Latest / Pharmacy Podcast Network / The Season to Innovate: Strategic Legal and Regulatory Considerations for Approaching Acquisitions and Vetting AI Vendors | NASP Specialty P

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The Season to Innovate: Strategic Legal and Regulatory Considerations for Approaching Acquisitions and Vetting AI Vendors | NASP Specialty P · Pharmacy Podcast Network

• 0:07
  Speaker 1: Thanks for listening to the Pharmacy Podcast Network.
• 0:23
  Speaker 2: You're listening to the NASP Specialty Pharmacy Podcast, a collaboration
• 0:28
  Speaker 2: between the National Association of Specialty Pharmacy and the Pharmacy
• 0:32
  Speaker 2: Podcast Network. Each episode dives deep into trends, challenges, innovations,
• 0:37
  Speaker 2: and patient centric practices shaping the future of this dynamic
• 0:41
  Speaker 2: and rapidly evolving industry. Whether you're a pharmacist or healthcare provider,
• 0:46
  Speaker 2: patient advocate, or industry leader, you'll hear expert insights, real
• 0:50
  Speaker 2: world evidence, and thought provoking discussion that highlights all that
• 0:54
  Speaker 2: makes specialty pharmacy special.
• 0:57
  Speaker 3: In support of NASP's mission to empower specialty pharmacy stakeholders
• 1:01
  Speaker 3: to advance the standard of patient care, NASP supports a
• 1:05
  Speaker 3: free market healthcare system in which all specialty pharmacies compete
• 1:08
  Speaker 3: on the same fare and level playing field, because that
• 1:11
  Speaker 3: is in the best interest of the patients we collectively serve.
• 1:14
  Speaker 3: NASP is committed to working with all stakeholders and policymakers
• 1:18
  Speaker 3: to ensure that all patients have access to the life
• 1:21
  Speaker 3: saving medications they need and the high touch patient care
• 1:23
  Speaker 3: and support services they deserve from the pharmacy of their
• 1:26
  Speaker 3: choosing Well.
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  Speaker 4: My name is Sheila Arquette, and I am the President
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  Speaker 4: and CEO of the National Association of Specialty Pharmacy. I
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  Speaker 4: am delighted to welcome my special guests, Simone Colgan Dunlap
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  Speaker 4: and Amy Cotton Peterson to this episode of the NASP podcast.
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  Speaker 4: Simone Colden Dunlap is National Vice Chair of the Coral's
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  Speaker 4: Health and Life Sciences Practice Group. Simone's practice is focused
• 1:49
  Speaker 4: on regulatory compliance related risk management in corporate and contracting
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  Speaker 4: matters for a variety of clients, with a particular emphasis
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  Speaker 4: on specialty pharmacy. Provide it's creative, practical, and strategic advice
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  Speaker 4: on a diverse array of regulatory compliance issues, including artificial intelligence, HIPPA,
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  Speaker 4: state privacy laws, the anti Kickback Statute, and civil monetary
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  Speaker 4: penalties law, and state pharmacy laws. Simone also has significant
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  Speaker 4: experience drafting and negotiating agreements, including distribution agreements, business associate agreements,
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  Speaker 4: GPO agreements, data use agreements, licensing agreements, specialty pharmacy service agreements,
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  Speaker 4: HUB agreements, marketing agreements, runs, consulting agreements, independent contractor agreements,
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  Speaker 4: and numerous other commercial contracts. She graduated cum laude from
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  Speaker 4: the University of Michigan Law School. Amy Cotton Peterson helps
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  Speaker 4: entities in the healthcare industry navigate the labyrinth of laws
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  Speaker 4: and regulations governing their operations and evolving businesses with deep
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  Speaker 4: knowledge of constantly evolving technologies, service models, and client needs.
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  Speaker 4: Advises on healthcare transactions, regulatory compliance related to lissure, privacy,
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  Speaker 4: medicaid and Medicare reimbursement, clinical trials, provider self referral and
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  Speaker 4: false claims, and provide our defense before licensing boards and
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  Speaker 4: regulatory agencies. Amy also counsels clients on business operations and development,
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  Speaker 4: including internal investigations and securing regulatory approval for novel business models.
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  Speaker 4: As a former licensed physical therapist, she brings an invaluable
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  Speaker 4: inside the industry perspective to the legal and regulatory challenges
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  Speaker 4: facing providers and related healthcare entities. Simon and Amy, thanks
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  Speaker 4: so much for joining me today.
