The Pharmacy Benefit

We explore how The Robinson-Patman Act, an antitrust law intended to shield businesses acting as buyers from unfair competition, has impacted the pharmaceutical market from a historical standpoint, how it might be applied in the future, and what it means for public policy on drug pricing and rebates. To explain this, JC Scott sits down with Ross Margulies, a Partner with special expertise in Medicare and Medicaid law at Foley Hoag LLP. JC and Ross discuss the antitrust litigations that have shaped the drug supply chain.

Although the COVID-19 vaccine rollout has had a successful start, major health inequities still exist in vaccine access for underserved communities and underrepresented minorities. 2 million Americans are being vaccinated a day, but less than 20% are underrepresented minorities. In this episode, guest host Claire Winiarek sits down with Dr. Elena Rios, President and CEO of the National Hispanic Medical Association (NHMA), and Dr. Sree Chaguturu, Senior Vice President and Chief Medical Officer of CVS Caremark. Claire, Dr. Rios, and Dr. Chaguturu discuss the unique social determinants for why these inequities exist, why it’s important to reframe COVID-19 vaccination campaigns for specific demographic groups, and how PBMs are working to educate underserved populations on the safety and efficacy of the COVID-19 vaccine. 

Although the COVID-19 vaccine rollout has had a successful start, major health inequities still exist in vaccine access for underserved communities and underrepresented minorities. 2 million Americans are being vaccinated a day, but less than 20% are underrepresented minorities. In this episode, guest host Claire Winiarek sits down with Dr. Elena Rios, President and CEO of the National Hispanic Medical Association (NHMA), and Dr. Sree Chaguturu, Senior Vice President and Chief Medical Officer of CVS Caremark. Claire, Dr. Rios, and Dr. Chaguturu discuss the unique social determinants for why these inequities exist, why it’s important to reframe COVID-19 vaccination campaigns for specific demographic groups, and how PBMs are working to educate underserved populations on the safety and efficacy of the COVID-19 vaccine. 

The Trump administration enacted the Rebate Rule just before leaving office in November 2020. Analyses on the rule, including from government actuaries, show that the rebate rule would increase Medicare Part D premiums by 25% and increase taxpayer costs by 170 billion dollars. PCMA filed a lawsuit to stop the rebate rule from taking effect. In this episode, host JC Scott speaks with April Alexander, General Counsel and Vice President of State Regulatory Affairs of PCMA; and Mark Newsom, principal and founder at Health Evaluation, LLC. JC, April, and Mark discuss the PCMA lawsuit, the impact of the last-minute rebate rule, and the Biden Administration's approach to addressing the rule.

Many Americans have expressed strong reservations about vaccines in general and a COVID-19 vaccine in particular, and remain unsure about whether to be vaccinated against the coronavirus (SARS-CoV-2). In this episode, guest host ClaireWulf Winiarek speaks with Janet McUlsky, convener of the COVID-19 Vaccine Education and Equity Project, and Susan Winckler, a former Chief of Staff to the FDA Commissioner and current CEO of the Reagan-Udall Foundation for the FDA, about these concerns and the potential messages and messengers that may help improve understanding. Only by meeting individuals where they are, and with empathy, can we promote equity and trust in the vaccines and support informed decision-making regarding whether to be vaccinated—particularly among communities of color.

To learn more about the important work underway by the COVID-19 Vaccine Education and Equity Project, or to join the initiative, visit covidvaccineproject.org. Findings from the COVID-19 Vaccine Confidence Project, led by the Reagan-Udall Foundation for the FDA, are at covid19.reaganudall.org.

A Historic Effort and Collaboration. Susan discusses that the vaccine was able to move along quickly due to significant collaboration and large numbers of people who were eligible for clinical trials. To ensure the vaccine could be distributed as soon as possible, manufacturers continued working on it at risk while they were under regulatory review so it could be distributed as soon as it was authorized. FDA staff members reviewed regulatory packages of the vaccine to move authorization along as quickly as possible. Janet shares that the thorough oversight and monitoring by the FDA, researchers, and physicians helped ensure the safety and effectiveness of the vaccine even though the process was much quicker.  Previous pandemics and other infectious threats in the last decade also resulted in more research that allowed manufacturers to advance the vaccine more quickly in the COVID-19 pandemic. 

