Life Science Compliance Update

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.

September 11, 2017

Louisiana Price Transparency Measures Go into Effect…With An Interesting Twist

Louisiana-barndominium

According to LexisNexis State Net, during 2017, about half of the states and Congress collectively introduced almost 90 measures intended to address soaring prescription drug prices. Most would either cap drug prices or force drug makers to be more transparent with how they devise pricing for at least some medications.

A handful of states, including Maryland (HB 631), Louisiana (SB 59) and Nevada (HB 539), have adopted such measures this year, and New York adopted a law in April as part of the budget that imposes greater scrutiny on drug makers over their pricing.

There is also word that the Trump administration is planning action. Although the Food and Drug Administration has no direct control over drug prices, in a June blog post FDA Commissioner Scott Gottlieb said his agency plans to encourage the development of additional lower-cost generic drugs. The effort would likely have a limited impact, however, as the growth in drug prices is largely driven by newer drugs under patent and without generic competition.

In mid-June 2017, Governor John Bel Edwards of Louisiana signed two drug price transparency measures. HB 436 – unanimously passed by the legislature – requires manufacturers engaging in the marketing of prescription drugs in the state to make quarterly reports of the wholesale acquisition cost (WAC) prices to the Louisiana Board of Pharmacy.

SB 59 – also passed unanimously – requires the Louisiana Board of Pharmacy to post on a website those WAC prices, organized by therapeutic category. Health profession licensing boards that regulate Louisiana prescribers are required to annually remind/advise them as to the availability of the website. Interestingly, however, is the mandate that the Board obtains private grant funding to implement and operate the website.

HB 436 requires that, “Each drug manufacturer or pharmaceutical marketer who engages in any form of prescription drug marketing to a prescriber, his designee, or any member of his staff in Louisiana shall provide to the Louisiana Board of Pharmacy no later than January first, April first, July first, and October first of each calendar year the current wholesale acquisition cost information for the United States Food and Drug Administration approved drugs marketed in the state by that manufacturer.”

The Senate bill requires “the Louisiana Board of Pharmacy … develop a website to contain prescription drug price information to be made available to Louisiana prescribers on the board's website with a dedicated link that is prominently displayed on the board's home page, or by a separate easily identifiable internet address.” The website shall include, at a minimum, the following data elements, separated by therapeutic category: (a) Name of the product; (b) Whether the drug is a brand name or a generic; (c) Drug strength; (d) Per-unit wholesale acquisition cost of the drug; and (e) Any disclaimers deemed appropriate by the board.

With respect to the grant, the law states, “Implementation of this Section shall be contingent upon the Louisiana Board of Pharmacy's obtaining grant funds from private entities for the development, implementation, operation, and continued maintenance of the drug pricing disclosure website.” It is also mandated that the “board shall actively seek grant funding to implement the provisions of this Section. Within ten months of successful receipt of grant funds sufficient in amount to implement the provisions of this Section, the board shall make the drug pricing disclosure website available to prescribers.”

We were unable to find any news as to the success of the finding of the grant funding. The bill became effective June 14, 2017.

September 07, 2017

New Report Outlines Steps for Greater Transparency

Nehi_transparencyreport_twitter_border

In July 2017, The Network for Excellence in Health Innovation (NEHI) released a new report that outlines steps for greater transparency in health care. The report states that helping consumers make well-informed decisions can lead to higher quality of care, greater patient satisfaction and better use of the nation’s health care resources.

NEHI found that most consumers make medical decisions without proper support, after interviewing health care industry experts, holding a discussion with thought leaders, and reviewing existing research.

Choosing a doctor, hospital, health insurance plan, or a course of medical treatment can be overwhelming, and these information gaps in the system cost both consumers and the nation. Their research revealed:

  • Consumers often don’t know that they may have multiple treatment options or that health care costs can vary widely for the same service.
  • While there are tools to help consumers with the decision-making process, these tools are not consistently available or useful.
  • If consumers make the wrong decision when selecting a health plan or provider, there could be expensive consequences.

The NEHI report states that “providing high-quality information to consumers through well-designed tools, as well as other resources to help them interpret that information, can address these issues and empower consumers to make superior choices. Having adequate information can also help to protect consumers from financial surprises, such as learning after the fact that a given provider is out-of-network and that treatment that has already been provided will not be covered by the insurer. The need to address the potential for unwelcome financial surprises is especially important as plans move toward increased cost sharing, narrower networks, and restrictions on pharmaceutical formularies.”

Based on their research, NEHI proposes a nine-step process to help consumers make more informed decisions and provides a number of recommendations. This includes a public awareness campaign, better marketing of the tools available to consumers and policy recommendations for lawmakers.

The nine steps include:

  1. Conduct public awareness campaign on choice and its consequences;
  2. Increase consumer awareness of tools and resources;
  3. Simplify presentation of data with access to greater detail if desired;
  4. Customize options presented based on consumer characteristics and preferences;
  5. Increase trust through involvement of neutral third parties in tool development and dissemination;
  6. Hold plans and providers accountable for data accuracy and protect consumers from the financial consequences of acting on inaccurate or incomplete data;
  7. Create tools, payment incentives, and liability protections to encourage providers to engage with consumers;
  8. Implement policy changes to broaden the availability of data and tools; and
  9. Create and pilot test a common, integrated platform through which consumers can access the full array of tools and resources.

The report concludes that while much of the onus to better engage consumers in decision-making will necessarily fall on health plans and providers, policymakers can also play a key role in making sure that consumers can get the information they need.

Specifically, policymakers can encourage the dissemination and implementation of best practices for creating meaningful transparency tools; implement protections for consumers who make decisions based on inadequate or inaccurate information; build on existing tools at the state and federal level; and incorporate incentives for providers in value-based payment arrangements to support shared decision-making with patients. Research compiled by NEHI suggests that these initiatives could lead to better quality of care, greater consumer satisfaction, and far better use of the nation’s health care resources.

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