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  Speaker 5: Thank you, Sheila retrilled to be here.
• 3:46
  Speaker 4: So let's get started on the acquisition front. What are
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  Speaker 4: the key steps entities should take when evaluating a target.
• 3:54
  Speaker 1: Sure, with evaluating any target, especially in healthcare and healthcare technology,
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  Speaker 1: your goal is to really look under the hood. So
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  Speaker 1: after the financial diligence and the modeling. I generally think
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  Speaker 1: about it as starting very broad and then narrowing the scope.
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  Speaker 1: So first you get a overall idea of the company's operations, models,
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  Speaker 1: revenue streams, etc. And then you evaluate the company structure.
• 4:20
  Speaker 1: You decide what you are going to buy. Is it
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  Speaker 1: the entire company through an equity purchase or do you
• 4:26
  Speaker 1: just need one specific asset. So you want to make
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  Speaker 1: that determination and that will frame your diligence. So then
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  Speaker 1: you start to get more into the weeds and really
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  Speaker 1: start to evaluate the company's operations and compliance so compliance
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  Speaker 1: with applicable regulation licensure, also evaluate any contractual arrangements and
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  Speaker 1: make sure that they comply with law, including fraudways and
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  Speaker 1: abuse and data privacy laws. And then during this phase
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  Speaker 1: you also look at the target's history of any discipline
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  Speaker 1: or litigation or any threatened actions or any facts that.
• 5:02
  Speaker 5: Could lead to those types.
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  Speaker 1: Of actions against the company. So the goal of this
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  Speaker 1: diligence phase is to really find out as much as
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  Speaker 1: you can about the asset so that you can evaluate
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  Speaker 1: first the value to you and if it's a viable asset,
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  Speaker 1: and also assess the risk to you as the buyer
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  Speaker 1: and to do that, of course, it's very important to
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  Speaker 1: review the documents, the contracts, the policies and procedures, but
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  Speaker 1: more importantly you really need to know how those are
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  Speaker 1: implemented and the overall culture. So, for example, you might
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  Speaker 1: have a company that has hundreds of compliance related policies
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  Speaker 1: or volumes of procedures, but then when you start asking
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  Speaker 1: questions and talking to key personnel, you understand their compliance
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  Speaker 1: culture maybe lacking, and the policies may only be as
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  Speaker 1: good as the paper they'll print it on. So overall,
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  Speaker 1: start broad and then you can narrow down to evaluate
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  Speaker 1: those really important aspects of the company.
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  Speaker 4: What are some common mistakes companies or unexpected pitfalls in
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  Speaker 4: m Andy that he should keep in mind?
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  Speaker 1: Sure, I would say there's two main common mistakes or pitfall.
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  Speaker 1: Probably the most common pitfall we see is a blind
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  Speaker 1: reliance on the company's information and interviews but not taking
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  Speaker 1: the steps to verify. You know, in the old days
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  Speaker 1: we used to do this via on site visits to
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  Speaker 1: a target entity, and while that can still be very important,
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  Speaker 1: most verification is now done digitally, So the key is
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  Speaker 1: to really do as much primary source and outside verification
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  Speaker 1: as possible. So, for example, for licensure, you would want
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  Speaker 1: to do primary source verification, you go to the agencies
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  Speaker 1: to verify. For litigation, you'd want to do a litigation
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  Speaker 1: and lean search. It's just amazing to me how much
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  Speaker 1: can come up on these searches that can be really material.
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  Speaker 1: And then specific to data security, you may engage a
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  Speaker 1: third party vendor to test the company's network security.
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  Speaker 3: You know.
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  Speaker 1: Rushing or neglecting this phase of DITI really can lead
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  Speaker 1: to inheriting unstable systems, you know, or historical breaches or
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  Speaker 1: compliance gaps. The other uh common pitfall is really failing
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  Speaker 1: to plan appropriately, So overestimating synergies can really lead to
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  Speaker 1: some failed cost projections and difficult integration and underestimating integration
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  Speaker 1: complexity can also be an issue. You know, technology integration
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  Speaker 1: can be a big pain point for companies. So data mapping,
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  Speaker 1: system compatibility, cybersecurity risks and all of those issues really
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  Speaker 1: require early planning.
