Healthcare law is continuously changing. Compliance with state and federal statutory and administrative laws and regulations is crucial to the ongoing success of all health care providers. Hospitals, physicians, nursing homes, DME companies, pharmacies, therapists, psychologists, and all other medical providers and contractors need comprehensive internal policies and procedures that implement and document effective compliance procedures to ensure the best quality of care for their patients and protect against civil exposure and criminal liability.
Health care providers must navigate many complicated regulations, such as the federal physician self-referral prohibition (commonly known as the Stark law), the federal Anti-Kickback Statute, the False Claim Act, and a myriad of rules and regulations established by the Centers for Medicaid and Medicare Services (CMS) and the U.S. Department of Health and Human Services Office of Inspector General (OIG). The State of Louisiana has many statutes and the Louisiana Department of Health and Hospitals (La. DHH) regulations that are similar but not the same as the federal laws and regulations but which must also be complied with by healthcare providers in Louisiana. Some of these rules differ depending on the type of healthcare provider. Public healthcare providers are also subject to additional laws and regulations. It is important for healthcare providers to have an attorney experienced in these laws and regulations when negotiating contracts, including employment contracts, staffing agreements, partnership contracts, lease contracts, provider contracts, coding and billing agreements, purchasing agreements, laboratory and pathology contracts, radiology agreements, and consulting agreements.
Employment and staff credentialing standards are crucial to maintaining professionalism and minimizing risk and liability. Granting physician privileges, credentialing physicians and ancillary medical staff, establishing patient standards of care, and staff and employee disciplinary matters significantly impact operations and potential liability of hospitals and other healthcare providers. Peer review, utilization review, compliance, and risk management analysis often overlap, and proper policies and procedures are crucial to avoid regulatory problems and sanctions and civil liability to staff and patients.
Healthcare law includes federal and state regulations regarding privacy regarding personal health information (PHI) regarding patients and employees. The Health Insurance Portability and Accountability Act (HIPAA) is applicable to all healthcare providers and their business associates. HIPAA and the regulations promulgated pursuant thereto contain both privacy and security rules regarding PHI and minimum standards for releasing same. The Health Information Technology for Economic Clinical Health Act (HITECH Act) and the regulations promulgated pursuant to it created additional rules and requirements regarding PHI and obligations when healthcare providers or their Business Associates learn of a breach of PHI. Louisiana law also creates privacy rights in PHI and establishes procedures regarding disclosure of same.
Obtaining proper informed consent is critical for all healthcare providers. Both federal and Louisiana state law establish minimum standards for informed consent which vary depending upon the procedure and the place of service. Failure to obtain the proper informed consent in written form places healthcare providers at risk of liability to patients as well as violates the Conditions of Participation for Medicare which could result in sanctions.
Medicare, Medicaid, and insurance companies have requirements regarding when medical services are necessary and whether such services may be provided in a physician office, acute care hospital, or a surgical center. Necessary services in a hospital setting may be provided on an inpatient or outpatient basis. It is critical for hospitals to have policies and procedures ensuring proper documentation establishing all patients meet the admission requirements for the patient status assigned by physicians. Claims filed with Medicare can be reviewed by Medicare Administrative Contractors (MAC), Zone Program Integrity Contracts (ZPIC), Comprehensive Error Rate Testing (CERT) contractors, and Recovery Audit Contractor (RAC). Louisiana Medicaid claims are also subject to RAC and other audits. Insurance companies also have review and audit procedures to ensure compliance. Failure to have proper documentation can result in significant financial problems and potential sanctions.
Pamela Breedlove has represented acute care, critical access, and surgical hospitals, DME companies, and physicians in North Louisiana in these areas. If you are a hospital administrator, compliance officer, physician, DME manager, or other healthcare provider or supplier in Louisiana and would like to schedule a consultation regarding healthcare law issues, contact Pamela Breedlove at (318) 423-0845 or [email protected] for more information.