FDA Seeks to Regulate Laboratory Developed Tests

On July 31, 2014, the Food and Drug Administration (“FDA”) announced that it would begin regulating laboratory developed tests (LDTs).  According to the FDA, LDTs are designed, manufactured, and used within a single lab, and include some genetic tests and tests that are used by various health care professionals.  These tests are developed by hospitals, academic, […]

Proposed Rule to Extend and Amend the Exception to Donate Electronic Health Records Items and Services

The Office of Inspector General for the Department of Health and Human Services (OIG) and the Centers for Medicare and Medicaid Services (CMS) published on April 10, 2013 proposed rules to extend and amend the Electronic Health Records (EHR) donation exceptions under the Anti-Kickback Statute and Stark Law, respectively. The proposed rules would extend the […]

Selected Bills before New York State Senate Health Committee for the 2013 Session

A few bills of note for health care providers in New York were introduced in the New York State Senate with the opening of the 2013 legislative session.  Each of these bills was formally introduced on January 9 and referred to the Senate Health Committee. An act allowing patients to see their laboratory results upon […]

HIPAA: Conversion to Version 5010

As of January 1, 2012, all healthcare providers were required to transition from version 4010/4010A to version 5010 standards for submitting electronic transactions, and the failure to comply may result in claim denials or a government investigation. CMS has repeatedly postponed enforcement, but it appears the agency will begin to enforce civil monetary penalties against […]

Legal Hurdles Mount for Lab Corp and Quest

The U.S. Department of Justice (DOJ) and the Federal Trade Commission (FTC) recently released their Annual Report for Fiscal Year 2011 under the Hart-Scott-Rodino Antitrust Act. In brief, the Hart-Scott-Rodino Act allows the DOJ and FTC to block transactions believed to be harmful to competition and consumers. The Annual Report reviews the enforcement activities undertaken by these […]

The Wild, Wild West of Billing by Out-of-Network Labs and Waivers of Patient Responsibility

O’Connell & Aronowitz attorneys, Jeffrey Sherrin, Kurt Bratten, and Charles Dunham, spoke at a national meeting of clinical laboratories in Las Vegas on May 19, on the complicated issue of referrals to and billing by out- of-network (OON) clinical laboratories, and the waiver of patient responsibility.  Waivers of copays, deductibles and balance billing have been used […]

HHS Proposes Rule Giving Patients Direct Access to Lab Test Results

Yesterday, the U.S. Department of Health and Human Services (“HHS”) published a proposed rule in the Federal Register which would allow medical patients to get their laboratory test results directly from the lab.  A copy of this proposed rule is available here.  At present, only a handful of states allow direct access to lab results.  […]

CMS Officially Withdraws Physician Signature Requirement

As we previously reported here and here, it was just a matter of time before the Center for Medicare & Medicaid Services (CMS) officially withdrew its rule requiring physician signatures on all laboratory requisitions for clinical diagnostic laboratory tests paid under the Clinical Laboratory Fee Schedule (CLFS). Today, CMS formally withdrew this requirement based on […]

Clinical Laboratories Recover over $5 Million in Landmark Victory over New York State Department of Health

Over $5 million is being refunded by the New York State Department of Health (NYSDOH) to 35 clinical laboratory members of the American Association of Bioanalysts (AAB), as a result of a lawsuit filed 12 years ago by O’Connell and Aronowitz.  The case was handled by Jeffrey J. Sherrin. As we previously reported, on February […]

CMS Will Change Physician Signature Requirement for Laboratory Requisitions

As we previously reported, on February 11, 2011, the Center for Medicare & Medicaid Services (CMS) informed various trade associations that it was pulling back a new rule requiring physician signatures on all laboratory requisitions. Although an official announcement to this effect was expected due to concerns expressed by lab associations and others, it appears […]