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  Speaker 4: So are there key concepts that are important to understand
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  Speaker 4: and M and A that may not be obvies?
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  Speaker 3: Sure?
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  Speaker 2: I guess probably two things.
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  Speaker 1: First, the buyer's ability to use data is going to
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  Speaker 1: be really dictated by what the seller has promised consumers,
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  Speaker 1: so valuations can change based on that data use. So
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  Speaker 1: buyers really need to do that appropriate diligence to understand
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  Speaker 1: the limitations that they might have on data use. And second,
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  Speaker 1: more broadly, understanding that it's highly unlikely, if not almost impossible,
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  Speaker 1: that a company, especially in health care or even startups
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  Speaker 1: and technology drive the speed limit one hundred percent of
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  Speaker 1: the time, you know, meaning there's going to be compliance
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  Speaker 1: gaps and therefore there's going to be risk to you
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  Speaker 1: as a buyer. But you can use diligence terms in
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  Speaker 1: the purchase agreement and remedies such as repine, warranty insurance to.
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  Speaker 5: Mitigate those risks.
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  Speaker 1: But I guess caution that you do want to make
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  Speaker 1: sure that you have a viable recourse. So, for example,
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  Speaker 1: if your recourse is an indemnity against the seller entity,
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  Speaker 1: you need to make sure at the time you sign
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  Speaker 1: the agreement that there's either an ESCRA hold back or
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  Speaker 1: that the seller remains intact and are financially able to
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  Speaker 1: pay any amounts it could be due to.
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  Speaker 5: You under the purchase agreement.
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  Speaker 4: So now let's shift right to the ever popular topic
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  Speaker 4: of AI and focusing more specifically on AI vendors. If
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  Speaker 4: your enterprise determines that using an AI vendor versus creating
• 9:13
  Speaker 4: or buying a solution is the appropriate course, what are
• 9:16
  Speaker 4: the steps companies should take to vet a vendor.
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  Speaker 5: That's a great question, Sheila, So a little bit of context.
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  Speaker 5: Despite the slick marketing that surrounds a lot of AI
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  Speaker 5: tools and suggests that AI can really be a solution
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  Speaker 5: to almost everything, and there are a number of really
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  Speaker 5: great applications and use cases for AI. In order to
• 9:41
  Speaker 5: be able to realize good return on investment, companies need
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  Speaker 5: to understand that AI tools are not a panacea or
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  Speaker 5: fixed to every problem. Some of the research we're seeing
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  Speaker 5: on AI investment from places like McKinsey, Deloitte and others,
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  Speaker 5: as well as our own experience, suggests that ROI from
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  Speaker 5: AI maybe limit or lagging. At least to date, we
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  Speaker 5: are seeing many companies view incorporating AI as a strategic imperative,
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  Speaker 5: but we're seeing them flounder and implementation. So a critical
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  Speaker 5: first step because of this context, is defining the scope, objectives,
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  Speaker 5: and measurable goals of a desired use case, and that
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  Speaker 5: planning should include engaged stakeholders. You've got to bring in
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  Speaker 5: your compliance folks, your IT folks, your privacy folks, your
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  Speaker 5: legal folks, and your clinical teams, and they're going to
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  Speaker 5: need to be committed to following the implementation of that
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  Speaker 5: AI tool through to decommissioning, so not just upfront, but
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  Speaker 5: through an entire process up to the point where you're
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  Speaker 5: no longer using it. Another critical concept is knowing the
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  Speaker 5: problem you're trying to solve and assessing how success will
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  Speaker 5: be measured for that particular tool. You should also have
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  Speaker 5: a great handle on your risk tolerance and budget upfront.
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  Speaker 5: Other critical steps include understanding your data issues upfront. You've
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  Speaker 5: got to assess your data readiness to ensure your data
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  Speaker 5: is going to be accurate, complete, structured, and labeled for
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  Speaker 5: that particular AI use case, and that can take time,
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  Speaker 5: and a lot of companies don't think about the budget
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  Speaker 5: that they need to support that, and they don't think
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  Speaker 5: about the cost if they're going to try to outsource
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  Speaker 5: that work to vendors. Another really important concept here as
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  Speaker 5: a step is understanding the federal, state and regulatory requirements
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  Speaker 5: that are applicable to the specific type of AI solution
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  Speaker 5: that you're using, and applicable reimbursement we're not seeing a
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  Speaker 5: lot of reimbursement of specific AI tools, but that's going
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  Speaker 5: to be a conversation that evolves in the future. And
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  Speaker 5: on the regulatory front, this is really no different than
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  Speaker 5: any other assessment of solutions or tools you're doing now.
