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Market Access Strategic Execution Consultant

IPI Model has picked the wrong target, and an unfair scapegoat

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As promised on my previous blog, here’s my full take on the Advanced Notice of Proposed Rulemaking (ANPRM) (which is essentially a PRE-proposed rule) for CMS’ proposed International Pricing Index (IPI) Model. 

The Trump administration is claiming that the IPI Model will help to curb the skyrocketing health care costs. On the contrary, there seems to be a consensus among manufacturers and providers that although health care costs are skyrocketing, targeting Medicare Part B drugs in the proposed manner will actually INCREASE overall health care costs and DECREASE quality of care.

Here’s the proposed IPI Model in a nutshell:

  1. The IPI Model would impact selected drugs that are administered by providers in the outpatient setting (clinics and hospital outpatient departments) IF they are prescribed within predetermined locations
    1. The ANPRM hasn’t specified which drugs or which geographic locations would be impacted. Nonetheless, the impact would be significant as it would cover 50% of Part B drug claims (wow!)
    2. The ANPRM states that  radiopharmaceuticals and certain ESRD drugs would be excluded from the IPI Model
  2. CMS would set the Medicare payment amount for the selected Part B drugs to closely align with international prices
  3. Private vendors would be allowed to negotiate prices for drugs, take title to drugs, and compete for physician and hospital business (essentially, the drugs would have to be “white bagged”) 
  4. Physicians would be reimbursed a FLAT add-on payment for administering these selected Part B drugs (instead of ASP plus 4.3%)

I studied the publicly available comment letters submitted in response to this ANPRM in order to learn about the implications of the proposed IPI Model. Here are my two main takeaways:

  1. Manufacturers and providers BOTH agree that decreasing the list prices and increasing PBM involvement will actually increase overall health care cost and decrease quality of care
  2. A sound alternative to the currently proposed provisions of the IPI Model is a value-based care initiative. I think that’s an excellent way for providers, manufacturers, and payers to meet half-way–though implementation of such innovative payment systems is new and therefore has its own challenges.

Below is a visual summary of the proposed IPI model and its implications. 

Now that you know about the proposed provisions of the IPI Model, what now? Well, it’s not too late. Its important to put up a fight against the IPI Model for 2 reasons:

  1. The IPI Model, if finalized, would serve as a hook for President Trump’s campaign to counter the Democratic opponents who are intently discussing their own proposed health care reforms. Since the IPI Model is based on the assumption that high health care costs are due to high drug prices, manufacturers would become scapegoats for President Trump’s 2020 campaign
  2. If your drug happens to be targeted by the IPI Model, then you will have to lower your list price to the international pricing index (ouch!)

When the proposed rule for the IPI Model is released, make your voice be heard. Another strategy is to partner with provider organizations (such as COA and AMA) to double the strength of your team.

It’s time to make big strides and turn heads–let’s go.

Trump’s International Price Index model is bad news for market access

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I have learned to take legislative developments as a grain of salt. However, it seems like the International Price Index (IPI) model is an exception.

Christina Sandefur of Goldwater Institute, Mallory O’Connor of Mallinckrodt Pharmaceuticals, and Ross Margulies of Foley Hoag provided eye-opening insights into the political and legislative trends impacting market access at the CBI 7th Annual Reimbursement and Access conference. 

There seems to be a consensus among these folks that the IPI model, which would peg drug prices to the same prices that are paid overseas, is likely to be enforced in some form (despite the precedence of Trump’s other other rules being rendered either illegal or ineffective). Seema Verma just announced this week that CMS is working ‘fast and furious’ to release the proposed rule for the IPI model as the administration is facing increasing pressure to release a concrete healthcare plan in time for the 2020 election. 

The IPI model will be dangerous for market access for a couple of reasons:

  1. PhRMA believes that lowering US drug prices to that of an international price index would disincentivize R&D efforts and would also lead to a lag in market entry for new products.
  2. The Community Oncology Alliance (COA) believes that the Competitive Acquisition Program (CAP) portion of the IPI model could eliminate wholesalers altogether and make PBMs as the sole middlemen in the drug distribution channel.

Experts believe that the proposed CMS rule for IPI model will likely be released this Fall and the final rule will likely be released in Spring 2020. 

The IPI model, as it currently stands, would apply to Medicare Part B single-source products and biologics.

