Physician-Industry Collaboration: Organizational Considerations for the Future of Innovation and Growth in Dermatology

Abstract

The U.S. medical environment continues to evolve with issues from Privacy to EMR, Insurance regulations, Physician Access and Healthcare Reform, and MACRA (Medicare Access and CHIP Reauthorization Act) on the discussion table. Not since the advent of Medicare and Medicaid in the mid 1960’s, have we seen such widespread changes in the medical healthcare environment (Centers for Medicare and Medicaid Services). Physicians, industry, patients and consumers are affected by the changes. These four groups have historically worked as separate entities, but are now key stakeholders in the future of dermatology. As stakeholders collaborating in building a future together, the dermatologists/physicians will help to ensure and preserve the quality of patient care and best patient outcomes. In 2 Executive Forum meetings February 21-23, 2014 and June 3-4, 2016 the leaders from the Women’s Dermatologic Society and Industry, explored several important areas, six of which will be reviewed in this article 1) A five-year outlook of Dermatology and Medicine; 2) The New Practice Environment; 3) Access of Industry to Dermatologists and Trainees; 4) Doing Things Differently; and 5) Female Leadership 6) Unmet Needs. The collaborative group explored solutions for our specialty and the patients we serve.

Introduction

In keeping with its mission of “Physicians, Leaders and Mentors,” the Women’s Dermatologic Society brought together key physicians and industry leaders to identify the challenges, brainstorm solutions, and envision the future of the dermatology specialty. (See Table I, Table II.)

Table I.

Financial Relationships Between Physicians and Industry – 2007 Report:

94% Physicians Had Relationships

83% Physicians Received Gifts from Industry

28% Received Payment for Professional Services such as Consulting and Research Participation

60% of those 28% were involved in Medical Education (this signifies a lot of them were in academic medicine)

40% of those 28% were involved in Creating Clinical Practice Guideline

By 2001 Industry was considered the Major Source of Research and Development Funding

60% of 100 Billion Dollars in Funding Annually

33% of all CME

Table II.

Needs of Residents In-Training

PATIENT CARE
Access to Medications
Formulary Navigation
Hands on Training
Comprehensive Resident Education
Someone to fill in the Gaps
PRACTICE MANAGEMENT
Transitioning from Residency or Fellowship to private/group practice
Billing
Staffing
Work/Family Balance
Business
PROFESSIONAL SKILL DEVELOPMENT
Clinical Trials Education/Participation
Improved Accessibility to Investigator-Initiated Research Funding
Leadership Development
CME/MOC

The Women’s Dermatologic Society is the third largest Dermatologic Society in the U.S., and is composed of members from 32 countries. Membership is 90% female, 10% male, and encompasses the diversity of Dermatology with academic, private practice, practice, and industry membership (Toolkit for Physician Financial Transparency Reports (Sunshine Act)).

Forum Discussion Topics

The Future Outlook

Insurance reimbursement and formulary covered prescriptions continue to decline. Office-based dermatologic disorders are not viewed as life -threatening or often as important as other medical issues, which further threatens adequate reimbursement. In contrast, hospital-based inpatient dermatology services, such as leg ulcer care, are highly utilized and adequately reimbursed (Turhune, 2012). As a result, a two-tier system of self-pay and insurance reimbursement has developed. For example, acne, the most common skin disorder in the U.S., is not covered by insurance in many states (Drummond, 2013). Given their uncertainty about insurance reimbursement, patients are often forced to pay for treatment as an out-of-pocket expense. Similar to Dentistry, success will be mandated by balancing the cash pay vs. insurance-reimbursed segments within the medical practice. Nationally, the demand for dermatological services is increasing and the specialty is experiencing workforce challenges, with physician extenders increasingly becoming the primary providers for dermatology services (American Medical Association).