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  Speaker 5: You just need to be cognizant of the fact that
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  Speaker 5: the regulatory landscape is shifting. So there may be things
• 12:00
  Speaker 5: that you hadn't thought about, like chat bought laws that
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  Speaker 5: you know weren't in place a couple of years ago.
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  Speaker 5: So we need to be mindful of the fact that
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  Speaker 5: the regulatory landscape is shifting. Understanding also as a critical step.
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  Speaker 5: You know whether or not this solution is going to
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  Speaker 5: impact your current policies, whether you need to revise them,
• 12:24
  Speaker 5: whether new ones are needed. That needs to be considered,
• 12:26
  Speaker 5: how are you going to integrate this, how are you
• 12:28
  Speaker 5: going to audit it? And then the final step again,
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  Speaker 5: it is not something that's atypical. It's you need to
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  Speaker 5: assess the vendor right, understand the vendor's economic health, understand
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  Speaker 5: their operations, run them through your standard diligence process, maybe
• 12:41
  Speaker 5: add a few extra bells and whistles. This is a
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  Speaker 5: conversation we have with companies about vendors all the time,
• 12:48
  Speaker 5: understanding things like if they're not if they don't have
• 12:51
  Speaker 5: a lot of assets, how are you going to stand
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  Speaker 5: behind their indemnification obligations. You can have the greatest and dem
• 12:56
  Speaker 5: the obligations ever in the contract, but if they don't
• 12:59
  Speaker 5: have the assets to back them up, than they're kind
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  Speaker 5: of useless.
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  Speaker 4: So what are some of the key risks of contracting
• 13:08
  Speaker 4: with an AI vendor and how can companies mitigate those?
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  Speaker 5: Sure so, much like the regulatory analysis, the key concepts
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  Speaker 5: in AI contracting are similar to what you would normally see.
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  Speaker 5: It's all the same issues that we typically think about
• 13:26
  Speaker 5: when we're looking at any vendor. You need to think
• 13:29
  Speaker 5: about things like IP infringement and failure to meet service levels.
• 13:34
  Speaker 5: There are certain of these risks that are heightened in
• 13:36
  Speaker 5: the AI context. So those risks include things like privacy
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  Speaker 5: and security breaches. Because AI uses a lot of data,
• 13:44
  Speaker 5: typically uses a lot of large volume of data, so
• 13:48
  Speaker 5: regulations that apply to personal data or company proprietary or
• 13:52
  Speaker 5: confidential data are things that we see having heightened risks.
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  Speaker 5: And because of the volume of data involved in a
• 14:01
  Speaker 5: lot of AI use cases, you have more chances for
• 14:04
  Speaker 5: an issue more potential penalties if something does go wrong,
• 14:07
  Speaker 5: So that's definitely an area of heightened risk. Regulatory non
• 14:12
  Speaker 5: compliance and how AI tools are deployed beyond privacy includes
• 14:17
  Speaker 5: things like, you know, are we triggering licensing requirements? You know,
• 14:21
  Speaker 5: is this practice of medicine is a practice of pharmacy here?
• 14:24
  Speaker 5: There are other pharmacy laws that are implicated. Got to
• 14:27
  Speaker 5: think through consumer protection laws. If it's software as a service,
• 14:31
  Speaker 5: do we have an FDA overlay? All of those things
• 14:35
  Speaker 5: need to be considered. You also have risks that come
• 14:40
  Speaker 5: from not regulatory issues, but things like operational disruption or
• 14:44
  Speaker 5: performance issues, and we can mitigate a lot of these
• 14:48
  Speaker 5: risks in contracts by using as an You mentioned some
• 14:51
  Speaker 5: of the contractual risk shifting mechanisms that we're all familiar with,
• 14:55
  Speaker 5: like non infringement remedies and indemnity insurance and AE reports,
• 15:00
  Speaker 5: incident response, service level agreements. All those are great tools. Again,
• 15:04
  Speaker 5: want to underscore that strong vendor diligence upfront is critical
• 15:09
  Speaker 5: and also be mindful that that regulatory landscape changing and evolving.
