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CMS is hosting an educational call on November 2, 2016 to discuss reporting obligations under the June 23, 2016 Clinical Diagnostic Test Payment System final rule.  As previously reported, under the Protecting Access to Medicare Act (PAMA), certain laboratories must report data to CMS on private payor rates and volume of clinical laboratory tests,…

Last week, the OIG released two new studies analyzing what and how Medicare pays for clinical laboratory tests (“lab tests”).

The first study, Medicare Payments for Clinical Diagnostic Laboratory Tests in 2015: Year 2 of Baseline Data, analyzed Medicare Part B claims data for lab tests performed in 2015 and reimbursed under the Clinical Laboratory Fee Schedule.  OIG compared this data with the same claims data for 2014, and found that, among other things:
Continue Reading New OIG Studies Reveal Clinical Lab Test Payment Trends and CMS’ Progress in Implementing PAMA

CMS has released the preliminary 2017 Medicare clinical laboratory fee schedule (CLFS) payment determinations for new and reconsidered test codes, including determinations regarding whether CMS will use crosswalking or gapfilling to establish payment rates for specific tests.  CMS will accept public comments on these preliminary determinations through October 2016.  Also, CMS has released the 2016…

A number of recent Congressional hearings have focused on health policy issues, including: 

  • Senate Health, Education, Labor, and Pensions Committee hearings on laboratory testing in the era of precision medicine, and the safety of cosmetics.
  • A House Judiciary Committee hearing on “Treating the Opioid Epidemic: The State of Competition in the Markets for Addiction Medicine.”

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In order to assist the clinical laboratory community in meeting new Medicare reporting requirements under the Protecting Access to Medicare Act of 2014 (PAMA), CMS has posted a Clinical Laboratory Fee Schedule Data Reporting Template and a “Quick User Guide” to the template.  By way of background, PAMA requires CMS to base Medicare…

CMS has announced that the next meeting date of the Advisory Panel on Clinical Diagnostic Laboratory Tests will be September 12, 2016.  The meeting is expected to cover:

  • Payment options for routine chemistry tests that are currently paid as Automated Test Panels (ATPs) under the new payment system for clinical diagnostic laboratory tests effective January

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On June 23, 2016, the Centers for Medicare & Medicaid Services (CMS) is publishing a major final rule to base Medicare clinical laboratory fee schedule (CLFS) reimbursement on private insurance payment amounts, as required by the Protecting Access to Medicare Act of 2014 (PAMA). In an important change from the proposed rule, CMS will implement the new payment policy beginning January 1, 2018, rather than in 2017. Once in effect, the impact will be significant; CMS estimates that the final rule will reduce Medicare payments by $390 billion in FY 2018 and by $3.93 billion through FY 2025. The following is an overview of the complex new payment methodology.  Additional details are available in our Client Alert.
Continue Reading CMS Finalizes Changes to Medicare Clinical Lab Test Payment Policy, Pushes Back Effective Date to 2018

CMS has scheduled a July 18, 2016 public meeting on payment for new and substantially revised clinical diagnostic laboratory test codes for payment under the 2017 Medicare clinical laboratory fee schedule (CLFS).  The meeting also will address reconsideration requests regarding final determinations made last year. Registration will open on June 6, 2016, and the deadline …

On February 9, 2016, the Obama Administration released its proposed fiscal year (FY) 2017 budget, which contains significant Medicare and Medicaid reimbursement and program integrity legislative proposals – including $419 billion in Medicare savings over 10 years. These proposed policy changes would require action by Congress, and Republican Congressional leaders have already voiced general…

The House Energy and Commerce Health Subcommittee has scheduled a November 17, 2015 hearing on the regulation of diagnostic tests and laboratory operations.   The hearing will feature FDA and CMS officials who will testify on “each agency’s respective responsibilities and areas of expertise in the regulation of diagnostic tests, as well as what their roles…

On October 1, 2015, the Centers for Medicare & Medicaid Services (CMS) published its long-awaited proposed rule to base Medicare clinical laboratory fee schedule (CLFS) reimbursement on private insurance payment amounts beginning January 1, 2017. CMS estimates that the new policy, which was mandated by the Protecting Access to Medicare Act of 2014 (PAMA), will reduce Medicare CLFS payments by $360 million in FY 2017 and by $5.14 billion over 10 years. CMS will accept comments on the proposed rule until November 24, 2015.
Continue Reading CMS Proposes Major Changes to Medicare Clinical Lab Test Payment Policy

CMS has announced its preliminary 2016 clinical laboratory fee schedule (CLFS) payment determinations for new and reconsidered test codes.  These preliminary determinations will be the subject of an October 19, 2015 meeting of the Advisory Panel on Clinical Diagnostic Laboratory Tests. The public may attend the meeting in-person (registration required), view via webcast, or…

CMS is finally taking steps to implement the Medicare clinical laboratory payment reforms mandated by the Protecting Access to Medicare Act of 2014 (PAMA).  Under PAMA, CMS must base Medicare payment rates for clinical laboratory tests on private payor rates beginning January 1, 2017. The statute requires that CMS establish the parameters for the…

CMS has announced that the first meeting of the Advisory Panel on Clinical Diagnostic Laboratory Tests will be held on August 26, 2015. The Panel will recommend crosswalks for new laboratory codes, recommend an appropriate coding structure for drugs of abuse testing, and recommend crosswalks for such drugs of abuse testing. Registration for the…

On October 27, 2014, CMS published a notice announcing that it is establishing an Advisory Panel on Clinical Diagnostic Laboratory Tests, as authorized by the Protecting Access to Medicare Act of 2014 (PAMA). The Panel will provide recommendations to CMS on the following issues:

  • Calculation of weighted median for laboratory services using private payor

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On September 30, 2014, the Food and Drug Administration (FDA) announced the availability of two draft guidances intended to implement a new regulatory oversight framework for LDTs, which are defined by the FDA as “a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory” and which are intended for clinical use. Release of the documents follows on the heels of FDA’s notification to Congress in late July of its intent to issue draft guidance in this area. The first draft guidance, “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (Framework Guidance), describes a risk-based framework for addressing the regulatory oversight of LDTs. The Framework Guidance also describes FDA’s priorities for enforcing pre- and post-market requirements for LDTs, and the process by which FDA intends to phase in enforcement of FDA regulatory requirements for LDTs over time. The second draft guidance, “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)” (Notification and Reporting Guidance), describes the process for clinical laboratories to notify FDA of the LDTs they manufacture as well as the Medical Device Reporting (MDR) requirements for clinical laboratories that manufacture LDTs. Both draft guidances reflect the FDA’s effort to take steps to encourage the advancement of personalized medicine by helping to ensure the reliability of certain diagnostic tests. The guidances are neither final nor in effect at this time. 

The following is an overview of the specific issues addressed in the draft guidances:Continue Reading FDA Releases Two Draft Guidance Documents on Proposed Laboratory Developed Test (LDT) Regulatory Oversight