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Archive | Regulatory

 

CMS releases new proposed PT regulations

The Centers for Medicare and Medicaid Services (CMS) has issued proposed regulations which would, among other things, includes regulatory revisions to the Clinical Laboratory Improvement Act Amendments of 1988 (CLIA 88). Specifically, the proposed rule would implement the “Taking Essential Steps for Testing Act of 2012” (Pub. L. 112-202). Enacted on December 4, 2012, the […]

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PT Referral Bill Becomes Law

 On December 4, 2012, President Obama signed into law H. R. 6118 — the Taking Essential Steps for Testing (TEST) Act of 2012. The new law, which passed the U. S. House of Representatives in September and the Senate in November by voice vote, resolves a longstanding unresolved issue with respect to CLIA enforcement – […]

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Dissecting the Supreme Court’s Obamacare Ruling

President’s Corner, Summer 2012

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ACOs: Do You Need a Consultant?

Rules establishing “Accountable Care Organizations” (ACOs) – a new health care payment and delivery reform model linking provider reimbursements to quality metrics – took effect in January. COLA is working on a few initiatives intended to better define how a laboratory should integrate into the ACO model. In the meantime, this article in Amednews examines […]

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COLA Engages Clients on Proposed Federal Rule

Several federal agencies have proposed amending the patient privacy provisions of two federal laws, the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and the Health Insurance Portability and Accountability Act of 1996 (HIPAA). In effect, the new rule – CMS-2319-P: Patients’ Access to Test Reports – would repeal exceptions to an individual’s right of access […]

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Accountable Care Organizations (ACOs): One Perspective

According to a recent article on AAFP’s “News Now” site, a nationally-recognized expert on healthcare payments and quality issues believes that primary care physicians, not hospitals, should take the lead on creating ACOs. Click here to read comments made by Harold Miller, executive director of the Center for Healthcare Quality and Payment Reform and president/CEO […]

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Credit: Architect of the Capitol

Federal Regulation of LDTs Proposed

Congressman Michael Burgess, M. D. (R-TX), a member of the House Energy and Commerce Committee, has introduced legislation to create a process through which so-called “Laboratory Developed Tests” (LDTs) would be regulated. The legislation – H.R. 3207, the Modernizing Laboratory Test Standards for Patients Act – would establish a notification and review process at CMS […]

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Industry News

Questions About New Lab Test Access Rule Addressed

The Centers for Medicare and Medicaid Services (CMS) prepared the following FAQ sheet answering questions about a proposed new rule to allow patients direct access to their testing results from previously-exempted labs. To view the proposed regulation, click here. Frequently Asked Questions CMS-2319-P: Patients’ Access to Test Reports 1. What are the proposed changes to […]

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Credit: Architect of the Capitol

New Federal Rule To Give Patients Direct Access to Lab Results

Several federal agencies have jointly proposed a rule which would allow patients to have direct access to lab test results, rather than having to go through their physicians. The proposed rule would amend the patient privacy provisions of two federal laws, the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and the Health Insurance Portability and […]

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