Tag Archives: professional issues

by | September 26, 2022 · 5:02 PM

Unprofitable Genetic Testing Labs – The Size of the Loss, The Reasons for the Loss, and What It Means for Genetic Counseling and Genetic Counselors

By Katie Stoll, MS, Jessie Conta, MS, and Michael Astion, MD, PHD

Genetic counseling is a critical part of the genetic services process, beyond just coordination and ordering of a genetic test. However, as the genetic counseling profession has grown alongside the expansion of genetic testing, it has become increasingly intertwined with and dependent upon the financial success of commercial genetic testing laboratories. The relationship risks undervaluing genetic counseling and the breadth of the services genetic counselors provide.

The genetic testing industry has seen rapid growth over the past two decades, with many new companies and billions of dollars invested into start-up genetic testing labs. Despite the enthusiasm of venture capitalists and other investors, commercial genetic testing labs are largely unprofitable, and the losses are significant and sustained. This is shown in Tables 1 and 2 below which are derived from analyzing publicly available, quarterly and annual financial reports (10-Q and10-K Filings) of publicly traded companies whose primary business is clinical genetic/genomic testing.

As shown in the tables, it is common for publicly traded, genetic testing labs to report annual losses of >$100 million. In 2021, only one lab, Fulgent, made a profit (Table 1). However, Fulgent’s 2021 – 2022 quarterly reports (Table 2) indicate that profits aren’t attributable to genetic testing, but rather to COVID test sales, which accounted for ~88% of their 2021 revenue. Myriad has seen a consistent decline in revenue since the US Supreme Court’s ruling in 2013, which forbid human gene patenting and therefore caused Myriad to lose their lucrative BRCA testing monopoly. Although the losses have not been as severe as their competitors, Myriad has not been profitable since 2019, and they have reported greater losses in the first two quarters of 2022 than their annual loss in 2021.

Profit and loss data is difficult to obtain from private genetic testing companies such as Color Genomics, as well as from genetic testing labs owned by much larger, diversified companies, as is the case with Ambry being owned by Konica Minolta. Similarly, profit and loss data on genetic testing is unavailable from integrated health systems, academic medical centers, or publicly traded labs –like Quest, LabCorp, and BioReference— who only have a small portion of their overall testing business in genetics. In regards to academic labs and labs in integrated health systems, our experience, as well as discussions we have had with colleagues strongly suggest that genetic testing is performed at a financial loss, and that it is the overall profit of these full-service labs that allow them to support genetic testing.

Why aren’t genetic testing companies profitable?

Publicly traded genetic testing labs are unprofitable for a variety of reasons. The top reasons are poor reimbursement from insurance plans and patients; intense competition; and excessive expenses for sales, marketing, and executive compensation. In addition, the inclusion of genetic counseling, which companies have highly valued as part of their testing service, adds an expense that is not seen in the other analytic sections of a full-service clinical lab.

Insurance reimbursement

The service of genetic testing is a costly one to deliver and is much more expensive than a lab’s cost to perform other tests. For example, the fully loaded cost of performing a typical test in a highly automated, hospital-based core laboratory is in the range of $10-$20 per test. This includes common tests like complete blood counts, electrolytes, basic coagulation tests, thyroid screening tests, and liver function tests.  For an insurance plan this type of common testing is >65% of their expenses. The cost to labs of genetic testing is much higher, often 10-100-fold higher. Genetic testing usually represents < 20% of an insurance plan’s spending on lab tests.

Why is genetic testing so costly to labs? The main reason is that it is difficult scale genetic testing in a manner analogous to common, high-volume laboratory tests. Compared to common tests, genetic testing is more labor-intensive, more time consuming, involves higher-wage staff, and involves technology that has a higher cost per test. Genetic testing is time consuming because it requires complex tasks not seen with common tests, such as variant analysis, curation, review, and updating. And for many companies, it also includes providing the genetic counseling service, which is often bundled into the service of providing the test. Overall, genetic testing is a personalized, complex technical service which has resisted, for now, the type of full automation that has benefited other parts of the clinical lab.

The high cost for performing genetic testing necessitates high costs to patients and their insurance companies. Historically, insurance companies are mediocre at regulating high-volume, low-cost lab tests because it is too cumbersome and expensive to manage. However, insurance companies have many effective tools for regulating high-cost procedures, including genetic tests. The result is that high-volume, low-cost laboratory tests have a relatively open door to reasonable insurance payments, and insurers invest only a little energy toward closing that door. In the case of genetic testing, the door is closed or only partially open.

Besides negotiating fees with certain labs, the main method that insurance plans use to control genetic test reimbursement is detailed medical necessity policies tied to preauthorization systems. Insurance companies either develop the policies and pre-auth systems or purchase them from third-party benefits managers. Overall, the method involves using software that aids decision making in combination with genetic counselors, nurses, and physicians who adjudicate cases at various decision levels. This approach is then married to an insurance plan’s usual and customary procedures for handling grievances from patients and labs that have been denied payment. For insurance plans, this type of complex system, which is both software and labor intensive, would have a poor return on investment if applied to low-cost, high volume lab tests. But for genetic testing, this type of system has an excellent return on investment, and so insurers are highly motivated to regulate genetic testing. In addition, these insurance systems tend to be overly tuned to block fraud, waste and abuse, and often delayed in keeping up with scientific evidence. Therefore, insurance systems may block some medically necessary genetic testing.

Patients bear high out-of-pocket costs for genetic testing. This is because they are financially liable when their insurers do not cover the test, and, even when insurers provide coverage, there still can be high deductibles or co-pays. In the laboratory industry, it is very expensive to recover the money that the patient owes, and poor financial recoveries from patients is common. This failure to recover the patient portion of the bill adversely affects the bottom line of genetic testing labs.

Response to poor reimbursement from insurers and patients

Many labs performing genetic testing have responded to preauthorization requirements by investing in resources – which sometimes can create an entire division or department – that provide support with prior-authorizations, as well as appeals and support when test coverage is denied. This can help grow the testing business because it removes a barrier that blocks some providers from ordering testing. However, the removal of the barrier comes at a high cost to the genetic testing lab.

To help patients directly, some labs have promised patients low out-of-pocket costs either through reducing the patient’s responsibility under their insurance plan, or by promoting self-pay options that avoids involving the insurance plan. Thus, some labs promise patient out-of-pocket maximums, typically advertised as about $100 when insurance does not cover testing.

