Health Law Committee Legislative Health Care Update and Overview of Cms Rules and Waivers for Covid-19 - Part 2

• Jurisdiction: California,United States
• Author: H. Thomas Watson, Carol Scott, and Katherine Bowles
• Citation: Vol. 2021 No. 1
• Publication year: 2021

Health Law Committee Legislative Health Care Update and Overview of CMS Rules and Waivers for Covid-19 - Part 2

H. Thomas Watson, Carol Scott, and Katherine Bowles

H. Thomas Watson, a Certified Appellate Specialist, is a partner at the appellate firm Horvitz & Levy LLP. Tom has published and presented extensively on numerous legal topics, including appellate procedure, medical expense damages, health law, and insurance law.

Carol Scott is the founding partner of the Law Offices of Carol D. Scott, a boutique law firm specializing in health care law and business law. She specializes in advising healthcare providers and consumers on business, regulatory, and transactional issues, including sales, acquisitions, fraud and abuse, security, privacy, licensing, accreditation, and bioethics. She is admitted in California and the District of Columbia and active in State and local Bar associations.

Kate Bowles, RN, Esq. draws upon her experience as a Registered Nurse and as a graduate of Penn Nursing to bring deep industry knowledge and expertise when representing healthcare providers at the largest healthcare boutique law firm in Los Angeles - Nelson Hardiman LLP.

LEGISLATIVE HEALTH CARE UPDATE

Although the COVID-19 pandemic resulted in a shorter legislative session and fewer bills sent to the Governor for signature, the Legislature passed, and the Governor signed, a number of bills that will have a significant effect on consumers' access to health care and the health care industry as a whole.

Medical Exemptions for Vaccinations

Senate Bill 276, 2019-2020 Reg. Sess. (SB 276) (Pan) and Senate Bill 217, 2019-2020 Reg. Sess. (SB 217) (Pan), impose new, more stringent requirements on physicians, parents, and schools with regard to the requirements for medical exemptions for vaccinations for school-age children. Although the bills went into effect in January of 2020, compliance will not be mandatory until January 1, 2021. Under current law, schools cannot admit students who do not have State-mandated childhood immunizations unless the student has a medical exemption from a physician. Instead of permitting physicians to write up their own exemptions based on criteria developed by each practitioner, SB 276 requires the State to develop standard requirements for exemptions and requires all practitioners to use a state-mandated electronic form for issuing an exemption, which form will be available on a state registry. The form, which must be signed by the child's physician and certified as true and accurate, will outline the medical requirements for granting an exemption. At a minimum, the physician must conduct a physical examination of the child and provide specific reasons for the exemption and indicate whether the exemption is permanent or temporary and if temporary, must specify the time period for which the exemption applies and the specific vaccination that is exempted and the medical condition justifying the exemption. The State Health Department is required to conduct an annual review of medical exemptions that fall into the following categories: (i) schools with an overall immunization rate of less than 95%, (ii) physicians and surgeons who submit five or more medical exemption forms in a calendar year, and (iii) schools that do not report immunizations. A companion bill, Senate Bill 714, 2019-2020 Reg. Sess. (SB 714), provides public health officials the authority to review, and, in some cases, revoke, questionable medical exemptions, and provides for an appeal mechanism that parents can use if an exemption is denied or restricted. Students who had medical exemptions issued before January 1, 2020, can continue in school until they enroll in the next grade span (birth to preschool, kindergarten to sixth grade, and seventh to twelfth grade), but after July 1, 2021, a student cannot be admitted or advanced to the seventh grade unless their physician has completed the state-mandated form.

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Expanded Scope of Practice for Nurse Practitioners and Nurse Midwives

With the passage of Assembly Bill 890, 2019-2020 Reg. Sess. (Wood) (AB 890), California joins

twenty-three other states in allowing nurse practitioners to practice independently within the full scope of their license without the supervision of a physician or the use of standardized procedures. Supporters of the bill have indicated that this change will help address health care provider shortages, especially in rural and underserved communities. The bill provides for a three-year transition period and will go into effect in 2023. The California Board of Nursing will define the minimum standards necessary for a nurse practitioner to practice independently and when a physician must be consulted.

Senate Bill 1237, 2019-2020 Reg. Sess. (Dodd/Burke/Mitchell) (SB 1237), the Justice & Equity in Maternity Care Act, expands the role of certified nurse midwifes and permits them to practice independently without physician supervision for normal low-risk births, and to provide prenatal, intrapartum, and postpartum care, including family-planning care for the mother, and immediate care for the newborn without physician supervision as long as the nurse midwife complies with specified professional standards. Certified nurse practitioners may also order supplies and devices, may order and administer non-scheduled drugs, and order and conduct diagnostic tests and obtain reports without physician supervision. Certified nurse-midwives may care for patients whose condition falls outside of the certified nurse practitioner's independent scope of practice, as long as the nurse-midwife and a physician have signed mutually agreed upon policies and procedures that delineate the parameters for consultation, collaboration, and transfer of care; however, the concept is not that the midwife will operate under physician supervision, but that the midwife will work in a collaborative manner with the physician to encourage collaborative, team-based care. Midwives would still be required to refer all emergencies to a physician immediately, but the midwife is authorized to provide emergency care until physician assistance is available. Certified nurse-midwives who are not under the supervision of a physician must provide written notice to the patient and obtain the patient's written consent.

In the past, women who wanted to use nurse midwives were limited to selecting a nurse midwife who was able to obtain physician supervision, and, even though physicians were not always willing to provide such supervision, it was a crime for a nurse midwife to practice without physician supervision.

Drug Costs

Assembly Bill 824, 2019-2020 Reg. Sess. (Wood) (AB 824) The Legislature passed and the Governor signed a bill authorizing the State Attorney General to prosecute drug pharmaceutical companies that engage in a practice called "pay for play," which means paying generic drug manufacturers to keep the lower-cost generic versions of their medications off the market. Under this new law, "pay for play" is illegal and constitutes unfair competition and an unfair business practice, and violators are liable for any remedies available under state antitrust and unfair business practice and unfair competition laws.

COVID-19 Related Bills

The Legislature passed two bills that require stockpiling of personal protective equipment (PPE). Assembly Bill 2537, 2019-2020 Reg. Sess. (Rodriguez) (AB 2537) requires health care facilities to maintain a year's supply of PPE, and provides for fines of $25,000 for hospitals and health facilities that violate the law. The bill also establishes a Personal Protective Equipment Advisory Committee to develop guidelines and future changes to the PPE needed for outbreaks. A second bill, Senate Bill 275, 2019-2020 Reg. Sess. (Pan) (SB 275) requires that the California Department of Public Health establish a ninety-day stockpile of PPE to be used by healthcare and other essential workers during a pandemic.

Other COVID related bills are as follows:

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Assembly Bill 685, 2019-2020 Reg. Sess. (Reyes) (AB 685) requires that employers report workplace outbreaks of COVID-19 to local public health authorities within forty-eight hours and provide written notice within one business day to employees who may have been exposed to the COVID-19 virus at their worksite. The law enhances Cal/OSHA's enforcement of COVID-19 infection prevention requirements by allowing for citations for serious violations related to COVID-19 to be issued more quickly and requires employers to notify employees not only of actual, but potential exposure, as well as COVID-19-related benefits and protections, and disinfection and safety...