Bill Extends Sunshine Act to NPs and PAs

October 09, 2015

Physicians are not the only clinicians who receive lunches, speaking fees, and textbooks from drug and device makers.

By virtue of their ability to prescribe medicine and order other treatments for patients, physician assistants (PAs), nurse practitioners (NPs), and other kinds of advanced practice registered nurses (APRNs) also receive cash and in-kind payments from industry.

That is why two US senators introduced legislation on October 7 to bring these clinicians under the Sunshine Act, a section of the Affordable Care Act that requires drug and device makers to tell the government what they give physicians. The idea is to discourage conflicts of interest that could cause a physician to favor treatments that are not the best for the patient's health or pocketbook. Advocates of transparency in the relationship between clinicians and industry have called the omission of NPs and PAs a significant loophole in the law.

The news organization ProPublica analyzed Medicare's Part D prescription drug program recently and found that NPs and PAs accounted for roughly 1 in 10 scrips in 2013. These clinicians wrote almost 14% of prescriptions for all patients in 2014, according to research firm IMS Health.

Under the Sunshine Act, drug and device makers must notify the Centers for Medicare & Medicaid Services of any "transfer of value" of $10 or more to physicians. Transfers of value less than $10 that add up to more than $100 a year also are reportable, as are ownership stakes in drug and device makers.

The first batch of payments, covering the last 5 months of 2013, were posted on the Open Payments website of the Centers for Medicare & Medicaid Services on September 30, 2014. In June 2015, the Centers for Medicare & Medicaid Services published industry payments to physicians in 2014 totaling almost $5.25 billion. Of this amount, $2.02 billion took the form of general payments, $2.52 billion funded research, and $703 million represented ownership stakes in drug and device companies.

The bill amending the Sunshine Act to include PAs, NPs, and other kinds of APRNs is sponsored by Sen. Chuck Grassley (R-IA) and Sen. Richard Blumenthal (D-CT).

Sham Speaking Fees for an APRN

Elissa Ladd, PhD, an NP and associate professor of nursing at the MGH Institute of Health Professions in Boston, Massachusetts, has studied the financial relationship between her profession and industry. Dr Ladd told Medscape Medical News that she has seen an uptick in payments to NPs since the passage of the Affordable Care Act. "NPs represent a growing field," she said, "and the money spent on them is nonreportable."

The proposed amendment to the Sunshine Act "is really good news," she said. "It makes no sense to exclude a very large group of prescribers from the law."

Dr Ladd pointed to the federal court case of an APRN in Connecticut as example of how industry largesse can corrupt clinical judgment.

In June, Heather Alfonso pleaded guilty to accepting $83,000 in kickbacks from a pharmaceutical company in exchange for prescribing fentanyl sublingual spray (Subsys, Insys Therapeutics) for cancer pain. Prosecutors described her as one of the heaviest prescribers of the drug in the nation.

The kickbacks took the form of speaking fees from the drug's manufacturer at more than 70 dinner programs. For most of them, Alfonso did not make any presentation about the drug in question, and her listeners were not licensed to prescribe controlled substances, according to prosecutors. She received roughly $1000 for each event. Alfonso admitted that the money influenced her prescribing.

"Most NPs are good, conscientious prescribers," Dr Ladd said. "But those influences are felt by us as well as the medical community."

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