Handling Vaccine Skepticism. Janet and Susan agree that to distribute the vaccine to more individuals, it will take conversation and dialogue over dismissiveness to answer the questions of those hesitant to receive it. Much of the hesitance comes from marginalized communities due to racial and ethnic disparities in healthcare. It’s necessary to invite questions to discuss how the vaccine was developed so quickly, who authorized the vaccines, and how the clinical trials were diverse across race, ethnicity, and age to make sure the vaccine works for everyone.

Distributing Vaccine Information. Trusted messengers are necessary in both listening to concerns and responding thoughtfully. Local healthcare professionals are credible messengers to answer questions in one-on-one conversations. Janet shares that the COVID-19 Vaccine Education and Equity project provides discussion guides for people to talk among various groups about the data behind the vaccine to ensure no shortcuts were taken, especially among marginalized groups and those with prior health conditions. Personal conversations can answer why the “risk-benefit” weighs on the side of getting the vaccination.

All Hands On Deck. The private sector is helping employers by passing around data and information to help people feel calm and confident that the vaccine is safe and effective. Susan adds that it’s necessary to give health professionals the right information as they tend to be the de facto health experts in their social circles. Health professionals should be prepared with answers and resources to welcome questions and provide accurate answers. 

COVID-19 Vaccine Discussion Guide.

You can subscribe to The Pharmacy Benefit on Spotify, Google Podcasts, Apple Podcasts, and all other major platforms.

Host JC Scott speaks with Megan Hauck, a former Health Policy Advisor to President George W. Bush, Senator Mitch McConnell, and Chris Jennings, former Senior Advisor for Health Policy for both the Clinton and Obama Administrations. In this episode, Scott, Hauck, and Jennings discuss the election results, what a new president and Congress will mean for healthcare policies, and speculate how shifts in the House and Senate will impact the future of healthcare.

The failure of polling. The results of the election, specifically regarding the performance of Republicans in the House and Senate, were a big surprise to many. Hauck calls for polling to be modernized while Jennings argues that the media and its consumers over-utilize polling. With the massive turnout, the voters clearly called for collaboration in fighting Covid-19.

Policies the Trump Administration might push in these final weeks. Regarding healthcare, the administration is currently examining the Rebate Rule and a proposal to tie drug prices to an international benchmark. It’s normal for an administration to push out prioritized regulations in their last eight weeks. Technically, Congress can overturn them under the Congressional Review Act, but this can be an arduous process. Hauck points out that the Trump administration will prioritize its own policies over those that will help Congress in the long run, something that is unusual compared to previous presidents’ administrations.

Narrow majority chambers, will they come together for healthcare? Jennings suggests that there will be bipartisan interest in preventing future pandemics, once we have control over the virus. Until then, Covid-19 is expected to be the primary focus regarding healthcare. The pandemic has also exposed the shortcomings of the healthcare system and exacerbated Medicare solvency, leaving public healthcare and Medicare as the next big issues to tackle. President-elect Biden will likely address states who have not expanded Medicaid. Hauck and Jennings also discuss how Biden’s previous experience in the Senate will impact his ability to navigate Congress as President.

Refusal to transition. With President Trump refusing to concede, there is an unprecedented lack of communication between the Trump and Biden teams. This means that the incoming Biden administration does not have access to key departments and information for fighting Covid-19, including the distribution of vaccines and testing dynamics. Hauck and Jennings both share experiences of their duties when they worked during presidential transitions, agreeing that it’s a patriotic duty to assist the next team coming in and that the delays are inexcusable — but not insurmountable.

More elections to come, more predictions. Midterm elections are coming in 2022. With narrow majorities in both chambers, Hauck and Jennings offer their predictions for the House and Senate outcomes.

You can subscribe to The Pharmacy Benefit on Spotify, Google Podcasts, Apple Podcasts, and all other major platforms.

