Life Science Compliance Update

April 25, 2017

AMA Releases Satisfaction and Stress Survey Results of Physicians

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At the end of March 2017, the American Medical Association (AMA) released survey findings that explored the experiences, perceptions, and challenges that are currently facing physicians in the current healthcare environment.

1,200 physicians, residents, and medical students (400 of each) participated in the online survey, which when respondents knew they would become physicians, who encouraged them down that path, what challenges they face professionally, and whether they are satisfied with their career choice.

According to the survey, nine in ten physicians are satisfied with their career choice, despite challenges common to each career stage. Three quarters of medical students, residents, and physicians said that helping people is a top motivator for pursuing their career and sixty-one percent of all respondents said they would encourage others to enter the field of medicine. Personal experiences as a patient, volunteer, and with family members played a role – across career stages – in realizing one’s calling to practice medicine. Additionally, seventy-three percent of respondents knew before they reached the age of twenty and/or graduated college that they wanted to be physicians, and nearly a third knew before by the age of twelve.

“Physicians may be discouraged at times, but almost every single one of us remains confident in our decision to enter medicine and continues to be driven by our desire to help our patients,” said Andrew W. Gurman, M.D., AMA president. “As an organization, the AMA is constantly striving to deliver resources that empower physicians to maximize time with their patients and help them succeed at every stage of their medical lives. Understanding the challenges physicians face, as well as their motivations for continuing on, is critical to fulfilling that mission.”

The AMA survey, which was conducted in February 2017, found administrative burden, stress, and lack of time were among the top three challenges of respondents. For residents, however, long hours and on-call schedules were also among their top challenges. More than half of students – fifty-three percent – indicated that stress was one of their top three challenges.

Despite these challenges, only thirteen percent of all respondents indicated they had regularly questioned their decision to practice medicine – and more than half of those cited burnout as their top reason for questioning.

These survey findings are released as the AMA launches a comprehensive brand initiative that strives to demonstrate to physicians, residents and medical students the many ways the AMA listens, supports and empowers them to succeed throughout their unique journeys with timely and relevant resources.

The brand initiative is expected to reach physicians through print, digital and social media platforms. It is intended to recognize and celebrate the core reasons that physicians choose the profession while also highlighting the broad array of initiatives and resources the AMA provides in support of physicians.

April 24, 2017

ACR Announces Health Policy Priorities

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On March 31, 2017, the American College of Rheumatology announced its 2017 health policy priorities, providing detailed policy recommendations to improve access to care and treatments for the millions of Americans living with arthritis and other rheumatologic diseases. 

The policy prescriptions come in the wake of a new Centers for Disease Control and Prevention report showing arthritis prevalence is at an all-time high. According to the report, roughly fifty-four million Americans – one in four people – now live with arthritis, and they estimate that approximately seventy-nine million Americans will have arthritis by the year 2040.

“As the alarming CDC data indicates, now more than ever we need policies that ensure the one-quarter of Americans living with arthritis can access and afford specialized care,” said Sharad Lakhanpal, MD, MBBS, President of the American College of Rheumatology.

While the demand for arthritis care is growing, the pool of U.S. rheumatologists – doctors who provide specialized care to Americans living with arthritis and other rheumatologic diseases – is shrinking as more rheumatologists retire from the profession and fewer new doctors enter the rheumatology subspecialty. According to the ACR’s 2015 workforce study, the demand for rheumatology care exceeded the supply by 36 percent for adult rheumatologists and 33 percent for pediatric rheumatologists in 2015 – a gap that is projected to widen to 138 percent and 61 percent respectively by 2030.

The ACR’s policy priorities for 2017 include actions that Congressional and Administration leaders can take to ensure a thriving rheumatology workforce, as well as to address current healthcare access and affordability issues.

