All posts by dlemle

ACLA Statement on LDT Proposed Rule Comments by FDA and CMS

Washington, D.C. – In response to a joint release from the U.S. Food & Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) on a proposed rule to regulate laboratory developed tests (LDTs) as medical devices, the below statement can be attributed to American Clinical Laboratory Association (ACLA) President Susan Van Meter.

“ACLA late last year provided extensive comments urging the FDA to withdraw the proposed rule that seeks to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act. We firmly maintain that LDTs are not medical devices and regulating them as such would be harmful to patients and would severely hamper innovation in the next generation of diagnostics. Laboratories and the LDTs they develop have made – and continue to make – extraordinary contributions to patient care and public health. Every day, LDTs help physicians and patients to diagnose diseases and make informed health care choices. Rather than imposing a device framework that is inappropriate for LDTs, ACLA encourages FDA to work with Congress, ACLA, and other stakeholders to develop legislation that would establish a role for FDA in the regulation of LDTs aligned with their already robust oversight.”

Read ACLA’s full comment letter here.

###

The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.

ACLA Welcomes Mary Lee Watts and Elyse Oveson to Key Positions

Washington, D.C. – The American Clinical Laboratory Association (ACLA) has welcomed Mary Lee Watts as Vice President of Government Affairs and Policy and Elyse Oveson as Chief of Advocacy Operations.

As Vice President of Government Affairs and Policy, Mary Lee will lead development and implementation of the organization’s strategic advocacy agenda to promote policy priorities in the areas of reimbursement, regulatory, and public health preparedness and infrastructure. She will also guide comprehensive advocacy efforts to influence policies and legislation that reflect the value of clinical diagnostics, support innovation, and expand access to testing services that improve health. 

Mary Lee most recently served as Director of Federal Affairs at the American Society for Microbiology, where she oversaw policy development, outreach and engagement with Congress and federal agencies with a broad focus on annual appropriations and issues impacting the microbial sciences and public health. She previously held advocacy positions with the American Association for Cancer Research, American Society for Nutrition, and the Academy of Nutrition and Dietetics. Mary Lee holds a Master of Public Health degree in Nutrition from the University of North Carolina and a Bachelor of Science degree in Molecular Biology from Vanderbilt University. Additionally, she was recognized with a 2023 Top Lobbyist award by the National Institute for Lobbying & Ethics (NILE).

As Chief of Advocacy Operations, Elyse will leverage her policy and advocacy expertise and trade association experience to guide the organization’s execution of advocacy priorities. She will also advance ACLA’s strategic initiatives that highlight the value of clinical laboratories for policymakers and other key stakeholders.

Elyse previously served as Senior Director of Federal Relations for the Healthcare Association of New York State (HANYS), where she helped execute federal regulatory and legislative advocacy agendas, with an in-depth understanding of policy priorities related to hospitals, post-acute care settings, and safety net providers. She has held legislative positions with a former member of the New York State congressional delegation and with Park Strategies, LLC. Elyse has a Master of Arts degree in Government from Johns Hopkins University and a Bachelor of Arts degree in Political Science from Union College.

“Mary Lee and Elyse bring a deep understanding of the health policy landscape and strong successes in advocacy that will further enhance ACLA’s mission to advance the policy priorities of the nation’s leading clinical laboratories, and the patients and clinicians they serve,” said ACLA President Susan Van Meter. “We’re thrilled that Mary Lee and Elyse have joined ACLA and know the knowledge and leadership they bring to their respective roles will be invaluable to our members.”  

Additionally, ACLA is pleased to announce that Holly Grosholz, who joined ACLA in 2022, has been promoted to Senior Director of Government Affairs. In her new role, she will manage the implementation of ACLA’s strategic advocacy agenda and coordinate with Congress and federal agencies on priority topic areas. This includes leading Congressional and stakeholder efforts relating to the Saving Access to Laboratory Services Act, a key policy issue for the organization. Holly previously served as Director of Government Relations at the Medical Imaging & Technology Alliance (MITA). Prior to MITA, she worked at the American Public Health Association. Holly earned a Bachelor of Arts degree in Political Science at Bucknell University.

###

The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.

