Tag Archives: Clinical Laboratories

CMS Announces July 18 Public Meeting on 2017 Medicare Clinical Lab Fee Schedule

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 for presenter registration and submission … Continue Reading

Extensive Medicare & Medicaid Funding and Program Integrity Provisions in Obama’s Released FY 2017 Budget Proposal

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 opposition … Continue Reading

Upcoming Health Policy Hearings

Several Congressional hearings are scheduled next week and into December on health policy issues, including: A November 17 Senate Finance Committee hearing entitled “Physician Owned Distributors: Are They Harmful to Patients and Payers?” A November 17 House Judiciary Subcommittee on Regulatory Reform hearing on “The State of Competition in the Pharmacy Benefit Manager and Pharmacy … Continue Reading

House Energy & Commerce Panel Releases Draft Bill to Regulate Diagnostic Lab Tests, Schedules November 17 Hearing

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 … Continue Reading

CMS Proposes Major Changes to Medicare Clinical Lab Test Payment Policy

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 … Continue Reading

CMS Releases Preliminary 2016 Determinations for New Clinical Lab Tests, Announces October 19 Open Meeting on Clinical Lab Payments

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 listen … Continue Reading

OMB Reviewing CMS Proposed Rule on PAMA Clinical Lab Test Payment Policy

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 private … Continue Reading

First Meeting of Advisory Panel on Clinical Diagnostic Laboratory Tests on August 26, 2015

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 meeting … Continue Reading

CMS Seeking Nominations for New Advisory Panel on Clinical Diagnostic Lab Tests

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 rates. … Continue Reading

FDA Releases Two Draft Guidance Documents on Proposed Laboratory Developed Test (LDT) Regulatory Oversight

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 … Continue Reading

House Panel to Examine FDA Lab-Developed Test Policy

On September 9, 2014, the House Energy and Commerce Subcommittee on Health is holding a hearing entitled “21st Century Cures: Examining the Regulation of Laboratory Developed Tests.” The hearing will focus on the FDA’s recent guidance on the regulation of lab developed tests and its “impact on innovation and the practice of precision medicine.”… Continue Reading

Questionable Billing for Medicare Clinical Lab Claims

According to an OIG report, “Questionable Billing for Medicare Part B Clinical Laboratory Services,” Medicare allowed $1.7 billion for clinical laboratory claims in 2010 associated with eight types of “questionable billing.” Such indicators of questionable billing identified by the OIG include: claims for beneficiaries with no associated Part B service with ordering physician; claims with beneficiaries living … Continue Reading

OIG Issues Special Fraud Alert on Lab Payments to Referring Physicians

Today the HHS OIG issued a Special Fraud Alert highlighting its concerns regarding two trends involving transfers of value from laboratories to physicians that the OIG believes “present a substantial risk of fraud and abuse under the anti-kickback statute.” Specifically, the OIG details risks involved with certain compensation paid by laboratories to referring physicians and physician … Continue Reading

CMS Adopts Final Rule to Reduce Provider Regulatory Burdens

On May 12, 2014, the Centers for Medicare & Medicaid Services (CMS) published a final rule that reforms federal health policy regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. The rule also is intended to eliminate or reduce requirements that impede quality patient care or that … Continue Reading

Individualized Quality Control Plan for CLIA Laboratory Non-Waived Testing (May 19)

CMS is hosting a provider call on May 19, 2014 regarding the Clinical Laboratory Improvement Amendments (CLIA) Individualized Quality Control Plan (IQCP), which is a new, voluntary quality-control option for laboratories performing non-waived testing. The IQCP is intended to provide laboratories with more flexibility in customizing Quality Control (QC) policies and procedures according to test method … Continue Reading

CMS Releases Physician-Specific Medicare Charge/Payment Data

CMS has released its highly-anticipated data files with Medicare payment data for individual Medicare physicians and certain other Part B suppliers as part of the Obama Administration’s initiative “to make our healthcare system more transparent, affordable, and accountable.” Specifically, the “Physician and Other Supplier Public Use File” contains information on utilization, payment (allowed amount and Medicare … Continue Reading

HHS OIG Identifies “Top 25” Priorities

The OIG has released its “Compendium of Priority Recommendations,” which lists 25 priority issues for which the OIG has open recommendation and that, if implemented, would best protect the integrity of HHS programs. The 25 top priorities are as follows: Medicare Policies and Payments: address wasteful Medicare policies and payment rates for clinical laboratories, hospitals, and … Continue Reading

President Signs Medicare Physician Fee Schedule/SGR Patch with Numerous Health Policy Provisions

On April 1, 2014, President Obama signed into law H.R. 4302, the "Protecting Access to Medicare Act of 2014" ("the Act"). The Act includes a one-year Medicare physician fee schedule fix that averts a nearly 24 percent payment cut set for April 1, 2014, but which falls far short of earlier hopes for full repeal of the current sustainable growth rate (SGR) formula. The Act also includes numerous other Medicare payment and policy changes, including skilled nursing facility value-based purchasing provisions, reforms to the physician fee schedule relative valuation process, a new framework for clinical laboratory payments, a variety of changes impacting imaging services, changes in the exceptions for long term care hospitals, and extension of certain expiring provisions. In other areas, the bill includes a one-year delay in the transition to ICD-10, changes to the timetable for Medicaid disproportionate share hospital cuts, and "front-loading" of the 2024 Medicare sequestration reduction.… Continue Reading

CMS Public Meeting on Clinical Lab Codes (July 14)

CMS is holding a public meeting on July 14, 2014 to receive comments on the appropriate basis for establishing payment amounts for new or substantially revised HCPCS codes being considered for Medicare payment under the clinical laboratory fee schedule for 2015. The meeting also provides a forum for those who submitted reconsideration requests regarding final … Continue Reading

Final HIPAA Rule Gives Patients Right to Access Test Results Directly from Labs

On February 6, 2014, the Department of Health & Human Services (HHS) published a final rule making changes to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations to provide individuals with a greater ability to directly access their laboratory test reports. The rule is … Continue Reading
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