For self-pay options that do not involve insurance, the price for genetic testing for patients is often much lower than the list price available to care providers, and it is highly likely that price does not cover the costs of the tests. The current going rate at most labs for self-pay testing for multigene panels is around $250, which is usually much less than what labs try to collect from payers, including Medicare and Medicaid for the same test.

Sales and Marketing

A review of publicly available, 10-K submissions, show that it is not unusual for genetic testing companies to have marketing and sales budgets around 40-50% or more of revenue, which is much higher than typically seen in established, full service clinical laboratories. This most likely relates to the goal of growing revenue and capturing market share, despite the high cost of achieving this in a competitive, and poorly reimbursed business. Those NSGC parties, sponsored luncheon and dinner events, “free” CEU opportunities, and even the complementary genetic counseling, all come at a cost for the marketing and sales budgets of these companies.

Executive compensation

Another contributor to financial losses in publicly traded genetic testing labs is the high pay of executive leadership, including chief executives. Review of executive compensation data shows that executive pay is often inversely correlated with net profits – the longer that a company lasts, regardless of how deep the losses grow, executives tend to be well rewarded. For example, Natera reported compensation for the company’s chief executives totaling $8 million while company losses totaled $128 million in 2018. Contrast this to 2021, when Natera’s C-Suite compensation was > $53 million despite company losses that were > $471 million.

Although these companies are not generating operating profits, their investors aren’t necessarily hurting as a result. Stock prices for boutique, genetic testing labs don’t often sync with the lab’s financial health, and based on reported trading of company insiders, some investors are gaining significant wealth despite the losses of these labs. For example, Invitae hit all time stock highs in December 2020 despite enormous losses reported in every quarter that year. The net loss for Invitae in 2020 was >$600 million, while that same year Invitae insiders cashed out more > $46 million in stock. Another example is that the current CEO of Natera cashed in nearly $76 million in stock over the past four years, while cumulative losses for Natera totaled >$ 1 billion over that same period.

What is at stake for genetic counseling?

A 2018 publication in the Journal of Genetic Counseling analyzed the financial challenges of commercial genetic testing labs and what that could mean for genetic counselors. The authors speculated that genetic testing companies may not find a path to profitability, and their ability to support genetic counseling services may subsequently decrease.

Since this initial analysis, the losses of these companies have continued to grow, and investors have become less enthusiastic. This has put pressure on many companies to change and adjust their business strategy in order to survive. For some, this means cost cutting measures to decrease their cash burn with hopes to increase the odds of profitability. And as predicted, difficult decisions are taking place with many genetic testing companies resulting in layoffs of staff, including genetic counselors. Last month, Invitae announced layoffs of over 1,000 staff, including most of their clinical genetic counselors. SEMA4 and Ambry Genetics have also had layoffs in recent months. Given the overall picture of the financial health of all these labs, and increasing challenges in raising funds, it is likely there will be more layoffs to come for genetic counselors and others who work at these companies.

What does the current financial state of genetic testing laboratories mean for the delivery of genetic services and for the genetic counseling profession? A substantial portion of genetic counseling is now delivered through genetic testing laboratories who have packaged genetic testing with the offer of genetic counseling to draw in clients. If we see fewer companies maintaining genetic counselors on their staff, where will genetic counseling support come from for these patients? In addition to the labs themselves, many of the growing genetic counseling telehealth companies are closely tied to the testing laboratories, with much of their funding and contracts coming through commercial laboratories rather than direct patient referrals or contracts with clinics. It seems possible that these arrangements could also be negatively affected with current financial pressures and cuts to “extra” costs. Genetic counseling is not an “extra” bonus service, but rather a critical part of the genetic services process. Relying on genetic testing companies’ funding to ensure access to this service does not appear to be a sustainable model.

For genetic counseling services to be sustained, independent of the financial health of corporate testing laboratories, it is essential that genetic counseling be recognized and reimbursed as an independent service, with inherent value that is separate from genetic testing. Recognition by the Centers for Medicare and Medicaid Services is a necessary step towards sustainable and independent genetic counseling services, regardless of service delivery modality. I hope you all will join in continued advocacy to see the Access to Genetic Counselor Services Act H.R. 2144 / S. 1450 enacted into law.

Michael L. Astion is a clinical pathologist who is Medical Director, Department of Laboratories at Seattle Children’s Hospital and Clinical Professor of Laboratory Medicine at the University of Washington. For almost two decades he worked at the University of Washington, Department of Laboratory Medicine where he was a Professor and Director of Reference Laboratory Services. His career is divided between clinical service, teaching, clinical service, and research and development. He is the editor-in-chief of Patient Safety Focus, which appears quarterly within AACCs Clinical Laboratory News. He is one of the founders of PLUGS (Patient-centered Laboratory Utilization Guidance Services), a national collaboration whose mission is to improve test ordering, retrieval, interpretation and reimbursement. Dr. Astion is a frequent speaker at professional meetings, where he lectures on issues related to laboratory test utilization; test interpretation; laboratory economics and outreach; and medical errors.

Jessie Conta is a licensed genetic counselor in the Department of Laboratories at Seattle Children’s Hospital. She received her Master of Science degree in genetic counseling from Brandeis University. As the Manager of the Laboratory Stewardship Program at Seattle Children’s, she leads genetic test stewardship interventions, including insurance alignment related to genetic testing. Jessie is also a co-founder and Director of Genetic Counseling Services for PLUGS (Patient-centered Laboratory Utilization Guidance Services), a national collaboration whose mission is to improve test ordering, retrieval, interpretation and reimbursement.

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by | July 28, 2022 · 7:47 AM

NSGC Board: With Roe Overturned, and Over a Decade Without Medicare Recognition, It’s Time For Change 

A Guest Post by Misha Rashkin et al

The Supreme Court’s recent decision to overturn Roe v. Wade is an historic event, and in many ways genetic counselors are in the eye of the storm. The National Society of Genetic Counselors (NSGC) has historically remained silent on the issue of reproductive rights, citing Medicare recognition as a bipartisan issue that supersedes patients’ reproductive freedom. Though the threat of losing Roe has been clear since Brett Kavanaugh joined the Supreme Court, and all but inevitable after Justice Coney Barrett took the oath, NSGC leadership has continued to focus solely on Medicare reimbursement. After more than a decade of following this strategy, NSGC is nowhere near getting our bill passed, and now patients are losing fundamental rights. It’s time for change.

