In The News

Congress Passes 21st Century Cures Act, Bringing Forth New Era for Biomedical Innovation

December 7, 2016 

WASHINGTON, DC — FasterCures, a center of the Milken Institute, commends the U.S. Senate on today’s strong, bipartisan support of the 21st Century Cures Act (H.R. 34), which passed the Senate on a 94-5 vote, matching the U.S. House of Representatives’ vote of 392-26 on Nov. 30. The bill will now be sent to the White House. In last Saturday’s weekly address, President Barack Obama said that he would sign the bill into law as soon as it reaches his desk, enacting $4.8 billion of new funding for the National Institutes of Health (NIH) and $500 million for the Food and Drug Administration (FDA), as well as a comprehensive suite of policy provisions that will strengthen the entire biomedical innovation system.

“This landmark legislation will accelerate cures for many life-threatening diseases and help advance precision medicine,” said Michael Milken, chairman of the Milken Institute. “It assures patient-focused drug development, adds rigor to clinical trials, expands compassionate use of new drugs by dying patients, speeds the review of vaccines, addresses antibiotic resistance, responds to the opioid crisis and strengthens the nation’s research infrastructure.”

FasterCures has been honored to work with leaders in Congress, NIH and FDA throughout the bill’s journey. This is the culmination of more than two years of hard work and dedication by the bill’s bipartisan congressional champions and their staffs. House Energy and Commerce Committee Chairman Fred Upton and Representative Diana DeGette, with Ranking Member Frank Pallone, reached out to stakeholders throughout the medical research system to gather up the best ideas and translate them into legislation. Senate Health, Education, Labor and Pensions Chairman Lamar Alexander and Ranking Member Patty Murray also championed the effort and moved a set of bipartisan bills through their committee.

As the bill moved toward votes on the floors of both chambers, strong commitment from Speaker Paul Ryan, Majority Leader Kevin McCarthy and Democratic Leader Nancy Pelosi, in partnership with their Senate colleagues, Majority Leader Mitch McConnell and Democratic Leader Harry Reid, resulted in the overwhelmingly bipartisan votes we’ve seen in the past few days. Improving the biomedical innovation system is truly something that all can agree on.

“The time for medical research progress is now. We are so pleased that Congress seized this opportunity and united around this strong legislation,” said Margaret Anderson, executive director of FasterCures. “This act will invest in and strengthen the federal research system, which will support the United States’ long-standing tradition of scientific progress and hopefully spur advances for the many patients who are desperately waiting for effective treatments and cures.”

The 21st Century Cures legislation addresses the entire biomedical innovation system, and would support many of the recommendations from FasterCures’ Rx for Innovation project. Here are just a few examples from this comprehensive legislation:

  • Enhances patient centricity in biomedical product development and regulatory approval.
  • Bans efforts to block data sharing between health information systems, and provides the Department of Health and Human Services the authority to levy civil penalties against offenders.
  • Reforms FDA hiring authorities to fill the agency’s vacancies by enabling it to compete more effectively with industry to hire and retain the best and brightest experts to review medical product applications.
  • Expands the translational work done by the NIH’s National Center for Advancing Translational Sciences.
  • Catalyzes innovation in clinical trials and regulatory approval, without diminishing FDA’s authority to determine what constitutes a safe and effective medical product.

The new funding for NIH will provide $1.5 billion for the Precision Medicine Initiative, $1.8 billion for the Beau Biden Cancer Moonshot and $1.5 billion for the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative. All of these initiatives have the potential to significantly advance our understanding of disease and identify opportunities for new therapies.

FasterCures looks forward to working with Congress, the Obama administration and the incoming Trump administration to help implement the 21st Century Cures Act, realizing its promise to support scientific breakthroughs, translate those discoveries into medical products and deliver those treatments and cures to the patients who need them. There are approximately 10,000 diseases and 500 treatments; even with today’s vote, we still have work to do.

New From AHRQ - Be Prepared to be Engaged: A Patient-Based Intervention Strategy for Primary Care

Patients and their families who arrive well-prepared to primary care visits are more likely to have important questions and concerns addressed by their health care team. Evidence suggests that engaging patients and families in discussions about their care leads to significant improvements in patient safety, care quality and patient experience. AHRQ’s new Be Prepared to be Engaged strategy, part of the agency’s Guide to Improving Patient Safety in Primary Care Settings by Engaging Patients and Families, features strategies for patients to prepare for primary care visits and improve the likelihood of leaving their visit with an understanding of their diagnosis and care plan, all of which can improve patient safety.

