By Daniel Witke
The 21st Century Cures Act was recently signed by President Obama and will allocate over $6 billion to health-care initiatives in the next ten years.
$4.8 billion will be distributed to three signature research programs: Vice President Joe Biden’s Cancer Moonshot, the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative and the Precision Medicine Initiative. The proposed legislation would also give states one billion to fight the opioid crisis and deliver an additional $500 million to the FDA. The bill received overwhelming bipartisan support after a 392-26 vote in the House and a 94-5 vote in the Senate.
As we begin 2017, it is important to understand how these provisions will play a role in the ever-changing landscape of health-care.
Winners: Pharmaceutical and Medical Device Companies, Medical Centers and Mental Health Facilities
The $4.8 billion allocated over the next ten years will help the Cancer Moonshot, BRAIN and PMI by providing the funding needed for research. Universities and medical centers will use the funds for research grants towards cancer, neuroscience and genetic medicine. The bill attracted lobbying activity from 60 schools, 36 hospitals and several dozen groups representing physician organizations.
With opioid-related deaths continuing to rise in this country, the one billion in state grants over the next two years will be allocated to facilities and research.
Representative Tim Murphy (R-Pa.), who is also a psychologist, was a driving force behind the bill because of the provisions that will fund mental health-care programs.
“To all the families who brought their stories out of the shadows, that dared to share their sorrows, their hopes, their shattered dreams, today is a day of joy,” said Murphy.
The Cures Act has provisions that will allow drug and device companies to push their products through the FDA faster. The massive lobbying effort from 58 pharmaceutical companies, 24 device companies and 26 biotech companies supported this provision. According to the Advanced Medical Technology Association, which represents 300 medical device companies, the Cures Act will allow a quicker path for breakthrough medical technologies to help patients with life threatening conditions.
“Passage of this important legislation is a milestone in improving the innovation ecosystem for medical technology and ensuring the availability of new lifesaving, life-enhancing devices and diagnostics for patients,” said Advanced Medical Technology’s CEO, Scott Whitaker.
However, the bill has been the subject of debate. It includes provisions that will greatly impact the FDA, Consumer and Patient Safety Groups, and Public Health.
Losers: The FDA, Consumer and Patient Safety Groups, and Public Health
One notable opponent of the bill was Senator Elizabeth Warren (D-Mass). One of Warren’s biggest criticisms is the faster approval of prescription drugs and medical devices.
“Pushing treatments without scientific evidence that they work is fraud – fraud that can hurt people,” said Warren.
The FDA is currently the fastest regulatory system in the world and can be potentially life-threatening if the approval process is pushed even faster. Rita Redberg, editor of the journal for JAMA Internal Medicine wrote this bill could amount to a dangerous trade-off: “In our rush to find new effective treatments, we should not harm our patients with ineffective toxic ones.”
The legislation also affects consumer and patient safety groups.
Dr. Michael Carome, Director of Public Citizen’s Health Research Group, said he was especially concerned about the provisions relating to the drug approval process.
“The summary data could hide important information about the safety and effectiveness from the FDA scientist reviewing the data,” Carome said. “I’m disappointed to see it. ’’
Finally, the bill will cut $3.5 billion over the next ten years from the Prevention and Public Health Fund, which was established under the Affordable Care Act. The fund sets aside money for prevention programs to help battle Alzheimer’s disease, hospital acquired infections and chronic illnesses.
With this legislation affecting so many different areas of health-care, it is more vital than ever to monitor these provisions. No matter the time, day or year, TogoRun is beyond ready to tackle the challenges ahead.
By: Annie Martello
At TogoRun, we pride ourselves in finding and telling the untold stories—stories about important people and organizations who have not received the recognition they deserve.
When it comes to healthcare policy in the U.S., the Department of Health and Human Services, the Centers for Medicare and Medicaid Services, the Food and Drug Administration and the White House are household names; however, there are many other groups frequently overlooked despite their influence in building the future of healthcare.
In this edition of HCPolicy Power Players, we focus on profiling the non-profit/non-partisan National Quality Forum (NQF).
The National Quality Forum is a non-profit and non-partisan membership organization whose mission is to drive improvements in healthcare. The NQF was established in 1999 based on recommendations made by the President’s Advisory Commission on Consumer Protection and Quality in the Health Care Industry. These recommendations concluded that an organization was needed to promote and ensure patient protections and healthcare quality through measurement and public reporting. Its current President and CEO is Christine K. Cassel, who previously held the same title at the American Board of Internal Medicine (ABIM) and the ABIM Foundation.
The NQF is comprised of more than 400 member organizations that represent a vast range of healthcare interests. From consumers and physicians, to government and public health agencies, to pharmaceutical and medical device companies, the NQF spans the spectrum of healthcare.
What It Does
The NQF works to achieve its mission by setting and shaping national quality improvement priorities, endorsing and setting national standards, advancing electronic measurement, and promoting outreach and education programs.
