Claims for Patent: 8,666,778

Summary for Patent: 8,666,778

Title:	Systems and methods for processing requests for pharmaceuticals that require insurer preapproval
Abstract:	Systems, methods, and apparatus for managing patients in need of a predetermined pharmaceutical that requires preauthorization based upon patient clinical data are provided. Prescription information is obtained for each respective patient. Such information includes an identity of the patients and amounts of the pharmaceutical that has been prescribed to the patients. Further, clinical information associated with each patient is received. The clinical information one or more determinants that each contributes to providing a basis for authorizing or denying patient coverage for the pharmaceutical. At least one determinant in the one or more determinants is not a standardized code. Coverage for a patient for the predetermined pharmaceutical is requested by transmitting the prescription and clinical information to a specialty pharmaceutical distributor at a remote location. A grant or denial of coverage for the patient is then received from the remote location and stored in an electronic record associated with the patient.
Inventor(s):	Medvitz; Mark (Chester County, PA), Kumpf; Mike (Carroll County, MD)
Assignee:	MedImmune, LLC (Gaithersburg, MD)
Application Number:	13/895,088
Patent Claims:	1. A method for processing a request for a prescription for the specialty pharmaceutical palivizumab using software dedicated to processing requests for prescriptions solely for palivizumab, the method comprising: (A) obtaining with a user interface device of a provider system prescription information for palivizumab for a patient, the user interface device comprising a user input device and a display device, the software causing the display device to display an electronic form dedicated to receiving the prescription information solely for palivizumab, wherein the prescription information comprises a plurality of elements, the electronic form comprising blocks for receiving via the user input device elements comprising (i) information identifying the patient, and (ii) a prescription for an amount of palivizumab; (B) receiving with the user interface device patient clinical information, the software causing the display device to display an electronic form dedicated to receiving patient clinical information relevant to palivizumab, wherein the patient clinical information comprises a plurality of determinants which collectively assist in determining whether a patient is a good candidate for palivizumab and contribute to a basis for authorizing or denying coverage to said patient for palivizumab, the electronic form comprising at least five blocks for receiving via the user input device a corresponding at least five determinants from the group of determinants consisting of a gestational age of the patient, a weight of the patient, a categorical indication as to whether the patient has congenital heart disease, a categorical indication as to whether the patient has chronic respiratory disease arising in the perinatal period, a categorical indication as to whether the patient has a chronic pulmonary disease, a categorical indication as to whether the patient has a congenital anomaly of the respiratory system, and for at least one of said categorical indications, one or more additional determinants associated with the categorical indication; wherein at least one determinant is not a standardized code; (C) storing the prescription information and the patient clinical information in a non-transitory computer-readable medium; (D) requesting coverage for the patient for palivizumab by sending the prescription information and the patient clinical information from the provider system to a specialty pharmacy that is configured to use the prescription information and the patient clinical information to make a coverage decision as to whether to grant coverage to said patient for palivizumab, wherein said coverage decision made by the pharmacy is based upon (i) a set of guidelines provided by an insurer of the patient, (ii) the prescription information, and (iii) the patient clinical information; and (E) displaying with the display device the coverage decision made by the pharmacy. 2. The method of claim 1, wherein the electronic form dedicated to receiving patient clinical information relevant to palivizumab further comprises one or more blocks for receiving via the user input device at least one determinant comprising an indication of whether the patient spent time in a neonatal intensive care unit (NICU). 3. The method of claim 1, wherein the electronic form dedicated to receiving patient clinical information relevant to palivizumab comprises one or more blocks for receiving via the user input device at least one determinant associated with congenital heart disease, said associated determinant selected from the group of determinants consisting of (i) a categorical indication as to whether the patient has a moderate pulmonary hypertension or a severe pulmonary hypertension, (ii) an identity of a medication that is being given to the patient for the congenital heart disease, and (iii) a date when the medication for the congenital heart disease was administered to the patient. 4. The method of claim 1, wherein the electronic form dedicated to receiving patient clinical information relevant to palivizumab comprises one or more blocks for receiving via the user input device at least one determinant associated with chronic pulmonary disease, said associated determinant selected from the group of determinants consisting of (i) a categorical indication as to whether the patient receives supplemental oxygen, (ii) a categorical indication as to whether the patient receives a corticosteroid, (iii) a categorical indication as to whether the patient receives a diuretic, and (iv) a categorical indication as to whether the patient receives a bronchodilator. 