Last Friday afternoon CMS released its eagerly anticipated final rule (the Final Rule) implementing the Protecting Access to Medicare Act of 2014 (PAMA), which, together with the Final Rule, will make sweeping changes to the...more
Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential...more
10/23/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Certificates of Compliance ,
Civil Monetary Penalty ,
CLIA ,
Clinical Laboratory Testing ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Food and Drug Administration (FDA) ,
Healthcare ,
Hospitals ,
Laboratories ,
Laboratory Developed Tests ,
Medicaid ,
Medicare ,
Sanctions
On September 25, 2015, the Centers for Medicare & Medicaid Services (CMS) announced publication of the proposed rule (the “Proposed Rule”) implementing substantial changes to the Medicare Clinical Laboratory Fee Schedule...more
9/29/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
Comment Period ,
Cost-Sharing ,
Data Collection ,
Diagnostic Tests ,
Medicaid ,
Medicare ,
Medicare Part B ,
MPFS ,
PAMA ,
Proposed Regulation ,
Reimbursements ,
Reporting Requirements
On July 7th, the House introduced much anticipated bipartisan telehealth legislation. The Medicare Telehealth Parity Act of 2015, introduced by Representative Mike Thompson (D-CA) and co-sponsored by Representatives Gregg...more
7/14/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Patients ,
Pending Legislation ,
Physicians ,
Telehealth ,
Telemedicine
In early April, Colorado joined multiple other states in passing a biosimilar substitution law that addresses the circumstances under which an FDA-approved interchangeable biosimilar product may be substituted for the...more
Drug and device manufacturers breathing a sigh of relief after completing their 2013 data submissions under the Physician Payment Sunshine Act (the “Sunshine Act’) must now contend with four proposed changes to the Sunshine...more
7/9/2014
/ Centers for Medicare & Medicaid Services (CMS) ,
Medicaid ,
Medical Devices ,
Medicare ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Physician Payments ,
Physicians ,
Prescription Drugs ,
Proposed Regulation ,
Reporting Requirements
With the June 30 deadline for Phase 2 Sunshine Act reports by pharmaceutical and medical device manufacturers (“Applicable Manufacturers”) and group purchasing organizations (“GPOs’) quickly approaching, the Centers for...more
Three weeks after the commencement of data collection under the Physician Payment Sunshine Act (the “Act”), the Centers for Medicare & Medicaid Services (“CMS”) continues to issue guidance to assist applicable manufacturers...more
With the August 1 deadline for data collection under the Physician Payments Sunshine Act (the “Act”) looming, CMS recently released two mobile applications (“Apps”) to help physicians and industry track payments and transfers...more
Yesterday, the Department of Health and Human Services (“HHS”) and the Department of Justice (“DOJ”) released their Annual Report for the Health Care Fraud and Abuse Control Program (the “Program”). The report highlights the...more