Simplify your independent pharmacy inventory ordering with AAP’s Scan & Toss.
You now have the freedom to quickly purchase from API Warehouse and AAP’s primary contracted wholesaler, anywhere you go, straight from your mobile device. Scan & Toss is an app you can use on your mobile devices in your pharmacy. You scan the barcode you want to order and the product goes in your cart. You can select the quantity from there.
Plus, we are introducing a new feature to the app. Take advantage of our Scan & Toss NEW opt-in feature: Allow your Scan & Toss mobile app or desktop program to examine the NET cost of each item you enter or scan between API Warehouse and our primary contracted wholesaler. Scan & Toss will automatically place the lowest cost item in your order queue. Read more.
Bulk ordering with SmartSync can keep your independent pharmacy’s shelves stocked.
What are your patients’ biggest frustrations when it comes to their medications? Cost? Insurance coverage? How about availability? Have you had to tell a patient their prescription is delayed because you are out of an item they need? We have an answer for that! It’s called SmartSync, AAP’s customized intelligence-based bulk ordering program. SmartSync makes ordering pharmacy stock easy. Read more.
Here are your top independent pharmacy news stories for the week of September 27, 2024, including PBM reform in Alaska and Congress’ focus on PBMs and spread pricing.
PBM reform in Alaska
Alaska Governor Mike Dunleavy (R) has signed H.B. 226 into law, a bill spearheaded by the Alaska Pharmacy Association to overhaul pharmacy benefit manager (PBM) practices. The new legislation establishes a duty of care for PBMs toward plan sponsors, benefits administrators, and covered individuals, while introducing new requirements for transparency and disclosure. Read more.
AAP is excited to announce registration for the 2025 AAP Annual Conference is now open. Being held April 10-12 in Austin, Texas, this is the one conference all community and independent pharmacists should attend.
This pivotal event is crucial for pharmacists striving to excel in the industry. The 2025 AAP Annual Conference offers a plethora of benefits designed to significantly enhance your practice and foster professional growth.
One of the foremost reasons to attend is the chance to uncover innovative strategies to elevate your community pharmacy. Sessions led by industry experts provide invaluable insights into the latest trends, technologies and best practices.
Plus, the smaller nature of this event versus one held in a large arena, allows for pharmacists to connect and network on a more meaningful level. And being an AAP Member is vital for supporting community pharmacists. By attending the annual conference, you’ll gain a deeper understanding of how AAP Membership can impact your professional development and access essential resources to help you succeed.
Benefits of Attending the AAP Annual Conference
The 2025 AAP Annual Conference in Austin is a must-attend for community pharmacists looking to advance their professional growth and stay updated with industry trends. Key benefits of attending include:
Networking with industry professionals: The 2025 AAP Annual Conference gathers community pharmacists, industry leaders and experts from across the nation, creating a fertile ground for networking and establishing valuable connections. Engaging with like-minded professionals facilitates knowledge sharing, collaboration and potential partnerships that can benefit your pharmacy practice.
Access to cutting-edge pharmacy technology: The event showcases the latest innovations and advancements in pharmacy technology. From automated dispensing systems to digital health solutions, you’ll discover tools that can streamline operations, improve patient care, and enhance efficiency.
Educational sessions on relevant topics: The 2025 AAP Annual Conference offers a diverse range of sessions specifically tailored to community pharmacists. These sessions cover alternative revenue streams, regulatory updates and emerging trends. Attending these sessions will expand your knowledge, keep you informed about industry changes, and equip you with practical skills to better serve your patients.
By attending the AAP Annual Conference, you’ll gain valuable insights, forge meaningful connections, and remain at the forefront of the pharmacy profession. Don’t miss this opportunity to elevate your practice and make a positive impact in your community! Register now.
U.S. House Committee Chair Calls Out PBM CEOs for False Claims
On August 28, House Oversight and Accountability Committee Chairman James Comer (R-Ky.) sent letters to the CEOs of CVS Caremark, Express Scripts, and OptumRx asking that they “correct the record” for false and contradictory statements made during the committee’s July 23 hearing.
Comer pointed out that the three CEOs’ testimony was contrary to the findings in both the FTC’s report from earlier this summer and the committee’s staff report. The executives claimed that their PBMs don’t steer patients to their own pharmacies, that they have opaque contract negotiations and opt-out terms, all of which run counter to bipartisan findings.
Comer also noted that under the law those who are untruthful in committee testimony under oath run the risk of a fine or five years imprisonment. The committee is asking the CEOs to provide their corrections to the record within three weeks.
Join Nic Bernabe, Product Manager from Outcomes, to discuss their latest innovation, PillCount.
PillCount, Outcomes’ latest innovation, is built to advance your pharmacy into the next era. Equipped with powerful iPad processing capabilities, PillCount runs their advanced AI software, which is continually evolving to deliver near-perfect counting accuracy of 99%, exceptionally fast counting speeds and the capacity for future enhancements. As a cloud-based solution, PillCount eliminates the need for manual software updates, offering automatic updates instead. Outcomes prioritize security, proudly holding hi-trust and SOC 2 certifications. All these features are integrated into a compact footprint that can be easily repositioned and tailored to fit the unique layout of your pharmacy.
The U.S. Food and Drug Administration on Thursday approved updated COVID-19 vaccines from Moderna and Pfizer/BioNTech for fall 2024.
Moderna and Pfizer said updated mRNA shots will be available in the next few days.
The US Centers for Disease Control and Prevention recommended in June that everyone over six months receive both an updated COVID-19 vaccine and a flu shot this year.
The FDA said Thursday that people five and older are eligible to receive an updated Pfizer or Moderna Covid-19 vaccine as long as it has been at least two months since their last dose.
AAP understands that every independent pharmacy is different. Both the customer mix and product mix are unique to your pharmacy, so one purchasing option will not work for all owners. AAP Pharmacy Business Advisors have the tools to analyze your business and help you choose the right model for your pharmacy. Read more.
Many buying groups tell you they can make your pharmacy more profitable. But can they prove it? AAP can. Here is the information you need to know about the actual value of AAP programs.
What is ProfitAmp?
ProfitAmp is a comprehensive business intelligence tool that delivers a deeper look into your independent pharmacy operations.
How does ProfitAmp work?
ProfitAmp analyzes your dispensing data through your Pharmacy Management System to identify key dispensing trends, missing patients and income.
How much revenue does ProfitAmp generate?
Through an easy-to-use dashboard, ProfitAmp provides customizable reports with immediately actionable data that pharmacies can use to improve patient care, increase revenue, adherence and more. Pharmacies actively using the Missing Refills Opportunity Queue generated, on average, an additional $21,991.82 in revenue in January 2024. Read more.
One of the first steps of opening and running an independent pharmacy is to select the correct buying group. Here are the top 10 FAQs we hear.
1. What is an independent pharmacy buying group?
A buying group consists of independent pharmacies joined together in negotiating the cost of drugs with a wholesaler. This aggregated buying power provides economy of scale to allow independently owned businesses to compete more effectively with large chains. Read more.
The evolution of LTC Pharmacy at Home services are continuing through this year. The need for better pharmacy care for people who are homebound or need assistance with activities of daily living (ADLs) is a reality with the increasing elderly population. According to projections in a new report from the Population Reference Bureau (PRB), the aging of the baby boom generation (those born between 1946 and 1964) could fuel a 75 percent increase in the number of Americans ages 65 and older requiring nursing home care, to about 2.3 million in 2030 from 1.3 million in 2010. New facilities are not being built today to accommodate people with institutional needs.
Being a part of a buying group is critical to the success of independent pharmacies.
Buying groups help lower the cost of inventory. But knowing which type of buying group works best for your community pharmacy is essential.
There are three main types of independent pharmacy buying groups – for-profit, an association and a cooperative. For-profit organizations give their profits generated by the group back to the owner of the organization.
With an association, income is generated in the form of administrative fees collected from suppliers contracted to provide goods and services. Profits generated are used to support the association.
An independent pharmacy cooperative, also known as a pharmacy buying cooperative or a pharmacy cooperative purchasing group, is an organization formed by a group of independent pharmacies that come together to pool their resources and purchasing power for the purpose of obtaining better pricing, discounts and other benefits from suppliers, wholesalers, like API Warehouse, manufacturers and other vendors. These cooperatives are established to help independent pharmacies compete more effectively with larger pharmacy chains and benefit from economies of scale.