Through NQF-convened partnerships, like the National Priorities Partnership (NPP), the NQF helps to set and shape national healthcare improvement priorities and then determines the best course of action to meet them. The NPP is a cooperative of 52 major national organizations with a shared vision to create a healthier population through a safe, effective, equitable and value-driven healthcare system. Through the NPP, the NQF was able to establish a national blueprint for achieving this high-value healthcare system—The National Quality Strategy. The NQS sets clear goals to help the nation focus its efforts and have a coordinated plan of attack.
The National Quality Forum uses a rigorous and formal process to evaluate and endorse several different kinds of standards—performance measures, best practices, frameworks and reporting guidelines. NQF’s “Consensus Development Process” involves eight steps:
- Call for nominations
- Call for candidate standards
- Candidate consensus standard review
- Public and member comment
- Member voting
- Consensus Standards Approval Committee (CSAC) decision
- Board ratification
Advancing Electronic Measurement
The National Quality Forum has developed health IT initiatives to support the prevailing move toward electronic measurement. In 2011, the NQF converted 113 of its endorsed quality measures into an electronic format—eMeasures. eMeasures provide greater consistency and standardization in measuring performance results. In 2011, the NQF also released the Measure Authoring Tool, which allows for the development of standardized eMeasures for use across electronic health records (EHRs) and clinical IT systems.
Additionally, the NQF has developed the Quality Data Model (QDM). The QDM is an information model that acts as a guide for the effective automation and standardization of electronic health record use. The QDM makes data entered into EHR systems more easily measurable and identifiable.
Outreach and Education
The NQF provides reports, tools, events and information for use by physicians, healthcare communicators, consumers and others in the healthcare industry. Some of its main outreach and educational materials include: a directory of reports, endorsement summaries, endorsed measures, graphics, a Health IT knowledgebase and an action registry.
Why Quality Standards Matter
In 1999, the Institute of Medicine estimated in its famous “To Err Is Human” report, that as many as 44,000 to 98,000 people die in U.S. hospitals each year as the result of medical errors. More recent studies report that these numbers are actually much higher than previously believed. According to a 2013 estimate published in the Journal of Patient Safety, more than 400,000 Americans die annually in part because of avoidable medical errors.
These errors also have a serious fiscal impact. One of the most recent studies to measure these expenses found that medical errors cost the country around $19.5 billion annually, most of which is spent on extra care and medication.
Due to its stringent and involved consensus process, NQF-endorsed measures are considered the “gold standard” for healthcare measurement in the U.S. The federal government and many other private sector organizations use NQF-endorsed measures above all others and nearly all are in use.
Apart from its endorsed standards, one of the initiatives the NQF is best known for is the creation of its report on Serious Reportable Events (SRE) in 2009. Serious Reportable Events are “preventable, serious, and unambiguous adverse events that should never occur.” These events usually end in death or serious harm to a patient due to medical error and are often referred to as “never events,” as they should never happen. The NQF has compiled a list of 28 SREs in six categories— surgical, product or device, patient protection, care management, environment and criminal. By identifying these SREs, the healthcare industry can work to eliminate them.
Today, the NQF continues to push for the reduction and proper handling of medical error. One of its recent initiatives includes advocating for legislation that would require hospitals to adopt written policies that address the management of adverse events.
The Bottom Line
The NQF persists as one of the strongest voices in championing the enforcement of quality in all areas of healthcare. It can be counted on to advocate on behalf of all major legislation and initiatives that focus on improving the healthcare system. Its strong advocacy for policies to promote safe and high-quality healthcare coupled with its leading-edge efforts makes the NQF an organization to know and follow.
By: Emma Berry
The word of the day is “Cuba.” With the restoration of Cuban-American relations, Cuba is re-entering the U.S. media stream in no small way. In the past month, America has been excited about the re-establishment of the embassies, enraptured by the U.S.-Cuba showing in the Gold Cup quarterfinals and abuzz with discussion of President Obama’s foreign goals for our neighbors to the South. We talk about what America can do for Cuba, but what are we not talking about? After over half a century of silence, what is still unheard?
Healthcare is a universal necessity that affects quality of life, both mentally and physically. The conversation it sparks bridges cultural gaps and unites even conflicting nations under a common goal.
World Health Organization (WHO) director-general Dr. Margaret Chan called the elimination of the transmission of a virus one of the “greatest public health achievements possible.” Now, Cuba has done just that. The island nation has a history of successful disease interventions: Medicines for diabetic foot ulcers, lung cancer and hepatitis B. It developed a meningococcal vaccine more than 20 years before America did. And, in early July, the WHO announced that Cuba had effectively eliminated mother-to-child HIV transmission, a massive stepping stone towards an HIV-free generation. With 1.2 million Americans infected with the virus and an estimated 12 percent unaware that they are ill, this is a topic the U.S. should be talking about. But we’re not.
