Life Science Compliance Update

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29 posts from January 2014

January 31, 2014

Non CME Strategies a Possible Adjunct to CME Activities

The Accreditation Council for Continuing Medical Education (ACCME) requires Continuing Medical Education (CME) providers to utilize non-education, or non-CME, strategies "to enhance change as an adjunct to its activities/educational interventions." Global Education Group has produced a brief video, available on You Tube, for accredited CME providers that hones in on three concrete non-CME strategies to enhance CME programming and thus fulfill ACCME's Criterion 17.

Background on Non-Education Strategies

When reporting about ACCME news, we recently noted that ACCME added new examples of compliance with the criteria for achieving Accreditation with Commendation, including Criterion 17. Regarding non-education strategies, ACCME notes:

The ACCME is looking for evidence of the use of strategies such as, but not limited to, rewards, process redesign, peer review, audit feedback, monitoring, reminders as tools to enhance, or facilitate, change. Some providers are concerned that some of these may be considered 'educational' as they potentially change what people 'know' or because they inform learners (e.g., "It may be time for you to call back your patients with…"). In C17, the ACCME is looking for tactics that go beyond the educational activity or intervention. Essentially, the ACCME is looking for providers to broaden the range of tools they use to facilitate change.

Specific non-education strategy examples offered by ACCME include participant reminders following CME events, working with others to facilitate a peer to peer feedback system to reinforce new practices, or incorporating questions about practices incorporated from a CME event into patient satisfaction questionnaires. The Massachusetts Medical Society offers additional suggestions, including pocket guidelines for physicians, information posted on a website, screening tools, and pedometers or other giveaways to support the CME activity.

In an ACCME video addressing ways providers use non-educational strategies to creatively support CME activities, the speaker stresses "the literature shows that reminders as an adjunct to learning, changes and maintains the change in practice." That is the overall goal of quality CME.

Global Education Group's Adjunct Strategies for CME Success

Global Education Group's video targets three non-education strategies to benefit both CME participants and patients:

Resource Center: A resource center is a place, usually on the web, where physicians and patients can go to find information on standards, FAQ's, and other issues that demonstrate best practices. These types of resource centers are great where therapeutic standards or therapies are emerging, or where hands-on practices require improvement.

Patient reminders or "Did You Know" sheets: A patient reminder, or "Did You Know" sheet, is simply a sheet (paper or electronic) and usually includes a link to a patient advocacy organization within the sheet. These are great for disease or treatment areas where early diagnosis or patient adherence/compliance is a critical issue.

Patient Surveys: Global has worked closely with one of our partners, Clinical and Patient Educators Association, to do quite a few different patient surveys in several different therapeutic areas. These surveys are incredibly useful because they empower the patient to drive future education. For example, for one patient survey we did, we asked patients with MS how many times their medication had been changed. 21% stated that it had been changed more than 4 times since initial diagnosis. As another example in the area of diabetes, we found out that only about half of the diabetes patients we surveyed stated that they were taking their medication directly as prescribed. As well, most of these respondents stated they were not communicating this information with their physician or specialist, which is obviously a problem.

January 30, 2014

Pharmaceutical and Device Healthcare Fraud: Enforcement Perspectives for 2014

CBI's Pharmaceutical Compliance Congress started off both mornings of their two day conference with a matter sure to get industry members' attention: enforcement. A variety of government attorneys offered a glimpse into their approach to healthcare fraud, and shared insights into what they consider to be best practices regarding compliance. Carmen Ortiz, U.S. Attorney for the District of Massachusetts, began by highlighting the high priority areas of 2014. The "enforcement panel" of five government attorneys followed, splitting their time between healthcare fraud on the one hand, and the importance of robust compliance programs on the other. On Wednesday, Assistant Attorney General, Stuart Delery, spoke regarding civil enforcement and non-monetary penalties the Department of Justice (DOJ) has utilized.

Healthcare Fraud Landscape

Healthcare is entering a new era. The Centers for Medicare and Medicaid Services (CMS) expects a 6.1% growth of health care spending in 2014 due to implementation of the Affordable Care Act (ACA), the aging baby-boomer population, and the end of the federal government sequester.

