Clinical Laboratories

News & Analysis as of

Summary of Clinical Laboratory Fee Schedule Reform Provisions in the Protecting Access to Medicare Act of 2014

On April 1, the Protecting Access to Medicare Act of 2014 was enacted into law (Pub. L. 113-93). Section 216, entitled Improving Medicare Policies for Clinical Diagnostic Laboratory Tests, modernizes the Medicare payment...more

Medicare OPPS Lab "Packaging" Policy Raises Bundle of Issues

In previous Payment Matters articles, we described a policy included in the 2014 hospital outpatient prospective payment system (OPPS) final rule that would “package” certain clinical laboratory tests into OPPS, and CMS...more

Provisions of Interest to Labs in the Protecting Access to Medicare Act of 2014

The Protecting Access to Medicare Act of 2014 (HR 4302), signed by President Obama yesterday, contains a number of provisions that are important to clinical laboratories, and they include...more

Sweeping Changes to Medicare Payment for Clinical Laboratory Services

On March 31, 2014, the Senate gave final approval to the Protecting Access to Medicare Act of 2014 (the Act), which includes significant reforms to the way Medicare pays for clinical diagnostic laboratory services. The House...more

Lab Results on Demand: CLIA/HIPAA Amendment Increases Patient Access

A new final rule (the “Final Rule”) from the Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention, and the Office for Civil Rights (collectively, the “Agencies”) gives patients and their...more

CMS Take Steps to Modernize Clinical Lab Policies

Through two recently issued regulations, the Centers for Medicare and Medicaid Services have announced their intention to reform and improve Medicare policies addressing clinical diagnostic laboratory services. These...more

CMS Provides Guidance Regarding OPPS "Packaging" of Clinical Laboratory Tests

In a previous Payment Matters article, we described a new CMS policy under which, effective January 1, 2014, hospitals would no longer be permitted to bill Medicare separately for clinical laboratory tests for hospital...more

CMS Finalizes HIPAA and CLIA Amendments Intended to Increase Patient Access to Test Results

Yesterday the Centers for Medicare & Medicaid Services (CMS) finally published the long-awaited final rule amending the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and...more

Changes Ahead for Laboratories Doing Business in Pennsylvania

New legislation enacted last month will change the way many laboratories do business in Pennsylvania. Senate Bill 1042 (SB 1042), which amends Pennsylvania’s Clinical Laboratory Act (the Act), now prohibits several practices...more

CMS "Packages" Clinical Laboratory Tests Into Outpatient Prospective Payment System

Hospitals Lose Right to Bill Separately for Laboratory Tests for Outpatients - As part of its calendar year 2014 hospital outpatient prospective payment system (OPPS) policy changes, the Centers for Medicare & Medicaid...more

OMB Extends Review of Rule That Would Require Labs to Release Results to Patients

The Office of Management and Budget has extended its review of a proposed rule that would require HIPAA-covered laboratories to make test results available to patients. In our previous post on this issue way back in...more

CMS Announces Plans to Modernize and Update the Clinical Laboratory Fee Schedule

On November 27, 2013, Centers for Medicare & Medicaid Services posted the final 2014 Medicare physician fee schedule and, in it, announced plans to change how and how much Medicare pays for clinical diagnostic laboratory...more

CMS Issues Medicare Physician Fee Schedule Without Finalizing Proposal Most Harmful to Independent Laboratories

On the day before Thanksgiving and a little over one month after the end of the government shutdown, the Centers for Medicare & Medicaid Services (“CMS”) published a rule finalizing revisions to payment policies under the...more

Ordering/Referring Provider Edits To Be Turned On Effective January 6, 2014

On November 6, 2013, CMS announced that it plans to turn on claims processing edits (effective January 6, 2014) to deny Part B clinical laboratory and imaging, and DMEPOS, and Part A home health agency claims that fail...more

HHS Delays Require Changes to Notice of Privacy Practices for Certain Clinical Laboratories

Last week the Department of Health and Human Services (“HHS”) announced that it has postponed the Sept. 23, 2013, HIPAA Omnibus Rule deadline for many clinical laboratories to revise their notices of privacy practices...more

FTC Files Complaint Against Lab Over Failed Health Information Security

In a reminder that the U.S. Department of Health and Human Services (“HHS”), with its HIPAA security requirements and enforcement authority, is not the only game in town when it comes to health information privacy, the...more

Is Medicare Zero for Three? Diagnostics Policy Proposals for CY2014

Introduction - Each July, the Medicare agency makes policy proposals for changes in reimbursement for services delivered by physicians, hospital outpatient centers, and independent laboratories. For CY2014, CMS...more

2013-2014: Evolving Challenges for Value-Priced LDTs

Introduction - In 2004, the Genomic Health Oncotype DX breast cancer molecular test was launched and within five years had substantially changed the standard of care for patients with early breast cancers. How has the...more

FTC Complaint Against Medical Laboratory Signals Agency’s Continued Intent to Assert Authority in Data-Security-Breach Actions

In taking action against medical laboratory LabMD, the U.S. Federal Trade Commission demonstrated its continued intent to assert authority through the Federal Trade Commission Act in data-security-breach actions. On August...more

OIG rejects management arrangement that carves out federal healthcare program patients

The Office of Inspector General of the Department of Health and Human Services recently posted an Advisory Opinion describing a proposed arrangement by a clinical laboratory. ...more

Proposed Medicare Cuts Would Significantly Impact Independent Laboratories

Last week, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule setting forth revisions to payment policies under the Medicare Physician Fee Schedule (MPFS) and other revisions to Medicare Part B for...more

CMS Proposes Changes to Modernize and Update the Clinical Laboratory Fee Schedule

On July 8, 2013, the Centers for Medicare & Medicaid Services (CMS) released a pre-publication version of the 2014 Medicare Physician Fee Schedule and the 2014 Medicare Hospital Outpatient Prospective Payment System Notices...more

CMS Issues Second Set of Proposed Rule in Response to Executive Order 13563

The proposed rule, issued on February 7, 2013, would make reforms to existing Medicare regulations applicable to hospitals, ambulatory surgical centers, intermediate care facilities for individuals who are intellectually...more

CMS Issues Proposed Rule to Reform "Unnecessary, Obsolete, or Excessively Burdensome" Medicare Participation Standards

On February 4, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to reform Medicare regulations that CMS views as unnecessary, obsolete, and/or excessively burdensome on hospitals and health care...more

Washington Attorney General's Office Opinion Undermines Electronic Health Records Donation Programs

In 1949, the Washington Legislature enacted what has become known as the “anti-rebate statute,” codified as RCW Chapter 19.68. Rep. Eileen Cody recently asked the state Attorney General (AG)’s Office whether this statute...more

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