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CMS’ most popular episode-based payment initiative requires careful internal analysis of costs and competencies, and recognition of improvement levers.

3 Steps for BPCI Advanced Success

Efforts are under way by health plans and technology providers, aided by new standards developed by the Centers for Medicare and Medicaid Services (CMS), to make the prior authorization (PA) of prescription drugs more seamless. Panelists during a session at the Pharmacy Benefit Management Institute’s Annual National Conference in Orlando discussed how technology is advancing to allow the prior authorization process to operate behind the scenes through electronic systems that are integrated with health plan information.

Eventually, the hope is that the systems set up to manage e-prescribing and prior authorization will be integrated with electronic medical records to allow providers to see which drugs require prior authorization at the point of prescribing and facilitate that process

“Instead of PA being something that engages members and providers, in this day and age where we have the access to data, this can be something behind the scenes that we would just code for in the benefit design,” said Kerri Tanner, Pharm.D., chief pharmacy officer, PayerAlly, a specialty pharmacy consulting firm, who moderated the session.

Before that goal of an integrated electronic prior authorization process can be realized, however, several challenges need to be addressed, including the adoption of new standards and the integration of systems. Even more critical, however, is convincing providers of the benefit such a system.

“There’s far too much faxing still happening in healthcare today,” Tim Capstick, regional vice president of health plans at SureScripts said. Surescripts processes about 23 billion transactions a year, but just 10% of those are e-prescribing transactions. The cost of implementing electronic systems is still a barrier for smaller health plans, PBMs and providers, he said.

“There’s some opportunity in the prior authorization space and in healthcare in general to tap into the clinical information exchange and automate that use,” Capstick said. “We as the stakeholders need to help some of the smaller organizations so that they can adopt the technology.”

The panelists at the session discussed how a prospective workflow for prior authorization can reduce the administrative workflow for providers and their staff and create a more efficient process for making sure that patients are able to get the appropriate medications.

Humana was an early adopter of e-prescribing and prior authorization with the implementation of a retrospective system in 2014, which Morgan Bojorquez, associate vice president, pharmacy clinical integration, at Humana, said created many efficiencies and enabled a prior authorization workflow that had a turnaround time of 12 hours.

Humana has also initiated a prospective workflow from the electronic health system, but found that prescribers are more likely to adopt a retrospective system. “They wait for the pharmacist to tell them that the medication requires PA for the patient,” Bojorquez said.

Humana strives to implement solutions that support physicians at the point of prescribing, as well as pharmacists. One example, he mentioned was the process Humana implemented for approving prescriptions for GLP-1 therapies. “We have the ability at the point of sale, to evaluate the full medication profile of a patient when a claim comes in for a GLP-1. We don’t stop every claim,” he said.

For about 10% of claims Humana processes for a GLP-1 therapy, there is no evidence of diabetes. For those claims, Bojorquez said Humana leverages in real-time medical and pharmacy claims to look at historical medications to see if patients have diabetes. “We try to completely avoid the PA process by leveraging data and technology to facilitate that process.”

Bojorquez said this is the future of prior authorization. But to be implemented on a larger scale will mean bringing together data from multiple sources and unifying standards.

CMS is leading the way in bringing new standards for interoperability of data. Earlier this year, 

 the Fast Healthcare Interoperability Resources (FHIR) standard for application programming interfaces to improve the electronic exchange of healthcare data and to streamline prior authorization processes.

These standards would allow for electronic prior authorization for medical services. Payers will be required to implement the prior authorization standards by Jan. 1, 2027, although some operational provisions should begin in January 2026. The standards apply across programs the CMS oversees, including Affordable Care Act plans, Medicaid and Medicare Advantage, and the Children’s Health Insurance Program.

At this point, the CMS rule doesn’t apply to prior authorization for prescriptions, but that could change in the future, according to an 

One limiting factor, however, for widespread adoption of electronic prior authorization is the restriction of access to data for non-treatment use under the rules of the Health Insurance Portability and Accountable Act (HIPAA). “In many cases, there are handcuffs on what you can do that use patient data for up to and including a prior authorization. If those handcuffs were to come off and it’s done responsibly, we could really streamline and make the prior authorization process is very efficient,” Capstick said.

That’s where he said that qualified health information networks come in. These are network of organizations that work together to share data and ensure interoperability between the networks they represent. There are 

 qualified health information networks, according to the Office of the National Coordinator for Health Information Technology (ONC).

