Life Science Compliance Update

February 06, 2018

Tomorrow: CMS To Host Open Payments Webinar/Q&A


Tomorrow, February 7, 2018, the Centers for Medicare and Medicaid Services (CMS) will be hosting a Webinar and Question and Answer session with CMS Open Payments program experts from 2:00 pm to 3:00 pm EST. CMS has been hosting these every few months for stakeholders to get some of their important questions answered.

During this webinar/Q&A session, the Open Payments team will present an overview of system enhancements and data submission activities and will then be able to respond to your questions about the 2017 Open Payments program year.

If you have a question, you must go online and register at least fifteen minutes prior to the webinar here. Once you are registered, you will receive an email with instructions on how to join the call and ask a question.

If you do not have a question, but want to listen to the call to gain insightful information, you can dial in to (844) 396-8222 and enter meeting number 900 984 780 when prompted.

January 12, 2018

Media Has it Out for Pharma…Still


Many would say that the media is no friend to the pharmaceutical industry. However, CNN has recently started to (seemingly) build a case against Avanir Pharmaceuticals for its promotion and marketing of its pseudobulbar affect (PBA) drug, Nuedexta.

In October 2017, CNN published its first article on the subject, where it was noted that the company “aggressively targets frail and elderly nursing home residents for whom the drug may be unnecessary or even unsafe.” While PBA afflicts less than 1% of Americans, it is most commonly associated with patients who have multiple sclerosis (MS) or ALS.

Then, in December 2017, CNN published another article on the company, once again dinging them for payments made to physicians and alleging that physicians had criminal convictions in their history for illegal prescribing.

According to CNN, Nuedexta's financial success is being propelled by a sales force focused on expanding the drug's use among elderly patients suffering from dementia and Alzheimer's disease, and high-volume prescribing and advocacy efforts by doctors receiving payments from the company.

Avanir Pharmaceuticals paid nearly 500 doctors to speak or consult on its drug, Nuedexta, between 2013 and 2016, according to government data. Through a review of the top prescribers and top paid physicians in this group, CNN identified a dozen who have been disciplined by state medical boards. These offenses included the harmful treatment of nursing home residents and "grossly negligent acts" involving the inappropriate prescribing of dangerous and addictive drugs -- resulting in probation, suspension, fines and revoked licenses.

Between 2013 and 2016, Avanir and its parent company, Otsuka, paid doctors nearly $14 million for Nuedexta-related consulting, promotional speaking and other services, according to government data. Paying doctors for promotional speaking is legal and is defended as a way for experts in their fields to share important experience and information about medications, but it's long been a controversial practice.  

Since 2012, more than half of all Nuedexta pills have gone to long-term care facilities. The number of pills rose to roughly 14 million in 2016, a jump of nearly 400% in just four years, according to data obtained from QuintilesIMS, which tracks pharmaceutical sales. Total sales of Nuedexta reached almost $300 million that year.

CNN noted that between 2013 and 2016, Avanir and its parent company, Otsuka, paid doctors nearly $14 million for Nuedexta-related consulting, promotional speaking and other services, according to government data. Paying doctors for promotional speaking is legal and is defended as a way for experts in their fields to share important experience and information about medications, but it's long been a controversial practice.  

In an emailed statement, the company said PBA is often "misunderstood" and that the condition can affect people with dementia and other neurological disorders, which are common among residents in long-term care facilities. A company website states PBA can afflict up to roughly 40% of dementia patients -- a figure that is based on an Avanir-funded survey and was repeatedly disputed by medical experts interviewed by CNN, including some of those paid by Avanir.

Avanir said it "vehemently oppose(s) any mischaracterization" of its interactions with physicians and other members of the medical community, explaining that these relationships are ethical and are used as a way to share important information and raise awareness of medical conditions and treatments that could help patients.

In response to the articles, the Pharmaceutical Research and Manufacturers of America, which represents drug makers across the country, said companies should strive to work with speakers who meet ethical and professional standards. "In the rare instance where there is an outlier," the group said on its website, "companies take corrective action."

This is one example of the way the media can use Open Payments to support cases against pharma companies. The ease with which Open Payments can be found highlights the need for companies to vet to whom they give money.

November 09, 2017

Senators Blumenthal and Grassley Ask CMS to Continue Funding Open Payments


In a letter to Acting Secretary of the U.S. Department of Health and Human Services (HHS) Eric D. Hargan, United States Senators Richard Blumenthal (D-CT) and Chuck Grassley (R-IA) ask HHS to prioritize funding for the Center for Medicare and Medicaid Services’ Center for Program Integrity (CPI), a program that enhances transparency in transactions between medical providers and pharmaceutical companies.

The CPI’s Open Payments database, created under the bipartisan Physician Payments Sunshine Act, mandates disclosure of billions of dollars in payments from manufacturers to prescribers and hospitals. This is of concern at a time when over-prescribing of opioid medications has exacerbated a public health crisis nationwide.

“As part of your ongoing commitment to the mission of CPI, we encourage you to continue to prioritize funding and administration of the Open Payments database,” wrote the Senators. 

The letter also references “[r]ecent reports [that] have raised concerns about the effect payments to health professionals may have on opioid prescribing practices, which in many ways has exacerbated this ongoing public health epidemic. Pending litigation against a fentanyl manufacturer has revealed instances of regular weekly contact with high-volume prescribers, in addition to a large number of total payments.”

In their letter, the Senators acknowledge often, “relationships between academic medicine and industry are necessary and beneficial,” but express concern that “some financial relationships influence prescribing and drive up costs.”

Blumenthal and Grassley are the lead sponsors of a bill to expand the Physician Payments Sunshine Act disclosure requirements to nurse practitioners and physician assistants, who are currently not mandated to disclose transactions with manufacturers.

The Provider Payment Sunshine Act, S. 308, would require drug companies and medical device makers to publicly disclose their payments to nurse practitioners and physician assistants for promotional talks, consulting and other interactions. The disclosures already apply to doctors, dentists, chiropractors, optometrists and podiatrists under the Physician Payment Sunshine Act, co-authored by Grassley and enacted in 2010 adopted as part of the Affordable Care Act (aka Obamacare). The records that apply to doctors are publicly available in the federal Open Payments database. 

Nurse practitioners and physician assistants write a significant number of prescriptions in Medicare and nationwide, and they were among the top prescribers for some drugs, including narcotic controlled substances, according to a ProPublica analysis. 

Blumenthal and Grassley are often on the same page when it comes to publishing payments from industry to physicians and other prescribers.

“There ought to be a complete record for consumer benefit,” Grassley has said. “The goal of sunshine for payments to doctors is to help the public. It makes sense to apply the sunshine to anyone who prescribes medicine. This bill is meant to continue the transparency that brings accountability in this part of the health care system.”

“It’s absolutely essential that companies disclose gifts and payments made to any health care provider who prescribes medications – not just doctors,” Blumenthal said. “Our bipartisan bill will rein in bad behavior by increasing transparency and accountability across the healthcare industry. Increased access to information is in the public’s best interest, and this legislation will ensure healthcare consumers receive safe, efficient, and cost-effective practices.”


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