Life Science Compliance Update

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15 posts from March 2018

March 20, 2018

Prime Therapeutics Proves PBMs’ Value


On February 20, 2018, Prime Therapeutics issued a press release that highlighted the way it – as a leading pharmacy benefit manager – has helped save its clients billions of dollars. The 2017 drug trend reports noted that its clients saw overall expenditure reductions (per member, per month) across all three lines of business (commercial, Medicare, Medicaid) as compared to 2016. Additionally, corresponding annual savings delivered to clients in 2017 exceeded $3 billion across all three lines of business.

“Our outstanding 2017 drug trend results are hard won, especially as we continue to see ongoing and significant price increases for medicines in some of the most expensive disease categories,” said Jim DuCharme, Prime’s president and CEO. “These outcomes require many dedicated employees working tirelessly on behalf of our clients and their members to deliver optimal care and prescription drugs at the lowest net cost. Our close alignment with 22 Blue plan clients – 18 of whom are owners – allows us to see the complete pharmacy and medical drug picture to help us drive total cost of care outcomes.”

While specialty medicines continue to exert upward pressure across commercial and Medicare part D clients, Prime was able to offset those spending pressures by delivering substantial savings in other areas, including:

  • Negotiated discounts – In 2017, Prime secured substantial discounts including competitive rebates and more than $1 billion from pharmacy MAC pricing, illustrating the important role generics play in controlling drug costs. Client adoption of Walgreens-anchored networks also exerted downward pressure on trend. Incremental negotiated savings exceeded $1.9 billion.
  • Utilization management – Prime’s efforts to promote appropriate use of medicines approached $2.3 billion in total savings across all three lines of business.
  • Pain medication management – Prime is particularly proud of our efforts in managing controlled substances such as opioids. Not only has Prime decreased pain medicine expenditures across all three lines of business (-14.6 percent in commercial, -12.2 percent in Medicare and -9.8 percent in Medicaid), but these results build on Prime’s controlled substance successes over the past five years. These successes include decreasing by 71 percent the number of commercial members who were at high-risk for misuse* and reducing their health care costs by $1,500 PMPY.  

“While we’re thrilled drug expenditures for our clients declined in 2017, this doesn’t mean drug costs no longer present a challenge,” said David Lassen, chief clinical officer at Prime. “Low trend is not synonymous with low cost. Prescription drugs still represent 20 to 30 percent of costs for our health plans and employers. And out of the 46 drugs the FDA approved in 2017, eight of them drove commercial trend by about 1 percent, at an average price tag of $96,000 annually.”

“PBMs play a crucial role in counterbalancing upward forces in drug spending,” DuCharme concluded. “Without our active and assertive efforts to help drive clinically appropriate use and lowest net cost, spending on prescription drugs would be much higher. We’re proud to stand alongside our clients in this important work, helping people get the medicine they need to feel better and live well.”

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.




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