American Associated Pharmacies (AAP) is an independent pharmacy cooperative.
Our income is generated in the form of administrative fees collected from suppliers that contract to provide goods and services. Qualified profits generated are shared among all members in the form of an annual Board-declared Patronage Dividend.
Learn more about other key features of an independent pharmacy cooperative.
A PSAO acts as a conduit between the independent pharmacy and third-party payers, negotiating contracts and attempting to ensure equitable reimbursement rates, in addition to evaluating all Terms and Conditions of the agreement.
Independent pharmacies grapple with numerous challenges in the constantly evolving healthcare sector. From managing regulatory compliance to optimizing pharmacy operations, staying competitive calls for strategic solutions. This is where a Pharmacy Services Administration Organization (PSAO) becomes instrumental.
For independent pharmacies striving to flourish in the industry, comprehending the role of a PSAO is crucial. By teaming up with a PSAO, pharmacies can more efficiently steer through the intricacies of regulatory compliance.
A PSAO also aids independent pharmacies in maximizing their operations. From simplifying claims processing to providing access to valuable resources and services, a PSAO may bolster pharmacy efficiency and profitability.
Deciphering the Role of a PSAO
Forming an alliance with a Pharmacy Services Administration Organization (PSAO) may offer numerous benefits to an independent pharmacy. A PSAO acts as a strategic collaborator, providing support and resources to help pharmacies navigate the complex landscape of pharmacy reimbursements, contract negotiations, and pricing with payers.
Often a key advantage of collaborating with a PSAO is the enhanced ability to maximize pharmacy reimbursements. PSAOs possess expertise in understanding the complexities of third-party reimbursement systems and may help pharmacies optimize their reimbursement rates. By utilizing their industry knowledge, administrative efficiencies for third-party payers and a readily available contracted network of pharmacies, PSAOs may aid pharmacies in securing higher reimbursement rates from payers, ultimately boosting the financial health of the pharmacy.
Furthermore, PSAOs attempt to play a pivotal role in negotiating contracts and pricing with payers on behalf of independent pharmacies. These organizations have established relationships with payers and hold the necessary expertise to negotiate favorable terms for pharmacies. By collaborating with a PSAO, independent pharmacies may benefit from the expertise of the organization, and their work toward fair and competitive pricing for the network pharmacies’ provision of products and services.
Moreover, PSAOs provide valuable administrative support to pharmacies, streamlining processes and reducing administrative burdens. They offer access to technological solutions, such as electronic claims processing and reconciliation, which can enhance efficiency and accuracy in pharmacy operations. Additionally, many PSAOs offer audit protection programs that aid the pharmacy in preparation for and response to audit requests from third-party payers. This allows pharmacists to concentrate more on patient care and less on administrative tasks.
In summary, collaborating with a PSAO, like AlignRx, may offer independent pharmacies a range of benefits. From maximizing pharmacy reimbursements to negotiating contracts and pricing with payers, PSAOs provide valuable support and resources that help pharmacies thrive in an increasingly competitive healthcare landscape.
The payment model in independent pharmacies refers to how the pharmacy receives payment for the products and services it provides.
Independent pharmacies, like other businesses, have various payment models that dictate how they generate revenue. Here are some common payment models in independent pharmacies:
1. Traditional Retail Model: Customers pay for prescription medications and over-the-counter products at the time of purchase. The pharmacy establishes the pricing for these products and generates revenue through the sale of these products.
2. Third-Party Payer Reimbursement: Independent pharmacies often work with third-party payers such as insurance companies and pharmacy benefit managers (PBMs). In this model, the pharmacy dispenses medications to patients and the third-party payer reimburses the pharmacy based upon the terms and conditions established by the third-party payer for the cost of the medication plus a dispensing fee.
3. Cash Payment for Services: Some independent pharmacies offer additional services beyond dispensing medications, such as medication therapy management (MTM), immunization and health screenings. In this model, the pharmacy establishes the pricing for those services and the patients may pay cash directly for these services.
4. Membership or Loyalty Programs: Independent pharmacies may implement membership or loyalty programs where customers pay a fee to become members and, in return, receive discounts on medications, services or other perks.
5. Compounding Services: Pharmacies that specialize in compounding medications may charge fees plus the cost of the medications for the customized preparation of medications tailored to individual patient needs. These offerings contribute to the pharmacy’s revenue generally at a much greater profit margin than traditional prescription dispensing.
6. Clinical Services and Consultations: Some independent pharmacies offer clinical services, such as medication therapy management (MTM) consultations. In these cases, patients may pay a fee established by the pharmacy for personalized consultations with pharmacists to optimize their medication regimens.
7. Collaboration with Healthcare Providers: Independent pharmacies may collaborate with healthcare providers or 340 B clinics to provide pharmaceutical services. Payments in such models may be based on a fee-for-service arrangement or other negotiated terms.
The specific payment model adopted by an independent pharmacy can vary based on factors such as the pharmacy’s business strategy, the services offered, the customer base and the regulatory environment. Independent pharmacies often need to navigate complex reimbursement processes and stay informed about changes in healthcare policies and insurance regulations to ensure financial sustainability.
If you have any questions about your store’s payment model, talk to your AAP Territory Manager.
What do dispensers need to know about the FDA letter regarding exemptions for small businesses?
As pharmacies have been preparing for the final deadline for DSCSA Interoperability, the FDA has once again thrown another curveball. DSCSA regulations are already confusing, and this new exemption only adds to that confusion.
The FDA has issued a Small Business Exemption for small dispensers. They define a small dispenser as having fewer than 25 full-time pharmacists and pharmacy technicians. Small dispensers meeting these criteria now have until November 27, 2026, to be compliant with the Enhanced Drug Distribution Security requirements. This means that small dispensers will have extra time to be compliant with serialization, product verification and product tracing.
It is important to note all the other DSCSA regulations will still be in place and enforced on November 27, 2024. In fact, this Small Business Exemption for DSCSA makes it easier for the Boards of Pharmacy and FDA to strongly enforce the remaining requirements of the law which include:
Collecting and saving all transactional (T3) data for at least six years
Reconciling all drugs with your T3 data
Verifying trading partners are licensed
Documentation of standard operating procedures for DSCSA
Identifying and investigating any suspect product
Reporting illegitimate product to the FDA with Form 3911
Obtaining GLNs for every physical location
Confirming product identifiers are on the smallest salable unit for every product
Small dispensers who qualify for the exemption, will have to meet the above requirements, but may not have to:
Collect and receive serialized data (EPCIS)
Conduct a product verification on suspect product (VRS)
Conduct product tracing on a suspect product
Overall, most of the law is still on track for the November 27, 2024, deadline. Pharmacies need to be prepared for this new complex law which will impact how the pharmacy conducts business. The difference is small dispensers have been given a little more time for the interoperable aspects of the law.
InfiniTrak provides complete DSCSA compliance, including the interoperable phase of the law. All dispensers, large and small, can achieve compliance now with the Infinitrak platform. InfiniTrak’s association with many of the industry partners offers affordable discounted pricing.
Most pharmacies are continuing to move forward towards full compliance now rather than later. As a result, the pharmacies are delivering a higher level of patient safety and benefiting from the added value provided by the InfiniTrak platform.
In today’s fast-paced world, convenience and efficiency are paramount, especially in healthcare. Pharmacies must embrace technological advancements to provide top-notch service and maintain a competitive edge. One such advancement is the mobile app, a tool that has become indispensable in enhancing patient care and streamlining pharmacy operations.
The Role of Mobile Apps in Pharmacy Care
Mobile apps have revolutionized many aspects of our daily lives, and healthcare is no exception. These apps offer many benefits in pharmacy care, enhancing patient experience, improving medication adherence, and optimizing pharmacy operations.
Many people over 40 will check out the reading glasses floor display when visiting the pharmacy. They will see various styles and lens powers if your display is well stocked. Many will give several pairs a quick test run to find the correct viewing power.
Convenience: Drugstores like to put the medication in the back because prescriptions are considered “destination products” or the sole reason customers might even be in the store. Customers usually make their way through the store counter-clockwise and likely pass items or displays the store wants you to see.
