Life Science Compliance Update

May 04, 2018

ACCME Adopts New Strategic Plan

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Recently, the Accreditation Council for Continuing Medical Education (ACCME) held its March meetings with its Board of Directors, during which the Board adopted a new strategic plan. The new strategic plan discusses the ACCME’s goals to drive transformation in the learning environment, support the continuing medical education (CME) community, and simplify and align regulatory systems.

The Board ratified 57 accreditations, including 22 CME providers achieving Accreditation with Commendation and 26 providers achieving Accreditation. Of the 26 achieving Accreditation, fourteen need to submit progress reports. In addition, two initial applicants achieved Provisional Accreditation while three initial applicants did not. In addition the Board ratified 14 progress report decisions, including 11 CME providers demonstrating compliance with all the requirements previously found in noncompliance and three CME providers not yet demonstrating compliance with all requirements. Currently, there are 1,770 providers in the ACCME system, including ACCME-accredited, state-accredited, and jointly accredited providers.

Strategic Plan

In creating the strategic plan, the ACCME Board of Directors, executive leadership, and ACCME staff, worked together in a strategic planning process. The groups reviewed the ACCME’s trajectory, identified opportunities and challenges, and interviewed stakeholders to gain their insights and perspectives. The new strategic plan comprises six priority areas: Augment Awareness of CME’s Value; Assure Accreditation Quality and Equivalency; Accelerate the Evolution of CME; Assist CME Educators; Advance Data Systems; and Advocate for CME Scholarship.

Augment Awareness of CME’s Value

Leaders at healthcare institutions, professional societies, and other health-related organizations have the capacity to inspire staff and members to engage in professional development, and to infuse their environments with a positive culture of learning that promotes interprofessionalism. The ACCME aims to encourage leaders to recognize that educational programs can create intellectual fulfillment and restore joy in practice; relieve clinicians of administrative burden through simplification, alignment, and collaboration; create and sustain functional interprofessional teams that learn together and take care of each other; and facilitate meaningful improvements in the quality and safety of patient care.

Assure Accreditation Quality and Equivalency

ACCME Accreditation standards ensure that CME continues to be high-quality, effective, independent, free of commercial bias, and based on valid content. The ACCME accreditation system is recognized as a national model by federal and state government agencies, other healthcare accrediting bodies, and the profession of medicine. It is important that the ACCME and its Recognized Accreditors regulate and accredit appropriately to meet the expectations of the profession and stakeholders.

Accelerate the Evolution of CME

Healthcare is continuing to evolve, and therefore, the educational system to support practitioners must also evolve. The advancements in educational technology such as adaptive e-learning and simulation create new opportunities to design ever more effective and efficient educational programs. The ACCME’s commendation criteria are designed to help providers evolve their educational strategy and build their capacity to create longitudinal relationships with learners that meet their needs as individual clinicians, and as members of teams, institutions, and communities.

Assist CME Educators

The CME community is made up of educators and administrators who are developing, implementing, measuring, and sharing effective practices in the development of learning, skills, and attitudes that support the delivery of high-quality care. These professionals and volunteers need their own support system and ability to learn from and with each other, so they can efficiently adopt and implement effective practices. The ACCME aims to identify, publicize, and promote effective practices for developing, implementing and measuring offerings that support learners in delivering high-quality care.

Advance Data Systems

ACCME plans to develop and promote a data system that supports and is accepted by all who are involved in developing and implementing continuing professional development (CPD) systems. Given access to their own data, learners can use it to reflect on their learning, and share it with credentialers, certification boards, licensing authorities, and others. Such a data system would also support greater engagement in the CPD system, build more self-awareness, help clinicians find and choose activities that fit their specific needs, facilitate self-reflection and the construction of an individualized educational plan, and serve as a powerful repository for generating and answering research questions.

Advocate for CME Scholarship

The last priority pillar in the strategic plan is to develop and promote strategies that encourage providers and learners to engage in scholarship and support research that can lead to improved educational programs. There is significant opportunity for growth in the area of CME research. The ACCME has already embraced research by including it as a component of the commendation criteria, and they continuously seek strategies that will encourage providers to engage in scholarship and sharing, and promote the willingness of clinicians to allow their data to be used for scholarly pursuits.

