The government recently took the unusual step of filing an amicus brief in a civil case involving Stark Law and Anti-Kickback Statute (“AKS“) issues. See, Ameritox, Ltd. v. Millennium Laboratories, Inc., Case No. 14-14281 (U.S. Court of Appeals for the 11th Circuit). The amicus brief provides insight into – and…
On January 20, 2015, the Food and Drug Administration (“FDA”) published two draft guidance documents that revealed its way of thinking on the regulation of low risk general wellness products and regulation of medical device accessories. Broadly speaking, the proposed guidance indicates that the FDA will not regulate low risk…
According to a new report from the Office of Inspector General (“OIG”) published on January 13, 2015, the OIG is concerned with the financial incentives created by the current Medicare payment system with regard to hospice beneficiaries in assisted living facilities. For example, hospices received significantly higher Medicare payments for…
The 2015 Home Care Prospective Payment Final Rule (effective January 1, 2015), relaxes the face-to-face encounter regulations as set forth by the Patient Protection and Affordable Care Act (“PPACA”). During an open door forum held on December 16, 2014, CMS announced that it modified documentation requirements “in an effort to…
On December 18, 2014, a U.S. District Court judge dismissed a lawsuit the American Hospital Association (“AHA”) filed against the Department of Health and Human Services (“HHS”) seeking HHS to process their administrative appeals in accordance with statutory timelines. In its order, the Court acknowledged that the Office of Medicare…
The Centers for Medicare and Medicaid Services (“CMS”) is charged with the implementation of the Physician Payments Sunshine Act. CMS developed the Open Payments Program to keep track of data on consulting fees, research grants, travel reimbursements and other gifts made by certain manufacturers and organizations to physicians and teaching…
On October 31, 2014, the Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) released its Fiscal Year (“FY”) 2015 Work Plan summarizing its new and ongoing investigative, enforcement, and compliance priorities for the upcoming fiscal year. For FY 2014, the OIG reported recoveries of over…
In a letter dated December 4, 2014, the American Hospital Association (“AHA”) submitted comments in response to the Office of Medicare Hearings and Appeals (“OMHA”) request for information on current and potential initiatives to resolve the current backlog of appeals at the administrative law judge (“ALJ”) level. In its letter,…
In a letter dated December 3, 2014, the American Medical Association (“AMA”) urged the Centers for Medicare and Medicaid Services (“CMS”) to resolve the two-year backlog of Medicare and Medicaid appeals. The AMA noted that while it appreciated the recent efforts of the Office of Medicare Hearings and Appeals (“OMHA”)…
In the December 2014 issue of BCBSM’s The Record, BCBSM reminds pharmacies that the following documents should be available to BCBSM if contacted for an audit in order to avoid preventable findings which could result in significant financial recoupment: Prescriptions. Original prescriptions for written and verbal orders must be submitted…