Highlights from the 2022 Hub and Specialty Pharmacy Models East conference

Were you able to make it to the 2022 Hub and Specialty Pharmacy Models East conference (Hub East) this year? If not, don't worry, we've got you covered! Grab a cup of coffee, settle in, and enjoy our roundup of conference presentations from some of the most influential experts in the hub space. 

Enforcement Insights -- Understand DOJ Priorities for 2022 and Beyond

Daniel Sale, Partner, King & Spalding LLP (moderator)

Lee Cortes, Chief Health Care Fraud Unit, U.S. Attorney's Office, District of New Jersey

Steven Sharobem, Assistant U.S. Attorney, The United States Attorney's Office for the District of Massachusetts

Jolie Apicella, Assistant U.S. Attorney, Chief Health Care Fraud, U.S. Attorney's Office, Eastern District of New York

This session allowed the audience to hear directly from 3 U.S Attorneys on the most recent and impactful issues impacting bio/pharmaceutical manufacturers on topics such as patient assistance, copay, and charitable foundations.

To begin, the panelists provided an overall outlook for charitable patient assistance programs. They see 2 opposing forces: 1) the need for patient support for high-priced meds, and 2) the need for oversight to ensure appropriate behavior. The panel asks themselves a long list of questions as they investigate a charitable program: What is the true intent of the program? Is it actually designed to support in a charitable manner patients who cannot otherwise afford their medicines, or is the program designed to promote the product? Is it to prop up drug prices, or does it truly help as many patients as possible? The answer to these questions at some point can suggest a kickback issue.

Neither prescribers nor patients should be induced. But if reps are talking to doctors about PAP support as a reason to prescribe, that could be considered an inducement. And if patients are seeing the PAP as a reason to get the HCP to prescribe a certain brand, that could be considered an inducement. Importantly, even properly designed programs can go off the rails if one employee goes beyond what the program allows; this one individual can put companies in danger. Not surprisingly, programs are not targeted equally, according to the panelists. Prosecutors tend to focus on big programs that affect a lot of people and include a great deal of monetary support.

Another red flag is a drug whose price rockets higher suddenly. Prosecutors dig through the data to find out why the price rose so quickly. They do not just assume that the prices were raised across the board and the company offers a limited PAP in a concerted effort to increase profit. Instead, they ask many questions of many stakeholders to try to get a real and true understanding of the real goals and design of the program.

The panel went on to touch briefly on other significant issues within the prosecutorial role:

1. Charitable Foundations narrowly defining their funds so they benefit certain companies
2. Foundations correlating funding requests to the reimbursement of a single product within a fund
3. Foundations allowing donors access to non-aggregated data (so the company can see how their money is being used by the charitable foundation)
4. General inappropriate influence exerted by a manufacturer donor over “independent” foundation
5. Drug price increases antithetical to market forces
6. Direct charitable assistance vs through a charitable foundation

That last item sparked a discussion of the dangers of a manufacturer establishing its own internal 501c3 foundation to manage a charitable patient assistance program. The charity must be able to make a completely truly independent decision to support a needy patient. When a manufacturer sets up its own internal foundation, it raises a red flag regarding dangerous connections about seeking data, receiving data, how the money is being used, etc. In all of these issues, independence is the touchstone.

An audience question brought to light the fact that even prior authorization support programs can be seen as inducements to prescribe, IF they are designed to be driving sales. Again, federal prosecutors ask questions to identify intent: How is the policy written? How is it structured? What are the rep sales scripts? How are HCPs informed of the program? Has the program grappled with these issues? If so, how? In one example, the PA call center agents were lying about prior step therapy and were paid bonuses based on the number of cases managed. This was an easy prosecution.

Ultimately, prosecutors work to identify the true intent of the program and attempt to determine if either HCPs or patients were induced by the program to prescribe or use a given product.

