations for the process for conducting continuing review. OHRP is accepting comments on the revisions until January 5, 2010.

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The Agency for Healthcare Research and Quality (AHRQ) has released a "Horizon Scan" entitled "To What Extent do Changes in Third-Party Payment Affect Clinical Trials and the Evidence Base?" The analysis examines the extent to which payment policies may be influencing clinical trial participant recruitment, participation, and retention rates   The report found that several large-scale clinical trials have encountered substantial difficulties due to the deterrent effect of payment policy on participation, with a bigger impact on medical device trials than drug trial. The report called for better coordination among all parties involved in trials, including a strategy covering which costs will be covered and which party will be responsible for such costs.

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A number of Congressional committees have held hearings recently on health policy issues, including the following:

• An Energy and Commerce Health Subcommittee hearing on breast cancer prevention, research, treatment, and quality of care legislation (H.R. 995, H.R. 1691, H.R. 1740, and H.R. 2279).  
• House Oversight and Government Committee hearings on Medicaid pediatric dental services and the Administration's flu vaccine program. 
• A Senate Veterans’ Affairs Committee hearing on the Department of Veterans’ Affairs contracts for health services.
• Senate Aging Committee hearings on how successful health systems keep costs low and quality high, and the cost of federal long-term care insurance.
• A Senate Judiciary Committee hearing on "Prohibiting Price Fixing and Other Anticompetitive Conduct in the Health Insurance Industry," focusing on legislation to repeal a federal antitrust exemption for health insurance and medical malpractice insurance companies.  

In addition, several hearings are scheduled for October 15.  The Senate Small Business Committee is holding a hearing on "Sensible Health Care Solutions for America's Small Businesses." The Senate HELP Committee will examine health care equality for women.  The Energy and Commerce Oversight Subcommittee is holding a hearing on the problem of underinsurance.

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The Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program is soliciting applications for a total of $100 million in Recovery Act funding for AHRQ Clinical and Health Outcomes Initiative in Comparative Effectiveness Grants. The purpose of the grants is to conduct large projects in comparative effectiveness aimed at generating new knowledge to help inform decision making in priority areas of clinical care. Research priorities highlighted in the funding announcement include: arthritis and non-traumatic joint disorders; cancer; cardiovascular disease; dementia; depression and other mental health disorders; developmental delays, attention-deficit hyperactivity disorder and autism; diabetes mellitus; functional limitations and disability; infectious diseases including HIV/AIDS; obesity; peptic ulcer disease and dyspepsia; pregnancy including pre-term birth; pulmonary disease/asthma; and substance abuse. Letters of intent are due November 18, 2009.  

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A number of Congressional committees have held hearings recently on health policy issues, including the following:

• A House Science and Technology Committee hearing on "The Potential Need for Measurement Standards to Facilitate the Research and Development of Biologic Drugs." 
• A House Veterans Affairs Health Subcommittee hearing on the Veterans Affairs (VA) Department’s pharmaceutical policy, including an examination of formulary, patient safety, and management issues.   
• A Senate Judiciary Committee Terrorism and Homeland Security Subcommittee hearing on "Strengthening Security and Oversight at Biological Research Laboratories." 
• House Energy and Commerce Committee hearings on pandemic flu preparedness, "Solving the Medical Isotope Crisis," and the Ryan White Extension Act of 2009.

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On July 24, 2009, the House of Representatives approved H.R. 3293, legislation to fund the Departments of Labor, Health and Human Services (HHS), and Education for fiscal year (FY) 2010. Among other things, the legislation would increase funding for: the HHS Health Care Fraud and Abuse Control Program; health professions training; NIH biomedical research programs; CDC public health programs, Substance Abuse and Mental Health Services Administration mental health and substance abuse programs; and healthcare-associated infection reduction efforts. The legislation now moves to the Senate.

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A number of Congressional panels have held hearings recently on health policy issues, including the following:

• A Senate Commerce Subcommittee on Consumer Protection hearing on "Competition in the Health Care Marketplace." 
• A House Judiciary Subcommittee on Courts and Competition Policy hearing on "Biologics and Biosimilars: Balancing Incentives for Innovation.” 
• A House Energy and Commerce Oversight Subcommittee field hearing on "Terminations of Health Policies by Insurance Companies: State Perspectives and Legislative Solutions." 
• A House Judiciary Commercial and Administrative Law Subcommittee hearing on "Medical Debt - Is Our Healthcare System Bankrupting Americans?"