FDA Proposed Rule to Regulate LDTs as Medical Devices Would Slow Development of Critical Lab Tests and Should be Withdrawn, ACLA Urges

FDA Regulation of LDTs is Misguided; Requires Congressional Authorization

Washington, D.C. – The American Clinical Laboratory Association (ACLA) today submitted comments urging the U.S. Food and Drug Administration (FDA) to withdraw its proposed rule to regulate laboratory developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act. 

LDTs are an indispensable pillar of the nation’s health care system, providing patients and physicians with diagnostic information to inform clinical care, power precision medicine, contribute to the discovery of novel therapeutics, and lead the fight against emerging pathogens. Laboratories and the LDTs they develop have made – and continue to make – extraordinary contributions to the public health. FDA’s proposed rule, if finalized, would jeopardize the ongoing ability of laboratories to develop and offer innovative LDTs essential to delivering the latest scientific advances in diagnostics to patient care.  

“ACLA has grave concerns with FDA’s proposed rule, both as a matter of public policy and law, and urges FDA to withdraw it,” said ACLA President Susan Van Meter. “FDA fails to provide a sound justification for its unilateral action, which would impose ill-suited and inflexible medical device authorities on LDTs. The net result of this action would be to reduce patient access to essential testing, including for rare diseases, and hamper innovation in the next generation of diagnostics. Device authorities are rigid and would not allow LDTs to keep pace with scientific advances. Further, the proposed rule exceeds FDA’s legal authority, as LDTs are not devices and cannot be regulated as such.”

In its comments, ACLA provided a detailed assessment of FDA’s cost-benefit analysis included in proposed rule. In short, FDA significantly underestimates the costs associated with implementing the rule and vastly overestimates the claimed benefits.  

The FDA’s proposed rule fails to recognize the essential role that LDTs play in health care delivery and the already significant federal and state regulation and assessment of LDTs. In fact, laboratories and the LDTs they offer are subject to robust regulation under federal and state statutes, supplemented by rigorous accreditation standards and review by payers.

For several years, ACLA has worked collaboratively with FDA, Congress, and key stakeholders on legislation that could have established an appropriate regulatory system for all diagnostics, complementary to the already robust oversight of LDTs. The goal has been to develop a regulatory approach that would account for the unique attributes of laboratory diagnostics while balancing diagnostic innovation, maintaining access to important tests, and regulatory oversight. 

ACLA steadfastly maintains that legislation is the right – and only – approach for further oversight of LDTs. ACLA believes the proposed rule represents regulatory overreach and should be withdrawn.

Read the full comment letter here.

###

The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.

ACLA Statement on One-Year Delay to Clinical Laboratory Payment Cuts Being Included in Congressional Spending Package

Washington, D.C.– The American Clinical Laboratory Association (ACLA) commends the inclusion of critically needed relief from looming Medicare payment cuts to clinical laboratory services in the short-term spending package passed by Congress on Wednesday, November 15.

The bill provides a one-year reprieve from Medicare cuts of up to 15 percent for approximately 800 laboratory services that would have gone into effect in January 2024. ACLA remains focused on securing passage of the Saving Access to Laboratory Services Act (SALSA), which would mitigate years of pending reductions, setting Medicare payment for clinical laboratory services on sustainable pathway.

“ACLA is grateful to Congress for including a short-term reprieve from Medicare laboratory payment cuts and data reporting as part of the stopgap funding bill. Resumption of year-over-year cuts would threaten patient access to quality clinical laboratory services, reduce investment in innovation for the next generation of diagnostics, and weaken the nation’s clinical laboratory infrastructure,” said ACLA President Susan Van Meter. “We are thankful to Senators Sherrod Brown (D-OH) and Thom Tillis (R-NC), and Representatives Richard Hudson (R-NC), Bill Pascrell, Jr. (D-NJ), Gus Bilirakis (R-FL), Scott Peters (D-CA), Brian Fitzpatrick (R-PA), Larry Bucshon (R-IN), Ann Kuster (D-NH), and Dan Crenshaw (R-TX), the bipartisan champions of the Saving Access to Laboratory Services Act (SALSA), and the dozens of co-sponsors across both chambers for ensuring cuts will not resume in January. The one-year delay is essential and in 2024 we will continue partnering with the 70 patient and provider organizations and the bipartisan and bicameral SALSA champions in Congress to advance SALSA as a sustainable, long-term solution to this problem.”

