Pfizer is one of the world’s largest pharmaceutical companies. "Pfizer’s purpose is helping people live longer, healthier, happier lives. The route to that purpose is through discovering and developing breakthrough medicines; providing information on prevention, wellness, and treatment; consistent high-quality manufacturing of medicines, consumer products; and global leadership in corporate responsibility" (Pfizer, 2007). On a day to day basis appropriate access to patient-related data for drug development and marketing efforts is critical (Pfizer, 2004, p.1). Pfizer may obtain and use personal data from patients through coupon programs, health fairs or clinical trials. In any instance, Pfizer must be sure the data is aggregated and de-identified, or have the individual’s consent (Pfizer, 2004, p. 1). Pfizer has carefully developed guidelines to combat federal and state laws and regulations. As the law evolves, Pfizer appropriately adjusts the guidelines. When a consumer is asked to provide personally identifiable information, the consumer must be given an option to decline. "All coupon programs and rebate offers must contain appropriate privacy language and conform to Pfizer’s consent requirements" (Pfizer, 2004, p. 6). Physicians must "obtain patients’ permission before Pfizer personnel may be allowed to observe any consultation, examination and/or treatment" (Pfizer, 2004). "A doctor who provides disease screening services may suggest a treatment based on screening results, but cannot prescribe a specific drug or treatment" (Pfizer, 2004, p. 9). The doctor can encourage the participant to give the results to his/her own healthcare provider. In short, no patients’ personal information can be used for any purpose without his/her explicit consent. Tenet Healthcare Corporation "Tenet Healthcare Corporation, through its subsidiaries, owns and operates acute care hospitals and related health care services" (Tenet, 2007) "On September 27, 2006, Tenet Healthcare Corporation signed an annual update of its ongoing corporate integrity agreement (CIA) with the Office of Inspector General (OIG)" (Jones, 2007, p. 7). Tenet, as are many other healthcare organizations, is faced with “inadequate medical record documentation; poorly executed patient informed consent; inadequate patient education; poor physician-patient communication; lack of medical necessity for performed medical services; and improper performance of medical services” (Jones, 2007, p. 8). As a part of the CIA, Tenet has agreed to measures such as “a clinical quality department, including a chief medical officer, senior officers, and clinical quality staff; clinical audits; physician credentialing; physician privileging; physician peer review; evidence-based medicine programs; standards of clinical excellence; utilization management and review; quality metrics; and other quality improvement measures” (Jones, 2007, p.
Phiprivacy.net. (n.d.). Incidents Involving Patient or Health-Related Data [Pdf file of privacy breach articles for 2008]. Retrieved from http://www.phiprivacy.net/MedicalPrivacy/Chronology_2008.pdf
State and federal regulations, national accreditation standards, and clinical practice standards are created, and updated regularly. In addition, to these regulations, OIG publishes a compliance work plan annually that focuses on protecting the integrity of the program, and prevention of fraud and abuse. The Office of the Inspector General examines quality‐of‐care issues in nursing facilities, organizations, community‐based settings and occurrences in which the programs may have been billed for medically unnecessary services. The Office of the Inspector General’s work plan for the fiscal year 2011 highlights five areas of investigation for acute care hospitals. Reliability of hospital-reported quality measure data, hospital readmissions, hospital admissions with conditions
The Texas Medical Institute of Technology, through programs such as Chasing Zero, is bringing a public voice to the issue of healthcare harm. The documentary is a stirring example of the quality issues facing the healthcare system. In 2003, the NQF first introduced the 30 Safe Practices for Better Healthcare, which it hoped all hospitals would adopt (National Quality Forum, 2010). Today the list has grown to 34, yet the number of preventable healthcare harm events continues to rise. The lack of standardization and mandates which require the reporting of events contributes to the absence of meaningful improvement. Perhaps through initiatives such as those developed by TMIT and the vivid and arresting patient stories such as Chasing Zero, change will soon be at hand.
... Health Information Privacy For Consumers. Retrieved April 22, 2009, from U. S. Department of Health and Human Services: http://www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/index.html
In the United States, healthcare fraud and abuse are significant factor associated with increasing health care costs. It is estimated that federal government spends billions of dollars on the health care cost (Edwards & DeHaven, 2009). Despite the seriousness of fraud and abuse offenses, increasing numbers of healthcare providers are seeking new and more profitable ways to build business relationships. These relationships include hospital mergers, hospital-physician joint ventures, and different types of hospital-affiliated physician networks to cover the rising cost of health care (Showalter, 2007, p 111-114). When these types of arrangements are made, legal issues surrounding the relationship often raise. There are five important Federal fraud and abuse laws that apply to the relationship and to physicians are the False Claims Act (FCA), the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (Stark law), the Exclusion Authorities, and the Civil Monetary Penalties Law (CMPL) and (Office of Inspector General (OIG), 2010). Out of five most important laws that apply to the relationship and the physicians, we are going to focus on the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (Stark law).