The ACR’s policy priorities for 2017 include:

  • Healthcare reform legislation that prioritizes affordable coverage for chronically ill patients, including coverage for Americans with pre-existing conditions, limits on out-of-pocket costs, and tax credits based on income. 
  • Repeal of the Independent Payment Advisory Board, an agency created under the Affordable Care Act (ACA) that has the power to impose arbitrary payment cuts on medical providers. These cuts would disproportionately impact small and rural rheumatology practices already struggling to stay financially viable.
  • Appropriate MACRA implementation, including optimizing the Merit-Based Incentive Payment System for rheumatology care and supporting a rheumatology-inclusive Alternative Payment Model.
  • Proper valuing of cognitive specialty care, including new ICD-10 service codes that more adequately reflect rheumatology care in reimbursement.
  • Adequate funding for FDA biosimilars review, to ensure the introduction of additional safe and effective therapies and lower biologic drug costs. 
  • Limits on overly restrictive insurance practices, including step therapy, prior authorization and specialty drug tiers.
  • Adequate insurance coverage for biologic therapies, including coverage of administration for complex drugs, and Medicare coverage of reimbursement at true ASP+6%.
  • Increased medical research funding for rheumatic diseases, including arthritis medical research funded by the National Institutes of Health, Centers for Disease Control and Prevention, and Department of Defense.
  • Interventions to address the rheumatology workforce shortage, including Medicare funding for general Medical Education, funding for additional rheumatology fellowship positions, and support for the Pediatric Subspecialty Loan Repayment Program.

“We look forward to working with Congressional leaders and the Administration to advance policies that ensure access to high-quality, specialized care for the 54 million Americans living with chronic and debilitating rheumatologic diseases,” concluded Lakhanpal.

You can find the full text of the ACR 2017 Health Policy Statements here.

March 06, 2017

ASCO Removes Restrictions on Researchers’ Conflict of Interest

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The American Society of Clinical Oncology (ASCO) has removed all restrictions on author relationships previously in the 2013 Policy for Relationships with Companies statement, and all eligible manuscripts and abstracts otherwise will be considered for peer review, regardless of any financial relationships of authors. The decision was announced in the Journal of Clinical Oncology, the official journal of ASCO, in January 2017.

The 2013 policy restricted publication and presentation of research in certain ASCO forums, making abstracts and articles describing company-funded original research to be ineligible for consideration if the first, last, or corresponding author had been a company employee, investor, or paid speaker during the previous two years. ASCO felt that since they are a “leading source of cancer information worldwide,” and therefore, they “have a responsibility to ensure that important new information is disseminated to our members and the larger cancer community.”

The policy prompted researchers to voice their concerns of barring “ASCO members and highly qualified scientists from presenting their important original research to the oncology community in a setting where the work could be critically reviewed and discussed.” Following the outpour of such concerns, the restrictions were placed on hold and ASCO collected data for the following two years on the relationships of authors who submitted manuscripts or abstracts.

The collected data showed that potentially restricted submissions amounted to less than two percent of accepted journal articles, and roughly eleven percent of accepted meeting abstracts. The largest number of the abstracts related to developmental therapeutics and tumor biology, and a majority of them were accepted for poster presentation or publication. Turning to the remaining small number of abstracts accepted for oral presentation, ASCO examined the existing conflict of interest management strategies that the organization employs, such as slide review and live audit, when a heightened risk of bias is identified through disclosure.

Chief Medical Officer of ASCO, Richard L. Schilsky, MD, along with his ASCO colleagues, finally decided, “We have reached the conclusion that continued disclosure of commercial relationships, rigorous peer review, and management of potential conflicts of interest for all work submitted to ASCO best support our goals of trust and transparency and providing value to our members as a source for scientifically sound and unbiased original research.”

“ASCO continues to support universal and accessible disclosure of financial relationships with companies by authors, speakers, reviewers and participants in ASCO activities,” Schilsky and colleagues wrote. “ASCO welcomes further research and engagement with audiences on the most effective ways of communicating and managing disclosure information and on the impact of conflict of interest policies on scientific discourse.”

ASCO notes that it is important to point out that the ASCO policy continues to meet (or exceed) standards for accredited continuing medical education providers developed by the Accreditation Council for Continuing Medical Education Standards for Commercial Support as well as the standards for other interactions with companies described in the Council of Medical Specialty Societies Code for Interactions with Companies. Thus, eliminating author restrictions on submissions does not remove the prohibition on some company employees as speakers at ASCO meetings where accredited continuing medical education is offered.

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