Frances-Ann Moran
Executive Director, Compliance & Training Practice, Life Compliance Solutions, LLC
Partner at Life & Moran, LP

And

Kim Life
Executive Director, Life Sciences Practice, Life Compliance Solutions, LLC
Partner at Life & Moran, LP

The United States is leading the way toward increased transparency by life sciences companies and healthcare organizations. In recent years, six states have enacted legislation that requires certain life sciences companies to report details related to financial interactions with healthcare professionals and healthcare organizations. Some states have also imposed spend limits, constraints around such activities as in-office meals, and detailer registration and education requirements.

Then, in March 2010, President Obama signed the Patient Protection and Affordable Care Act (“PPACA”). Section 6002 of the PPACA embodies the Physician Payments Sunshine Act (“Sunshine Act”). This legislation, co-sponsored by Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI), requires drug, device, biologic, and medical supply companies to report a wide range of payments to physicians and teaching hospitals in all states. The first report is due March 31, 2013; it will cover data for the fiscal year 2012.

The Department of Justice’s Office of the Attorney General, FDA officials, and officials at the Office of the Inspector General of the Department of Health and Human Services have publically stated their goals for more investigations, higher fines, larger judgments, and longer sentences. Investigations, indictments, and penalties are increasing – they are doing what they say they would be doing.

Seven healthcare companies are already reporting healthcare professional spend data under settlement agreements with the government. Their data, analyzed and uploaded into a searchable database by ProPublica, a Pulitzer Prize winning news organization, and their media partners, has been the subject of a viral response. Companies, healthcare professionals, and patients alike have been shocked and embarrassed by some of the reports stemming from the data the companies disclosed.

The publication of spend data in 2013 under the Sunshine Act will only increase public and governmental scrutiny. In light of the furor created by the ProPublica disclosure, Massachusetts’ recently released spend data, and revitalized and energetic government investigation, life sciences companies are re-evaluating their technical and information requirements.

In-house compliance professionals are teaming with their learning and education colleagues to develop effective training that meets both the legal requirements and the company’s cultural requirements.

How this Impacts Your Existing Training Programs and Strategies

Life science companies need to take a fresh look at the content of their training programs, as well as the way compliance is trained in general. The government’s aggressive pursuit of civil and criminal cases against companies and employees in the industry, and the facts and circumstances of the big ticket cases to date, require a new approach.

Compliance professionals and their commercial colleagues realize that a few slides, charts, and frequently asked questions about the rules are not enough. The goal of any corporate education program (whether compliance or general operations focused) should be to change behavior for the betterment of the individual and the organization.

To achieve a truly effective learning program, the learning solution should be approached through these four steps:

  1. Clarifying and documenting the end goals in clear and simple language
  2. Identifying the knowledge required to meet these goals
  3. Identifying what you want the participants to do that they do not do now
  4. Identifying what you want them to absorb as part of their world view of the business and their role within it

The primary purpose of a robust corporate training program is not merely to prevent events that lead to fines and penalties. All training programs should strive to improve the business and its stakeholders to improve the bottom line. Yet this very principle is what many compliance training programs have left behind.

The new and existing federal and state transparency and disclosure legislation, and the crack-downs on fraud and abuse cases, give corporate training departments the motivation to boost their compliance training strategies with a healthy dose of commercial perspective. As companies work diligently and thoughtfully to build effective compliance systems and processes to comply and reduce risk, they should also take note of opportunities to develop and strengthen strategic relationships through the new compliance procedures.

Where Compliance Meets, Supports, and Improves Commercial

Undoubtedly, field employees and representatives will face questions and demands concerning the risks that healthcare professionals face in their relationship with the company; policy changes from the company, associations, institutions, and facilities; and fears of public and peer perceptions.  Also, Key Opinion Leader consultants must be prepared to explain the interpretations, policies, and procedures put in place by the company that have been designed to protect patients and the reputation of the consultant healthcare professional.

To successfully navigate the new field challenges and retain important relationships, training must go beyond charts and FAQ lists. Effective training must create a tangible understanding of the interpretations and processes that are designed to protect patients, the employer, and the healthcare professional under the new legislation. Training participants should be able to use their understanding to bolster the company’s objectives in other corporate programs – such as clinical research and healthcare professional education programs.

Training participants will be prepared to perform their tasks compliantly, and enhance and strengthen relationships, if they leave training:

  1. Believing in the importance and integrity of the employer’s compliance goals and programs;
  2. Understanding how their actions drive the process, and how the process may impact the healthcare professional, and why;
  3. With the ability to effectively communicate these new understandings to healthcare professionals and other stakeholders in the field.