Strengthen Program Strategy for Operational Alignment

Melissa Beatty, Director Patient Services and Reimbursement, CTI Bio Pharma

Melissa speaks from 13 years of experience in the supply/vendor side as well as several years recently on the manufacturer side. She opened her talk by defining “commercial strategy.” It’s not the same as our mission statement, our goals, or our sales strategy. Instead, it starts with modeling and understanding the external individuals representing the “4 Ps of Commercial Strategy”: Patients, Payers, Prescribers, and Pharmacies. For each of these 4 stakeholder groups, we must recognize and seek to accommodate their unique needs and wants.

But building a commercial market access strategy goes far beyond the external participants. Melissa quickly turned to what is often a much tougher challenge for market access specialists: understanding and satisfying key internal stakeholders. Marketing, Sales, Internal MLR, the Executive Team, etc. Each of these groups has its own needs, goals, and expectations. And each individual within each group has his or her own knowledge, experience, beliefs, and outlooks in play. Issues surrounding special departmental needs, program/budget ownership, and internal visibility complicate things even further. Sad but true, “internal alignment is the toughest job that we have.” In the end, says Beatty, the market access role may be the most disliked in the company.

Internal groups often don’t really understand how the market access role and specialty work. It’s not easy to gather data, it’s not fast, and it’s not cheap. “Our #1 challenge is assuming that people know what we know,” says Melissa. To make matters worse, there’s often a lack of understanding of who’s doing what. Is market access doing PAP/hub/copay, or is it marketing? The market access professional has to be the planner, educator, and supporter.

So what are the key steps in moving toward a solid commercial market access strategy? Beatty sees these 4:

1. Assess
   1. The market and market needs
   2. Your needs, strengths, challenges, and risk balance

2. Align on
   1. What to expect
   2. Market /industry/partner limitations

3. Build your service plans and ensure that
   1. Individual department processes will drive utilization
   2. Your partners are on the same page and in agreement on their roles and needs
   3. You have visibility to actionable insights
   4. There is real value for those involved

4. Remain diligent, focused, and engaged so you
   1. Optimize opportunities for improvements
   2. Don’t compromise your strategy based on “fire drills” or “the new shiny toys”
   3. Evaluate your needs, successes, and challenges on a daily basis

In the end, we need to be wise and thoughtful as we plan commercial strategy, thereby leaving more money and energy to better serve patients.

Telehealth, Telemedicine and Virtual Care: Define Their Role in the Evolving Healthcare Landscape

Naomi Lopez, Director of Healthcare Policy, Goldwater Institute

Lopez opened her talk with a startling factoid establishing the idea that telehealth is nothing new: In 1879 Lancet published an article discussing how telephones could reduce unnecessary office visits. But even now, in the wake of the COVID-19 pandemic, we’re still not fully harnessing the power of telehealth/telemedicine.

While the early COVID response by insurers and state governments encouraged telehealth, many of the flexible rules implemented then (waived telehealth copays, allowing telecare from out-of-state providers, etc.) are being rolled back or allowed to expire. In fact, as of July 1, 2022, more than 2/3 of states offer no telehealth legislation or licensure flexibility. Lopez argues that states have an obligation to extend or reintroduce telehealth flexibility as an integral part of our national health system.

She makes the case that the flexibilities instituted during the pandemic should now be made a permanent part of the healthcare access landscape. Unfortunately, many states are missing this opportunity, to the detriment of patients and access to care. Reforms would give patients access when and where they need it, and often at a lower cost.

Arizona is leading the way in making temporary accommodations permanent, having recently passed House Bill 2454. The bill is based on the idea that patients should be able to obtain medically appropriate care, if they so choose, in a manner of their choice. The bill allows the provision of almost any care that can be reasonably provided through technology, and has accommodation for both synchronous and asynchronous remote interaction.

This law, and others like it, provide key benefits to individual patients, but their most important value is in the ways they will transform the healthcare delivery landscape, especially in relation to rural healthcare. Additionally, hospitals will be able to retool their offerings in a way that not only allows for the financial flexibility of telemedicine, but also better meets the needs of their patients. Telehealth legislation will also offer insurers the opportunity to untether coverage and payment decisions, encouraging new payment models that work better for working families.

