“Method For Repurposing Ndc Codes In A Pharmaceutical Database For Allergens” in Patent Application Approval Process (USPTO 20210287174): Patent Application

2021 OCT 04 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- A patent application by the inventors PULITZER, Jovan Hutton (FRISCO, TX, US); STRADER, James (AUSTIN, TX, US), filed on December 21, 2020, was made available online on September 16, 2021, according to news reporting originating from Washington, D.C., by NewsRx correspondents.

This patent application has not been assigned to a company or institution.

The following quote was obtained by the news editors from the background information supplied by the inventors: “Immunotherapy basically involves a series of allergy shots given to reduce one’s sensitivity to various allergens that may cause an allergic reaction. This immunotherapy can either be venom based or environmentally based. For venom based immunotherapy (VIT), treatments are available for allergies to stings such as honeybees, Yellowjackets, Hornets, paper wasps, fire ants and snakebites. For such things as insect stings, very small amount of the insect venom is injected under the skin in a dilute saline solution. This type of therapy is recommended for all patients who have experienced systemic reaction to insect sting and have specific IgE to venom allergens shown either my skin or blood test. Individuals with a history of a systemic reaction to an insect sting are at an increased risk of subsequent systemic sting reactions. VIT as compared to Environmental Immunotherapy is different than pollins and the such that one might be exposed to in the environment in that VIT is basically associated with allergens that are flown around inside a special injection device that, when counter, may threaten the lives of those who are sent to to it . . . Insect venom allergy or snake venom. The primary offenders associated with VIT are prone primarily insects that sting rather than those that might or, as noted hereinabove, snakes. The insects that sting are typically members of the order of Hymenoptera of the class insect. This can include members of the Vespid family, Yellowjackets, yellow Hornets, white-faced Hornets and wasps. There also the class of Apids, including honeybees and bumblebees. There’s also the Formicid family that consists of fire ants and Harvester ants.

“To desensitize an individual against a particular venom, the process is to immunize the individual with small and graded doses of the venom. This is compared to the use of an anti-venom which is manufactured via a purified process in another animal such as a sheet. For example, the approved anti-venom for the pit viper (rattlesnake, copperhead and water moccasin) is based on a purified product made in sheet known as CroFab. These anti-venoms are typically administered through intravenous techniques. However, there are some antivenoms for such things as stonefish and redback spider that are administered intramuscularly. These antivenoms are injected after a bite, as they are designed to bind to and neutralize the venom, halting further damage, but do not reverse damage already done. This is compared to desensitizing an individual by small graded doses.

“In general, and antigen is any structural substance that serves as a target for the receptors of an adaptive immune response or, alternatively, and more simply stated, and antigen is any substance that causes an immune system to produce antibodies against it. An allergen is a type of antigen that produces an abnormally vigorous immune response in which the immune system fights off a perceived threat that would otherwise be harmless to the body. These reactions are termed allergies. Thus, by providing small graded doses of venom as the allergen, this would produce some type of immune response in the immune system that would generate anti-bodies to fight off the perceived threat. For small doses, the immune system can initially accommodate this and, as a doses increase, the immune system will continue to adapt and build up antibodies to this allergen, i.e., the venom of the particular insect or snake or other such. These allergens associated with the venom immunotherapy are specifically associated with allergens that originate from the internal organs of animals, insects or reptiles.

“Currently, most allergens associated with venom immunotherapy are not readily reimbursed when received from a pharmacist for the simple reason that the NDC code is not included in the database to which the pharmacist has access. Without an NDC code in the database, the pharmacist cannot access that information. By not being able to access information, the pharmacist cannot interface with a benefits provider for reimbursements nor can they have access to the Average Wholesale Price (AWP), which is the benchmark that has been used for many years for pricing and reimbursement of prescription drugs for both government and private payers. Initially, this AWP was intended to represent the average price that wholesalers used to sell medications to providers, such as physicians, pharmacies, and other customers. However, the AWP is not a true representation of actual market prices for either generic or brand drug products. AWP has often been compared to the “list price” or “sticker price”, meaning it is an elevated drug price that is rarely what is actually paid. AWP is not a government-regulated figure, does not include buyer volume discounts or rebates often involved in prescription drug sales, and is subject to fraudulent manipulation by manufacturers or even wholesalers. As such, the AWP, while used throughout the industry, is a controversial pricing benchmark.

“The AWP may be determined by several different methods. The drug manufacturer may report the AWP to the individual publisher of drug pricing data, such as Medi-Span. The AWP may also be calculated by the publisher based upon a mark-up specified by the manufacturer that is applied to the wholesale acquisition cost (WAC) or direct price (DIRP). The WAC is the manufacturer’s list price of the drug when sold to the wholesaler, while the DIRP is the manufacturer’s list price when sold to non-wholesalers. Typically a 20% mark-up is applied to the manufacturer-supplied WAC or DIRP, which results in the AWP figure.

