Life Science Compliance Update

December 02, 2016

New Report Demonstrates Effectiveness of IPCE

Report-writing

On April 20, 2016, the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) convened a Leadership Summit for Jointly Accredited Providers at the ACCME’s offices in Chicago.  

The goal of the summit was to provide an opportunity for jointly accredited providers – as leaders in the continuing healthcare education community – to work collaboratively to identify organizational models that are effective in promoting and improving interprofessional collaborative practice (IPCP) through interprofessional continuing education (IPCE) and to share success stories that demonstrate the impact of their educational efforts.

A new report, crafted based on the 2016 Joint Accreditation Leadership Summit, shows how IPCE contributes to improving healthcare team collaboration and patient care. The report includes best practices, challenges, case examples, key recommendations, and data about the value and impact of IPCE.

Report Highlights

Inclusive Team

IPCE builds team collaboration across multiple professions, from chaplains to community health workers – from physicians to psychologists – from safety experts to social workers. Additionally, teamwork takes a fundamental, on-going commitment to the principles of IPCE – the secret to collaboration is to actually collaborate.

Patient-Centered Teams

IPCE also creates a safe space where all learners, including patients, have a voice. Education that includes patients as planners, teachers, and learners, motivates powerful and lasting change. The report encouraged participants to ask: how is the structure helping patients? What professions affect patient outcomes? It is important to remember that the purpose and value of the program is to support the patient.

Cultural Care, Compassionate Value

By bringing together teams, IPCE effectively builds skills that are essential for improving care for patients and communities, such as cultural competency, compassionate values, and communications. The report notes that IPCE is a philosophy and that you “have to be a true believer, keep on living it, preaching it,” encouraging leaders to “infuse your enthusiasm into the program.”

Public Health Priorities

IPCE programs partner with institutions and communities to address quality, safety, and public health concerns such as sepsis, obesity, end-of-life care, heart disease, and cancer.

Recommendations

The report also included eight recommendations for creating and sustaining a successful ICPE program: develop buy-in from leadership; support your organization’s strategic mission; build your IPCE team and model best practices; involve patients; implement a phased-in approach; focus on quality; measure outcomes; and communicate the value of IPCE.

Videos

Along with the report a series of videos was released, which feature educators describing their goals and accomplishments, what brings them joy and pride in their work, and advice for creating IPCE programs.

Comments from Leadership

All three jointly accredited provider groups support the report, with each having a representative offer comments on the report.

“This report illustrates how jointly accredited providers are working every day to make a difference. These efforts have made, and will continue to make, a substantial difference to healthcare teams and the patients they serve. Interprofessional continuing education creates empowered teams that think courageously together, solve complex problems, and see the value of their own and their colleagues’ contributions. I encourage health system leaders and other stakeholders to recognize that an investment in education is an investment in people and to think about how they can leverage the power of education to support their community of clinicians and patients.”— Graham McMahon, MD, MMSc, President and CEO, ACCME

“We are not going to change the healthcare system unless professionals in practice learn from, about, and with each other and foster that learning in the students coming up behind them. This report shows the important work being done by jointly accredited providers and documents the benefits and outcomes of their work. As accreditors, it shows us what we need to do better to support that work going forward.”—Peter H. Vlasses, PharmD, DSc (Hon), BCPS, FCCP, Executive Director, ACPE

“As evidenced by this report, our community of continuing education providers has demonstrably improved collaborative care among healthcare professionals and patient outcomes. ANCC is so proud of the enthusiasm, commitment, and dedication that shines through in their examples. We hope that the stories and strategies provide both inspiration and practical tips for educators across the healthcare professions who are striving to benefit patients by building stronger teams.” — Kathy Chappell, PhD, RN, FNAP, FAAN, Senior Vice President, Certification/Measurement, Accreditation and Research, ANCC

December 01, 2016

Price, Verma Picked for Top Trump Cabinet Slots

Donald-J-Trump

Ever since the election, there has been much hubbub about who President-Elect Donald Trump will choose to fill important cabinet positions in his administration. Step by step, we are slowly seeing the Cabinet be put together. Recently, Mr. Trump announced his picks for the head of Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services (HHS).

Health and Human Services

Georgia Representative Tom Price, an orthopedic surgeon, has been tapped by Mr. Trump to take the helm as Secretary of Health and Human Services. One of the main refrains we heard from Mr. Trump throughout the campaign was that he would “repeal and replace” the Affordable Care Act (ACA). While many have made similar calls, not many have actually drafted, let alone introduced, alternatives with which to “replace” the ACA.

Dr. Price has introduced bills that have offered detailed, comprehensive replacement plans in every Congress since 2009, when Democrats started their work on the ACA. During a 2009 debate, Dr. Price discussed a “stifling and oppressive federal government,” and his concerns that the ACA and other laws interferes with the ability of patients and doctors to make medical decisions.

