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Prescription Drug Labeler Code

Confusion often arises when evaluating what the labeler code is and who assigns it. When drugs are labeled, the first section of the NDC (National Drug Code) number is classified as the labeler code. Labeler codes are requested by the manufacturer and are required for any manufacturer or distributor who lists NDCs with the FDA. A Labeler Code Request SPL file must be sent to the FDA, where it will then be reviewed, and a labeler code will be sent within 10 business days. This code is assigned by the FDA and identifies the firm who manufactures or markets the drug. This code is required before the drug listing can be submitted. In the event that the code has not been used in a listing for 24 months, the code will become inactivated following notification from the FDA.

Medical Device Labeler Code

For the labeling of medical devices, per FDA rules, Unique Device Identifiers (UDI) are now to be used instead of NDCs or NHRICs (National Health Related Item Code). The FDA accredited three organizations as UDI issuing agencies: GS1, Health Industry Business Communications Council (HIBCC), and International Council for Commonality in Blood Banking Automation (ICCBBA). Each issuing agency has a unique UDI format that was reviewed and approved by FDA as part of its process for accrediting issuing agencies.

Medical devices are to be assigned a UDI, which identifies devices from the manufacturing process through distribution and patient use. To acquire this code, the device manufacturer must contact one of the UDI issuing agencies accredited with the FDA to generate an identifier, which is then submitted, along with the device information, to the Global Unique Device Identification Database (GUDID) for approval. The UDI consists of a device identifier (DI) and a production identifier (PI).

The PI portion of the UDI includes information such as lot numbers, serial numbers, and expiration dates. The main purpose for this code is to improve patient safety, increase post market surveillance, and facilitate medical device innovations. A major benefit to the UDI is identifying medical devices in the event of recalls. These unambiguously facilitate the traceability through the supply and market chains. The UDI is found on the device label, packages, or on the device itself. For most nonsterile devices, the UDI will be found on the device itself. Sterile devices must consult the FDA for alternatives.

The remainder of this article will focus on the DI portion of the UDI created using the standard developed by GS1, an information standards organization. The DI identifies the labeler and the specific version or model of a device. GS1 developed a suite of standards that provide information regarding the identification of the product, services, logical matters (such as service relations), and even physical locations. Companies can utilize the GS1 system to create an identifier and obtain a barcode label for their medical device.

Companies first apply for a GS1 company prefix code. This prefix code will recognize the company’s ownership of the identifier and the product to which the identifier is attached. For pharmaceutical manufacturers or repackagers also selling devices, companies may request that their assigned NDC Labeler code be incorporated into their GS1 Company Prefix, if available.  To acquire the prefix, the company must purchase the membership from GS1 and declare the number of products that will use the prefix. The length of the prefix is dependent upon the number of products the company plans to identify using the prefix.

Each product from a given company will possess a global trade identification number (GTIN) beginning with the company’s prefix code. The GTIN is assigned by the manufacturer, who must follow the rules outlined by GS1 to ensure it is unique and correctly formatted. The GTIN serves to identify trade names of a company. This includes any products or services that exist to be priced, ordered, or invoiced at any point within the supply chain as they move toward the ultimate end user. This number is used to identify various packaging levels for a product, such as the quantity of items in the box or the quantity of boxes within the carton.

For the purposes of the UDI, when the GS1 standard is used to create the DI portion the identifier, the GTIN-14 format is utilized.  Compendia then reformat the GTIN-14 into an 11-digit product identifier that can be used for billing claims for medical devices or digital therapeutics.

In the example below, the entire identifier is the UDI.  Within the identifier, the numbers in parentheses are known as Application Identifiers (AI), which specify what the values in the four sections shown in the example represent. The DI portion of the UDI is the 14-digit number, or the GTIN-14, that follows the AI labeled (01).  The rest of the UDI is the PI portion.  The first digit of the GTIN-14 identifies the packaging level and the last digit is the check digit.  The 12 digits in the middle consist of the variable length GS1 Company Prefix and the variable length item identifier.

Navigating these codes and labeling processes can be confusing and difficult. Pharmacy Healthcare Solutions offers the knowledge and experience to ensure accurate knowledge is conveyed while following respective guidelines. Contact PHSL for assistance with questions related to labeler code assignment or help with listing these products in the leading drug pricing compendia.

Posted September 2023

Most people know that for a prescription drug to be on the market, it must receive approval from the United States Food and Drug Administration (FDA). Did you know that many medical devices and Digital Therapeutics (DTx) are also approved and regulated by the FDA?

