Regulatory Issues

Advocates Urge Congress to Finalize 21st Century Cures

August 2, 2016

Congress returns in September from a seven-week recess—and ready, many patients and advocates hope, to push the 21st Century Cures Act over the finish line. Senator Lamar Alexander (R-Tenn.) expects the Senate to resume work on the bill, which he says could be “the most important legislation Congress passes this year.” The bill passed the House of Representatives in July 2015 with bipartisan support.

FDA Hearings Underscore Need for Clear Policy on Biosimilars

July 20, 2016

July 12 and 13 hearings of the FDA’s Arthritis Advisory Committee cleared the way for two new biosimilars, adalimumab and etanercept. The committee unanimously supported manufacturers’ applications for the drugs – but that wasn’t the only point of consensus. Participants and even committee members expressed concerns about unfinished regulatory policy and the need to prioritize patient safety.

CMS Models Shake Up Cancer Care

July 7, 2016

The Centers for Medicare and Medicaid Services’ Oncology Care Model is off and running. As announced during The White House’s cancer summit at Howard University, more than 200 physician practices and 3,200 oncologists have enrolled – effective July 1.

A Reality Check on Health Care Value Models

June 23, 2016

High drug prices have led to a proliferation of value models that investigate how the United States can control ballooning health care costs. But just how realistic are these models – and their implementation?

Patients May Face Premium Spikes for 2017 Health Plans

June 9, 2016

Health care in 2017 is shaping up to be expensive. Citing financial losses, private insurers who offer health plans through an Affordable Care Act exchange want to increase their premiums – some by double digits.