Non biologics - Development costs and timelines Opportunities and Challenges with Biologics Clinical Development of Biologics — how is it different? New clinical trials rules and its impact Current requirements of Indian Clinical Trial Application CTA and how this will change with the new clinical trial regulation Substantial amendments and non-substantial amendments Ethical considerations for clinical trials performed in children guideline compared with adults Influencing the best strategy for the different regulations across India and globally Key development for sponsors and investigators to insure if they meet regulatory necessities when performing multi-country clinical trials Conducting direct-to-patient trials using technologies, such as apps and wearables to report data and analyse current strategies and relevant regulations Assuring the efficacy and success of clinical trials — What is a best practice for working with regulatory agencies?
Such a study may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy. The analysis may focus only on the relative medical benefits and risks of each option, or it may also weigh both the costs and the benefits of those options.
In some cases, a given treatment may prove to be more effective clinically or more cost-effective for a broad range of patients, but frequently a key issue is determining which specific types of patients would benefit most from it. Complaint Any circumstance where a member expresses dissatisfaction about any aspect of a care or service within the managed care organization MCOwith a provider, or other members which does not rise to the level of a formal grievance.
Complaints are usually generated by a telephone call or inquiry that is generally the result of a misunderstanding or misinformation and may be resolved informally.
An unresolved complaint or a succession of related complaints may become a grievance. Compliance More accurately referred to as adherence. The ability of a patient to take his or her medication or follow a treatment protocol according to the directions for which it was prescribed; a patient taking the prescribed dose of medication at the prescribed frequency for the prescribed length of time.
Concurrent Review Review of a procedure or hospital admission done by a health care professional other than the one providing the care, during the same time frame that the care is provided.
Usually conducted during a hospital confinement to determine the appropriateness of hospital confinement and the medical necessity for continued stay.
Confidentiality The protection of individually identifiable information as required by state or federal law or by policy of the healthcare provider. Continuum of Care Clinical services provided during a single inpatient hospitalization or for multiple conditions over a lifetime.
It provides a basis for evaluating quality, cost, and utilization over the long term. A spectrum of health care options, ranging from limited care needs though tertiary care, which has become the focus for an integrated delivery system to provide the appropriate expertise for the patient without providing a more expensive setting than necessary.
Contract A legal agreement between a payer and a subscribing group or individual which specifies rates, performance covenants, the relationship among the parties, schedule of benefits and other pertinent conditions. The contract usually is limited to a month period and is subject to renewal thereafter.
Contracts are not required by statute or regulation, and less formal agreements may be made. Contract Provider Any hospital, physician, skilled nursing facility, extended care facility, individual, organization, or agency licensed that has a contractual arrangement with an insurer for the provision of services under an insurance contract.
Contract Year A period of twelve 12 consecutive months, commencing with each Anniversary Date. May or may not coincide with a calendar year. A drug used to improve complexion, or to enhance beauty. For example, the cost of establishing an immunization service might be compared with the total cost of medical care and lost productivity that will be eliminated as a result of more persons being immunized.
Cost-benefit analysis can also be applied to specific medical tests and treatments. The general set of financing arrangements whereby the consumer must pay out-of-pocket to receive care, either at the time of initiating care, or during the provision of health care services, or both. This includes deductibles, coinsurance and copayments, but not the share of the premium paid by the person enrolled.
See Co-Payment and Co-insurance. Cost Shifting The redistribution of payment sources. Typically, cost shifting occurs when a discount on provider services is obtained by one payer and the providers increase costs to another payer to make up the difference.
Cost-Effectiveness Usually considered as a ratio, the cost-effectiveness of a drug or procedure, for example, relates the cost of that drug or procedure to the health benefits resulting from it. In health terms, it is often expressed as the cost per year per life-year saved or as the cost per quality-adjusted life-year saved.
Coverage Gap Under Medicare Part D prescription drug coverage, the coverage gap is when Medicare temporarily stops paying for prescriptions.
Beneficiaries in the coverage gap are responsible for payment of the entire cost of medications. Also known as the donut or doughnut hole. Covered Benefit A medically necessary service that is specifically provided for under the provisions of an Evidence of Coverage.
A covered benefit must always be medically necessary, but not every medically necessary service is a covered benefit. For example, some elements of custodial or maintenance care which are excluded from coverage may be medically necessary, but are not covered.Gmail is email that's intuitive, efficient, and useful.
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Find stories, updates and expert opinion. AAPPO - American Association of Preferred Provider Organizations.
The leading national association of preferred provider organizations (PPOs) and affiliate organizations, and was established in to advance awareness of the benefits — greater access, choice and flexibility — that PPOs bring to American health care.
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