As Ebola ravaged nations in West Africa last year, international providers traveled to the region to lend a healing hand. America sent 65 health workers to Liberia. Cuba sent 165. Cuba, whose cultural approach to medicine teaches a sense of responsibility to help people in need, simply asks students of Havana’s Latin American Medical School (ELAM) to work in underserved world communities in exchange for their education.
Cassandra Curbelo, an American ELAM student, said that the school teaches students to “better understand what patients’ lives are like.” As America strives to achieve equal access to healthcare and transition to patient-centered care, this is a topic the U.S. should be talking about. But we’re not.
So why isn’t it a topic of discussion?
Healthcare isn’t sexy. The top social media influencers in the healthcare space are not celebrities or glamorous public figures. They are educational institutions, renowned doctors and top tier news outlets. When social media users discuss Cuba on Twitter, they aren’t talking about HIV or Ebola- they are talking about soccer, travel and Obama.
Healthcare doesn’t have the “wow” factor that many other high-profile topics have in today’s media landscape. What it does have, however, is need. The world needs healthcare; it needs access, treatment and resources. Healthcare deserves to be talked about so that it can continue to be improved.
America has a population of over 300 million people, a GDP per capita of over $50,000 and spends 17.6 percent of its total GDP on healthcare – more than any other nation. Cuba is home to just 11 million people, only slightly larger than New York City. It has a GDP per capita of about $10,000. For every $20 that the U.S. spends per capita on health, Cuba only spends about $1.
But we have comparable age structures and life expectancies. Birth rates in both countries are significantly lower than the world average. Infant mortality rates are even closer – Cuba has the 33rd lowest rate and the U.S. has the 34th.
To put that into perspective, New Jersey, one of America’s wealthiest and healthiest states, has a comparable population size to Cuba and spends over $1,000 more per capita on healthcare than the U.S. national average. Yet, the health outcomes are surprisingly similar. New Jersey’s life expectancy is only three years longer than Cuba’s and its infant mortality rate, in the lowest 15% of America, is still higher than the Caribbean country’s.
When it comes to public health, Cuba and the United States have a great deal in common despite our socioeconomic differences.
The question now becomes: What can we stand to learn from Cuba and what, in turn, can Cuba learn from us?
America’s public perception of Cuban relations is historically negative, but this new relationship provides both countries with an opportunity to collaborate for the first time since 1961. Collaboration, however, requires an open flow of both communication and information.
Regardless of personal or political beliefs, Cuba’s healthcare system is something we should be talking about because improving the quality, safety and effectiveness of the global healthcare structure is beneficial to all. Maybe we can learn from Cuba’s low-cost public health system and maybe they can learn something from our emerging health tech revolution.
As President Obama strives to foster a sense of friendship with Cuba, it is important to remember that this means an open dialogue between both nations. America needs to continue to discuss Cuba in order to understand what that friendship will mean for our country, exchange ideas on what healthcare can and should be and recognize opportunities to learn. After over half a century of silence, we can’t afford to sacrifice more.
To some, he was an icon; to others, he was an activist. Many even considered his views and positions rather outlandish during the 80’s.
The truth is Charles Everett Koop, who died on February 25, 2013, was a talented pediatric surgeon determined to make people’s lives better. This may be nothing new for a physician, but what made Dr. Koop unique was his ability to influence public opinion about an array of social and health issues, such as: smoking, HIV, homosexuality and sex education. In 1981, President Ronald Reagan appointed him to the post of surgeon general and, for the next seven years, Dr. Koop, with his navy blue uniform and trademark bushy white beard, was a man on a mission – to change public attitudes and policies about major health issues. Continue reading
Today’s Ragan’s Health Care Communication News features an insightful article from our D.C. Managing Director, Anne Woodbury, that spotlights the power of finding champions in Congress who have a personal connection to your issue. Woodbury touches on some historic examples of Congressional leaders whose personal health care experiences inspired their strong advocacy on specific health issues. She also shares some of the stories we found while researching the backgrounds of new members of Congress in the FRESHMAN HEALTHBOOK. Check it out here.
Happy New Year from all of us at TogoRun! We wanted to start the year off with a fresh look at the stakeholders who will be driving much of the health policy work in Washington, DC. Yesterday, Congress swore in the 113th Congressional Freshman Class. Simultaneously, TogoRun released our powerful new resource: THE FRESHMAN HEALTHBOOK. We’ve heard that this resource is already proving to be an excellent tool for our clients, the media and the broader health care advocacy community.
THE FRESHMAN HEALTHBOOK examines each new member’s health care-specific background and identifies his/her positions on key health care issues, such as the Patient Protection and Affordable Care Act (ACA), medical innovation, children’s health, mental health, Medicare, physician reimbursement, reproductive rights and veterans’ health. Each member’s profile offers insights and perspectives that may help advocates find common ground for engagement.