News & Events

Dave Schuetz Attending NCPDP’s February Work Group Meetings

PHSL Senior Consultant Dave Schuetz will be attending the NCPDP Joint Technical Work Group Meetings February 5 – 7, 2020 at the Omni Houston Hotel in Houston, TX.  The Work Group Meetings provide a venue for NCPDP members and industry stakeholders to come together to address issues and create solutions for pharmacy and healthcare.

Contact PHSL if you would like to schedule a meeting with Dave while at the Work Group Meetings.

ComputerTalk for the Pharmacist November/December 2019

PHSI President Tim Kosty and Vice President Don Dietz contributed to the November/December 2019 edition of ComputerTalk for the Pharmacist. In their Viewpoints article, Tim and Don discuss how the oversupply of pharmacists along with evolving technology may lead to new offerings of innovative clinical services.

Click here to read Tim and Don’s article entitled “2020: Clinical Services Out of Necessity?” You can read full versions of current and past ComputerTalk issues at

Tim Kosty to Present at ASAP 2020 Annual Conference

PHSI President Tim Kosty will be presenting at the American Society for Automation in Pharmacy (ASAP) 2020 Annual Conference on January 15-17 in Amelia Island, Florida. Tim will be discussing the California Consumer Privacy Act (CCPA), including requirements that covered businesses must comply with, system changes required, and potential unintended consequences for businesses and consumers. To schedule a meeting with Tim during the conference, please click here to contact PHSI.

Last Call for USP Chapter <800>

On December 1, 2019, changes will go into effect that impact pharmacies, pharmaceutical manufacturers, and wholesalers. The United States Pharmacopeia (USP) introduced its new chapter <800> on handling hazardous drugs. Regulatory agencies worldwide will begin enforcement on December 1, 2019.

The USP initially announced a June 1, 2019 rollout for chapter <800>, but a six-month extension has provided pharmacies, long-term care facilities, and other affected entities increased time to bring their facilities and standard operating procedures up to code.

Several important considerations exist for pharmacies and other entities that handle hazardous drugs:

  • New requirement for externally vented, negative pressure labs for manipulations (other than counting or repackaging) of hazard drugs (HDs)
    • Splitting/crushing (HD) tablets no longer allowed in regular workspace
  • New requirements for designated areas for receipt, unpacking, and storage of HD

For more information on compounding and handling hazardous drugs, full chapters are available for free download at:

While facilities dedicate significant energy, time, and resources into finalizing compliance, new regulations on hazardous waste (HW) disposal from the Environmental Protection Agency (EPA) have already gone into effect. August 21, 2019 marked the federal effective date of EPA’s Resource Conservation and Recovery Act (RCRA) Part 266 Subpart P policy on hazardous waste pharmaceuticals.

New requirements for HW management under Subpart P may prove costly for both pharmacies that produce over 220 lb. of hazardous waste in one calendar month and for manufacturers that function as reverse distributors.  Key takeaways include:

  • Sewer prohibition: HW pharmaceuticals may not be disposed of down the drains or flushed
  • Requirements for EPA-approved HW transporters for shipment of non-creditable HW pharmaceuticals
    • Non-creditable HW pharmaceuticals —defined as pharmaceuticals that do not have a reasonable expectation to be used/reused or reclaimed—must be shipped using an EPA-approved HW transporter
    • Potentially creditable HW pharmaceuticals—those in original packaging, undispensed, and expired less than one year–have a reasonable expectation to receive manufacturer credit. Potentially creditable products can be shipped from healthcare facilities using common carriers (e.g., UPS, USPS, FedEx)
  • New standards for residues remaining in “empty” containers:
    • “Empty” containers are defined as empty vials, syringes, unit-dose, and stock/dispensing bottles smaller than 1 liter or 10,000 pills
    • Residues of empty containers are not regulated as HW, but containers larger than these sizes are deemed as HW.

PHSI’s view is that manufacturers and distributors of bulk package-sized hazardous drugs, such as warfarin and spironolactone, should take a closer look at the new EPA and USP <800> regulations. Buyers may become more hesitant to purchase large quantities of hazardous pharmaceuticals. Hazardous drugs deemed broken/leaking, repackaged, dispensed, and expired past 1 year automatically become classified as non-creditable HW. An increase in generated hazardous waste each month may result in a healthcare facility becoming required to abide by all sections of Subpart P.  Subpart P went into effect on Aug 21, 2019 in Iowa, Alaska, Indian Country, and some U.S. territories. Remaining states have until July 21, 2021 to adopt the new regulations. Check with your state for specifics.

PHSI would like to thank our student, Carissa Dolan, LECOM Pharm.D. Candidate, for her contributions to this article.


Posted November 2019

2019 Fall Newsletter:

2020 Formulary Exclusion Lists

2020 Formulary Exclusion Lists

2020 Formulary Exclusion Lists:

A Review of Express Scripts, CVS Caremark, and OptumRx

It’s that time of year again, PHSI’s annual review of the PBM formulary exclusion list updates!  Express Scripts (ESI), CVS Caremark, and OptumRx have published their formulary exclusion lists for 2020.  Based on PHSI’s calculations, OptumRx leads the way with 246 new formulary exclusions.  Of those 246 exclusions, 169 (69%) were for brands that have covered generic equivalents.  CVS Caremark added 100 new exclusions; 32 of those 100 exclusions (32%) were for brands with available generics.  ESI will exclude an additional 35 drugs, 13 (37%) of which are multisource brands.  The new 2020 exclusions, as researched by PHSI, are as follows:

Chart 1 New Formulary Exclusions

Excluded multisource brands with available generics are as follows:

Chart 2 New Formulary Exclusions - Brands with Generics

During the review, PHSI made the following observations:

  • OptumRx seemed to pay more attention to the topical corticosteroids class this year, excluding an additional 13 agents that may not have specific generic equivalents. Examples of excluded agents include Psorcon cream, Ultravate lotion, and Cloderm cream.
  • With the 2020 additions, OptumRx more than tripled the number of drugs on its list of excluded brand-name medications with generic equivalents. The total number of drugs on OptumRx’s list of excluded brand-name medications with generic equivalents is now approximately double that of ESI’s list.  Optum indicates that “these brand-name medications have been identified as having available generic equivalents covered at Tier 1 on the formulary.”  This change may signal OptumRx’s increased commitment to reduce unnecessary drug spend.
  • ESI seemed to focus on the hematological class for 2020, with approximately 14% of the new exclusions coming from this category. ESI’s list of agents excluded for 2020 includes Jadenu, Jadenu Sprinkle, Nuwiq, Granix, and Mulpleta.  PHSI believes that ESI may be leading the PBM charge as it relates to hematological agent exclusion.  With many new hematological products expected to launch, we anticipate that this will become a more tightly controlled category in subsequent years.
  • CVS focused heavily on the dermatological category for 2020 exclusions, with an additional 19 dermatology agents being added to the exclusion list. Examples of excluded agents include mupirocin cream, Acanya, Finacea Gel, and fluocinonide cream 0.1%.
  • CVS is making a strong push to exclude high cost dietary supplement agents. Twenty-five dietary supplements were added to the exclusion list for 2020, with folic acid being the preferred on-formulary alternative.  Because these products are not FDA-approved and often have high costs, this can be an effective way to manage plan drug spend.  Examples of excluded dietary supplements include Xyzbac, Mebolic, Dexifol, and Vasculera.
  • CVS Caremark is becoming manufacturer-specific in their formulary exclusions; they note five products where specific NDCs are excluded. For example, CVS’s formulary excludes benzonatate NDCs 69336-0126-15 and 69499-0329-15.  Excluded NDC 69336-0126-15 has a per-unit WAC of $71.42, while pharmaceutically equivalent GPI competitors have WAC pricing of $2.20 per unit.  For a product that may be reimbursed at a non-MAC rate, choosing the correct manufacturer’s product can have impactful reimbursement consequences for payers.
  • With the launch of lower cost generic tadalafil, all three major PBMs have chosen to exclude brand Cialis in 2020.
  • As mentioned in our 2019 Exclusion List Review, ESI continues to use indication-based management for the “inflammatory conditions” drug class. Reviewing the updates to that category, Inflectra and Renflexis are no longer preferred agents for 2020.

Each of the major PBMs has taken a different approach to managing drug spend in 2020 and formulary exclusions continue to play a major role.  PBMs exclude products because of clinical, financial, and humanistic reasons.  They are making value judgments and have decided covering these products is no longer warranted.  This article represents PHSI’s analysis of publicly available information regarding the three PBMs’ formulary exclusion lists for 2020.  Readers are encouraged to assess the lists for themselves.  Links to the exclusion list source information are provided below.


Posted November 2019

2019 Fall Newsletter:

Last Call for USP Chapter <800>

ComputerTalk for the Pharmacist September/October 2019

PHSI Consultant Ashley Ellek contributed to the September/October 2019 edition of ComputerTalk for the Pharmacist. In the Viewpoints article, Ashley discusses upcoming Drug Supply Chain Security Act (DSCSA) deadlines for wholesalers and the impact on manufacturers and pharmacies. The article also outlines requirements for pharmacies coming in November 2020.

Click here to read Ashley’s article entitled “Pharmacy Requirements for DSCSA Deadlines”.  You can read full versions of current and past ComputerTalk issues at

ComputerTalk for the Pharmacist July/August 2019

PHSI Consultant and Partner Ann Johnson contributed to the July/August 2019 edition of ComputerTalk for the Pharmacist. In the Viewpoints article, Ann discusses the biosimilar four-character suffix assignments and the impact of these suffixes on product appearance in EHRs, pharmacy management systems, and wholesaler ordering systems.

Click here to read Ann’s article entitled “Impact of Biologic and Biosimilar Naming Suffixes.”  You can read full versions of current and past ComputerTalk issues at

Digital Therapeutics & The Role of the Pharmacist presented at ASAP by Ann Johnson

PHSI Consultant, Partner Ann Johnson presented at the American Society for Automation in Pharmacy (ASAP) 2019 Midyear Conference. Along with a background on digital therapeutics, Ann discussed the FDA’s Proposed Framework for “Prescription Drug-Use-Related Software” and opportunities for adherence initiatives, data available from digital therapeutics, and the role that pharmacists can play. Click here to view Ann’s presentation slides.

Digital Therapeutics and the Role of the Pharmacist


You can access all of the 2019 ASAP Midyear Conference presentations at

Drug Topics June 2019

Fred Gebhart writes about pharmacy technology maintenance in Drug Topics.  PHSI Consultant and Partner, Melissa Krause, was quoted in the June 2019 issue of the publication.  To see the entire article, “Why Technology Upkeep is Up to You,” visit

ComputerTalk for the Pharmacist May/June 2019

PHSI Consultant Dave Schuetz contributed to the May/June 2019 edition of ComputerTalk for the Pharmacist. In the Viewpoints article, Dave discusses the importance of regularly scheduled reviews of pharmacy invoices to ensure that wholesaler contractual terms are being met or exceeded.

Click here to read Dave’s article entitled “Wholesaler Agreements: Pricing Caveats”. You can read full versions of current and past ComputerTalk issues at