Clinical Laboratory Fee Schedule (CLFS)

Clinical Laboratory Fee Schedule (CLFS) / en Sat, 26 Apr 2025 00:11:54 -0500 Wed, 31 Jul 24 11:47:24 -0500 Medicare Physician Fee Schedule Proposed Rule for CY 2025 <div class="container"><div class="row"><div class="col-md-8">The Centers for Medicare &amp; Medicaid Services (CMS) July 10 issued its physician fee schedule (PFS) <a href="https://public-inspection.federalregister.gov/2024-14828.pdf">proposed rule</a> for calendar year (CY) 2025. The rule also includes proposals related to the Medicare Shared Savings Program (MSSP) and the&nbsp;Quality Payment Program (QPP), both of which were created by the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015. Comments on the proposed rule are due to CMS by Sept. 9. The final rule will be published on or around Nov. 1, and finalized policies will generally take effect Jan. 1, 2025.<div class="panel module-typeC"><div class="panel-heading"><h2>Key Highlights</h2>CMS’ proposed policies would:<ul><li>Reduce the PFS conversion factor by 2.8% to $32.36, as compared to $33.29 in CY 2024.</li><li>Delay implementation of the rebased and revised Medicare Economic Index (MEI) until future rulemaking.</li><li>Extend certain telehealth waivers through 2025, including the waiver allowing for reporting of enrolled practice addresses instead of home addresses when providers perform services from their home.</li><li>Establish new payments for practitioners offering certain behavioral health crisis services and digital mental health treatment as well as for interprofessional consultations by non-physician mental health practitioners.</li><li>Codify policies established in its revised guidance for the Medicare Part B and Part D Drug Inflation Rebate Programs and propose new and revised policies for these programs.</li><li>Revise the data reporting period and phase-in of payment reductions for clinical laboratory tests under the Clinical Laboratory Fee Schedule (CLFS).</li><li>Add provisions for Medicare Parts A and B overpayment, including adoption of&nbsp; new standards for investigation and identification of overpayments, and extension of deadlines to investigate and calculate overpayments in certain circumstances.</li><li>Exclude suspected anomalous spending from financial calculations for the MSSP.</li><li>Require MSSP accountable care organizations (ACOs) to report a new Advanced Alternative Payment Model (APM) Pathway Plus measure set and streamlines reporting options.</li><li>Add six new Merit-based Incentive Payment System (MIPS) Value Pathways (MVPs) for CY 2025 and solicit feedback on mandating MVP participation starting with the 2029 reporting period.</li></ul></div></div><h2><a>AHA Take</a></h2>CMS’ proposed payment update poses a significant threat to patient access to care and provider financial stability, particularly for safety-net providers. Our concern is heightened because this proposed cut comes in the wake of decreases to physician payment over the last two decades. Indeed, inflation and rising input costs continue to outpace reimbursement for services covered by the PFS.The AHA also is concerned with policy proposals regarding Medicare Parts A and B overpayments. While we appreciate that CMS is seeking to ensure providers have adequate time to conduct appropriate investigations of potential overpayments, the proposed 180-day window for investigations is not sufficient for large health care providers, such as hospitals and health systems to fully investigate and calculate overpayments. Additional flexibility is needed to support providers that are making good-faith efforts to investigate and calculate overpayments but may not be able to complete this process in six months.We thank CMS for proposing to extend certain telehealth flexibilities through 2025. However, the AHA urges CMS to work with Congress to adopt permanent waivers of other provisions, such as eliminating the originating and geographic site restrictions for all telehealth services and expanding telehealth eligibility to certain practitioners. Without action, many of these critical waivers are scheduled to expire at the end of 2024.We also are pleased that CMS proposes to exclude suspected anomalous spending from financial calculations for the MSSP, specifically excluding such spending from performance year financial calculations and benchmarking.<h2><a>What You Can Do</a></h2><ul><li>Share this advisory with your chief medical officer, chief financial officer and other members of your senior management team, as well as key physician leaders and nurse managers.</li><li>Register&nbsp;<a href="https://aha-org.zoom.us/webinar/register/WN_vJNHoZDBRZmc__V7S_2wSw">here</a> to participate in AHA’s members-only webinar on Friday, Aug. 9 at 1 p.m. ET to discuss the proposed rule.</li><li>Assess&nbsp;the potential impact of the proposed payment and quality changes on your Medicare revenue and operations.