Given the timeline of the IPI model and its serious implications, I believe that it’s critical for all market access teams to be educated on this topic and unite with providers in order to put up a fight.

I, myself, have embarked upon a research project to learn more about the implications of the IPI model for clients and determine what actions should be taken.

It’s time to make big strides and turn heads–let’s go.

Launch excellence for market access teams: best practices to meet your business objectives

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New product launches can be challenging, causing much distress and havoc that could’ve been avoided with the proper insights, planning, and coordination. 

Tami Carten, a highly experienced and effective senior leader in market access, offered sage advice for launch best practices at the CBI 7th Annual Reimbursement and Access conference. I believe that operating under her 3-fold execution strategy will enable you to save time, money, and sanity–irrespective of the market landscape and unique product profile. Tami’s strategy ensures the correct mindset and involvement of the right resources to achieve your business goals. After all, there’s a budget for everything, so it’s important not to waste it with meaningless action.

Here, I present a visual rendition to summarize Tami’s strategy for launch excellence. Check against her best practices to make sure you haven’t overlooked something.

It’s time to make big strides and turn heads–let’s go.

Launch excellence: meet business objectives with this 3-fold execution strategy

Intelligence and dependability over all other qualities

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When you meet a content developer for the first time, what questions do you ask in order to understand if she’s the perfect fit for your job? Most people pass judgement based only on these 2 questions: “Do you have experience in writing xx project?” and “What’s your rate?”

Are these questions enough? Or should you be probing more?

In the spirit of summer vacations (since it is August), imagine you’re taking a family trip to the beach. You should be confident that (a) the GPS will actually guide you to the correct destination, and (b) your vehicle will safely take you to your destination without breaking down. If you didn’t have confidence in these two things, you would download another GPS app and you would get another car, right?

Apply the same logic to your market access projects: much of your project depends on your writer, so you should be confident that she is (a) intelligent (understands the market and relevant trends–if not, then can find out the information on her own; understands the customer/audience needs; is clinically savvy) and (b) dependable (sticks to the project to the end–no matter what; is mindful of timing; is willing to work with the team at-large).

An intelligent and dependable content developer can bring peace of mind to your team and is worthy of showing off to your clients–both of which help to bring in revenue for your organization.

In my experience, finding a content developer who is BOTH intelligent and dependable is rare. You are lucky to have found her, so take notice.

It’s time to make big strides and turn heads–let’s go.

Effective advisory reports are concise and actionable

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An advisory report summarizes an advisory board meeting and relays key information that informs business decisions. The advisory report comes into the hands of many key decision makers who are all very busy. Therefore, it’s critical that someone takes the time upfront to create a concise and actionable report that can be easily understood. 

Here are some tips that can help you create an advisory report that your client will fall in love with: 

  • Provide the plethora of information into bite-size morsels that can be easily understood. Think of how you can categorize the information so that it makes sense (this might require some thinking).
  • Within each category, start with the ideas that resonate the most. Then, work your way down to the ideas that resonate the least.
  • Try to eliminate bullets using effective visualization (this can also require some critical thinking).
  • Craft the executive summary slide in such a way that readers can grasp key concepts right away.
  • Craft the conclusion slide effectively so that your recommendations and rationale are easily understood.

Prior to drafting the advisory report, you might want to confirm with the client if they have a particular format in mind. After completing your initial draft, run it by your team members for feedback; after all, 2 heads are better than 1. 

Below an example of what a basic advisory report can look like.

It’s time to make big strides and turn heads–let’s go.

Staying relevant by staying up-to-date

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The health care landscape is in constant flux so it’s important to be connected to folks and stay abreast with the latest trends and insights that relate to market access. Next week will be a big week to learn much and meet many at the CBI 7th Annual Reimbursement and Access conference in Philadelphia, PA. Here are the sessions that I will be attending.

It’s time to make big strides and turn heads–let’s go.

 

DAY 1

State of the industry: political and legislative trends impacting health care coverage and access

  • Evaluate the current political landscape and state of the President’s Blueprint
  • Anticipate new reimbursement models for PBM formulary management
  • Discuss the potential of point-of-sale rebates and the impact on the patient OOP cost
  • Gain insight into the state of oral arguments in the ACA legal challenge
  • Analyze how innovation will continue to force change within the health care landscape

Assess potential for changes to pharmaceutical pricing, discounting and reimbursement for the future

  • Over the last six months there have been a number of potential disruptors to pharmaceutical pricing. One of which was the potential removal of Safe Harbor Protection for Rebates. As we saw the official order withdrawn, in the same week the Most Favored Nation potential drug pricing policy was introduced. This session provides an update on current, proposed changes affecting pharmaceutical pricing and reimbursement. Point of sale rebates used to provide access to discounted medicines will also be discussed.