Knowing they must see the pharmacist or their staff, having a reading glass display near the pharmacy counter increases the likelihood that they will peruse it to see what is new and purchase a pair or two.
This placement makes it easier for customers to ask the pharmacist questions about reading glasses, making them more likely to buy readers and accessories.
Website users logging in to RxAAP.com now have a convenient new tool to manage their pharmacy information. The brand-new User Dashboard on RxAAP.com now appears first for all users who use log-in credentials to access the site. This data is accessible to AAP Members and API Customers logging in. Visitors from the general public will still see content from the standard home page.
The dashboard allows our pharmacies to view all their purchasing data, rebate information, AAP programs and benefits in one place. Please note that financial information is visible only to those with an executive password.
When you are logged in, you can see which programs your pharmacy is participating in, like ProfitAmp business analytics, SmartSync bulk-ordering and Scan & Toss ordering system.
Plus, you can view your financial and operational data from API Warehouse and our national primary wholesaler, all in one location, including purchase amounts and rebate deposit dates.
In the Communication Preferences section, you can update your contact information and manage your email subscriptions by choosing which categories of messages you wish to receive, like weekly newsletters, financial notices and order shipping delays. You’ll also learn about AAP’s ongoing initiatives and find a link to refer other community pharmacies to AAP or API.
Contact information for your Territory Manager, Member Support Representative and API Customer Service Team can all be found on your User Dashboard, too. Click here and log in now to check it out.
AAP is one of the largest independent pharmacy co-ops in the U.S., with more than 2,000 Members. AAP offers competitive pricing through our subsidiary, API Warehouse and the collective buying power through our multiple prime vendor agreement options. Learn more about how AAP can help your independent community pharmacy not only survive but thrive. Contact AAP today.
When you do a search online, odds are you are using Google to do it. So, when you search your store online, what is the first thing you see? It needs to be a Google Business Profile. That’s how you manage your independent pharmacy’s online listing.
Your Google Business Profile gives customers a map and directions to your store, helps you respond to reviews, and updates your contact information and opening hours. It should look like this.
All this makes your customer’s ability to find your information quick and easy. Without the profile, customers need to click into a search result and possibly visit a few different pages on your website to find your phone number or directions. And the best part is it’s easy to set up. Take a few minutes to make sure your customers can easily find you.
It’s a fact that a significant portion of your customers likes watching videos. That’s why businesses are investing in producing video content for social media. And it doesn’t take a full-sized crew to make an effective marketing video. You can do it on your own with your cellphone.
As a video director, you need to make sure your video has good framing (camera is eye-level with you), good lighting and good audio. Pro tip: Invest in a wireless lavalier microphone that works with your phone for $20 and get a ring light to improve your video.
But, as a video producer, you need to consider:
Who is your audience? Remember to answer why they should care about your message within your content or script.
Brand your video. It can be as easy as showing your store logo on clothing or in the background.
Grab the viewer’s attention in the first 5-10 seconds. But you need to know the ideal video length per social media platform. For example, TikTok is only 10-15 seconds, while Twitter is 20-40 seconds and Facebook is 30-90 seconds.
Include a call to action. You HAVE to tell your audience what you want them to do. Do you want them to go to your website? Come in the store? Support an event?
With a little time, effort and strategy, you can easily share video content that’s of value to your patients and customers.
Pacience Edwards, PharmD, manager of compliance at Outcomes, discussed how technological solutions can aid pharmacies during a session at the Outcomes 2024 SYNC National Conference in Orlando, Florida.
The COVID-19 pandemic changed the health care landscape both directly and indirectly in many ways. Al- though the public health crisis led to a significant amount of burnout among health care workers and put more pressure on an already overburdened system, the increased utilization of telehealth services was seen by many as a positive outcome.
Due to a lack of access brought on by COVID-19, telehealth services in the US increased by 154% during the early phases of the pandemic and then eventually stabilized at levels 38 times higher compared to those in 2019.1 This has led to many benefits for both patients and providers, such as improving access to care and reducing resources used in health care facilities.
Still deciding whether to attend the AAP Annual Conference in April? In-person events offer several valuable advantages that contribute to a unique and enriching experience for AAP Members. Here are the top 7 reasons to attend in-person professional events:
1. Networking Opportunities:
– Face-to-face interactions provide valuable networking opportunities. You can meet and connect with other independent pharmacists, potential business partners and industry experts.
2. Engagement and Interaction:
– In-person events foster a high level of engagement. You can actively participate in discussions, Q&A sessions and hands-on activities.
– Your ability to ask questions directly and receive immediate responses enhances the learning experience.
3. Immersion and Experience:
– Physical events often create a more immersive and memorable experience. Live demonstrations, product showcases and interactive exhibits provide a hands-on experience.
4. Building Trust and Relationships:
– Meeting people in person helps build trust and strengthens relationships. Face-to-face interactions allow for better communication and understanding.
– Personal connections formed at in-person events often translate into long-lasting professional relationships.
5. Serendipitous Opportunities:
– In-person events provide opportunities for serendipitous encounters and discoveries that may not occur in a virtual setting. Chance meetings and impromptu conversations can lead to new ideas and collaborations.
6. Professional Development:
– You can gain insight from keynote speakers, panel discussions and workshops in a more immersive manner. Direct interaction with experts enhances the learning experience.
7. Motivation and Inspiration:
– Being part of a live audience can be motivating and inspiring. The energy and enthusiasm generated at in-person events can have a positive impact on you.
The unique value offered by in-person events like the AAP Annual Conference, particularly in terms of human connection and experiential learning, continues to make them a valuable and preferred option for many independent pharmacists. Join us in San Diego, April 4-6!
Top Pharmacy News Story #1: Medicare kicks off first price review
The federal government is set to begin price negotiations on the ten costliest prescription drugs covered by Medicare this week. The negotiations, as mandated by the Inflation Reduction Act, are scheduled to run through Aug. 1 before final prices are announced on Sept. 1. It’s uncharted territory for Medicare, which has never before been able to directly haggle with drugmakers over prices.
The ten drugs under negotiation are Eliquis, Jardiance, Xarelto, Januvia, Enbrel, Imbruvica, Farxiga, Entresto, Stelara, Fiasp and Novolog. Together, these ten drugs accounted for $50.5 billion, or 20%, of Medicare Part D spending from June 1, 2022, to May 31, 2023 according to the CMS.
Top Pharmacy News Story #2: A third class-action lawsuit has been filed against PBMs by independent pharmacies
Another class action lawsuit has been filed against Express Scripts alleging that the massive pharmacy benefit manager, one of the largest in the world, colluded with several smaller PBMs to rig reimbursement rates and shake down pharmacies for higher fees.
The lawsuit claims that Express Scripts used its dominant market position to push rival PBMs to impose excessive back-end fees on pharmacies and then share the revenue with Express Scripts. Express Scripts announced one such arrangement in 2019 with Prime Therapeutics, a smaller PBM.
Independent pharmacies do not need to sign up to benefit from the potential class action.The plaintiffs involved will ask the Court to allow it to pursue its claims on behalf of other pharmacies. If the Court permits that, pharmacies across the U.S. will be able to share in any money or other legal relief that is obtained.
Top Pharmacy News Story #3: City of Boston Sues Major PBMs Over Role in Opioid Crisis
The City of Boston, the Boston Public Health Commission and the Boston Housing Authority filed a lawsuit in Suffolk County Superior Court and names some of the largest PBMs in the US, including Express Scripts and OptumRx.
Boston’s lawsuit accuses the pharmacy benefit managers of colluding with drug makers to maximize profits by prioritizing the prescribing of addictive opioids despite the risks. The companies, the lawsuit alleges, profited from deals with drug makers that made it easier to prescribe opioids in exchange for financial incentives.
AAP celebrates the passage of H.B. 5378 in the U.S. House of Representatives
This week, the U.S. House of Representatives passed H.R. 5378, Lower Costs, More Transparency Act. According to NCPA, this legislation shines a light on PBM operations and tactics and encourages reform. It would help provide desperately needed relief while also saving taxpayer resources, prohibiting spread pricing and seeing that pharmacies are paid in a way that would cover their dispensing costs.