What are medical devices and how are they different from DTx?

Medical devices are defined by the FDA as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals.” Some examples of medical devices include blood glucose monitors, insulin pumps, and heart monitors.

The Digital Therapeutics Alliance defines digital therapeutics as “a subset of digital health, evidence-based therapeutic interventions driven by high quality software programs to prevent, manage, or treat a medical disorder or disease.” To read more on digital therapeutics, click here for a previous PHSL blog post on the topic. While medical devices have been around for quite some time, digital therapeutics are a more recent development in the medical world. Some examples of digital therapeutics include reSET (a 90-day program for adults with substance use disorders), Somryst (an application for adults with depression and insomnia), and EndeavorRx (a video game for children with ADHD).

With hundreds of thousands of smart phone applications offering health-related functions, it is important to note that most of these digital health tools do not require FDA approval, since they are deemed relatively low-risk. As the name implies, Prescription Digital Therapeutics (PDTs), on the other hand, require a prescription and may come to the market in one of several ways.

The FDA segments devices into three classes, with “computerized behavioral therapy devices” (i.e., digital therapeutics) being listed as a Class II device. FDA guidance on the classification of medical devices is as follows:

• Class I- low risk. Class I devices pose almost no risk to patient safety and require the least regulatory control.
• Class II- moderate risk. Class II devices require regular assessment or premarket notification to prove safety and effectiveness.
• Class III- high risk. Class III devices are vital to health maintenance and even survival of patients. They are the most tightly regulated class of devices and require premarket approval.

For DTx products seeking to come to market, several pathways may be followed.  If a device manufacturer can show that their product is substantially equivalent to an existing product and demonstrates benefit, the manufacturer may be able to submit for 510(k) clearance, also known as premarket notification, or PMN.  For newer low to moderate risk devices where no existing device exists for comparison and a PMN is not an option, manufacturers may seek to be approved as de novo.  For these products, manufacturers will need to provide clinical data to show that the digital therapeutic is both safe and effective.  For newer devices that fall into the high risk, class III category, manufacturers will need to submit for premarket approval, or PMA.  For these products, manufacturers will need to provide clinical data showing that the product is both safe and effective for its intended use.

Before sending an application to the FDA, sponsors must also pay medical device establishment user fees and provide various other documentation, including eCopy (electronic copies of FDA device submissions), eSTAR (electronic submission template and resources), and an outline of small business determination program highlighting price reduction in user fees. When preparing applications, sponsors should consider important aspects of regulation including design controls, nonclinical testing, consensus standards, clinical evidence, and labeling requirements.

What happens after the FDA receives the application?

The FDA will perform a series of reviews. An administrative review will be conducted to ensure that the submission is sufficiently complete to FDA standards. After the administrative review, device submissions will then undergo an interactive review. During the interactive review, the FDA will contact applicants and efficiently move through the review. Sponsors are also able to track their submissions through an online portal provided by the FDA.

After the FDA reviews the device and decides that it can be brought to market, a series of steps must be taken before the device is available to patients.  Note that all of the step components may not be applicable for DTx products, as a physical product is not created.

1. Sponsors must register their organization, their location, and list the medical device(s) they market with the FDA.
2. Sponsors must practice Good Manufacturing Practices when producing the device
3. Sponsors must follow labeling requirements and follow regulations established by the FDA.
4. Sponsors must ensure that their devices are not misbranded or adulterated.

Is there any way to expedite this process?

Yes, the FDA established a new program in 2017 called the Breakthrough Devices Program which expedites the process, allows sponsors to receive feedback more quickly, design flexible clinical trials, and ultimately get the device to market quicker. As of 2021, 617 medical devices qualified for the program. For example, EndeavorRX, the video game for children with ADHD, took this route. By expediting the approval process, digital therapeutics are made available faster to help more people.

Similarly, the FDA developed the Safer Technologies Program (STeP) to expedite the approval of devices for less serious conditions.

Finally, the FDA implemented a precertification pilot program consisting of nine volunteer companies with the goal of developing a new regulatory framework focusing on medical devices and technology. While the pilot program is still in progress, it was designed to be adaptive to fix medical software glitches as quickly as possible. Interestingly, the FDA regulates the companies rather than the devices themselves under this model.

Where do digital therapeutics fit in?

