New State Legislation & Regulations

New State Legislation & Regulations Affecting Pharmaceutical Manufacturers

We recently sent an important Legislative Watch update to our MediSpend customers on January 16, 2018.  We are posting a summary here for your convenience along with links to the legislation. 

New Jersey 

Last week we sent out an alert summarizing the final rules in New Jersey regulating exchanges with prescribers. The final rule places an annual cap on payments to New Jersey licensed prescribers for certain bona fide services. The limit does not apply to research and educational payments. The rule also prohibits pharmaceutical companies from providing any item that does not advance disease or treatment education and places a $15 limit on meals.

On January 16th, New Jersey released a final clean version of the law. You locate an outline of this version here. 

Nevada

Nevada has also released templates and FAQs for reporting requirements pursuant to Senate Bill 539 earlier this month. There are two different reports required by the pharmaceutical manufacturers and one report to be reported by individual pharmaceutical sales representatives. The FAQs clarified that the transparency law applies equally to all pharmaceutical representatives and not just those who are engaging in the sales and marketing of the diabetes-related treatments.

Manufacturers must submit a list of all pharmaceutical sales representatives who market prescription drugs on behalf of the manufacturer. Additionally, manufacturers must submit a report to the Nevada Department of Health and Human Services (DHHS) containing price information for prescription drugs. Pharmaceutical benefit managers must also submit reports on pricing.

Finally, pharmaceutical sales representatives must submit to DHHS by March 1st for the previous calendar year, a report of all compensation or prescription drug that was provided to a provider of health care that is licensed, certified, or registered in Nevada.

When contacted by MediSpend, DHHS stated, “the reporting period for 2017 will be from October 1 through December 31. For 2018, the reporting requirement will be for the entire year. The first report is due March 1, 2018 per the law.”

An outline of these regulations as well as the templates provided by DHHS can be found here. 

Maine

In November of 2017, Maine enacted a law banning gifts to physicians from pharmaceutical manufactures as part of Chapter 117 of the Pharmacy Act. The State has since published a revised version of the law on their legislative website. The Statute prohibits a manufacturer or its agents from offering or giving the following to a practitioner:

  • a cash gift in any amount; or
  • a gift for which reciprocity is expected or implied to a practitioner

The law does carve out exceptions for certain items of minimal value, education, and honoraria. The law can be found here. 

MediSpend Regulatory Team


Posted on Feb 14, 2018 1:15:00 PM

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