This bill also includes the Drug Price TransparencyAct which would save taxpayers more than $1 billion over the next 10 years and prohibit spread pricing.
The bill now moves on to the U.S. Senate for passage. We will keep you informed when the vote is scheduled.
CMS issues warning to PBM-insurers, calling for reform
The second PBM reform news story is the warning issued by CMS to PBM insurers, calling on them to make sure independent pharmacies are adequately reimbursed.
The letter goes on to state, “In addition, we know that the increasing level of vertical integration that is occurring among plans, PBMs, and their own pharmacies has the potential to result in anticompetitive behavior and place independent pharmacies at a disadvantage. We urge plans and PBMs to engage in sustainable and fair practices with all pharmacies – not just pharmacies owned by PBMs – and we are closely monitoring plan compliance with CMS network adequacy standards and other requirements.” Read the full letter here.
Cigna calls off merger with Humana
According to Reuters, U.S. health insurer Cigna has called off its attempt to negotiate an acquisition of Humana after the pair failed to agree on price. Cigna has announced plans to buy back $10 billion worth of shares.
A Cigna-Humana combination would have created a company with a value exceeding $140 billion, based on their market values, but was certain to attract fierce antitrust scrutiny. The discussions came six years after regulators blocked other deals between Humana-Aetna and Cigna-Anthem.
Cigna is still exploring the sale of its Medicare Advantage business, which manages government health insurance for people aged 65 and older, and its performance has been disappointing to investors.
Flu is on the rise while RSV in children may be peaking
The CDC announced on Friday that flu cases are rising while RSV cases in children and the elderly may be at the peak.
In the meantime, COVID-19 continues to cause the most hospitalizations and kills about 1,000 every week.
According to IBM’s Predictive Flu 14-day Trigger, these will be the top risk-of-flu predictions for the next week:
Top Markets for Projected Flu Activity (Next 2 Weeks):
Columbus (OH)
Zanesville (OH)
Marquette (WI)
Providence-New Bedford (RI)
New York (NY)
Salt Lake City (UT)
Colorado Springs-Pueblo (CO)
Helena-Great Falls-Missoula (MT)
Seattle-Tacoma (WA)
WSJ reports Cigna and Humana in talks to merge
On Wednesday, the Wall Street Journal reported that Cigna and Humana are discussing a stock-and-cash deal to merge. The merger may be completed as soon as the end of the year.
The rumored deal comes after reports in November that Cigna was exploring the possibility of selling it’s Medicare Advantage business. A Cigna spokesperson at the time said the company does not comment on “rumors or speculation.”
The Cigna-Humana deal, however, will likely face anti-trust challenges over their PBM businesses. The combination of Express Scripts and Humana’s PBM would control about 35% of the market.
Neither company has yet to conform WSJ’s report.
Thousands of California pharmacies stop flavoring kids’ meds while awaiting new CBP rules
More than 3,000 California pharmacies earlier this month suspended their practice of flavoring medication because they’re awaiting new rules from the California Board of Pharmacy. CBP is charged with applying federal guidance that characterized the service as drug compounding, meaning the mixing of prescription medication.
The suspension of flavoring services by pharmacies follows new guidance from the United States Pharmacopeia, even though in 2010, the California Board of Pharmacy explicitly stated in its lawbook that drug compounding does not include “the addition of flavoring agent(s) to enhance palatability.”
California’s Board of Pharmacy is now preparing rules that will adopt the federal guidance. While these rules will not ban flavoring, pharmacists must comply with more stringent regulations when providing the service.
The Food and Drug Administration approved using Eli Lilly’s diabetes drug Mounjaro for weight loss
The obesity medication will be marketed under the name Zepbound and contains tirzepatide, the same active ingredient in the diabetes drug Mounjaro. The approval makes it the second in a new class of drugs to receive the agency’s OK as an obesity treatment. The drug will have a list price of $1,060, which is about 20% less than Novo Nordisk’s rival drug Wegovy.
Like semaglutide, the compound in Ozempic and Wegovy, tirzepatide (the compound in Zepbound) slows down the emptying of the stomach. People feel fuller, quicker and for longer. All three drugs alsotarget the area of the brain that regulates appetite. But Ozempic has NOT received FDA approval for weight loss yet.
Semaglutide simulates a single hormone in the body, while tirzepatide mimics two, which experts say may be why it’s often more effective at triggering weight loss. In a 72-week clinical trial, funded by Eli Lilly, participants with obesity taking the highest dose of tirzepatide lost around 18 percent of their body weight on average.
According to Lilly, people with commercial insurancewhose plan covers Zepbound may be eligible to pay as little as $25 for a one-month or three-month prescription. Those without coverage may be eligible to pay $550 for a one-month supply via a savings card program.
Maximize Your Independent Pharmacy’s Sales with AAP Retail Plan-O-Grams
AAP Retail Plan-O-Grams was developed through a unique approach to creating OTC plan-o-gram sets that draws from sources of retail data.
AAP’s Retail Plan-O-Grams is a visual merchandising tool that shows the placement of products on shelves in a store. Retail Plan-O-Grams can also show the layout of an entire store.
The most efficient shelf assortments based on your pharmacy’s needs
Additional rebates on items you purchase – the more you purchase, the more rebate dollars you earn
OTCs for your Plan-O-Gram are directly refillable for purchase from the Scan & Toss app
And best of all, there is no cost to participate! Increase your store’s sales and profits with AAP Retail Plan-O-Grams. Contact your Territory Manager to learn more about this program.
Selecting the right independent pharmacy buying group can affect your overall success
Whether you’re a new pharmacy owner or a seasoned operator, selecting the right independent pharmacy buying group can affect your overall success. You should regularly evaluate your business partners – wholesale suppliers, vendors, secondary suppliers and pharmacy buying groups. They are key components in the overall success of an independent pharmacy business operation.
The stakes are high when the responsibility of choosing business partners, more specifically a buying group, falls on your shoulders. We believe the following factors are the most important when selecting a supplier to meet your business objectives.
1. Does the pharmacy buying group’s mission align with your own?
It’s important to question your group’s mission, values, goals and company culture when assessing whether or not they could be a good fit. When a group’s values align with yours, it’s typically a good indication that the partnership will work well. Differences in overall mission, values, goals and culture could potentially lead to conflict.
2. What is the business structure of the organization?
Is the group a for-profit entity, nonprofit, not-for-profit, or cooperative? Most groups will have fees or earn administrative dollars. Are the profits retained by the organization owners or shared with the member owners?
3. What type of additional products or services does a group provide?
Do some deep digging to understand the types of discounts, programs, analytics or services the group offers. There are strengths and economies realized with group buying power that, when used effectively, will provide efficiencies for group participants.
4. Does the group or wholesale supplier require a contractual termination commitment?
Your business will change and evolve. It is important that your business relationships provide flexibility. Understand there may appear to be advantages today for a two- or three-year purchasing commitment, but will those same advantages apply in 12 months, or even six months, as your business changes? Be careful not to put limitations on your business success by entering a fixed, long-term binding commitment.
5. Does the group provide a customized and flexible purchasing program?
When it comes to purchasing inventory for your pharmacy, there are many market forces and uncertainties that may require agility and change. Your pharmacy buying group’s ability to allow you to maintain flexibility, while also advising you on adjustments to optimize your buying strategy, is crucial. Do keep in mind that while it is easy for a group to claim they are flexible, real-world customer experience will usually indicate otherwise.
6. Does the group show you how to purchase inventory?
Wholesale supplier Brand Rx pricing, Generic Rx pricing, OTC pricing, rebates, secondary suppliers pricing, etc., are all tied together. Too much exclusive focus on any one element, without the consideration of the others, can negatively impact store profits. Aggregating purchases is the foundation of most groups, but no two pharmacies are the exact same. What works for one may be detrimental for another. It’s important to understand how to navigate and then maximize YOUR bottom line.
Still don’t feel confident in your ability to select an independent pharmacy buying group? Contact AAP to learn more about how we can help you select the right independent pharmacy buying group.
AAP is an independent pharmacy cooperative and buying group
AAP is a completely Member-owned independent pharmacy cooperative, where our Members are the stakeholders guiding how the business is operated. Additionally, millions in board-declared Annual Patronage Dividends are returned to Members each year.