In addition, the following hearings and markups currently are scheduled:

• The Senate Special Committee on Aging is holding a hearing July 29 on medical research and education.
• On July 29, the Senate Homeland Security and Governmental Affairs Committee is voting on a number of bills, including S. 372, the "Whistleblower Protection Enhancement Act of 2009" and S.1508, the "Improper Payments Elimination and Recovery Act." 

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On July 7, 2009, the National Institutes of Health (NIH) published a notice its final “Guidelines for Human Stem Cell Research.” The guidelines, which implement President Obama’s March 9, 2009 Executive Order on federal funding for stem cell research as it pertains to extramural NIH-funded stem cell research, establish policy and procedures under which the NIH will fund such research, and seek to ensure that NIH-funded stem-cell research “is ethically responsible, scientifically worthy, and conducted in accordance with applicable law.” The guidelines are effective July 7, 2009.

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The Agency for Healthcare Research and Quality (AHRQ) has released its annual report on state quality of care, based on data from the 2008 National Healthcare Quality Report. The 2008 “State Snapshots” summarize health care quality by: (1) type of care (preventive, acute and chronic care); (2) setting of care (hospitals, ambulatory, nursing homes and home health care); and (3) clinical areas (cancer, diabetes, heart disease, maternal and child health and respiratory disease). This year the report also includes information regarding the following special focus areas: diabetes, asthma, Healthy People 2010, clinical preventive services, and health disparities. As in previous years, the 2008 report found that no state does well or poorly on all quality measures.

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A number of Congressional panels have held hearings recently on health policy issues, including the following:

• An Energy and Commerce Oversight and Investigations Subcommittee hearing on "Terminations of Individual Health Policies by Insurance Companies.”
• A Senate Homeland Security and Governmental Affairs Subcommittee on Oversight hearing on S. 372, the "Whistleblower Protection Enhancement Act of 2009."
• An Energy and Commerce Health Subcommittee hearing entitled "Medical Devices: Are Current Regulations Doing Enough for Patients?"

In addition, on June 24, 2009, the House Small Business Regulations and Healthcare Subcommittee is holding a hearing on "Health Information Technology and the New Challenges Faced by Solo and Small Group Healthcare Practices." Also on June 24, the Senate Homeland Security and Governmental Affairs Committee is holding a hearing on "Type 1 Diabetes Research: Real Progress and Real Hope for a Cure."

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HHS has released a series of American Recovery and Reinvestment Act (ARRA) Implementation Plans, detailing how the department is addressing key aspects of the legislation. Specifically, the plans highlight the following areas: Improving and Preserving Health Care (including increases in the Medicaid Federal Medical Assistance Percentage); Accelerating the Adoption of Health Information Technology; Strengthening Scientific Research and Facilities; Improving Children and Community Services; Strengthening Community Healthcare Services; Supporting Comparative Effectiveness Research; Promoting Prevention and Wellness; and Improving Accountability and Information Technology Security. The updates include funding tables and discussions of objectives and planned activities, among other features.

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On May 8, 2009, HHS published an advance notice of proposed rulemaking seeking comments on whether the HHS should amend its regulations on the responsibility of applicants for promoting objectivity in research for which Public Health Service (PHS) funding is sought. Specifically, HHS is considering whether to revise current regulations to provide a more rigorous approach to investigator disclosure, management of conflicts, and federal oversight. The notice invites comments on a range of related issues, including: the scope of the regulation and disclosure of interests; the definition of a “significant financial interest”; identification and management of conflicts; how to assure institutional compliance; reporting on conflicts of interest; and standards regarding institutional conflict of interest. Comments will be accepted until July 7, 2009.

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On April 17, 2009, HHS issued guidance specifying the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals, as required by the American Recovery and Reinvestment Act of 2009 (ARRA). This guidance was developed through a joint effort by the HHS Office for Civil Rights, Office of the National Coordinator for Health Information Technology, and CMS. This guidance relates to two breach notification regulations – one forthcoming rule to be issued by HHS for covered entities and their business associates under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and one issued April 20 by the Federal Trade Commission (FTC) for vendors of personal health records and other non-HIPAA covered entities. If entities subject to the regulations apply the technologies and methodologies specified in the guidance to secure information, they will not be required to provide the notifications required by the regulations in the event the information is breached. In addition to this guidance, HHS has issued a request for information (RFI) soliciting public comment on the ARRA breach notification provisions to inform future rulemaking and updates to the guidance. Comments must be submitted by May 21, 2009.   The guidance is applicable upon issuance (April 17, 2009,), but will apply to breaches 30 days after publication of forthcoming interim final regulations. If HHS determines that the guidance should be modified based on public comments, the Department will issue updated guidance prior to or concurrently with the regulations. The FTC rule, which requires vendors of personal health records and related entities to notify individuals when the security of their individually identifiable health information is breached, is subject to public comment through June 1, 2009.  

