Health Care Policy, Law and Ethic

As a Chief Nursing Officer, I’m responsible for one of the state’s largest Obstetric Health Care Centers. I just received word of some fraudulent behaviors in the center. To mitigate this type of behaviors I must evaluate how the healthcare Qui Tam affects health care organizations, provide four examples of Qui Tam cases that exist in a variety of health care organizations, Devise a procedure for admission into a health care facility that upholds the law about the required number of Medicare and Medicaid referrals, Recommend a corporate integrity program that will mitigate incidents of fraud and assess how the recommendation will impact issues of reproduction and birth, and Devise a plan to protect patient information that complies with all necessary laws. After completing my evaluation on Qui Tam I will be able to provide a proper protocol to handle or prevent future issue and grow awareness on how fraudulent behavior affects the health care center.

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Qui Tam is Latin for “he who brings a case on behalf of our lord King, as well as for himself”. Qui Tam allows a private citizen (relator, whistleblower) to bring a lawsuit on behalf of the government, as well as himself, against a defendant who may has knowingly committed fraud or criminal act in which the government was victimized (Showalter, 2012). The private citizen need not have been personally harmed by the defendant’s conduct (Department of the Interior Office of Inspector General, 2010). The government can choose to take over the prosecution, but if the government declines the private citizen can proceed alone. How Healthcare Qui Tam affects health care organizations.

Healthcare is a multi-billion dollar industry and has attracted those who want to defraud health insurance companies and the government (Showalter, 2012). Based on the healthcare industry monetary value it has become the fertile soil for white –collar crimes that end in criminal convictions and financial penalties (Showalter, 2012). The punishment for payment fraud and abuse is shared with the abuser and the organization. When an employee is involved in act of fraud and abuse management, officers as well as the organization is held accountable. They share in the punishment even if management, officers or the organization is aware of the abusers actions. . One way to minimize exposure to fraud and abuse is to have a strong corporate compliance program in place. Developing a strong compliance programs will ensure an organization’s adherence to federal and state regulations such as false claim act, anti-kickback statues, the Starks self-referral laws and HIPAA. Using government regulation as the bases of an organizations compliance program will help significantly in the effort to prevent fraud, abuse and waste within the organization (Showalter, 2012).

Healthcare Qui Tam along with state and government regulations has pushed organizations to develop new or stronger compliance programs in the hopes to prevent fraud, promote integrity and improve billing accuracy. Not only has it push health care organization to create compliance program to protect the company these policy also include process for an employee to anonymously report and undesirable conduct they may see. Companies have also created their own fraud and abuse compliance departments that are responsible for educating the staff of any federal and state regulations and created requirement for and standards each depart must to abide by. This department will also be responsible for the investigation of any reported behavior. These measures are put in place to prevent any possible fraud and abuse acts with in the organization. Examples of Qui Tam cases that exist in a variety of health care organizations. To remedy abuse associated with ghost billing, up coding, unbundling, and billing for inadequate or unnecessary care the government put in place the false claims act. During January 2009 through 2012 the justice department used the false claim act to recover more than 9.5 billion dollars in health care fraud cases. Below is an example of a False Claim Act Case.

Example of FCA
Nelson v. Alcon Laboratories, No. 3:12-cv-03738-M (N.D. Tex.)

•Complaint filed : September 14, 2012

•Complaint unsealed : July 16, 2013

•Intervention status : Declined

•Claims: False claims to Medicare, Medicaid, TRICARE and the federal defense procurement programs in violation of the Civil False Act (FCA), 31 U.S.C. § 3729 et seq. •Name of Relator: Michael Nelson and Steve Gonzales

• Defendant’s Business: Pharmaceutical manufacturer

•Relators’ Relationship to Defendant: Former employee

•Relators’ Counsel: Bell, Nunnally & Martin, LLP

•Summary of case: Alcon Laboratories allegedly failed to adhere to FDA regulations in manufacturing, packaging and delivering nonprescription and prescription eye care products sold to the U.S. government under Medicare, Medicaid, TRICARE, and other insurance programs held by a variety of military and federal employees and their dependents. Alcon even provide the eye care product to the U.S. Department of Defense

•Current status: The U.S. declined to intervene in the case: relator may proceed on their own

•Reason to Watch: This case was viewed similar to United States ex rel. Eckard v. GlaxoSmithKline and SB Pharmco Puerto Rico, which was settled in 2010. This case involved both civil and criminal allegation, but the focus was on failing to comply with the FDA’s regulations regarding manufacturing practices and product quality. This case resulted in a guilty from the defendant, a civil settlement of $600 million, and a criminal fine of $150 million.