Our large co-op is comprised of more than 2,000 independent pharmacies and has the high-volume buying power to aggressively compete like the chains, while Members sign no long-term vendor contracts.
With AAP, you can quickly adapt to changing market forces with our flexible purchasing options. You can enjoy agility within your PVA as you buy from either API Warehouse and/or our primary national wholesaler, to easily adhere to compliance requirements.
Our independent pharmacy cooperative Members also have access to proprietary business tools, like ProfitAmp business intelligence, SmartSync bulk ordering program, Scan & Toss ordering solution, free OTC Retail Plan-O-Grams and more! These tools help you optimize your buying strategy and profit margin.
Contact us to receive your store-specific, custom purchasing analysis.
On Tuesday, the FDA approved the updated Novavax COVID-19 vaccine. The shot is expected to roll out weeks after updated vaccines from Pfizer’s and Moderna’s
Novavax’s single-strain vaccine targets omicron subvariant XBB.1.5, for emergency use in people ages 12 and up.
The Centers for Disease Control and Prevention is now including Novavax’s shot in the same recommendation it issued last month for updated vaccines from Pfizer and Moderna. That recommendation says all Americans ages six months and older can receive an updated Covid jab.
Novavax announced that doses of the shot will likely be available within the next few days.
A class-action lawsuit has been filed against CVS Health, Caremark and Aetna to recover millions of dollars for independent pharmacies in what lawyers say are wrongfully assessed pharmacy DIR fees for Medicare Part D prescriptions.
The suit claims that Caremark violated federal antitrust laws and state laws governing contracts while assessing DIR fees. The lawsuit also claims Caremark’s arbitration agreement is unenforceable.
NCPA will provide more information on the case as it develops. In the meantime, the lawyers representing the independent pharmacies will be at the NCPA Annual Convention in Orlando, October 14-17. If you would like to join the class-action lawsuit, this will be your first chance to speak to the attorneys. They will be available to meet with you privately to discuss other actions you can take to recoup wrongfully assessed DIR fees.
National and state news affecting independent pharmacies
National Pharmacy News
This week, PBM’s were in the spotlight at the Capitol. During the House Committee on Oversight and Accountability hearing about PBMs, lawmakers from both sides of the aisle agreed that PBMs have too much power and very little transparency.
“Instead of fierce competition, now just three PBMs control 80% of the market, and each of the three major PBMs is owned by a major health insurer and owns or is owned by a pharmacy,” stated committee Chair James Comer (R-Ky.). “This means that when they negotiate with a health insurer, they are either negotiating with themselves or one of their direct competitors. The committee has made it a priority to expose the anticompetitive tactics by PBMs that are increasing healthcare costs for Americans and harming patient care.” Read more about the hearing.
State Pharmacy News
Florida: Florida lawmakers approved the rules to implement several provisions of the Prescription Drug Reform Act (SB 1550). The rules increase accountability among PBMs. They include all application forms for PBMs seeking to operate in Florida in 2024. Any PBM that attempts to continue operating in Florida next year, and has not been approved as an insurance administrator, can be fined up to $10,000 per violation per day. Read more.
Washington: The Washington State Pharmacy Association (WSPA), NCPA, and NACDS are celebrating a settlement of a six-year lawsuit with the state of Washington. The state agreed to these terms among others:
Conduct a cost of dispensing study to move to cost-based dispensing fees
Provide more than $60 million in retroactive payments to pharmacies in Washington State’s fee-for-service Medicaid program
Use, for now, Oregon’s cost-based dispensing fees and tiers from July 1, 2023, going forward, until a new cost-based dispensing fee obtains necessary state and CMS approval.
FDA approved updated versions of the Covid-19 vaccines made by Moderna and Pfizer as hospitalizations rise.
The vaccines are approved for those 12 years and up and are authorized under emergency use for those six months and up. A different vaccine made by Novavax is currently under review with the FDA for use in ages 12 and up.
Health experts will meet this week to discuss recommendations for using the new vaccines and are expected to be available by mid-September.
For these shots to reach the public, the CDC has to make an official recommendation, which could come as soon as Tuesday.
In June, US health officials told drugmakers to reformulate shots in time for fall that would protect against the XBB.1.5 subvariant that accounted for about 40% of Covid infections at the time.
Pfizer and Moderna have both said their updated shots also protect against EG.5, currently the most widely circulating variant.
In a plan to reduce costs, Reuters is reporting that Walmart is asking some of its 16,000 pharmacists across the country to voluntarily take pay cuts and reduce their work hours. The cuts, which are aimed at pharmacists in higher wage brackets, show how current demand for expensive weight loss GLP-1 medications, coupled with Walmart’s $3.1 billion opioid settlement, are adding to the company’s financial woes.
Walmart states that it was reducing the number of hours it was offering some pharmacists, claiming a drop-off in demand for medications during the summer and requests from pharmacists for a less demanding job. Read more.
CMS selects first drugs for Medicare price negotiation
The Centers for Medicare & Medicaid Services has released the first ten drugs that will be available for price negotiation under Medicare Part D. Under the Inflation Reduction Act, Medicare will be able to negotiate the prices of prescription drugs with participating drug companies beginning this year and in 2024, which will become effective in 2026.
HHS officials call for reclassification of marijuana to Schedule III drug
Bloomberg is reporting that officials with the U.S. Department of Health and Human Services are recommending easing restrictions on marijuana and reclassifying it under the Controlled Substances Act. A top official with the department wrote a letter to a Drug Enforcement Agency administrator saying that marijuana should be classified as a Schedule III drug, which means it has a low potential for abuse. Marijuana is currently a Schedule I drug, meaning it has no medically accepted use and a high potential for abuse. The decision to reclassify marijuana resides with the DEA, which could take months to complete its evaluation.
The Food and Drug Administration has issued a one-year delay on the final enhanced drug distribution security requirements under the Drug Supply Chain Security Act (DSCSA). Those requirements were set to take effect in November. The new date will be Nov. 27, 2024.
The decision to delay the DSCSA requirements was made after several advocates warned the FDA that the supply chain was not ready to comply. The extended time aims to allow each sector of the pharmaceutical supply chain time to develop the systems and processes necessary for efficient transactions. Read more.
According to the Centers for Disease Control, new COVID vaccines are expected in September. Vaccines from Moderna, Pfizer and Novavax will be designed to target omicron subvariant XBB.1.5.
Those vaccines still need approvals from the Food and Drug Administration and the CDC, which will form eligibility guidelines.
The arrival of updated vaccines offers some peace of mind to Americans as the U.S. sees an increase in COVID cases and hospitalizations. The current surge appears to be fueled by newer strains of the virus like EG.5, or Eris, an omicron subvariant that accounted for 17.3% of all cases as of last week, according to the CDC.
But the efficacy of the new COVID vaccine boosters is unknown against another new omicron strain of the virus called BA.2.86, which has been identified in a very small number of cases in the U.S., U.K., Denmark and Israel. Read more.
To order your vaccine program supplies from API Warehouse, like gloves and syringes, click here.
After announcing last week that it was selling off Winn-Dixie and Harveys Supermarkets to Aldi, and Fresco y Más to an investment company, the news broke this week that Southeastern Grocers is selling the pharmacy business to CVS and Walgreens.
According to internal emails obtained by the Tampa Bay Times, Southeastern Grocers told its pharmacists that it will sell all of its Winn-Dixie and Harveys pharmacy business by the end of the year.
“Prior to the closing of the proposed merger agreements recently announced, Southeastern Grocers has entered into agreements to transfer prescription files to certain CVS Pharmacies and Walgreens,” confirmed Southeastern Grocers communication director Meredith Hurley in an email. Read more.
AAP is helping our Members prepare for the 2024 DIR Fee Hangover
According to a survey by NCPA, approximately 98 percent of pharmacists are concerned about the upcoming 2024 DIR fee hangover and the impact it could have on their pharmacies. Many are even worried that it could lead to pharmacy closures. So, the time to prepare is NOW!
Here are five useful tips to help you prepare.
#1. According to NCPA, the first tip for preparing for the DIR fee hangover is going back to your accounting basics and understanding your cashflow.