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The National Institutes of Health (NIH) is requesting public comment on draft guidelines entitled "National Institutes of Health Guidelines for Human Stem Cell Research."   The draft guidelines are designed to implement President Obama’s March 9, 2009 Executive Order on stem cell research as it pertains to extramural NIH-funded research, including informed consent procedures. Under the draft guidelines, NIH could fund research using human embryonic stem cells that were derived from embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose, and funding would continue to be allowed for human stem cell research using adult stem cells and induced pluripotent stem cells (although there are some uses of human embryonic stem cells and human induced pluripotent stem cells that are nevertheless ineligible for NIH funding). NIH funding for research using human embryonic stem cells derived from other sources, including somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes, is not allowed under these guidelines.  Comments must be received by May 26, 2009.  NIH also has issued an update on the status of ongoing research, and of applications pending review or to be submitted, prior to the issuance of final guidelines. 

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On April 8, 2009, President Obama signed an Executive Order establishing a White House Office of Health Reform within the Executive Office of the President. The goal of the office is to provide leadership to the executive branch in establishing policies, priorities, and objectives for the federal government's comprehensive effort to improve access to health care, the quality of such care, and the sustainability of the health care system. The order also directs the HHS Secretary to establish within HHS an Office of Health Reform to coordinate closely with the White House Office of Health Reform.

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The NIH is highlighting a new funding opportunity under the ARRA that will support approximately $200 million in large-scale research projects that have a high likelihood of enabling growth and investment in biomedical research and development, public health, and health care delivery. The purpose of this new program, the Research and Research Infrastructure "Grand Opportunities" (GO), is to support high-impact ideas that lend themselves to short-term funding and may lay the foundation for new fields of scientific inquiry. Grant applicants may propose to address either a specific research question or the creation of a unique infrastructure/resource designed to accelerate scientific progress in the future.   NIH examples of the types of projects that could be funded under this program include the identification and validation of biomarkers in human genetics and biology that indicate the risk for disease or that could serve as a marker of disease progression and/or responsiveness to treatment, or research on information technology to enable physicians to share radiological images across health care institutions.  

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On March 19, 2009, HHS announced the members of the Federal Coordinating Council for Comparative Effectiveness Research. The Council was authorized by the American Recovery and Reinvestment Act (ARRA) as part of a major expansion of federal efforts to compare the effectiveness of different medical treatments, including both infrastructure changes and an infusion of $1 billion in funding for comparative effectiveness research. The Council is charged with helping to coordinate and guide investments in comparative effectiveness research, advising the President and Congress on federal comparative effectiveness research infrastructure needs, and reviewing federal agency organizational expenditures for comparative effectiveness research. The Council must report to the President and Congress by June 30, 2009 on current federal comparative effectiveness research and recommendations for research conducted under ARRA funding. The members of the Council are as follows:

• Anne Haddix, chief policy officer, Office of Strategy and Innovation, Centers for Disease Control and Prevention;
• Thomas Valuck, Medical Officer and Senior Adviser, CMS Center for Medicare Management;
• Peter Delany, Director, Office of Applied Studies, Substance Abuse and Mental Health Services Administration;
• Carolyn Clancy, Director, Agency for Healthcare Research and Quality;
• Deborah Parham Hopson, Associate Administrator, HIV/AIDS Bureau, Health Resources and Services Administration;
• David Hunt, Chief Medical Officer, Office of the National Coordinator for Health Information Technology;
• James Scanlon, Acting Assistant Secretary for Planning and Evaluation, HHS;
• Elizabeth Nabel, Director, National Heart, Lung, and Blood Institute, National Institutes of Health;
• Garth Graham, Deputy Assistant Secretary for Minority Health, Office of Minority Health, HHS;
• Jesse Goodman, Acting Chief Medical Officer, Food and Drug Administration, and Director, FDA Center for Biologics Evaluation and Research;
• Michael Marge, Acting Director, Office on Disability, HHS;
• Neera Tanden, Counselor, Office of the Secretary, HHS;
• Joel Kupersmith, Chief Research and Development Officer, Department of Veterans Affairs;
• Michael Kilpatrick, Director of Strategic Communications for the Military Health System, Department of Defense; and
• Ezekiel Emanuel, Special Advisor for Health Policy, Office of Management and Budget

In a related development, the Institute of Medicine is accepting public comments on priorities for comparative effectiveness research under the ARRA.  Stakeholders can submit answers to a questionnaire through March 27, 2009.