“The publishers then in turn sell these published AWPs to government, private insurance, and other buyers of prescription drugs, who use these data tables to determine reimbursement and retail prices. Because AWP is a component of the formulas used to determine reimbursement, elevated AWP numbers can drastically increase the dollar amount that government, private insurance programs, and consumers with coinsurance must pay.

“Pharmacies typically buy drugs from a wholesaler and then sell them to the public. Many patients have coinsurance or copayments, where they only pay for a portion of their prescription cost. The insurance company then pays the rest of the cost (the reimbursement) to the pharmacy. Insurance companies include prescription benefit manager (PBM), health maintenance organization (HMO) or government programs, such as Medicaid or Medicare Part B or D. In addition, the pharmacy receives a dispensing fee for filling the prescription. Fees are, for example, set between $3 to $5 per prescription, but may vary by state.

“Reimbursements are based on AWPs. However, pharmacies purchase drugs based on the WAC. The difference between the WAC (what the pharmacy actually paid for the drug) and the reimbursement from insurance (based on AWP) is known as the spread, and equates to the profit that the pharmacy receives.

“Market pricing on brand drugs tend to be about 16.6 percent less than the AWP. However, the relation of AWP to generic pricing is not clear. Older generics tend to have a large spread between the AWP and WAC, which in turn gives a large spread, and higher profit margins for the pharmacy or other provider of the drug. Many payers, such as PBMS or HMOs, will determine a maximum allowable cost (MAC) pricing on generics to avoid being overcharged. Newer generic products, compared to older generics, may not have as favorable of a spread, thus the need for MAC.

“Collusion between AWP publishers and wholesalers to artificially inflate the AWP, and in turn increase the spread, has led to court cases in the U.S. In these cases, it was alleged that increasing the spread benefited the wholesaler because customers (pharmacies and large institutions) were more likely to buy from them than a competing wholesaler where the spread was not as desirable. The publisher of AWPs profited because pharmacies were more likely to buy the pricing lists from the publisher that noted the higher AWPs used in calculating the spread, than to buy them from other publishers with lower AWPs. Due to this pricing fraud, many payers, including government payers, are no longer using AWP for pricing, and are switching to other more transparent pricing benchmarks, such as WAC or AMP (average manufacturers price). However, AWP may still be found in use in the U.S. because it has been the standard for decades.

“However, in order for a pharmacist to access the AWP and to be able to interface with benefits providers, the product associated with an NDC must be in the database. Currently, nonvenoms are an item that does not exist in the database.”

In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventors’ summary information for this patent application: “In one aspect thereof, a method for adjudicating reimbursement for venom derived allergens between a pharmacist and a reimbursing entity is provided. The method comprises obtaining at a central control center National Drug Codes (NDC’s) for a plurality of venom derived allergens at a defined concentration level, each NDC uniquely identifying that particular allergen as to its manufacture, the particular allergen, the packaging and the defined concentration level, and further obtaining information as to a description of the particular venom derived allergen, concentration level and manufacturer determining by the central control center an Average Wholesale Price (AWP) for each of the venom derived allergens associated with each of the NDC’s, storing in a central control database the obtained NDC’s in association with an associated AWP and associated information for the venom derived allergen, which associated information includes translation information to allow practitioners to determine from a desired diluted level and number of doses of a desired NDC carrying venom derived antigen and a known dilution procedure how to translate back to the amount of base concentration of the NDC carrying venom derived antigen used to create the desired diluted level and number of doses, accessing a third-party database accessible by a pharmacist and determining if any of the NDC’s in the central control database are contained within the third-party database and, if not, transferring the associated NDC’s not in the third-party database and that exist in the central control database for each of the venom derived allergens to the third-party database in association with the AWP and associated information for each of the venom derived allergens for each of the NDC’s, and uniquely associating each of the NDC’s in the third-party database to the central control center for adjudication information, and creating an adjudicating database at the central control center having defined benefits associated with reimbursable entities for each of the NDC’s stored in the third-party database and in the central control database in association with the translation information for each of the NDC-carrying venom derived antigens, wherein a pharmacist can access this information by accessing a particular NDC in the third-party database to obtain information regarding reimbursable benefits from the central control center and enter the diluted level and number of doses and a claim with the central control center for adjudication of the amount of base concentrate venom derived antigen used and wherein the central control center is able to process any claim made by the pharmacist and reimburse the pharmacist accordingly for the base concentrate venom derived antigen used to provide the desired diluted level and number of doses of the desired NDC carrying venom derived antigen.”