As of now, digital therapeutics follow the same pathways as other devices in the market.  Do you think that a new regulatory framework designed specifically for digital therapeutics will come into effect as a subset of medical devices? How do you think this will impact the market?

Posted August 2023

On December 22, 2021, the Federal Food and Drug Administration (FDA) made news headlines by issuing an emergency use authorization for the use of Pfizer’s ritonavir-boosted nirmatrelvir (Paxlovid) for the treatment of COVID-19. This was followed a day later by the emergency use authorization of Merck’s drug molnupiravir (Lagevrio), also for the treatment of COVID-19. Both drugs came at a critical time in the pandemic and could be used for treatment within 5 days of symptom onset for patients with mild to moderate COVID-19 who were at high risk of disease progression.

The FDA authorization came with additional verbiage allowing pharmacists in all 50 states to prescribe Paxlovid without an order from a physician. The initial labeling for Paxlovid had specific wording allowing state-licensed pharmacists to prescribe the antiviral for COVID-19, as long as they had current significant medical history to understand the patient’s hepatic/renal function and their current medication history. The label also issued guidance for pharmacists on how to refer patients’ care to other providers, should the pharmacy not be equipped to manage care under their clinical scope. The ability for pharmacists to provide care for COVID-19 through the prescribing of these antivirals depended on a positive test result or “current diagnosis of mild-to-moderate coronavirus disease 2019 (COVID-19)” according to the FDA. In February 2023, the FDA changed the guidelines to include the ability for pharmacists to prescribe to individuals “who are at high risk for progression to severe COVID-19, including hospitalization or death.”

As of May 25, 2023, Paxlovid is approved by the FDA for the “treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.” A letter from the FDA states that pharmacists can continue to prescribe Paxlovid, since an Emergency Use Authorization (EUA) still exists and has not been revoked. This EUA has been supplemented with additional information due to Paxlovid’s full approval, but the EUA package insert still includes the ability of pharmacists to prescribe Paxlovid, provided that they still meet the prescribing . There is no indication that pharmacist prescribing will continue if the EUA is revoked.

The revised Letter of Authorization for Paxlovid allows pharmacists to prescribe these antivirals for patients who are suspected of having COVID-19 through their symptomatic or contact history and allows pharmacists to utilize their clinical judgement when treating these individuals. This streamlines the process for treating high-risk individuals who may not have received their testing results, enabling them to initiate therapy as long as they meet the other requirements for prescribing. In many pharmacy chains, while the pharmacy often collected the specimen, COVID-19 testing and result interpretation was outsourced to laboratories. In some instances, results were communicated between the patients and their specific laboratory, keeping the pharmacist unaware of the patient’s status and unable to initiate antiviral therapy if required. With the new changes to the authorized labeling, the pharmacists’ scope has now expanded in terms of COVID-19 antivirals.  It will be interesting to see how this may expand a pharmacists’ scope elsewhere.

Posted June 2023

In late January of 2023, major news outlets reported information about pharmacist shortages throughout the country.   Major retail pharmacy chains, such as CVS and Walmart, also announced that they were cutting pharmacy hours due to lack of staffing.  As pharmacy wait times increased and delays in getting prescriptions to patients occurred, people began to wonder if there truly was a pharmacist shortage contributing to the concerns at retail pharmacies throughout the country.

As of the end of 2022, there were 142 pharmacy schools in the country accredited by the Accreditation Council for Pharmacy Education (ACPE).  This is a significant increase of over 75% from 2000 when there were only 80 accredited schools of pharmacy in the country. Since 2000, the number of pharmacy students graduating each year has risen dramatically, from 7,760 graduates to over 14,000 graduates in 2019-20. When comparing the recent number of pharmacy school graduates with the job outlook from the Bureau of Labor Statistics, which estimates approximately 13,600 new pharmacist jobs, it appears that there is not a true pharmacist shortage.

Where there seems to be a shortage is in overall staffing in pharmacies, specifically for technician positions. In a survey conducted by the National Community Pharmacist Association (NCPA), many pharmacies are stating that their number one problem was finding pharmacy technicians (88% of respondents) followed by front-end staff (56% of respondents). This shortage can result in increasingly stressful environments for retail pharmacists, as they may need to play different roles, perform more duties, and oversee more services with fewer staff members.  This is coupled with an increased workload as pharmacies shift towards clinical centered services. This pharmacy environment concern is substantiated by a 2019 National Pharmacist Workforce study, which shows many pharmacists experiencing stressful conditions in the pharmacy, as well as increased harassment. This situation is further compounded by the fact that many young pharmacists are looking for other pharmacy opportunities outside of the retail space.

