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American People
 

June 2012 Council Currents


Building Lasting Endurance

Extending Our Reach

Just Released: NHC Focus Group Study on HIPAA Privacy Rule

The National Health Council (NHC) is committed to reducing barriers to health research. To that end, the NHC conducted focus groups from December 2011 to February 2012 to explore patient and caregiver views on the federal HIPAA Privacy Rule and its ramifications for medical research. To learn more about the HIPAA Privacy Rule click here.

 

The study’s findings suggest that although patients and caregivers will generally support changes to the HIPAA Privacy Rule once they understand it, getting agreement on what changes to make to the rule will be a challenge. The findings also suggest that patients and caregivers will want some personal and all contact information deleted from records if they are to be used for research. 

 

The focus groups included 59 participants from across the U.S. including adult patients, family caregivers of children with chronic conditions, and family caregivers of adults with chronic mental conditions that limit their ability to live independently. Prior to the focus groups, no participant had been aware of the HIPAA Privacy Rule; however, all participants in the study considered medical research essential to advancing the discovery of better treatments and cures.

 

To read the full NHC study on the HIPAA Privacy Rule click here. 

 

The focus groups were funded by the National Institutes of Health, in partnership with the Indiana University Center on Law, Ethics, and Applied Research in Health Information.

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The Supreme Court and the Affordable Care Act

On March 26-28 the Supreme Court heard oral arguments to determine whether or not certain provisions of the Patient Protection and Affordable Care Act are constitutional. While avoiding the more technical aspects of the issue, the National Health Council released a statement that reaffirmed the patient community’s support for the Affordable Care Act. The statement was signed by NHC president Myrl Weinberg and the chief executive officers of approximately 30 NHC member patient advocacy organizations. 

 

The Court will determine the constitutionality of a federal requirement that individuals purchase a minimum level of insurance coverage and the expansion of the Medicaid program. The court is expected to rule on the case in June. While many legal experts feel strongly that the court will uphold the Medicaid expansion, their views on the insurance mandate are more varied. The NHC feels that the Court will uphold the mandate and is encouraging members to continue working on issues related to implementation, notably working with the states to choose their essential health benefits benchmark plans.

 

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NCATS and the NHC

In May, the new National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS) announced that it was partnering with three businesses, Pfizer, AstraZeneca, and Eli Lilly (all of whom are members of the NHC) to find new therapeutic targets for compounds owned by industry but not brought to market.

 

“The Discovering New Therapeutic Uses for Existing Molecules initiative will encourage the testing of these compounds for their effectiveness against a variety of diseases and conditions,” the National Health Council said.

 

The NHC statement, which was sent to the media and policy makers on Capitol Hill, praised the initiative as a way to help deliver cures and treatments to patients with chronic diseases and disabilities. The National Health Council made clear that this initiative would complement – and not supplant – the MODDERN Cures Act.

 

National Health Council President Myrl Weinberg has been nominated to serve on the NCATS Advisory Council.  

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Creating an Essential Health Benefits Package

The NHC continues to engage in the Department of Health and Human Services’ (HHS) efforts to implement the provisions of the Affordable Care Act related to the definition of the essential health benefits (EHB) package. In April, the NHC submitted comments to HHS regarding a pre-regulatory guidance document on the actuarial value and cost-sharing reduction provisions of the EHB. The comment letter touched on several key areas: ensuring the standard population used to determine the actuarial value of a package is representative of people who would buy qualified health plans; ensuring innovative plan designs; providing patient protections; defining federal and state oversight mechanisms; and minimizing the overall out-of-pocket (OOP) spending for most enrollees by maintaining the OOP maximum for individuals with income between 250% and 400% of the federal poverty level during 2014 and 2015 with analysis about the OOP cost implications informing the policy for 2016 and beyond.