What is Next for Genetic Counselors?

  • Going forward, there will be laws proposed in many states that could regulate what genetic counselors can document or say to their patients. 
  • To enact change, NSGC leadership will need to get involved in many legislative, legal, and electoral efforts. 
  • Electoral efforts will need to focus on local elected officials like District Attorneys offices, ballot measures, and state constitutional amendments. 

Bottom line: It is not acceptable for NSGCs political operation to remain silent on reproductive choice. We must act on issues that impact our professional lives and the wellbeing of our patients. To remain silent is to capitulate.

What about our bill to be recognized by Medicare? 

  • Based on public records, NSGCs efforts to have Congress recognize genetic counselors as Medicare providers has been ongoing since 2007, longer than many counselors’ careers. 
  • Our bill has been introduced three times as HR 7083 in 2018, HR 3235 in 2019, and HR 2144 in 2021, and has yet to be considered by a single committee in Congress. 
  • While progress has been minimal, costs have ballooned 450% over 10 years, from $80,000 per year to $360,000 per year! 

Bottom line: Sacrificing our commitment to patient autonomy and agency is a grave ethical error for an industry that prioritizes these values. Sticking with the status quo is a failure of the leadership’s ethical and fiduciary responsibility. Board members are required to accept their fiduciary responsibility for NSGC the same as they would for their own personal finances.

What Can NSGC Do To Repair the Damage?

  • The NSGC Board should put out a Request For Proposals (RFP) requesting bids from new lobbying firms every few years, beginning now. This is standard practice for nonprofit organizations. Smith Bucklin has not been held accountable for their lack of progress. 
  • RFPs should include lobbyists who have worked to get mid-level providers recognition.
  • This process should be transparent and prioritize bids from political operatives who have:
    • Experience working with our targeted committees (Energy & Commerce, and Ways & Means in the US House) to move our legislation forward.
    • Experience working on reproductive freedom at the state and federal level. 

Bottom Line: The Board should create a process where an RFP is put out at some regular cadence, such as every three years. It’s time to hold our Director of Government Relations and lobbyists accountable. If you agree, please sign this petition to register your support for accountability, transparency and change. 

[alphabetical order]

Barbara Biesecker, PhD, MS, CGC

1989-1990 NSGC President

Jordan Brown MA, MS, CGC

2022 Chair, NSGC Public Policy Committee

Member, NSGC Reproductive Freedom, Access, and Justice Task Force

Founding Member, Genuine Collective

Elizabeth Fieg, MS, CGC

2020-2022, Public Policy Committee Member

Michelle Fox, MS, CGC

2020-2021, NSGC Director at Large

2008 Chair, Jane Engelberg Memorial Fellowship 

Shreshtha Garg, MS, CGC
2020-2021 Chair, Equity and Inclusion Implementation Committee

Carrie Haverty, MS, CGC

2022 Chair, NSGC Membership Committee

Brianne Kirkpatrick, MS, CGC

204-2017, NSGC Public Policy Committee Member

Shelby Koenig, MS, CGC

Member, NSGC Reproductive Freedom, Access, and Justice Task Force

Megan Mckenna, MS, CGC

NSGC Member since 2020

Kristen Miller, MGC, CGC

2022 Senior Co-Chair, NSGC Prenatal SIG

Ana Morales, MS, CGC

2016-2020, ABGC Board of Directors (President, 2019)

2022, NSGC Expert Media Panel

2022, NSGC Practice Guidelines Committee Member 

Shivani Nazareth, MS, CGC

2020-2021, NSGC Director at Large

2021-2022, NSGC Reproductive Freedom, Access and Justice Task Force Member

2013-2016, Public Policy Committee Member

Kate Partynski Emery, MS, CGC

NSGC Member Since 2015

Aarti Ramdaney, MS, CGC

2019-2021, NSGC Prenatal SIG Co-Chair

Misha Rashkin, MS, CGC

2018 Chair, NSGC Public Policy Committee

Hillary Rieger, MA, MS, CGC

NSGC JEDI Task Force, 2021-22 

Sally A. Rodríguez, ScM, CGC

2021-2023, NSGC Membership Committee Member

2021-2023, NSGC Justice, Equity, Diversity, & Inclusion (J.E.D.I.) Committee Member

Katie Sagaser, MS, LCGC

2020-2022 NSGC Public Policy Committee Member

2019-2020 NSGC Prenatal SIG Co-Chair

Founding Member, GENUINE Collective

Kendra Schaa, ScM, CGC

2020-2021, Chair, NSGC Access & Service Delivery Committee

2017-2020, Member, NSGC Access & Service Delivery Committee

Heather Shappell, MS, CGC

2020-2021, NSGC Director at Large

Ashley Svenson, MS, CGC

2021-2022, NSGC Reproductive Freedom, Access, and Justice Task Force Member

Elizabeth Varga, MS, CGC

2018-2019 NSGC Director at Large

2016-2017 Co-chair, Pediatric Subcommittee, Cancer SIG

2014 Chair, Nominating Committee, American Board of Genetic Counseling

Chelsea Wagner, MS, CGC

2022-Present, Prenatal SIG Co-Chair

2022-Present, NSGC Abstract Review Committee

2019-2021, NSGC Marketing and Communications Working Group

2017-2020, NSGC Membership Committee

Kate L Wilson, MS CGC

2014 Chair, NSGC Access and Service Delivery Committee

2018 Chair, NSGC Education Committee

2012 Chair, NSGC Prenatal SIG

2017 Chair, NSGC Laboratory/Industry SIG

Beth Wood Denne, MS, CGC

2019 NSGC Cares Task Force

2011 Chair, Annual Education Conference

2013-2016, ABGC Board of Directors (President, 2016)

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by | October 12, 2021 · 2:44 PM

An offer too good to be true? Might be a kickback.

Consider this imaginary scenario from three perspectives:

#1 You are an administrator for a large healthcare system in your community that is facing a greater demand for mental health services than ever before. Qualified mental healthcare providers are in high demand leading to psychiatrists and counselors demanding higher wages; yet reimbursement from Medicare and Medicaid haven’t kept up.