In recent years, the role of a pharmacist has been expanded to offer more patient-centered services. Pharmacists are now able to be utilized in various health settings outside of the typical retail space, and that shift can be seen with the increase in pharmacy residencies. According to the American Society of Health-System Pharmacists (ASHP), there are 5,682 residency positions as of 2022. This is an increase of 26% or about 1,196 positions since 2017, specifically in areas such as palliative care, emergency medicine, and community-based programs. As these opportunities for residency expand across the country, more and more pharmacy students can pursue areas of pharmacy outside of the typical retail space.

The combination of expanded services and opportunities for pharmacists, as well as shortages in other critical staffing areas, shows that there is not necessarily a “pharmacist shortage” but rather more pharmacists shifting towards other, less stressful environments versus retail pharmacy. Companies such as Walgreens have said they plan to address these issues by increasing pharmacy automation to reduce the burden of filling prescriptions to free up their pharmacists to pursue other clinical care as their roles expand. How will pharmacies address these issues?

References:

• https://ncpa.org/newsroom/news-releases/2022/08/11/survey-three-quarters-community-pharmacies-report-staff-shortages
• https://www.aacp.org/sites/default/files/2020-03/2019_NPWS_Final_Report.pdf
• https://www.cnn.com/2023/01/27/business/cvs-walmart-pharmacy-hours/index.html
• https://www.aacp.org/article/academic-pharmacys-vital-statistics#:~:text=In%202019%E2%80%9320%2C%2014%2C320%20first,degrees%20were%20awarded.
• https://www.goodrx.com/hcp/pharmacists/trends-pharmacy-school-enrollment
• https://www.wsj.com/articles/walgreens-turns-to-prescription-filling-robots-to-free-up-pharmacists-11664713243?mod=article_inline

Posted: May 2023

Per the Digital Therapeutics Alliance, digital therapeutics deliver “evidence-based therapeutic interventions that are driven by high quality software programs to treat, manage, or prevent a disease or disorder.”  Prescription Digital Therapeutics (PDTs) require a prescription order from a healthcare provider and often provide a continuum of care in the management of chronic disease. The American Psychological Association shows support for this type of care stating that, “They can be used independently or as an adjunct to medications or other therapies to optimize patient care and health outcomes.”

PDT reimbursement lacks clear definition. The Centers of Medicare and Medicare Services (CMS) has been releasing codes, such as Level II HCPCS code A9291, for the streamlining of claims, but federal coverage through Medicare/Medicaid or private payers for digital therapeutics remains elusive. A contributing factor is the uncertainty around the FDA’s ability to regulate these products. “The faster cycles of innovation and the speed of change for medical device software would benefit from a new regulatory approach,” according to an FDA report. Express Scripts has taken steps to offer coverage options via the Evernorth Digital Health Formulary®. This indicates coverage through the pharmacy benefit; however, the HCPCS code also provides an avenue for medical benefit coverage.

Highmark, a payer-provider organization, is the first large commercial insurer to state that they will pay for claims for PDTs with restrictions. Other payers have covered certain products, but Highmark will approve claims for FDA-approved PDTs and cover a growing number with the caveat that they are prescribed as an outpatient treatment for the FDA-approved indication. This is different from Evernorth’s Digital Formulary with Express Scripts, where the coverage is only available on an individual plan’s basis of coverage.  Instead, Highmark is expanding coverage and paying for PDTs that are deemed medically necessary by a provider. The digital therapeutics covered by Highmark, per their statement, are listed below with expanded coverage to other products likely, according to a senior medical director in the system.

Will other commercial insurers follow suit in coverage of PDTs?  Will CMS streamline the process for reimbursement and provide Medicare/Medicare coverage of these products? Those interested in this topic may wish to follow the bipartisan Access to Prescription Digital Therapeutics Act of 2023 (S. 723/H.R. 1458) for updates.

Posted April 2023

A lifesaving treatment to reverse opioid overdoses has just been shifted from Rx to OTC, making it available without a prescription throughout the US. The medication, Naloxone, is a competitive inhibitor of the mu-opioid receptor. This means that it antagonizes the actions of opioids, reversing their effects. It rapidly reverses an opioid overdose but will have no effect if the patient has not taken any opioids. According to the National Institute on Drug Abuse, there were over 80,000 deaths involving overdoses on opioids in 2021. In much of the country, insurance companies, governments, and non-profit organizations subsidize Naloxone distribution. A large-scale national study published in the peer-review journal Addictive Behaviors showed that states that enacted Naloxone access laws decreased opioid overdose deaths by 14%.