There are many key performance indicators, or KPIs, in pharmacy. One cash flow KPI is the Current Ratio, which is current assets divided by current liabilities. How you classify those current assets and liabilities is vital to an accurate ratio. The industry average is around 2.5 to 1, so $2.50 of cash, receivables and inventory for every $1 of current debt. It is wise to know your ratio and aim for a 3 or 3.5 to 1 current ratio going into 2024. This would give you a cash flow cushion to hopefully weather any DIR unknowns.
#2. Our second tip to help you thrive during the 2024 DIR hangover is by increasing your gross margin. The average pharmacy gross margin is anywhere from 23-24%. Increasing this margin will go a long way to improving your cash flow.
One way to increase revenue is to find niches markets, such as women’s health, travel vaccines, pet meds, or nutritional supplements, to fill the holes in your community’s healthcare. Offering unique services to your patients will go a long way to improving your gross margin.
#3. You can find our third tip in the EnlivenHealth DIR Fee Hangover Playbook. To predict the DIR fees that PBMs will attempt to collect in the first quarter of 2024, look at the DIR fees collected from the same timeframe in 2023. (This should be easy to do in your third-party reconciliation platform.) Once you have that number, set it as your savings benchmark. That’s the amount of cash you need to set aside by the beginning of 2024 to avoid the sting of the DIR Fee Hangover.
#4. Our fourth tip is keeping your expenses in check. Your expenses are one of the most important factors to your cash flow and bottom line. When you are trying to figure out the best ways to combat the DIR hangover, your time is best spent focusing on the expenses that will make a big impact: cost of goods sold and wages.
Maximize your PVA
Make sure you are maximizing your purchasing with your Prime Vendor Agreement (PVA). AAP now offers multiple options for stores to help create a buying plan to fit your needs. A good PVA can increase your margin percentage. Contact our team to see which PVA option is right for you.
Keep wages in check
Technology and automation are two ways to help run payroll effectively. Check out the AAP Preferred Partners to see if any of them can help with your store’s needs.
#5. Our fifth tip is to open a business line of credit. If you are worried about cash flow next year, it can be a useful tool to have available for short-term cash flow issues.
Funds are typically drawn from the line of credit by using a business checking account, a small business credit card or even a mobile banking app.
But a word of caution, these can be dangerous cash flow tools in a pharmacy because they are NOT free money. Lines of credit are usually higher-interest debt. These are not mid- or long-term debt cash flow solutions for a pharmacy, and you shouldn’t rely on them for those needs.
Any time access to a line of credit is utilized, there must be a plan in place on how and when it will be paid back. Long-term cash flow issues within a pharmacy should not be addressed with short-term debt solutions such as a line of credit.
If we learned anything from the COVID-19 pandemic, it’s that independent pharmacists are innovators. Preparing now will help you thrive in 2024.
The Teamsters Union members voted to approve the tentative contract agreement reached last month, ending contentious labor negotiations that threatened to disrupt package deliveries for thousands of pharmacies nationwide.
The Teamsters said in a statement that within the highest voted election ever, 86% of the votes casts were in favor of ratifying the contract.
The union ratified more than 40 supplemental agreements except for one that covers about 170 members in Florida. The national master agreement will go into effect as soon as that supplement is renegotiated and ratified, it said.
UPS said voting results for contracts covering employees under two local unions are expected soon. The new contract sets a new standard for pay and benefits.
“Our members just ratified the most lucrative agreement the Teamsters have ever negotiated at UPS,” Teamsters General President Sean M. O’Brien said in a statement. “This contract will improve the lives of hundreds of thousands of workers.” Read more.
Moderna’s updated COVID-19 vaccine is effective against Eris variant
In this Weekly Rx Roundup, Moderna reports an initial study data showed its updated COVID-19 vaccine to be effective against the “Eris” and “Fornax” subvariants in humans.
The company expects the updated shot to be available, pending approval from the FDA, in the coming weeks for the fall vaccination season.
Pfizer has reported that its updated COVID-19 shot showed success at neutralizing activity against the Eris subvariant in a study conducted on mice. Pfizer has yet to complete its study in humans.
Eris, the nickname for EG.5, is a sub-lineage of the still-dominant Omicron variant. EG.5 accounted for about more than 17% of COVID-19 cases in the U.S., according to the latest government data. Infections from Fornax, officially known as FL 1.5.1, are also rising across the country.
Two big PBM stories in this Weekly Rx Roundup
Shares of CVS Health plunged 8% on Thursday after Blue Shield of California said it will drop the company’s pharmacy benefit management services and instead partner with Mark Cuban’s Cost Plus Drugs company and Amazon Pharmacy to save on drug costs for its nearly 5 million members.
The announcement hints at the potential for health insurers to abandon the traditional pharmacy benefit manager, or PBM, system and sent shares of other companies that offer PBM services lower.
CVS Health’s Caremark has been Blue Shield’s PBM partner for more than 15 years.
The other big story is that the United States Tenth Circuit Court of Appeals on Tuesday issued an unfavorable decision in the Pharmaceutical Care Management Association (PCMA) v.Mulready appeal.
The decision overturns Oklahoma’s effort to regulate pharmaceutical benefit managers (PBMs) – and likely would have implications for other states as well. The ruling allowing PBMs to escape certain state regulation by hiding behind the alleged preemption of that law by federal ERISA and Medicare Part D laws.
“The Tenth Circuit decision is inconsistent with what other federal courts have decided, and it departs from the Supreme Court’s unanimous Rutledge decision, which clearly held that PBMs can’t hide behind ERISA. It must be overturned,” said B. Douglas Hoey, CEO of the National Community Pharmacists Association.
AAP is following this story closely and will keep you updated as it unfolds.
The Food and Drug Administration approved the first-ever pill for postpartum depression. In trials, the treatment improved depression symptoms among new mothers as early as three days after they started the medication.
The medication, called zuranolone, is taken daily for two weeks. In clinical trials involving women who experienced postpartum depression, the drug improved symptoms — such as anxiety, difficulty sleeping, loss of pleasure, low energy, guilt or social withdrawal. Read more.
By understanding the independent pharmacy business, we can work to make the most of our distinct advantages to meet consumer needs
McKinsey & Company conducted a consumer survey of more than 1,000 people and leads us to better understanding the independent pharmacy business in the U.S. They published their findings in this article, laying out how the retail pharmacy landscape has changed over the years, how consumer preferences have evolved, and how different types of retail pharmacies may respond as a result.
The U.S. retail pharmacy landscape faces saturated retail locations, ongoing labor shortages, inflationary pressure and a leveling-off of generic drug penetration. To effectively compete in this environment, all independent and community pharmacies can strive to better understand and adapt to changing consumer preferences.
This study gives us a snapshot of the market, where we are trailing the big chains and where we can make substantial gains.
How the retail pharmacy landscape has evolved
Over the past two decades, the retail pharmacy landscape has evolved substantially. This survey breaks down the retail pharmacy sector into four categories: retail chains, regional pharmacies such as mass retail and grocers, independent pharmacies, and mail-order and online pharmacies.
According to McKinsey & Company, the number of independent pharmacies has decreased by nearly 50 percent since 1980, leveling off at about 20,000 locations since 2000. While filling about 48,000 prescriptions a year, independent and community pharmacies remain viable through effective collaboration with other independents and wholesalers. This cooperation has taken the form of support from wholesalers like API Warehouse, pharmacy service administrative organizations, and group-purchasing organizations like AAP.
Understanding the independent pharmacy business in the U.S. is key for retail pharmacies. We can ensure we understand and meet consumers’ needs so we are a preferred destination. Click here to read the full report and gain more insight to understanding and improving your pharmacy’s business.
Schedule meetings with your local policymakers during the August legislative recess
The August legislative recess is here. This is the perfect time to invite your local state and federal policymakers to your store and explain how they can help your business.
With the flurry of activity this year on Capitol Hill lawmakers looking to hold PBMs’ feet to the fire, AAP and NCPA members have testified before the House Oversight and Accountability Committee and the Ways and Means Health Subcommittee, as well as the Senate Commerce Committee.
