UNITING THE PATIENT VOICE IN PUBLIC POLICY
CHAMPIONING THE NEEDS OF PATIENTS
STRENGTHENING THE PATIENT ADVOCACY COMMUNITY
UNITING THE PATIENT VOICE IN PUBLIC POLICY
In January, the NHC successfully launched PuttingPatientsFirst.net, a website that provides tools for people with chronic conditions to help them understand how the health insurance marketplace works and how to choose the right plan for them. The site includes an out-of-pocket calculator that allows people to input their actual provider visits, hospitalizations, and medications to learn how their health needs will impact their total out-of-pocket costs for the year, depending on what type of health insurance plan they choose. The website also has a library of resources created by the NHC and its member organizations, such as overviews of the marketplace and disease-specific insurance information.
The site also includes a section called Share My Story where patients can share their experiences with enrolling in marketplace plans and describe any difficulty they have affording their coverage or accessing their needed health services. The information collected from this site and data from a statistically relevant national survey will be used by the NHC to advocate for needed modifications to the marketplace before open enrollment in late 2014 and assist the patient advocacy community in developing a longer-term strategy.
The NHC is leading a strong push to grow the list of cosponsors for the MODDERN Cures Act (H.R. 3116), legislation spearheaded by the NHC to speed up the development of new and better treatments and companion diagnostics for people with unmet medical needs. The Act, which was reintroduced in the House by Representative Leonard Lance (R-NJ) in September 2013, currently has 35 bipartisan cosponsors, and the NHC is working with potential Senate sponsors to have the Act introduced in the Senate.
The effort will be greatly aided by patient advocacy organizations conducting their patient fly-in events when their advocates will be asking their members of Congress to cosponsor the legislation. If your organization is thinking about including MODDERN as a priority for your event, please contact Eric Gascho, Assistant Vice President, Government Affairs, at email@example.com.
After many rounds of constructive feedback, the NHC is close to finalizing its patient information collection tool to aid in the development of treatments for people with chronic conditions. This tool is intended for use by the FDA and patient advocacy organizations to help capture and organize information gathered from people with chronic diseases and disabilities and their family caregivers about their views on specific conditions and available treatment options.
This tool was used by the narcolepsy community in preparation for their Patient-Focused Drug Development (PFDD) meeting with the FDA last September. A survey modeled on the tool had a much higher participation rate, despite narcolepsy’s relatively small patient population, than data sources produced for previous PFDD meetings focusing on other conditions. Representatives of the narcolepsy community were pleased with the results of their survey and have cited the NHC’s work as a reason for its success.
The NHC also is in the process of finalizing a guide on how to best operationalize the tool, depending on a particular organization’s resources. Once final, the NHC will share this guide with its patient advocacy organization members and other patient organizations, with an emphasis on organizations that will be participating in upcoming PFDD meetings with the FDA.
One lesser known section of the Affordable Care Act is a requirement for pharmaceutical manufacturers to disclose any contributions made to physicians. While the general intent was to create more transparent relationships between industry and treating physicians, it is also impacting the research portfolios of patient organizations. The Centers for Medicare and Medicaid Services (CMS) has interpreted the legislation in a way that is causing pharmaceutical companies to disclose the names of any researchers who receive funding from a patient organization which has received money from the company.
In December, the NHC wrote a letter to CMS expressing concern with the agency’s interpretation and informing them that patient organizations have stringent processes to independently evaluate and award grants, regardless of the funder, and that revenue from a particular grant or sponsorship is indistinguishable from other sources.
The NHC and staff from member patient advocacy organizations held a meeting on February 5 with representatives of CMS to discuss the concerns. The NHC has developed language it will be sharing with CMS along with a request that the text be incorporated into a Frequently Asked Questions document to clarify that the reporting requirements are not applicable to funding provided to patient organizations for their research programs.
After delaying the Fiscal Year (FY) 2014 budget negotiations until January 2014, Congress was able to pass a comprehensive spending measure to fund the federal government through the remainder of the fiscal year, which ends September 30, 2014. The legislation, which passed with broad bipartisan support, restored much of the sequestration cuts, including a $1 billion (3.5 percent) increase over FY 2013 appropriations to the National Institutes of Health funding. The Centers for Disease Control also saw a slight increase over FY 2013 levels. Other notable provisions of the spending measure restored the previously sequestered FDA user fees and, for the first time ever, allocated money for the ACA Prevention Fund.