Host JC Scott speaks with Amy Bricker, Senior Vice President of Health Services Supply Chain at Express Scripts and previous commissioner for MedPac. November is National Diabetes Month, and the discussion this week revolves around how PBMs help keep the costs of insulin down and improve patient care. 

Getting Support for Diabetes in America

List prices for insulin have not gone down, leaving some diabetes patients with high costs for the live-saving medicine, either as high insurance co-pays or deductibles or the high cost of insulin itself. While there have been some improvements in delivery technology and formulations, Bricker points out that these innovations don’t justify the high prices pharmaceutical companies continue to charge. To some extent, the lack of competition in the market is causing this, which is why PBMs are so important.

How Express Scripts is Helping

Last year Express Scripts saw a 5% decrease in spending from those enrolled in their clinical solution, thanks in part to discounts but more critically through leveraging formularies, utilization, and diabetes care value program that ensures patients get complete care, communicated in ways that work best for them.

The Effects of Coupon and Discount Programs

Bricker argues that well-intentioned programs like 340B are out of control and no longer helping patients. She believes this and other coupon programs require major reform or even elimination, because they operate in the background and disrupt formularies.

CMS Part D Senior Savings Model

The Centers for Medicare & Medicaid Services established a voluntary Part D plan that limits insulin’s cost share to $35 a month per beneficiary. Approximately a third of Medicare beneficiaries are affected by diabetes and companies such as Express Scripts and Cigna will participate in this program. While Medicare Part D definitely needs reform, steps such as these are a great starting point and crucial to those within the program.

What Does the Future Look Like?

Bricker says we need to encourage manufacturers to lower prices, but that needs to be encouraged by legislation or regulation — while always keeping the patient top of mind. She advocates for Part D reform to establish more programs like the #35/month cost share.

You can subscribe to The Pharmacy Benefit on Spotify, Google Podcasts, Apple Podcasts, and all other major platforms.

Host JC Scott speaks with two guests from Humana Pharmacy Solutions. The first, Dr. Mona Siddiqui, is senior vice president of clinical strategy and quality at Humana. Her background is in public service, especially with HHS and the Center for Medicaid and Medicare Innovation. The second is Dr. Scott Greenwell, senior vice president of pharmacy solutions at Humana, who played an integral role in launching Humana’s Medicare Part D program. The discussion is around innovation in service delivery both before, during, and after the pandemic. 

Analyzing Trends to Improve Programs: Data-driven program design utilizing almost-real-time data from CMS or FDA can have an enormous impact on end users. Bringing together data assets from Humana’s insurance side, home segment, and pharmacy segment has provided insight into differing needs of pharmacy customers, most recently during the pandemic.

Social Determinants During the Pandemic: During Covid social determinants of health are of paramount interest. Humana focused on listening to customer needs, including food scarcity, loneliness, transportation access, early prescription refills, mail delivery, and allowing periodic lab requirements to be postponed. 

Will Changes Made During the Pandemic Last?: You can’t put the genie back in the bottle. Consumers will expect changes like mail delivery to remain in place even after the pandemic is under control. Surprisingly, even seniors preferred an end-to-end digital experience; they are used to seamless digital experiences now because of entities like Amazon. 

Meeting Consumer Expectations with Technology: Humana began in 2015 with the real-time benefit check transaction as an early transparent digital process. This was integrated into the physician’s existing workflow and the response was that this was just what had already been expected. Even those who have been uncomfortable with digital tools approve of them when the experience is frictionless for patients and providers.

Specialty Drugs in Disease-specific Clinical Initiatives: Where traditional rebate tools will not work, as with specialty drugs, Humana sometimes uses value-based contracting. The company also has a program called UM Ultra, which creates personalized utilization management, such as looking at dose optimization, so that patient value is balanced with drug cost. 

Promoting Covid Testing: In addition to covering testing costs, Humana has also made at-home testing kits available. And it created a drive-thru PCR test partnership with Wal-Mart that delivers results digitally and refers out as well, when necessary. And, again, the purely digital process has proved more popular than the drive-thru process, counterintuitively for some. 

