Life Science Compliance Update

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27 posts from December 2016

December 30, 2016

OIG Issues Semiannual Report to Congress


The Department of Health and Human Services (HHS) issued its Semiannual Report to Congress, covering April 1, 2016 to September 30, 2016, on November 30, 2016. The Report summarizes the activities of the HHS Office of Inspector General (OIG) for the six-month period that ended September 30, 2016. OIG provides independent, objective oversight for HHS programs. OIG is a multidisciplinary organization principally comprising auditors, investigators, and evaluators who work in concert to protect the integrity of HHS programs, as well as the health and welfare of the people they serve.

During this reporting period, OIG expanded its focus on the quality and safety of care provided to vulnerable populations, including those in non-institutional settings. Programs that deliver health care in non-institutional settings are increasingly popular choices that help beneficiaries live in their homes and communities while avoiding costly and potentially disruptive facility-based care. Over half of all spending on Medicaid long-term services and supports is now for home and community based services (HCBS), exceeding Medicaid spending on institutional services.

OIG’s examinations of HCBS programs have revealed gaps in policies and controls to protect patients. For example, during this reporting period, OIG identified troubling compliance issues with requirements for monitoring and reporting critical incidents involving developmentally disabled Medicaid beneficiaries at group homes in Massachusetts and Connecticut.

This Report outlines many areas of improvement requiring sustained HHS attention. Program integrity must be a top priority as HHS programs continue to grow in size and complexity and incorporate new paradigms focused on value, quality, and patient-centered care. Since its 1976 establishment, OIG has worked collaboratively with its partners to protect and oversee HHS’s vital health and human services programs. The achievements of this office would not be possible without the dedication and professionalism of OIG’s employees. Once again, I would like to express my appreciation to Congress and to the Department for their sustained commitment to the important work of our office.

Numbers At-A-Glance

For FY 2016, OIG reported expected recoveries of more than $5.66 billion consisting of nearly $1.2 billion in audit receivables and about $4.46 billion in investigative receivables. The investigative receivables include about $953 million in non-HHS investigative receivables, resulting from work in areas such as the States’ shares of Medicaid restitution.

Also during FY 2016, OIG reported 844 criminal actions against individuals or entities that engaged in crimes against HHS programs. OIG reported 708 civil actions, which include false claims and unjust-enrichment lawsuits filed in Federal district court, CMP settlements, and administrative recoveries related to provider self-disclosure matters. The CMP recoveries have increased almost five-fold over the past 3 years.

Health Care Fraud Strike Force Teams and Other Enforcement Actions

The Health Care Fraud Prevention and Enforcement Action Team (HEAT) was started in 2009 by HHS and DOJ to strengthen programs and invest in new resources and technologies aimed at preventing and combating health care fraud, waste, and abuse. Health Care Fraud Strike Force teams, a key component of HEAT, coordinate law enforcement operations conducted jointly by Federal, State, and local law enforcement entities.

The Strike Force model operates in Miami, Florida; Los Angeles, California; Detroit, Michigan; southern Texas; Brooklyn, New York; southern Louisiana; Tampa, Florida; Chicago, Illinois; and Dallas, Texas. During FY 2016, Strike Force efforts resulted in the filing of charges against 255 individuals or entities, 207 criminal actions, and $321 million in investigative receivables.

One example of Strike Force action is the unprecedented nationwide sweep in 36 Federal districts, with the assistance of 24 State Medicaid Fraud Control Units (MFCU). The sweep resulted in criminal and civil charges against 301 individuals, including 61 doctors, nurses, and other licensed medical professionals, for their alleged participation in health care fraud schemes involving approximately $900 million in false billings.

Prescription Drugs

Part D is the fastest growing component of the Medicare program, and Medicaid expenditures for prescription drugs are also increasing, influenced by Medicaid expansion and increasing expenditures for expensive specialty drug costs. HHS’ oversight of prescription drug programs face numerous challenges, affecting beneficiary and community safety and the integrity of the benefit itself.

High Part D Spending on Opioids & Growth in Compounding Drugs Raise Concerns Medicare Part D spending for commonly abused opioids exceeded $4 billion in 2015, and spending for compounded topical drugs increased more than 3,400 percent since 2006. This data brief builds on OIG’s June 2015 data brief, which described trends in Part D spending and identified questionable billing by pharmacies. It updates information on spending for commonly abused opioids and provides data on the dramatic growth in spending for compounded drugs.

