News & Events

NCPDP recognized PHSL Senior Consultant Dave Schuetz

Congratulations to PHSL Senior Consultant Dave Schuetz for being recognized by NCPDP as Most Valuable Participant (MVP) for dedication as a task group leader for the WG2 Product Review and Billing Unit Exception Task Group at the February 2024 Work Group meeting.  Thanks for all of your efforts and leadership!

Dave_Schuetz_MVP

 

Posted: February 2024

PHSL to Attend AMCP 2024 Annual Conference

PHSL President Ann Johnson and Director of Business Development Karlo Zovko will be attending the AMCP Annual Meeting on April 16-18 in New Orleans, LA.  AMCP expects to bring together over 4,000 industry leaders, health care professionals, and stakeholders for opportunities to network and attend sessions on trending topics.

Contact PHSL if you would like to schedule a meeting with Ann and Karlo while at the AMCP 2024 Conference.

Medicare Prescription Payment Plan…aka OOP Price Smoothing presented at ASAP by Ann Johnson

PHSL President Ann Johnson presented at the American Society for Automation in Pharmacy (ASAP) 2024 Annual Conference. Ann’s presentation discussed the Inflation Reduction Act’s “price smoothing” provision, including implications for patients, payers, and pharmacies.

Click here to view Ann’s presentation slides.

Pharmacy Technology & Management Review January/February 2024

PHSL Senior Consultant Patricia Milazzo and PHSL Intern Logan Graham contributed to the January/February 2024 edition of Pharmacy Technology & Management Review (PTMR). In their Viewpoints article, Patricia and Logan discuss opportunities for pharmacies to bill for clinical services through medical billing and the challenges of incorporating the process into their pharmacy system and workflow.  Click here to read the article “Pharmacy and Medical Billing.”

Florida Medication Importation Approved by FDA

On January 5th, the Food and Drug Administration (FDA) announced approval for the state of Florida to purchase and import medications in bulk from a Canadian wholesaler. This approval limits the import use to Florida’s Medicaid program, government clinics, and state prisons.

FDA Importation History

In 2020, the FDA approved plans to allow states to establish prescription drug import programs with the intended goal of reducing drug prices for US citizens. Florida was the first state to apply for approval in 2020. The federal court issued a January 5, 2024 deadline for the agency to rule on the state’s application after Florida sued the agency for “reckless delay.” Florida estimates the state would save approximately 150 million dollars on drugs to treat HIV, AIDS, diabetes, hepatitis C, and certain psychiatric conditions. As of January 2, 2024, Colorado, New Hampshire, Texas, and Vermont have applications in various stages of the approval process.

Hurdles

Per Dr. Robert Califf, FDA commissioner, the agency will perform a serious vetting of applications for public health protection. States will be required to provide importation details to ensure the drug’s potency, how the state’s program will prevent counterfeit products from entering the United States, and what drugs the state seeks to import. The Canadian seller who purchases the drug directly from the manufacturer must be identified. In addition, the proposal must demonstrate where and how significant cost savings for consumers would occur. US product labeling must be approved and put on the medications. The FDA will be monitoring the state for adherence to federal regulations, especially mandatory reporting of adverse drug events.

Certain drugs are excluded for importation.

  • Controlled substances (all)
  • Biological products including insulin
  • Infused or intravenously injected drugs
  • Inhaled drugs used during surgery
  • Any drugs assigned a REMS (risk evaluation and mitigation strategies)

PHSL assumes the focus of importation will be single-source brand drugs that are available in both the US and Canada in the same active ingredient, strength/concentration, route of administration, and dosage form. This would likely include oral maintenance therapies for chronic conditions that are frequently prescribed and dispensed to maximize the program impact. While there may be instances of multisource generic drugs that are less expensive in Canada, the general knowledge has been that US generics are competitive or less expensive at the pharmacy.

Even with FDA approval, importation is complex, with additional requirements for states who want to participate. After the 2020 ruling, Canada enacted a law to prevent manufacturers and wholesalers from exporting drugs which are in short supply. Some pharmaceutical companies have contractual arrangements with drug-shipping companies prohibiting deliveries to the US. Additional lawsuits are expected to be filed. PhRMA, Pharmaceutical Research and Manufacturers of America, has announced it will “consider all options” to prevent importation, including taking legal action.

Mandatory State Requirements for the FDA

  • What drugs does the state seek to import?
  • Who is the Canadian seller and does this Canadian seller purchase the drug directly from its manufacturer?
  • Who is the importer in the U.S. that would buy the drug directly from the foreign seller in Canada?
  • Who is the relabeler responsible for meeting U.S. labeling requirements?
  • Who is the qualifying lab that would conduct testing of the drug for authenticity and degradation?
  • How is the supply chain secured against counterfeit products? (remember, DSCSA is in place in the US and includes 2D barcode requirements)
  • SIP (Section 804 Importation Programs) would initially be authorized for 2-year periods with the possibility of 2-year extensions.
  • Post-importation requirements for each drug include:
    • Consumer cost savings reports
    • Adverse Event Reporting on Canadian products

Imported Prescription Operations and Billing

The importation ruling creates unanswered questions for pharmacies, regardless of location or type of pharmacy, in addition to PBMs (prescription benefit mangers), wholesalers, payers, and government agencies other than the FDA. Clarification is particularly needed around digital data requirements. The scope of potential system enhancements is unknown. Canadian imports will need to conform to current standards for electronic prescribing, product tracking, dispensing, labeling, and billing, or systems will need enhancements if the data is not in compliance with current US industry standards.