New Practice Environment

Increased and optimal utilization of social media and technology will be critical in communicating with patients and colleagues in this new practice environment. A key organizational message of the Women’s Dermatologic Society is providing service to women and families worldwide. This message, as well as the goal to address career challenges, is gender-neutral and should engage both male and female dermatologists and trainees. Partnering with industry colleagues in providing unique educational opportunities for our membership is in the best interest of all stakeholders. A series of challenges were identified:

• Regulatory Challenges – Managed care is crippling companies. Doctors spend a third of their time checking the boxes. These regulations are a large part of private practice , requires a lot of time and increases physician stress. Both physician and Industry are affected by 1) Alternative Payment Models 2)Health Care Systems 3) PQRS/MU/Now MIPS Under New MACRA LAW

• Drug Access Challenges – There are two opportunities for Industry and WDS to collaborate: Number one is transparency. Why do some medications cost more than others? How are these formulary’s produced? Number two is educating patients as to what is going on. Patients have the impression that physicians are writing expensive drugs but pharmacists are recommending generic. It’s a big challenge as a physician to educate the patient and make sure they understand what is about to happen over the next few days and weeks as to what drug they will actually get/use and what are the risks and benefits of the drug the patient finally receives which may be very different from what was written. Some of the most FAQ’s of patients are is the prescription written brand or generic? Which brand? Is it on my Formulary? What Tier? Is it Cheaper with a Specialty Pharmacy?

• Business Challenges – Right now in private practice, you are running a business. What is coming with these corporate buy outs and how can one prepare? How are Physicians going to differentiate themselves as dermatologists from primary care and nurse practitioners? How do we negotiate working with extenders, differentiating dermatologists, understanding profitability, and dealing with physician burnout.

Outcome: New Practice Environment

• 1)Explore opportunities of Synergy between WDS & Industry with the Drug Access and Business challenges. Industry partners can share experiences on how to run a business creating transparency, b) drug pricing knowledge and development of educational materials for our patients c) high level discussions examining practice efficiency and burnout prevention. The IVWG forum will continue to address these subjects and strategize physician resources with our industry partners.
• 2)Utilize social media to address issues such as burnout and constantly update the information.
• 3)Look for opportunity to non-branding patient education symposiums on a regional level.
• 4)Collaborate and form alliances with all stakeholders to keep current with information in this rapidly changing area

Access To Dermatology Trainees

Pharma Code and Sunshine Act have impacted greatly on Dermatology Trainees. In 2015-2016 Academic Year it affected 116 Dermatology US Residency Programs totaling 1,354 Dermatology Residents. Many of these programs altogether prohibit or significantly restrict Access to Industry Representatives REF

Current Pharma guidelines have limited the access of pharmaceutical representatives to physicians, including residents and fellows, outside of CME meetings. The provision of prescription samples to patients is restricted and industry-sponsored events at training institutions are prohibited. Limitation of prescription sampling leads to a negative Impact on patient care resultant from a limited exposure and experience by trainees with newer medications, formulations and treatment planning. In distinction Private Practitioners can see Sales Reps in Their Offices, allow lunches for physicians and staff, accept samples, and use branded Pharmaceutical aids/signs/pamphlets as part of patient care. REF

The Sunshine Act, Data Collection Began August 2013 and Public Reporting in 2014. The act mandates reporting of all financial interaction by Physicians with the pharma industry. Payments Requiring Reporting per the Sunshine Act are 1) Transactions of $10 or more 2) Transactions Under $10 if they total $100 in a Calendar Year 3) Teaching Hospitals must also report Payments.

This mandatory reporting has further decreased dermatologists’ interaction with the industry representatives, both in educational and advisory capacities. The goal of the Sunshine Act to improve transparency has resulted in unintended repercussions and consequences well as perceived Stigma that financial relationships between Physician and Industry are tainted or not appropriate.