OIG will continue to conduct investigations and reviews to address the ongoing problems created by opioid abuse and the emerging problems linked to compounded drugs. The Centers for Medicare & Medicaid Services (CMS) has taken steps to combat the problems associated with commonly abused opioids, such as identifying outlier prescribers. CMS also needs to assess the implications of the compounded drug trends identified in this data brief and take action where needed to protect the integrity of the program.

CMS Should Address Medicare’s Flawed Payment System for DME Infusion Drugs

This review, following up on an earlier recommendation, investigated the impact of the current Part B payment methodology on provider reimbursement rates for two vital drugs: pump administered insulin and milrinone lactate. We found that in 2015, Medicare paid suppliers 65 percent less than their cost for pump-administered insulin, which hindered beneficiary access to the drug. Using the same reimbursement methodology, Medicare paid suppliers of milrinone lactate, an infusion drug used to treat congestive heart failure, 20 times the drug’s cost, thereby creating incentives for overutilization and improper billing. Therefore, OIG continued to recommend that CMS take action to ensure that payment amounts for infusion drugs more accurately reflect provider acquisition costs.

As written in a January 2017 article in Life Science Compliance Update, it is too soon to tell the effect the Trump Administration will have on the pharmaceutical industry. This report and the recommendations contained therein highlight some of the focuses of OIG, but those have the propensity to change, depending on the incoming Administration. 

December 29, 2016

FDA Plans to Study Social Media Promotion


On November 7, 2016, the Food and Drug Administration (FDA) announced its plan to research methods for including risk information about pharmaceutical and medical device products in promotional internet communications that have character space limitations, such as sponsored links and microblogs. This move seems to be a step in line with the FDA’s plan to align drug promotion regulations with more modern communications technologies and platforms since releasing draft guidance in June 2014, “Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.”

When the FDA released the Social Media Guidance, it generated a significant amount of worry in the life sciences industry because it simply put the old rules for traditional communication platforms (i.e, print media, radio, and television) to the newer technologies (i.e., social media and other internet uses). Essentially, the Social Media Guidance required companies to include all relevant risk and benefit information in all internet promotions, even if that form of communication has character limitations. The FDA previously stated that the alternative is to not use the character space limited platforms to promote regulated products.

The FDA’s reasoning has long been questioned, since links to the complete product risk information can be more easily included in shorter communications. FDA did mention links to “a more complete discussion of risk information about the product” in the Social Media Guidance, but only as an additional element to a promotional communication that includes full benefit and risk information.

The Proposed Studies

The announcement proposes four different studies to gather data on participants’ retention of risk information communicated through sponsored links and microblog posts. The four studies will present participants with different promotional communications about two fictional drugs:

  1. A sponsored link to a fictional weight loss drug embedded in Google search results related to weight loss
  2. A sponsored link to a fictional migraine drug embedded in Google search results related to migraine
  3. A promotional tweet for a fictional weight loss drug embedded in a Twitter search page related to weight loss
  4. A promotional tweet for a fictional migraine drug embedded in a Twitter search page related to migraine

The FDA will tailor the promotional communication and participant instructions to gather data on circumstances that may affect the user’s retention of provided risk information in each study. Each participant will be presented with risk information either within the character-limited communication itself, or through a link provided in the communication. Second, each participant will then be instructed to either browse information about weight loss or migraine, or to perform directed searches for specific information.

It is the FDA’s belief that in each case, users will be more likely to retain risk information and have a greater sense of relevant risks when the risks are presented within the primary promotional communication and when users are searching for specific information about conditions or treatments.


The proposal is welcome, as the flow of information about FDA’s social media policies more or less stopped at the release of the June 2014 draft guidance. Only one OPDP letter issued in 2016 cited social media activity, leading to even further gaps and confusion.

If the studies support the FDA’s hypothesis, it is likely that the agency will not allow exceptions to the benefit/risk information requirement, even as communication and social media platform technology continues to evolve. However, if the studies show that risk information retention and perception of risk are statistically similar across some or all of the variables, the FDA will then be forced into reconsidering whether alternative methods of product risk communication may be acceptable.

If you have any comments on the proposed studies, you can go to, search for docket number FDA-2016-N-3585, and submit a comment electronically.

December 28, 2016

UN Panel Releases Report on Access to Medicines


In September 2016, the United Nations Secretary General issued a report on its Panel on Access to Medicines. The Panel called for a “new deal to close the health innovation and access gap.”

According to a press release issued by the Panel, “the world must take bold new approaches to both health technology innovation and ensuring access so that all people can benefit from the medical advances that have dramatically improved the lives of millions around the world in the last century.” The Panel was convened by the UN Secretary-General to propose solutions for addressing the incoherencies between international human rights, trade, intellectual property rights, and public health objectives.


