Life Science Compliance Update

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29 posts from February 2017

February 28, 2017

Trump Executive Order Targets Regulations

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On one of his first few days on the job, President Donald Trump signed an executive order that would require all government agencies to eliminate two regulations for every one new regulation instituted.

The order was characterized by the Administration as a plan to help benefit small businesses. However, it is likely to have an impact on the United States Food and Drug Administration (FDA) as it applies to every agency (other than those related to military or national security), or any other agencies exempted by the Office of Management and Budget (OMB).

How this plan will work for an agency like the FDA is hard to comprehend: most of the regulations are intertwined with one another. As the EO is written, if the agency needed to put in place a new regulation, it would then have to presumably cut out two other, unrelated regulations that are linked to public health.

Another problem is that, according to the text of the EO, the directions apply to FDA guidance documents as well. This will be a large problem for pharmaceutical and medical device companies that rely on such guidances to understand FDA’s interpretations of the law. The EO defines the term ‘regulation’ or ‘rule’ to mean “an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.

The way this EO is implemented across the federal government is going to come largely from the OMB director, who will provide the heads of agencies with guidance addressing, among other things, “processes for standardizing the measurement and estimation of regulatory costs; standards for determining what qualifies as new and offsetting regulations; standards for determining the costs of existing regulations that are considered for elimination; processes for accounting for costs in different fiscal years; methods to oversee the issuance of rules with costs offset by savings at different times or different agencies; and emergencies and other circumstances that might justify individual waivers of the requirements.” 

Prior to releasing this EO, President Trump said, “This will be the biggest such act that our country has ever seen. There will be regulation. There will be control. But it will be normalized control where you can open your business and expand your business easily.”

"If you have a regulation you want, No. 1, we're not going to approve it because it's already been approved, probably, in 17 different forms," Trump said from the White House. "But if we do, the only way you have a chance is we have to knock out two regulations for every new regulation."

Although many of Trump's other executive orders have been met with criticism, this latest policy is not unfounded. Back in 2010, the United Kingdom adopted a similar policy, though its implementation did not apply to taxes, certain European Union legislation, non-business regulations and "regulation for civil emergencies," according to the U.K. government.

OMB Issues Guidance

On February 2, 2017, the OMB did issue guidance to the Agencies, highlighting what to expect and how to handle this executive order. The Q&A offers some clarity and boundaries for the EO signed last Monday, noting: “The EO’s requirements for Fiscal Year 2017 apply only to those significant regulatory actions, as defined in Section 3(f) of Executive Order 12866, an agency issues between noon on January 20 and September 30, 2017.”

But the OMB guidance does offer some wiggle room for FDA in terms of issuing draft or final guidance (2017 guidance plans for FDA's Center for Drug Evaluation and Research are here) noting that “significant guidance or interpretive documents will be addressed on a case-by-case basis.”

As far as what existing regulations if repealed would be considered part of the “two out” part of the EO, OMB notes, “Any existing regulatory action that imposes costs and the repeal or revision of which will produce verifiable savings may qualify.”

The guidance also offers FDA, which is an agency that deals with public health and safety, some ways to waive the “two out, one in” requirements of the EO. “Emergencies addressing critical health, safety, or financial matters, or for some other compelling reason, may qualify for a waiver from some or all of the requirements of Section 2,” the guidance notes.

But if a new regulation is implementing a new law from Congress (for instance, with FDA’s pending implementation of the 21st Century Cures Act), OMB clarifies that agencies should still “identify additional regulatory actions to be repealed in order to offset the cost of the new significant regulatory action, even if such action is required by law.”

Qordata Hosting Compliance Insights Webinar March 1

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On Wednesday, March 1, 2017, qordata is hosting a webinar, titled, “Making Analytics Work at Merck USA.” The webinar features Wendy Derosa, Associate Director, Data Analytics and Transparency at Merck USA and Bryan Timer, Associate Director, Data Analytics & Transparency at Merck USA.

The journey between understanding the compliance requirements behind CMS Submission, and integrating that with Merck’s internal systems resulted in a successful intersection of technology, legal and sales. Attendees of this webinar will learn how Ms. Derosa and Mr. Timer took a global challenge and turned it into a success story for Merck USA and its counterparts across the world.

Agenda of Webinar

This webinar will take a high-level approach to Compliance. The presenter will share her own experiences in joining this role as the Sunshine Act was being introduced in USA. Attendees will benefit from learning how a global organization such as Merck was able to combine resources from technology, operations, sales and legal to roll out a precise and multi-channel reporting solution.