A well-known pharmaceutical company approaches you with a new program which includes a computer program that will interface directly with the healthcare system’s electronic medical record. This program has a suite of tools that will provide patient education, screen patients for depression and other mental health concerns and can make recommendations for treatment based on chatbots and pre-programmed algorithms. The program also allows for ease of ordering and delivery of medications, directly to the patients that are identified as possibly benefiting them. The system will check insurance benefits, handle billing, and provide education to the patient making the whole process seamless and burden-free for your clinical staff and providers. And the pharmaceutical company will provide direct access to mental health counselors and psychiatrists to take care of your patients when there are needs beyond what the chatbot and videos can provide. This is all offered to your healthcare system free of charge. This is a departure from how mental health services have been offered previously within in your healthcare system, however you are convinced that this program it would increase access to care that is desperately needed and greatly benefit your budget as well.  

#2 You are a psychiatrist that has worked in a community health practice for many years. The work is taxing and not well supported. When you were recruited by a pharmaceutical company it felt like an easy choice. The pay that was offered was nearly double what you were paid when working for community health and the perks, benefits and hours allow for a much-improved work-life balance. And with so many tools for efficiency and support, you believed that more patients would be reached in the system through access to medications than you could have ever reached through traditional clinical care.

#3 You work in business development for a pharmaceutical company. Integrating into healthcare systems with tools to boost clinic efficiency and support health care providers like free electronic mental health screening questionnaires and algorithms for treatment recommendations means that more patients will be reached, and more prescriptions will be sold. Direct access to patient information input into company tools, such as the questionnaires, as well as control over the tools and their internal algorithms mean that the company can engineer the tools to make recommendations for prescribers that will garner the highest payment from insurance payers. This direct access is solid gold in the pharmaceutical business. The salaries of psychiatrists and mental health professionals are easily paid for by a fraction of the increased revenues in prescription sales. And the opportunity to have psychiatrists and mental health counselors on the pharmaceutical company staff, to interact directly with healthcare system providers and staff as well as patients has shown to be a powerful sales tool that gives healthcare systems the confidence to utilize the company’s platform.

Could this scenario happen? If so, is there a problem with it?

Let’s first consider the positives:

  • Improved patient access for a needed service.
  • Earning potential for expert healthcare providers.
  • Pharmaceutical company is making a healthy profit (as a successful business should)

And the negatives?

  • The pharmaceutical company is essentially monopolizing prescribing for the healthcare system.
  • In the interest of profits, the pharmaceutical company is incentivized to influence prescribing to maximize reimbursement.
  • Excessive prescribing practices may result, that are not necessarily in the best interest of the patient and may incur great costs for the payers and broader health system.
  • The healthcare system is allowing sensitive patient information to be shared with the pharmaceutical company which may also raise patient privacy and data sharing concerns.

Such a scenario is ethically murky and likely would be problematic given state and federal anti-kickback statutes. While patient access to services may be increased, there is a risk that the profit interests of the pharmaceutical company would be prioritized over the best interests of the patients and the healthcare system.

The anti-kickback laws are intent-based, criminal statutes that prohibit intentional remuneration, whether monetary or in-kind, in exchange for referrals or other Federally funded health care program business.

From the Office of the Inspector General (OIG): The types of remuneration covered specifically include, without limitation, kickbacks, bribes, and rebates, whether made directly or indirectly, overtly or covertly, in cash or in kind. In addition, prohibited conduct includes not only the payment of remuneration intended to induce or reward referrals of patients but also the payment of remuneration intended to induce or reward the purchasing, leasing, or ordering of, or arranging for or recommending the purchasing, leasing, or ordering of, any good, facility, service, or item reimbursable by any Federal health care program.

Further the OIG  states that remuneration to encourage referrals in health care can lead to:

  • Overutilization
  • Increased program costs
  • Corruption of medical decision making
  • Patient steering
  • Unfair competition

The above imaginary scenario could be especially problematic given the involvement of healthcare providers, psychiatrists and mental health counselors. The practice of using physicians or other health care professionals involved in direct marketing activities has been termed, “white coat” marketing. See OIG Advisory Opinion No. 11-08: “White coat marketing is closely scrutinized under the anti-kickback statute because physicians and other healthcare professionals are in an exceptional position of public trust and thus may exert undue influence when recommending health care-related items or services…Given the nature of these relationships, when physicians or other health care professionals market items and services to their patients, patients may have difficulty distinguishing between professional medical advice and a commercial sales pitch.”

How does this connect to genetic counseling?

Currently, throughout the United States, genetic testing laboratories are approaching physician clinics, hospitals, and healthcare systems with proposals to help streamline genetic services. These laboratories promise a bi-directional interface with the local EMR to ease test ordering and reporting. They provide screening tools to identify patients who meet clinical guidelines for genetic testing and videos to provide information to support pretest consent. They provide insurance authorization and billing follow-up. And they provide genetic counseling support to patients who use their tests. Furthermore, the labs are often making big claims about the potential for downstream revenue that could be generated from more genetic testing in the system in terms of imaging, risk reducing surgeries, procedures, etc. that may be recommended once high-risk patients are identified.

Could any of these complementary services, in exchange for genetic test orders, be considered an illegal kickback or remuneration? Could the complementary genetic counseling services provided to patients be considered “white-coat” marketing? 

The answer to that question may depend on if there can be a monetary value assigned to provision of genetic counseling services. And, since genetic counselors aren’t recognized under federal CMS as reimbursable, it is possible that there is no clear assignable value for genetic counseling services that would be considered a remuneration by CMS.     

Genetic counselors are often leaving clinical positions for higher paying positions with industry, and healthcare organizations are finding it increasingly difficult to maintain their own locally hired staff. This taken with the fact that healthcare systems have difficulty getting reimbursed for independent genetic counselors who are on staff with their organization, offers of complementary lab-provided genetic counseling bundled up with ease in test ordering are appealing. Labs see marketing by genetic counselors as a powerful sales tool to increase genetic test orders and offer genetic counselors attractive positions in terms of pay and other benefits. And then labs make deals with hospitals, clinics, and healthcare organizations to offer full service genetic healthcare solutions by labs that want to be the one stop shop. With companies that have an interest in selling more and more tests, and healthcare systems having a hard time retaining genetic counselors or getting reimbursed for their services, we will likely see automated processes constructed by the labs to make recommendations about test orders.

