BY MARY M. BEARDEN AND ALLISON SHELTON, Brown & Fortunato, P.C.
This year has seen many changes in state leadership. Texas elected a new governor for the first time in fourteen years, and we have a new lieutenant governor, attorney general, comptroller, land commissioner, and agriculture commissioner. The major issues for the 84th Legislature were roads, education, and oil and gas. Although healthcare was not a major priority, the legislature passed and Governor Abbott signed several bills that will impact hospitals and other providers, including House Bills 635, 1945, 751, and 2020, and Senate Bills 1899, 1881, and 373. This article provides an overview of these bills which are currently in effect.
On June 19, 2015, Senate Bill 1899 and its House companion, House Bill 2020, were signed by the Governor. These bills are designed to provide physicians and healthcare facilities with the option to utilize the skills of a paramedic in emergency and urgent care settings. Senate Bill 1899 expands the scope of practice for emergency medical technician-paramedics (EMT-Ps) and licensed paramedics by allowing such personnel to provide advance life support under the delegation and direct supervision of a licensed physician in a healthcare facility.
The term “healthcare facility” includes hospitals and freestanding emergency medical care facilities. Such healthcare facilities may adopt a policy permitting EMT-Ps and licensed paramedics to provide the care necessary to sustain life in an emergency situation, including intravenous therapy, intubation, defibrillation, or drug therapy procedures. A physician must directly supervise any EMT-P or licensed paramedic who provides advanced life support in a healthcare facility. Moreover, the law requires that the physician be in the same area or an area adjacent to the area where the EMT-P or paramedic is performing the procedure. The physician must also be immediately available to provide assistance if needed. Senate Bill 1899 became effective on June 19, 2015.
Senate Bill 1881 may affect the disclosure of protected health information by healthcare providers. This bill creates a new form called a “Supported Decision- Making Agreement” as an alternative to a traditional guardianship. A “supporter” is named in the agreement to assist an adult with a physical or mental impairment to make life decisions, such as where to live, where to work, and what types of services, support, and medical care the adult should receive. However, the agreement does not impede the self-determination of the adult; a supporter does not make decisions for the adult. Rather, the supporter assists the adult in collecting sensitive information, including medical and treatment records. Under the law, the supporter must ensure protected health information under HIPAA is kept privileged and confidential. Senate Bill 1881 became effective on June 19, 2015.
On May 28, 2015, Governor Abbot signed into law Senate Bill 373, which relates to hospitals and potentially preventable adverse events. Prior to the passage of Senate Bill 373, hospitals had to report any kind of healthcare-associated infection or potentially preventable adverse event to the Texas Department of State Health Services (DSHS). After receiving the report, DSHS completed an investigation and issued a Statement of Deficiency. In response to the Statement of Deficiency, the hospital would submit to DSHS a Plan of Correction. Prior to the passage of Senate Bill 373, DSHS had the discretion to conduct a follow-up visit to review plan implementation.
Senate Bill 373 requires DSHS to conduct the follow-up visit and to ensure deficiencies that contributed to the preventable adverse event are being addressed. Furthermore, Senate Bill 373 establishes more detailed requirements that must be met by the hospital’s Plan of Correction. Now DSHS may require that a Plan of Correction include staff training and education, supervision requirements for certain staff, increased staffing requirements, increased reporting to the Department, and a review and amendment of hospital policies relating to patient safety. The law also requires ongoing monitoring by DSHS to ensure continued compliance. Senate Bill 373 became effective on September 1, 2015.
On June 9, 2015, House Bill 635, also known as the fetal remains bill, was signed into law by Governor Abbott. Some hospitals consider the remains of a fetus as human waste before a certain gestational period and dispose of the fetal remains in accordance with the hospital’s disposal procedures for other human waste. This bill requires hospitals, at the request of a parent, to release the remains of an unintended, intrauterine fetal death, in a manner appropriate under law and the hospital’s policy for disposition of a human body. Fetal remains weighing less than 350 grams shall also be released upon the request of a parent of the unborn child, in a manner that is appropriate under law and consistent with hospital policy. The goal of House Bill 635 is to ensure that any parent who has to endure the trauma of losing a child before birth is able to recover the fetal remains from a hospital for burial purposes. House Bill 635 became effective on September 1, 2015.
On May 28, 2015, Governor Abbott signed into law House Bill 1945, which attempts to clarify the line between the business of insurance and a physician’s practice model. Specifically, the bill addresses payments made and services provided pursuant to a medical service agreement for so-called “concierge medicine” or “direct primary care.” The bill creates a type of “safe harbor” for physicians who provide direct primary care services to patients for a direct fee by declaring that such physicians are not insurers and are not subject to regulation by the Texas Department of Insurance.
Under the law, “direct primary care” means a primary medical care service provided by a physician in return for a set fee. The fee may include a monthly retainer, membership fee, subscription fee, fee under a medical service agreement, or fee for service, visit, or episode of care. A medical service agreement must be a signed, written agreement between the patient and the physician to provide direct primary care services for a direct fee for a period of time. The law is written broadly to include practitioners other than primary care physicians if the practitioner is the patient’s main source for regular healthcare services. House Bill 1945 became effective on May 28, 2015.
On June 19, 2015, Governor Abbott signed House Bill 751, which permits the substitution of therapeutically equivalent drugs. Only drugs deemed by the United States Food and Drug Administration as therapeutically equivalent drugs in the “Orange Book” are approved for substitution under this bill. Unlike a pharmaceutically equivalent drug, which could be substituted prior to the passage of this bill, a therapeutically equivalent drug does not have the same active ingredient as the drug being substituted. Instead, the therapeutically equivalent drug is expected to have the same clinical effect as the drug being substituted. There is a requirement that within three days, the pharmacist must communicate to the prescribing practitioner the specific product provided to the patient. A pharmacist may rely on electronic health record or billing systems entries as the method of communication if the pharmacist reasonably concludes that the system is accessible by the prescriber. Otherwise, the pharmacist must relay the information by telephone, facsimile, electronic transmission, or other means. House Bill 751 took effect on September 1, 2015.
House Bills 635, 1945, 751, and 2020, and Senate Bills 1899, 1881, and 373 are currently in effect. Healthcare providers should carefully review these bills and ensure that their policies and procedures are consistent with the new requirements. Moreover, healthcare providers should train their staffs on the new legal requirements affecting the facility’s operations.