</li><li>Submit comments to CMS with your specific concerns by Sept. 9 at&nbsp;<a href="http://www.regulations.gov">www.regulations.gov</a>.</li></ul>See the PDF below for the complete analysis of the proposed rule.</div><div class="col-md-4"><a href="/system/files/media/file/2024/07/medicare-physician-fee-schedule-proposed-rule-for-cy-2025-advisory-7-31-2024.pdf" target="_blank" title="Click here to download the Regulatory Advisory: Medicare Physician Fee Schedule Proposed Rule for CY 2025 PDF."><img src="/sites/default/files/2024-07/cover-medicare-physician-fee-schedule-proposed-rule-for-cy-2025-advisory-7-31-2024.png" data-entity-uuid data-entity-type="file" alt="Regulatory Advisory: Medicare Physician Fee Schedule Proposed Rule for CY 2025 cover." width="NaN" height="NaN"></a></div></div></div> Wed, 31 Jul 2024 11:47:24 -0500 Clinical Laboratory Fee Schedule (CLFS) CLIA final rule addresses Certificate of Waiver sanctions, personnel qualifications /news/headline/2024-01-02-clia-final-rule-addresses-certificate-waiver-sanctions-personnel-qualifications The Centers for Medicare &amp; Medicaid Services and the Centers for Disease Control and Prevention Dec. 28 released a <a href="https://public-inspection.federalregister.gov/2023-28170.pdf">final rule</a> updating Clinical Laboratory Improvement Amendments fees and clarifying CLIA regulations. Within the final rule, CMS amends provisions governing alternative sanctions (including civil money penalties, a directed plan of correction, a directed portion of a plan of correction and onsite state monitoring) to allow for the imposition of such sanctions against non-compliant laboratories operating under Certificates of Waiver, rather than being limited only to imposing principal sanctions of revocation, suspension or limitation of a laboratory’s CLIA certificate. AHA last August <a href="/lettercomment/2022-08-23-aha-cms-proposed-rule-risks-weakening-clias-high-regulatory-standards">commented</a> on the rule as proposed, urging CMS to avoid changes that would weaken the program’s high regulatory standards and so is pleased that the agency has removed the proposed addition of a nursing degree qualification for high complexity testing personnel. AHA is reviewing the policy and will update members with further information as appropriate. Tue, 02 Jan 2024 15:02:00 -0600 Clinical Laboratory Fee Schedule (CLFS) House subcommittee advances Medicare legislation /news/headline/2023-11-15-house-subcommittee-advances-medicare-legislation During a legislative <a href="https://energycommerce.house.gov/events/health-subcommittee-markup-of-21-legislative-proposals" target="_blank">markup</a>&nbsp;Nov. 15, the House Energy and Commerce Health Subcommittee advanced to the full committee AHA-supported legislation (H.R. 6366) that would extend for one year the Geographic Practice Cost Index floor for physician work under the Medicare Physician Fee Schedule and delay for one year payment reductions of up to 15% under the Medicare Clinical Laboratory Fee Schedule. The bill also would delay for one year a CLFS requirement that certain hospital outreach laboratories, independent clinical laboratories and physician offices report private payer data for certain clinical laboratory services. Without congressional action, the changes are scheduled to take effect Jan. 1 under the Protecting Access to Medicare Act of 2014. &nbsp; In addition, the subcommittee advanced legislation (H.R. 6364) that would prevent Medicare from publicizing a telehealth provider’s home address when the provider delivers telehealth services from their home. AHA has further <a href="/testimony/2023-10-19-aha-statement-committee-energy-and-commerce-subcommittee-health-re-medicare-legislative-proposals" target="_blank">urged</a> Congress to remove a requirement that these telehealth providers report their home address on Medicare enrollment and claims forms effective Jan. 1, 2025. &nbsp; The subcommittee also advanced legislation (H.R. 6369) that would extend the 3.5% incentive payment for eligible Advanced Alternative Payment Model participants for the CY 2026 period. AHA supports the extension, but would prefer Congress to restore the incentive payment to 5% and remove the legislation’s payment reductions for longstanding participants. Wed, 15 Nov 2023 14:27:11 -0600 Clinical Laboratory Fee Schedule (CLFS) Congress Urged to Pass Medicare Laboratory Payment System Update /lettercomment/2023-05-22-congress-urged-pass-medicare-laboratory-payment-system-update May 22, 2023 <table border="0" cellpadding="1" cellspacing="1"> <tbody> <tr> <td>The Honorable Kevin McCarthy Speaker U.S. House of Representatives Washington, DC 20515</td> <td>The Honorable Charles Schumer Majority Leader U.S. Senate Washington, DC 20510</td> </tr> <tr> <td> The Honorable Hakeem Jeffries Minority Leader U.S. House of Representatives Washington, DC 