Additionally, the Drug Price Transparency in Medicaid Act, was unanimously advanced out of the Energy and Commerce Committee to the House floor as part of the PATIENT Act. These are all encouraging developments, but we need to keep the pressure on policymakers to finish the job and send a comprehensive PBM reform bill to the president’s desk.
This can best be accomplished by hosting members of Congress and candidates in your pharmacy for one-on-one meetings, giving them a firsthand look at the important role you play in your community and in helping your patients, and highlighting the harm abusive PBM practices have on both your pharmacy and your patients. If you aren’t sure how to contact them, you can look up their information here.
During the August legislative recess, members of Congress are usually home meeting with constituents. This is a very opportune time to host your legislators in your pharmacy.
We need all community and LTC pharmacists to participate in this important month of action and keep the pressure on our elected officials to take strong legislative action.
When you do host your local lawmaker, let AAP know. Send us an email and pictures so we can share with our other Members on social media and in our weekly newsletter.
Take advantage of this great opportunity to promote yours and every independent and community pharmacy.
Join your colleagues all over the country for NCPA’s Month of Action and get the attention of the people whose vote matters to your pharmacy’s future. Invite your Congressional rep or Senator for visit while they are form for the August recess. Make sure they understand how important it is to keep pressure on PBMs and fight for a competitive and fair business environment.
Pressure is working. In the past week, Senate Finance Committee approved legislation that includes strong PBM reforms, passing the Modernizing and Ensuring PBM Accountability Act by a vote of 26-1. Now it’s on the way to the full Senate before it can proceed to the House of Representatives. Keep the momentum going by contacting your lawmaker today and getting them to visit your pharmacy. The fight isn’t over, so let’s put the action in Month of Action.
Pfizer’s New Migraine Treatment Now Available in U.S. Pharmacies
After FDA approval in March, Zavzpret is now available in U.S. pharmacies. The medication is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for acute migraine treatment in adults. For the nearly 40 million Americans living with migraines, this approval provides an alternative option for relief, especially for those who have contraindications or poor responses to triptans and other acute migraine medications. Read more.
Breaking News: PBM reform bill advances in Senate vote
More good news for independent pharmacies – a PBM reform bill advances in Senate vote. On July 26, the U. S. Senate voted 26-1 to advance the Modernizing and Ensuring PBM Accountability Act to a vote of the full Senate. This vote is a big step for independent pharmacies because this PBM reform package contains several provisions to enhance transparency into PBM-insurer operations, improve patient access to community pharmacies, and ensure fair pharmacy reimbursements that are based on actual acquisition and dispensing costs.
After a full U.S. Senate vote, the next step would be a vote in the House of Representatives. No date has been set for that, however.
The package also contains language from two other bills: the Drug Price Transparency in Medicaid Act (S. 1038), which creates a fairer reimbursement rate for pharmacies operating in Medicaid managed care, and the Protect Patient Access to Pharmacies Act (S. 2052), which reforms Medicare Part D by clarifying and providing enforcement tools for the any willing pharmacy law. NCPA has more details about the PBM reform bill that advanced in Senate vote
The agreement was announced Tuesday, the first day that UPS and the Teamsters returned to the bargaining table after negotiations broke down earlier in July.
Negotiators for UPS and the Teamsters Union had already reached tentative agreements on several issues, including cameras and air conditioning in the delivery trucks. But clashes continued over increasing pay for part-time workers, who make up more than half of the UPS employees represented by the union.
Teamsters will begin voting on the new five-year contract Aug. 3 and concludes Aug. 22.
Another blow to was dealt to the PBM industry last week. Federal Trade Commission voted unanimously to warn that some of its previous advocacy statements related to PBMs no longer reflect current market realities. The decision effectively removes a major line of defense for the PBM-insurers in litigation, arbitration, and lobbying against state and federal reforms.
Our friends at NCPA were instrumental in persuading the commissioners to reconsider the agency’s prior statements and ultimately bring it to a vote. Read more on NCPA.org.
The AAP is in Boston this week at RBC. Come meet with our team and get updates on the AAP Prime Vendor Agreement, ProfitAmp, AlignRx and more. Plus, relax and enjoy some fun with Virtual Reality, cornhole and a golf putting green!
New Jersey joins in the fight against PBMs
New Jersey Governor Phil Murphy signed three bills to help make prescription drugs more affordable for New Jerseyans. The three bills will work together to cap certain out-of-pocket costs, establish greater oversight of Pharmacy Benefit Managers, and promote transparency across the pharmaceutical supply chain. Read more.
Birth control goes OTC
The U.S. Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy. Opill is the first daily oral contraceptive approved for use in the U.S. without a prescription. Approval of this progestin-only oral contraceptive pill provides consumers a choice to purchase oral contraceptives without a prescription at independent and community pharmacies. Read more.
To prevent a repeat of last winter’s “tripledemic” of respiratory illnesses, Americans will be encouraged to roll up their sleeves not just for flu shots but for two other vaccines, one of them entirely new.
The three shots — flu, Covid and R.S.V. — may help to reduce hospitalizations and deaths later this year. But there are uncertainties about how the vaccines are best administered, who is most likely to benefit, and what the risks may be.
For older and immunocompromised Americans, all three vaccines are vital. Yet it’s unclear how many Americans will opt for the shots. 71% of adults ages 65 and older got a flu shot this past winter, but only about 43% chose to get the Covid booster.
The misery of the past winter may help change minds. The flu may have led to as many as 58,000 deaths, peaking in December, according to the C.D.C. Covid claimed roughly 50,000 lives between November and March.
R.S.V. kills up to 10,000 people each year, most of them older. Infections this year peaked in November and resulted in about twice as many hospitalizations, including children, as in prepandemic years.
Only the Covid and flu vaccines were available last fall. The R.S.V. vaccines for adults are new, and in clinical trials proved to be highly effective against infection of the lower respiratory tract, which includes the lungs.
FDA approves Alzheimer’s drug Leqembi
The Food and Drug Administration fully approved the Alzheimer’s treatment Leqembi, which will expand access to the expensive drug for older Americans.
Medicare announced shortly after the FDA approval that it is now covering the antibody treatment for patients enrolled in the insurance program for seniors, though several conditions apply.
Leqembi is the first Alzheimer’s antibody treatment to receive full FDA approval. It is also the first such drug to receive broad coverage through Medicare. Read more.
Five Adalimumab biosimilars launched on July 1 in the U.S.
July 1 marked the launch of five different adalimumab (Humira) biosimilars, setting off the first round of therapeutic alternatives into the market, including adalimumab-abdm (Cyltezo), adalimumab-aqvh (Yusimry), adalimumab-bwwd (Hadlima), adalimumab-adaz (Hyrimoz), and adalimumab-fkjp (Hulio). These medications join adalimumab-atto (Amjevita), the first adalimumab biosimilar that launched earlier this year.1Read more at Drug Topics.
CMS issues revised guidance to Medicare Drug Price Negotiation Program
CMS recently issued revised guidance to Medicare Drug Price Negotiation Program. CMS noted that the majority of the comments received from supply chain entities on this topic, including manufacturers and pharmacies, supported the use of a standardized, published pricing metric to calculate the refund due from the manufacturer to the pharmacy for the pass through of the maximum fair price as required under the program. Read more.
The Protect Patient Access to Pharmacies Act (S. 2052) was introduced this week to the U.S. Senate. This bill addresses the abusive business practices by pharmacy benefit managers (PBMs) that have resulted in the growth of pharmacy direct and indirect remuneration (DIR) fees and have led to pharmacy closures.
The bill, supported by NCPA and APhA among others, will help to secure Medicare patients’, who are typically seniors, freedom to receive medications and care from the pharmacy of their choice by improving enforcement of the “any willing pharmacy” law. This law is intended to prevent the exclusion of pharmacies from Part D plan networks.
The Patient Access Act is only the most recent effort working toward DIR fee relief as the Centers for Medicare and Medicaid Services’ (CMS) proposed rule made in early 2022 goes into effect in the beginning of 2024. CMS’ proposed rule will work to reduce the financial burden on independent pharmacies and increase transparency in the PBM industry. Read more.
Approval for GLP-1-based weight loss pills on the FDA horizon?
