Cooley Partner with NY Health Business Leaders

“Cooley is proud to partner with NY Health Business Leaders on their Q2 2018 NYC Healthcare Investment Update.  In the second quarter of 2018, both deal volumes and aggregate dollars raised remained at historically high levels. In Q2 2018, Cooley handled 224 disclosable deals, representing more than $7.5 billion of […]

Revisions to New Jersey Prescriber Gift Ban Law Proposed – Comments Due October 5th

Revisions to the Limitations on and Obligations Associated with Prescriber Acceptance of Compensation from Pharmaceutical Manufacturers law, N.J.A.C. 13:45J-1.1 et seq. (NJ Gift Ban Law), have been proposed by the New Jersey Attorney General. The NJ Gift Ban Law, originally adopted effective January 16, 2018 and previously discussed on this blog, drew […]

OIG Releases Report Re: Open Payments Program

The Health and Human Services Office of Inspector General (OIG) recently released a report on its review of the Open Payments program, titled “OPEN PAYMENTS DATA: REVIEW OF  ACCURACY, PRECISION, AND CONSISTENCY IN REPORTING.” The OIG reviewed data from calendar year 2015 available as of June 2016. The OIG’s key takeaway […]

CMS Releases Guidance Allowing Step Therapy for Part B Drugs

Today, the Centers for Medicare & Medicaid Services (CMS) released guidance and a Fact Sheet that will provide Medicare Advantage (MA) plans the option of utilizing “step therapy”  for Medicare Part B drugs.   Recall, the concept of changing the way Medicare pays for Part B drugs was first discussed in the Administration’s May 2018 Blueprint.

FDA Releases Draft Guidance Regarding Indications and Usage Section of Drug Labeling

The U.S. Food and Drug Administration (FDA) announced today the availability of a new draft guidance titled, “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.” This draft guidance provides insight into the FDA’s current thinking related to the INDICATIONS AND USAGE section […]

CMS Requests Information Regarding The Stark Law’s Potential Barriers to Coordinated Care

On June 25, 2018, the Centers for Medicare and Medicaid Services (“CMS”) published a Request for Information (“RFI”) in the Federal Register regarding section 1877 of the Social Security Act, also known as the “physician self-referral law” or the “Stark Law”. The Stark Law is a strict liability statute that: […]

CMS Releases 2017 Open Payments Data

The Centers for Medicare & Medicaid Services (CMS) released today the 2017 data disclosed by 1,525 manufacturers and group purchasing organizations (GPOs) related to payments and transfers of value provided to physicians and teaching hospitals, as well as ownership or investment interests held by physicians and their immediate family members. […]