Examples of digital integrity issues may include:

  1. Are new NDCs (National Drug Code) assigned to imported products? (this was the case for varenicline during the shortage where the FDA permitted Canadian product to be sold in the US)
  2. Will the NDC be identified as an “imported repackaged NDC” by the compendia NDC databases?
  3. Will the FDA provide an electronic identifier that would flag imported products? If not, what data will be used to identify imported products in the electronic prescription ecosystem?
  4. Is the process for ADR reporting the same as domestic products?
  5. Will there be new pricing benchmarks?
  6. Will or how will CMS (Centers for Medicare and Medicaid Services) include imports in calculating NADAC (National Average Drug Acquisition Cost)?
  7. Can organizations “force” patients to use imported products or can a patient opt-out of using a Canadian product?

Other unresolved issues remain.

  1. How to calculate the FDA-required “consumer savings”
    • How will savings be passed to the consumer? Florida’s Medicaid program, government clinics, and state prisons are less like commercial and Medicare Part D plans where tiers and copays influence patient costs and options. This requirement to pass, document, and report savings to the consumers will become a more relevant requirement if imported drugs are allowed for commercial use in non-government owned pharmacies open to the public. If general use is permitted, the state will be required to calculate and report savings to the consumers.
  2. Industry guidance on product returns and reverse logistics processes including recalls.

Importation has periodically been proposed as a viable method of lowering drug costs going back to the early 2000s, but it remains to be proven if the obstacles can be overcome on both sides of the border. Will consumers actually see a reduction in prescription costs? More to come!

 

Posted January 26, 2024

Winter 2024 Newsletter:

Pharmacy Network Strategy

Pharmacy Network Strategy

As the pharmacy benefits management (PBM) industry has become increasingly consolidated, entering into a pharmacy network agreement becomes increasingly challenging for pharmacies, especially independent pharmacies that lack the volume of their large chain competitors. The top three PBMs – Caremark (CVS Health), Evernorth/Express Scripts (Cigna), and OptumRx (United Healthcare) control 79% of total prescription claims managed. The next top three PBMs – Humana Pharmacy Solutions, Prime Therapeutics/Magellan Rx, and MedImpact control 17% of total prescription claims managed. This leaves just 4% of the market share managed by all other independent PBMs (and cash pay).1 While challenging, there are still inroads to PBM networks, and this article discusses these considerations.

Approximately half of all states in the United States have some variation of Any Willing Provider (AWP) regulations for fully insured plan sponsors/payers. It is important to understand that AWP laws require fully insured/ managed care plans to accept any qualified provider who is willing to accept the terms and conditions of that pharmacy benefit plan. The pharmacy, particularly an independent or small chain with relatively low volumes, will typically not have the opportunity to negotiate more favorable terms and conditions or drug reimbursement levels.

PSAOs are the typical option for retail pharmacy PBM network inclusion; however, the contract terms can be disadvantageous from a reimbursement or preferred status standpoint. Specialty pharmacies are not typically included in PSAO-negotiated PBM arrangements.

One way to potentially tip the scale in a pharmacy’s favor is to differentiate as a specialty pharmacy, specifically if the pharmacy can focus on value-added clinical programs (e.g. utilization management, outcomes based, etc.). Hospital pharmacies that service the specialty prescription needs of outpatients of 340B covered entities may find it worthwhile to gain entry to PBM networks, instead of contracting this function out.

Entering Medicaid networks requires a state-by-state approach. Just because your pharmacy may contract with a PBM that services managed Medicaid or Fee-For-Service (FFS) Medicaid plans, your pharmacy will not automatically gain entry into these networks.

With so many considerations that can impact a pharmacy’s network strategy, it is helpful to start with a clear understanding of your pharmacy’s product and payer mix. With this in mind, the pharmacy is positioned to consider focusing their efforts on certain products and/or payers (e.g., commercial vs. government).

PHSL can serve as your resource, assisting with opportunity identification or helping to develop a specific network entry strategy.

1 Drug Channels, May 23, 2023. https://www.drugchannels.net/2023/05/the-top-pharmacy-benefit-managers-of.html

 

Posted January 26, 2024

Winter 2024 Newsletter:

Florida Medication Import Approved by FDA

340B: Past, Present, and Yet to Come

PHSL President Ann Johnson contributed to the December 2023 Pharma & Life Sciences Edition of MedHealth Outlook. In this feature, Ann highlights the importance of understanding the current 340B program, as well as its origins and future direction, as it impacts all stakeholders in the pharmacy chain. Click here to read the article.