I believe genetic counselors can offer excellent services regardless of who employs them. I know that many lab-employed genetic counselors are working hard and taking great care of their patients. And I believe that the tools that the companies provide do have the potential to expand access to genetic testing. What worries me though is that this expansion of testing may not ultimately be what is best for patients and will cost the healthcare system (and thus all of us) greatly. As this landscape continue to shift, with genetic counseling being offered as an incentive to promote test orders of specific test brands, the practice of independent genetic counseling services as we have known them may soon vanish. Our ability to provide unbiased counseling that allows patients to make informed choices about what is best for them (which may not always be a genetic test) and our ability to select that best test, regardless of testing laboratory, will be a thing of the past.

Legislation has been introduced that would allow for genetic counselors to be reimbursed by Medicare, Access to Genetic Counselor Services Act of 2021 H.R. 2144 and S.1450. Medicare recognition of the genetic counseling profession is crucial to ensuring access to independent services. Please consider contacting your representatives and senators to voice your support of these important bills. Learn more here.

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by | February 29, 2016 · 12:25 PM

The GC Crucible: the pressures on modern genetic counselors open the doors to opportunity

A Guest Post By Brianne Kirkpatrick

In a chemistry lab, a ceramic crucible held over an open flame melds disparate materials into a single, new, cohesive thing. Indestructible, it stands up to the heat and pressure. When used in metaphor, it’s a severe test or tribulation that leads to transformation. What comes out of a metaphorical crucible is the true character brought about by the need to adapt and change in a new environment.

 

If there is one thing I can get behind, it’s a belief that our job as genetic counselors is getting

harder. We work in a cauldron of new pressures and new challenges, ones that are causing us to adapt and discover what is at the core of our profession and what make us strong and unique, as individuals and as a cohesive group. We’re in a crucible right now, and that Bunsen burner is cranked up high.

 

Our clinical challenge is that the more we learn about genetics, the more complexity we discover (see item two in Laura Hercher’s top ten stories list for 2015 ). More information makes our job harder, even as it provides new hope for our patients. Similarly, the challenges of discovery and complexity that complicate our lives also provide new opportunities for genetic counselors.

 

How do we capitalize on those opportunities? Here are three suggestions:

 

  1. Rally around the development of the Genetic Counseling Assistant vocation. The NSGC funded a grant to study this, and there have been discussions about this at recent meetings and on various listservs. GCAs job are available, and individuals are employed as GCAs around the country already, in laboratory and clinical settings. Like a para-legal to a lawyer, GCAs master administrative tasks and carry the burden of extra work that often sidelines the genetic counselor or reduces his or her efficiency – phone calls, paper work, records requests, insurance pre-certifications, initial intakes, and the like. The only way we are going to keep up with the demand for GC services is to increase efficiency for ourselves and free up genetic counselors from work that impedes their ability to serve all who need and are seeking their services.

 

  1. Evolve or die. We as a profession must figure out how the future of genomics will include us. To do this we must immerse ourselves in current issues – in the clinic, in the research world, in the spheres of business and government – and then speak up when the genetic counselor voice must be heard. Get involved in your state’s genetic counselors’ group (consider founding one if it doesn’t exist). Volunteer in groups and for projects of the National Society of Genetic Counselors. Develop a professional social media presence. I chose to involve myself in the NSGC Public Policy Committee, believing strongly that taking a stand on issues of policy that affect us as genetic counselors allows us to determine our profession’s destiny, not others. Every committee and special interest group and task force of the NSGC contributes important work to the genetic counseling profession, but none of that work happens unless individuals decide to take that step and get involved.

 

  1. Embrace the expansion of our professional opportunities, despite the shortage of genetic counselors to fill existing clinical and laboratory roles. GC’s are finding opportunities to do something new and different, which is fitting for a group who collectively are thinkers outside of boxes. For as long as the profession has existed, GCs have used creativity, ingenuity and chutzpah, trailblazing new roles out of necessity. In every city and in every specialty area, there was a “first” GC there. If you have been contemplating blazing your own trail, now might be a good time to test out the waters, to find your niche and try something you’ve been dreaming of.

 

There are role models for those looking for them, as GCs excel at identifying needs and making connections. We’re problem-solvers and sleuths, and we’re a resourceful bunch. From this, we have seen Bonnie Liebers develop Genetic Counseling Services, which creates specialized teams of genetic counselors for growing businesses who need them, utilizing a world-wide network of CGCs. A group of GCs recently published an article in the Journal of Genetic Counseling sharing their experiences working for startup companies. I recently launched my own solo venture, WatershedDNA, to provide consultations on ancestry and other home DNA tests, both privately and as a part of larger projects or for companies. The niche I found was filling a need for genetic genealogists, adult adoptees, the donor-conceived community and others, all of them looking for someone who understood the psycho-social dimensions and the science behind genetic testing for ancestry and ethnicity. A perfect role for a genetic counselor, and a match for my own natural interests and passion.

 

Currently, I work one-on-one with clients referred to me by the genetic genealogy community, mostly individuals who have already pursued a home DNA test or are considering it. Just as in a clinical setting, we begin with family history when available and identify a client’s goals and areas of concern. We review any results they already have and discuss additional testing options, and how they might affect them and family members, now and in the future. Working fee for service and owning my own business come with financial uncertainty and lots of unknowns, but it gives me other freedoms, including flexibility and the sense of adventure that comes with pursuing an entrepreneurial path (like my father and grandfather – genetics?). It isn’t easy; I’m a worrier by nature, and some days that Bunsen feels like it’s a-burnin’ hotter than usual. But like the genetic counseling profession as a whole, I’ve found myself in the midst of a crucible that isn’t trying to destroy me; it is providing me an opportunity. A chance to change and create, to extend the reach of genetic counselors. It will engender a future of great things, if I allow it.

 

Let’s be willing to face the uncertainty that the wild west of genetics brings, be daring, and embrace the shades of gray as we blaze new trails. None of us chose the profession of genetic counseling because we thought it would be easy.

 

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by | August 6, 2013 · 7:08 AM

Work, Life & Flexibility in Genetic Counseling

Work/life balance is one of the perks of our profession. Right?

I remember learning that great work/life balance was a benefit of the profession when considering genetic counseling as a career. I now routinely share this ‘fact’ with students who are interested in learning more about becoming a genetic counselor. In comparison with most of my friends– who work in advertising, pr, law and finance– my work/life balance is incredible. I can put in a full day of work, head to the gym and be home by 7pm to enjoy a leisurely evening. My hours are very predictable – and when I leave work I’m not on my phone all night like so many others I know.  So, last summer when the popular article Why woman still can’t have it all was circulating among my female friends, I read it with some distance. 

