Claims submissions

It is possible to access point-of-service (POS) benefit validation, eligibility verification, and pricing information and claims submission data when drug benefits are separate. 

Direct claim. The plan member pays for the prescription at the pharmacy, then submits a claim form for reimbursement. This was the most common method before the use of electronic claim submissions. Discount prescription card system. Plan members are issued a card or coverage document to be presented at the pharmacy when a prescription is filled. The member pays 100% of the negotiated discormt-ed cost of the prescription. This method has become more popular with Medicare eligible patients who do not currently have prescription drug coverage, but join or purchase a card program from a third-party organizahon such as AARP or the manufacturer. 

Efficacy Supplement = submissions for such changes as a new indication or dosage regimen for an approved product, a comparative efficacy claim naming another product, or a significant alteration in the patient population e.g., prescription to Over-The-Counter switch ... 

The FDA evaluates each tumor marker test against its own labeling claims as to how well it performs and compares it with other cleared and marketed devices identified in the 510(k) submission. The intended use claim for monitoring must be supported by valid scientific and clinical data. Labeling a tumor marker test for a particular claim can mean that the testing system may have to show supporting data for that claim. For example, a tumor marker proposed for a monitoring claim will require laboratory and clinical data to support that claim (4,5). 

One additional strategic issue must be recognized in drug development. Submission of data to support the use of a medicine response test must be coordinated with the submission of the application for marketing of the medicine. In the U.S., both centers are under the umbrella of the FDA, but this is not necessarily true in all countries. The timing of these submissions is critical to ensure that the test will be available at the time of the approval of the drug. Furthermore, as mentioned above, for maximum efficiency in the approval of subsequent test improvements, DNA samples of patients whose data support the claims for the medicine response test need to be maintained according to GLP. 

Tier I review A focused administrative but nonscientific labeling review of submissions for low-risk products. This type of review would include no evaluation of data to substantiate product performance claims. 

After its submission to a patent office, the patent application is briefly reviewed and, if all the required information is provided, a formal filing date is issued. A detailed examination of the patent will then be undertaken by patent office experts, whose assessment will be based upon the four main criteria previously outlined. A report is subsequently issued accepting or rejecting the patent claim. The applicant is given the opportunity to reply, or modify the patent and resubmit it for further evaluation. In some cases, two or three such cycles may be undertaken before the patent is granted (or perhaps finally rejected). 

NDA) approvals. Since 1991, the FDA has persistently approved 70-80% of all NDAs submitted. Although the quality bar at the FDA has clearly been raised as clinical standards of care have improved, FDA is certainly not as much of a bottleneck as critics claim. The reason is that prior to deciding on an NDA submission, the pharma industry itself looks very carefully at the approvability of a developmental drug. 

Under the act, a dietary supplement manufacturer is required to make certain submissions or notifications to the FDA only when specific health claims are made for the product. And the primary responsibility for the safety of the supplement rests with the product manufacturer any required regulatory submissions can be made up to 30 days after the supplements are already available for sale to the general public. There are also no regulatory restrictions on the serving size a manufacturer chooses for the supplement, nor on the amount of included active ingredients. As such, the potency and dosage of creatine supplements may vary widely from manufacturer to manufacturer. 

Item 7 also requires submission of either a claim of categorical exclusion from the requirement to submit an environmental assessment or an environmental assessment [21 CFR 25.15(a)], When... 

If the patent information described in subsection (b) could not be filed with the submission of an application under subsection (b) because the application was filed before the patent information was required under subsection (b) or a patent was issued after the application was approved under such subsection, the holder of an approved application shall file with the Secretary, the patent number and the expiration date of any patent which claims the drug for which the application was submitted or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug. If the holder of an approved application could not file patent information under subsection (b) because it was not required at the time the application was approved, the holder shall file such information under this subsection not later than 30 days after the date of the enactment of this sentence, and if the holder of an approved application could not file patent information under subsection (b) because no patent had been issued when an application was filed or approved, the holder shall file such information under this subsection not later than 30 days after the date the patent involved is issued. Upon the submission of patent information under this subsection, the Secretary shall publish it. 

If drugs are not approved for lack of evidence to support safety, efficacy, or quality claims, Health Canada will not grant a marketing authorization for the drug however, the sponsor has the opportunity to offer additional supporting data and resubmit the submission at a later date. 

Improprieties of authorship. Giving credit improperly or not giving credit at all in published materials. Publishing the same results in more than one place and claiming that each is an exclusively published report. Listing as authors individuals who have not made a definite contribution to the work published. Submission of multiau-thored manuscripts to publishers without the agreement of all authors on the content of the text. 

Any submission requiring action by the FDA must include either an environmental assessment (EA) or a claim of categorical exclusion from the requirement for an EA. INDs are frequently submitted with a request for categorical exclusion from EA, since they generally involve relatively small amounts of drug and treatment of a limited number of recipients such that the environmental exposure is usually low. 

The requirements for the format and content of the IND application, as well as the requirements governing the use of the IND, are provided in Title 21 of the Code of Federal Regulations (21 CFR), Section 312. Unlike an NDA, the FDA does not formally approve an IND submission. If the FDA reviewers believe that the proposed clinical trial(s) submitted in the IND are acceptable from a safety and risk versus benefit viewpoint, the IND is in effect, and the compound that is the subject of that IND may be shipped in interstate commerce for the purpose of conducting specific clinical trials. Drugs shipped under an IND have specific labeling requirements, and false or misleading statements, as well as any claims regarding safety and efficacy, are prohibited. 

After submission to a patent office, the file is examined for some basic formal requirements and, if adequate, is given a filing date. A first indication about the chances of a patent application may be obtained from a search report which is issued by the European Patent Office and also for international patent applications under the Patent Cooperation Treaty (see below). In most cases, the search report will list a number of earlier patents or publications and indicate whether these interfere with the proposed claims of the examined file. As a consequence of the search report the applicant can amend the proposed claims before the examination is initiated. 

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