On March 4, President Obama released a $3.9 trillion FY 2015 budget. The budget included a $200 million increase for NIH, a $358 million increase for FDA (though the majority of the increase was to the food program), and a $243 million decrease for CDC, all compared to final FY 2014 spending. While it is highly unlikely these figures will be included in final appropriations, it sets a general baseline for the Congressional Democrats during the appropriations process.
CHAMPIONING THE NEEDS OF PATIENTS
The Patient-Centered Outcomes Research Institute (PCORI) is developing what it calls “usefulness criteria,” which are based in part on the NHC’s publically released work on the creation of a comparative effectiveness research (CER) usability framework to help patients make better decisions at the point of care.
This is a huge win for the patient community because a core function of usability is ensuring the needs of patients are the focus at each stage of CER. Much of PCORI’s work to establish criteria will be conducted by the Patient Engagement Advisory Panel, which includes NHC Executive Vice President and Chief Operating Officer Marc Boutin and is chaired by Charlotte Collins of the Asthma and Allergy Foundation of America, an NHC member.
PCORI has also announced that it will award up to $15.5 million in 2014 for the Eugene Washington Engagement Awards. This program’s goal is to expand the role of stakeholders, such as patients and health care providers, in strengthening the patient-centered outcomes research community. The program is also designed to engage patients in the research process and promote dissemination and implementation of CER findings. PCORI will fund proposals in three categories: Knowledge Awards, Training and Development Awards, and Dissemination Awards. PCORI has added a page to its website to offer more information about the awards and the application process.
- February 26, 2014 – NHC Assistant Vice President of Government Affairs Eric Gascho presented to the American Foundation for Suicide Prevention on the NHC’s new website, PuttingPatientsFirst.net.
- February 25, 2014 – Gascho presented on the MODDERN Cures Act to rare disease advocates during a gathering as part of Rare Disease Week.
- February 19, 2014 – Gascho was a panelist for a FasterCures webinar on Patient-Focused Drug Development.
- February 14, 2014 – Gascho appeared on Talkline with Hoppy Kercheval, a West Virginia radio program, to discuss PuttingPatientsFirst.net.
- February 11, 2014 – Gascho spoke about PuttingPatientsFirst.net at PhRMA’s annual Washington Representatives Retreat.
- January 27-29, 2014 – NHC Executive Vice President and Chief Operating Officer Marc Boutin talked about PuttingPatientsFirst.net at PhRMA events in Colorado, Oregon, and Washington.
- January 27, 2014 – Gascho presented on the MODDERN Cures Act at a meeting of ALS Association advocates.
- January 24, 2014 – Boutin spoke about PuttingPatientsFirst.net at an American Foundation for Suicide Prevention meeting in Colorado.
- January 14, 2014 – Gascho presented on patient engagement and the NHC information tool at a Drug Information Association meeting on Pharmacovigilance and Risk Strategies.
- January 9, 2014 – Boutin spoke about the Putting Patients First® Initiative at BIO’s Alliance Development Committee meeting.
- December 12, 2013 – Gascho presented on a webinar about implementation of the Affordable Care Act for the U.S. Hereditary Angioedema Association.
- March 5, 2014 – Boutin will present during a DIA/FDA webinar on the patient provisions of FDASIA.
- April 22-23, 2014 – Boutin will present at a Brookings-DIA conference on medical product innovation and stakeholder collaboration.
- June 23-26, 2014 – Boutin will present during the Patient Focused Drug Development panel discussion at the BIO 2014 conference.