Anti-Kickback Statue is a criminal statute that prohibits the exchange or offer of an exchange, of any value or form, in the efforts to induce or reward the referral of federal health care program business. This statue was creates to establish penalties for individual and entities on both sides of the prohibited exchange. If convicted the violator can be fined up to 25,000 and sentenced up to five years. In lieu of the fine and the jail time the violator(s) can be excluded from participating in federal health care programs. Listed below is an example of an anti-kickback statue case.

Example of AKS

United States ex rel. Nevyas v. Allergan, Inc., No. 2:09cv432 (E.D. Pa).

•Complaint Filed: January 30, 2009 ( Second Amendment Complaint Filed September 27, 2010)

• Complaint Unsealed: December 16, 2013

•Intervention Status: Unclear from docket

• Claims: The relators assert that the defendant caused the submission of claims for payment for prescription drugs induced by illegal kickbacks in violation of the FCA, as well as analogous false claims statutes of 19 states and the District of Columbia

•Relators’ Names: Herbert J. Nevyas.;
Anita Nevyas-Wallace, M.D.

• Defendant’s Business: The defendant is an international biopharmaceutical company •Relators’ Counsel: Pietragallo, Gordon, Alfano,Bosick& Raspanti LLP (Philadelphia, Pa)

•Relators’ Relationship to Defendant: The relators are third party physicians who claim they were offered the alleged inducements by the defendant.

• Current Status: Ongoing

•Summary of Case: The relators allege the defendant violated the Anti-Kickback Statues buy offering ophthalmologists and optometrists to prescribe the defendant’s exclusive chronic dry-eye prescription drug Retasis®. According to the defendant Allergan offer free consulting services, free acesss to a restricted website, invitation to and payment of expenses related to advisory board meetings and offers to fund independent research.

•Reason to Watch: The defendant entered into a five year Corporate Integrity Agreement with the Department of Health and Human Services, Office of Inspector General in connection with a settlement of an unrelated criminal investigation and Qui Tam action. Some of the conducted listed in this case may have occurred while the defendant CIA was in place. Also point out possible compliance issues for pharmaceutical companies seeking to grow their business through relationship with physicians (Abhar, Grammel, McGinty, & Willis, 2014) Example of billing for unnecessary services and ghost billing United States ex rel. Fife v. Lymphedema and Wound Institute, Inc., Civ. No. 04:11-CV-271 (S.D. Tex.).

•Complaint Filed: September 22, 2011

•Complaint Unsealed: November 25, 2013

•Intervention Status: The United States intervened.

•Claims: Defendants allegedly submitted false claims for treatment of lymphedema •Name of Relator: Dr. Caroline Fife

•Defendants’ Businesses: The individual defendants are the executives and owners of the defendant company and its affiliates, whose employees provide physical therapy and treatment for lymphatic disease. The individual defendants also managed and operated a network of sleep-study clinics.

•Relator’s Relationship to Defendants: Relator is a competing physician and professor at the University of Texas who often treated patients who had stopped receiving treatments from defendants’ facilities. •Relator’s Counsel: Ahmad, Zavitsanos, Anaipakos, Alavi & Mensing P.C. (Houston, TX)

•Summary of Case: The Relator alleged that the defendant provider used unqualified massage therapist to provide services to their lymphedema patients. Also according to the relator the defendant bill for unnecessary services as well as services and supplies that were never rendered. Lastly, the relator alleged the defendant used similar scheme to inflate billing services that were rendered at their sleep clinic.