Medicare reimbursement for clinical laboratory services has been set on an unsustainable path of multi-year, double-digit reimbursement cuts resulting from the Protecting Access to Medicare Act of 2014 (PAMA), which relied on a narrow and unrepresentative sample to set Medicare reimbursement rates for hundreds of common laboratory tests. Since the enactment of PAMA, there have been three rounds of payment cuts of up to 10 percent that have impacted 72 percent of tests on Medicare’s Clinical Laboratory Fee Schedule.

Learn about ACLA’s “Stop Lab Cuts” campaign here, which seeks Congressional action on planned Medicare payment cuts to clinical laboratories and features broad support from organizations serving patients, providers, and hospitals.

###

The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.

Clinical Laboratories Empower Patients to Take Charge of Diabetes

November is American Diabetes Month, a chance to bring awareness to the fundamental role of clinical laboratories in diagnosing and managing this chronic, progressive health condition. Diabetes affects more than 37 million Americans, yet more than 20% people who have it are unaware.[1]

One of the main tests used in both diagnosis and treatment of diabetes is the A1C, also known as the hemoglobin A1C or HbA1c.[2] It is an important tool that measures average blood sugar levels over the prior three months, and is relied upon to manage diabetes and detect chronic high-glucose levels that correlate with a risk of long-term complications.[3]

Other tests include:

  • Blood tests such as a fasting blood test, which measures the level of glucose after an overnight fast; glucose tolerance test, which measures levels before and after drinking a liquid that contains glucose, and random blood sugar tests, which show blood glucose levels at the time of testing.[4]
  • Genetic testing, done by specialized clinical laboratories to identify genetic risk factors for diabetes and to help develop appropriate treatments and pregnancy planning in families affected by rare forms of diabetes associated with gene mutations.[5]
  • Urine testing, used to check levels of blood sugar and ketones, is another tool in diabetes management. Ketones are chemicals produced in the liver that can build to dangerous levels when there is not enough insulin to allow blood sugar into cells for energy. This can cause diabetic ketoacidosis, which can be life-threatening.[6]
  • C-peptide tests to assess the level of this hormone, which is produced in the pancreas and helps glucose get into cells to produce energy. Measuring C-peptide in a sample of blood or urine is a way to measure how much insulin is being produced in the body.[7]

Annual recommended blood testing can detect prediabetes, a treatable condition in which glucose levels are elevated but have not yet progressed to diabetes. As with other diseases, early detection allows prompt treatment that can delay or prevent serious complications associated with later stages of the disease. Clinical laboratory tests inform patients and their caregivers when glucose levels are too high or too low, guiding treatment toward better control of the disease.

There was a time when diabetes inevitably led to a life of illness. But today, thanks to advances in clinical testing that allows for earlier detection and tighter control of blood glucose levels, people with diabetes can reduce their risk of life-limiting complications and live longer, healthier lives.


[1] American Diabetes Association, https://diabetes.org/about-diabetes/statistics/about-diabetes#:~:text=Prevalence%3A%20In%202019%2C%2037.3%20million,of%20the%20population%2C%20had%20diabetes.&text=Diagnosed%20and%20undiagnosed%3A%20Of%20the,and%208.5%20million%20were%20undiagnosed.

[2] https://www.cdc.gov/diabetes/managing/managing-blood-sugar/a1c.html#:~:text=The%20A1C%20test%E2%80%94also%20known,care%20team%20manage%20your%20diabetes.

[3] The United States National Library of Medicine, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4933534/#:~:text=HbA1c%20is%20an%20important%20indicator,of%20long%2Dterm%20diabetes%20complications.

[4] Centers for Disease Control & Prevention, https://www.cdc.gov/diabetes/basics/getting-tested.html.

[5] National Institute of Diabetes and Digestive and Kidney Diseases, https://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes/monogenic-neonatal-mellitus-mody#:~:text=Some%20rare%20forms%20of%20diabetes,from%20one%20or%20both%20parents.

[6] Centers for Disease Control & Prevention, https://www.cdc.gov/diabetes/basics/diabetic-ketoacidosis.html#:~:text=People%20with%20type%202%20diabetes,that%20produces%20acids%20called%20ketones.

[7] MedlinePlus, https://medlineplus.gov/lab-tests/c-peptide-test/#:~:text=This%20test%20measures%20the%20level,can%20be%20used%20for%20energy.