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On March 11, 2009, President Obama signed into law H.R. 1105, an omnibus spending bill that completes work on the remaining FY 2009 appropriations bills, including funding for the Department of Health and Human Services (HHS). Among other things, the law (PL 111-008) increases funding for the Food and Drug Administration (FDA) by $335 million above 2008 levels to help FDA improve the safety of domestic and imported food and medical products. The measure also includes increased funding compared to FY 2008 levels for the National Institutes of Health (NIH), the Centers for Disease Control and Prevention, community health centers, health professions training, childhood immunizations, and rural hospital programs. Moreover, the act funds a new initiative to reduce hospital and clinic infections and requires national and state plans to combat infections. 

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On March 9, 2009, President Obama signed an Executive Order lifting the ban on federal funding for embryonic stem cell research. The document provides that the HHS Secretary, through the Director of NIH, “may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.” The NIH Director must issue guidance on appropriate human stem cell research within 120 days of the order. In addition, Obama signed a Presidential Memorandum directing the head of the White House Office of Science and Technology Policy to develop recommendations to “guarantee scientific integrity throughout the executive branch,” including providing that:

• The selection of scientists and technology professionals for science and technology positions in the executive branch is based on those individuals’ scientific and technological knowledge, credentials, and experience;
• Agencies make available to the public the scientific or technological findings considered or relied upon in policy decisions;
• Agencies use scientific and technological information that has been subject to well-established scientific processes, such as peer review; and
• Agencies have appropriate rules and procedures to ensure the integrity of the scientific process within the agency, including whistleblower protection.

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HHS has announced the creation of the Office of Recovery Act Coordination to help ensure the timely and transparent distribution of an estimated $137 billion in American Recovery and Reinvestment Act (ARRA) funds managed by HHS. Dennis Williams will lead the new office and serve as the HHS Deputy Assistant Secretary for Recovery Act Coordination. As of March 11, 2009, HHS has distributed $3 billion in ARRA funds to support a variety of policies and programs, including community health centers and state Medicaid programs. In a related development, NIH has announced the availability of $1.5 billion in ARRA grants to fund scientific research, construction and improvement of research facilities, and the purchase of scientific equipment. 

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The National Advisory Council for Healthcare Research and Quality will meet on April 3, 2009 to discuss Agency for Healthcare Research and Quality (AHRQ) initiatives, including the AHRQ budget for FY 2009, comparative effectiveness, and AHRQ activities under the American Recovery and Reinvestment Act (ARRA).

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On February 25, 2009, the House of Representatives approved H.R. 1105, an omnibus spending bill to complete work on the remaining FY 2009 appropriations bills, including funding for HHS. Among other things, the bill includes increased funding compared to FY 2008 levels for the NIH, the Centers for Disease Control and Prevention, community health centers, health professions training, childhood immunizations, and rural hospital programs. The bill also funds a new initiative to reduce hospital and clinic infections and requires national and state plans to combat infections. The bill now is pending before the Senate. 

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On March 4, 2009, the House Energy and Commerce Committee approved the following health policy bills: H.R. 1256: Family Smoking Prevention and Tobacco Control Act; H.R. 1259, the Dextromethorphan Distribution Act of 2009; H.R. 1246, the Early Hearing Detection and Intervention Act of 2009; H.R. 1253, the Health Insurance Restrictions and Limitations Clarification Act of 2009; H.R. 20, the Melanie Blocker Stokes Mom's Opportunity to Access Health Education, Research, and Support for Postpartum Depression Act; H.R. 479, the Wakefield Act (addressing emergency medical services for children); H.R. 577, the Vision Care for Kids Act of 2009; H.R. 756, the National Pain Care Policy Act of 2009; H.R. 914, the Physician Workforce Enhancement Act of 2009; and H.R. 307, the Christopher and Dana Reeve Paralysis Act. The legislation now moves to the full House for further consideration. 

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The Agency for Healthcare Research and Quality, through its Effective Health Care program, will sponsor an invitational symposium on clinical and comparative effectiveness research methods in June 2009 (dates to be confirmed). The symposium is a follow up to the 2006 AHRQ conference on Emerging Methods in Comparative Effectiveness and Safety; papers presented at that conference appeared in a 2007 Medical Care supplement. The 2009 conference will focus on empirical studies and methodological advances appropriate for publication as a supplement in a peer-reviewed journal. AHRQ is inviting participation in this second symposium through submission of a brief abstract on relevant research by February 13, 2009. Preference will be given to research that can be presented at the symposium as a prelude to publication in the journal supplement and that will be complete or nearly so by early summer 2009.