•Current Status: The parties settled the claims related to lymphedema treatments for $4.3 million. Additionally, the defendant company’s founder and CEO voluntarily submitted to a 10-year exclusion from federal health benefit programs and the defendant company entered into a five-year Corporate Integrity Agreement (CIA) as of June 25, 2013 (Abhar, Grammel, McGinty, & Willis, 2014).

•Reasons to Watch: Although the amount of the settlement — $4.3 million — is relatively modest when compared with the $165 million in fraudulent Medicare billings alleged in the complaint, the voluntary exclusion of the defendant company’s CEO from participation in federal health care programs is severe, as an excluded individual will likely find it difficult to continue working in the health care industry (Abhar, Grammel, McGinty, & Willis, 2014).

Example of up-coding

United States ex rel. Oughatiyan v. IPC The Hospitalist Company Inc., Civ. No. 09-C-5418 (N.D. Ill.). •Complaint Filed: September 1, 2009

•Complaint Unsealed: December 5, 2013

•Intervention Status: The United States intervened, but Illinois and the other 12 plaintiff states declined to intervene

•Claims: Defendants allegedly encouraged the filling of up-coded claims for services in inpatient and long-term care facilities to federal care programs

•Name of Relator: Dr. Bijan Ouhatiyan

•Defendants’ Businesses: National hospitalist independent contractor company and its local subsidiaries “employing physicians and other health care providers who work in more than 1,300 facilities in 28 states.”1 Hospitalists are physicians who assist in directing and coordinating inpatient care from admission to discharge, and only work in hospitals or long-term care facilities (Abhar, Grammel, McGinty, & Willis, 2014).

•Relator’s Relationship to Defendants: Relator is a former employee/independent contractor of dependent.

•Relator’s Counsel: Goldberg Kohn Ltd. (Chicago, IL)

•Summary of Case: Relator alleges that IPC The Hospitalist Company (IPC) engaged in the following schemes to cause its employed hospitalists to bill for the services they rendered at the highest reimbursement levels even though such codes were inappropriate, a practice called “upcoding.” The lawsuit contends that IPC trained its physicians to bill at the highest levels without regard to the actual complexity of the services provided. Additionally, IPC allegedly tracked the coding statistics of its hospitalists and used the results to pressure hospitalists to upcode their services to achieve productivity and profit goals. As a result of these practices, according to the relator, the medical documentation of the actual work done did not support the billing records submitted by the hospitalists (Abhar, Grammel, McGinty, & Willis, 2014).

•Current Status: Ongoing

•Reasons to Watch: The defendant has another case (United States ex rel. Ziaei v. IPC The Hospitalist Company Inc., et al., Civ. No. 2:12-cv-01918 (D. Nev.)) with similar allegation, but was dismissed. Our Facility admission Policy, which is in accordance with Medicare and Medicaid referral guidelines. Medicare and Medicare Referral guidelines are based on the Stark law. To prevent any issues or conduct that violates the Stark law our facility will participate in CMS Provider Enrollment, Chain and Ownership System (PECOS). We will require all qualifying providers to register their NPI with Medicare and Medicare by the deadline date. This system will allow us to submit claims, referral, and review for admittance. This program will catch any potential violations of abuse and fraud. The Physician Self -Referral law is listed below. “The Physician Self-Referral Law (Stark Law) (42 U.S.C. Section 1395nn) prohibits a physician from making a referral for certain designated health services to an entity in which the physician (or an immediate member of his or her family) has an ownership/investment interest or with which he or she has a compensation arrangement, unless an exception applies.

Penalties for physicians who violate the Physician Self-Referral Law (Stark Law) include fines as well as exclusion from participation in all Federal health care programs” Corporate integrity program that will reduce fraud and impact issues of reproduction and birth. A Corporate Integrity program is put in place to ensure the organization and the employees would not knowingly violate any laws that control the conduct of the organization operations. Staff will receive training regarding the health care center’s Corporate Integrity Program and all law associated with the program.