On February 15^th, 2023, a joint meeting was held with the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). They voted unanimously to make the nasal-spray version of Narcan available without a prescription. The meeting discussed the adequacy of data presented in the supplemental new drug application submitted by Emergent Biosolutions Inc. for a nonprescription application.

On March 29^th, 2023, the FDA approved Narcan, 4mg naloxone hydrochloride nasal spray for OTC, nonprescription use to Emergent Biosolutions Inc. The expected over-the-counter availability is anticipated to be the late summer of this year. Some states already had special processes to provide specific naloxone products to patients without a physician’s prescription, but this change makes the drug available nationwide without a prescription.

While this approval is a substantial public health win, there is always the barrier of patient costs. In a study published in the JAMA Health Forum in August 2022, the mean out-of-pocket costs for insured patients was $28.46, and uninsured patients paid an average of $6.93 more. Current WAC pricing for a two-pack of Narcan costs around $125; it is unclear whether Emergent Biosolutions Inc. will continue to sell the drug at that cost. No current information on how much OTC Narcan will cost when it becomes available.  What impacts do you expect from this announcement?

Posted: March 2023

The Department of Health and Human Services (HHS) is planning for the federal Public Health Emergency (PHE) for COVID-19 to expire at the end of the day on May 11, 2023.¹ The end of this era, which began as a declaration under Section 319 of the Public Health Service (PHS) Act, will result in anticipated changes across COVID-19 testing, vaccines, treatments, and Medicaid coverage requirements. The effects that these changes will have on PBMs and payers are considered below.

Tests

The requirement for private insurance companies to cover COVID-19 tests without cost sharing, both for OTC and laboratory tests, will end. This implies that PBMs/payers would be able to choose to remove member coverage for COVID-19 at-home tests. Payers will have to weigh the cost-benefit of removing at-home test coverage vs. members potentially electing more costly lab testing or foregoing testing (and the window for early treatment) altogether, which could lead to costlier medical treatments down the road.

Vaccines

As of February 2023, Congress has not agreed to the president’s requests for additional government funding to provide vaccines free of charge.² However, vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) are a preventive health service and therefore HHS expects that most private insurance plans will fully cover COVID-19 vaccines without a co-pay. PBMs/payers may see their vaccine costs increase due to members potentially having used and now losing access to free COVID-19 vaccines and boosters that had been previously available.  Pfizer has previously announced that their COVID-19 vaccine will cost $110-$130 per dose once the PHE ends.³

Treatments

HHS acknowledges that “out-of-pocket expenses for certain treatments [e.g., Paxlovid and Lagevrio] may change, depending on an individual’s health care coverage, similar to costs that one may experience for other drugs through traditional coverage,”¹ implying that programs like 2022’s federal government purchase and free distribution (throughout select pharmacies) of 20 million courses of Paxlovid will no longer continue. PBMs/payers may therefore see an increase in claims for COVID-19 treatments. The estimated cost of one course of Paxlovid treatment in 2022 was $530⁴, and 2023 costs may be higher.

Medicaid

During the COVID-19 public health emergency, the federal government prohibited states from removing people from the Medicaid program once they had enrolled. In late 2022, Congress communicated to states that they can start removing ineligible people (i.e., due to excess income or relocation out of state) in April 2023. PBMs/payers may see additional membership applications from members’ dependents that lose access to Medicaid once the prohibition is lifted.

What other impacts to PBMs and payers do you expect to see when the Public Health Emergency ends May 11^th?  PHSL will continue to monitor and report upon changes.

¹  https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html

² https://wusfnews.wusf.usf.edu/politics-issues/2023-02-01/how-will-life-change-once-the-covid-19-emergency-ends

3 https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html

⁴ https://www.talktomira.com/post/how-much-does-paxlovid-cost-and-where-to-get-it

Posted: March 2023

The terms brown bagging, white bagging, and clear bagging are frequently used to describe the way in which a specialty medication is obtained prior to patient administration by a healthcare professional.¹ Brown bagging is the term used when a patient obtains their medication from a specialty pharmacy and takes it to the provider’s office for administration of the medication.  White bagging refers to the process by which a provider orders and receives a patient’s medication from a specialty pharmacy and stores it until they ultimately administer the medication to the patient.  One caveat with white bagging is that providers must stock and store medications for each patient separate from the office or hospital stock, which can be logistically burdensome. Clear bagging is similar to white bagging with one key distinction.  Clear bagging involves the provider obtaining the specialty drug from a specialty pharmacy within the same health system.²

