News & Events

PHSL Vice President Melissa Krause presented at the American Society for Automation in Pharmacy (ASAP) 2022 Annual Conference. Melissa’s presentation discussed different perspectives on interchangeable biologics, addressed how interchangeable biologics and unbranded biologics are being displayed in pharmacy management systems, and included recommendation on what pharmacists need to cut through confusion and ensure correct dispensing and reimbursement.

Click here to view Melissa’s presentation slides.

PHSL President Ann Johnson will be participating in AMCP’s newly developed Digital Therapeutics Advisory Group.  Ann, along with other leaders in the field, will be providing guidance to AMCP in its efforts to establish the leadership role of managed care pharmacy professionals in digital therapeutics. The Digital Therapeutics Advisory Group will identify potential partners and assist in the creation and dissemination of tools and resources to enhance the coverage and utilization of digital therapeutics.  Ann’s knowledge surrounding the drug pricing compendia and the importance of listing new digital therapeutic products should be an asset to the organization.  Find out more about the Digital Therapeutics Advisory Group at https://www.amcp.org/corporate-opportunities/partnership-forums.

PHSL President Ann Johnson and Co-Founder Tim Kosty contributed to the January/February 2022 edition of ComputerTalk for the Pharmacist. In their Viewpoints article, Ann and Tim discuss recently announced changes to Walgreens’ and CVS’s corporate strategies concerning their retail pharmacy locations and the impact this may have on the rest of the retail pharmacy industry.

Click here to read the article “Rethinking the Pharmacy Business Model.” You can also access the full versions of current and past ComputerTalk issues at https://www.computertalk.com/issue-archive/.

It has now been more than eight years since the Track-and-Trace law, known as the Drug Supply Chain Security Act (DSCSA), was signed.  The Act outlines the steps that participants in the pharmaceutical supply chain and pharmacy industry must take to build a system that identifies and traces pharmaceuticals and facilitates the exchange of information at the individual package level by showing where a drug has been in the supply chain.  The deadline to implement all of this is the tenth anniversary of the Act being signed, November 27, 2023.

Recently, the HDA (Healthcare Distribution Alliance) Research Foundation published a survey[1] that assessed the industry’s progress.  The Foundation’s survey concluded that industry business partners are just now beginning to establish interoperable connections and work with data exchange in a production environment.

Even though over 80% of manufacturers have prepared to send data downstream, few are exchanging data in production today. Currently, almost 60% of manufacturers say they are not sharing data with distributors.  A little over 60% of manufacturers plan to connect directly with distributors, but nearly 40% of manufacturers will rely on third-party logistics providers, adding a layer of complexity to the process.  Only 16% of manufacturers are connected to dispensers.  Manufacturers stated they have run into obstacles like a lack of resources, slow movement in the industry as a whole, and delays caused by “either past or potential future enforcement discretion.”[2]

Around 50% of distributors are setting up connections currently, while approximately 40% are connected to manufacturers in a production environment; none have any connections with dispensers.  Even when implemented, 45% of distributors don’t plan to establish a direct connection with dispensers.  This indicates many distributors have a significant amount of work to do over the next two years to meet the November 2023 deadline.  Some survey respondents said COVID-19 has curtailed adoption of the standard.  There is also a question as to the number of business partners that prefer a direct connection versus a portal connection. The top distributor obstacle identified was a lack of trading partner understanding or commitment.

Currently, the only “widely recognized”[3] international standard developed to comply with the Track-and-Trace law is GS1’s Electronic Product Code Information Services (EPCIS), which allows trading partners to exchange the transaction data required to comply with the law.  Responses from the survey indicate that industry movement to implement EPCIS is slow possibly due to a lack of IT resources for testing and implementation, the obligation to make IT upgrades required before implementation, or the need to concentrate on error resolution stemming from this process.

Implementation of DSCSA processes has been difficult based on the survey responses.  If funding exists, the Foundation plans to conduct more surveys over the next two years to gauge progress.  Based on the progress still required for a November 2023 implementation, there is a possibility that this deadline, established in 2013, will be extended.  In the meanwhile, PHSL encourages organizations to talk with their software vendors or IT support to determine if the requisite steps are being taken to address this issue.