ACLA Statement on House Energy and Commerce Subcommittee Hearing on Medicare Legislation

Washington, D.C. – The American Clinical Laboratory Association’s (ACLA) President, Susan Van Meter, issued the following statement after the House Energy and Commerce Committee’s Health Subcommittee hearing examining Medicare reforms to improve patient access to care.

“ACLA is grateful for the Health Subcommittee’s consideration of legislation to provide relief for yet another wave of scheduled Medicare payment cuts. Set to resume on January 1, 2024, these anticipated cuts once again threaten access to critical clinical laboratory services that America’s seniors depend on. The Saving Access to Laboratory Services Act (SALSA) is a bipartisan and bicameral long-term solution that will help protect patient access to testing, support investment in diagnostics innovation, and strengthen the nation’s public health infrastructure. ACLA is deeply appreciative of subcommittee members who have co-sponsored SALSA and urges Congress to Stop Lab Cuts this year.”

Learn more about ACLA’s “Stop Lab Cuts” campaign here, which features broad support from organizations serving patients, providers, and hospitals.

###


The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.

Clinical Laboratories Key to Breast Cancer Diagnosis and Treatment

In the United States, a woman’s average risk of developing breast cancer at some time during her life is about 13%, meaning women face a one in eight chance of developing the disease.[1] October, National Breast Cancer Awareness Month, highlights the burden of this disease to increase patient knowledge and to highlight the critical importance of regular screenings to improve survival rates.

Clinical laboratories play a vital role in all aspects of breast cancer care, including identifying the disease, describing, and understanding its traits, and providing critical information that can guide decisions on individualized treatment.

While breast cancer accounts for 30% of all new female cancers each year,[2] men are affected, too, though at a much lower rate of about one in every 833 men.

The causes of breast cancer are complex, with some types related to hereditary genetics and others linked to gene changes in cancer cells. The most well-known genetic determinants are inherited mutations in the BRCA 1 and BRCA 2 genes (BReast CAncer genes 1 and 2), which can be passed from either parent to child. When present, these mutations significantly increase the risk of breast cancer in women. For instance, among women who inherit a harmful BRCA 1 variant, 55% to 72% will develop breast cancer by age 70-80 years. Of those with the harmful BRCA 2 variant, 45% to 69% will develop breast cancer by that age.[3]

However, the risk for any one woman may involve many factors. Clinical laboratories conduct multi-gene biomarker testing, which helps identify patients at risk and those who are likely to benefit from a given therapy.

Genetic testing performed by clinical laboratories helps recognize whether someone has an inherited gene that could increase the chance of developing breast cancer. Those who have received a diagnosis of breast cancer are offered clinical laboratory tests to identify and characterize cancerous cells through the examination of biopsy samples. These tests reveal the type of breast cancer, the stage or extent of the cancer, and help guide a patient’s treatment plan.

Clinical laboratories also analyze the size of a tumor, determine whether there is possible lymph node involvement, and describe microscopic characteristics of tumors. This information helps to predict the likelihood of cancer recurrence and helps patients and oncologists to design long-term treatment strategies, which may include breast surgery, chemotherapy, hormone therapy, radiation, or other options.

Once surgery or other treatments have been completed, clinical laboratory tests can, by examining surgical margins and lymph nodes, detect any remaining cancer cells, which can suggest the need for further treatment. Biomarker testing on cancer tissue or fluid helps determine the most effective treatment options in individual cases.

Clinical laboratories also can perform advanced genomic and molecular testing to help pinpoint changes in DNA that may spur the growth of an individual’s tumor. This information can help oncologists make decisions regarding targeted drug therapies or immunotherapy drugs for treatment.

Adjuvant chemotherapy after breast surgery has been shown to reduce the recurrence of cancer, leading a National Institutes of Health panel to recommend it in most patients, but in some cases, it may be unnecessary. Gene assay tests can help predict the possible benefits of chemotherapy treatment, identifying patients with early breast cancer who may be spared adjuvant chemotherapy.[4] Gene expression tests provide more information about the cancer cells and help tailor personalized treatment, predicting which patients are most likely to benefit from chemotherapy to reduce the risk of recurrence of cancer after breast surgery.

Other clinical laboratory tests, such as a complete blood count (CBC), blood chemistry tests, and tumor markers, can help determine if a patient is well enough to undergo surgery, chemotherapy, or immunotherapy as part of treatment.