Conclusion

The Board meeting and new strategic plan continue ACCME’s promise to continue to promote the development of high-quality CME that provides immediate and long-term benefits to society and fulfill the responsibility to maintain the highest standards of integrity and transparency.

May 03, 2018

Maine Passes Drug Transparency Law – A Study

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We try to keep our readers in the loop with transparency and other related legislation that are happening throughout the country. On May 1, 2018, the governor of Maine, Paul LePage, allowed legislation to pass into law without his signature that: (1) authorizes a study to review and overview drug prices and (2) has implications for top 25 drugs of different types.

As noted in our previous article on the legislation, the Maine Data Health Data Organization now will be required to provide a report containing the following information about brand name and generic drugs by December 1, 2018, and annually thereafter: the 25 most frequently prescribed drugs in Maine; the 25 costliest drugs as determined by the total amount spent on those drugs in the state; and the 25 drugs with the highest year-over-year cost increases as determined by the total amount spent on those drugs by the state.

The Report

One interesting piece of the legislation that we have not previously noted is that the legislature, and Governor LePage by allowing the bill to go into law, are paying the Maine Health Data Organization $25,000.00 for an initial investment of the report and plan.

As outlined in the legislation, the Maine Health Data Organization (MHDO) will be responsible for developing a plan to collect data from manufacturers related to the cost and pricing of prescription drugs in order to provide transparency in and accountability for prescription drug pricing.

MHDO also shall consult with other state and national agencies and organizations to determine how to institute such data collection. The organization shall submit the plan, its findings and any recommendations for suggested legislation to the Legislature no later than April 1, 2019.

The joint standing committee of the Legislature that has jurisdiction over judiciary matters may report out legislation related to prescription drug price transparency and MHDO’s findings and recommendations to either the First or Second Regular Session of the 129th Legislature.

The initial investment is a “one-time allocation” to allow the MHDO to “collect and present certain data to the Legislature and to develop a plan for further data collection.” Such verbiage makes it seem as though this $25,000.00 will be enough for year one, but it is almost impossible to say if that amount will be enough for future collection years, or if after one year the MHDO will come back and request more or less money to achieve the goals set forth by the legislation.

May 02, 2018

SCOTUS Denies Review of J&J Case

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On Monday, April 16, 2018, the United States Supreme Court denied a request by Johnson & Johnson to review a whistleblower case against the company’s subsidiary, DePuy Orthopaedics, Inc.. Johnson & Johnson requested that the high court review a July ruling by the First Circuit Court of Appeals that revived a whistleblower lawsuit against the company.

The lawsuit was filed by British orthopedic surgeons – Antoni Nargol and David Langton – who alleged that DePuy marketed defective metal-on-metal Pinnacle-branded hip implant devices to doctors who then turned around and sought government reimbursement for the products. Nargol and Langton had previously implanted the Pinnacle devices in patients and have served as expert witnesses in product liability cases against DePuy.

In 2012, Nargol and Langton filed a False Claims Act suit alleging that the company made false statements to the Food and Drug Administration (FDA) about the safety of the Pinnacle devices. They also accused DePuy of dumping latently defective devices on doctors, who would then unknowingly submit claims for reimbursement to Medicare and Medicaid for the flawed products.

DePuy’s lawyers had argued that the First Circuit wrongly overturned the decision that dismissed the case because the doctors had not alleged any specific false claims for payment were submitted in violation of the False Claims Act. The First Circuit determined that the lawsuit was sufficient with the simply fact that DePuy allegedly caused doctors to submit false claims for reimbursement to the federal government and New York state.

DePuy wanted the Supreme Court to review the case because it has now created a circuit split about with what particularity a whistleblower’s complaint must state the false claims for reimbursement were submitted to the government for payment. DePuy, through its lawyers, noted that five circuits require specificity, including dates and amounts of false claims, while six circuits take a more relaxed approach, allowing the complaints to simply show “reliable indicia” that the false claims were submitted.

The Pinnacle hip implant devices are no longer sold but continue to be the subject of many product liability lawsuits. Two federal trials resulted in verdicts totaling well over $500 million after post-trial reductions for the product.

Justice Samuel Alito took no part in considering the petition by the company, as financial disclosure documents show he holds Johnson & Johnson stock.

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