Realign access strategies to overcome challenges of copay assistance and PBM restrictions

  • Analyze the current landscape of models of PBM restrictions and state efforts to ban them
  • Discuss strategies to promote patient education and informed discussion to facilitate access
  • Gain insight into trends showcasing impacts to patient OOP spend, access and adherence
  • Hear considerations for manufacturers to identify the effect of copay accumulators and maximizers on brands
  • Develop strategies to continue to support patients and address compliance concern

Compliance spotlight: trends in enforcement and oversight--what companies can do to ensure compliance

  • Zero-in on top areas of focus, including relationships between manufacturers and charitable organizations, pre-approval communications, anti-kickback and pricing transparency
  • Gain insight into recent trends in enforcement oversight and focal points for 2020
  • Share key takeaways from recent high-profile cases to mitigate risk moving forward

New product launch in the era of precision medicine

  • Explore product launch scenarios and patient service paradigms
  • Delve into the role of digital health, how it assists and implications for channel strategies
  • Understand data needs and the role of the patient journey
  • Ensure teams, including the c-suite, are on the same page for consistent and timely effective decision support

Manufacturer spotlight--forward-thinking strategies to ensure market access and adherence

  • Gain insight into innovative reimbursement, market access and launch strategies
  • Discuss strategies to streamline income verification, refill reminders and electronic prescriptions
  • Employ technology to support patient access and adherence
  • Identify lessons learned and best practices to manage specialty pharmacies
  • Navigate from access to utilization — Education, data and pull-through

Medicare and marketplace coverage policies impacting access

  • Review the current state of policy affecting the six protected drug classes in Part D
  • Analyze the proposed shift of drugs from Part B to Part D and associated changes in total spending and patient cost-sharing
  • Discuss the increase in Medicare beneficiaries enrolling in Medicare Advantage Prescription Drug (MAPD) plans
  • Navigate complexities of changes allowing step edits in Part C on patient access
  • Gain insight into the potential ripple effects of Medicare changes on commercial coverage
  • Identify considerations to alleviate the impact of step therapies and prior authorization requirements

New product commercialization/launch scenario planning

  • Discuss timeline considerations for submitting NDAs, PDUFA dates, etc.
  • Employ strategies to ensure effective communication internally during launch
  • Identify best practices for due diligence for hub selection and patient assistance programs
  • Evaluate the evolution that can occur in all aspects of a launch’s timeline and maturity
  • Review the importance of redefining strategy based on the stage of launch

DAY 2

Changing the landscape for prior authorization and reimbursement support--reexamining the roles of the manufacturer and pharmacy

  • Explore the existing landscape regarding manufacturers’ and pharmacy providers’ roles in the PA process
  • Identify regulatory and payer enforcement trends regarding PA activities
  • Address HIPAA, privacy and confidentiality considerations regarding access to PHI, including the role of third-party hubs
  • Discuss activities of PBMs and PBM-owned pharmacies when independent providers submit PA requests

Trends in benefit design and the continued shift to high deductible plans

  • Review recent trends in prescription drug pricing and coverage/formulary design
  • Gain insight into efforts to promote value-based insurance design in both public programs and the commercial market
  • Explore best practices and innovations in pharmacy management and reimbursement
  • Examine implications for consumer affordability (premiums and OOP costs)

Pathways to improvement--insight on achieving a value-driven, transparent and affordable health care system

  • Explore how CMS’ interoperability mandate will use transparency to fix every problem in health care (and what new problems it will create)
  • Gain insight into ACA and how it might be the path to universal coverage after all
  • Discuss commercial risk adjustment and the challenges it is currently facing

Paving the way for global access and commercialization

  • Hear considerations for support that allows product access outside of the U.S.
  • Leverage various access programs to access medicines prior to EU or in-country licensing
  • Capture data, develop relationships and use insights to determine if it makes sense to launch in a particular country
  • Gain insight into best practices to build a European presence

