Providing an assessment of risk for hereditary cancer and offering genetic testing requires planning for any practice. Learn what systems you have in place to provide this service to your patients.
When ordering genetic tests, oncology providers must ensure that the medical, psychological, and ethical consequences of the testing have been considered. Additionally, they must provide accurate interpretation of tests and ensure that communication of risk information is clear for both the patient and family.
In-House vs. Referral: What’s Right for Your Practice
The purpose of conducting a needs assessment is not only to identify and address deficiencies, but also to recognize resources that may already be in place. The assessment should be conducted in order to establish a clear picture of what services can already be provided and by whom, and where resources are insufficient.
The questions below are designed to assist with the identification of strengths and weaknesses that exist within the practice or care center, and the surrounding community.
- Do you have criteria or a defined process for who should be counseled or referred for counseling and testing?
- Do you have support for a person or persons to provide pre- and post-test counseling?
- Do you have an identified person with the knowledge and time to provide pre- and post-test counseling?
- Can you provide access to preventative and surveillance options for patients who test positive for pathogenic mutations?
- Are personnel able to provide information for families?
- Can you provide counseling personnel with ongoing education in this rapidly changing field?
- Consultation space: Do you have space for consultation with patients (both pre- and post-test counseling sessions)?
- Support services:
- Do you have staff for screening and scheduling for counseling sessions?
- Do you have staff for prior authorization for genetic testing?
Resources for Building or Enhancing Your Cancer Genetics Program
National Society of Genetic Counselors: Practice Resources for Starting, Expanding, and Supporting a Cancer Genetics Program
For More Information
- Locating Cancer Genetics Specialists
- Quality Assessment & Improvement
- Genetic Testing Coverage & Reimbursement
- Glossaries of Genetic Terms and Concepts
Locating Cancer Genetics Specialists
Genetic specialists can help identify those at risk for an inherited cancer syndrome and facilitate discussions about screening and prevention options. The specialist may also help patients and providers apply the results of genetic testing to medical management decisions.
- American Board of Genetic Counseling (ABGC)
- American Board of Medical Genetics (ABMG)
- American College of Medical Genetics, Provider Directory
- National Cancer Institute, Cancer Genetics Service Directory
- National Society of Genetic Counselors: Find a Genetic Counselor Directory
Genetic Testing Coverage & Reimbursement
Most health insurance plans will cover the cost of genetic testing when recommended by a physician. However, all coverage and reimbursement is subject to Medicare, Medicaid, and third-party payer benefit plans. Therefore, ASCO strongly encourages you to verify with the patient’s insurer to understand what type of services will be covered.
Medicare is prevented from covering preventive services unless explicitly authorized by Congress. Tests performed in the absence of signs, symptoms, complaints, or personal histories of disease or injury are not covered unless explicitly authorized by statute; a family history of disease does not meet the personal history criterion. Medicare coverage for genetic counseling is also limited by the program’s screening exclusion. Therefore, Medicare does not currently provide coverage for genetic testing in individuals without a personal history of cancer. However, Medicare will cover genetic testing for BRCA1 and BRCA2 under the following conditions:
An individual with a personal history of breast cancer and one or more of the following:
Diagnosis before the age of 45 with or without a family history
Diagnosis before the age of 50 or two breast primaries, with at least one close blood relative with breast cancer diagnosed before 50, or at least one close blood relative with ovarian cancer/fallopian tube/primary peritoneal cancer
Two breast primaries when first breast cancer diagnosis occurred prior to age 50
Diagnosis at any age, with at least two close blood relatives with breast and/or epithelial ovarian/fallopian tube/primary peritoneal cancer
A close make blood relative with breast cancer
A personal history of epithelial ovarian/fallopian tube/primary peritoneal cancer
Of an ethnicity associated with higher mutation frequency (e.g. Ashkenazi Jewish); no additional family history required
