Drug and device manufacturers will need to update their reporting systems and provide new training to their sales staff in the coming years based on changes to the Physician Payment Sunshine Act included in the final opioid...more
Clinical laboratories and hospitals should note the potential changes to the Protecting Access to Medicare Act of 2014 (“PAMA”) reporting requirements tucked into the 1,400 page Physician Fee Schedule Proposed Rule (the...more
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
On October 30, 2014, the Centers for Medicare and Medicaid Services (“CMS”) announced the procedure for applicable manufacturers and group purchasing organizations (“GPOs”) to report payment and ownership information that was...more
As my colleague Brian Dunphy previously reported, CMS temporarily closed the Open Payments system earlier this month. Open Payments is the online system through which pharmaceutical and device manufacturers covered by 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
Last week, the Centers for Medicare & Medicaid Services (“CMS”) clouded the process for pharmaceutical and medical device manufacturers, and group purchasing organizations (“GPOs”), to register and submit reports under the...more
Seventy-four state and federal physician organizations, including the American Medical Association, recently asked the Centers for Medicare & Medicaid Services (“CMS”) to exclude textbooks and peer-reviewed medical journal...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
In anticipation of the start of data collection under the Physician Payments Sunshine Act, the Centers for Medicare & Medicaid Services (“CMS”) continues to issue guidance on data collection and reporting in an effort to...more
The Centers for Medicare & Medicaid Services (“CMS”) recently launched the National Physician Payment Transparency Program: OPEN PAYMENTS website, which provides Sunshine Act compliance resources, including Fact Sheets and...more
Originally published in the Health Care Fraud Report, 17 HFRA 219, on 03/06/2013.
The final rule (the ‘‘Final Rule’’) implementing the Physician Payments Sunshine Act (‘‘Sunshine Act’’), published in the Federal...more
The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more
2/5/2013
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Continuing Medical Education ,
Data Collection ,
Enforcement ,
GPOs ,
Medicaid ,
Medical Devices ,
Medical Supplies ,
Payment Records ,
Pharmaceutical Industry ,
Physicians ,
Reporting Requirements ,
Sunshine Act
The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more