Key billing and cost considerations exist for health professionals administering most specialty medications. Physician offices may use a process called buy-and-bill. The “buy” portion refers to the provider being responsible for the ordering and purchasing of a specialty drug.  The “bill” phrase refers to the provider billing third party payers for reimbursement.  The billing process includes reimbursement for the drug, the administration of the drug, and any related services associated with the drug and its administration.  Under the different forms of bagging, the specialty pharmacy will work with the payer to determine the medical vs. pharmacy benefit billing for the drug.  The buy-and-bill method for providers utilizes medical benefit billing and reimbursement. The provider’s office manages the drug inventory to align with patient appointments, as forgetfulness or lack of coordination could impact adherence and health outcomes.  This method means that the provider’s office is responsible for higher upfront costs and the management and storage of the medication. ³ However, this method is also likely to be more profitable for the provider.

The significant expenses associated with specialty medications and their administration has payers searching for a way to cut costs without sacrificing care.  One popular and proven solution is called Site of Care Optimization,⁴ which encourages patients to move from the traditional and higher-priced locations of drug administration to lower cost options.  Magellan’s annual Medical Pharmacy Report highlights the magnitude of the cost savings stating, “Commercial medical benefit drug costs in the hospital outpatient setting were often double that of the physician office. Compared to the commercial population… Oftentimes, administrative code reimbursement is four times more expensive in the hospital than physician office setting for commercial members.”  This presents payers with a phenomenal opportunity to cut costs for patients without sacrificing care.⁵ How do you envision the future of specialty drug delivery and administration?

References:

1. Rayburn K. What is the difference between white, Brown, and clear bagging? Patient Empowerment Network. https://powerfulpatients.org/2022/05/25/what-is-the-difference-between-white-brown-and-clear-bagging/. Published May 25, 2022. Accessed November 2, 2022.

2. Brown bagging versus white bagging: Value-based Cancer Care. Value Based Cancer Care. https://www.valuebasedcancer.com/issues/2013/september-2013-vol-4-no-8/1341-brown-bagging-versus-white-bagging#:~:text=%E2%80%9CBrown%20bagging%E2%80%9D%20is%20when%20a%20patient%20acquires%20specialty,the%20patient%20visits%20the%20physician%E2%80%99s%20office%20for%20administration. Published July 25, 2013. Accessed November 2, 2022.

3. DeMarzo A, Nbpas. What is buy and Bill? Prior Authorization Training. https://www.priorauthtraining.org/what-is-buy-and-bill/. Published March 22, 2021. Accessed November 2, 2022.

4. Orabi C. Site of care optimization: What is it and what do you need to know? CIVIC Infusion | Medical Infusion Specialists. https://www.civicinfusion.com/CIVIC-Blog/site-of-care-optimization-what-is-it-and-what-do-you-need-to-know. Published November 13, 2020. Accessed November 2, 2022.

5. Site of Care Optimization. National Infusion Center Association. https://infusioncenter.org/infusion-center-news/site-of-care-optimization/. Published September 14, 2019. Accessed November 2, 2022.

Posted: February 2023

As we prepare for 2023 formulary exclusions to be implemented, we wanted to look back at 2022 formulary exclusions for Express Scripts (ESI), CVS Caremark, and OptumRx. Based on PHSL’s review, ESI led the way with over 108 formulary exclusions. CVS Caremark added 95 new exclusions, while OptumRx only excluded an additional 80 drugs. Although CVS Caremark excluded nearly 100 new drugs, they noted that 99.61% of their clients would not be impacted by any medication changes because of the formulary removals. The 2022 exclusions, as researched by PHSL, are as:

During the review, PHSL made the following observations:

• ESI focused more attention on dermatologic agents and autonomic & central nervous system products. Examples included Tazorac 0.05% Cream, Fabior, and Ultravate for dermatologic agents. Examples of autonomic & central nervous system products included Dhivy, Baclofen solution, and Lybalvi.
• CVS Caremark’s main focus was on dermatologic agents and pain medications, with 14 exclusions in each category. Examples included ivermectin gel, desonide gel, and for the dermatologic agents. Meloxicam capsules, butalbital-acetaminophen 25-325 mg tablets, and diclofenac potassium 25 mg tablets are some of the pain medications excluded from formulary last
• OptumRx focused on dermatologic agents and chemotherapy agents. Dermatologic agents excluded by OptumRx and other PBMs included Tazorac 0.05% Cream and Fabior. Inqovi, a chemotherapy agent, was excluded from formulary without a formulary alternative. OptumRx advised patients to consult with their provider about clinically appropriate options.
• All three PBMs excluded an oral formulation of diclofenac last With both ESI and CVS excluding diclofenac potassium 25 mg tablets and OptumRx excluding diclofenac 35 mg capsules.
• CVS Caremark greatly restricted coverage of diabetic supplies and needles. Any insulin needle or syringe that was NOT BD Ultra-Fine brand was excluded. Any test strip NOT Accu-Chek or OneTouch brand was excluded. CVS Caremark excluded any glucose monitoring system that was NOT the DEXCOM Continuous Glucose Monitoring System (DEXCOM G6), Omnipod Insulin Infusion Pump, or Omnipod Dash Insulin Infusion Pump.
• In addition, CVS Caremark no longer covered any brand name prenatal . CVS Caremark included four specific prenatal vitamins on their formulary: Prenatal Tab 27-1mg, Prenatal Tab Plus, Prenatal Vitamin Tab Low Iron, and Tricare Tab Prenatal.
• It is important to note that CVS Caremark excluded only a specific NDC for albuterol sulfate CFC- free aerosol (NDC:66993-0019-68), manufactured by PRASCO Laboratories. Manufacturers that are covered include: Glaxosmith, Cipla, Hikma, Teva, Sandoz, Civica, Par Pharma, and Padagis.
• It is important to note that CVS Caremark excluded only a specific NDC for paroxetine HCl ER (NDC:), manufactured by APOTEX. Manufacturers that are covered include: Rhodes Pharma, Kremers Urban, Lupin Pharma, Westminster, and Modavar Pharma.
• OptumRx still requires prior authorization for Hepatitis C, Multiple Sclerosis, and Immunomodulator treatments. Avsola replaced Simponi Aria and Renflexis as preferred immunomodulators. Kesimpta and dimethyl fumarate DR replaced Tecfidera for multiple sclerosis preferred treatments. There was no change in preferred Hepatitis C medications.
• As mentioned in our 2021 Exclusion List Review, ESI continues to use indication-based management for the “inflammatory conditions” drug class.

Each of the major PBMs took a different approach to managing drug expenditures in 2022, with formulary exclusions continuing to play a major role. PBMs exclude products because of clinical, financial, and humanistic reasons. Each PBM makes value judgements and determines what coverage is no longer warranted. This article represents PHSL’s analysis of publicly available information regarding the three PBM’s formulary exclusion lists for 2022. Readers are encouraged to assess the lists for themselves, using the exclusion list source information provided in the links below.

• CVS Caremark 2022 Exclusion List
• Express Scripts 2022 Exclusion List
• OptumRx 2022 Exclusion List

Stay tuned for PHSL’s review of the PBM 2023 formulary exclusion lists, coming soon!  How do you expect that the 2023 formulary exclusions will compare with those in 2022?

Additional Resource:

• 2022 CVS Caremark Formulary Updates | CVS Health Payor Solutions
• CVS Caremark Preferred Drug List
• CVS Caremark Formulary Watch
• 2022 CVS Caremark Formulary

Posted: December 2022

Hearing loss is a critical public health issue. Nearly 30 million adults in the US have some degree of hearing loss. Untreated hearing loss increases the risk of social isolation and depression and is one of the greatest modifiable risk factors for dementia. Although use of hearing aids has increased in the past several years, studies have found that in people over the age of 70 years, only about 18% who owned hearing aids used them. ^1,2

In the past, the only hearing devices available in stores were known as Personal Sound Amplification Products (PSAPs), which are not alternatives to hearing aids. These devices are made for people without any hearing impairment to amplify sounds in certain situations, such as for recreational activities like bird watching or hunting. These are regulated as consumer electronics and not medical devices and may be more variable in terms of quality.⁷

The price of hearing aids has been a major obstacle for people. Traditional Medicare does not cover prescription hearing aids, which can cost between $4,000 and $5,000. Medicare Advantage plans typically include some coverage, but people still pay roughly 79% out of pocket. ¹ There is a large potential market for over the counter (OTC) hearing aids. Roughly 90% of adults with hearing loss can be helped by OTC hearing aids, but sales have been restricted to licensed audiologists and other specialists, which has continued to keep prices high. Effective October 17^th, 2022, consumers can buy OTC hearing aids in stores and online.¹