Finally, the area that excites Lopez the most is that telehealth reform will give seniors more long-term care choices, especially the option to age at home or in the community. Expanded telehealth availability will give seniors the option to avoid or delay placement in long-term care facilities.

There are many legitimate concerns about permanent telehealth, but the results of the proof-of-concept experienced during the pandemic showed that many of those concerns can be successfully dealt with.

Ultimately, says Lopez, “telehealth holds enormous potential for healthcare access.” And while there’s never going to be a magic bullet for healthcare reform, reforms such as those in Arizona can help the nation realize the potential of these innovative patient-centric care models using already available technology and communication tools.

The Regulatory Sprint Toward Coordinated Care: Can Healthcare Marketers Keep Pace?

Bill Trombetta, PhD, Professor of Healthcare Strategy and Marketing, St. Joseph's University

Dr. Trombetta opened his talk with 2 case studies of seemingly innocuous patient support programs, both of which actually had exposure to fraud and abuse regulations and Antikickback Statute liability. His advice is that before a brand team establishes any type of patient support initiative, they should do these 4 things:

1. Get an advisory opinion from the Federal Trade Commission
2. Request a business review from the Department of Justice
3. Review previous OIG advisory opinions at https://oig.hhs.gov/compliance/advisory-opinions/
4. Apprise your State Attorney General of your plan

With that as background, Trombetta used the remainder of his time making the case that US healthcare must — and is — moving away from volume-based care and toward value-based care. To begin, he described the Department of Health and Human Service’s “Regulatory Sprint to Coordinated Care.” The Regulatory Sprint (launched in 2018 and completed in 2020) was intended to reduce regulatory obstacles and accelerate the transformation of healthcare delivery from volume based to value based, thereby establishing a system that essentially achieves Dr. Donald Berwick’s famed “Triple Aim”:

1. Improve the individual experience of care
2. Improve the health of populations
3. Reduce the per capita costs of care for populations

But the Regulatory Sprint is only part of the federal government’s way of pushing providers toward value-based care. Another example is the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), a bipartisan law that created the Quality Payment Program, which includes several key elements:

• Repeals the Sustainable Growth Rate formula
• Changes the way that Medicare rewards clinicians for value over volume
• Streamlines multiple quality programs under the new Merit Based Incentive Payments System (MIPS)
• Gives bonus payments for participation in eligible alternative payment models (APMs)

Despite the government's push toward value-based care, the US today remains a mostly fee-for-service model. In recent years, only a small percentage of health system revenue was based on downside risk. But large health systems are beginning to change. In UnitedHealthcare Group’s OptumCare plan, for example, two-thirds of physician facilities are in risk-bearing arrangements. And as UnitedHealthcare adds new providers, they will seek to move them into value-based agreements.

In other examples of how change is beginning, Trombetta called out ChenMed and Oak Street Health as specific instances of healthcare providers making bold steps toward value-based care, including taking on the financial responsibility for the health of their patients. And even some states are joining the shift to value-based, coordinated care. California Medicaid has gotten a head start on the idea of coordinated care, introducing programs giving air conditioners to asthma patients and providing transportation and housing for certain patients. Some California doctors are even making patient house calls.

Throughout his presentation and the ensuing Q&A, Dr. Trombetta acknowledged the tension between healthcare entities as they work through Triple Aim, fraud and abuse, and antikickback regulations. He presented a positive, forward-looking view of how healthcare stakeholders can and should work together to move from volume-based healthcare to value-based healthcare.

Join us in San Diego September 14-15

Next month, our team will be attending and presenting at Hub and Specialty Pharmacy Models West on September 14 and 15 at the Sheraton San Diego Hotel & Marina in San Diego, CA. Visit the Informa website to register. We hope to see you there!