SB0331: ANALYSIS AS ENACTED (Date Completed: 1-29-19)

RATIONALE

Genetic counseling is the process of helping a person or family evaluate and understand the risk of inheriting or passing on a genetic or inherited medical condition (e.g., cancer, cystic fibrosis, sickle cell anemia, or hemophilia). Genetic counselors are healthcare professionals who have specialized education and training in genetics, genomics, and counseling. They are responsible for interpreting genetic tests, assessing the risk of genetic disease, providing education and supportive counseling, and serving as patient advocates for people and families who have or may be at risk for genetic or inherited conditions. Genetic counselors work in a variety of settings, such as hospitals, clinics, or research facilities, and may provide general care or specialize in one or more areas.

Although requirements for licensure vary from state to state, all states that currently license genetic counselors require applicants to have graduated from a master's degree program accredited by the Accreditation Council for Genetic Counseling (ACGC), and have current American Board of Genetic Counseling (ABGC) certification. (In order to be certified by the ABGC, applicants must possess a master's degree in genetic counseling from an ACGC-accredited program, and must pass the ABGC certification examination.) It was suggested that the State implement a licensing process for genetic counselors to ensure Michigan residents receive accurate genetic testing and information from qualified providers, and to make the State more attractive to prospective genetic counselors.

CONTENT

The bill amends the Public Health Code to do the following:

-- Require the Department of Licensing and Regulatory Affairs (LARA) to promulgate rules specifying the minimum standards for the licensure of genetic counselors.

-- Prohibit an individual from engaging in the practice of genetic counseling unless he or she was a licensed genetic counselor, beginning one year after the rules take effect.

-- Prescribe the scope of practice of genetic counseling.

-- Require a temporary licensed genetic counselor to work under the supervision of a qualified supervisor.

-- Establish fees for genetic counselor application processing, licensure, and temporary licensure.

-- Require the Michigan Board of Medicine to include one genetic counselor.

The bill also does not require new or additional reimbursement or mandated workers' compensation benefits for services rendered by an individual who is licensed as a genetic counselor.

The bill will take effect on March 28, 2019.

Genetic Counselor Licensure

The bill requires LARA, in consultation with the Michigan Board of Medicine, to promulgate rules that specify the minimum standards for licensure, temporary licensure, and license renewal of genetic counselors.

Beginning one year after the rules take effect, an individual will not be permitted to engage in the practice of genetic counseling unless he or she is licensed as a genetic counselor.

Under the bill, "practice of genetic counseling" means any of the following services:

-- Obtaining and evaluating individual, family, and medical histories to determine the genetic risk for genetic or medical conditions or diseases in a client, the client's descendants, or other family members of the client.

-- Discussing with a client the features, natural history, means of diagnosis, genetic and environmental factors, and management of the genetic risks of genetic or medical conditions or diseases.

-- Identifying and coordinating appropriate genetic laboratory tests and other diagnostic studies for genetic assessment of a client.

-- Integrating genetic laboratory test results and other diagnostic studies with personal and family medical history to assess and communicate a client's risk factors for genetic or medical conditions or diseases.

-- Explaining to a client the clinical implications of genetic laboratory tests and other diagnostic studies and their results.

-- Evaluating the responses of a client and the client's family to a genetic or medical condition or disease and providing client-centered counseling and anticipatory guidance.

-- Identifying and using community resources that provide medical, education, financial, and psychological support and advocacy to a client.

To be licensed as a genetic counselor, an individual must do all of the following:

-- Submit an application prescribed by the Board.

-- Pay a fee.

-- Provide satisfactory evidence of having current certification through a nationally recognized certifying agency for genetic counselors or medical geneticists approved by the Board.

A temporary licensed genetic counselor must work under the supervision of a qualified supervisor at all times during which the temporary licensed genetic counselor engages in the practice of genetic counseling. ("Qualified supervisor" means an individual who was a genetic counselor and who held a license other than a temporary or limited license.)

Except as provided below, an individual who is not licensed as a genetic counselor is prohibited from using in connection with his or her name or place of business, the title "genetic counselor", "licensed genetic counselor", "gene counselor", "genetic consultant", or "genetic associate", or any words, letters, abbreviations, or insignia indicating or implying that an individual holds a license to engage in the practice of genetic counseling.

Additionally, the bill specifies that the prohibition and the licensure requirement do not apply to an individual who is certified by the American Board of Medical Genetics and Genomics as a Doctor of Philosophy Medical Geneticist, or holds an equivalent certification as determined by the Board, or an individual who is licensed by the State to engage in the practice of a health profession other than the practice of genetic counseling when acting within the scope of his or her health profession and doing work of a nature consistent with the individual's education and training.

To obtain a license renewal as a genetic counselor, a licensee must present to the Board satisfactory evidence that in the period since the license was issued or last renewed, the licensee has maintained certification through a nationally recognized certifying agency for genetic counselors or medical geneticists approved by the Board.