The author Anne-Marie Slaughter, a professor and former director of policy planning at the State Department, challenges the popular assumptions that if a woman 1) has enough ambition, 2) marries a supportive-enough partner and 3) plans her pregnancies accordingly, she can have a successful career in a position of power and nurture a happy and healthy family life all at once.

In her words,

Women of my generation have clung to the feminist credo we were raised with, even as our ranks have been steadily thinned by unresolvable tensions between family and career, because we are determined not to drop the flag for the next generation…I still strongly believe that women can “have it all” (and that men can too). I believe that we can “have it all at the same time.” But not today, not with the way America’s economy and society are currently structured.

The author goes on to argue that having flexibility in the workplace (namely the ability to determine your own schedule and work from home when needed) is one of the single most important factors in helping to balance a successful career and busy home life.

I am currently on maternity leave, and thinking back to this article I realize that the author’s focus on flexibility really stuck with me. While there are many things I enjoy about working in a busy clinical setting, flexibility is not one of them.

F&A June 2013

If I’m not able to make it in for my 9am patient, then it falls on the shoulders of a colleague, pushing back her own 9:30am appointment, which in turn will affect a whole day full of patients. Like many counselors I know, I very rarely miss a day of work unscheduled. But as I look towards the future imagining an ill child or a caregiver who calls in sick—I realize I may no longer have as much control as I used to. I am reminded daily by my giggling and communicative 5-month old daughter that it is no longer just me I have to worry about. I’m learning that my definition of ‘work/life balance’ may be about to change.

Out of curiosity, I went to Professional Status Survey to get a sense of how we as a profession rate our work/life balance.  Looking at the most recent versions of the National Society of Genetic Counselors and the Canadian Association of Genetic Counsellors surveys, it appears that the question has not been formally asked.

Beyond the clinic

Increasingly, genetic counsellors are working in a wider category of roles and environments. In fact, we have used this blog to highlight diverse GC roles in the past. My childless self had previously seen this primarily as a sign of the genetics field expanding. But it now occurs to me, this may also be in part a result of GCs looking to find a professional opportunity that better suits their lifestyle. I recently came across a nice interview on the Counsyl blog about a genetic counselors’ decision to trade-in clinical life to work from home that would support this view.

The trend towards a non-traditional work environment is happening in almost every sector. Many argue that our society is at a turning point, where lengthening commutes and new technological capabilities are prompting employees and employers to re-consider the traditional workday. For instance, Medcan Clinic – my current employer – has recently increased our services to include Saturday clinics. As our society – including our patient population – increasingly values flexibility, our profession will have to continue to adapt. Responding to changing patient and employee schedules will likely become an even bigger focus in the coming years; and as a result we can expect to see the creation of even more non-traditional services, roles and communication formats.

How might the GC profession maintain its positive work/life reputation in a world that increasingly values flexibility?

The medical world tends to lag other professional service industries when it comes to making change. I recognize that the structure of the traditional genetics clinic will not likely undergo any wholesale changes overnight. Nevertheless, I think this is an important conversation for us to start having now. In fact, I’ll be participating in a panel on technology and innovative communication in genetic counseling at this year’s NSGC conference in Anaheim (excuse the shameless plug).

I would love to hear from other GCs who have thoughts and experiences around this topic. Where do you think the GC role currently stacks up for work/life balance? Have you found ways to integrate more flexibility into your role? Where do you see opportunities & challenges for GCs to better manage work/life as our profession evolves?

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by | January 15, 2012 · 1:04 PM

Blind Spot: Genetic Counselors and Financial Conflict of Interest

Many people don’t know that the human eye has a blind spot in its field of vision. There is a part of the world that we are literally blind to. The problem is, sometimes our blind spots shield us from things that really shouldn’t be ignored. Sometimes our blind spots keep our lives bright and shiny.
– Meredith Grey, character from ABC TV Series Grey’s Anatomy

It’s safe to say that genetic counselors are not in it for the money. I prefer to believe that our practice is guided by what we perceive to be our patients’ best clinical and psychosocial interests, with no concern for fiscal gain for ourselves. But however bright and shiny we may be, we are only human and subject to the same economic pressures, character flaws, and temptations as everybody else. I am not claiming that there is wide scale greed and corruption in the profession. What worries me more is that our blind spot can prevent us from detecting or admitting the possibility of a conflict of interest.

This topic has not been openly discussed among genetic counselors, so it’s about time the subject was broached. I suspect this discussion will evoke discomfort, defensiveness, and not a little denial.  Financial conflicts of interest might arise in many areas of genetic counseling but I will explore just three: when genetic counselors work for laboratories as expert advisors on genetic testing, when we need to justify our clinical positions to hospital administrators, and at our  annual education conference.

 Medical laboratories and their employees are driven by a genuine desire to help referring physicians and their patients. I have been uniformly impressed by the help I receive from lab counselors who have walked me through the testing maze in complicated clinical situations. But let’s face it – labs are profit-driven corporate entities. If an insufficient number of tests are ordered, the laboratory and its investors lose money. Hopefully laboratory directors do not set monthly test quotas (“Resta, I better see 150 TRFs for our new autism screen next month or you are out of a job.”). But if the number of tests drops below a certain threshold, some manager somewhere is going to notice. Labs may choose to discontinue that particular test, but more likely they will try to boost test uptake.
The need to make a profit, with the attendant job security for us, is a powerful motivator that can subconsciously influence conversations between lab counselors and healthcare providers. Think of those gray situations where multiple tests can be ordered but it is unclear just how likely they are to be positive or clinically useful (“Well, this doctor does not want to leave any stone unturned  in working up this family so maybe I should suggest Test X that she hadn’t thought of, even if is very unlikely to be positive and will not change clinical management.”).
Or consider labs that offer SNP testing for risk assessment for common disorders like diabetes or cardiovascular disease, tests that do not yet have proven clinical value. One might justify such testing under the rubric of “Patients Have A Right To Know.” But patients also assume that because a test is available and yields a precise sounding risk estimate, it must have some clinical value, and therefore patients think they have a right to know. Is offering such tests motivated by an altruistic desire to ensure that patients’ rights are not denied, by profit-seeking, or by misguided clinical judgment? The answer is murky.

