Logo financial-legal-forms_edited.jpg

 Compliance Policy

Genetic WellCare Life Association

GWCLA, is an organization of Professional Healthcare Advocates dedicated to Educating & Partnering with Physician and the Community all across Nation. We are Advocates Educating about the importance of Modernized Genetic Testing  by helping Communities Pre- qualify and receive the Cancer Genomic Test and Pharmacogenomics Test through their healthcare benefits and their physician,  along with a host of other Modernized Genetic Tests.  GWCLA, believes that by providing genetic screenings early, we can help save lives.


GWCLA, Business Model is to be compliant first, and to stay current with all CMS updates, to keep our Advocates informed.  We REQUIRE that ALL GWCLA  Advocates and corporate employees are HIPAA Certified and always adhere and comply responsibly to ALL federal, state regulatory authorities, EKRA (Eliminating Kickbacks and Recovery Act of 2018), CMS (Centers for Medicare and Medicaid Services) and Medicare at all times.


GWCLA, Training and our system have been designed to insure that every contact with physicians and clients is compliant and delivered with the utmost respect and sensitivity. Compliance is always KEY in every aspect of GWCLA.



The Medicare and Medicaid Patient Protection Act of 1987 is referred to as the Anti-kickback Statute.  The statute provides criminal penalties for certain acts impacting Medicare and Medicaid reimbursable services.  Particularly, the statute prohibits the offer or receipt of certain remuneration in return for referrals for or recommending the purchase of supplies and services reimbursable under government healthcare programs. Advocates CANNOT offer to give money back to individuals or physicians, EVER.
The Medicare anti-kickback statute prohibits (1) the willful solicitation or receipt of remuneration in return for referrals of Medicare patients for any service for which payment may be made in whole or in part under Medicare or a State health care program, and (2) the offer or payment of remuneration to induce such referrals.  Persons who violate the statute shall be guilty of a felony and upon conviction, shall be fined not more than $25,000 or imprisoned for not more than five years, or both. Thus, the Act explicitly prohibits any remuneration knowingly and willfully offered or paid to induce, or solicited or received in return for, Medicare or Medicaid patient referrals.
Most providers are aware that paying kickbacks for referrals is a felony under the Anti-kickback Statute (AKS), 42 U.S. Code § 1320a–7b (b)(1)1. You can get into very big financial trouble, and lose your license. Unlike Stark law, 42 U.S.C. 1395nn., which only applies to physician referrals, the AKS applies to remuneration paid to anyone for arranging in whole, or in part, the furnishing of services or items covered by a federal healthcare program. This means the AKS is broad enough to cover payments to a sales force which is paid on commission. The actual wording of the statute reads:
Whoever knowingly and willfully solicits or receives any remuneration (including any kickback, bribe or rebate) directly or indirectly, overtly or covertly, in cash or in kind—in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal healthcare program, or in return for purchasing, leasing, ordering, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal healthcare program, shall be guilty of a felony and upon conviction thereof, shall be fined not more than $25,000 or imprisoned for not more than five years, or both.

Stark Law is a set of United States federal laws that prohibit physician self-referral, specifically a referral by a physician of a Medicare or Medicaid patient to an entity providing designated health services (“DHS”) if the physician (or an immediate family member) has a financial relationship with that entity. (read entire article). Advocates CANNOT offer to pay a physician for conducting any of the tests. A physician CANNOT become an Advocate unless, they are retired and no longer practicing medicine. A physician CANNOT be paid to offer the test to their patients.

To protect consumers, the law is very specific about what GWCLA Advocates may or may not do. For example:

Advocates CANNOT market through unsolicited contact, including:

  • Telemarketing calls, including voice mail messages, emails or texts

  • Door-to-door solicitations, including leaflets or flyers at your home or car

  • Approaching Medicare beneficiaries in common areas, like parking lots, hallways, lobbies, and sidewalks.

Advocates CAN speak with a client on the phone only if the client calls you first.

Advocates CAN go to client’s home only if you have previously been invited by client to do so
Advocates CANNOT dress up as a medical provider of any type unless they are a licensed medical provider.

GWCLA,has taken the financial obligations to make sure all employees are statutory employees who are paid a salary with tax withholdings and who are also offered benefits. Section 530 of the Internal Revenue Code (IRC) includes a safe harbor provision relating to the classification of workers as independent contractors. Under this provision, a company is not liable for employment taxes if it can demonstrate that a reasonable basis for treating workers as independent contractors exists, and if the employer can meet three reasonable basis standards.

The Affordable Care Act includes a safe harbor for affordability for employee health care coverage. If it’s not affordable, you can’t be held to a responsibility to pay for it.

Another safe harbor provision is the IRS Special Accounting Rule that allows employers to treat non-cash fringe benefits provided in November or December as being provided in the following year.