A close relative with a known BRCA1 or BRCA2 gene mutation
An individual with a personal history of epithelial ovarian/fallopian tube/primary peritoneal cancer
A male with a personal history of male breast cancer
Medicare also provides coverage for Lynch Syndrome (hereditary nonpolyposis colorectal cancer [HNPCC]) for those who meet any of the following criteria:
Individuals with a first-degree relative with known mutation
Individuals meeting either the revised Bethesda guidelines or Amsterdam Criteria (see table below)
Individuals diagnosed with endometrial cancer under age 50. (Endometrial cancer for those under 50 years is not included in the revised Bethesda guidelines, however per the NCCN, recent evidence suggests these individuals should be evaluated for Lynch Syndrome)
|Amsterdam II criteria||
Revised Bethesda Guidelines
At least three relatives must have a cancer associated with HNPCC (colorectal, cancer of endometrial, small bowel, ureter and renal pelvis); and ALL of the following criteria should be present:
Individual must meet ONE of the following criteria:
* MSH6 sequence analysis is considered medically necessary for persons meeting the above criteria for genetic testing for HNPCC, and who do not have mutations in either the MLH1 or MSH2 genes; or single site MSH6 testing for testing family members of persons with HNPCC with an identified MSH6 gene mutation. PMS2 mutation is only necessary if no mutation is found in the other genes.
**Microsatellite instability (MSI) testing or immunohistochemical (IHC) analysis of the tumor is considered medically necessary as a preliminary testing strategy in individuals with colorectal cancer who meet the revised Bethesda guidelines in an effort to identify those individuals who should proceed with HNPCC mutation analysis.
***Lynch Syndrome tumors/cancer include colorectal, endometrial, gastric, ovarian, pancreas, ureter and renal pelvis, biliary tract, brain (usually glioblastoma as seen in Turcot Syndrome) and small intestinal cancers, as well as sebaceous gland adenomas and keratoacanthomas in Muir-Torre syndrome.
Several state Medicaid programs offer coverage for BRCA testing; however this coverage varies by state. Further, the Essential Health Benefit Package of the Affordable Care Act (ACA) includes a provision for coverage of genetic counseling related to hereditary breast cancer because it has a USPSTF B rating, however the law is silent about covering the cost of the genetic testing for a BRCA mutation. It is important to note that this provision applies only to those Medicaid patients who are newly eligible under the ACA Medicaid expansion and does not apply to current Medicaid beneficiaries. The ACA does provide an incentive (1% increase in Federal Medical Assistance Percentage) for states that provide coverage for their current Medicaid recipients. ASCO recommends consulting your state Medicaid guidelines to understand what genetic testing and counseling services may be covered for your patients. To find out what your state Medicaid program may cover, visit the State Medicaid & CHIP Profiles page.
Genetics Provisions in the Affordable Care Act
With the passage of the Affordable Care Act (ACA), beginning in 2014, health insurance plans cannot refuse coverage to an individual nor charge more for coverage because of an individual’s pre-existing health condition. Further, once an individual has insurance coverage, the coverage cannot refuse to cover treatment due to a pre-existing condition; this is true even if a patient has been turned down or refused coverage in the past.
One exception: Grandfathered individual health insurance plans. The only exception is for grandfathered individual health insurance plans – the kind purchased by an individual and not provided through an employer. These policies do not have to cover preexisting conditions. However, an individual can now switch to a Marketplace plan during open enrollment and immediately get coverage for the preexisting conditions.
The ACA established a set of “Essential Health Benefits”, or core services that must be offered by individual and group insurers with no co-pay. Specifically, for women who are at an increased risk, plans are required to cover, without copay, counseling and genetic testing for BRCA mutations. However, coverage of genetic counseling and testing for other cancer syndromes is not required under the ACA, leaving this provision up to individual health plans to determine if and how they will cover these services. Further, the law removes the ability of insurance plans to have lifetime coverage limits.
Comments or Questions? Please contact us at Prevention@asco.org
Content last reviewed December 2018
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