The webinar will be conducted as an exchange of questions and answers between both Merck representatives and Mohammad Ovais, Founder and CEO of qordata. Responses may be as detailed as possible, and will include input from slides. The total duration per question is framed within 5 minutes, so that the topic may be covered holistically and in-depth.

The agenda will focus on the following topics:

  • Challenges of introducing an internal compliance reporting mechanism in a multi-market organization like Merck
  • Integrating technology with sales, operations and compliances for timely identification and redress of data errors
  • Transition from basic internal reporting to a culture of advanced spend analytics
  • Tools and resources for enhancing compliance program

Expected Takeaways from the Webinar

With speakers like Ms. Derosa and Mr. Timer, attendees can expect to:

  • Acquire insights into how technology integrated with sales, compliance and operations can assist in timely identification of data errors
  • Learn about tools and resources that assist in formulating sophisticated compliance programs
  • Acquire detailed information about how data analytics helped Merck USA with its compliance efforts

If you are a decision maker responsible for designing and executing internal compliance structures within the realm of the global Compliance, Technology, Internal Audit and Marketing C-Suite, you are highly encouraged to attend. Life Sciences Industry participants seeking solutions to program challenges will benefit from the compliance-analytics experience at Merck USA.

If you are interested in attending this webinar, you can register for free here.

February 27, 2017

Senate Finance Committee Hearing on Seema Verma Confirmation

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On February 16, 2017, the Senate Finance Committee held a hearing to discuss the nomination of Seema Verma to be the Administrator of the Centers for Medicare and Medicaid Services (CMS). The hearing provided a little bit of insight into her plans for Medicare and Medicaid reform, should she be approved by the full Senate.

Ms. Verma did not offer many specifics on what types of reforms she will pursue, and she did not react to the recently-proposed CMS rule on market stabilization. She was particularly non-committal about the prospect of a Medicare premium support model and expressed enthusiasm for changing Medicaid, expressing a desire to attain better outcomes while noting multiple policy options available. Verma also discussed drug prices and praised the current negotiating abilities of pharmacy benefit managers and plan sponsors in Part D.

Chairman Orrin Hatch opened the hearing by complimenting Ms. Verma and her work on the Healthy Indiana Medicaid waiver plan, while Ranking Member Ron Wyden expressed concerns about Ms. Verma’s conflicts of interest and ability to lead CMS in a direction that benefits all Americans.

Ms. Verma stood up for herself and her past, noting that she has devoted her career working on policy for the most vulnerable Americans, and that she started her career by working on healthcare solutions for those affected by HIV/AIDS. She further noted that she wants to put the power to make healthcare decisions in the hands of the patients, along with pledging to modernize CMS and combat fraud.

Medicare

A topic that has received much discussion, whether Medicare and other government plans should be able to negotiate their own drug prices, was touched upon by Senator Debbie Stabenow. Verma did not really answer the question directly, instead noting that under her direction, CMS would do everything in its power to get affordable prices for seniors. She further noted her appreciation for PBMs and the Part D program that are already performing that function to the best of their ability.

Senator Bill Nelson asked Ms. Verma whether she would turn Medicare into a voucher program. She explained that it is not her intention, and that she is more interested in giving beneficiaries the choices and options they deserve.

Medicaid

Several of the senators were concerned about various aspects of Medicaid. Senator Robert Menendez expressed concerns that, if the Affordable Care Act were repealed, many children with autism would lose access to vital treatment and therapy. He asked Ms. Verma what she would do to protect their care, and she stated she had actually been advised by the Office of Government Ethics to refrain from engaging in matters related to mental disorders and care, due to a conflict of interest with her husband’s child psychiatry practice.

Senator Maria Cantwell shared “grave” concerns about block granting Medicaid and wondered how Ms. Verma would handle such a proposal. Ms. Verma noted that Medicaid does not currently encourage innovation due to its rigidity, and that the system needs to be rebalanced to allow more state leadership and flexibility for creativity. She stated that any reform would focus on ensuring better outcomes for patients.

Senator Sherrod Brown asked Ms. Verma to work with state Medicaid directors and encouraged her to have open communications with them. Ms. Verma seemed receptive to the idea, further agreeing with Senator Brown that CHIP funding should be extended for at least eight more years, in line with what HHS Secretary Price recently threw his support behind.

Senator Tim Scott asked for policy ideas that would work best to strengthen Medicaid on a state level. Ms. Verma noted that what works in one state may not work in another, that there is no one-size-fits-all solution to Medicaid that would be applicable to all fifty states.

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