Publications

White Papers

White Papers
Date
Teaser
July 2017
“The Potential FDA Impact of the 2018 Presidential Budget Request”
June 2012
“Review and Analysis of CMS's 2006 MEDCAC Panel on Lumbar Fusion for Treatment of DDD”
September 2010
CHALLENGES IN IDE CLINICAL TRIALS: Study Enrollment & Reimbursement
July 2008
The Challenge of Orthobiologics: Navigating the Coverage and Reimbursement Landscape in a Complex Marketplace
February 2008
Pre-Clinical Testing of SpinalImplants:Safety Versus Substantial Equivalence
September 2007
European Regulatory Overview
September 2006
“Nucleus Arthroplasty™ From the U.S. Regulatory Viewpoint”

News Letters

News Letters
Date
Teaser
January 2013
The recent release of the Foreign Corrupt Practices Act (FCPA) Resource Guide by the U.S. Department
October 2012
FDA has released the long-awaited proposed final rule for implementation of the unique device identification (UDI) regulation passed by Congress in 2007.
July 2012
Patient Protection and Affordable Care Act: An Effort to Lower Cost and Reduce Waste
April 2012
The Confusion of Interspinous Plates
January 2012
CMS Requires Medicare Pre-Payment Audits for Cardiovascular and Orthopedic Procedures Effective Jan. 1
August 2009
U.S. Healthcare Finance Remains a Major Focus of Federal Regulators
June 2009
111th Congress Continues its Focus on US Health Care Reform
April 2009
Charles Schneider, Vice President of Reimbursement Musculoskeletal Clinical Regulatory Advisers, LLC
February 2009
Prepared By: CHARLES E. SCHNEIDER, VP of Reimbursement1-Musculoskeletal Clinical Regulatory Advisers, LLC
January 2009
Non-Surgical Treatment Options Can Address Chronic Pain Due to Lumbar Spinal Stenosis
December 2008
CHARLES E. SCHNEIDER, Vice President of Reimbursement Musculoskeletal Clinical Regulatory Advisers, LLC

Fact Book

Fact Book
Date
Teaser
2010
In 2010, the worldwide orthopedic industry is estimated to be an approximately $40 billion dollar market in end user revenues of orthopedic technologies. Orthopedic technologies are constantly evolving in all ways, including:
MCRA is not a law firm and neither provides legal advice to its clients nor can affirm the legal or regulatory validity of the materials of which it provides. MCRA recommends that its clients consult an attorney to discuss any legal issues that relate to its business and/or MCRA services