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May 14 — Drug and device manufacturers will be required to report payments or transfers of value to advanced practice nurses practicing in Connecticut beginning in January 2015, under new legislation signed May 8 that makes Connecticut the first state to adopt such a mandate.
The new law, P.A. 14-12, requires manufacturers of covered drugs, devices, biological and medical supplies to report the same information required by federal law to be reported for payments or transfers of value to physicians or teaching hospitals. It was signed by Gov. Dannel P. Malloy (D) May 8.
Under the law, manufacturers that fail to file a required report are subject to a civil penalty of $1,000 to $4,000 for each payment or transfer not reported.
The reporting requirement was included in a measure which allows advanced practice registered nurses (APRNs) who have been licensed and are practicing in collaboration with a physician for at least three years to practice independently. The bill had been proposed by the governor in order to increase access to health care in the state.
Language (Section 5) requiring manufacturers to report payments or transfers of value to APRNs was added during debate on the Senate floor in April in order to bring the reporting requirements into line with those required for physicians under federal law, according to Senate Majority Leader Martin Looney (D).
Looney told Bloomberg BNA May 14 that lawmakers felt it was important that, if APRNs were going to have increased independence, they should be subject to parallel transparency requirements as physicians.
Lynn Rapsilber, chair of the Connecticut Coalition of Advanced Practice Nurses (CCAPN), told Bloomberg BNA May 14 that nurses already sign in when attending educational luncheons or seminars and thus the amendment simply puts into law a system that is already in place.
Thomas Tremble, vice president of state government affairs for the Advanced Medical Technology Association (AdvaMed), a trade group for device makers, said in a phone interview with Bloomberg BNA May 13 that the association currently is reviewing the legislation and in discussions with its members to determine the impact of the new law on the industry.
He said there is some concern about Connecticut putting into place a requirement that no other state has adopted.
John Murphy, associate general counsel at the Pharmaceutical Research and Manufacturers of America (PhRMA), told Bloomberg BNA in an e-mail May 14, “Highlighting the very crucial and collaborative relationships between physicians and industry is a positive effort that ultimately benefits patients; nevertheless, this law's expansive Connecticut notification requirements are problematic for the biopharmaceutical industry.” Murphy added, “Given Connecticut's strong efforts to increase biotech presence within the state, we hope to continue working with legislators to provide context and education about negative impacts this legislation could have on the biopharmaceutical industry.”
The reporting language applies to U.S. manufacturers of drugs, devices, biologicals or medical supplies that are covered by Medicare or the state Medicaid or Children's Health Insurance Program plan, including a plan waiver. They must report the information to the Department of Consumer Protection quarterly with the first report due by Jan. 1, 2015. The law also allows the commissioner to publish the information on the department's website. The reporting provision actually takes effect Oct. 1.
The reporting requirement doesn't apply to transfers made indirectly to an APRN through a third party, in connection with an activity or service in which the manufacturer is unaware of the APRN's identity.
The bill requires these manufacturers to report the same information required by the federal Physician Payment Sunshine Act (part of the Affordable Care Act) for payments or transfers of value to physicians or teaching hospitals. This sunshine reporting, also referred to open payments reporting, at the federal level is being implemented by the Centers for Medicare & Medicaid Services.
Laura F. Laemmle-Weidenfeld, an attorney with Patton Boggs LLP in Washington, told Bloomberg BNA May 14 that the state law on payments to APRNs doesn't appear to be preempted by federal law. This is because federal rules (42 C.F.R. 403.914) preempt the states from requiring different reporting of the same physician-payment information that's required under the federal sunshine (open payments) law, and Connecticut's law covers information from non-physicians.
Language included in an amendment to the state's budget implementation bill (H. 5597), passed in the final hours of the 2014 legislative session, clarified that the required information must be reported quarterly to the state's Department of Consumer Protection, rather than the Department of Public Health.
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The text of the legislation (P.A. 14-12) is at http://www.cga.ct.gov/2014/ACT/PA/2014PA-00012-R00SB-00036-PA.htm. Scroll down to Section 5.
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