3.4 Suppliers And Labor

Erica Lindsay, PharmD, MBA, JD, is a health care attorney practicing in the greater Chicagoland area. She has worked in pharmacy management and compliance for more than 15 years. Dr. Lindsay consults clients through complex pharmacy regulations and guidelines, including 340B, Medicare and Medicaid billing, and HIPAA compliance. She is on faculty of PharmCon providing instruction on pharmacy legal and regulatory issues. Dr. Lindsay is active in various organizations including the American Bar Association where she is Vice of the Nursing and Allied Healthcare Professionals Task Force and members of the Health Care Compliance Association, Cook County Bar Association, and the Chicago Bar Association. She is a graduate of Florida A&M University

A compliance program is a process or system that finds all consumer laws and guarantees that have breached (refer to part A).

The twenty-first century has seen pharmaceutical companies grow in unprecedented size and strength. Due to the unprecedented growth the larger pharmaceutical companies have gained leverage and power in the prescription drug industry, but they lack innovation to market and they seek ways to help the business continue to increase its profits. The pharmaceutical industry was once ethically sound and was a valuable player in the development of human health. However, overtime with the lack of innovation pharmaceutical companies are becoming an unethical market that exploits patients, doctors and anyone else it can to increase its profitability. With eyes only on profitability this can create a hazard for patients because there

The advancement of these types of compliance plan guidance’s is established on our trust that a health care professional can use internally restraint to more proficiently observe adherence to appropriate decrees, regulations and plan requirements. Foundations for an Effective Compliance Program: This compliance guidance for physician practices includes features that the OIG has persisted to be the foundation for an effective compliance program:

Effective healthcare organizations routinely monitor and audit compliance performance. The processes ensure that the organization complies with regulations and uncovers compliance risks.

The purpose of this assignment is to review the factual content of and critically reflect upon the legal compliance considerations of eight major areas including, the Joint Commission, HIPAA/HITECH, Health Finances, Revenue Cycles, Medicare Recovery Audit Contractors, OIG work plan, OIG Corporate Integrity Agreement (CIA), the False Claims Act, and compliance and Provider Self Disclosure Protocol. These key elements have been provided by the GRC software Compliance 360 webpage.

Compliance programs are more focused on risk management. The duties include informing staff about the laws and guidelines regulating the business and monitoring adherence to these policies (Nelson, 2012). (Nelson, 2012) By monitoring compliant behavior the programs reduce the episodes of litigation, negative press, loss of support, and confidence from the public(Nelson, 2012).

Summary: In terms of total sales, Pfizer is the world’s largest pharmaceutical company that creates products that serve approximately 150 million people worldwide and sales of approximately $50 billion in 2009. Formed in 1849 as a chemicals business, it has realigned itself to become the world’s leading research based pharmaceutical company and has produced drugs such as penicillin, Lipitor, Viagra, Detrol, and Geodon and thousands of others throughout its history. Focused now on expanding its international offerings, it looks to China, India, and Russia as high potential markets. In addition to human pharmaceuticals, Pfizer has diversified into the animal pharmaceutical market that has augmented sales and profitability to

After reviewing the Office of Inspector General (OIG) Supplemental Compliance Guidelines for Hospitals I have found that there is great purpose for a compliance document in a healthcare facility. The purpose of this document in a healthcare facility is to be able to act as a guideline for healthcare facilities to consider, develop, and implement a compliance plan that meets federal regulations. Healthcare facilities have these compliance documents to help to cover and verify all that all services ordered for a patient were reasonable and necessary services for the patient to be treated accordingly and without fail. These compliance documents need to be retained to reflect that the healthcare facility’s efforts comply with Federal health care

Hi Kimberly, I agree with you. In the past, physicians may choose a drug or device product based on the potential profit. The federal government designed the Anti-Kickback law to fight against fraud and abuse. In addition, it helps identify a valid reason for the payment exchange between the pharmaceutical company and the physician.

To assist in the prevention of errors, abuse and fraud in healthcare, the Federal OIG (the Office of Inspector General) and Medicare respectively publish the Compliance Program Guidance for Individual and Small Group Physician Practices and the Medicare Carrier’s Manual. In order to stay in federal compliance and prevent errors or worse, is it beneficial to be familiar with these documents. In a large company, while the Medical Office Specialist is the person that must be familiar to with the Medicare website this person is also the designated Compliance Officer and is responsible for providing the information on rules and guidance to the coders. To contact your medical office specialist, please refer to the company website or phone directory for your division. Remember, the federal government is not forgiving on errors when your response is ‘I don’t know’.

Big Pharma has not had much say whether or not their ethics code would change. The pharmaceutical industry is getting a major overhaul of their sales and marketing strategies. The International Federation of Pharmaceutical Manufacturers &Associations (IFPMA), started their changes by adding into their code of ethics and by vowing to publicize all names of companies that wrongfully market their products. According to an article in Medicine, Health Care, and Philosophy, Badcott (2013) states, “Under the international group's newly revised code of ethics, pharmaceutical representatives cannot lavish expensive gifts on doctors to influence prescribing practices. Still permitted are lesser gifts such as pens or stethescopes.” In order for a code of ethics to be effective there must be repercussions when the rules are broken. This seems to be the main issue that Big Pharma is having trouble with. They made the change in policy, but who is enforcing it? An ethical code is not useful if they are not effectively implemented and communicated. Badcott (2014) goes on to say, “While PhRMA has no rule to punish violators, the IFPMA pledges to immediately post information about incidents-including the name of the company involved-on its Web site.” While public shaming is a step in the right direction for holding the industry accountable, is it enough to make a difference? The reaction of the industry to stakeholder concerns is what will have the greatest

They are not obligated to provide these drugs to countries who cannot afford it. This is centered around the viewpoints of the Libertarian. Libertarians believe that they do not have to perform acts that are beneficial to others and their ideas/thoughts are more self-centered (Shaw & Berry, 2013, 115-118). Thus, supporting the idea that companies do not have to make drugs available in poor countries at little or no cost. These companies made their own profit selling and distributing drugs. Being that they made their own money and did not violate any laws, there is no sense of obligation to provide such drugs in poor

Over the past couple of decades, a sudden change has started to take over the way business is done. The time when no rules applied, and anyone could do what they pleased at the cost of others or the environment is rapidly ending. Instead, companies today have become aware that it is essential for them to employ ethics and morality in their actions, if not they will be heavily scrutinized and rejected by the public. This way of thinking also applies to the pharmaceutical industry, which over the past century has been rapidly expanding. Do to the fact that this industry can determine the health and lives of millions of people, it is imperative that this industry follow an ethical and moral path.

For CVS’s legal concern, not only do they have to follow federal and state guideline for employees, they have to follow federal guidelines for pharmaceuticals, legal requirements for their nurses, doctors and pharmacist. In addition CVS is expanding into global markets, and that opens them up to foreign legal requirements. Socially, CVS Caremark has a long-standing track record of sound corporate governance and stands firmly committed to acting with integrity and holding