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  Speaker 5: Technology is changing and evolving, so this is not an
• 15:17
  Speaker 5: area where you want to negotiate the agreement and throw
• 15:20
  Speaker 5: it on the shelf for the next ten years and
• 15:22
  Speaker 5: never look at it. We need to be prepared to
• 15:25
  Speaker 5: look at your contracts assess your vendor relationships frequently.
• 15:32
  Speaker 4: So we always worry about appropriately protecting data in specialty
• 15:36
  Speaker 4: pharmacy and healthcare in general. How should entities think about
• 15:40
  Speaker 4: data issues when dealing with an AI vendor.
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  Speaker 5: Yeah, so in reviewing the AI solution, providers and their
• 15:48
  Speaker 5: legal teams need to understand the source of the data
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  Speaker 5: used in the AI solution and also consider what types
• 15:56
  Speaker 5: of data are used to make sure that they're complying
• 15:59
  Speaker 5: with all the applicable laws. So, if you've got personal
• 16:02
  Speaker 5: information involved in healthcare, we often have protected health information
• 16:07
  Speaker 5: or sensitive clinical information involved, you have to consider laws
• 16:10
  Speaker 5: like HIPPA. You have to consider do you have the
• 16:13
  Speaker 5: appropriate patient authorizations if you need them. Your contracts also
• 16:17
  Speaker 5: need to contemplate the between the you and your vendor.
• 16:23
  Speaker 5: Who's going to own the data with regards to input
• 16:26
  Speaker 5: and outputs. Are you going to let them do things
• 16:31
  Speaker 5: like train their algorithm? Are you going to let them
• 16:34
  Speaker 5: make disclosures to third parties? All of these things need
• 16:37
  Speaker 5: to be thought through and in addition, if there's deidentification
• 16:42
  Speaker 5: or anonymization that's going to occur. How involved do you
• 16:46
  Speaker 5: want to be in that process? Do you want to
• 16:48
  Speaker 5: rely on a representation and warranty in the contract or
• 16:51
  Speaker 5: do you really want to understand and get in the
• 16:53
  Speaker 5: weeds on what exactly is occurring? Do they have an
• 16:56
  Speaker 5: expert opinion in place? So recommendation is data de identification
• 17:02
  Speaker 5: and an hoonoization standards should be clearly defined in your agreements.
• 17:05
  Speaker 5: Whether or not you want to go the extra mile
• 17:07
  Speaker 5: of understanding all the technical details maybe something that you
• 17:11
  Speaker 5: decide from a risk tolerance perspective, but it's something to
• 17:14
  Speaker 5: definitely be aware of. And in addition, you should consider
• 17:18
  Speaker 5: things like data segregation protocols and how you want to
• 17:22
  Speaker 5: handle post termination handling of data. I think the key
• 17:26
  Speaker 5: takeaway for me here is we can't It's really difficult
• 17:29
  Speaker 5: for your privacy and legal teams to come in after
• 17:32
  Speaker 5: the fact and try to fix gaps or band aid things.
• 17:36
  Speaker 5: These types of issues need to be addressed early in
• 17:39
  Speaker 5: the model to avoid disruption and help you succeed with
• 17:43
  Speaker 5: the tool.
• 17:46
  Speaker 4: So what are some common mistakes companies make in vetting
• 17:48
  Speaker 4: an AI vendor and what are the risks if they're
• 17:51
  Speaker 4: not addressed.