Background: Merck & Co. is an American pharmaceutical company and one of the largest pharmaceutical companies in the world. In 1971 the United States approved the use of an MMR vaccine made by Merck, containing the Jeryl Lynn strain of mumps vaccine. In 1978 Merck introduced the MMR II, using a different strain of the rubella vaccine. In 1997 the FDA required Merck to conduct effectiveness testing of MMRII. Initially it was over 95%; to continue the license; Merck had to convince the FDA that the effectiveness stayed at a similar rate over the years.
Researchers who conduct interventional clinical research have put into question the Privacy Rule and how it will affect their research activities. The Department of Health and Human Services, Food and Drug Administration and Protection of Human Subjects Regulations are advised to take measures to protect the
Health Care Fraud and Abuse Control Program. (2003). Annual Report For FY 2002. Office of the Inspector General, U.S. Department of Health and Human Services website. Retrieved May 26, 2011, from http://oig.hhs.gov/publications/docs/hcfac/HCFAC%20Annual%20Report%20FY%202002.htm.
While working seemingly endless days, many nurses do not realize the many influences that affect their professional practice or how client care is delivered. Besides their employer, health care organizations are highly regulated by federal, state, and local laws and regulations. In addition to the rules set by governments, most medical establishments want to be accredited by The Joint Commission (TJC), a non-government regulatory agency. TJC does not have the authority to cite or fine a facility for not meeting standards or responding to its custodian alerts (The Joint Commission, 2011). However, these standards carry considerable weight through the loss of millions of dollars from Medicare and Medicaid programs.
While the patient’s personal health history is very important to provide information about their allergies, prescriptions, over-the-counter drug use, alcohol or tobacco use, and social drugs it is most effective to obtain the multi-generational health history (Lilley, Snyder, and Collins, 2016). Multi-generational
...icare patients. Help put an end to healthcare fraud by identifying, reporting and preventing it from taking place.
Healthcare services have been on the rise for over 10 years now. According to a 2012 consumer alert, the industry provided $2.26 trillion in payments for more than four billion health insurance benefit claims in the year 2011(Fraud in Health Care). The bulk of the claims and the mainstream of fraud and abuse stem from the Medicare system professionals, who are knowledgeable about the process and persuade new clients into handing over their pertinent information in hopes of deception and illegitimate claims. Multiple and double billing, fraudulent prescriptions, are some of the major flaws in this organization that has made the healthcare services industry curdle. (AGHAEGBUNA, 2011) This is a non-violet crime and is often committed by very educated people including business people, hospital, doctors, and administrators.
The World Health Organization outlines 6 areas of quality that help shape our definition of what makes quality care. Those areas are; (1) Effective: using evidence bases practice to improve health outcomes based on needs of individuals and communities. (2) Efficient: healthcare that maximizes resources and minimizes waste. (3) Accessible: timely care that is provided in a setting where the skills and resources are appropriate for the medical need and is geographically reasonable. (4) Acceptable/Patient-Centered: healthcare that considers individual needs, preferences, and culture. (5) Equitable: healthcare quality that does not vary because of race, gender, ethnicity, geographical location, or socioeconomically status. (6) Safe: healthcare that minimizes harm and risks to patients. (Bengoa, 2006)
Laws and regulations state there are no exceptions to disclosing information of a patient without consent. If a patient gives consent to a family member the healthcare provider may devise a code to give family members so they may confirm their identity.
Understanding quality measurement is essential in improving quality. Teams need to be able to understand whether the changes being made are actually leading to improved care and improved outcomes. For data to have an impact on an improvement initiative, providers and staff must understand it, trust it, and use it. Health care organization must understand the measurement of quality provided by the Institute of Medicine (patient outcomes, patient satisfaction, compliance, efficiency, safe, timely, patient centered, and equitable. An organization cannot improve its performance if it does not know how it is performing. Measuring quality improvements is essential as it reflects the quality of care given by the providers and that by comparing performance