Genetic counselors who work in medical centers are just as liable to conflicts of interest as their laboratory counterparts. In these tough economic times, we are being called upon to justify our jobs to administrators who face dwindling budgets and might have less of an appreciation for clinical and psychosocial issues. In response, we might look to increase our patient volumes, and one way to do that is to expand the indications for referral to genetic counseling beyond what might be considered “medically necessary.” You might then tell your boss that broadened guidelines will increase downstream revenue through more extensive screening and increased rates of prophylactic surgery. Surely we are not talking our patients into salpingo-oophorectomies or breast MRIs to enrich the hospital’s coffers or to secure our jobs, but that is the  message we are communicating to hospital administration (for the moment, ignoring the fact that we have little data to prove that assertion).

Or think about fetal diagnostic testing through maternal serum, which will presumably reduce the need for amniocentesis and CVS. Even if maternal serum testing proves to be not quite  diagnostic and still require invasive testing for verification, First Positive rates will be much lower than with traditional serum/ultrasound screening. This in turn might lower departmental revenue by reducing the number of counseling referrals,  invasive procedures, and karyotypes. Just how will those economic considerations affect our job security, how we evaluate these new tests, how we present them to our patients, and how we integrate them into our clinics?

The National Society of Genetic Counselors (NSGC), our collective face that we present to the public, has expanded its financial relationship with private laboratories. For example, in 2011, about 25% of the revenue from the Annual Education Conference came from corporate exhibitors and sponsors (contributing ~$216,000 of the total conference revenue of ~$820,000). Our professional relationships with labs are critical on many levels. But  accepting money  from them tacitly – if not officially – condones their services. NSGC would probably not accept certain labs as exhibitors or sponsors if those labs offered questionable  services, like using genetic testing to find the perfect mate or to improve your sex life through nutrigenomics. Excluding some labs lends a certain amount of legitimacy to those labs  from whom we do accept funds.

And let’s not forget those breakfasts and evening debaucheries that some private labs sponsor at every Annual Education Conference, or those  exhibitor booths where we fill our corporate-logo imprinted conference tote bags with giveaway geegaws and doodads (“Oh, I’m just bringing these home for my kids. I am certainly not going to use this lab just because they gave me a glow in the dark double helix pen and a piece of chocolate. Even if it is a Dove dark chocolate.”).

You are deluding yourself if you think these drinks and trifles do not subtly affect your selection of  a lab to run your tests. Just about every research study on this topic has concluded that those not-so-freebies do influence healthcare providers. Besides, if those giveaways didn’t help a business’s bottom line, do you think they would waste money giving them away? And when we go home and take those tote bags to the grocery like responsible Green Citizens, we become walking billboards that announce to the world that NSGC and Lab X are awfully cozy with each other.

I am not saying that genetic counselors should be unconcerned about their institutions’ bottom lines, or that the NSGC should abandon relationships with corporate sponsors. I have no idea of the magnitude of the problem because it has not been systematically studied. It is almost impossible to study it ourselves; those of us in the middle of are likely to have a hard time seeing it. Somebody outside of our profession needs to study this.

What the profession can do for itself is to clearly define financial conflicts of interest and develop guidelines to help genetic counselors navigate the treacherous waters of the Great Sea of Conflicts of Interest.

Am I being overly worried? Are there other aspects of genetic counseling that are vulnerable to these concerns? Share your thoughts and comments and air out this dusty old closet that we have avoided opening.

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by | May 3, 2010 · 4:15 AM

Social Media as Support Resources

Some of you may remember a post I made a few months ago, Emerging Technology vs Old School. I discussed briefly how we have to find ways to incorporate technology into our profession in positive ways.  I also touched on how we cannot forget that there are people who do not have access to technology and they ARE getting left behind.

We cannot ignore either group.  How can we make sure both groups have access to the same information but in different ways?  This is not the main focus of this post.  I just wanted to remind readers that even though in this post I focus on resources that are more available to people who have access to technology, we must not forget that not everyone has access.

Facebooking, Twittering, and Blogging are what I think of when I think of social media.  Facebook groups can serve as support groups.  Blogs can serve as an excellent way to share thoughts and emotions.  Twitter can help connect people going through similar situations.

Since I have Google alerts set up on my Google readers I oftentimes run across blogs written by people who have experienced genetic counseling or have children with genetic conditions.  I have found that reading strangers’ blog posts about their daily life with a genetic condition and their perspective of genetic counseling has taught me so much more than I could ever learn from reading a textbook.

I get their honest opinion.  I learn how misconceptions develop.  I learn about different attitudes and perspectives.  I learn more about people’s thought processes.  This allows me to see their situation from their point-of-view which in turn helps me as a genetic counselor.  An example of a powerful blog website is, CaringBridge.

CaringBridge is a blog website that “connects family and friends when health matters the most.”

“Human connection. That’s the heart of the CaringBridge experience.”

I have read several CaringBridge blogs written by parents with children who have a genetic condition.  I have also read CaringBridge blogs written by people with genetic conditions.  I have read personal stories about how many families are thankful for CaringBridge blogs.  It allows them to share news with concerned ones without having to worry about making multiple calls.  It allows them to express personal thoughts through writing that they may not normally express which helps with the coping process.  It also allows them to find other people who are going through similar situations as they are.  It makes people feel less lonely during scary times.

If used correctly, social media could be a great support resource for patients.   Social media should NEVER replace actual information or serve as a sole resource.   They should simply serve as support resource in the same sense as recommending books and connecting patients who may be going through similar situations.

Would you (or have you) ever suggest social media as a form of support resource for your patients?   How do you make sure it’s appropriate for your patient?

Would you ever use social media as a teaching tool for yourself or for genetic counselor students?  If so, how do you do this?

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by | February 11, 2010 · 11:28 PM

Emerging Technology vs Old School

I don’t know about you but I have a love-hate relationship with technology.  It can make things simpler but it can also make things more difficult.  There are days where I miss old school…..you know….regular paper and pens.  There are also days where I am thankful for oodles of information available at a click.

Regardless of if you love or hate technology, we are in the middle of a technology revolution.  We  have to figure out ways to incorporate technology into our profession in positive ways.   We cannot ignore this revolution.

There has already been some resistance to the incorporation of technology within our profession.   There has been a lot of valid concerns about direct-to-consumer services, telephone genetic counseling, and online family history/pedigree programs.

Patient 2.0 is the concept where people meet online to discuss their health, clinical trials, which hospitals to avoid, which doctors to see, and treatments.  While this encourages people to take charge of their health it can be a danger if they believe inaccurate information found online.   Does Patient 2.0 do more harm than help or is it vice versa?