AHRQ Funding Opportunity:  Developing Measures of Shared Decision Making (R01)

A new funding opportunity announcement from AHRQ solicits applications for research projects to develop, test and evaluate measures of shared decision making for research conducted in clinical settings. Shared decision making is a collaborative process in which patients and members of their clinical team make health care decisions that are informed by scientific evidence as well as patients’ values and preferences. Each project is expected to produce valid and reliable measures of shared decision making, along with instructions for implementing the measures, as well as documentation on the development, testing and evaluation of the measures. Maximum costs for each project are $500,000 per year and $1.5 million for entire project periods up to three years.

AHRQ Publications Summarize Evidence on Behavioral Programs for Types 1 & 2 Diabetes

New publications from AHRQ summarize the effectiveness of behavioral programs to supplement clinical care for people with type 1 and type 2 diabetes, conditions that affect about 29 million Americans. The publications, developed for clinicians and consumers, reflect findings of an AHRQ-funded systematic review that examined behavioral programs for diabetes self-management including patient education, dietary interventions and structured exercise or physical activity interventions. Findings show, for example, that people with type 1 diabetes who participated in behavioral programs had greater reductions in hemoglobin A1C levels at 6 months, but that more research is needed to know if reductions can be sustained for 12 months or longer. For people with type 2 diabetes, 11 or more hours of behavioral programs resulted in improvements in glycemic control. AHRQ’s new online publications for clinicians summarize the effectiveness of behavioral programs and indicate the strength of evidence behind the findings:

Summaries for patients are written in plain language:

Call (800) 358-9295 or email for printed versions of the patient publications.

New AHRQ Publications Summarize Evidence on Treating Low Back Pain

New evidence-based publications from AHRQ can help clinicians, patients and their families make informed decisions about treating low back pain, a condition that affects eight out of 10 people at least once in their lifetimes. Noninvasive Treatments for Low Back Pain: Current State of the Evidence is a clinician publication that summarizes the benefits and harms of noninvasive treatments for acute, subacute and chronic low back pain.

The publication summarizes findings in an AHRQ-funded systematic review that examined interventions including exercise, medications, acupuncture and superficial heat. The clinician publication also evaluates the strength of evidence for each finding. Also available is a new continuing education module based on the evidence review, as well as a plain-language publication for patients, Noninvasive Treatments for Low Back Pain – A Summary of the Research for Adults.

End-of-life care options for people with Alzheimer’s

Caring for someone in the final stage of life is always hard. It may be even harder when the person has Alzheimer’s disease.

Palliative care and hospice services provide care for a very ill person to keep him or her as comfortable and as pain-free as possible. Palliative care provides comfort care, along with any medical treatments a person might be receiving for a life-threatening illness. When a person is near the end of life, hospice care gives family members needed support and help with their grief, both before and after the person with Alzheimer’s dies.

What else can you do as a caregiver? Try making connections through senses like hearing, touch, or sight to bring comfort to the person with Alzheimer’s disease. Being touched or massaged and listening to music, “white” noise, or sounds from nature seem to soothe some people and lessen their agitation.

Learn more about end-of-life care and Alzheimer’s disease.

Final Recommendation Statement: Statin Use for the Primary Prevention of Cardiovascular Disease in Adults

The U.S. Preventive Services Task Force released today a final recommendation statement on statin use for the primary prevention of cardiovascular disease in adults. The Task Force found that statin use is beneficial for some people ages 40 to 75 years who are at increased risk for cardiovascular disease, but did not find enough evidence to recommend for or against statin use for people older than age 75 years. To view the recommendation and the evidence on which it is based, please go to The final recommendation statement can also be found in the November 13, 2016 online issue of JAMA.

Wyden Releases Report on Dangers of Underfunding Opioid Abuse

Earlier this year, Congress passed the Comprehensive Addiction and Recovery Act of 2016(CARA), but did not authorize funds for the policies it created. Shortly after that, the White House requested $920 million that would expand access to treatment in states as part of a larger effort to combat the opioid epidemic – Congress has not acted on that request.