 

The key focus of the NHC’s EHB initiative has been the continued advocacy for the inclusion of patient protections and federal and state oversight mechanisms. The NHC joined the Parkinson’s Action Network and the National Alliance on Mental Illness to circulate a sign-on letter that stressed the need for patient protections and oversight. The letter also expressed concern that a minimum of one drug per class in an EHB formulary would be inadequate to meet the needs of patients. The letter was signed by more than 100 organizations and was sent to HHS Secretary Sebelius on April 11.

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Supporting the User Fee Act Reauthorization

The NHC remains closely involved in the reauthorization process of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA). The NHC supported the provisions in PDUFA related to benefits and risks in the FDA decision-making process, biomarkers and patient reported outcomes in clinical trial design, and expanded resources for rare disease product development. The NHC also advocated for the inclusion of provisions in MDUFA related to benefit-risk, the qualification of biomarkers, and the development of companion diagnostics.

 

Both agreements will officially reauthorize the user fee programs for five years. The legislation will also establish new user fee programs for generic drugs and biosimilars. The House and Senate have both passed legislation, but the two chambers must work together to agree on one final bill to send to the President for signature. It is expected that they will do so by July 4.

 

FDA is already in the early stages of the implementation of a new benefit-risk framework. One of the first steps in this process was to hold a public meeting on benefit-risk on May 18. NHC Executive Vice President Marc Boutin served on a panel of patient representatives and spoke about the need for patient input at various stages throughout the research and regulatory processes. He also presented an outline to determine the 20 disease categories on which the FDA will base 20 meetings that are mandated by the PDUFA agreement. NHC also submitted a letter to the FDA explaining the outline.  

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Reaching New Audiences Through WebMD

WebMD is the leading website for health information and, working with the NHC, delivers important messages and information to help people with chronic diseases and disabilities and their family caregivers through the blog A Different Normal: Living with a Chronic Condition.


The blog features guest writers from NHC’s member organizations and chronic disease experts from WebMD. It is a way for organizations to provide meaningful information and patients to ask questions, share their powerful stories, and provide personal knowledge of the subject.

 

As Kim Richardson, Strategic Expert Coordinator for WebMD, discussed at a recent NHC Communications Affinity Group meeting, “the blogs are a great opportunity, a place where information meets real life….This blog is about the people not just the conditions.”

 

WebMD has begun filling the editorial calendar through the summer of 2012. NHC member patient advocacy organization and non-profit organization members interested in participating in this initiative should contact Nancy Hughes, NHC Vice President of Communications and Marketing, at nhughes@nhcouncil.org.

 

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HealthResearchFunding.Org

The National Health Council’s unique web database HealthResearchFunding.Org has grown to include more than 580 peer-reviewed health research proposals. The database, which was created by the NHC with input from the NIH Office of Extramural Programs, provides information to NHC members on worthwhile but unfunded research proposals that have been peer reviewed.

Of the NIH peer-reviewed proposals on the database:  

 

  • Average NIH percentile score of 51% [Percentage of applications that received a better overall impact/priority score from the study section during the past year]
  • Average NIH impact/priority score of 25 [Overall impact/priority scores range from 10 (high impact that the project is likely to have on the research field involved) through 90 (low impact)]
  • 90 proposals from principal investigators who received NIH K-Awards [Career development awards}


The most recent proposals submitted on HealthResearchFunding.Org include

  • The Striated Organelle: A Molecular Motor for Vestibular Type I Hair Cells?
  • Randomized Study of Health Care Services for HIV Infected People Who Use Drugs
  • Different Measures of Muscle Mass, CVD Morbidity, and Cause-Specific Mortality
  • Crossroads Between Flaviral Phosphorylation, Arthropod Signaling, and Behavior
  • Epilepsy Birth Control Registry: A Prospective Study

 

The goal of HealthResearchFunding.Org is to foster support for new research that will provide hope to patients and their families for new and better treatments. In addition, the database offers NHC members the ability to fulfill their missions to support research for prevention, detection, diagnosis, and treatment of chronic diseases and disabilities by brokering a user-friendly, reliable information exchange among interested parties.