- February 24, 2014 – Gascho talked about the importance of patient engagement and the need for a formal process for including this information in the FDA’s drug review process (Subscription required) – The Pink Sheet
- February 19, 2014 – Gascho discussed cost-sharing trends and prescription drug plans – EP Vantage
- February 18, 2014 – National Health Council Chief Executive Officer Myrl Weinberg wrote about the importance of understanding all costs associated with health care and how PuttingPatientsFirst.net can educate consumers about picking health insurance based on personal and budgetary needs – American Journal of Pharmacy Benefits
- February 17, 2014 – Boutin discussed recent proposed changed to Medicare Part D that would limit patient access to some drugs (Subscription required) – BioCentury
- February 9, 2014 – Weinberg participated in a discussion about multiple chronic conditions – BioCentury TV
- February 4, 2014 – Boutin commented on the use of drug company patient assistance programs in the health insurance marketplace – Washington Post
- February 4, 2014 – Gascho discussed PuttingPatientsFirst.net – Comcast Newsmakers
- January 29, 2013 – Boutin discussed how the tools on PuttingPatientsFirst.net will help people with chronic conditions select health insurance plans – Health News Colorado
- January 29, 2014 – Boutin talked about how picking the wrong health plan can increase out-of-pocket costs – Portland Business Journal
- January 28, 2014 – Boutin talked about concerns people with chronic conditions have about the benefits offered in the new health care plans – Forbes
- January 28, 2014 – Boutin was interviewed about the safeguards put in place in the Affordable Care Act to protect people with chronic diseases and disabilities – CNNMoney.com
- January 2, 2014 – Boutin discussed how the Affordable Care Act is impacting people with chronic diseases and disabilities – Money
- December 31, 2013 – Boutin discussed how out-of-pocket costs may cause serious problems for people with chronic diseases and disabilities – Kaiser Health News
- December 12, 2013 –Weinberg participated in a discussion about the biggest health care accomplishments of 2013 and what’s coming in 2014 – PhRMA Conversations
- December 11, 2013 – Boutin talked about how information on doctor networks and drug formularies is not typically available on the health insurance marketplace – Washington Post
- December 9, 2013 – Boutin discussed concerns over inadequate drug coverage in the health insurance marketplace – Washington Post
IAPO will be hosting its 6th Global Patients Congress from March 29-31 in Ascot, UK. The focus will be on how to provide global access to patient-centered health care. Leading up to the Congress, IAPO will be using HealthUnlocked – a health-focused social network – to start the discussion. For more information about the event, click on this program link.
The Center for Information and Study on Clinical Research Participation (CISCRP) is developing a new traveling exhibition that will present the clinical research process through the eyes of volunteers who give the gift of their participation. This 1,000 square foot exhibition will travel to museums in 12 cities, including Washington, DC, during the course of a three‐year tour, reaching elementary through high school age children and their families, and serving as an anchor for a media awareness campaign in each city.
The Medical Heroes exhibition will present authentic stories and voices of clinical research volunteers who have participated in or are currently enrolled in clinical trials spanning pharmaceuticals, gene therapy, medical devices and procedures, behavioral interventions, and observation studies.
Hearing from volunteers participating in a wide range of clinical trials will help visitors understand that clinical trials are more than treatments of last resort. Museum visitors will also be able to participate in a simple clinical trial and make decisions about participation: for example, using a blood pressure cuff to record their heart rate before and after doing jumping jacks. Multimedia exhibits will enable visitors to play the role of friend and advisor to volunteers who are figuring out what questions to ask and making decisions about participation.
CISCRP will be holding a meeting to unveil the museum initiative to patient organizations and other stakeholders on April 7 from 9 a.m. to noon at Foley and Lardner LLP, 3000 K Street NW, Suite 600, in Washington, DC. Please RSVP to Ellyn Getz at firstname.lastname@example.org (617-725-2750) if you and your colleagues are interested in attending. A light breakfast will be served.
AAHRPP will be hosting its annual conference in Salt Lake City, Utah, from April 23-25. The event will focus on the theme Leading the Way: From the Essentials to the Cutting Edge, and will include discussions on comparative effectiveness research, data sharing, and managing institutional review boards. For more information about the conference, please consult the agenda.
Five new organizations were accredited by AAHRPP in December. The newly accredited organizations are:
- Asan Medical Center, Seoul, Republic of Korea
- First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), Nanjing, China
- Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA
- McLaren Health Care Corporation, Flint, MI
- North Shore-LIJ Health System, Manhasset, NY
AAHRPP has accredited organizations in 46 states, Canada, China, India, Mexico, Republic of Korea, Singapore, and Taiwan. The National Health Council is a founding member of AAHRPP.
STRENGTHENING THE PATIENT ADVOCACY COMMUNITY
The largest gathering of representatives from NHC patient organizations met for the 27th Annual Voluntary Health Leadership Conference from February 12-14 in Tucson, Arizona. Each year the NHC brings together the chief staff person and board volunteers from member patient advocacy organizations to learn about current health policy and ways to strengthen their respective organizations.