20515</td> <td> The Honorable Mitch McConnell Minority Leader U.S. Senate Washington, DC 20510</td> </tr> </tbody> </table> Dear Leader Schumer, Speaker McCarthy, Minority Leaders Jeffries and McConnell: As organizations representing clinical and pathology laboratories, health care providers, laboratory professionals, and diagnostic manufacturers, we urge Congress to take immediate action to pass S. 1000 / H.R. 2377, the Saving Access to Laboratory Services Act (SALSA). This bicameral, bipartisan legislation would update Medicare’s payment system for laboratory services to make it predictable and sustainable, ensuring our nation’s laboratory infrastructure is equipped to support the full range of testing that patients need for day-to-day care as well as during times of public health crisis, while fostering innovation in new diagnostics. Without congressional action, Medicare reimbursement cuts – a fourth round scheduled to begin January 1, 2024 – could jeopardize access to many clinical laboratory tests that are used to diagnose, monitor, prevent, and manage common diseases for Medicare beneficiaries. Clinical diagnostic tests are foundational to clinical decision making, informing 70 percent of medical decisions that guide patient care. For example, in 2020 Medicare beneficiary care was supported by more than 17 million hemoglobin A1C tests that assessed diabetes risk, 28 million tests that diagnosed and monitored heart disease, and 90,000 tests that diagnosed leukemia and hereditary breast and colon cancer. A strong, national laboratory infrastructure is critical to ensuring that testing can be rapidly developed and made widely available when pathogens of concern are identified. Simply put, clinical laboratories strive to be prepared for whatever the next pathogen of concern may be and in times of emergency are part of the nation’s critical infrastructure. Furthermore, a healthy laboratory industry is essential to foster innovation in advanced diagnostics, which has not only led to earlier detection of disease but has also become a crucial tool in how care is delivered. In cancer, early detection and diagnosis of cancer and cancer biomarkers facilitate an understanding of disease progression and selection of an appropriate treatment regimen for each patient. Enactment of SALSA would address what has been years of deep Medicare payment cuts, while updating Medicare’s payment system to ensure clinical laboratory services are on a sustainable pathway forward. Between 2017 and 2022, payment for some common tests for diseases like diabetes, cancer, and heart disease were cut by 27 percent. The next round of Medicare cuts would drop reimbursement up to another 15 percent for about 800 laboratory tests widely used to screen and manage many serious diseases. It is essential that Congress protect patients by acting this year to fix the Medicare payment model for clinical diagnostic tests. Because of the serious implications for patients who rely on routine as well as advanced diagnostic laboratory services, Congress has acted three times to delay these cuts in recent years, but permanent reform is needed now. Fortunately, the Saving Access to Laboratory Services Act would update Medicare’s payment system, which would help protect access to clinical laboratory testing, support investment in innovation, and strengthen America’s clinical laboratory infrastructure. On behalf of clinical laboratories, laboratory professionals, health care providers and stakeholders across the country, we urge you to pass the Saving Access to Laboratory Services Act before the end of the year. We would welcome the opportunity to discuss this critical issue with you and your staff, further. Please reach out to Holly Grosholz at hgrosholz@acla.com and Meg Riley at mriley@dc-crd.com should you have additional questions or wish to schedule a meeting with our organizations. Sincerely, AdvaMedDx ADVION (Formerly the National Association for the Support of Long Term Care (NASL)) American Academy of Family Physicians American Association for Clinical Chemistry American Association of Bioanalysts American Clinical Laboratory Association American College of Medical Genetics and Genomics American College of Osteopathic Family Physicians �� Association American Medical Association American Medical Technologists American Society for Clinical Laboratory Science American Society for Clinical Pathology American Society for Histocompatibility and Immunogenetics American Society for Microbiology American Society of Nephrology AMGA Association for Molecular Pathology Association of American Medical Colleges Association of Pathology Chairs Association of Public Health Laboratories California Clinical Laboratory Association COLA Inc. College of American Pathologists Federation of ��s Infectious Diseases Society of America (IDSA) Medical Group Management Association (MGMA) National Independent Laboratory Association National Rural Health Association New Jersey Association of Mental Health and Addiction Agencies, Inc. New York State Clinical Laboratory Association Personalized Medicine Coalition Point of Care Testing Association The Gerontological Society of America Mon, 22 May 2023 11:38:19 -0500 Clinical Laboratory Fee Schedule (CLFS) CMS: Clinical laboratories must report private payer data beginning Jan. 1  /news/headline/2022-11-07-cms-clinical-laboratories-must-report-private-payer-data-beginning-jan-1 Independent, physician office and hospital outreach laboratories that meet the definition of an applicable laboratory under the Clinical Laboratory Fee Schedule must report certain private payer data between Jan. 1 through March 31, 2023, the Centers for Medicare &amp; Medicaid Services said in a <a href="https://www.cms.gov/outreach-and-educationoutreachffsprovpartprogprovider-partnership-email-archive/2022-11-03-mlnc#_Toc118275856">reminder</a>&nbsp;last week. The AHA and 25 other organizations have <a href="/news/headline/2022-09-08-congress-urged-update-medicare-laboratory-payment-system">urged</a>&nbsp;congressional leaders to enact the Saving Access to Laboratory Services Act (H.R.8188/S.4499), bipartisan legislation that would further delay Medicare’s CLFS payment reductions and reduce burdensome reporting requirements for these laboratories, who without congressional action face another 15% payment cut in January. Mon, 07 Nov 2022 16:01:00 -0600 Clinical Laboratory Fee Schedule (CLFS) Congress Urged to Update Medicare Laboratory Payment System /lettercomment/2022-09-08-congress-urged-update-medicare-laboratory-payment-system September 8, 2022 &nbsp; <table border="0" cellpadding="1" cellspacing="1"> <tbody> <tr> <td>The Honorable Nancy Pelosi Speaker U.S. House of Representatives Washington, DC 20515</td> <td>The Honorable Charles Schumer Majority Leader U.S. Senate Washington, DC 20510</td> </tr> <tr> <td>The Honorable Kevin McCarthy Minority Leader U.S. House of Representatives Washington, DC 20515</td> <td>The Honorable Mitch McConnell Minority Leader U.S. Senate Washington, DC 20510</td> </tr> </tbody> </table> Dear Speaker Pelosi, Leader Schumer, Minority Leaders McCarthy and McConnell: As organizations representing laboratories, health care providers, laboratory professionals, and diagnostic manufacturers, we respectfully urge Congress to take action to protect patient access to clinical laboratory services by enacting the Saving Access to Laboratory Services Act (SALSA/H.R. 8188/S.4449) prior to January 1, 2023. SALSA is bipartisan and bicameral legislation to update Medicare’s payment system for clinical diagnostic lab services, ensuring seniors and patients have access to essential diagnostic tests. In 2014, Congress passed The Protecting Access to Medicare Act (PAMA/P.L. 113-93) to reform the Medicare Clinical Laboratory Fee Schedule (CLFS) to a single national fee schedule based on private market data from all types of laboratories that service Medicare beneficiaries, including independent labs, hospital outreach labs, and physician office labs (POLs). Unfortunately, the first round of data collection in 2017 failed to capture adequate and representative private market data, leaving out virtually all hospital outreach labs and significantly under sampling POLs. The significant under sampling led to nearly $4 billion in cuts to those labs providing the most commonly ordered test services for Medicare beneficiaries. For context, the total CLFS spend for 2020 was only $8 billion, less than 3% of Medicare Part B spending. Congress has intervened on a bipartisan basis three times to delay the next CLFS reporting periods and twice to delay cuts to maintain access to lab services for patients. However, without a sustainable solution to this problem, labs face another round of cuts of up to 15% in January of 2023. This, at a time when we remain at the forefront of patient care and responding to public health disruptions and threats such as COVID-19. The Saving Access to Laboratory Services Act (SALSA/H.R. 8188/S.4449) is a permanent solution that would set Medicare reimbursement for lab services on a sustainable path forward. SALSA will give CMS with new authority to collect private market data through statistically valid sampling from all laboratory segments for the widely available test services where previous data collection was inadequate. The bill ensures true private market rates are included, provides a much-needed reduction in reporting burden, and protects labs and Medicare from dramatic rate increases or decreases with a gradual phase-in approach going forward. In short, enactment of the Saving Access to Laboratory Services Act (SALSA/H.R. 8188/S.4449) is urgently needed this year, to allow laboratories to focus on providing timely, high quality clinical laboratory services