ComputerTalk for the Pharmacist November/December 2023

PHSL President Ann Johnson and Vice President Melissa Krause contributed to the November/December 2023 edition of ComputerTalk for the Pharmacist. In their Viewpoints article, Ann and Melissa discuss anticipated changes to the pharmacy industry in the coming year, including topics such as pharmacy closures and consolidation, vaccines, biosimilars, and 340B.

Click here to read the article “What’s to Come in 2024.” You can also access the full versions of current and past ComputerTalk issues at https://www.computertalk.com/issue-archive.

ComputerTalk for the Pharmacist September/October 2023

PHSL President Ann Johnson and Senior Consultant David Schuetz contributed to the September/October 2023 edition of ComputerTalk for the Pharmacist. In their Viewpoints article, Ann and Dave discuss challenges and solutions related to the FDA policy requiring the use of UDIs and prohibiting the use of NHRICs or HRIs and NDCs on medical devices.

Click here to read the article “Are You Ready for UDIs?” You can also access the full versions of current and past ComputerTalk issues at https://www.computertalk.com/issue-archive/.

Get Ready: Medicare Model Guidelines Version 9 Are Coming

Medicare Part D coverage for prescription drugs is a federal program that is administered via private entities.  Each approved Medicare Part D plan must offer at least a standard level of coverage.  The list of covered drugs, or formulary, must include at least 2 drugs in the most commonly prescribed categories and classes.  United States Pharmacopeia (USP) works in concert with the Centers for Medicare and Medicaid Services (CMS) to provide and regularly update the specific set of drug categories and classes, known as the Medicare Model Guidelines (MMG).  This provides Medicare Part D plans one option to follow to determine the required covered classes to offer to Medicare beneficiaries.  Medicare Part D plan sponsors also have the option to create their own drug classification listing that must be approved by CMS prior to implementing.

The previous version of the drug categories and classes, called the Medicare Model Guidelines version 8 (MMG v8.0), was published in 2020.  USP released a draft of the updated version 9 document in June 2023.  The draft Medicare Model Guidelines version 9 (MMG v9.0) are intended for use September 15, 2023. The new version includes additions, changes, and removals that have been made to the guidelines.

Class Additions:

Version 9 saw several class additions, with one new class being “Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonists,” which is under the “Antimigraine Agents” category. Under the category “Cardiovascular Agents,” USP added the classes “Mineralocorticoid Receptor Antagonist” and “Sodium-Glucose Co-Transporter 2 Inhibitors (SGLT2i).”  Assuming no changes when the final version is revealed, plans will be required to cover two drugs from each of these classes moving forward.

Along with the changes mentioned above, many new drugs have been FDA approved since the release of MMG v8.0. Twenty new FDA approved drugs were added into the class “Molecular Target Inhibitors.” This number of additions to an already highly populated class is unique, but due to the use in oncology, plans will likely not limit coverage for most of these drugs. Two of the new classes added in this version, “Mineralocorticoid Receptor Antagonist” and “Sodium-Glucose Co-Transporter 2 Inhibitors (SGLT2i)” only contain 3-4 example drugs.  Plans could seize this new opportunity to limit coverage to two drugs in each of the classes, generating competition for formulary position.

Some newly approved drugs have been placed into more general classes that are described as “Other.”  There is the possibility of USP adding additional classes to offer more specificity for these new drugs in the final guidelines.  If additional classes are added, certain drugs may benefit by being the only product or a pair of products in the class.  In this potential scenario, these drugs would likely gain broad coverage from Medicare Part D plans without offering the level of rebates found in highly competitive classes. In contrast, if these drugs remain in the general “Other” class, they may not gain coverage as broadly among Medicare Part D plans.

Class Changes:

The class known in version 8 as “Gamma-aminobutyric Acid (GABA) Augmenting Agents” had a verbiage change to “Gamma-aminobutyric Acid (GABA) Modulating Agents” for version 9. Changing these terms depicts the agents as having a controlling influence on GABA, which more closely fits the actions of the example drugs.

In draft version 9, two previous categories, “Hormonal Agents, Suppressant (Adrenal)” and “Hormonal Agents, Suppressant (Pituitary),” were combined by USP into one category named “Hormonal Agents, Suppressant (Adrenal or Pituitary).” This change would combine more drugs into a single category, allowing plans more discretion to make formulary coverage decisions.

Drug Recategorization:

Along with updating drug categories and classes, USP also adjusted the placement of certain drugs within the existing structure and are shared in the following table.

Medicare Model Guidelines Chart

Watch for the official final release of the Medicare Model Guidelines version 9 in September 2023.  These changes impact manufacturers and Medicare Part D plans regarding formulary coverage and competition.

 

Posted August 30, 2023

Fall 2023 Newsletter:

FDA Novel Drug Approval Trends