In addition to any other requirements of Article 15 (Occupations) of the Code, the Board must perform other functions and duties as necessary to carry out the regulation of genetic counselors.

Fees

For an individual licensed or seeking licensure to engage in the practice of genetic counseling, the bill prescribes a $230 application processing fee, a $54 per-year license fee, and a $50 per-year temporary license fee.

After LARA determines that it has recouped its upfront costs from application processing fees from individuals who are licensed or seeking licensure to engage in the practice of genetic counseling, the application fee will be reduced to $75.

Board of Medicine

The Code requires the creation of the Board of Medicine to consist of the following 19 voting members who meet the requirements of Part 161 (General Provisions): 10 physicians, one physician's assistant, and eight public members.

Under the bill, the Board, instead, must consist of 10 physicians, one physician's assistant, one genetic counselor, and seven public members.

If there are eight public members of the Board when the bill takes effect, each public member may continue in office until he or she resigns or otherwise vacates the office, or until his or her term expires. The Governor may not appoint a genetic counselor member to the Board until there are only seven public members.

MCL 333.16338 et al.

ARGUMENTS

(Please note: The arguments contained in this analysis originate from sources outside the Senate Fiscal Agency. The Senate Fiscal Agency neither supports nor opposes legislation.)

Supporting Argument

Genetic counseling is a valuable tool for people who have or may be at risk for certain genetic or inherited conditions, and is an important aspect of their preventative medical care. According to the National Institutes of Health, genetic testing is available for over 2,000 rare and common conditions. Additionally, there are a number of different types of genetic tests available, including diagnostic testing to identify a genetic condition or disease; predictive and presymptomatic testing to identify genetic variations that increase a person's chance of developing a specific disease; prenatal testing to identify if a fetus has a certain disease; pharmacogenetic testing that provides information about how certain medicines are processed in a person's body; and research testing that helps scientists learn more about how genes contribute to health and disease.

Misinterpreting or misunderstanding genetic histories or test results can delay diagnosis and treatment. For example, according to testimony before the Senate Committee on Health Policy, a 50-year-old woman who had a family history of Huntington's disease had genetic testing done to determine whether she was at an increased risk for developing the disease. With the correct tests ordered, she was told that she was not at risk. However, she later developed symptoms, and it was discovered that the results of her genetic test had been misinterpreted. In a separate case,

a woman who had a family history of an inherited mutation of the BRCA2 gene underwent incorrect testing. Instead of ordering the BRCA2 test, her healthcare provider incorrectly ordered a BCR-ABL1 test, which is used to identify the presence of a gene that confirms a diagnosis of chronic myelogenous leukemia or acute lymphoblastic leukemia. (The BRCA2 gene produces tumor suppressor proteins. Specific inherited mutations of the BRCA2 gene increase the risk of developing certain types of cancers, particularly female breast and ovarian cancers.)

Requiring genetic counselors practicing in Michigan to be licensed protects Michigan residents from receiving inaccurate information about genetic risks. The bill requires the Department of Licensing and Regulatory Affairs to establish minimum standards for licensure as a genetic counselor. Additionally, applicants must provide satisfactory evidence that they had current certification through a nationally recognized certifying agency for genetic counselors or medical geneticists approved by the Board of Medicine, such as the ABGC. This ensures that Michigan residents receive reliable information from people who are properly educated and trained to understand it.

Also, genetic counseling is a growing profession. According to the U.S. Bureau of Labor Statistics (BLS) and the ABGC, the number of genetic counselors employed in the United States increased from approximately 2,400 in 2014, to over 4,000 in 2016. The BLS also predicts a 29% growth rate for genetic counseling jobs between 2014 and 2024. According to the National Society of Genetic Counselors, as of November 2018, 25 states have enacted legislation that governs the licensure of genetic counselors. Providing for licensure will attract prospective genetic counselors to the State, and will help retain those who choose to complete their education in Michigan.

Legislative Analyst: Tyler VanHuyse

FISCAL IMPACT

The bill will have an indeterminate fiscal impact on the Department of Licensing and Regulatory Affairs, and no fiscal impact on local units of government. Under the bill, LARA is responsible for administering a program to license genetic counselors, which will result in new ongoing administrative costs, as well as program startup costs such as rule promulgation, staff training, and information technology. To offset these costs, the bill establishes a schedule of fees to be paid by individuals seeking licensure. To provide some perspective, the fees are fairly consistent with the license fees for other medical professions and, generally, the fee revenue for those license programs covers LARA's regulatory costs. However, other medical professions have a relatively high number of licensees so fixed costs can be spread over a large number of licensees. In the case of genetic counselors, it is unknown how many individuals will apply; therefore, it is difficult to estimate the revenue and costs, so the fiscal impact of the bill is indeterminate.

Fiscal Analyst: Elizabeth Raczkowski

This analysis was prepared by nonpartisan Senate staff for use by the Senate in its deliberations and does not constitute an official statement of legislative intent.