PHSL has written about Track-and-Trace since President Obama signed this Act in 2013. Please see the below publications for more information:

http://phsirx.com/news-events/publications/computertalk-januaryfebruary-2015

http://phsirx.com/news-events/publications/computertalk-marchapril-2014

http://phsirx.com/blog/update-track-and-trace-enforcement-delayed

http://phsirx.com/blog/track-and-trace-staggered-deadlines-may-lead-to-workflow-disruption

[1] https://www.hda.org/resources/epcis-implementation-benchmarking-survey EPCIS Implementation Benchmarking Survey (hda.org)

[2] https://www.hda.org/~/media/pdfs/industry-relations/hda-foundation-epcis-report.ashx

[3] https://www.hda.org/~/media/pdfs/industry-relations/hda-foundation-epcis-report.ashx

Posted January 5, 2022

Winter 2022 Newsletter:

National Drug Price Reduction Plan

On September 9, 2021, the U.S. Department of Health & Human Services (HHS) published their Comprehensive Plan for Addressing High Drug Prices.  This plan was established in accordance with an executive order from President Biden and focuses on three principles:

1. Make drug prices more affordable and equitable
2. Improve and promote competition
3. Foster innovation to promote better health care and improve health

This review will focus on certain ideas from the HHS Plan and does not opine upon every specific target action.

HHS Drug Rebate Negotiation

One focus of the report is the legislation that currently prohibits the HHS Secretary from negotiating directly with drug manufacturers for Medicare rebates.  The report briefly describes how this portion of the law and Medicare program contrasts with the Veteran’s Affairs (VA) drug procurement program and mandatory rebates in Medicaid.  The report indicates that HHS could negotiate lower prices (greater rebates) that reduce patient out-of-pocket costs and premiums; those lower prices could be extended to employer coverage, the ACA marketplace, and other individual market health coverage.  This description lacks the detail to answer questions around how this potential change would impact the current commercial pricing and administration system, i.e., what could be the unintended consequences of this action?

In the current Medicare Part D system, drug manufacturer rebates are negotiated through plan sponsors/PBMs and passed on to the Centers for Medicare & Medicaid Services (CMS).  If the HHS Secretary were to gain the ability to negotiate drug rebates, how might this impact Medicare Part D plan sponsors?  PHSL has identified the following four scenarios:

1. HHS/CMS intervention would dictate formulary selections and limit options for plan sponsors to differentiate between covered drugs, making most plans very similar and reducing the plan options to beneficiaries
2. HHS/CMS continues to permit unique formularies, and lower pricing would only be invoked when CMS rebate is greater than the plan obtains
3. New HHS rebates may be a supplemental rebate for CMS only, permitting unique plan sponsor formularies
4. New HHS rebates may be a required rebate on all negotiated drugs, similar to the Medicaid Rebate system, permitting unique plan sponsor formularies and cost profiles

Proposals being discussed are focused on limiting negotiations to 10 drugs in 2025 and increasing to 20 drugs in 2028.  The maximum price Medicare pays would be the non-federal average manufacturer price.  The focus will be the top 50 high-cost drugs but exempts small-molecule drugs for their first 9 years and biologic drugs for their first 13 years after approval or licensure.  The implementation and impact to Medicare Part D plan sponsors is still unclear.

For Medicare Part B, where there are no current rebates and no current method to direct treatment to discounted options (formulary and utilization management), PHSL sees two main options for HHS to lower drug prices through negotiation:

1. Allow formulary/utilization management edits in Medicare Part B to direct therapy to lower cost drugs (due to newly negotiated rebates)
2. Require mandatory rebates on all negotiated drugs, similar to the Medicaid Rebate system

Lowering costs for Medicare Part B has already encountered one hurdle, as the U.S. House of Representatives Energy and Commerce Committee did not pass this legislation. The debate continues in the House Ways and Means Committee and in the Senate.