The Empowering Patients First Act, legislation introduced by Dr. Price, would repeal the Affordable Care Act and offer age-adjusted tax credits for the purchase of individual and family health insurance policies. The bill would also create incentives for people to contribute to health savings accounts; offer grants to states to subsidize insurance for high-risk populations; allow insurers licensed in one state to sell policies to residents of others; and authorize business and professional groups to provide coverage to members through association health plans.

According to Michael C. Burgess, a Representative from Texas, believes Mr. Trump made a good choice, noting that, “the practicing physician and the patient could not have a better friend in that office than Tom Price.”  

Centers for Medicare and Medicaid Services

Reuters announced Mr. Trump’s selection for the administrator of CMS, Seema Verma, an Indiana health policy consultant. Ms. Verma would bring with her experience in implementing the ACA, working across the aisle, and working with Vice President-elect Mike Pence. She was the architect of the Healthy Indiana Plan, Indiana’s coverage expansion for low-income individuals.

The Healthy Indiana Plan is an interesting plan, as it was designed to appeal to both political parties. HIP 2.0 asks covered patients to make a small monthly payment in order to access their health insurance. If they miss a payment, it can result in a six-month lockout from insurance coverage. While those provisions are not allowed under traditional Medicaid, Indiana received a federal waiver to implement them. Now, other Republican-led states have contacted Verma’s consulting firm to help submit their own Medicaid expansion proposals to the federal government, to include more conservative provisions.

If confirmed by the senate, Ms. Verma would likely grant even more latitude to states in crafting their Medicaid programs, similar to the latitude she worked to get for Indiana.

Dr. Price and Ms. Verma still have to be confirmed by the Senate before officially taking office, but one can make some assumptions about priorities of each individual, as well as the administration overall, given their history.  

November 30, 2016

21st Century Cures No Longer Includes Open Payments Exemption for Reprints, Textbooks and Non Promotional Education

Images

We previously wrote about the updated version of the 21st Century Cures bill – one that we, along with many others, thought would pass both the House and the Senate with minimal edits, if any. However, the new bill no longer includes a provision that would have exempted drug makers from disclosing non promotional continuing medical education (CME) payments to physicians, including text books and reprints.

The version of the bill released late last week would have allowed manufacturers to be exempt from reporting industry payments to physicians for textbooks, journal reprints, and for speaking at continual medical education events.

This change follows a speech by Senator Elizabeth Warren on Monday, where she described the exemption as covering up bribery. She relayed her belief, which is that drug companies have opted to “cozy up to enough people in Congress to pass this Cures bill that would let drug companies keep secret any splashy junkets or gifts associated with ‘medical education’ and make it harder for enforcement agencies to trace those bribes.”

The opposition to the exemption even crossed party lines, with Senator Chuck Grassley planning to “object to unanimous consent to take up the 21st Century Cures Bill in the Senate,” unless the reporting exemption was removed. As a reminder, Grassley was a co-author of the Physicians Payment Sunshine Act, which requires drug makers and medical device makers to disclose payments they make to physicians to a public database.

Grassley believes that the “Sunshine Act brings transparency to a big part of the health care system for public benefit. Transparency brings accountability wherever it’s applied. With taxpayers and patients paying billions of dollars for prescription drugs and medical devices, and prices exploding, disclosure of company payments to doctors makes more sense than ever.”

He further went on to say, “a lot of earlier payments to doctors were under the umbrella of Continuing Medical Education. We shouldn’t create a loophole that would let drug and medical device companies mask their payments to doctors under a payment category that’s too broad and could gut the spirit and the letter of the Sunshine Act."

Grassley, Warren, and other critics of the exemption have long complained that CME and textbooks have the ability to influence physicians to prescribe expensive brand-name drugs, and that transparency is undermined if drug and device companies are permitted to avoid reporting the value of such sessions and handouts.”

John Kamp, executive director of the Coalition for Healthcare Communication, however, expressed his disappointment at the removal of such a “reasonable provision that enables doctors to be fully informed about medicines.”

This is a disappointment but the vast majority of accredited CME still falls under an exemption for Open Payments reporting as long as the applicable manufacturer does not select or pay the covered recipient speaker directly, or provide the continuing education provider with a distinct, identifiable set of covered recipients to be considered as speakers for the continuing education program.   

Interestingly enough, the 21st Century Cures Act is one of the most lobbied healthcare bills in recent history, with almost 1500 lobbyists representing 420 companies, universities, and other organizations looking to influence the bill’s contents..

It was just last summer when more than 100 national and state medical societies backed a Senate bill to create the exemption, complaining of “onerous and burdensome reporting obligations…that have already chilled the dissemination of medical textbooks and peer-reviewed medical reprints and journals,” seeking to avoid “a similar negative impact” on CME.

The House is still expected to pass the bill on Wednesday, November 30, but only time will tell if it will pass with this most recent edit, and what other edits may be waiting in the wings.

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