Breast cancer is the most common cancer in women, with more than 2 million cases diagnosed worldwide in 2018,[5] and nearly 300,000 new cases expected in the U.S. this year.[6] But over the years, the prognosis for long-term survival has improved dramatically. Currently, five-year survival rates for women with non-metastatic breast cancer are 91%, and the 10-year survival rate is 85%.[7]

This hopeful trend is attributed in large part to widespread use of screening programs that lead to early diagnosis, when treatment is most effective, and to advances in molecular understanding of tumors, and subtype classification that leads to treatment personalization.[8] Clinical laboratories play an essential role in this progress, resulting in better outcomes for all people with breast cancer.

For additional information on breast cancer, visit https://www.cdc.gov/cancer/breast/basic_info/what-is-breast-cancer.htm.


[1] American Cancer Society, https://www.cancer.org/cancer/types/breast-cancer/about/how-common-is-breast-cancer.html#:~:text=Overall%2C%20the%20average%20risk%20of,will%20never%20have%20the%20disease.

[2] American Cancer Society, https://www.cancer.org/cancer/types/breast-cancer/about/how-common-is-breast-cancer.html#:~:text=Overall%2C%20the%20average%20risk%20of,will%20never%20have%20the%20disease.

[3] National Cancer Institute, https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet.

[4] The New England Journal of Medicine, https://www.nejm.org/doi/full/10.1056/nejmoa1804710.

[5] National Institutes of Health (NIH), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7308500/

[6] American Cancer Society, https://www.cancer.org/cancer/types/breast-cancer/about/how-common-is-breast-cancer.html#:~:text=Overall%2C%20the%20average%20risk%20of,will%20never%20have%20the%20disease.

[7] American Society of Clinical Oncology (ASCO), https://www.cancer.net/cancer-types/breast-cancer/statistics#:~:text=The%205%2Dyear%20relative%20survival%20rate%20for%20women%20in%20the,vary%20based%20on%20several%20factors.

[8] National Institutes of Health (NIH), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7308500/.

ACLA Opposes Unilateral FDA Action to Regulate Laboratory Developed Tests Under Medical Device Authority

Washington, D.C. – The American Clinical Laboratory Association (ACLA) today issued the following statement after the U.S. Food and Drug Administration (FDA) released a proposed rule that would seek to regulate Laboratory Developed Tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act. ACLA does not believe that FDA’s actions are in the best interest of patients or our nation’s health care system. Because the proposed rule exceeds FDA’s existing authority, ACLA plans to submit comments urging FDA to withdraw the proposed rule and resume work with Congress, the laboratory community, patient groups, and other stakeholders toward a legislative solution that provides a framework that is appropriate for the unique attributes of LDTs.

“ACLA has long taken the position that FDA does not have statutory authority to regulate LDTs under its medical device authority and strongly opposes unilateral action that exceeds the Agency’s current authority. LDTs are not medical devices. To the extent that FDA secures legislative authority to regulate LDTs, it must be through a regulatory framework that works with, not against, the LDT regulation already in place through the Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA).

Any expansion of FDA’s role in this framework should be tailored by Congress to fit LDTs, just as has been done for food, supplements, drugs, and cosmetics – each of which has a distinct framework suited to the unique characteristics of its category. We also are concerned that FDA is already under resourced and not prepared to complete all of the new work the Agency has now proposed to undertake. FDA seriously risks falling behind on its current public health priorities. 

ACLA strongly believes FDA regulation of LDTs could only be done through legislation that establishes a diagnostic-specific, risk-based framework that recognizes the essential role of clinical laboratories in advancing public health, preserving and fostering innovation, and maintaining access to critical testing services that physicians and patients rely on every day.

During the last Congress, ACLA worked collaboratively with bipartisan co-sponsors of the Verifying Accurate Leading-edge IVCT Development (VALID) Act, committees of jurisdiction, FDA, and private sector stakeholders to provide expertise around key provisions of the legislation that resulted in significant improvements in the bill to help protect access and innovation for patients. While VALID was not enacted by Congress last December, ACLA remains committed to working productively with Congress on diagnostic-specific legislation. 