Government officials passed sunshine laws however ACCCME and Residency training programs choose to interpret them in a variety of restrictive fashions. It has Resulted in Reduced Access to Trainees, Physicians, Thought Leaders Outside of CME Events and a possible reduction in the pipeline of Clinical Trial Investigators. REF

The Pharma code impact resulted in the following specific mandates at 2 US University- Hospital based Dermatology Residency Training Programs REF

• 1)House staff should not attend non-ACCME industry events described as CME.
• 2)Acceptance of gifts of value by house staff from industry is prohibited.
• 3)Industry-supplied food to house staff is not permitted unless in connection with 4) ACCME-accredited programming must be in compliance with ACCME guidelines.
• 4)House staff may not directly accept travel funds or reimbursement of expenses from industry other than for legitimate contractual services.
• 5)House staff are prohibited from allowing their presentations of any kind to be ghostwritten by any party, industry or otherwise.
• 6)Access by Industry Representatives to any ACCME accredited event is prohibited unless required for training or treatment purposes,
• 7)Access by Industry representatives shall be restricted to non-patient care areas and should take place only by appointment or invitation of the faculty member
• 8)Involvement of trainees in such meetings should occur only for educational purposes and always under the direct supervision of the faculty member so counter detailing can be provided at all times)

WDS Opportunities: Three major areas for innovative impact were identified

• 1)Modeling Behaviors in Education System
• 2)Hands on Training Aspect
• 3)Education Gaps on New Products

Mentoring/Behavior Modeling

The WDS Pioneered the first formal Mentoring program within the specialty of Dermatology REF. Mentoring, networking and grassroots initiatives, such as those sponsored by WDS Regional networking groups Facilitate Networking and Relationship Building between Industry Reps and Local Dermatologists and can bridge the learning gaps for trainees and young physicians, while ensuring appropriate trainee-industry relations. WDS agreed the Primary Concern of both Physicians & Industry is Patient Care and Treatment of Dermatologic Disease. The specific issues vary by perspective but there are overlap areas of concerns and opportunities for collaboration for the WDS as Bridge/Connector Organization to Residents/Young Dermatologists In-Training, Residency Programs/Academic Departments and Industry Partners. WDS Resident/Fellow Membership (as of June 1, 2016) equals 563 therefore as a professional organization WDS Can Provide Access to over 40% of US Dermatology Residents/WDS can provide the professional development of relationships and this will be a real possibility as an organization to partner with the development of materials and modeling of behaviors. Interactions between Industry Representatives and Dermatologists are not modeled well in the context of Residency Programs. We know what cannot be done but there is little written about modeling of modern professional and acceptable physician/ industry relationship. Development of a model of cordial, professional, and mutually beneficial relationships/interactions is critically needed by the specialty. A WDS member shared with the group the Resident’s perspective “ If you, the residents, don’t see it modeled, you will be fearful of it, less likely to take on those relationships when you finish. If these naiive residents then do take those relationships, they will not know the difference between appropriate and non-appropriate. “ There is a need to counter and correct the thought that “any interaction is bad interaction”. What really equals appropriate and not? The group felt strongly that Program Directors need to be closely involved in the development of a standard core curriculum for Industry relations based on content not void.

Hands on training- Opportunities

WDS has existing mentorship and regional networking opportunities for hands on training by and for members at all levels of experience in pursuit of professional training. Academic Dermatologists Committee is available to pursue web-based curriculum formulation considerations, Clinical Trial Curriculum and Investigator-Initiated Grants curriculum. The Resident Liason and Young Physicians committee are organized for communication and dissemination of information and resources. The Business Committee is available for practice management modeling and mentoring.

Education gaps on new products, technology and practice management

Industry leaders may have the opportunity to assume the role of educators. So You can have a Medical liason not a sales representative come from Industry come to the Residency Program and give a presentation with the Program Directors in attendance. Merz, Valelant, Galderma mentioned they all have Clinical education programs geared to provide education gaps on novel therapeutics, devices, awareness of disease state presentations and understanding of formulation differences. The WDS Business Committee can be a resource for educational materials in the area of Practice management tailored to the specific needs of a Trainee. Regional Networking groups may also provide real world experiences for trainees

Needs of Residency Programs & Academic Departments

Outcome

Open communication with program directors/chairs as well as the development of educational materials which may include live presentations as well as videos and webinars that programs can incorporate. Develop a new non branded paradigm in educating residents in the role of pharma and have it standardized in a professional way so they can enter practice understanding the rules.