“The intention is to remove the handcuffs, so to speak, of the information that is in an EMR, and open that up to not only treatment use cases but also non-treatment use cases, payment and operations,” Capstick said. “The networks start off in a treatment space, but but will need partners, health plans, payers, providers, etc, to look at use cases on the payment and operations side and build the workflows that are proper and everybody can agree to the terms of how information will be exchanged.”

Technology is advancing to allow the prior authorization process to operate behind the scenes through electronic systems that are integrated with health plan information. 

New Standards Could Pave the Way for More Efficient Prior Authorization | PBMI 2024

During an interview, Joseph Shields of TransparencyRx discusses the PBM legislation that is expected to move forward in Congress in the next few months.

Joseph Shields is Optimistic about PBM Reform Legislation | PBMI 2024

Joseph Shields, managing director of TransparencyRx, provided insights into the ongoing efforts to reform pharmacy benefit managers (PBMs) and the broader healthcare market.

During an interview ahead of the annual meeting of the Pharmacy Benefit Management Institute, Shields said he was optimistic that PBM reform legislation reaching President Joseph R. Biden’s desk before the end of the end. He noted that recent actions in the House and Senate indicate a growing alignment on the need for comprehensive reforms that address issues such as market concentration, spread pricing models, and transparency.

Looking ahead, Shields expressed cautious optimism that meaningful PBM reform could be enacted before the end of the current Congressional session. He believes that such reform could not only improve transparency and competition in the healthcare market but also lead to significant federal savings, which could be redirected to other healthcare initiatives.

Greg Baker, CEO of AffirmedRx, did not hold back in criticizing CVS Caremark, Optum Rx and Express Scripts and their group purchasing organizations today at the PBMI Annual National Conference

Group Purchasing Organizations of 'Big 3' PBMs Clouds Transparency | 2024 PBMI

Greg Baker, CEO of AffirmedRx, gave a presentation at the 2024 PBMI Annual National Conference in Orlando titled, "Unveiling the Shadows: Exploring Detrimental PBM Trends and Their Impact on Employers." In this interview recorded prior to the meeting, Baker discussed what he views as the lack of transparency in the group purchasing organizations (GPOs) that the large PBMs have set up to manage rebates and ongoing vertical integration in the healthcare industry. Baker also discusses the differences between the cost-plus products that the major PBMS are offering and Mark Cuban Cost Plus Drug Company. Baker says Mark Cuban Cost Plus discloses how much it paid for a drug at a single price whereas the PBMs disclose a range that Baker says leads to a lack of transparency about the what the drug actually cost. AffirmedRx is one of the smaller PBMs challenging the major PBMs with business practices that they say are more transparent and can save employers money.

Greg Baker, CEO of AffirmedRx, did not hold back in criticizing CVS Caremark, Optum Rx and Express Scripts and their group purchasing organizations today at the PBMI Annual National Conference.

Group Purchasing Organizations of 'Big 3' PBMs Cloud Transparency, Says Critic | PBMI 2024

Mike Baldzicki envisions a time when cell and gene therapies will be administered at ambulatory infusion centers instead of hospital centers of excellence. Aided by newer technology — such as smart infusion pumps, technology that delivers precise medication and remote monitoring — infusion centers of excellence will be able to provide a more cost-efficient solution for delivering these and other infusion therapies.

“The rare disease pipeline and the gene cell therapy markets are growing, and there are nuances around having to customize patient care that will impact the medical benefit,” said Baldzicki, who is chief commercial officer at Polaris Specialty Pharmacy. “How do we adjust to the next phase of healthcare, looking at how do we quickly work with consumers but also looking at how do we manage cost?”

During a session at the Pharmacy Benefit Management Institute’s Annual National Conference in Orlando, Baldzicki discussed how infusion centers will be able to meet the needs of the growing number of patients who will be eligible for infusion and cell and gene therapies.

“I'm a big believer that, based on the pipeline we’re seeing in gene and cell therapy, ambulatory infusion centers will become an appropriate site of care,” he said. “Digital technology and AI and adaptive tools will allow for a holistic approach and allow for us to customize programs based on the appropriate site of care.”

The cell and gene therapy market is growing. There are more than 30 cell and gene therapies approved by the FDA, according to the 

. And many more are in development. There are currently more than 600 gene and therapy programs in development, and the FDA expects to approval between 10 and 20 news cell and gene therapies by 2025.