• 17:53
  Speaker 5: Sure, so I think that probably the biggest mistake you
• 17:57
  Speaker 5: can make is not vetting the vendor at all. The
• 18:00
  Speaker 5: race to be to others to the solution. There's a
• 18:02
  Speaker 5: lot of excitement around what AI can do, the possibilities
• 18:05
  Speaker 5: in AI, and just skipping over some of these key
• 18:08
  Speaker 5: steps that we typically go through with vendor diligence is
• 18:13
  Speaker 5: probably the biggest mistake we see. Another big one that
• 18:16
  Speaker 5: that Amy highlighted earlier is you know, overlooking clinical validation
• 18:20
  Speaker 5: and integration considerations. Oftentimes, you know, again in the race
• 18:25
  Speaker 5: to implement something, we overlook how difficult the integration is
• 18:30
  Speaker 5: going to be, and we underestimate an under budget the
• 18:34
  Speaker 5: change management that's going to be needed for things like
• 18:36
  Speaker 5: clinical training and workflow alignment. Another place where we see
• 18:41
  Speaker 5: mistakes occur is not clearly defining what success means and
• 18:45
  Speaker 5: objectively measurable terms, both in the contract but also in
• 18:49
  Speaker 5: business expectations. So you have a product, you're using it,
• 18:53
  Speaker 5: you've launched it, and then how do if you haven't
• 18:56
  Speaker 5: to find success, how are we evaluating whether we're achieving
• 19:01
  Speaker 5: what we hope to achieve. A final note here is
• 19:05
  Speaker 5: that you know really the time period before the contract
• 19:10
  Speaker 5: is inked is when your vendors are going to be
• 19:12
  Speaker 5: the most forthcoming and cooperative. So if you're not comfortable
• 19:17
  Speaker 5: with the vendors transparency and sophistication at that early moment,
• 19:23
  Speaker 5: signing the deal and going forward with it is really
• 19:26
  Speaker 5: going to improve the relationship you have with the vendor.
• 19:31
  Speaker 5: So this is really the time pre contract, during the
• 19:33
  Speaker 5: contract phase when we should be getting gate that level
• 19:36
  Speaker 5: of detail and really understanding your vendor.
• 19:40
  Speaker 4: That's when they're on their best behavior.
• 19:43
  Speaker 5: That's right, the dating phase.
• 19:48
  Speaker 4: Any final words of advice, Yeah.
• 19:52
  Speaker 5: So prioritize solutions that are going to drive real value.
• 19:55
  Speaker 5: I think that's a key one. Understanding your need and
• 19:58
  Speaker 5: really prioritizing those things you think you're going to drive
• 20:01
  Speaker 5: real value for your enterprise is the number one piece
• 20:04
  Speaker 5: of advice. Invest that time in selecting the right vendor
• 20:08
  Speaker 5: through appropriate vetting, and then follow through with effective implementation.
• 20:14
  Speaker 5: You're monitoring that progress and then scale it accordingly and
• 20:18
  Speaker 5: as always, work closely with your legal and compliance teams.
• 20:23
  Speaker 5: And I think my final note and Amy, I don't
• 20:24
  Speaker 5: know if you have anything to add, is expect change.
• 20:28
  Speaker 5: We aim for greatness certainly, but be prepared to work
• 20:31
  Speaker 5: for it. This is much more iterative than some of
• 20:34
  Speaker 5: the other changes we've seen in the past, so to
• 20:38
  Speaker 5: just be prepared for that piece of it.
• 20:40
  Speaker 1: Yes, Simone, I think that's great advice, and I would
• 20:44
  Speaker 1: only add from the M and a standpoint, very simple,
• 20:47
  Speaker 1: invest in planning, invest in diligence. You'll save yourself a
• 20:51
  Speaker 1: lot of headache later on.
• 20:55
  Speaker 4: One hundred percent agreed. Right, that's with everything, right, Well,
• 21:00
  Speaker 4: thank you both so much, Simone and Amy for chatting
• 21:02
  Speaker 4: with me and sharing this valuable information.
• 21:05
  Speaker 1: Well, thank you so much for having us. I really
• 21:08
  Speaker 1: loved being here and appreciate everything that you all do.
• 21:13
  Speaker 5: Yeah, it's always a pleasure, Sheila, Well.
• 21:16
  Speaker 4: Thank you both for all that you do, all the
• 21:17
  Speaker 4: support that you offer to our members. It's incredible and
• 21:20
  Speaker 4: we really, you know, love having our legal professionals and
• 21:24
  Speaker 4: our law firm members. She just adds such a an
• 21:26
  Speaker 4: added dimension to membership. So thank you. And as a reminder,
• 21:30
  Speaker 4: NSP corporate members are invited to be my guest on
• 21:32
  Speaker 4: one complimentary podcast per year. For more information about this
• 21:36
  Speaker 4: or other NASP membership benefits and events, please feel free
• 21:39
  Speaker 4: to reach out to membership at NA sp n e
• 21:43
  Speaker 4: t dot org or visit our website at www dot
• 21:47
  Speaker 4: NA s p n et dot org. Until next time,
• 21:51
  Speaker 4: have a great day,