The panel suggested that governments should initially form a working group to begin negotiating a Code of Principles for Biomedical R&D, and report annually on their progress in negotiating and implementing the Code in preparation for negotiating the Convention.

Transparency was a recurring theme throughout the report. The Panel repeatedly raised concerns regarding the negative impact of insufficient transparency on both health technology innovation and access, and was highly critical of the lack of transparency surrounding bilateral free trade and investment negotiations. The Panel believes transparence is a core component of robust and effective accountability frameworks needed to hold all stakeholders responsible for the impact of their actions on innovation and access.

The panel also recommended the UN General Assembly convene a Special Session no later than 2018 on health technology innovation and access to agree on strategies to and an accountability framework that will accelerate efforts toward promoting innovation and ensuring access in line with the 2030 Agenda for Sustainable Development.

These recommendations come at the end of a ten-month process for the Panel under the leadership of Ruth Dreifuss, the former President of the Swiss Confederation and Festus Mogae, the former President of the Republic of Botswana.

According to President Ruth Dreifuss, “Policy incoherencies arise when legitimate economic, social and political interests and priorities are misaligned or in conflict with the right to health. On the one hand, governments seek the economic benefits of increased trade. On the other, the imperative to respect patents on health technologies could, in certain circumstances, create obstacles to the public health objectives and the right to health.”

Reactions to the Report


In a statement released September 14, Stephen J. Ubl, President and CEO of Pharmaceutical Research and Manufacturers of America (PhRMA), noted, “The UN High Level Panel (HLP) on Access to Medicines was a missed opportunity to address the wide array of barriers to access that far too many people face every day.”

Ubl continued, noting “the ability of patients to obtain quality care depends on many factors – including health care infrastructure, government policies, adequacy of funding, the presence of trained health care providers, health literacy and stigma. Addressing these barriers, in the pursuit of universal health coverage, requires collaborative efforts and creative solutions which are workable in the long term and practically implementable.”

PhRMA wishes the report focusesd more on providing the opportunity for an “informed, balanced, and inclusive dialogue” that could have made a difference in the lives of patients without adequate access to treatments for the aforementioned, and other, reasons. Instead, the Panel’s report acknowledges its limitations in its mandate and unable to look at all factors. As such, the report focuses narrowly on solutions which fail to recognize and address the complexity of biopharmaceutical research and development and the significant work already taking place to advance access to care.

In sum, Ubl closes out by strongly stating, “Neither this report nor its recommendations can be a sound basis for further consideration or action by the UN system.”


The European Federation of Pharmaceutical Industries and Associations (EFPIA) agreed, at least in part, with PhRMA’s reaction to the report. While EFPIA “concurs with the report’s positive assessment of the pace of rapid scientific progress and its subsequent observation that many patients around the world still do not have access to these innovative and life-saving medicines, but the report fails to address key issues such as healthcare infrastructure and capacity.”

According to EFPIA Director General Richard Bergstrom, “For EFPIA and its member companies, access remains a priority, and with this in mind, we reiterate our commitment to partnering and finding solutions that aim to bring better healthcare.” However, he concluded his statement by saying, “We regret that the limited focus of the HLP report fails to move us forward on these key issues.”

United States

The United States also released a statement on the report through the Under Secretary for Public Diplomacy and Public Affairs of the State Department. That statement notes deep disappointment with the report, “which detracts from, rather than advance” critical objectives of increasing safe, effective, affordable, and life-saving medicines around the world, and to support policies that drive development of new medicines.

The United States believes that the narrowly-focused mandate was flawed and unlikely to lead to outcomes that adequately address the complex issue of access to care. The report stated the belief that we can both increase access to medicines and support innovation for the development of new and improved drugs for the world’s most critical health challenges. There can be no access to drugs that have not been developed: support for innovation is essential.

According to the statement, the United States Government “remains committed to advancing access to existing and new medicines, including by supporting innovation through robust intellectual property protections and working with public and private partners to find new solutions to the world’s pressing public health challenges.”

Doctors Without Borders

One of the few organizations that seems to agree with the UN report is Doctors Without Borders. Rohit Malpani, director of policy and analysis for Doctors Without Borders’ access campaign, stated,

[The report] puts forth actionable recommendations to help overcome the challenges that our medical teams have faced for decades – being left essentially empty-handed when the medicines, vaccines and diagnostics we need for our patients don’t exist, or are too expensive. [Its] global scope recognizes that today all countries face challenges in ensuring availability and affordable access to the medical tools that people need to live healthy and productive lives.

Additional Information

For a Fact Sheet issued by the UN Panel, click here.

For a letter issued by the Panel’s Co-Chairs, click here


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