Clinical laboratory testing is an essential part of health care that informs 70 percent of health care decisions. Billions of tests are run each year by ACLA member laboratories that are certified under CLIA and accredited by the College of American Pathologists (CAP). These include tests developed during health emergencies like COVID-19 and MPX and for unmet needs. For example, the only clinical tests currently available to detect fentanyl with xylazine are LDTs.

The current system works well for patients and significant changes to the regulatory structure should be done carefully and thoughtfully to avoid unintended consequences that could reduce access to testing, undermine innovation in next generation diagnostics, and increase health care costs.

ACLA believes there remains bipartisan interest in Congress and among key stakeholders to establish a pathway tailored to the dynamic nature of laboratory diagnostics, rather than applying a framework that Congress never intended for this purpose. ACLA urges FDA to resume its work toward a legislative solution. Pursuing a significant change in the regulatory framework without congressional authorization does not benefit patients and risks FDA falling behind on its current public health priorities.”

###

The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.

ACLA, Key Stakeholders Urge Medicare Administrative Contractors to Ensure Access to Genetic Testing for Oncology

Washington, D.C. – The American Clinical Laboratory Association (ACLA), along with 44 stakeholders, sent a letter to Medicare Administrative Contractors (MACS), Novitas Solutions Medical Affairs and First Coast Service Options, Inc. (FCSO), raising significant concerns with their draft local coverage determinations (LCDs) that, within their jurisdictions, would harm access to clinically appropriate genetic testing for Medicare beneficiaries with cancer. The signatories united in opposition to the draft LCDs include the nation’s leading cancer-related provider groups and patient advocates. The concerns raised by the broad group echoed those detailed in a separate letter ACLA sent to the MACs on the same date.

As it currently stands, the draft LCDs, entitled “Genetic Testing for Oncology,” would automatically deny coverage for any genetic tests not currently included within at least one of three identified third-party “knowledgebases.” ACLA and fellow signatories note that this approach does not comport with the requirements of the Social Security Act and implementing guidance, nor does it give stakeholders sufficient information to evaluate the contractors’ coverage decisions through the required notice-and-comment procedures and process.

Under the draft LCDs, if a genetic test is not included in the “knowledgebases” and non-covered, a provider, organization, or Medicare beneficiary may submit a reconsideration request. However, this process is not transparent, can take years and would delay patient access to testing.

All patients, especially those with cancer, require timely access to diagnostics that inform their treatment. ACLA and stakeholders believe there is broader concern that the draft LCDs’ presumptive non-coverage approach will create additional barriers for Medicare beneficiaries seeking access to newer, and often more innovative, diagnostics.

“Medicare beneficiaries with cancer should have robust and timely access to valuable, appropriate genetic tests used to guide their treatment,” said Susan Van Meter, ACLA President. “We urge Novitas and FCSO not to finalize this LCD as drafted and instead work with stakeholders to address our significant concerns.”

The letter is available here and the appendix can be found here. A complete list of signatories is below:

Advanced Practitioner Society for Hematology and Oncology

AliveAndKickn

American Cancer Society Cancer Action Network

American Clinical Laboratory Association

American College of Medical Genetics and Genomics

American Gastroenterological Association

American Society for Clinical Pathology

American Society for Radiation Oncology

Association for Molecular Pathology

Association of Community Cancer Centers

Biomarker Collaborative

Bladder Cancer Advocacy Network (BCAN)

Blood Profiling Atlas in Cancer (BLOODPAC)

Cancer Support Community

Cancer Support Community Delaware

Cancer Support Community Greater Lehigh Valley

CancerCare

Caregiver Action Network

Cholangiocarcinoma Foundation

College of American Pathologists

Community Liver Alliance

FORCE: Facing Our Risk of Cancer Empowered

Free ME from Lung Cancer

GI Cancers Alliance

Gilda’s Club South Florida, Inc.

GO2 for Lung Cancer

ICAN, International Cancer Advocacy Network

Living Beyond Breast Cancer

Lung Cancer Research Foundation

LUNGevity Foundation

MET Crusaders

National Alliance of State Prostate Cancer Coalitions

National Marrow Donor Program/Be The Match

National Ovarian Cancer Coalition

Patient Advocates In Research (PAIR)

Patient Empowerment Network

PD-L1 Amplifieds

Raymond Foundation

Sharsheret

The Clearity Foundation

The Exon 20 Group

The Life Raft Group

The White Ribbon Project

Triage Cancer

Upstage Lung Cancer

###

The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.