Health Law Compliance & Regulations

The Spiers Group has a proven track record in a broad range of compliance issues. In a highly regulated health economy, complex rules create a minefield for violations with severe consequences on the career of a medical professional. Ever more aggressive enforcement actions, including the expansion of criminal sanctions that can accompany civil penalties, make this an area of great concern for practitioners.

The Affordable Care Act made changes in the interplay of various statutes and regulations. These changes underscore the importance of a strong compliance plan.  Understanding the interactions between federal statutes and their parallels in state law, as well as implementing an ongoing compliance plan, takes a team like that of the Spiers Group.

Having practiced medicine for twenty years before becoming a specialized healthcare attorney, Dr. Spiers has firsthand knowledge of frustrations associated with regulatory compliance and unique insight into the law and processes involved in resolving compliance challenges. He offers advisory, consultative, and litigation services on a range of issues.

Stark Law/Self-Referral

Physician self-referral or Stark Law governs referrals made by physicians for Medicare and Medicaid patients, in which physicians may not have a financial interest—investment, structured compensation, ownership—in the facility to which he is referring a patient.  Such referrals are interpreted by the law as conflicts of interests and violations can lead to significant sanctions. Most states have laws similar to the federal regulations, and unfortunately healthcare practitioners seeking full compliance may overlook these to their detriment.

False Claims

The False Claim Act is a federal law that prevents a person or organization from making a false record or claim regarding any federal healthcare program. Examples of false claims include billing for services not provided, billing for a singular service more than once or making false statements to obtain payment for services. Violations can result in significant fines and penalties.

Anti-Kickback Statutes

The False Claim Act is a federal law that prevents a person or organization from making a false record or claim regarding any federal healthcare program. Examples of false claims include billing for services not provided, billing for a singular service more than once or making false statements to obtain payment for services. Violations can result in significant fines and penalties.

Privacy

The Privacy Rule or HIPPA (The Health Insurance Portability and Accountability Act of 1996) is one of several federal regulations governing the sharing of health information and sets rules and limits on who has access to that information. The rule applies to all protected health information including electronic, written or oral, and requires doctors, pharmacists and other healthcare providers to explain and monitor how patient information is shared. Many providers fail to fully understand the impact of HIPPA and related laws on their practices.  Patients themselves are often confused by the subtle differences between certain healthcare privacy laws and more conventional privacy laws. Even in the most recently “simplified” form, state and federal privacy regulations are complex, and require experienced guidance and counseling.

EMTALA

The Emergency Medical Treatment and Active Labor Act (EMTALA) governs how and when a patient may be refused treatment or transferred from one hospital to another when he is in an unstable medical condition. Its purpose is to prevent medical facilities from rejecting patients, refusing to treat them or transferring them to other facilities because they are unable to pay or are covered under the Medicare or Medicaid programs. Violations can have significant financial implications for facilities who refer or accept patients. Because of the complex rules governing health care, practitioners who think themselves shielded from sanction can be mistaken.  

Biomedical Research Law

To ensure the integrity of research projects, data, use of federal grants, and the health and safety of research subjects, the federal government through the Department of Health and Human Services (HHS), has imposed research compliance laws. Informed consent, protocol deviations/violations, drug/device accountability, inadequate medical records, IRB approval, IND/IDE applications, clinical trial billing, conflict of interest, privacy/HIPPA, and governmental investigations, are just a few of the compliance issues that can be brought to bear in the clinical research arena. A proactive compliance strategy is the ideal strategy.