Building value and establishing market access pathways for cell and gene therapies

  • Explore approaches and considerations to achieve market access and secure reimbursement
  • Overcome challenges in reimbursement evaluation given the robust pipeline and potential significant costs
  • Analyze value-based agreements and payment options
  • Employ best practices to better anticipate challenges and make plans to mitigate

Payer negotiations for improved profitability--a role play exercise

  • Examine payer dynamics, a market overview and access challenges
  • Complete a SWOT analysis for an incumbent company, new entrant and PBM
  • Leverage PBMs competition and preferred/exclusive formulary access to secure high rebates
  • Tackle the development of proposals by PBM, incumbent company and new company (formulary position, rebate rate, copay buydown, prior authorization, step edit and price protection)
  • Determine the impact of negotiation outcome on patients and PBM clients
  • Debrief on negotiation outcome

How your agency can rise above the rest

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Winning new clients is what brings in revenue, enabling you to continue offering your services, keep your staff employed, and make a difference in the world. That’s why your organization spends much fund, talent, and time on pitches and conference attendance in hopes to develop business. 

But have you considered your client’s perspective? The most common complaint from clients is that agencies show up on pitches with their so-called “big guns” who can make an impression with their deep knowledge and vast experience, though these people HARDLY get involved in the actual projects, leaving clients feeling like they’ve been tricked. I think the clients are catching on, which is why they’re now beginning to request that the actual team members who will be involved in the project to attend pitches.

How should this inform your business development strategy? EXECUTION of the project is equally as important as the initial win. Your pitch didn’t stop on game day–the marathon actually continues through the end of the project (which can be 2 months, or even a year). Top-notch execution means the piece has effective messages and supporting points, it’s accurate, it’s designed effectively, clients are satisfied on review teleconferences, and timelines are managed efficiently. 

Execution of a project is actually a form of marketing. You don’t have to take my word for it. Think about a time when you lost a client due to inaccuracies on a project. On the contrary, think about a time when you impressed a client so much with your impeccable work that (s)he felt obligated to tell 10 other people about your greatness, which lead to new business coming to you (instead of you going to it).

What kind of execution Dream Team can keep winning business for you? You need a team who is accurate, trustworthy, can collaborate effectively, is up-to-date on the trends, has insightful knowledge, and has the chops to develop effective communication tactics. Those fortunate to have a writer with all of these traits are sure to bring home the gold.

Your agency’s execution team is what sets you apart from the rest, so invest in a good one.

It’s time to make big strides and turn heads–let’s go.

 

Plan to have a smoother Q4

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Brand planning season is quickly drawing to a close–are you ready for the fourth quarter madness? 

In past years, what was it about Q4 that made it so unbearable? Was the it the unexpectedly high workload, the limited availability of writers to get the job done, the clashing priorities of planning for the Holidays vs. getting things done at work? 

Let’s resolve to make Q4 different this year. We are afforded the time over the next 2-3 weeks to get our ducks in a row before our clients return back to pavilion after Labor Day and send an urgent message to get a project done by tomorrow–or worse yet, yesterday. 

Urgency is going to arise as it does every Q4, but it doesn’t have to be stressful–as a matter of fact, I believe that we can actually ENJOY the ride if we have a Plan A, Plan B, and Plan C up our sleeves.

Seek out the status of ALL projects that still need to be started, or have yet to be finished (think way back to a lingering project that your team started in January). This may require some communication with team members (who may still be on vacation), so now is the time to begin digging up the information.

Match-up the projects with internal writers. Be cognizant of writers’ skill sets and availability over the next quarter (it’s helpful to know if someone has planned a 2-week vacation during Diwali, Thanksgiving, or Christmas).

Match-up projects with freelance writers. Being smart about knowing which projects to assign internally vs. outsourcing to freelancers is critical and can save your organization lots of money–at a time when revenue is scrutinized the most. Who are your go-to freelancers? What are their skill sets? Have you recently heard of a new freelancer that’s supposed to be really good, but don’t know her exact skill sets? NOW is the time to reach out and understand the freelancer’s capabilities, so you’re not scrambling later when time is of the essence. Who knows, that freelancer may just knock your socks off, leaving you wondering where she was all this time.

In the famous words of Benjamin Franklin, “By failing to prepare, you are preparing to fail.” Don’t fail. Plan now, when you still have time on your side.