The claims supplied by the inventors are:

“1. A method for adjudicating reimbursement for allergens, the method comprising: diluting a plurality of allergens, wherein each of the plurality of allergens is diluted by the steps of: extracting a defined amount of concentrated allergen extract from a container of concentrated allergen extract and disposing it within a first one of a plurality of sterile containers containing a dilutant, to provide a first dilution level, wherein each of the plurality of sterile containers is associated with a different dilution level, extracting a defined amount of diluted allergen from the first one of the sterile containers and disposing it within a second one of the sterile containers to provide a second dilution level, and progressively extracting a defined amount of diluted allergens from a previous one of the sterile containers to a next thereof containing a dilutant to provide progressively more diluted levels until a last of the sterile containers containing a final dilution level, to provide a plurality of defined concentration levels of diluted allergens, and obtaining, at a central control center, National Drug Codes (NDCs) for the plurality of allergens each at one of the plurality of defined concentration levels of diluted allergens, each NDC uniquely identifying a particular allergen as to its manufacture, the particular allergen, packaging, and a defined concentration level of the particular allergen, and further obtaining information as to a description of the particular allergen, the defined concentration level of the particular allergen, and manufacturer of the particular allergen; determining, by the central control center, an Average Wholesale Price (AWP) for each of the allergens associated with one of the NDCs; storing, in a central control database, the NDCs in association with an associated Average Wholesale Price (AWP) and associated information for NDC-carrying allergens, which associated information allows practitioners to determine from a diluted level and number of doses of one of the NDC-carrying allergens and a known dilution procedure how to translate back to an amount of a base concentrate of the one of the NDC-carrying allergens used to create the diluted level and number of doses; accessing a third-party database accessible by a pharmacist and determining if any of the NDCs in the central control database are contained within the third-party database and, if not: transferring NDCs not in the third-party database and that exist in the central control database for each of the allergens to the third-party database with the associated AWP and associated information for each of the allergens for each of the NDCs, and uniquely associating each of the NDCs in the third-party database to the central control center for adjudication information; and creating an adjudicating database at the central control center having defined benefits associated with reimbursable entities for each of the NDCs stored in the third-party database and in the central control database in association with the associated information for each of the NDC-carrying allergens.

“2. The method of claim 1, wherein the base concentrate of the one of the NDC-carrying allergens is any concentration level that is too toxic for a patient to be exposed to.

“3. The method of claim 1, and further comprising the step of a physician creating a script defining a desired diluted level and a number of doses of at least one of the NDC-carrying allergens.

“4. The method of claim 3, wherein the script includes desired diluted levels to be included within each dose.

“5. The method of claim 3, wherein diluting the plurality of allergens is performed by a pharmacist, and includes diluting the at least one of the NDC-carrying allergens to the desired diluted level and the number of doses defined by the script.

“6. The method of claim 1, wherein the associated information includes a table of dilution levels of the one of the NDC-carrying allergens associated with a plurality of dilution procedures wherein each of the dilution levels defines the number of doses at the dilution level and, via the known dilution procedure, the amount of the base concentrate of the one of the NDC-carrying allergens required to yield the dilution level and the number of doses.

“7. The method of claim 6, wherein each of the NDC-carrying allergens is defined as being able to be distributed in discrete quantities, each of the discrete quantities associated with a starting level of an NDC-carrying allergen and each of the discrete quantities adjudicatable.

“8. The method of claim 1, further comprising determining, by the central control center, the associated AWP for each of the allergens associated with one of the NDCs based on the obtained information as to the description of the particular allergen, the defined concentration level of the particular allergen, and the manufacturer of the particular allergen.

“9. The method of claim 1, further comprising: generating a link in the third-party database associated with a particular NDC of one of the NDCs that directs to the adjudicating database to obtain information regarding reimbursable benefits from the central control center and enter the diluted level and the number of doses and a claim with the central control center for adjudication of the amount of the base concentrate of the NDC-carrying allergen of the one of the NDC’s, and wherein the central control center is able to process any claim made by a pharmacist and reimburse the pharmacist accordingly for the amount of the base concentrate of the NDC-carrying allergen used to provide the diluted level and number of doses of the NDC-carrying allergen.

“10. The method of claim 9, further comprising: defining, based on the generated link in the third-party database, the central control center as an owner and a provider of the particular NDC, wherein the generated link causes the central control center to be associated with each of the NDC’s for which a unique link is generated and causes the central control center to be automatically included in adjudication of the plurality of allergens.”

URL and more information on this patent application, see: PULITZER, Jovan Hutton; STRADER, James. Method For Repurposing Ndc Codes In A Pharmaceutical Database For Allergens. Filed December 21, 2020 and posted September 16, 2021. Patent URL: https://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220210287174%22.PGNR.&OS=DN/20210287174&RS=DN/20210287174

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