Doing Things Differently

A consensus meeting with our industry partners provided important perspective and input into strategic planning for Dermatology. To facilitate that input, three needs were identified. 1) Provide continuing education for dermatologists about the requirements and ramifications of the Sunshine Act. 2) Educate the public about the value of physician-industry collaboration and dialogue. 3) Prevent “swapouts” of generic medication for a brand-name medication. Concern was expressed about the frequency of pharmacy “swapouts” when a brand-name medication is desired based on unique properties but a generic “equivalent” is substituted without the knowledge or understanding of the patient or notification of the prescribing dermatologist. Prevention of these “swapouts” is an opportunity for physicians, industry representatives, and patients to develop educational materials clarifying the importance of physician prescription compliance by pharmacy and insurance companies. Furthermore, The American College of Clinical Pharmacy issued the following guideline for pharmacists to abide by: Pharmacists should not solicit or accept gifts from industry that might influence or appear to influence objectivity, independence, or fairness in clinical and professional judgment).

Female Leadership

There is a heightened awareness regarding female leadership in the US sector but the numbers speak differently. Women make up about 50% of the labor force, but only about 5% of the CEOs are female REF Women are not the top earners. In the United States House of Representatives there is only 20% female

Within the house of Dermatology Kimball REF wrote a review on this. It looked at some stats –60% of Derm residents are female but only 16% Chairs and 20% Program Directors are female

Within the Academy’s Governance Structure (Councils, Committees, Task Forces, Ad Hoc Task Forces and Work Groups): There are Currently 130 Active Entities within the Academy’s Governance Structure 48 Women Serve as Chairs 23 Women Serve as Deputy Chairs REF The vision of our founder Wilma F. Bergfeld was to create female leaders and that is what WDS has done but it is the feeling that more has to be done. The group was asked what you wanted to see within female leadership? 1) Adopt an affirmative action movement. To insure that when women get into leadership roles they reach out to another female to help them be on a program. 2) No Woman Left Behind Act - WDS BOD Members Should Appoint Younger Members to Leadership Roles as Part of their Team

Outcomes: Female Leadership

• •Industry Sponsored Leadership Forum
• •Hold the IVWG Every Other Year or Yearly with the Possibility of an Update at the Summer Meeting or via Teleconference
• •Establish Structured Leadership Programs - Establish a Committee Leadership Orientation
• •Hold Chair Conference Calls or via the Website to Communicate Updates on what Other Committees are doing
• •Award Development/Rising Star Reception - It is Important to Show Appreciation to the Newer Members, as well as the Senior Members
• •Make sure Awards are Objective
• •Create a way to Recognize Allies of WDS (someone who is not a member 0062ut has helped with the mission and to move WDS forward)

Unmet Needs

A recent WDS member survey focused on unmet needs for the Dermatologist. The top two needs were 1) survival and growth of the dermatologist in the new health care environment, 2) positioning the dermatologist as the skin care specialist and experts in skin, hair, nail and mucous membrane disorders. The proposed solutions included: 1) an expansion of WDS networking events to include subjects such as government regulations and 2) Exploring and utilizing available social media for a public and physician communications campaign to emphasize the importance of the specialized training and abilities of Dermatologists.

Summary

The Key Factor for success is the recognition of the benefits of collaborative efforts between the stakeholders which are dermatologist/physician, industry (pharma) and the public. Resident Education will inevitably be the agent of change but their education may have to be supplemented by organizations such as the WDS who can bridge possible gaps. The changing practice environment is challenging, but offers us an opportunity to be proactive and innovative. Let us unite and take up this challenge.