It’s time to make big strides and turn heads–let’s go.

Become a shortcut Ninja to save 8 days per year (at least)

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If you ever get the privilege to watch software developers at work, you’ll notice they rarely move their their hands off of the keyboard because they know that keystrokes are faster than hovering a mouse, which is faster than than a swiping on a trackpad. 

On the flip slide, if software developers ever get the privilege to watch market access folks at work, they’ll laugh. Unlike the techies, us market access folks reach for the mouse (or worse yet, trackpad) with every other breath that we take, thereby sluggishly accomplishing tasks which should ideally take a mere few seconds.

I read a study suggesting that an individual can save 8 DAYS per year by learning keyboard shortcuts. I believe this is still an understatement, especially if a job requires an individual to be on the computer all day, everyday. 

In the spirit of lifelong learning, let’s make it a priority to learn and implement some simple keyboard shortcuts. There are many, many useful shortcuts out there–just Google “keyboard hotkeys” or “keyboard shortcuts,” and go to town. Let’s dedicate an hour everyday this week to learning and practicing shortcuts for the applications that we use the most. There are even apps out there that can help us practice until it becomes muscle memory.

Here are a few useful shortcuts from The Miller Group for a jump start on the journey to becoming a shortcut Ninja and to spare the humiliation from a software developer.

It’s to make big strides and turn heads–let’s go.

Useful Keyboard Shortcuts for Market Access

Alt+Tab

We tend to work with several applications at once. Use Alt+Tab to scroll through your opened applications and and easily switch between them.

 

Ctrl+Backspace

My favorite! Instead of hitting backspace to delete one character at a time, hold down the Ctrl key and tap backspace and delete entire words. Delete large paragraphs or sentences much quicker, without the help of a mouse.

Ctrl+Home or Ctrl+End

Need to jump to the top or bottom of your document? Use Ctrl+Home to move your cursor immediately to the top without scrolling. Use Ctrl+End to jump to the end.

Win+Home

Another favorite of my mine! Win+Home minimizes all applications except for the currently active window. This shortcut is useful when you need to switch to the desktop but don’t want to lose your current window.

Ctrl+Shift+T

Have you ever accidentally closed a browser tab and needed to get it back? Lose the mouse and use Ctrl+Shift+T to open the last closed tab in your browser.

Ctrl+F

Next time you need to find text in the current document/page, simply type Ctrl+F.

How leveraging technology can save your business

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What is the most annoying part of your job? Copy Supervisors may say, “having to REPEATEDLY coach my team on how to annotate and reference because they continue to make the same mistakes;” Account Supervisors may say, “having to REPEATEDLY estimate the resources and budget for different projects of the same type;” Account VPs may say, “having to REPEATEDLY create similar upfront slides for every pitch.” Doing something REPEATEDLY can become burdensome and thereby deplete the joy out of performing a duty and ultimately result in sloppy work. 

Believe it or not, failure to perfect these mundane tasks that lurk in every role can cost you your business. I believe that these tasks deserve to be perfected rather than ignored; but I also believe that humans don’t have to do them–find a way to leverage technology to do these mundane tasks accurately for you. It’ll save you time, sanity, and your business.

Here’s my personal story:

How I found a way to save writers 4+ hours per project

Back when I wrote my very first Payer Value Proposition, I remember staying up until 3:30 AM to finish the first draft–simply to reference the slides in the client-specific format. The entire night I was sulking over how I was losing sleep over a task that I admittedly felt was below me. Eventually, I finished referencing and handed over a completed draft on time.

But the next day, I was determined to find a way to make technology perform this mindless work for me so that I would never have to reference again–ever. Victory was mine when I found out that Zotero (a free online citation manager) and EndNote (a paid citation manager) could create the references for me–without the introduction of human errors. Having learned how to save 4+ hours per project, I now created more time to execute additional projects, catch-up with colleagues, learn a new skill, or step out for some fresh air.

Seeking out ways to leverage technology to perform tasks efficiently and accurately can enable you to get it right the first time, avoid time-consuming re-do’s, and impress your clients with impeccable accuracy. On the contrary, you risk losing your business by enduring the mundane tasks without learning how technology can do them for you.

It’s time to make big strides and turn heads–let’s go.

Krishna Patel, PharmD
Market Access Strategy and Execution Consultant
info@sojusllc.com
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