Deeper Than the Headlines: Teaching Compliance

Most doctors read medical journals to stay abreast of the most current treatment options or cutting edge research about advancements in clinical care. And more and more physicians are seeing articles in their medical journals about compliance, fraud and abuse.

For compliance officers, this can be a welcomed avenue for getting the compliance message out to physicians who might not otherwise readily accept the same message from compliance personnel who can sometimes be perceived as “watchdogs” or “bureaucrats.” If a respected medical journal is publishing articles about compliance, then take advantage of it. Send notes or links of the articles to your physicians because they be more likely to read an article from a medical journal. Just getting physicians engaged can sometimes be the biggest hurdle to overcome, but once it’s overcome, you might just find a physician champion to carry your compliance message to other clinicians.

The October 2016 issue of The American Journal of Gastroenterology includes an article entitled “Treacherous Terrain: How to Avoid Getting Caught in the Government’s Crosshairs” by Jacqueline C. Baratian , JD and William H. Jordan , JD (Am J Gastroenterol 2016; 111:1376–1377).
The article highlights some recent compliance enforcement topics and then provides some guidance for physicians. It might be the same message your compliance officer has been trying to share for years, but because it’s in a respected medical journal, you might just get your organization’s gastroenterologists and other physicians to read it.

Highlights from the article include:

• Do’s and Don’ts for physicians who participate in medical directorship agreements
• The government’s recent emphasis on individual accountability when it comes to enforcing cases of non-compliance
• How to stay on the safe side of interactions with medical device and pharmaceutical companies

Do’s and Don’ts for Physicians Who Participate in Medical Directorship Agreements 

A recent OIG enforcement centered on 12 physicians who were accused of participating as sham medical directors. It was alleged they received benefits for sending patients to a particular imaging center. In addition to the enforcement action taken, the OIG published a compliance alert about the risks of improper medical directorship agreements. The authors of this article suggested the following steps to avoid risks associated with serving as a medical director:

1. Payments for medical directorships should be set at fair market value and should not be determined based on the volume and value of referrals.
2. Documentation of physician time is key. Time sheets should reflect the hours physicians spent providing medical director services.
   Services set forth in the medical directorship agreement should reflect the services actually provided by the physician. In other words, any and all services provided should be clearly delineated in the agreement.
3. The business justification and commercial reasonableness for the medical directorship should be well documented.
4. Any costs (e.g., equipment, rent, and office staff ) that benefit the physician should be borne solely by the physician to avoid the exchange of improper remuneration.

Government’s Recent Emphasis on Individual Accountability

The Yates Memo, published in September of 2015, has been viewed as a sign of an increased emphasis by the Department of Justice to focus enforcement action towards individuals (physicians included), not just corporate entities.

The article highlights the six main points of the memo:

1. Corporations must provide to DOJ all relevant facts relating to individuals responsible for corporate wrongdoing.
2. From the inception of a criminal or civil corporate investigation, prosecutors should focus on individuals.
3. Criminal and civil attorneys handling corporate investigations should stay in routine communication with one another, presumably to discuss the full range of potential remedies against individuals.
4. Absent extraordinary circumstances and not without formal DOJ approval, DOJ attorneys should not release culpable individuals from civil and criminal liability.
5. Resolution of civil or criminal matters with a corporate entity by DOJ attorneys must include a clear plan to also resolve related individual cases.
6. Determination to pursue civil claims against a culpable individual should not be based on whether that individual can pay a large fine.

Physician Interactions with Medical Device and Pharmaceutical Companies

The article also highlights the recent $623 million Olympus settlement that involved a case alleging bribes and kickbacks paid to doctors to influence physicians’ use of Olympus’ gastroenterology scopes.

Some examples of the alleged improper activities included a $100,000 grant to a hospital because that hospital was the #1 Olympus account in the USA; travel and recreation (sending doctors to Japan for a week as a reward for the decision of a hospital to switch from a competitor’s products to Olympus’ products); and free products (providing a physician with ~$400,000 in endoscopes and other equipment to use without charge in his private practice).

The article recommends the following key takeaways for physicians interacting with device and pharmaceutical companies:

1. Avoid free gifts, items, or services and lavish entertainment and trips.
2. Review and comply with company compliance and legal policies.
3. Ask questions about related risks of potential arrangements.
4. Structure compensation or ownership arrangements through health-care counsel.
5. Ensure objective criteria for grants are followed to support desired quality and patient safety goals.
6. Do not ever seek to increase payments because you are a significant referral source.

None of these messages are necessarily breaking news to us as compliance professionals, but the publication and approach used for this message is unique and may be more welcomed by physicians. As compliance professionals, we need to utilize all the avenues available to us to communicate appropriate messages about healthcare compliance. This recent medical journal article could be an effective tool for you to use in physician outreach, compliance training, and education.