You can even ask healthcare questions on Twitter.  You can easily search for genetics apps on your iPhone/iTouch.  Some of these apps include; MGenetics, PubSearch, NextBio (correlated data from all public gene expression experiments), Odd Diseases: Genetics, and BioGene).  You can even listen to podcasts or genetic lectures at iTunes U.  If used correctly, apps could be developed to exposure middle and high school students to  the field of genetics.  Apps could also be developed as study tools for genetic counselors, however, we should not depend on these apps.

*Start rant:  Most podcasts and lectures are NOT captioned.  If you ever find yourself making a podcast please subtitle, caption, or make a transcript available.  THANK YOU! *End rant* 🙂

There is a new form being formed and it is a group with full access to technology.  What about those who do not have access to technology (e.g. Internet)?

Two concerns I would like to touch on:

1)      Should healthcare information online be regulated?  Should we start exploring ways to teach the public the limits of technology (e.g. don’t believe everything you read online)?

2)      It is easy to get lost in this technology revolution.  There will soon be a forgotten group.  People who do not have access to or do not feel comfortable with technology will be left behind.   How do we make sure this group will always have equal access to genetic services/information?

How can we combine the pros of both technology and old school in order to provide high quality genetic services for EVERYONE?

Thoughts?

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by | December 14, 2009 · 6:17 PM

Practicing What We Preach: Genetic Counselors, Disability, and Advocacy

Disclaimer:  I do not consider my deafness a disability, however, society defines it as a disability.   Therefore, I utilize quote marks and refer to it as “disability.”

As genetic counselors we are trained to respect and advocate for patients.  We are also trained to not to make pre-assumptions about their strengths, skills, and weaknesses.  Our training doesn’t always seem to apply outside of the counselor-patient setting.

As a deaf person, I knew it would be a difficult journey when I first applied to genetic counseling programs.  Little did I know how difficult it would be as a deaf person to find my place in this profession.  Genetic counselors learn about many different genetic conditions and work with many people who have various genetic conditions.  Oftentimes these genetic conditions fall under the category that society labels “disabilities.”  Even though I do not consider myself to have a “disability,” other genetic counselors sometimes took a different view.

Here are just a few of the barriers I have faced in this field because of my deafness:

  • I have been rejected from genetic counseling programs solely because I was deaf.
  • When I was invited for interviews for genetic counseling programs, I didn’t always have an interpreter available for the whole interview.
  • I was told by rotation supervisors that deaf people should not be genetic counselors.

The list goes on and on but my personal struggles are not the main focus of this post.  I just used some of my personal experiences to serve as examples.

Fortunately, these attitudes are not universal among all genetic counselors.  I have had some positive experiences during my brief career.  For example, I have never had people advocate for me as much as some groups within this field have.   It wasn’t until I started graduate school that, for the first time in my life, I truly felt like there were people out there who did want to see me succeed and were willing to go out of their way to advocate for me.

The barriers I have faced within this profession has made me question how genetic counselors truly view people with “disabilities.”  It has made me question if genetic counselors feel equal or above their patients who have “disabilities.”  Do genetic counselors serve as advocates because of some sort of deep need to help “poor unfortunates” or do they like being in the helper role and not because they truly want to see their patients be successful?  This is a very difficult question to ask of the profession and of ourselves.

I am playing the role of the devil’s advocate here.  This is not intended to be an attack against the genetic counseling profession.  Rather this post is intended to hopefully encourage genetic counselors to question why they may advocate for a person if they’re a patient but not if they’re not a patient.  What does it tell us about ourselves? Why does it appear that the role of serving as advocates have boundaries?  Where are those boundaries?  Should there even be boundaries?

Does it mean society’s attitude towards people with “disabilities” is so powerful and ingrained in us that we have to be specifically trained how to advocate and be on neutral grounds when counseling patients?   Does it mean our training is not good enough for it to cross over in all other aspects of our profession?

Is it that “disability” seems to go hand in hand with being a patient and it’s hard to separate those two?  Is it time to change our perspectives of people with “disabilities” to more than just patients?

I know it is possible for genetic counselors to pull together and advocate for other people.  My question is why doesn’t this happen on a more consistent basis?

Do genetic counselors need to analyze their perspectives on “disabilities” more thoroughly?  How can this be done?  I would love to see this profession become more welcoming to those with “disabilities” instead of constantly questioning their ability.  Oftentimes what one may see as a “disability” is that person’s strength.

I have seen this profession make attempts to make this field more diverse.  Usually diversity is thought to include people from different socioeconomic, ethnic, and religion background.  Why can’t diversity include people with “disabilities?”

I have learned so much from people within this field who have pulled together to advocate for me when the profession tried to work against me.  I want to make this field more accessible to people with “disabilities.” I want to pay forward what I have been given.

I genuinely want to hear your opinion regarding this topic.  It’s the only way I can start to understand why there are so many barriers within this profession and why we only seem to apply our training in certain settings (e.g. patients vs. professionals).

Changes won’t happen until we understand.  To understand something, we need to explore and question things.

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by | November 6, 2009 · 11:59 AM

Professional Certification Debate

I wrote on this blog earlier regarding anxiety surrounding the new ABGC certification exam. To my personal relief, I found out this week that I am amongst those who passed. However, I cannot help but wonder how the passing score was determined and what this new exam means for our profession. What does a passing score on this paricular exam really tell employers, doctors, and patients? Question-Marks

I have spoken to a number of counselors who felt the exam was not focused enough on the genetics that we have worked so hard to become beyond competent in. While I have many thoughts and concerns about the meaning of this exam and its impact on future of the profession, I am going to await further explanation from the ABGC before I write on this more.

If you want an excellent summary of the ongoing discussion amongst genetic counselors about the validity of the exam and results, please check out the blog authored by SLC graduates Sarah Savage and Catherine Clinton:

http://gcqc.wordpress.com/

I am particulary interested in how the previously certified counselors feel about the use of this new exam. Please leave your comments here or at the above named blog.

ANOTHER THOUGHT:  Maybe we should consider moving foward with a general genetic counseling exam and then have subspecialty GC exams i.e prenatal, cancer, metabolic, pediatrics, etc..so we can show where we have special genetics knowledge? Similar to the way in which the ABMG grants their certifcation to biochemical geneticists or cytogeneticists. THOUGHTS?

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