for patients, continuing to innovate, and building the infrastructure necessary to protect the public health. Again, for these reasons, we respectfully urge Congress to protect patients by enacting SALSA this year, prior to the resumption of cuts to laboratories on January 1, 2023. We would welcome the opportunity to discuss this critical issue with you and your staff, further. Please reach out to Tom Sparkman at <a href="mailto:mailto:tsparkman@acla.com">tsparkman@acla.com</a> and Erin Morton at <a href="mailto:mailto:emorton@dc-crd.com">emorton@dc-crd.com</a> should you have additional questions or wish to schedule a meeting with our organizations. Thank you for your time in considering this request. Sincerely, AdvaMedDx American Academy of Family Physicians American Association of Bioanalysts American Association for Clinical Chemistry American Clinical Laboratory Association �� Association American Medical Association American Medical Group Association (AMGA) American Medical Technologists American Society for Clinical Laboratory Science American Society for Clinical Pathology American Society for Microbiology (ASM) Association of American Medical Colleges Association for Molecular Pathology (AMP) Association of Public Health Laboratories California Clinical Laboratory Association (CCLA) COLA Inc. College of American Pathologists Federation of ��s Infectious Diseases Society of America Medical Group Management Association (MGMA) National Association for the Support of Long Term Care National Hispanic Medical Association National Independent Laboratory Association New York State Clinical Laboratory Association Point of Care Testing Association Thu, 08 Sep 2022 14:25:42 -0500 Clinical Laboratory Fee Schedule (CLFS) AHA to CMS: Proposed Rule Risks Weakening CLIA’s High Regulatory Standards /lettercomment/2022-08-23-aha-cms-proposed-rule-risks-weakening-clias-high-regulatory-standards The Honorable Chiquita Brooks-LaSure Administrator Centers for Medicare &amp; Medicaid Services Hubert H. Humphrey Building 200 Independence Avenue, S.W., Room 445–G Washington, DC 20201 RE: CMS-3326-P, Clinical Laboratory Improvement Amendments (CLIA) Fees: Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories: Proposed Rule (Vol. 87, No. 142), July 26, 2022. Dear Administrator Brooks-LaSure: On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, our clinician partners — including more than 270,000 affiliated physicians, 2 million nurses and other caregivers — and the 43,000 health care leaders who belong to our professional membership groups, the �� Association (AHA) appreciates the opportunity to comment on the Centers for Medicare &amp; Medicaid Services’ (CMS) proposed rule on Clinical Laboratory Improvement Amendments (CLIA) Fees, Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories. The objective of CLIA is to ensure high quality laboratory testing; indeed, since CLIA was enacted, the quality of laboratory testing has improved. In this rule, CMS proposes to update several components of the CLIA regulations, which the agency notes have not been substantially updated since 1992. In our comments below, the AHA offers feedback on the proposed changes to the testing personnel requirements and the application of alternative sanctions to certificate of waiver (CoW) laboratories. <h2>Testing Personnel Requirements</h2> The nation’s clinical laboratory professionals play a crucial role in health care. The testing they perform is key to the early detection, diagnosis and treatment of disease in patients. The more complex the test is to perform or interpret, the more stringent are the CLIA personnel, instrument and testing requirements. In the rule, CMS proposes to add nursing degrees, including an earned doctoral, master's and bachelor's degree in nursing, as a means to qualify as high complexity testing personnel. The AHA does not support this proposal. The types of laboratory tests classified by CMS as high complexity require a level of knowledge, training and result interpretation that we believe exceeds the typical nurses training — even at the doctoral and masters’ levels. High complexity tests also require extensive expertise in the technical aspects of clinical laboratory testing, such as complex and consistent sample preparation, which is critical to proper test completion and accurate interpretation of results, but is not taught in nursing programs. Further, nursing degrees generally include a lower amount and level of academic science and clinical training in non-waived laboratory testing that is necessary for qualified laboratory professionals. For example, bachelor’s degrees in medical laboratory science, biology and chemistry generally require at least 35 to 45 semester hours of academic science, with significant upper-level coursework. By contrast, bachelor's degrees in nursing often require less than 14 semester hours in