The domestic production activities deduction for U.S. manufacturing businesses provides a safe harbor provision that allows businesses to take this deduction if at least 20 percent of the total costs are the result of direct labor and overhead costs from US-based operations

Regulatory Compliance


Knowing and maintaining compliant standards are ongoing requirements for all Advocates. Advocates and corporate employees are required to be HIPAA certified and pass a comprehensive course covering the various rules and regulations that pertain to our business and follow them compliantly at all times. Weekly visual and recorded trainings are conducted twice a week, to further enhance the importance of staying compliant.
GWCLA, Advocates are required to study and understand the State and Federal guidelines that regulate the Genetic Cancer Screening and Pharmacogenomics industry, Advocates must conduct themselves in the most compliant manner at all times. Being professional is paramount to our success as a compliant company and even more important to our customers who look to us for education and advice.

How Advocates Are Compliantly Compensated


GWCLA, is committed to satisfying the requirements of CMS and Medicare by classifying Advocates as statutory employees. Statutory employees are allowed the benefit of direct deductions against income, enjoyed by Schedule C filers without the self-employment tax burden such filers face. However, the ability to file as a statutory employee applies only to the categories of employees listed in Sec. 3121(d)(3). To be classified as a statutory employee, the worker must exhibit more of the traits of an independent contractor than of a common law employee. Generally, this means that the employee has control over how work is accomplished with a minimum amount of input by the employer. Courts will often look to the intent of the parties to determine statutory employee status. A critical component of intent is whether the employer has checked the Form W-2 box identifying a statutory employee. However, as shown in Hathaway, even when the employer fails to check the box and withholds income taxes—factors indicating common law employee status—the overall facts may be support — allowing the worker to file a Schedule C.

Who is CMS: Centers for Medicare & Medicaid Services


The Centers for Medicare & Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (HHS) that administers the Medicare program and works in partnership with state governments to administer Medicaid, the Children’s Health Insurance Program (CHIP), and Health Insurance Portability and Accountability Act of 1996 (HIPAA). It also maintains quality standards in long term care facilities (more commonly referred to as nursing homes) through its survey and certification process, clinical laboratory quality standards under the Clinical Laboratory Improvement Amendments, and oversight of HealthCare.gov.

GWCLA Advocate Do’s and Don’ts


Advocates in the field, staff members within the corporate office working on behalf of GWCLA and all employees are expected to adhere strictly to all compliance requirements as set forth by The Centers For Medicare & Medicaid Services (CMS), which oversees MEDICARE.
It is the responsibility of GWCLA to require a comprehensive understanding of HIPAA rules & Regulations as a condition of employment. At GWCLA it is a necessary requirement to provide an AHIP or HIPAA certificate to Human Resources (HR) during the Registration Process. This is accomplished by providing an opportunity to register, study and satisfactorily complete a HIPAA Course at the Advocates expense (currently fifteen dollars).
It is the responsibility of GWCLA to continue with focused training throughout the Advocate’s tenure with GWCLA. This is accomplished by regularly offering Compliance Program Guidelines.
The Compliance Department has built a robust syllabus of instruction. This department teaches the Advocates expectations and requires them to learn the nuances of CMS compliance that will ensure a long and profitable statutory W-2 employee – Genetic Wellcare Life Association, LLC.

What is HIPAA


The Health Insurance Portability and Accountability Act was enacted August 21, 1996 by the United States Congress. HIPAA is a series of regulations governing the transfer of medical information, particularly its modernization by implementing electronic medical record systems.

In addition, it also addresses the issues of health insurance portability and patient privacy rights. The law is broken up into Title I and Title II, the latter of which is also broken up into separate Rules.

  • Title I is called “Health Care Access, Portability, and Renewability” and it deals with health care plans and policies. Title I regulates the amount of “exclusion” period, or time that health insurers can delay coverage for pre-existing conditions, and also allows ways for policy holders to reduce the exclusion period. Title I also enables people to carry their insurance from one job to the next.

  • Title II is called “Preventing Health Care Fraud and Abuse” and it is made up of five separate Rules: the Privacy Rule, Transactions and Code Sets Rule, Security Rule, Unique Identifiers or National Provider Rule, and the Enforcement Rule

Once HIPAA had been signed into law, the US Department of Health and Human Services set about creating the first HIPAA Privacy and Security Rules. The Privacy Rule had an effective compliance date of April 14, 2003, and it defined Protected Health Information (PHI) as “any information held by a covered entity which concerns health status, provision of healthcare, or payment for healthcare that can be linked to an individual”.

In Conclusion

GWCLA,  has and will continue to require strict adherence to regulatory authority guidelines from its leadership, advocates, corporate office employees, vendors and anyone participating in GWCLA, business. The systems and policy designed by Genetic Wellcare Life Association will be a leading example for other companies in this space.

GWCLA Advocate Requirements

GWCLA, has gathered a phenomenal group of talented, compassionate and knowledgeable professionals from across the United States. Each advocate undergoes a  rigorous training to understand their fiduciary responsibility to adhere to the laws within the industry. In addition, each Advocate is required to complete HIPAA Certification and complete GWCLA Training; a course designed to prepare Advocates for a successful and compliant career with GWCLA.