Life Science Compliance Update

September 14, 2017

Joint Commission Releases Report Regarding Pain Assessment and Management Standards

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The Joint Commission recently released a report to help hospitals better understand and comply with new pain assessment and management standards that will be applicable to all Joint Commission-accredited hospitals, effective January 1, 2018.

An independent, not-for-profit organization, The Joint Commission accredits and certifies over 21,000 health care organizations and programs in the United States. Joint Commission accreditation and certification is recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards.

The August 29, 2017, issue of the R3 Report highlighted the new pain assessment and management standards for hospitals that are accredited by the Joint Commission. The standards are in the following chapters of the hospital accreditation manual and are designed to improve the quality and safety of care provided by Joint Commission-accredited hospitals: Leadership; Medical Staff; Provision of Care, Treatment and Services; and Performance Improvement.

The new requirements include the following:

  • That the hospital has a leader or leadership team that is responsible for pain management and safe opioid prescribing and developing and monitoring performance improvement activities;
  • That the hospital provides nonpharmacologic pain treatment modalities;
  • That the hospital provides staff and licensed independent practitioners with educational resources and programs to improve pain assessment, pain management, and the safe use of opioid medications based on the identified needs of its patient population;
  • That the hospital provides information to staff and licensed independent practitioners on available services for consultation and referral of patients with complex pain management needs;
  • That the hospital identifies opioid treatment programs that can be used for patient referrals;
  • That the hospital facilitates practitioner and pharmacist access to the Prescription Drug Monitoring Program (PDMP) databases;
  • That hospital leadership work with its clinical staff to identify and acquire the equipment needed to monitor patients who are at high risk for adverse outcomes from opioid treatment;
  • That the medical staff is actively involved in pain assessment, pain management, and safe opioid prescribing through the following: participating in the establishment of protocols and quality metrics, and reviewing performance improvement data;
  • That the hospital has defined criteria to screen, assess, and reassess pain that are consistent with the patient’s age, condition, and ability to understand;
  • That the hospital screen patients for pain during emergency department visits and at the time of admission;
  • That the hospital treats the patient’s pain or refers the patient for treatment, whether it be nonpharmacologic, pharmacologic, or a combination of approaches;
  • That the hospital develops a pain treatment plan based on evidence-based practices and the patient’s clinical condition, past medical history, and pain management goals;
  • That the hospital monitors patients identified as being high risk for adverse outcomes related to opioid treatment;
  • That the hospital reassesses and responds to the patient’s pain through the following: (1) evaluation and documentation of response(s) to pain intervention(s), (2) progress toward pain management goals including functional ability (for example, ability to take a deep breath, turn in bed, walk with improved pain control), (3) side effects of treatment, and (4) risk factors for adverse events caused by the treatment;
  • That the hospital collects data on pain assessment and pain management including types of interventions and effectiveness;
  • That the hospital analyzes data collected on pain assessment and pain management to identify areas that need change to increase safety and quality for patients; and
  • That the hospital monitors the use of opioids to determine if they are being used safely (i.e., the tracking of adverse events such as respiratory depression, naloxone use, and the duration and dose of opioid prescriptions).

September 13, 2017

Novo Nordisk $58 Million Settlement and REMS - Off Label Prosecution Still Alive and Well

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Novo Nordisk will pay roughly $58.7 million to resolve claims that the company’s sales force downplayed the importance of mandated United States Food and Drug Administration (FDA) warnings about the cancer risks of its diabetes prescription, Victoza.

In a civil complaint filed on September 5, 2017, in the U.S. District Court for the District of Columbia, the government asserted claims under the FDCA, alleging that at the time of Victoza’s approval in 2010, the FDA required a Risk Evaluation and Mitigation Strategy (REMS) to mitigate the potential risk in humans of a rare form of cancer associated with the drug - Medullary Thyroid Carcinoma (MTC). The FDA-mandated REMS required Novo Nordisk to provide information regarding Victoza’s potential risk of MTC to physicians. Manufacturers that fail to comply with the requirements of the REMS, including requirements to communicate accurate risk information, leads the drug to be misbranded under the law.

The complaint alleges that some Novo Nordisk sales representatives gave information to physicians that created the false or misleading impression that the Victoza REMS-required message was erroneous, irrelevant, or unimportant. The complaint further alleges that Novo Nordisk did not comply with the REMS by creating the false or misleading impression about the Victoza REMS-required risk message that violated provisions of the FDCA and led some physicians to be unaware of the potential risks when prescribing Victoza.

As alleged in the government’s complaint, after a survey in 2011 showed that half of primary care doctors polled were unaware of the potential risk of MTC associated with the drug, the FDA required a modification to the REMS to increase awareness of the potential risk. Rather than appropriately implementing the modification, the complaint alleges that Novo Nordisk instructed its sales force to provide statements to doctors that obscured the risk information and failed to comply with the REMS modification. Novo Nordisk has agreed to disgorge $12.15 million in profits derived from its unlawful conduct in violation of the FDCA.

Novo Nordisk will pay an additional $46.5 million to the federal government and the states to resolve claims under the FCA and state false claims acts. This portion of the settlement resolves allegations that Novo Nordisk caused the submission of false claims from 2010 to 2014 to federal health care programs for Victoza by arming its sales force with messages that could create a false or misleading impression with physicians that the Victoza REMS-required message about the potential risk of MTC associated with Victoza was erroneous, irrelevant, or unimportant and by encouraging the sale to and use of Victoza by adult patients who did not have Type II diabetes. The FDA has not approved Victoza as safe and effective for use by adult patients who do not have Type II diabetes.

"At Novo Nordisk, we take our responsibility to communicate the safety and clinical benefits of our medicines seriously, and remain committed to properly addressing safety questions healthcare professionals ask every day," said Doug Langa, Executive Vice President, Head of North America Operations and President of Novo Nordisk Inc. "Our focus will always be to ensure that those caring for patients have the data they need to make the most informed treatment decision. While we do not agree with the U.S. government's legal conclusions and deny any wrongdoing, we're pleased to have negotiated a resolution that allows the company to return its full attention to developing medicines that help improve the lives of patients."

Analysis 

The bottom line for companies is to take their FDA issued REMS very seriously and take opportunities to ensure that clinicians understand those REMS.  This can be done through multiple venues and sales representatives need to see that these are not to be discounted.

Retrospect and Looking Forward: A Review of Three Full Years of Open Payments Data and Media Coverage

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Tomorrow, September 14, 2017, from 10:00 am EST – 11:00 am EST, qordata is hosting a webinar on the three years of Open Payments data that has been made public. The speaker is none other than our editor, Thomas Sullivan, who looks forward to sharing highlights on the full three years of Open Payments data, and give some insight on what likely lies ahead in the future.

In addition to reviewing the 2014-2016 Open Payments data, Mr. Sullivan looks forward to providing insights on the following:

  • Media coverage of Open Payments and the released data sets;
  • New State laws, including transparency laws and “gift bans”;
  • Recommendations on the Open Payments program;
  • Congressional actions on Open Payments; and
  • Where do we go from here

If you are a Chief Compliance Officer (CCO), Director of Compliance, or Compliance Manager, we encourage you to register and attend.

In the event that you are unable to attend the webinar live, recordings will be emailed to all registrants once available. Please click here to register.

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