On August 16^th, 2022, the FDA issued their final rule to establish a regulatory category for OTC hearing aids to improve access and lower prices for millions of Americans.  The goal of the final rule is to foster innovation and competition in the hearing aid technology marketplace. Many manufacturers and retailers have not said much about new products, prices, or distribution yet, but some details have surfaced. Best Buy plans to open hearing centers in more than 300 stores in the 4^th Quarter and has already added an online hearing assessment tool. Customers will be able to use this tool to assess their hearing and choose from nine brands; sales staff who have received specialized training will be able to provide assistance. Prices are said to range from $200 to $3,000, depending on varying functions. Sony also announced a partnership with WS Audiology Denmark, but specifics regarding their products have not been released. Bose Corp. has partnered with Lexie Hearing to create a new self-fitted OTC aid for around $900. Over time these prices are likely to fall as more competition enters the market.^1,3,5

Walmart, CVS, and Walgreens have made OTC hearing aids available on their websites as of October 17^th. Walmart plans to offer a range of various products priced from $199 to $999 per pair and has currently made them available in their vision centers at select stores in Colorado, Michigan, Missouri, Ohio, Pennsylvania, Tennessee, and Texas, and at 474 Sam’s Club Hearing Aid Center locations. CVS plans to have products in stores beginning in November 2022. Walgreens currently has hearing aids available online for $799 with comparable models from specialists ranging from $2,000 to $8,000 per pair. Walgreens also plans to sell these in stores in the future. Hy-Vee plans to start selling over-the-counter hearing aids online and in 34 locations across Iowa, Kansas, Minnesota, Missouri, Nebraska and Wisconsin. Hy-Vee will offer four models ranging in price from $499.99 to $999.99 and plans to make them available in 100 locations by the end of the year.⁵

Because these products are OTC, pharmacists will not be required to consult on these devices, but they are one of the most accessible healthcare professionals and will need to be able to help consumers in their selection when needed. In some cases, pharmacists will need to refer patients to audiologists and physicians for additional evaluation. They may also need to follow up with patients to ensure the device works as expected. To help pharmacists in this new role, the University of Pittsburgh has developed an online program, available for a fee, to teach pharmacists and pharmacy technicians how to help patients safely choose OTC hearing aids. Continuing education courses will also be produced to help pharmacists in recognizing hearing loss, helping patients in not over amplifying their devices, and much more. ^6,8

Sales will be restricted for OTC hearing aids to people 18 years old or older with perceived mild to moderate hearing loss, but there are people to help navigate this new market. The Hearing Loss Association of America published a tip sheet on buying hearing aids. Wirecutter posted a useful guide to selecting various products based on features, which is updated as new products emerge. Johns Hopkins Bloomberg School of Public Health created HearingNumber.org to help people find their level of hearing loss and learn about treatment options. This currently requires an Apple smartphone or tablet, but more options will become available in time.^3,1

There are some important things to think about when buying OTC hearing aids. What kind of functions does the device carry, such as Bluetooth capabilities? Are they sweat or water resistant? Do they include rechargeable batteries, or do batteries need to be replaced? What about return policies? There are some standard features that the FDA has made mandatory, such as the ability to adjust the volume, but return policies have been left to the states to decide.⁴

In the next several months we will likely see many changes coming. People across the country will begin to save hundreds to thousands of dollars while improving their quality of life. This will take time though; more retailers and manufacturers will need to enter the market to see prices continue to drop and to see new innovations arise.

Sources:

1. Hearing aids to be sold over the counter next week | The Seattle Times
2. Hearing Aids | FDA
3. FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans | FDA
4. What to Know About Over-the-Counter Hearing Aids – NBC4 Washington (nbcwashington.com)
5. Hearing aids OTC: CVS, Walgreens, Walmart, Best Buy selling over counter devices (axios.com)
6. Over-the-counter hearing aids have been greenlighted by the FDA – your local pharmacist will soon be able to sell you the device you need (yahoo.com)
7. Hearing Aids and Personal Sound Amplification Products: What to Know | FDA
8. Over-the-Counter Hearing Aids: Everything Pharmacies Need to Know (pbahealth.com)

Posted: November 2022