Written by Tom Crane and Brian Dunphy On March 23, 2012, the Department of Health and Human Services (HHS) issued its statutorily required report to Congress (Report) describing the implementation of the Medicare Physician Self-Referral Disclosure Protocol (SRDP) and the status of disclosures under the SRDP to date. The SRDP was authorized by the Affordable Care… Continue Reading
Category Archives: Clinical Laboratories
Subscribe to Clinical Laboratories RSS FeedMassachusetts Corporate Practice of Medicine Regulations Finalized
Posted in Clinical Laboratories, Home Health & Hospice, Hospitals & Health Systems, Long-term Care/Skilled Nursing Facilities, PhysiciansWritten by Rachel Irving and Ellen Janos The Massachusetts Board of Registration in Medicine recently released final revised physician licensing and discipline regulations, effective February 1, 2012. The final regulations mark the end of a six-year process to overhaul these regulations. Although the disciplinary regulations generated a great deal of controversy within the physician and hospital community,… Continue Reading
OIG Questions Laboratory Management Arrangement in Advisory Opinion 11-17
Posted in Clinical LaboratoriesWritten by Karen Lovitch and Stephanie Willis The OIG addressed yet another proposed laboratory management arrangement in OIG Advisory Opinion 11-17, which concerns a proposal by a laboratory management services company (“Requestor”) to enter into exclusive contracts with various primary care physicians and physician practices (collectively, “Physicians”) to operate allergy testing laboratories in the Phyiscians’… Continue Reading
Blood Samples Protected by State Genetic Privacy Law
Posted in Clinical Laboratories, Clinical Trials & Research/FDA, Privacy & Security/HIPAA/HITECH, UncategorizedWritten by Dianne Bourque and Thomas Williams On November 16th, the Minnesota State Supreme Court held that a blood sample itself is protected information under the Minnesota Genetic Privacy Act (the“GPA”). The decision arose out of a suit brought by nine families of newborns’ whose blood had been collected, tested, and retained by the state under… Continue Reading
CMS Publishes Final Medicare Physician Fee Schedule for CY 2012
Posted in Clinical Laboratories, Health Care Reform, Physicians, ReimbursementYesterday CMS released the Medicare Physician Fee Schedule Final Rule for CY 2012, along with a press release and fact sheet summarizing key issues, which include: imposition of a 27.4% payment reduction based on the Sustainable Growth Rate (SGR), absent subsequent action by Congress (which it has taken every year but one since the SGR formula was… Continue Reading
OIG Advisory Opinion 11-15 Nixes Laboratory Management Services Joint Venture
Posted in Clinical Laboratories, Fraud & Abuse, Pharma & Medical DevicesIn an Advisory Opinion long awaited by many in laboratory industry, the OIG concluded that a proposed arrangement that would have allowed physicians to profit from their own referrals for anatomic pathology services would “pose more than a minimal risk of fraud and abuse.” The American Clinical Laboratory Association and other industry organizations have been… Continue Reading
Proposed CLIA and HIPAA Amendments Would Increase Patient Rights and Administrative Burden for Labs
Posted in Clinical Laboratories, Privacy & Security/HIPAA/HITECHWritten by Dianne Bourque and Karen Lovitch CMS has announced the publication of a proposed rule that will require HIPAA-covered laboratories to make test results available to patients no later than 180 days after the rule’s effective date, which will be 60 days after publication in tomorrow’s Federal Register. In other words, laboratories, many of which interface with patients… Continue Reading
OIG: B-15 Exclusion of Individuals
Posted in Clinical Laboratories, Fraud & AbuseWritten by Ellyn Sternfield Sometime on August 5, 2011, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) blinked. In late 2010, OIG effectively warned the health care provider community that it would begin exercising its discretionary “B-15” authority to exclude individual owners, officers and managing employees of sanctioned entities from… Continue Reading
