Last week, the FDA released a draft guidance titled Product Identifier Requirements Under the Drug Supply Chain Security Act--Compliance Policy, with a 60-day comment period ending around September 3, 2017.
With the federal response to the opioid crisis still under development, state and local governments continue to file lawsuits against the pharmaceutical companies that manufacturer these products, accusing them of misleading doctors and consumers about the risks of addiction.
On June 21, the Food and Drug Administration announced a Drug Competition Action Plan in order to attempt to address ways that the agency's rules have been, in the agency's view, “gamed” to create obstacles that delay generic drug approvals to reduce generic competition.
In a move that practically all Medicare providers, suppliers, and Clinical Laboratory Improvement Amendments laboratories will welcome, the Centers for Medicare & Medicaid Services has declared that Plans of Correction and Allegations of Compliance no longer must be input directly onto the Statement of Deficiencies form (also known as “Form 2567”).
Earlier this year, ransomware known as Wannacry crippled Britain’s National Health Service and spread across the globe affecting many other organizations, large and small. Now, many organizations are grappling with a new onslaught caused by similar ransomware dubbed Petya.
Nevada is the latest state in the Union to adopt some form of a drug pricing transparency law, after Nevada Governor Brian Sandoval signed Senate Bill No. 539 into law on June 15, 2017. The breadth and scope of this particular bill is unlike any other transparency bill that we have seen to date, and has the potential to impact not only the manufacturers of the narrow class of drugs the bill focuses on, but all manufacturers with sales forces in Nevada, as well as non-profit patient assistance programs.
After weeks of closed-door meetings about the content of the Senate’s health care bill, Senate Republicans released a “discussion draft” of their legislation on Thursday. The bill, titled the “Better Care Reconciliation Act of 2017” or BCRA, is the Senate’s response to the bill passed by the House of Representatives in May.
Medical providers seeking to pursue state law claims for payment from health care payers scored a win in the Second Circuit last month in a holding that affirms providers’ ability to hold health care insurers and other payers to their payment representations and promises.