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President Bush recently signed into law the following health policy bills:

• S. 3560, the “QI Program Supplemental Funding Act,” which authorizes an additional $45 million for the Medicare Qualifying Individuals (QI) program, which helps certain low-income individuals pay their Medicare Part B premiums. The legislation also includes provisions to modify the patent protections applicable to antibiotics and clarify the ability of generic drug companies to gain approval of and market generic antibiotics. In addition, the bill expands education activities under the Medicaid Integrity Program (MIP) and extends funding for the Medicare Improvement Fund to make improvements under the original Medicare program.  
• H.R. 6353, the “Ryan Haight Online Pharmacy Consumer Protection Act,” which prohibits the sale of controlled substances over the Internet without a valid prescription and subjects on-line pharmacies to a series of new restrictions.
• H.R. 1343, the "Health Care Safety Net Act of 2008," which reauthorizes the Department of Health and Human Services Health Centers, National Health Service Corps, Rural Health Care, State Loan Repayment, and Primary Dental Workforce programs. 
• H.R. 6469, the "Stephanie Tubbs Jones Organ Transplant Authorization Act of 2008," which authorizes an increase in funding for the Organ Procurement and Transplantation Network.
• S. 2932, which reauthorizes the poison center national toll-free number, provides grants for poison centers, and expands poison prevention education efforts.
• Several measures aimed at expanding disease research and information resources: H.R. 1157, which authorizes grants for the development and operation of research centers for the study of environmental factors that may be related to the etiology of breast cancer; H.R. 1532, which reauthorizes the Preventive Health Services Regarding Tuberculosis program; H.R. 5265, which promotes research into the causes and treatments of various forms of Muscular Dystrophy; S. 1810, to authorize the HHS Secretary to collect and disseminate information regarding Down syndrome or other prenatally or postnatally diagnosed diseases and to coordinate the provision of support services for those who receive a diagnosis of one of those diseases; and S. 1382, which authorizes funding for the establishment of a national registry for the collection and storage of data on amyotrophic lateral sclerosis (ALS).  

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The AHRQ's Technology Assessment Program develops systematic reviews and health technology assessments at the request of CMS in order to inform national Medicare coverage policies. AHRQ has announced that beginning October 15, 2008, it will post draft Technology Assessment Program reports for public comment on its website.  In a related development, on October 14, 2008, AHRQ has announced that it will be releasing for public comment a draft White Paper on "Potential Conflict of Interest in the Production of Drug Compendia" on October 22, and comments will be accepted on the draft until November 5, 2008.

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There has been a flurry of recent legislative activity as the 110^th Congress prepares to adjourn in the coming days. Congress has taken action on a wide range of health policy bills, addressing such issues as FDA drug and device approvals, internet pharmacy regulation, health care workforce issues, insurance coverage, and medical treatment, and patent protection for antibiotics.   Specifically, the following legislation has been approved by the House and Senate and now await the President’s signature:

• H.R. 6353, the “Ryan Haight Online Pharmacy Consumer Protection Act,” which would prohibit the sale of controlled substances over the Internet without a valid prescription and subject on-line pharmacies to a series of new restrictions.
• S. 3560, the “QI Program Supplemental Funding Act,” which would authorize an additional $45 million for the Medicare Qualifying Individuals (QI) program, which helps certain low-income individuals pay their Medicare Part B premiums. The legislation also includes provisions to modify the patent protections applicable to antibiotics and clarify the ability of generic drug companies to gain approval of and market generic antibiotics. In addition, the bill would expand the education activities under the Medicaid Integrity Program (MIP) and extend funding for the Medicare Improvement Fund to make improvements under the original Medicare program. 
• Several measures aimed at expanding disease research and information resources, including: H.R. 1157, which would authorize grants for the development and operation of research centers for the study of environmental factors that may be related to the etiology of breast cancer; H.R. 1532, which would reauthorize the Preventive Health Services Regarding Tuberculosis program; H.R. 5265, which would promote research into the causes and treatments of various forms of Muscular Dystrophy; S. 1810, to authorize the HHS Secretary to collect and disseminate information regarding Down syndrome or other prenatally or postnatally diagnosed diseases and to coordinate the provision of support services for those who receive a diagnosis of one of those diseases; and S. 1382, which would authorize funding for the establishment of a national registry for the collection and storage of data on amyotrophic lateral sclerosis (ALS).

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The Agency for Healthcare Research and Quality (AHRQ) is establishing a new research portfolio, the Innovations Portfolio, which is designed to identify and support research that has the potential to accelerate improvements in the organization, delivery, and management of healthcare. AHRQ seeks ideas on priority topics and activities that should be addressed as components of the Innovations Portfolio, and will accept comments until October 14, 2008. 

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