As more people enroll in government funded healthcare, the government believes that more fraud is an inevitable result. The Department of Justice (DOJ) has made fraud a priority in 2014 for obvious reasons: fraud adds even more cost to an already expenses arrangement. Furthermore, fraud hurts patients and "threatens the strength and integrity of the healthcare system," a phrase that became a catchphrase at the conference this week.

Enforcement Figures

The enforcement panel stressed the large number of resources that the government has directed toward health care fraud enforcement. William C. Killian, of the Eastern District of Tennessee, said that his district averages $25 million in health care fraud each year. Ben Singer, Deputy Chief, U.S. Department of Justice Criminal Division, stated that his office has 38 prosecutors working solely on healthcare fraud. Singer's "Medicare strike forces" have charged 345 people with felony health care fraud, including 234 convictions, and recovered $1 billion dollars in ten cities alone.

The task forces get big results, and display them prominently in the news. The DOJ has leveled huge monetary fines against pharmaceutical companies recently: GSK, for $1 billion criminally and $2 billion resolution of civil liabilities; J&J, $2.2 billion for misbranding; Pfizer, for $2.3 billion; Abbot Laboratories, for $1.5 billion.

The U.S. Attorneys unanimously stressed the effectiveness of the coordination efforts between their criminal and civil division. Assistant Attorney Stuart Delery of the U.S. Department of Justice stated that Health Care Fraud Prevention and Enforcement Action Team (HEAT) increases coordination between the FDA, CMS, and U.S. attorneys' offices, and has spurred dramatic, billion dollar resolutions.

Sanford C. Coats, U.S. Attorney for the Western District of Oklahoma, also spoke about how healthcare fraud cases are not limited to big markets. His Oklahoma office won a $491 million judgment against Pfizer in August 2013, a case he believes would not have been possible even five years ago. Pooling departmental resources—combined with an increased public awareness of healthcare fraud issues—made the lawsuit possible.

Utilizing False Claims Act Qui Tams

Private whistleblowers often offer prosecutors the damaging facts they need to show that a company has engaged in wrongdoings. Whether the qui tam action stems from the company continuously rejecting an employee's internal complaint, or is brought by a disgruntled former employee (or both), whistleblowers stand to gain a lot of money. Plus, it only takes one to come forward with credible and supportive evidence of company misconduct.

Qui tam suits have been increasing at a rapid pace. The DOJ announced that the number of qui tam filed in 2013 grew to 752 in 2013 – over 100 more than the prior record established last year. DOJ recovered $3.8 billion in these cases.

How much money do these individual whistleblowers actually make?

  • $167.7 million from J&J
  • $96 million from GSK
  • $84 million from Abbot
  • $51.5 million from Pfizer

Holding Individuals Liable

Despite prosecutors blasting industry with billion dollar fines, Carmen Ortiz, U.S. Attorney for the District of Massachusetts, admitted: "We know the sole blame does not fall on the shoulders of the pharmaceutical corporations. Wherever there is a generous hand there's a greedy one prepared to pocket the cash." Physicians, who demand speaker arrangements, elaborate dinners, and trips, are equally culpable, she argues. Ortiz stressed her department's efforts to hold individuals criminally accountable, such as the executives at Orthofix. Thomas Guerreri, former vice president of sales at Othofix, is serving 8 months in prison for paying kickbacks to prescribe his company's products and for putting undue pressure on the sales team. Many other employees in the company are also serving prisons sentences.

However, it is worth questioning whether there is a disincentive to prosecute individuals if there is an opportunity for the government to obtain a large settlement from the company. Ortiz stated that the government always looks more toward criminal culpability than money, but noted that often the statute of limitations has run on individuals. Once the statute runs, she has to go after the company. 

CIAs and Non-Monetary Fines

The presenters placed a high level of importance on Corporate Integrity Agreements (CIAs). Ortiz noted that CIAs have the potential to provide clawbacks for executives, overhaul compensation programs for sales representatives, provide a certification of compliance by executives and board members, and also offer transparency.

