It’s All About State Compliance

Written by Alexis Stroud - Director, Quality and Compliance, QPharma

 We are approaching the end of 2010, and by now, you should have filed your state aggregate spend reports for D.C., Massachusetts, Maine, Minnesota, Vermont, and West Virginia* .  You are most likely also preparing for the Physician Payment Sunshine Provision, included in the Patient Protection and Affordable Care Act (PPACA).  But are you aware of the numerous other state laws and regulations that affect the sales and marketing teams within your organization?  In this post, I will review some of the state legislation that you should be aware of including:

•    Compliance Programs
•    Sample Theft/Loss Reporting
•    Sample Transparency
•    Lobbying
•    Data Privacy
•    Representative Licensing

*Medical Device companies – You are not off the hook!  You too are required to track and report aggregate spend in CA (declaration of compliance), MA, and VT.  You will also be required to report under the federal PPACA in 2013.

Compliance Programs
The company must have a compliance program in place with certain elements. For example:
•    Adhere to, at a minimum, PhRMA Code (CA, MA, NV, CT)
•    Program must be in accordance with OIG Guidance (CA, CT)
•    Compliance Training (CA, CT, MA, NV, VT)
•    Compliance Monitoring (CA, CT, MA, NV, VT)

Sample Theft/Loss Reporting
Certain states require the reporting of sample thefts and/or losses in addition to federal reporting. For example:
•    Vermont and Washington require reporting immediately
•    Arkansas, Florida, Hawaii,  Indiana, Louisiana, Oregon, Wyoming require reporting within 3 working days
•    Colorado and Ohio require reporting within 30 days
•    New Mexico, North Dakota, South Carolina, and Virginia also have reporting requirements

Sample Transparency
Vermont’s Senate bill 88 (“SB88”) amends Vermont’s Pharmaceutical Marketing Disclosure Law by requiring manufacturers of prescribed products to disclose to the Vermont Attorney General’s Office all free samples of prescribed products provided to health care providers during the preceding calendar years.
•    “Sample” includes starter packs and coupons or other vouchers that enable an individual to receive a prescribed product free of charge or at a discounted price

•    This bill requires manufacturers to identify for each sample the product, recipient, number of units, and dosage
•    The first report is due on April 1, 2012 for the previous year's sampling activity

Lobbying
These laws require “lobbyists” to register and file a report that contains certain expenditure data. For example:
•    Colorado requires expenditures in excess of $50 to be reported
•    Florida requires a signed statement under oath of expenditures in excess of $25
•    Connecticut and Kentucky require a report for all expenditures
•    Louisiana requires reporting on expenditures that exceed $50 on any one occasion or $250 in a reporting period

Data Privacy
These laws require that certain prescriber data remain private. For example:
•    New Hampshire became the first state to pass a law that restricts the sale and use of prescriber data.
•    Vermont enacted a data privacy law which keeps prescriber data confidential unless practitioners request that their data be made available to the public.

There are also several other states that provide prescribers the option to “opt out” of being included in lists.  This includes lists of practitioner licensure data used for practitioner validation.  States also vary on the type of information they will provide within the list.

Representative Licensing
D.C. is currently the only state which requires all “detailers” doing business in DC to be licensed and held to a professional code of conduct. The bill also requires detailers to have an appropriate educational background.

Keep On Top of State Laws!
These were just a few of the state issues you should familiarize yourself with.  Others include mid-level prescriptive authority, distributing controlled substances, distributor licensing (wholesaler, virtual, 3PL, samples only), and pedigrees.  Many of the states also have fines for violating their laws (and investigate noncompliance). Pleading ignorance is not acceptable, so it’s important that you understand the legislation and know how to comply with it.

Looking for Regulatory Compliance help? Email us your questions at info@qpharmacorp.com!

Vermont Disclosure of Free Samples - What Will Be the End Result?

written by Alexis Stroud - Manager, Regulatory Compliance at QPharma

On May 27, 2010, Vermont Senate Bill 88, An act relating to health care financing and universal access to health care in Vermont (S.88) became law, without the Governor’s signature. Among other things, S.88 amends Vermont's Pharmaceutical Marketing Disclosure Law by requiring manufacturers of prescribed products to disclose to the Vermont Attorney General's Office all free samples of prescribed products provided to health care providers during the preceding calendar year. The bill authorizes the Vermont Attorney General to publicly report aggregated sample distribution information.

Who is Required to Report?
Each manufacturer of prescribed products shall disclose to the office of the attorney general all free samples of prescribed products provided to health care providers during the preceding calendar year.

“Sample” is defined as a unit of a prescription drug, biological product, or medical device that is not intended to be sold and is intended to promote the sale of the drug, product, or device. The term includes starter packs and coupons or other vouchers that enable an individual to receive a prescribed product free of charge or at a discounted price.

What Information is Required to be Reported?
This bill requires manufacturers to identify for each sample the product, recipient, number of units, and dosage.

When is the First Report Due?
The first report is due on April 1, 2012 for the previous year's sampling activity.This section will not apply to samples of prescription drugs required to be reported under Sec. 6004 of the Patient Protection and Affordable Care Act (refer to the white paper “Physician Payment Sunshine Provisions Health Care Reform” for additional information on Sec. 6004), if as of January 1, 2011, the office of the attorney general has determined that the U.S. Department of Health and Human Services will collect and report state- and recipient-specific information regarding manufacturer distribution of free samples of such prescription drugs.

What are the Penalties for Noncompliance?
Failure to Disclose - A civil money penalty of no more than $10,000 per violation. Each unlawful failure to disclose shall constitute a separate violation.

Will the Information Submitted be Available to the Public?
This bill authorizes the Vermont Attorney General to publicly report aggregated sample distribution information. Public reporting will not include information that allows for the identification of individual recipients of samples or connects individual recipients with the monetary value of the samples provided (i.e. including the names or license numbers of individual recipients).

Current Controversy over Sample Disclosure
With the passing of this bill, Vermont has become the first state to enact sample disclosure reporting requirements. This bill was passed without Governor Douglas’ signature. He states, “… the drug sample reporting provision adds burdensome new regulations that are unnecessary and could make it difficult for low-income Vermonters to receive needed medications. These sections do not represent meaningful reform; rather they detract from the serious work ahead.” Although S.88 includes these provisions, Governor Douglas decided to allow the bill to become law because it includes a critical expansion of the innovative Vermont Blueprint for Health.

This provision was initiated over concerns that there is a correlation between the distribution of samples and the prescribing patterns of doctors who receive them. A number of senators objected to the sample disclosure requirements. Rutland senator Kevin Mullin argued that the bill would have a chilling effect on the use of free samples in Vermont.


Do you think the disclosure of this information will deter practitioners from accepting or requesting products? Should manufacturers be required to report the distribution of free samples and is there a benefit to making this information available to the public? Please share your opinions here...