•Code of Conduct

Promote and Preserve the organization values
Protect the privacy of the Health care centers patients
Protect the confidentiality of the patient and the employee information o Avoid all forms of discrimination
Act in accordance of all policies and procedures
Comply will all law that apply to the health center operations and practices o Disclose all potential conflicts of interest
No accepting of gift, goods and services
Adhere to all professional standard
Ensure consent for service is received and documented
Refusal for services are document
Patient is informed/education of risk and requires treat for their condition •Submission of claims only for services
That are actually for service renders
For services that the patient or patient represented consented to oFor services that are medical necessary for the patient condition That have appropriate documentation to support the claim

All services will be reviewed before billing
All billing staff will be trained and certified
No claim will be submitted that fall under the Physician Self-Referral law or Anti- Kickback statues Plan to protect patient information that complies with all necessary laws As one of the state’s largest Obstetric Health Care Centers in the area we have an extensive staff. The first policy is to provide excess to patient information that is in the scope of your job. For example the registration staff will not have access to the patient’s lab results and the lab technician will not have access to member complete medical history. When a staff member signs on to any system that houses patient information they will only be able to view or update information that is within the scope of the job responsibility. This way the patient private medical records are kept private. Education, training and yearly certification of Health Insurance Portability Act and the organization privacy policy will be required fall all staff members. Certification will only be provided to those that achieve at least an 80% on any test that is provided in training. Failure to comply will result in suspicion until certified or termination. For existing employees yearly certification will be done throughout web base training portal.

For our new employees training and certification will be part of their new hire orientation and any future required Training will be done through our train portal. The staff can access the training portal at home. This way our staff and complete the certification at the leisure (with in the due date). Also we have the proper process in place to such as authorization and de-identifying Protection Health Information when share and medical or any sensitive information with others. For example there maybe reason why a department must share the type of patient seen or the treatment provided. There should be not reason that patient’s name, address, or any information that may identify the patient be included in the report. We also require the patient to sign an authorization for every year, which will allow us to submit information to insurance companies for payment, medical necessity review, and appeals. We will also have the patient to sign an authorization form allowing us to speak with a specific individual, leave voice mail massages and or email the member about appointment and care. Any unauthorized disclosure of private health information the patient will be notified right away.

Various federal and state laws, regulations, rules and guidelines govern the use, Disclosure and protection of health information. These include certain provisions of the Health Insurance Portability and Accountability Act (HIPAA), certain provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act, the Confidentiality of Medical Information Act (CMIA), and any other patient privacy-related laws, regulations, rules and guidelines will be used as the bases of our privacy policies

Department of Health and Human Services. (November, 27 2013). Physician sefl Referral: CMS. Retrieved 15 2014, March, from Center of Medicare & Medicaid Services: Abhar, S., Grammel, S., McGinty, K., & Willis, S. (2014, February). Qui Tam Defense: MintzLevin. Retrieved March 16, 2014, from MintzLevin: Department of the Interior Office of Inspector General. (2010, October 6). False claim Act: office of Inspector General. Retrieved March 15, 2014, from Department of The Interior Office of Inspector General: Abhar, S., Grammel, S., McGinty, K., & Willis, S. (2014, February). Qui Tam Defense: MintzLevin. Retrieved March 16, 2014, from MintzLevin: Department of the Interior Office of Inspector General. (2010, October 6). False claim Act: office of Inspector General. Retrieved March 15, 2014, from Department of The Interior Office of Inspector General: Dunphy, B. P., Kingsbury, S. P., Miner, T. A., Foster, H. S., & Willis, S. D. (2012). Health Care enforcement : 2012 Trends . MintzLevin. Gumbert, J. G. (2003). Qui TamActions Under the False Claims Act. Medical Journal – Houston. Levine, R. H. (2005). Internal Investigations By Healthcare Organizations: Practical considerations. American Health Lawyers association. Showalter, J. S. (2012). The Law of Healthcare Adminstration (6th ed.). Chicago: Health Adminstration Press. Staman, J. (2013). Health Care fraud and Buse Laws affecting Medicare and Medicaid: An Overview. Congressional research Services report for Congress.

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