5. The method of claim 1, wherein said coverage decision comprises determining an age of the patient from the patient clinical information or the prescription information and wherein coverage to said patient for palivizumab is denied when the patient is more than two years old. 6. The method of claim 1, wherein the electronic form dedicated to receiving patient clinical information relevant to palivizumab comprises one or more blocks for receiving via the user input device one or more risk factors selected from the group consisting of a categorical indication as to whether the patient has a school-age sibling, a categorical indication as to whether the patient has been subjected to an air pollutant, a categorical indication as to whether the patient attends day care, a categorical indication as to whether the patient has severe neuromuscular disease, a categorical indication as to whether the patient is subject to crowded living conditions, a categorical indication as to whether the patient had a birth weight of less than 2500 grams, a categorical indication as to whether the patient was part of a multiple birth, a categorical indication as to whether there is a history of asthma in the patient's family, a categorical indication as to whether the patient suffers from a congenital abnormality or airway, and a categorical indication as to whether the patient has been exposed to tobacco smoke. 7. The method of claim 1, wherein the electronic form dedicated to receiving patient clinical information relevant to palivizumab comprises five or more blocks for receiving via the user input device a corresponding five or more risk factors selected from the group consisting of a categorical indication as to whether the patient has a school-age sibling, a categorical indication as to whether the patient has been subjected to an air pollutant, a categorical indication as to whether the patient attends day care, a categorical indication as to whether the patient has severe neuromuscular disease, a categorical indication as to whether the patient is subject to crowded living conditions, a categorical indication as to whether the patient had a birth weight of less than 2500 grams, a categorical indication as to whether the patient was part of a multiple birth, a categorical indication as to whether there is a history of asthma in the patient's family, a categorical indication as to whether the patient suffers from a congenital abnormality or airway, and a categorical indication as to whether the patient has been exposed to tobacco smoke. 8. The method of claim 1, wherein the requesting (D) comprises sending the prescription information and the patient clinical information from the provider system to a remote computer associated with the pharmacy in a packet-based form over a wide area network or Internet. 9. The method of claim 8, wherein the prescription information and the clinical information is sent in a secure manner over the wide area network or Internet. 10. The method of claim 8, wherein the prescription information and the patient clinical information is sent using the Hypertext Transport Protocol over a secure socket layer. 11. The method of claim 1, wherein the requesting (D) comprises sending the prescription information and the patient clinical information to the pharmacy by FAX or email. 12. The method of claim 1, wherein the electronic form dedicated to receiving prescription information for palivizumab for the patient further includes one or more blocks for receiving via the user input device one or more insurance information elements selected from the group consisting of an identification of the primary insurer for the patient, a primary cardholder name, a primary cardholder social security number, a primary policy number, a primary insurer telephone number, a primary employer, a primary group number, an identification of a secondary insurer for the patient, a secondary cardholder name, a secondary cardholder social security number, a secondary policy number, a secondary insurer telephone number, a secondary employer, and a secondary group number. 13. The method of claim 1, wherein the electronic form dedicated to receiving prescription information for palivizumab for the patient further includes six or more blocks for receiving via the user input device a corresponding six or more insurance information elements selected from the group consisting of an identification of the primary insurer for the patient, a primary cardholder name, a primary cardholder social security number, a primary policy number, a primary insurer telephone number, a primary employer, a primary group number, an identification of a secondary insurer for the patient, a secondary cardholder name, a secondary cardholder social security number, a secondary policy number, a secondary insurer telephone number, a secondary employer, and a secondary group number. 14. The method of claim 1, wherein the requesting (D) is done without human intervention. 15. The method of claim 1, wherein each determinant is not a standardized code. 16. The method of claim 1, wherein the electronic form dedicated to receiving prescription information for palivizumab for the patient further includes a plurality of blocks for receiving via the user input device elements comprising (i) at least one element comprising palivizumab delivery instructions selected from the group of an indication as to whether delivery to be made to the patient's home or to a medical facility, name of agency providing a home visit, name of medical facility, and delivery address; and (ii) at least one element comprising palivizumab administration information selected from the group of an amount of palivizumab to be administered to the patient, whether epinephrine is to be administered to the patient, known allergies of the patient, one or more scheduled dates for administration of palivizumab, number of doses of palivizumab to be administered, and dates of completed administrations. 17. The method of claim 1, wherein the plurality of determinants collectively satisfies the requirements of a plurality of supported insurers for palivizumab. 18. The method of claim 1, wherein the combination of supplying patient clinical information together with a prescription request is outside of a standards-based e-prescribing system. 