Articles and Blogs

New draft guidance (“Draft Guidance”) from the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) strongly highlights the need for Institutional Review Boards (“IRBs”) overseeing human subject research to keep detailed minutes of their meetings. Doing so, according to the Draft Guidance, will demonstrate to the IRBs’ research institutions…Read More

While hospitals have spent much of November 2015 grappling with the fallout of the Budget Act’s restriction on off-campus hospital outpatient departments (“HOPD”) (see Hall Render’s previous articles on the restriction, available here and here), another provider-based issue has quietly gone viral among interested parties, as well as being reported in local news outlets.  CMS…Read More

On November 16, 2015, the Centers for Medicare & Medicaid Services (“CMS”) issued a public inspection copy of the Final Rule related to the mandatory bundled payment program known as the Comprehensive Care for Joint Replacement (“CJR”) Model.  The CJR Model is a retrospective bundled payment program for lower extremity joint replacement (“LEJR”) procedures performed…Read More

Overview On October 30, 2015, the Centers for Medicare & Medicaid Services (“CMS”) announced the final rule (“Final Rule”)1 in follow up to the proposed rule published in July 2015 pertaining to payment policies under the Physician Fee Schedule for CY 2016 (“Proposed Rule”). In addition to changes to the Physician Fee Schedule and other updates…Read More

CMS Issues Final Joint Replacement Payment Rule On November 16, CMS released a final payment rule that creates bundled payments for hip and knee replacement surgery performed at most acute care hospitals in 67 geographic areas of the country. Under a model known as Comprehensive Care for Joint Replacement (“CJR”), a hospital where a joint…Read More

On October 27, 2015, the IRS released final allocation and accounting regulations for tax-exempt bonds (the “New Regulations”).  The New Regulations, which can be found here, make three major changes for issuers and borrowers of tax-exempt bonds, in that they:  (1) increase flexibility for how qualified equity is allocated to projects financed both with tax-exempt…Read More

On November 16, 2015, the Centers for Medicare & Medicaid Services (“CMS”) issued a public inspection copy of the “Final Rule” related to the Comprehensive Care for Joint Replacement (“CJR”) Model.  Also on November 16, CMS and the Office of the Inspector General (“OIG”) jointly issued notice of waivers of certain fraud and abuse laws in…Read More

CMS Makes Changes to RAC Program Processes On November 6, CMS announced that the number of medical records a recovery audit contractor (“RAC”) can request from health care providers to support audits is 0.5 percent of a facility’s total amount of paid Medicare claims from the previous year. Currently, the limit on the amount of documents…Read More

The Department of Health and Human Services Office of Inspector General (“OIG”) issued a report in June1 that is the equivalent of a “strongly worded letter” to the Centers for Medicare & Medicaid Services (“CMS”) for not implementing OIG’s past recommendations to prevent and combat fraud in the Medicare Part D Program (“Program”).  In July, Ann…Read More

The U.S. Department of Justice (“DOJ”) recently announced a $2.3 million settlement1 with a Hospital in Massachusetts (“Hospital”) to resolve allegations of Hospital’s failure to provide controls and safeguards against controlled substance diversion in violation of the Controlled Substances Act (“CSA”).2 According to the DOJ’s press release, this is the largest settlement related to drug…Read More