Life Science Compliance Update

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September 20, 2017

Draft Released on Nevada Pharmaceutical Representative Registration Procedure

Filling-out-form

Nevada passed legislation earlier this year, putting many new restrictions and regulations on the pharmaceutical industry there. Now, we see that the state is moving much quicker than we had anticipated on implementing those regulations.

Timeline

The legislation had many different parts to it, touching just about every facet of the pharmaceutical industry.  With many different parts, an extensive timeline is required, with many different deadlines.

It was required that by July 1, 2017, the Department of Health and Human Services (DHHS) was to adopt regulations to help them carry out the provisions of the bill, including the form and manner in which manufacturers need to provide information described in the bill.

Also on July 1, 2017, and on every July 1 in an odd-numbered year from here on out, DHHS shall determine whether there is sufficient funding in place to carry out the provisions of the bill and if there is insufficient funding, has the ability to suspend any component for which there is insufficient funding. Also, DHHS may apply for – and accept – any grants, bequests, devises, donations, or gifts from public and private sources.

By October 1, 2017, some of the first deadlines go into effect, including: amending the definitions to reference those as defined in the bill; requiring DHHS to post the information received from non-profits, pharmacies, and the list of essential drugs, along with the wholesale acquisition cost and reports as required by the bill; and extending protection to DHHS for any act, omission, error, or technical problem that results in a failure to provide any (or incorrect) information.

Also on October 1, 2017, any manufacturer, pharmacy benefit manager (PBM), or non-profit that fails to provide the required information to DHHS may be fined up to $5,000 per day. Additionally, any representative that doesn’t provide the required information can be fined up to $500 per day.

January 1, 2018, several rules regarding PBMs go into effect, including: a fiduciary duty to third parties with which it has entered into a contract to manage the plan of the third party and shall notify the third party in writing of any activity, policy, or practice of the PBM that presents a conflict of interest that interferes with the ability of the PBM to discharge that fiduciary duty. A PBM gag rule will also be instituted, disallowing a PBM from: prohibiting a pharmacist or pharmacy from providing information to a covered person about the amount of any copayment or coinsurance or information of a less expensive drug, penalizing the pharmacist or pharmacy for providing information or selling a less expensive alternative, prohibiting a pharmacy from offering or providing delivery services directly to a covered person, or charging a copayment or coinsurance that is greater than the amount paid to a pharmacy in their network.

On every April 1, manufacturers are required to start reporting: costs of producing drugs, total administrative expenditures, profits earned and percentage of total profits attributable to the drugs, total amount of financial assistance provided through patient assistance, costs associated with coupons, wholesale acquisition costs, increase history for five years, aggregate amounts of all rebates provided to PBMs, and any additional information DHHS requires under regulations.

Also required on April 1 annually is PBM reporting, which requires reporting of the amount of rebates negotiated for the drugs on the list, the amount of the rebate retained by the PBM, the total amount of rebates negotiated for recipients of government-funded health care, and rebates negotiated for recipients of non-governmental third parties.

Additional timeline requirements can be found here.

Draft Pharmaceutical Representative Registration Procedures

Any individuals who meet the requirements included on this site must register with DHHS by October 1, 2017, or within thirty days of hire, and must be registered before engaging in work in Nevada.

If you are a pharmaceutical representative and you physically visit Nevada for five days or more annually to communicate with health care providers, you meet the requirements and will need to register. Additional activities that will include you in the definition include:

  • Engage in the marketing of prescription drugs to doctors or other health care providers, pharmacists or pharmacy employees, and employees of medical facilities. Marketing includes providing educational presentations and/or details intended to inform prescribers about their products as a way to influence them to purchase or prescribe.
  • Meet with physicians or other healthcare providers to answer questions about product use and benefits or providing discussion and product information and resources to key decision makers while representing the manufacturer or supporting promotional efforts of the manufacturer.
  • Distribute FDA regulated product samples and product information.

Excluded activities – ones that you can engage in and not be considered a representative that needs to register – are:

  • Attending a trade conference or convention hosted in Nevada that is not solely marketed to health care providers licensed in Nevada.
  • Activities related to clinical trials, investigational drugs, or Risk Evaluation and Mitigation Strategies.
  • Activities performed by wholesale distributors who do not represent a single manufacturer.

To register, the employing manufacturer may send an email to drugtransparency@dhhs.nv.gov, and DHHS staff will include the person’s name on the registry. If staff are hired or terminated from a company, they must notify DHHS who will then add or remove them from the current registry.

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