 

Since January 2012, HealthResearchFunding.Org has been featured in the National Institutes of Health’s publication the PPP Advisor and on the California Healthcare Institute’s blog. If you have any questions about HealthResearchFunding.Org or would like to get involved, please contact Emily Noonan, NHC Associate Director of New Media and Special Projects, at enoonan@nhcouncil.org. 

 

HealthResearchFunding.Org was made possible with support from Pfizer Inc and the National Institutes of Health.


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International Alliance of Patients’ Organizations (IAPO)

The National Health Council (NHC) is proud to announce the election of NHC’s Executive Vice President and Chief Operating Officer, Marc Boutin, to the International Alliance of Patients’ Organizations (IAPO) Governing Board.  IAPO is a unique global alliance representing patients of all nationalities across all disease areas, and the NHC was instrumental in its creation and operations. Click here to read the NHC’s official announcement.

IAPO held its 5th Global Patients Congress: Achieving Patient-Centred Healthcare: Indicators of Progress and Success in London, England, from March 17-19.The Congress examined how to measure the extent to which patient-centred health care is achieved around the world.  The Congress not only highlighted examples of best practices of promoting patient-centred health care but examined how meaningful indicators can be developed to measure patient involvement within health care systems.

 

Both NHC President Myrl Weinberg and Boutin attended the meetings in London. To read more about the 5th Annual Global Patients Congress click here.



(From left to right) - IAPO Chair Elect Kin-Ping Tsang; Marc Boutin, National Health Council; Beatriz Soto Rivero, Spanish Association Against Osteoporosis; and Rebekkah Schear, LIVESTRONG.


(From left to right)- IAPO founding members: Rod Mitchell, European Federation of Crohn's & Ulcerative Colitis Associations; Myrl Weinberg, National Health Council; Virginia Ladd, American Autoimmune Related Diseases Association; and Albert van der Zeijden, Representative of the Council for the Chronically Ill and the Disabled in the Netherlands (CG Council).


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NHC Voice before Important Stakeholders


  • NHC President Myrl Weinberg was appointed to the Foundation for the National Institutes of Health (FNIH) Observational Medical Outcomes Partnership (OMOP) Executive Board and NHC Executive Vice President and Chief Operating Officer was appointed to the Community Health Charities Board of Directors.
  • On June 5, 2012 - Weinberg will moderate an Institute of Medicine panel on the role of the Cures Acceleration Network in advancing cross-sector collaborative translational science activities.
  • On June 3, 2012 – Boutin participated in a BioCentury televised interview on integrating patient perspectives into regulatory decisions.
  • On May 23, 2012 – Boutin presented at Indiana University’s Protecting Privacy in Health Research Conference.
  • On May 23, 2012 – Boutin took part in a panel on emerging approaches to engage patients and improve their health at the Partners in Patient Health event.
  • On May 22, 2012 – Boutin presented to the Marwood Group on the patient’s perspective on the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA).
  • On May 18, 2012 – Boutin presented at a Food and Drug Administration (FDA) panel on benefit-risk.
  • On May 14, 2012 – Boutin presented at The ALS Association’s Advocacy Day and Public Policy Conference on the MODDERN Cures Act.
  • On May 11, 2012 –Weinberg presented to the Rheumatology Collaborative Institute on health related outcomes.
  • On May 7, 2012 – Boutin presented at the California Healthcare Institute’s Congressional Briefing on PDUFA and MDUFA.
  • On April 27, 2012 – Weinberg presented at the Winston Health Policy Symposium on how patient advocates can positively influence public policy.
  • On April 24, 2012 – Boutin presented at The ALS Association’s Drug Company Working Group meeting on the MODDERN Cures Act.
  • On April 21, 2012 – Boutin presented at the HealthHIV’s Synchronicity conference.
  • On April 18, 2012 – Boutin presented the patient perspective at the Partners in Patient Health CER and Engagement Opportunities for Improved Patient Outcomes event.
  • On April 16, 2012 – Boutin presented at the Arthritis Foundation’s Public Policy Committee/Regional Advocacy Workgroup Luncheon on the Affordable Care Act and the Supreme Court case on constitutionality.
  • On April 12, 2012 – Boutin took part in a panel presentation at PhRMA’s Annual meeting.
  • On April 2, 2012 – Boutin presented at the Epilepsy Foundation’s public policy conference on the MODDERN Cures Act.
  • On March 28, 2012 – Boutin took part in an AvalereHealth expert panel on the evolving role of evidence.
  • Eric Gascho, NHC Director of Government Affairs presented at the FDA public meeting on MDUFA.
  • On March 22, 2012 – Boutin presented on essential health benefits to the Healthcare Industry Study Group at the Industrial College of Armed Forces, National Defense University.
  • On March 17- 18 –Weinberg and Boutin attended the 5th Annual International Alliance of Patients Organizations Global Patients Congress. At the conference, Boutin presented on a panel focusing on   patient-centered care and chaired a panel focusing on effective advocacy. Weinberg presented on the benefits of IAPO membership during the members only portion of the Congress.
  • On March 13, 2012 Boutin presented on the MODDERN Cures Act at the American Liver Foundation congressional fly-in.
  • On March 6, 2012 – Boutin presented at the 13th Annual PhRMA Patient Assistance and Access Programs Conference.
  • On March 1, 2012 – Weinberg was a panelist at the Brookings Institute expert workshop on Patient and Consumer Engagement in FDA’s Sentinel Initiative. Weinberg presented on facilitating patient and consumer engagement.

