Life Science Compliance Update

March 19, 2018

ACCME Announces New Collaboration with ABPath


The Accreditation Council for Continuing Medical Education (ACCME) and the American Board of Pathology (ABPath) are pleased to announce a new collaboration to simplify the integration of accredited continuing medical education (CME) and Continuous Certification (formerly referred to as Maintenance of Certification).

The ACCME and ABPath share a commitment to supporting pathologists’ continuing professional development and to improving pathologists’ performance and their care of patients. The collaboration is designed to expand the number and diversity of accredited CME activities that meet the ABPath’s Continuous Certification requirements and to streamline the process for accredited CME providers and ABPath diplomates. The ACCME and ABPath pursued this collaboration in response to the needs and requests of diplomates and of accredited CME providers that support pathologists’ lifelong learning and improvement.

The collaboration with ABPath continues the ACCME’s commitment to supporting the goals of Continuous Certification and Maintenance of Certification. The ACCME has also developed collaborations with the American Board of Anesthesiology (ABA), the American Board of Internal Medicine (ABIM), and the American Board of Pediatrics (ABP).

Under this collaboration, all accredited providers must clearly indicate to learners that the activity has been registered to offer credit in the ABPath Continuous Certification materials and brochures (not applicable to initial, save-the-date type activity announcements). The language shall note what type of credit is available (i.e., Lifelong Learning (Part II), Self-Assessment Module (SAM), and/or Improvement in Medical Practice (Part IV))and the number of credits.

All accredited CME providers in the ACCME System already use the Program and Activity Reporting System (PARS) to enter data about each of their CME activities. CME providers now have the option to also use PARS to register activities that began on or after January 1, 2018 for ABPath Continuous Certification. CME providers that choose to participate will use PARS to attest their activities’ compliance with ABPath Continuous Certification requirements. 

Comments from Leadership

“The ABPath is committed to a meaningful and relevant Continuous Certification program that demonstrates to the public and the profession that our diplomates are current in their medical knowledge and are continually striving to improve their practice and provide excellent patient care. Our partnership with ACCME and CME providers is another initiative to strengthen our Continuous Certification program and provide a service to our diplomates that facilitates their participation in the program, “ said Rebecca L. Johnson, MD, CEO, American Board of Pathology (ABPath). 

“We share a common mission with our colleagues at ABPath to facilitate the continuing professional development of physicians. We celebrate our collaboration because it will generate more opportunities for accredited CME providers to deliver relevant, effective, independent, practice-based education that counts for ABPath Continuous Certification. I look forward to working with ABPath, our community of accredited CME providers, and our community of diplomates to leverage the power of education to drive quality in our medical profession and improve care for the patients we all serve, said Graham McMahon, MD, MMSc, President and CEO, Accreditation Council for Continuing Medical Education (ACCME).

FDA announces Public Meeting on Evaluating Inclusion and Exclusion Criteria in Clinical Trials on April 16


On April 16 from 8:30am to 5pm, the FDA will be holding a public meeting entitled “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” The event is convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA. The purpose of the public meeting is to bring the stakeholder community together to discuss a variety of topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to facilitate the enrollment of a diverse patient population.


The public meeting will be held at the National Press Club, 529 14th St. NW, Washington, DC 20045. For additional travel and hotel information, please refer to the following website. There will also be a live webcast for those unable to attend the meeting in person. For further information, contact Dianne Paraoan at the FDA’s Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993, 301-796-2500,

Topics for discussion during this meeting include:

  • The risks and benefits of participation in clinical trials as well as potential regulatory, geographical, and socioeconomic barriers to participation.
  • The rationale for eligibility criteria in clinical trials, as well as the impact of exclusion criteria on the enrollment of populations, such as infants, children, pregnant and lactating women, elderly, individuals with advanced disease, and individuals with co-morbid conditions.
  • Alternative clinical trial designs that may increase enrollment of more diverse patient populations, while facilitating the collection of data to establish safety and effectiveness.
  • How appropriate patient populations can benefit from the results of trials that employ alternative designs.
  • How changes to eligibility criteria may impact the complexity and length of clinical trials, as well as the strength of data necessary to demonstrate safety and effectiveness.
  • Opportunities for using data from expanded access trials.



March 16, 2018

UnitedHealthcare Will Share Rebates with Patients


On March 6, 2018, UnitedHealthcare announced that beginning in 2019, the company will expand its pharmacy discounts to the seven million enrollees who are in fully insured commercial group plans at the point of sale for drugs, if a rebate is offered by the manufacturer.

The savings will apply to plan participants who are filling a prescription for a drug where the manufacturer provides a rebate. The savings from the rebates will be applied upfront, at the time of the sale, to ensure that patients are paying the lowest amount possible under their insurance plan. UHC notes that currently, rebates are used to keep premiums lower for the benefit of all insurance-holders, rather than be distributed to benefit individual consumers.

According to the press release, plan participants will be able to log into their online account through UnitedHealthcare to see what the discounted cost of their drug will be, which will show savings from the rebate. Not all drugs come with rebates that are paid to the health plan and it is likely that patients with high deductibles who buy drugs that carry large rebates will see the largest savings. Further, the amount of rebates can vary widely, with some drugs, like Humira and Enbrel that treat rheumatoid arthritis, being deeply discounted. Others, like medicines for rare conditions where there is no significant competition, have little to no rebates. 

“UnitedHealthcare is uniquely positioned to deliver new value and clarity to health care, and pharmacy benefits in particular,” said Dan Schumacher, president and chief operating officer, UnitedHealthcare. “Our differentiated pharmacy model, powered by OptumRx, is delivering solutions that lead to better health outcomes and make prescription drugs more affordable.”

“People use their pharmacy benefit more frequently than any other type of benefit, which means pharmacy provides the greatest opportunity for us to understand and meet their needs,” said Schumacher. “We believe our efforts to enhance value for our customers will not only benefit our members, but the health care system as a whole.”

This new plan by UHC addresses a central element of the United States Department of Health and Human Services (HHS) plan to lower prescription drug prices – an element that calls for insurers to directly share rebates with members.

HHS Secretary Alex Azar issued a statement in response to UnitedHealthcare’s announcement that they would begin to share manufacturer rebates and discounts with patients at the pharmacy. In his statement, he said,

“Today’s announcement by UnitedHealthcare is a prime example of the type of movement toward transparency and lower drug prices for millions of patients that the Trump Administration is championing. Empowering patients and providers with the information and control to put them in the driver’s seat is a key part of our strategy at the Department of Health and Human Services to bring down the price of drugs and make healthcare more affordable. We are already seeing clear momentum toward the type of innovation in the private-sector that will be an important part of the value-based transformation that is coming to America’s healthcare system.”


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