biology and/or chemistry, and usually only at the introductory level. By proposing that nursing degrees should be considered as equivalent to clinical laboratory science, biology and chemistry degrees, CMS’ proposal also would result in individuals with nursing degrees not being required to meet any other coursework or clinical training requirements under CLIA. We are concerned that this would weaken CLIA’s regulatory structure and its ability to continue to ensure the highest quality of laboratory testing. In its rationale, CMS states that nurses perform the majority of point-of-care (POC) testing, and therefore the agency does "not have any reason to believe that nurses would be unable to accurately and reliably perform moderate and high complexity testing." It is true that advances in the technology of laboratory testing have allowed more testing to be provided closer to where patients are located, through the expansion of POC testing in hospitals and health systems, and that nurses play an important role by performing such testing. However, these tests are mostly simple waived tests (such as dipstick urinalysis tests) performed at the patient’s bedside, for which there are no CLIA personnel requirements. Given the substantial difference in test complexity between waived and high complexity tests, we are not convinced by CMS’ rationale. The AHA encourages the agency not to finalize this proposal, which we believe would weaken CLIA’s intent to safeguard the quality of laboratory testing. <h2>Alternative Sanctions for Certificate of Waiver (CoW) Laboratories</h2> In the current CLIA regulations, CMS may impose alternative sanctions (i.e., directed plan of correction, civil money penalty, state onsite monitoring) in lieu of, or in addition to, the more onerous principal sanctions (i.e., revocation, suspension, or limitation sanctions) for non-compliance in all CLIA-certified laboratories, except for CoW laboratories. CoW laboratories are laboratories that only perform waived tests, that is, simple laboratory examinations and procedures that have an insignificant risk of an erroneous result. In our comments to a January 2018 CMS request for information, the AHA recommended that the imposition of alternative sanctions should be an option for all CLIA-certified laboratories, and noted that it should particularly be an option for proficiency test (PT) referral violations for waived tests. CMS notes that during the COVID-19 public health emergency, this additional authority was temporarily granted via an interim final rule related to the pandemic. The AHA supports CMS’ proposal to make this a permanent change by continuing to permit the use of alternative sanctions in CoW laboratories. The use of alternative sanctions instead of principal sanctions should continue to be an option to create parity for all certificate types, especially in cases of PT referral. We appreciate your consideration of these issues. Please contact me if you have questions or feel free to have a member of your team contact Roslyne Schulman, director of policy, at <a href="mailto:mailto:rschulman@aha.org" target="_blank">rschulman@aha.org</a> or 202-626-2273. Sincerely, /s/ Stacey Hughes Executive Vice President Tue, 23 Aug 2022 11:54:32 -0500 Clinical Laboratory Fee Schedule (CLFS) AHA, others urge Congress to delay clinical laboratory payment cuts, reporting /news/news/2021-11-30-aha-others-urge-congress-delay-clinical-laboratory-payment-cuts-reporting Twenty-five organizations, including the AHA, today urged Congress to immediately extend the hold on payment cuts and the private payer data reporting period under the Clinical Laboratory Fee Schedule due to the continued COVID-19 public health emergency.&nbsp; “While we are grateful that Congress delayed the implementation of CLFS cuts in 2021 as part of the Coronavirus Aid, Relief, and Economic Security Act, we urge you to extend this delay — for both the 2022 cuts and the next private payer data reporting period — as the Public Health Emergency has not ended, and laboratories must continue to respond,” the organizations said in a <a href="/lettercomment/2021-11-30-aha-others-urge-congress-delay-clinical-laboratory-payment-cuts-reporting">letter</a> to congressional leaders.&nbsp; “As we approach the end of the second year of the COVID-19 pandemic, our nation’s clinical laboratories continue to work tirelessly on the front lines of the response. However, the flawed implementation of the Protecting Access to Medicare Act (PAMA) has resulted in drastic cuts to some of the most frequently ordered clinical laboratory tests. In just a few weeks, laboratories are scheduled to see cuts as large as 15% to some of the most common tests on their menus — basic clinical laboratory tests that are essential to the health and wellbeing of Americans.”&nbsp; Tue, 30 Nov 2021 14:52:29 -0600 Clinical Laboratory Fee Schedule (CLFS)