SKILLS FOR SUCCESS

July/August 2006

Compliance and Communications Skills Needed Now More than Ever

Ilyssa Levins
President, HCIL Consulting

Healthcare professionals must remain hyper-focused on regulatory compliance and patient compliance to improve the industry’s reputation and enhance disease outcomes.

Regulatory Compliance
Today’s environment is infinitely more complex than it was just a few years ago because of new guidelines from the Pharmaceutical Research and Manufacturers of America (PhRMA), the Accreditation Council for Continuing Medical Education (ACCME), and the FDA. Additionally, the Office of the Inspector General (OIG) in the Department of Health and Human Services and the Department of Justice (DOJ) have become important overseers because they can impose monstrous fines on companies for their promotional practices. Medicare Part D further heightens scrutiny because the government is now a much bigger source of revenue for the industry. Companies cannot afford to pay the price for regulatory noncompliance, which can include not just monetary penalties, but also criminal prosecution, corporate integrity agreements, negative media attention, loss of business, damage to product reputation and very high legal fees.
That’s why we all need to know and apply the basics:

  • Establish a Culture of Compliance: Senior management commitment is needed for prevention, detection, and resolution of regulatory compliance problems. Internal protocols must be funded to assure that there is an infrastructure for proper regulatory and legal review of all programs.
  • Invest in Compliance Education: Today the cost of doing business must include a line item for compliance training, in order for all staff to become schooled on the fundamentals. Management must take additional time to further expand its own level of knowledge.
  • Align Regulatory Departments and Service Organizations: There has never been a better time to forge close working partnerships among company regulatory professionals, other internal functions and external agencies and consultants. This can be accomplished through facilitated alignment meetings that foster a dialogue between all parties.
  • Certify Agencies: Agencies need to stay current on regulatory issues since our business conduct and communications are more regulated than other industries. Standards for compliance certification could quickly become a mandatory criterion for agency selection by pharmaceutical companies.

“Agencies that represent drugs or devices must protect their client’s reputation, and that means preventing the likelihood of any regulatory violations,” says Lynn O’Connor Vos, President and CEO, Grey Healthcare Group and 2005 HBA Woman of the Year. “Compliance know-how is clearly an important step for agencies to take as they help restore trust in the pharmaceutical industry.”

Patient compliance
In its landmark 2001 publication, the Institute of Medicine declared that there is a chasm between the healthcare we have, and the care we could have. Why are patients getting sub-optimal outcomes? One major reason, cited by the World Health Organization, is non-adherence to medication: more than 50% of patients do not take their medications properly. Unfortunately, patients don’t receive the support they need to manage their conditions. For example, 42% of people with diabetes report that they were never advised—or are still confused—about how to manage their disease.

The results? Patients face loss of life and medical complications. Physicians are frustrated by poor patient outcomes. Payers (employers and the government) bear increased costs. Pharmaceutical companies lose sales and profits due to poor adherence.

That’s why we need to learn how to execute patient-centered healthcare, according to Maryann Kuzel, an expert in this emerging area. She advises:

  • Improve the patient-physician dialogue: Educate physicians and nurses to engage the patient in a discussion of needs, goals and barriers.
  • Activate and motivate patients: Use behavior-change methods to persuade and motivate passive patients to come active participants in their health
  • Involve all stakeholders in ongoing support: Partner with employers, managed care organizations, patient advocacy groups and other stakeholders to support patients in between physician visits

It’s a challenging, yet exciting time for professionals in healthcare. Ensure your compliance skills stay sharp. The focus on regulations and patients can help to rebuild confidence in our industry’s immeasurable value at a critical time.