Reimbursement planning and distribution systems in U.S. biomedical healthcare

Biomedicine

Healthcare system in USA

The health care system in the United States of America is a well established and structured system that aims at offering services to American citizens for the treatment and prevention of diseases, further more the system also seeks to promote mental and physical well being of its citizens. On a broader perspective the health care system in the U.S.A. can be defined as system concerned with where and how medical services are offered to America's citizens, secondly the system is concerned with medical expense and who pays for this and thirdly who offers these medical care services, for example, nurses, specialist physicians or primary care physicians.

Importance of knowing how to prepare healthcare system in the U.S.A.

The preparation of the healthcare system in the U.S.A. is a critical issue in the country because it is this system that's responsible for improving the overall health sector of the country, ensures good health to the Americans, provides affordable medical care and also the system is responsible for meeting the expectation of Americans in terms of health requirement and standards.

Distribution and payment flow for biomedical products

The distribution of biomedical products that are self administered is done through pharmacies who act as middlemen between biomedical wholesalers and patient, and the payment flow is through the patients to the retail outlets that include hospitals and pharmacies, from the retail outlet the payments get channeled to the wholesalers who are the biomedical product manufactures. Important to note about this distribution and payment flow is that pharmacies collects payments which are then given to insurance companies so as to get reimbursement for the biomedical product.

Another example of distribution and payment flow for biomedical products is the distribution of products to the patients through physician's office or hospital outpatient or inpatient; here payment is form the wholesaler to the biomedical product manufacturer.

Reimbursement planning activities

Reimbursement for products and services in the U.S. healthcare system consist of payment for supplies and services to the health facility and the payment for services provided by the physician, at times the reimbursement include payment for new products that will improve clinical services. Planning activities for reimbursement mostly commence at the product development stage when market assessment is being conducted, in this stage the three pillar of reimbursement that include coding, coverage and payment are addressed and a company can either seek assistance from reimbursement and regulatory experts or hire a professional reimbursement personnel who can be charged with responsibility of reimbursement planning activities. The planning activities first consider the targeted patient population and then develop strategy on how they can be reimbursed.

Reimbursement planning activities and pathway for in vitro diagnostics (IVDs)

The reimbursement planning activities for IVDs is similar to those of devices and infused drugs, whereby hospitals, laboratory services, physician's offices among other health providers who are primary purchasers of IVDs and reimbursement claims are made using code CPT or procedure code ICD-9. IVDs manufactures engage in reimbursement planning activities that includes; gathering relevant clinical data; collaborating with CMS groups to obtain coverage; Asses private payers so as to determine coverage cost; Identify applicable procedure codes; Identify the category for Medicare benefit; submit application for reimbursement and coverage level determination; await the determination done by either gap fill or cross-walk method and lastly work jointly with other payers of the targeted patient population.

Importance of knowing how to prepare CGMP regulatory compliance

Well developed current good manufacturing practices (CGMP) mainly aim at ensuring that only effective and safe products are allowed into the market. The CGMP regulatory compliance should cover manufacturing facilities and process it should also be applicable throughout the clinical studies stages. Well prepared CGMP regulations should include validation, sterility assurance, and the implementation of quality assurance program. Thus CGMP regulations on manufacturing process and controls cover personnel qualifications and training, sanitation, equipment verification, raw material acquisition, process validation, complaint handling, specification and quality control.

Management controls in Quality systems

Management controls in quality system can be done during the drug manufacturing process, by the management ensuring compliance in material acquisition, quality system, production system, laboratory system, packaging, facilities and equipment system.

The other way management controls quality system is in drug and diagnostic manufacture regulations. The CGMP regulations for biomedicine governs medical device manufacture and deign, and it seeks to ensure manufacture keep into consideration necessary measures so as to maintain reliability and safety of devices they make for patients.

Technical complexity vs. Trade secrets, IP concerns

Intellectual property or IP concern describes set of rights that are commercially valuable and are obtained after formally registering literary works, inventions or other creative thoughts. Intellectual property include trade secrets, copyrights, patents and trademarks, copy rights are concerned with artistic expressions, trademarks cover good-will symbols of a business, patent on the other hand cover inventions, designs or discoveries while trade secrets are "know-how" protected as long as they remain secrets.

Trade secrets are not spelt out in the detailed manufacturing process of products so as to gain commercial value or competitive advantage, and a common example of such a trade secret is Coca-Cola products formula. During development of a medicinal drug companies may usually publish the drug crystal structure but they will intentionally leave out the multiple structures that can help in complete understanding of how the drug has been developed, hence this unpublished part becomes a trade secret or know-how.

There has been technical complexity in maintain trade secrets due to the evolving technological advancement mostly in the field of medical devices or biotechnology, however biopharmaceutical companies keep trade secrets by only disclosing the Know-how to FDA fillings only.