Biosimilars and Generics

The HHS plan also advocates for reforms to reduce delays and barriers to introducing additional competitors, including generics, biosimilars, and competing brands prior to generic entry.  PHSL agrees that generics, biosimilars, and competing brands all offer competition and help to reduce net drug prices to payers, pharmacies, and patients.

The HHS plan advocates for the FDA to work with the Federal Trade Commission (FTC) to identify and address efforts by parties to impede generic and biosimilar competition.  This is already an existing function of the FTC, but any efforts to streamline the process and curtail false, misleading, or deceptive statements about generic and biosimilar products could have a meaningful impact.

Drug Pricing

There are several points focused directly on drug pricing, including an idea to stop unreasonable price increases by applying an excise tax.  This is a general action that would impact all stakeholders (payers, pharmacies, and patients) and would be opposed by drug manufacturers.  This option does not impose price restrictions and continues to permit drug price changes with taxes/penalties for larger price increases.  We would expect this provision to be challenged in court by the pharmaceutical industry.  What other industries face an excise tax based on their pricing behavior?  Why is the government targeting the pharmaceutical industry?

Specifically for patients, the plan describes caps on catastrophic and out-of-pocket spending, using an example for insulin products.  Depending on the implementation of this option, government and payer costs could increase, unless price concessions are shared by manufacturers to offset the difference between the previous uncapped patient cost and the new capped patient cost.

There are current efforts to increase price transparency, which allow market pressure to be exerted to influence prices.  The discussed legislation would require many health plans to annually report currently confidential information about prescription drug and other medical costs to the Departments of HHS, Labor, and the Treasury.  This information will inform leadership, and potentially the public, on prices experienced in the market.  Similarly, CMS is also implementing Affordable Care Act (ACA) provisions that require issuers of Marketplace plans or their PBMs to provide drug, rebate, and spread pricing information.

Testing New Models

The report also notes that the Medicare Part B payment methodology may be a potential area to test new models to determine if drug savings can be achieved.  The report identifies that a single payment limit, applicable to the reference biological product and the biosimilar product(s) of that reference biological product, could spur price competition and drive down average sales prices (ASP) for all products included in the payment limit calculation, resulting in savings for Medicare and supplemental insurers.

Conclusion

The HHS plan offers many targets to impact competition and drug pricing.  It offers a guide for legislators and policy makers to investigate and consider.  The probability of implementation and impact will vary for each target.  PHSL has reviewed several of these options and proposes some alternatives where a more meaningful impact could be achieved.  Of the options that PHSL has reviewed, which do you think are most likely to occur?

Posted January 5, 2022

2022 Winter Newsletter:

Track-and-Trace Implementation Update

PHSL President Ann Johnson and Co-Founder Tim Kosty contributed to the November/December 2021 edition of ComputerTalk for the Pharmacist. In their Viewpoints article, Ann and Tim share predictions for the upcoming year, including topics such as pharmacist clinical services, cash-paying customers at retail pharmacy, U.S. based API manufacturing, and consolidation within all sectors of the pharmaceutical market.

Click here to read the article “Prognostications for 2022” and read the full versions of current and past ComputerTalk issues at https://www.computertalk.com/issue-archive/.

PHSL President Ann Johnson contributed to the September/October 2021 edition of ComputerTalk for the Pharmacist. In her Viewpoints article, Ann reviews the history of 340B and provides an overview of recent manufacturer push-back that could lead to legislative changes in the future.

Click here to read the article “Changes for 340B Coming?” You can read full versions of current and past ComputerTalk issues at https://www.computertalk.com/issue-archive/.

PHSL Vice President Melissa Krause and PHSL Intern & Pharm.D. Candidate Emmanuel Anderson contributed to the July/August 2021 edition of ComputerTalk for the Pharmacist. In their Viewpoints article, Melissa and Emmanuel discuss unbranded biologics, including how unbranded biologics are being displayed in pharmacy management systems and what pharmacists need to do to make sure they are being reimbursed appropriately.

Click here to read the article “How Should Pharmacies Handle Unbranded Biologics?” You can read full versions of current and past ComputerTalk issues at https://www.computertalk.com/issue-archive/.