You can subscribe to The Pharmacy Benefit on Spotify, Google Podcasts, Apple Podcasts, and all other major platforms.

Host JC Scott speaks with Claire Winiarek, the VP for Policy of PCMA, about the increased use of mail delivery for prescriptions. Winiarek discusses the value of mail service for prescriptions both relative to the pandemic and beyond it.

PBM Mail Service Increases During the Pandemic: The top-line trend is increased mail delivery by 20 percent through July, year on year. At the tail end of the first quarter, early refills drove an increase, as well as at the end of the second quarter as people reached the end of their 90-day prescriptions.

PBM Response to Increasing Demand for Home Delivery: Part of the response was working with pharmacies to provide home delivery as well as mail delivery and to make consumers aware of the service. In addition, educating consumers about 90-day refills and arranging auto-ship through the mail has been an essential contribution to slowing the spread of the virus by making it possible for people to stay home. 

PBMs and Pharmacies Working Together: PBMs and pharmacies worked together early in the pandemic to develop practical, common sense alternatives to delivery signature requirements. 

PBMs and Delivery Challenges: Some PBMs are trying alternative carriers or changing when prescriptions are shipped to allow for potential delays. They’re also allowing for early refills and transition fills at local pharmacies. Behind the scenes, there are proprietary systems mapping the transit of prescriptions through the system so that delivery can be continuously fine- tuned. A well-funded Postal Service is critical for the affordability of this option.

Home Delivery Benefits Consumers: Prescription adherence rates improve from 77 percent for pharmacy pick up to 87 percent for mail delivery. This adherence, in turn, drives improvements to other outcomes such as emergency room utilization and rehospitalizations. Dispensation of medication is also safer when performed en masse in a factory setting as opposed to in local pharmacies. Of course, the scale also drives costs down for consumers, as does the convenience itself. Having 24/7 access to prescription counseling through PBMs can be another benefit both in terms of convenience and confidentiality. Data from IQVIA suggest that these increases in home delivery will be here to stay, along with telehealth and tele-pharmacy options. 

COVID-19 Test Kits Via PBMs: UnitedHealth Group is beginning to send lower-nose tests that are as effective as the tests developed earlier in the pandemic. CVS is also sending out test kits. 

Outlook for a Vaccine: Winiarek leads a stakeholder group with other drug supply chain partners, including pharmacies, manufacturers, grocers, and hospital pharmacists that has been discussing drug shortages and now plans for a COVID-19 vaccine. The discussion has centered around how the supply chain can support a scientific and evidence-based process of evaluation of vaccines. Planning ahead for the fact that supplies of the vaccine will be limited and developing policies for allocation, access, and safety are central to the group’s efforts. 

You can subscribe to The Pharmacy Benefit on Spotify, Google Podcasts, Apple Podcasts, and all other major platforms.

Host JC Scott speaks with Mark Newsom, the principal and founder at Health Evaluations LLC, on one of the executive orders Trump signed on drug pricing that affects prescription drug rebates for public programs. Newsom discusses how prescription drug premiums will certainly increase with the implementation of this rule.

What a Post-Rebate System Would Look Like For PBMs: With the removal of rebates for such programs, many players in the system are skeptical about how the shift in power will disturb the establishment of drug prices. Newsom speculates the balance shifting towards consumers sticking to the pricier branded drugs rather than their generic counterparts.

The Executive Order Could Still Have Its Meaning Altered: JC and Mark discuss what mysteries await with how Secretary of Health and Human Services, Alex Azar, moves forward with Trump’s order. Newsom also brings up how big changes in sectors such as pharmaceuticals and healthcare would bring risks if not properly tested and ironed out beforehand.

Taking a Step Back to See What is and isn’t Working: Newsom gives his own take on how the system as whole can fix the issues being presented while also keeping every party happy. From creating sufficient competition without giving one stakeholder too much leverage to how out-of-pocket protection can be implemented, most problems can be solved when everyone is on the board to discuss.

You can subscribe to The Pharmacy Benefit on Spotify, Google Podcasts, Apple Podcasts, and all other major platforms.