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Sharing the NHC Message and Knowledge with Others

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Center for Information and Study on Clinical Research Participation (CISCRP)

The Center for Information and Study on Clinical Research Participation (CISCRP), in collaboration with Pfizer Inc, conducted a study aimed at evaluating the practicality of providing trial results in non-scientific terms to clinical trial participants. As reported by the Wall Street Journal, the study confirms that an overwhelming majority of clinical study volunteers would like to receive more information about their trial participation. The study suggests that the research developed from the trial never actually reaches the participants.


CISCRP states on its website that it is not currently easy to find the results of a clinical study nor is it easy–to-understand the technical language provided by the researcher. CISCRP aspires to create easy to understand summaries of clinical trials and is working with federal programs such as clinicaltrials.gov, in addition to running its own site at www.SearchClinicalTrials.org, to provide more information and evidence to trial participants.

Click here to get more information about CISCRP and read their latest newsletter.

National Health Council is a proud supporter of the Center for Information and Study on Clinical Research Participation (CISCRP), and NHC President Myrl Weinberg is a member of the CISCRP Board of Advisors.


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AHRQ: Questions are the Answers

One of the best ways for patients with chronic conditions to communicate with their health care team is by asking questions. Establishing an effective line of communication with health care providers is important to building trust and an open exchange of information, which leads to better health outcomes. 

To that end, the NHC supports the Agency for Healthcare Research and Quality's (AHRQ) campaign "Questions are the Answer." This program provides excellent informative resources and tools that can be used to promote more effective patient communication.

For more information about this campaign, click here.


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AAHRPP

The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) is a nonprofit entity created to ensure the ethical treatment and safe participation of humans in clinical research.

The National Health Council is one of seven founding members of AAHRPP. Other members include organizations that represent the leadership of universities, medical schools, and teaching hospitals; biomedical, behavioral, and social scientists; and institutional review board professionals. As a founding member, the NHC established a financial relationship with AAHRPP upon initial conception; this relationship was concluded in December 2011 due to AAHRPP’s strong financial position and overall success.


The NHC will continue to work closely with AAHRPP to ensure that institutions engaging in human medical research are subject to the highest safety and ethical standards.

 
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