For Immediate Release
Pharmacy Healthcare Solutions, LLC of Pittsburgh
Adds Experienced Industry Commercial Thought Leader to Staff

Jeff Cook joins PHSL as Director of Business Development

PITTSBURGH (September 8, 2021) – Pharmacy Healthcare Solutions, LLC (PHSL) is pleased to announce the addition of Jeff Cook as Director of Business Development.

Jeff has over 30 years of commercial biopharmaceutical and medical device experience with notable companies such as Upjohn, Genentech, Johnson & Johnson/Cordis, Centocor, Possis Medical, CellzDirect, Acorda Therapeutics, and Ony Inc., and has experience with launching over 12 new biopharma and medical device products.

Prior to joining PHSL, Jeff has served in various roles and senior positions ranging from sales, sales management, marketing, managed markets, trade and distribution, and national accounts/contracting. He has worked extensively with physicians, retail and hospital pharmacies, managed care organizations, health systems/IDNs, and wholesalers. His well-rounded commercial experience will bring an additional perspective to the PHSL team and their clients.

PHSL President Ann Johnson notes that “Jeff’s background and past experiences will enable him to be a great asset to our organization.”

“We are thrilled to have Jeff join our team as we look forward to upcoming conferences and the opportunities they bring to connect with clients and colleagues,” said Melissa Krause, Vice President of PHSL.

ABOUT PHARMACY HEALTHCARE SOLUTIONS, LLC (PHSL)

Founded in 1996, Pharmacy Healthcare Solutions provides pharmacy consulting solutions in a variety of areas including, but not limited to, product and program development, market research, operational efficiency, claims-data analysis, and training program construction. www.phsirx.com

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For Immediate Release
Pharmacy Healthcare Solutions Celebrates 25 Years of Business

Pittsburgh, PA (September 1, 2021) –  Pharmacy Healthcare Solutions announces its 25^th anniversary as a pharmacist-led business consulting firm.

Co-Founders Tim Kosty and Don Dietz established Pharmacy Healthcare Solutions, Inc. (PHSI) in 1996, applying a wealth of knowledge and experience from pharmacy and management roles to address clients’ business issues. In 2019, PHSI transitioned to Pharmacy Healthcare Solutions, LLC (PHSL) under new ownership, with consultants Ann Johnson, Pharm.D. and Melissa Krause, Pharm.D. taking the helm as President and Vice President, respectively.

“The business has steadily grown and evolved over the past two and half decades,” noted Ann Johnson, PHSL President.  “Moving forward, we will continue to offer our clients the high-touch level of consulting services that they’ve come to expect from PHSL.”

“We are excited to celebrate 25 years of Pharmacy Healthcare Solutions.  This milestone illustrates the commitment our team has made to providing custom solutions built for our clients’ businesses.  We’re thankful to our founders, Tim and Don, for setting the company up for success,” stated Melissa Krause, PHSL Vice President.

Over the last 25 years, PHSL has grown to a team of fifteen employees.  All of PHSL’s consultants are pharmacists with a wide range of experience and expertise. Our consultants utilize their extensive pharmacy experience to provide innovative solutions for our clients. PHSL provides services for pharmacies, pharmaceutical manufacturers, PBMs, and technology companies related to business and marketing issues.

For more information on Pharmacy Healthcare Solutions and our consulting services please visit PHSL at http://phsirx.com/contact.

About Pharmacy Healthcare Solutions, LLC
Pharmacy Healthcare Solutions, LLC is a Pittsburgh, PA-based consulting company. PHSL consults with pharmaceutical manufacturers, PBMs, pharmacies (retail, specialty, mail service, LTC, and hospital outpatient), and technology companies on strategic business and marketing issues. Consulting projects across these market segments provide PHSL with the latest information on emerging trends, as well as new products and services. Our consultants have extensive retail, mail service, and managed care experience to create actionable recommendations for our clients’ challenging business issues.

PHSL is a nationally certified Women’s Business Enterprise (WBE) and Women-Owned Small Business (WOSB) by WBENC East, a regional certifying partner of the Women’s Business Enterprise National Council (WBENC).  For additional information, please visit www.phsirx.com.