All of this development will lead to increased costs to payers. In 2023, spending on cell and gene therapies increased 38% over 2022 to $5.9 billion in 2023, according to a recent report from IQVIA Institute for Human Data Science.

Spending on next generation therapies is expected to grow three and half times to $18 billion in four years.

By 2032, there could be almost 50,000 patients a year that could be treated with gene therapies, predicts a 

 by the Institute for Clinical and Economic Review (ICER) and NEWDIGS, Tufts Center for Biomedical System Design.

Over the past two years, gene therapies have been approved by the FDA with list prices that are higher and higher. The most recent, Lenmeldy, has the highest ever price for a new treatment: $4.25 million.

But the costs of treatment are not the only costs involve in gene therapy, which is a process. Some require that bone marrow be removed to manufacture the therapy, and the therapy is then reinfused into the patient. Some require the administration of chemotherapy prior to the gene therapy.

The FDA is also approving novel therapies for diseases with larger patient populations, Baldzicki said. “The definition of rare disease is changing. It usually means a population of 20,000 or less, but what we’re seeing in newer launches, especially therapies with a first-of-kind mechanism, is that they are hitting larger populations. This means we’re going to see population eligibility for a product launch in the hundreds of thousands. With price tags increasing, especially in rare disease, there will be hundreds of thousands of dollars of costs beyond the therapy…One claim could bankrupt a teachers’ union or school district overnight.”

Baldzicki said there is an opportunity for employers and payers to consider carving out the infusion services and provide care through ambulatory infusion centers. This, he said, is a growing area that has attracted the attention of private equity. 

 that global the ambulatory infusion center market to be at $47.1 billion in 2024, with 10.6% compound annual growth rate.

“We’re already seeing some innovative programs with the Blues plans working with provider groups to provide options outside of the hospital, whether buy-and-bill and treating the patient in the office, partnering with a specialty pharmacy or treating the patient at home,” he said. “We’re seeing new models and it’s just not for TPN and hydration product. It’s IVIG products. It’s rheumatology. Payers are getting more robust with their product selection because of the way they’re working with local provider groups.”

Baldzicki stressed that the provider is key for developing these programs. “We have to have a patient and provider focus. Larger groups are being more collaborative with providers so there is less disruption for the patients, and we are seeing more demand from patients.”


Digital technology, AI and other tools will allow for many specialty infusion therapies to be administered in ambulatory centers, allowing payers to customize programs.


The Future of Infusion Therapies Is in the Ambulatory Center | PBMI 2024

Congress has been considering legislation that would increase transparency into pharmacy benefit management (PBM) contracts and ban certain PBM practices, such as spread pricing. 

Patrick Cooney, president of The Federal Group, a Washington, D.C., lobbying firm, said in an interview conducted at the 2024 PBMI Annual National Conference that it is "highly likely that PBM legislation will get across the finish line," partly because provisions of the current bills will save Medicare money.  

Cooney said that the Federal Trade Commission interim report on PBMs that came out in July  is "galvanizing action as well" and that the Sen. Ron Wyden, D-Oregon, chair of the Senate Finance Committee "spoke very vehemently after the report came out that he was fully committed to getting something done quickly." 

Patrick Cooney, a Washington, D.C., lobbyist, discusses the politics of Congress passing PBM legislation this year

Patrick Cooney, The Federal Group, on the PBM legislation prospects

Cooney noted that Congress will be session for about three weeks before the Nov. 5 election, but it is unlikely that will any PBM legislation will pass before the election, but that still leaves the lameduck session after the election for legislation to get through the House and the Senate and eventually on to the president's desk for signing.

Cooney, who is a consultant to Pharmacy Benefit Management Institute, spoke at session of the conference on Wednesday that focused on poiicy and politics.

Patrick Cooney, president of The Federal Group, a Washington, D.C., lobbying firm says prospects for legislation passing this year, albeit during the post-election lameduck session, are good partly because the PBM legislation would produce Medicare savings that could be put toward other uses.

Will Congress Pass PBM Legislation This Year? It Is 'Highly Likely,' Says Patrick Cooney | PBMI 2024

Billing With Intravenous and Subcutaneous Therapies

Video content above is prompted by the following:

What is the difference in the billing process with IV and subQ therapies? 

Dr Seminerio highlights the differences in billing between intravenous and subcutaneous biologics.

Aditya Govil

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