19. A non-transitory computer-readable medium storing a computer program product, executable by a computer comprising a user interface device having a user input device and a display device, to process a request for a prescription solely for the specialty pharmaceutical palivizumab, the computer program product comprising instructions for causing the computer to perform the steps of: (A) obtaining with the user interface device prescription information for palivizumab for a patient, the instructions causing the display device to display an electronic form dedicated to receiving the prescription information solely for palivizumab, wherein the prescription information comprises a plurality of elements, the electronic form comprising blocks for receiving via the user input device elements comprising (i) information identifying the patient, and (ii) a prescription for an amount of palivizumab; (B) receiving with the user interface device patient clinical information, the instructions causing the display device to display an electronic form dedicated to receiving the patient clinical information relevant to palivizumab, wherein the patient clinical information comprises a plurality of determinants which collectively assist in determining whether a patient is a good candidate for palivizumab and contribute to a basis for authorizing or denying coverage to said patient for palivizumab, the electronic form comprising at least five blocks for receiving via the user input device a corresponding at least five determinants from the group of determinants consisting of a gestational age of the patient, a weight of the patient, a categorical indication as to whether the patient has congenital heart disease, a categorical indication as to whether the patient has chronic respiratory disease arising in the perinatal period, a categorical indication as to whether the patient has a chronic pulmonary disease, a categorical indication as to whether the patient has a congenital anomaly of the respiratory system, and for at least one of said categorical indications, one or more additional determinants associated with the categorical indication; wherein at least one determinant is not a standardized code; (C) storing the prescription information and the patient clinical information in a non-transitory computer-readable medium; (D) requesting approval for the patient for palivizumab by sending the prescription information and the patient clinical information from the computer to a specialty pharmacy that is configured to use the prescription information and the patient clinical information to make a coverage decision as to whether to grant coverage to said patient for palivizumab, wherein said coverage decision made by the pharmacy is based upon (i) a set of guidelines provided by an insurer of the patient, (ii) the prescription information, and (iii) the patient clinical information; and (E) displaying with the display device the coverage decision made by the pharmacy. 20. An apparatus for processing a request for a prescription for the specialty pharmaceutical palivizumab that requires preauthorization based upon clinical data of a patient, the apparatus comprising: a user interface device comprising a user input device and a display device; a processor coupled to the user interface device; and a memory, coupled to the processor, the memory storing a module comprising instructions for causing the processor to perform the steps of: (A) obtaining with the user interface device prescription information for palivizumab for a patient, the instructions causing the display device to display an electronic form dedicated to receiving the prescription information solely for palivizumab, wherein the prescription information comprises a plurality of elements, the electronic form comprising blocks for receiving via the user input device elements comprising (i) information identifying the patient and (ii) a prescription for an amount of palivizumab; (B) receiving with the user interface device patient clinical information, the instructions causing the display device to display an electronic form dedicated to receiving the patient clinical information relevant to palivizumab wherein the patient clinical information comprises a plurality of determinants which collectively assist in determining whether a patient is a good candidate for palivizumab and contribute to a basis for authorizing or denying coverage to said patient for palivizumab, the electronic form comprising at least five blocks for receiving via the user input device a corresponding at least five determinants from the group of determinants consisting of a gestational age of the patient, a weight of the patient, a categorical indication as to whether the patient has congenital heart disease, a categorical indication as to whether the patient has chronic respiratory disease arising in the perinatal period, a categorical indication as to whether the patient has a chronic pulmonary disease, a categorical indication as to whether the patient has a congenital anomaly of the respiratory system, and for at least one of said categorical indications, one or more additional determinants associated with the categorical indication; wherein at least one determinant is not a standardized code; (C) storing the prescription information and the patient clinical information in a non-transitory computer-readable medium; (D) requesting approval for the patient for palivizumab by sending the prescription information and the patient clinical information from the apparatus to a specialty pharmacy that is configured to use the prescription information and the patient clinical information to make a coverage decision as to whether to grant coverage to said patient for palivizumab, wherein said coverage decision made by the pharmacy is based upon (i) a set of guidelines provided by an insurer of the patient, (ii) the prescription information, and (iii) the patient clinical information; and (E) displaying with the display device the coverage decision made by the pharmacy.

Details for Patent 8,666,778

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Swedish Orphan Biovitrum Ab (publ)	SYNAGIS	palivizumab	For Injection	103770	06/19/1998		2027-06-29
Swedish Orphan Biovitrum Ab (publ)	SYNAGIS	palivizumab	Injection	103770	07/23/2004		2027-06-29