Since passing CARA, Congressional Democrats have expressed concern surrounding the lack of funding to the policies the bill authorized. Senate Democrats, including Sen. Wyden, expressed frustration when only $7 million was provided in the legislation after efforts to produce an amendment that would deliver offsets to cover the full funding request.

On October 12, 2016, Senator Ron Wyden released a report that outlines the consequences of underfunding treatment for opioid addiction. According to Senator Wyden, “Congress’ approach to funding opioid addiction treatment is nothing short of legislative malpractice. There is bipartisan agreement that the opioid epidemic has to be confronted now. Yet, with dozens of Americans dying from an opioid overdose every day, Congress is breaking its promise to families around the country by not providing every resource available. The time for a ‘down payment’ has long passed.”

In his press release announcing the report, Senator Wyden referred to a study published by the Journal of American Medicine that showed nearly eighty percent of Americans suffering from opioid addiction are unable to access the treatment they need, especially in rural areas across the country.

Senator Wyden, who represents constituents in Oregon, stated,

“Sadly, Oregonians are no strangers to the human toll of drug use and addiction devastating families and communities. I’m extremely disheartened that Congress has closed up shop yet again without acting on its core promise to provide essential funding for proven opioid addiction treatment and prevention efforts. Until states receive real investments in these programs, Congress has failed its job. Families in Oregon and across the country deserve far better.”

Sen. Wyden’s report addresses two key challenges: (1) the lack of available treatment facilities and services across the country, and (2) the barriers patients face when treatment facilities or services are actually available. Additionally, the report details case studies in five states struggling with high rates of opioid addiction, including Wyden’s home state of Oregon, California, Ohio, Pennsylvania, and New Hampshire.

The report notes that “states are doing all they can to fight the epidemic, but as it stands now they do not have the money to build that capacity.” It then issues a call to action for Congress – “It is time for Congress to act. Every day Congress does not do so, another 78 people die waiting for someone to answer their call for help.”

According to Senator Wyden, if the requested funding were provided, it would help states like Oregon battle the opioid epidemic, by allowing them to establish additional treatment centers, to provide life-saving anti-overdose medication, and to train medical personnel to increase the number of those being treated.

The report includes appendices, which provide for a detailed breakdown of how much each state would receive under President Obama’s $920 million proposal; a justification of how the $920 million will be used, including eligible activities; and a summary of a Centers for Disease Control and Prevention (CDC) report, “Increases in Drug and Opioid Overdose Deaths – United States, 2000-2014”. At the end of the report is a lengthy list of footnotes, which provide additional reading for interested parties.

Pushing for additional federal money to go towards combating the opioid epidemic has been a top issue for Democrats in political office. When Congress comes back to work, and a new president elected, it is more likely than not this issue will rear its head once again.

Data Driven Enforcement - Risks of Open Payments and Medicare Part D Data

On Monday, November 14th, 2016, qordata is hosting a webinar on the topic, ‘Data Driven Enforcement – Risks of Open Payments and Medicare Part D Data’ at 11am CST. The webinar aims to provide a review of the cases against Insys Therapeutics Inc., and analyze the data that prosecutors used as part of the allegations against the manufacturer. The speakers of the webinar, Brian A. Dahl, Principal, Dahl Compliance Consulting LLC, and Mohammad Ovais, Founder & CEO, qordata, will also discuss the ways in which compliance teams can analyze publicly available Open Payments and Medicare Part D data to avoid risks of kickback violations.

The webinar hopes to provide attendees with a working knowledge of: how to analyze spend data from Open Payments and prescriptions from Medicare Part D to highlight certain high risk physicians, some key similarities in high risk physicians that compliance should be aware of and stay on top of, and information on how to reduce compliance risks within your organization.


The webinar will start with a review of the cases filed against Insys Therapeutics Inc., and how publicly available Open Payments and Medicare Part D was used by investigators to place allegations on the manufacturer. From there, the discussion will turn to the importance of and how manufacturers can evaluate their spend data prior to CMS submission and how high risk physicians can be identified using spend and prescription data.


Attendees of the webinar will get to hear from Brian A. Dahl, Principal, Dahl Compliance Consulting LLC, and Mohammad Ovais, Founder & CEO, qordata.


We encourage our readers to consider attending, as Chief Compliance Officers, Directors of Compliance, Managers of Compliance, Compliance Analysts, and Compliance Specialists, among others, have the potential to greatly benefit from this webinar. If you are interested in the webinar, you can register for free HERE.