Life Science Compliance Update

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.”

June 16, 2017

Webinar on CMS Spend Submission


On Tuesday, June 20th, qordata is hosting a panel discussion webinar on “Learning From CMS Spend Submission.”

The webinar will run from 11:00 am EST – 12:00 pm EST and will include discussion from Chrissy Bradshaw of Porizo, April Pierce of Shire and Elizabeth Bodine of Merz USA. The three executives will share their experiences in implementing and working around the spend obligation.

The following topics would be covered in this Panel Discussion:

  • Best practices to follow after spend submission
  • Advanced spend data monitoring using Open Payments data
  • Identify outliers on the basis of benchmarks
  • Avoid litigations and Law suits
  • Improve compliance programs using data analytics

The agenda will cover: lessons learned by the pharmaceutical manufacturing industry from 2013 through 2017; preparation for changes in the Sunshine Payments Act; adjustments that are required in internal analytics systems; and how analytics have assisted other functions within their business.

Senior and mid-level transparency, corporate compliance and legal professionals from the pharmaceutical manufacturing industry are encouraged to attend, as are Pharma Sales Professionals interested in improving their reporting practices via technology.

If you can’t attend live we still encourage you to register for the event, as qordata will send out a recording and slides to those who are unable to attend live.

February 14, 2017

Connecticut APRN Reporting Policy Starting to Come to Fruition...Kind Of


We have previously written about Connecticut policy that was aimed at reporting payments from pharmaceutical and device manufacturers to nurse practitioners. Back when the law was originally passed, Connecticut planned to require pharmaceutical and device manufacturers to report payments and transfers of value to advance practice registered nurses (APRNs), starting July 2015. APRNs include: nurse practitioners, clinical nurse specialists, nurse anesthetists, and nurse midwives. The first reporting date is from July 1, 2015 to June 30, 2017, and requires annual reports on July 1, 2017 (rather than quarterly filings as was in the original legislation).

Under the Connecticut General Statutes, a licensed APRN who has maintained their license for at least three years, and engaged in the performance of advanced practice level nursing activities in collaboration with a physician for at least three years (and at least two thousand hours), may – with or without physician collaboration –

Perform the acts of diagnosis and treatment of alterations in health status and prescribe, dispense and administer medical therapeutics and corrective measures and dispense drugs in the form of professional samples in all settings. Any advanced practice registered nurse electing to practice not in collaboration with a physician shall maintain documentation of having engaged in the performance of advanced practice level nursing activities in collaboration with a physician for a period of not less than three years and not less than two thousand hours.

Companies are required to register and pay a fee.

Any eligible APRNs are required to submit written notice to the Department of Public Health of his or her intention or practice without physician collaboration prior to beginning such a practice. The Department of Public Health is responsible for annually publishing a list of such APRNs who are authorized to practice not in collaboration with a physician, which can be found here.

There are only roughly 450 providers listed who are authorized to practice not in collaboration with a physician. However, the list of providers does not include an address – just the provider name and license number. Such an effort at transparency could lead to unnecessary confusion and uncertainty, on the part of both patients and those trying to keep up with reported payments.  

With no address or much of any identifying information, it could be difficult to be certain that the APRN whose information they are looking at online is the APRN they are seeing. While there are many unique names on the list of APRNs who can practice without physician collaboration, even the most unique names can be shared by multiple people, not to mention many common names.

Further, we have seen the difficulties with the federal Open Payments, and how many payments get attributed to the incorrect physicians, with more information available to them than just a name and license number. Typically, there are hospital affiliations, addresses, etc. that help to identify and confirm physician identities. Even still, there are many payments that are misattributed year after year.

The dates of reporting is also news to applicable manufacturers (GPO's, Distributors, Drug and Device Manufacturers), It is not known why they went back to the July 1, 2015 recording date after the state legislature had delayed reporting.

This move by Connecticut was an expansion of the requirements from under the current Open Payments System; under federal law, APRNs are excluded from the reporting obligations.     

In the interim, keep your eye on Connecticut and other states who are also looking to expand the federal Sunshine Act, as well as moves made by Congress to expand the federal Sunshine Act even further (to be expounded upon in a future article).


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