Assistant Attorney General Stuart Delery said that DOJ has put "renewed emphasis on identifying non-monetary measures that will help DOJ to prevent the recurrence of misconduct." Delery cited the case of Ranbaxy, an Indian pharmaceutical company which pled guilty to charges that it had produced and distributed drugs which failed to comply with the FDA's current good manufacturing practice (CGMP) standards and falsified records. As part of the guilty plea, Ranbaxy agreed to a settlement agreement which placed heavy restrictions on three of the company's manufacturing facilities. If any of Ranbaxy's other facilities exhibited quality problems, they would be added to the CIA as well. RAPS reports, "just last week, the consent decree allowed FDA to move swiftly and respond forcefully" when it learned of a new data falsification claim made against one of Ranbaxy's facility.

Fundamentally, the DOJ wants to ensure high-level accountability for a companies' compliance efforts. For example, a 2012 CIA entered into with Abbott Laboratories regarding the company's marketing of its epilepsy drug Depakote requires Abott's CEO to "personally certify compliance" with the agreement. Abbot also agreed to report any probable violations of the Federal Food, Drug, and Cosmetic Act (FDCA).

The DOJ is not solely "interested in collecting a large fine," Delery stated. "We strive to give companies the incentive and the tools to craft better compliance practices in the future."

View our recent chart listing the pharmaceutical and device CIAs for 2014.

Compliance Programs: Best Practices

During the conference, government attorneys repeatedly stressed the vital importance of a robust compliance program. Several speakers stated that a "culture of compliance" should not be an empty phrase. Companies must have a visible, respected corporate compliance presence. Delery stated that no matter how well-designed a compliance program, there needs to be buy in at all levels of the company. Companies should ensure that executives are making informed, clear, and ethical decisions, and that there is a clear chain of command.

Perhaps most obviously, the U.S. Attorneys urged industry to cooperate with government: "Companies should be willing to self-report and take corrective measures." Once the government brings an action, the government advises companies to completely clean up and do internal investigations in order to lessen their liability to some extent. One of the responding enforcement attorneys used an example of his agencies' interactions with Temple University, where a doctor had billed for services he hadn't actually rendered. The prosecutor stated that because Temple came forward and disclosed what they had, gathered new information, and complied with the government, "criminal charges were not appropriate." Furthermore, because the university had a robust compliance program in place, the agency did not even mandate a CIA.

Ortiz suggests the following best practices:

  • Encourage and reward employees reporting concerns.
  • Mandate ongoing training.
  • Establish ethical compensation plans for sales representatives, not entirely tied to sales.
  • Conduct surprise site visits.

In regards to mitigating damage, the enforcement panel felt that they couldn't understate the importance of self-reporting.

Delery concluded his presentation on behalf of DOJ stating: "When a company or individual acts responsibly by timely and voluntarily disclosing unlawful conduct, we will give serious consideration to that disclosure in deciding whether or how to charge or resolve the matter." Furthermore, "we will credit actions taken once the government has started to investigate." One company, for example, replaced their entire C-level staff, hired dozens of compliance officers, changed the compensation structure of the company, and disclosed the questionable practices of former employees. While Delery stated that there is "no one formula for cooperation," working with DOJ would ensure that companies and their customers are "in the best possible position."

Notably, however, no U.S. Attorney could remember a situation where a voluntary disclosure had ever gone unprosecuted. The defense panel was quick to note that this revelation does not offer a lot of incentive to self-report. While a fair number of qui tams have been unsealed, and then declined by the government, cases that get voluntarily disclosed cannot go UN-disclosed.

Enforcement Priorities looking ahead to 2014

  • Manufacturing of Adulterated Drugs (Compounded Drugs) – view our recent coverage on compounding
  • Durable Medical Equipment Fraud
  • Home Health Care Fraud (Physical, Occupational, and Speech Therapy
  • Medical Identity Theft
  • Unnecessary Medical Services
  • Fraudulent Medical Research

______

Policy and Medicine will continue to post recaps of CBI's Pharmaceutical Compliance Congress, including updates on the Physician Payment Sunshine Act.

January 29, 2014

International Organizations Announce Consensus Framework for Ethical Collaboration

Recently, five global health organizations - the International Alliance of Patients' Organizations (IAPO), International Council of Nurses (ICN), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), International Pharmaceutical Federation (FIP), and the World Medical Association (WMA) – announced the Consensus Framework for Ethical Collaboration. This framework seeks to support partnerships that deliver greater patient benefits and support high quality patient care. Derived from the individual codes of ethical practice and health policy positions of the five supporting organizations, this framework is based on four overarching principles:

(1) putting patients first;

(2) supporting ethical research and innovation;

(3) ensuring independence and ethical conduct; and

(4) promoting transparency and accountability.

