Access to Genetic Counselor Services Act of 2019 (HR 3235, 116th Congress)

The Policy

What it does

Expands coverage of genetic counseling services under Medicare.

Synopsis

The Access to Genetic Counselor Service Act of 2019 (HR 3235) aims to:

  • Recognize certified genetic counselors as Medicare healthcare providers; and 
  • Cover genetic counseling by a certified genetic counselor under Medicare, which currently covers these services when they are performed by a physician.

According to this bill, a certified genetic counselor is an individual who:

  • Is licensed by the State in which they are providing genetic counseling services; or
  • Must be certified by the American Board of Genetic Counseling (ABGC), which meets the general criteria that is established by the Department of Health and Human Services (HHS), if the state does not license genetic counselors to provide genetic counseling services

The bill also states that genetic counselors would be paid 85 percent of what physicians received under the Medicare Physician Fee Schedule. A physician fee schedule is a complete list of medical fees used by Medicare to pay doctors and other healthcare providers. The fee schedule is used to reimburse healthcare providers on a fee-for-service basis.

Context

With the expansion of precision medicine and a heavy reliance on genetics in our healthcare system, there will be an increased need and demand for genetic counselors. A certified genetic counselor is an expert in the field of medical genetics and counseling. Compared to a general practitioner delivering genetic test results, a certified genetic counselor has greater expertise, given that they must be certified by a national exam from the American Board of Genetic Counseling. This exam assesses a counselors understanding of genetics, counseling, communication, and how to evaluate risk in families.

Currently, certified genetic counselors are not provided for under Medicare. However, genetic counseling services are covered by Medicare if those services are delivered by a physician whom Medicare would otherwise cover. The Centers for Medicare and Medicaid Services does not recognize certified genetic counselors as healthcare providers; therefore, certified genetic counselors cannot be reimbursed under Medicare for providing services.

Recent research has suggested that genetic counseling services can reduce health care costs and improve the quality of laboratory tests. Laboratory tests, in which a sample of blood, urine, or body tissue is sent to a lab for further testing, contribute to the overall health care costs in the United States. Although these tests are ordered and examined by a physician, it has been noted that, in some circumstances, laboratory tests are inappropriately ordered, leading to unnecessary testing and additional costs. According to one study, genetic counselors ordering appropriate laboratory tests for 50 cases saved nearly $99,0000, with an average of $2,000 saved per appropriate test ordered.

The Science

Science Synopsis

According to the Centers for Disease Control and Prevention (CDC), genetic counseling is a service that provides information about genetic conditions and how these conditions might impact an individual or their family. Genetic counseling can be seen as a process to assess and understand an individual’s or an entire family’s risk of having an inherited condition. The National Society of Genetic Counselors estimates that there are 5,000 certified genetic counselors.

The mapping of the human genome through the Human Genome Project (HGP) advanced the role of genetic counseling and introduced genetic testing. Genetic testing assesses DNA, the hereditary material that provides the instructions for bodily functions, and may uncover mutations within genes. Before the introduction of the HGP, genetic counselors clarified the genetic mechanisms of a disease through drawn-out pedigrees. Today, however, genetic counselors provide guidance, information, and feedback to patients who have a genetic disorder or are at risk of inheriting a genetic disease.

Most genetic counselors have a background that includes both genetics and counseling in order to translate test results and help guide patients on the best course of treatment. Genetic counselors provide information to patients regarding the following:

  • How an inherited disease might affect them or their family;
  • What tests should be performed in order to provide accurate information; and
  • How family health history impacts the chance of disease.

Similar to practicing physicians, genetic counselors may provide specialized or general care to patients. Areas of specialized care include prenatal and preconception, pediatrics, cancer, cardiovascular, and neurology. When preparing for pregnancy, genetic counselors can address issues including genetic conditions that run in the family, birth defects, a history of infertility, and assisted reproductive technology choices. During pregnancy, a referral may be made to a genetic counselor if irregular results are found using a blood test, chorionic villus sampling, amniocentesis, or ultrasound. Genetic counselors can also address concerns relating to pediatric care if a child is presenting symptoms of a genetic disease or disorder. In this case, a genetic counselor may provide information on birth defects, developmental disabilities, or newborn screening results. Individuals can also be referred to a genetic counselor to determine if they are at risk for or have a genetic disease. Genetic testing is commonly used to detect hereditary breast and ovarian cancers (including the BRCA1 and BRCA2 genes), cystic fibrosis, sickle cell disease, and many other disorders.

Scientific Assumptions

  • Genetic counselors provide better services than general practitioners: Compared to a general practitioner, a certified genetic counselor may provide better services because they are required to pass a national exam from the American Board of Genetic Counselor , which assesses a counselor’s understanding of genetics, counseling, communication, and how to evaluate risk in families. 
  • Genetic counseling provides accurate information about health outcomes: According to healthcare professionals and the National Society of Genetic Counselors, genetic counselors provide accurate and reliable information to patients by incorporating dependable genetic testing and comprehensive services.

The Debate

Scientific Controversies / Uncertainties

Although sequencing DNA to detect mutations and other abnormalities has become a prominent part of healthcare, there are still uncertainties involved in genetic testing. According to a study in the Journal of Genetic Counseling, one area of uncertainty in genetic testing is “determining the clinical validity of an identified variant.” Clinical validity denotes how accurately a given mutation is associated with a disorder or disease.

False-positive results are another source of uncertainty surrounding genetic testing. According to the National Cancer Institute a false-positive result is “a test result that indicates an individual is affected and/or has a certain gene mutation when he or she is actually unaffected and/or does not have the mutation.” In direct-to-consumer genetic testing , a recent study found a high rate (40%) of false-positive results for genes with potential clinical impacts.

Endorsements & Opposition

  • Representative Dave Loebsack (D-IA-2), press release, June 14th, 2019: “As personalized medicine and genetics become more prevalent in our healthcare system, it is as important as ever that Medicare recipients have access to certified genetic counselors. These genetic counselors help improve the quality of care and help reduce costs.”  
  • DUP15q Alliance, statement: “ We are requesting that members, who have connections to patient advocacy organizations, reach out and ask for a letter of support.”
  • Facing Our Risk of Cancer Empowered (FORCE), statement: “Please join us in supporting coverage of genetic counseling for Medicare beneficiaries and all Americans.”
  • John Richardson, NSGC Senior Director of Policy and Government Relations, statement, August 2019: “We can’t emphasize enough the importance of having everyone participate in the effort to enact H.R. 3235.”
  • National Society of Genetic Counselors, statement: “To support efforts to enact H.R. 3235, the National Society of Genetic Counselors (NSGC) has posted the following documents to help members become successful advocates in support of this bill. NSGC asks that members share the Patient/Family/Friends and Physician letter links, below, with their patients, family, friends, and colleagues.”

Potential Impacts

The Access to Genetic Counselor Services Act of 2019 proposes to improve general access to certified genetic counselors. In a press release, Representative David Loebsack (D-IA-2) states “Lack of access [to certified genetic counselors] can result in harm such as incorrect interpretations of genetic test results, failure to identify individuals’ genetic risk, and inaccurate risk assessments leading to inappropriate medical management and sometimes death.”

Recently, the National Society of Genetic Counseling commissioned a healthcare consulting firm to assess the cost-effectiveness of genetic counselors. The firm estimated that Medicare would save $4 billion over the span of a decade if genetic counselors were to be used to help make testing decisions with patients.