The buzz about Eli Lilly’s experimental pill for weight loss is growing. Retatrutide helped people lose an average of 15% of their body weight after 36 weeks on the highest dose in a mid-stage trial, and as much as 24% of their weight over 48 weeks — the biggest reduction reported to date in clinical trials of a new class of obesity treatments. These results are rivaling what’s seen with currently approved injectable therapies like Wegovy over longer durations.
The drug, orforglipron, had similar side effects as others in the class, known as GLP-1 receptor agonists: primarily gastrointestinal events like nausea, constipation and vomiting, researchers reported in a study published in the New England Journal of Medicine. Read more.
AAP Member Greg Mitchell sat down with Drug Topics to discuss the importance of being connected to your community when running a rural pharmacy. You can listen to the entire podcast here.
FDA Committee Recommends Development of Monovalent, XBB-Containing Vaccines for the Fall
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has unanimously recommended that COVID-19 vaccines being developed for this fall should only include protection against the XBB variant.
Trial results showed that among 101 participants who had previously received 4 doses of a COVID-19 vaccine, an XBB-containing vaccine was more effective against the currently circulating XBB variants. Read more.
ACA preventive care mandate maintained, for now
A federalappeals court maintained a freeze on a ruling that struck down the Affordable Care Act’s mandate that employers and insurers fully cover preventive health services while a legal challenge to the rule continues to wind through the courts.
The decision from the New Orleans-based U.S. 5th Circuit Court of Appeal means that over 150 million people’s health care coverage for certain cancer screenings, behavioral counseling and HIV prevention by the U.S. Preventive Services Task Force will remain in place for the time being.
Biden names Mandy Cohen — former North Carolina health secretary — to lead CDC
President Biden named Dr. Mandy Cohen as the next leader of the Centers for Disease Control and Prevention. Dr. Cohen served in top positions in state and federal government and in the private sector. She served as health secretary in North Carolina, where she worked on expanding access to health care for low-income residents and became the face of the state’s COVID-19 response during the public health emergency. Read more.
We are proud of AAP Member, Kevin Duane, and his fight against PBMs. His advocacy helped pass legislation in Florida and now he’s moved into the national spotlight.
If you didn’t catch his testimony before the bi-partisan U.S. House of Representatives Oversight Commitee, you can watch it here.
FDA approves first oral antiviral for treatment of COVID-19 in adults
FDA gave full approval of the oral antiviral, Paxlovid, for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19. This includes those at risk for hospitalization or death. Paxlovid is the fourth drug — and first oral antiviral pill — approved by the FDA to treat COVID-19 in adults. The U.S. government will continue to oversee the distribution of Paxlovid, and U.S. residents eligible for the medication will continue to receive the medicine at no charge, according to Pfizer. Read more.
N.Y. federal appeals court clears the way for Purdue Pharma bankruptcy deal
In a landmark ruling Tuesday, a federal appeals court in New York cleared the way for a bankruptcy deal forPurdue Pharma. The deal will shield members of the Sackler family, who own the company, from future lawsuits.
The 2nd Circuit Court of Appeals spent more than a year reviewing the case after a lower court ruled it was improper for Purdue Pharma’s bankruptcy deal to block future opioid-related lawsuits against the Sackler family. The Sacklers earned billions of dollars from the sale of OxyContin and other opioid pain medications.
This latest ruling overturns the lower court’s December 2021 decision and clears the way for a deal hashed out with thousands of state and local governments. Read more.
(Courtesy of NCPA) As part of its ongoing inquiry into pharmacy benefit managers (PBMs) and their impact on the accessibility and affordability of prescription drugs, the Federal Trade Commission issued compulsory orders to two group purchasing organizations that negotiate drug rebates on behalf of other PBMs. The orders will require these entities to provide information and records on their business practices. Having previously issued compulsory orders to the six largest PBMs in the U.S. healthcare industry, the FTC yesterday issued two additional orders to Zinc Health Services, LLC, and Ascent Health Services, LLC.
House panel advances transparency and PBM bills
(Courtesy of Axios) On Wednesday, a House Energy and Commerce Committee advanced a health markup in a unanimous 27-0 vote to:
Codify and strengthen Trump-era rules for hospitals and insurers to make health care prices available and more transparent.
Impose new transparency requirements on PBMs and ban “spread pricing” in Medicaid, where PBMs charge more than they pay for a drug and keep the difference. Read more.
1 in 5 older adults skipped or delayed medications last year because of cost
(Courtesy of NBC News) A growing number of older adults say they can’t afford their prescription medications, a study published Thursday in JAMA Network Open found.
About 1 in 5 adults ages 65 and up either skipped, delayed, took less medication than was prescribed, or took someone else’s medication last year because of concerns about cost, according to the study.
“That was pretty surprising,” said lead study author Stacie Dusetzina, a health policy professor at Vanderbilt University in Nashville, Tennessee. A study published in the journal Medical Care found that in 2016 about 1 in 7 older adults were not taking their medication as prescribed because of cost.
“So a pretty big jump,” Dusetzina said.
The study’s findings were based on a national survey taken by more than 2,000 older adults from June 2022 through September 2022. Read more.
A group of pricey breakthrough prescription drugs are poised to shake up the market this year — including an Alzheimer’s treatment that could be approved today by the FDA.
Why it matters: Though the drugs offer hope to patients with hard-to-treat conditions like Alzheimer’s or sickle cell disease, or who struggle with obesity, their potentially eye-popping prices are sure to create dilemmas for insurers, government programs and patients themselves.
The big picture: The approvals could fuel already-contentious debates around affordability and equity, giving ammunition both to those who say innovation doesn’t come cheap and others who contend medical advances are meaningless if patients can’t access them.
Although some of the drugs could be transformative, “they will create choices that need to be made and they will also create potential burdens, particularly on the most vulnerable, on people who are the least well-insured and people who live in states or happen to have insurance coverage that is the least generous,” said Rena Conti, a professor at Boston University’s Questrom School of Business.
None of the drugs would be subject to the price controls that congressional Democrats included in the Inflation Reduction Act.
Driving the news: The FDA is expected to today decide whether to approve Eisai and Biogen’s lecanemab, a treatment for Alzheimer’s disease, setting into motion another round of debate over how much the drug should cost and whether Medicare should cover it.
It would become the second FDA-approved Alzheimer’s treatment targeting amyloid plaques that are believed to contribute to the development of the disease. But it isn’t likely to cause as much controversy as Biogen’s Aduhelm did when it was approved in 2021.
Biogen initially priced that drug at $56,000 a year, drawing outrage from critics and presenting big questions about how Medicare could absorb the large spending spike if millions of beneficiaries tried to get it.
If lecanemab is approved, experts will be closely watching both its list price and whether the FDA limits its use to subgroups of Alzheimer’s patients. Both factors will be crucial in determining potential spending on the drug.
A cost-effective price would be between $8,500 and $20,600 a year, the Institute for Clinical and Economic Review said last month.
State of play: The drug pipeline is brimming with other experimental cures that could make headlines this year.
Data for another promising Alzheimer’s treatment by Eli Lilly that is similar to lecanemab is expected midyear, per a recent Cowen research note, and Medicare will almost certainly have to revisit its coverage policy for the entire class of drugs.
Several multi-million dollar gene therapies have already been approved. But this year the pipeline includes two treatments for sickle cell disease, which has a much larger patient population.
Clinical trial results for Eli Lilly’s obesity drug candidate are also expected in April, potentially ushering a new entrant to what could become a booming market. Disputes over coverage of obesity drugs already on the market will almost certainty continue.
Between the lines: Some novel drugs present an inherent dilemma: They’re worth a lot of money because of the way they can dramatically improve patients’ lives. Even so, manufacturers can still price these drugs well above what experts say they’re worth.
Gene therapies may cost millions per patient. Other drugs could cost much less per course, but cater to enormous patient populations or may require long-term use.
In any scenario, the expense could present complex problems to federal and state health programs, private insurers and patients who wind up on the hook for out-of-pocket costs.
“We’re fortunate there are so many treatments in the pipeline that promise to transform the quality of care for people with devastating diseases. While we recognize there are concerns about cost, the facts point to a health care system that can sustain this incredible innovation over the long haul,” said Priscilla VanderVeer, vice president of public affairs at PhRMA.
Yes, but: The final cost burden hinges on several factors, starting with where manufacturers set the launch price.