The Consensus Framework for Ethical Collaboration between Patients' Organizations, Healthcare Professionals and the Pharmaceutical Industry can be found here. The codes of practice for each supporting organization are available at IAPOICNIFPMA, FIPWMA.

According to the Framework:

"As developed and developing countries strive to address pressing health challenges in the complex and fast-evolving healthcare environment, collaboration between all partners is essential in ensuring proper delivery of the most appropriate care for patients worldwide.

In the 1980s international codes and guidelines were approved including the first IFPMA Code of Pharmaceutical Marketing Practices in 1981 and the WHO Ethical Criteria for Medicinal Drug Promotion in 1985. Since then progress has been made to ensure appropriate interactions and ethical promotion of medicines globally, including through self-regulatory and voluntary mechanisms such as codes of conduct and principles. These highlight the need for patients' organizations, healthcare professionals, and the pharmaceutical industry to work together for the benefit of patients, while recognizing each other's professional role in the context of the healthcare value delivery chain and maintaining their professional independence.

There is an important link between patients, healthcare professionals, the pharmaceutical industry and their organizations in providing best solutions to patients' health needs and each partner has a unique role and responsibility in ensuring that patients receive the most appropriate care. Patients must be informed and empowered to, along with their caregivers, decide on the most appropriate treatment options for their individual health needs and to participate responsibly in use of health resources and managing their own health. In this respect, healthcare professionals must ensure that the treatment options they offer to patients are appropriate. In turn, the pharmaceutical industry has a duty to provide accurate, fair, and scientifically grounded information for their products, so that the responsible use of medicines can be facilitated."

As noted in the health organization's release: "Advancing medical knowledge and improving health depend on regular information-sharing interactions between all partners. While individual codes of practice govern the activities of each group, this broad-based consensus framework applies across much of the healthcare community to include interactions involving patients, nurses, pharmacists, doctors, and the healthcare industry."

Furthermore: "Ensuring ethical conduct, transparency and accountability are key in the development and testing of medicines and other health technologies," said Marie-Paule Kieny, Assistant Director-General for Health Systems and Innovation at the World Health Organization.  "We encourage all organizations involved to examine ways to develop monitoring mechanisms that can support these principles."

About IAPO:
IAPO is the only global alliance representing patients of all nationalities across all disease areas and promoting patient-centered healthcare worldwide.  Our members are patients' organizations working at the local, national, regional and international levels to represent and support patients, their families and careers. IAPO has over 200 members which span over 60 countries and 60 disease areas and through its membership represents an estimated 365 million patients worldwide. 

About ICN:
The International Council of Nurses (ICN) is a federation of more than 130 national nurses associations representing the millions of nurses worldwide. Operated by nurses and leading nursing internationally, ICN works to ensure quality care for all and sound health policies globally.

About FIP:
The International Pharmaceutical Federation (FIP) is the global federation of national associations of pharmacists and pharmaceutical scientists and is in official relations with the World Health Organization (WHO). Through its 126 Member Organizations FIP represents and serves more than three million practitioners and scientists around the world. Its mission is to improve global health by advancing pharmacy practice and science to enable better discovery, development, access to and safe use of appropriate, cost-effective, quality medicines worldwide.

About IFPMA: 
IFPMA represents the research-based pharmaceutical companies and associations across the globe. The research-based pharmaceutical industry's 1.3 million employees research, develop and provide medicines and vaccines that improve the life of patients worldwide. Based in Geneva, IFPMA has official relations with the United Nations and contributes industry expertise to help the global health community find solutions that improve global health.

About WMA:
The World Medical Association (WMA) is an international organization representing physicians. The organization was created to ensure the independence of physicians, and to work for the highest possible standards of ethical behavior and care by physicians, at all times. The purpose of the WMA is to serve humanity by endeavoring to achieve the highest international standards in Medical Education, Medical Science, Medical Art and Medical Ethics, and Health Care for all people in the world.

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