Nearly 80 senior staff and volunteer leaders from 32 organizations heard from speakers on topics such as creating a culture of innovation, organizational transformation, and finding new ways to generate revenue. In addition, attendees heard from Dr. Christopher Austin, Director of the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health, and Dr. Tracy Gaudet, Director of the Office of Patient Centered Care and Cultural Transformation at the Veterans Health Administration.
Copies of the presenters’ slides, supplemental materials, and links to videos are available on the National Health Council website.
In November 2013, the Internal Revenue Service released proposed regulations to clarify permissible political activity by 501(c)4 organizations, which has the potential to set a precedent for other charitable organizations such as 501(c)3s. Included in this proposed rule are provisions that Independent Sector, a coalition of nonprofits, foundations, and corporate giving programs, has highlighted as particularly problematic:
- The proposed rule creates a “blackout period,” during which organizations are not allowed to mention a political candidate by name for 30 days before a primary election and 60 days prior to a general election. This applies to incumbents who are running for reelection, which would impact grassroots activity of patient organizations if it becomes applicable to 501(c)3s.
- Nonpartisan civic engagement activities such as voter guides, registration drives, and get-out-the-vote efforts will now be classified as political activity, which will prevent 501(c)3s from conducting these efforts.
- The rule remains silent on the increasing amount of money being funneled through 501(c)4 organizations and does not discourage bad actors.
Independent Sector submitted comments to the rule, which highlight their main points of contention, and the National Health Council signed onto their comments.
The NHC is happy to announce three new members. The Prevent Cancer Foundation is the NHC’s newest voluntary health agency, and the American Osteopathic Association and the Consortium of Multiple Sclerosis Centers joined in the professional and membership associations category. The NHC looks forward to working with these organizations to accomplish our mutual goals.
As part of its policymaking process and to encourage the professional development of the staff of member organizations, the NHC conducts several meetings throughout the year. Mark your calendars for these upcoming events:
- Government Relations Affinity Group – first Thursday of the month (except August and December). Open to the senior government affairs staff of VHA member organizations.
- Appropriations Issue Team – first Thursday of the month (except August and December). Open to senior government affairs staff of all NHC members.
- FDA Issue Team – third Thursday of the month (except August and December). Open to senior government affairs staff of all NHC members.
- Health Care Reform/CER Issue Team – third Thursday of the month (except August and December). Open to senior government affairs staff of all NHC members.
- Communications Affinity Group – March 12 from 2:30 to 3:30 Eastern Time. Open to senior communications staff of VHA member organizations. At times the meetings are also opened to other member categories.
- Grassroots Team – April 16 from 2:30 to 3:30. Open to advocacy staff of VHA member organizations.
- Chief Legal Officers Affinity Group – April and October. More information will be announced at a later date. Open to legal staff and CEOs of VHA member organizations.
Keep an eye out for future meetings of the Chief Financial Officers Affinity Group, Chief Development Officers Affinity Group, and the Chief Scientific/Medical Officers and Research Directors Affinity Group. All affinity group and Issue Team meetings are posted on the NHC web calendar.
To maximize the benefits of NHC membership for patient advocacy organization members, the NHC provides a number of avenues to showcase individual organizations. As a patient advocacy organization member, you can:
- Submit a short piece for the NHC/WebMD blog A Different Normal, a website that reaches millions of people with chronic diseases and disabilities and their family caregivers. For more information about how to submit a post for this blog, e-mail Nancy Hughes, Vice President, Communications and Marketing, at email@example.com.
- Post open positions in the NHC’s online Job Bank. To submit an opening for the Job Bank, e-mail Jill Roberts, Manager, Communications and New Media, at firstname.lastname@example.org.
- Announce your annual meeting, advocacy days, or other public activities on the NHC web calendar. Click here for instructions on how to list your organization’s event.
- Post a description of your organization, your logo, and web links in the NHC’s Resource Directory. The Resource Directory is a dynamic service where patients with chronic diseases and disabilities and their family caregivers can find links to various patient advocacy organizations, government services, and other useful resources. To post or update your organization’s current information, please contact Jill Roberts, Manager, Communications and New Media, at email@example.com. Please limit your organization’s description to no more than 200 words.
- List your Health Insurance Resources on PuttingPatientsFirst.net. The National Health Council is collecting resources to help people learn about and choose health insurance in the marketplaces. Please e-mail web links to your materials to Jill Roberts at firstname.lastname@example.org.