December 1, 2016
On Wednesday, November 30, the House passed the 21st Century Cures legislation 392-26, sending the sweeping FDA and CMS reform package to the Senate. Senate health committee Chairman Lamar Alexander (R-TN) says the bill has bipartisan support and will pass the Senate despite objections from Senators Elizabeth Warren (D-MA) and Bernie Sanders (I-VT) over certain provisions. President Obama threw his strong support behind the latest version of 21st Century Cures compromise legislation prior to the House floor vote and is expected to sign the measure.
Rep. Fred Upton (R-MI) and Sen. Lamar Alexander (R-TN) released the 996-page draft of the 21st Century Cures Act late last week, which would provide more than $4.8 billion over a decade to the National Institutes of Health for the Precision Medicine Initiative, the BRAIN Initiative and the Cancer Moonshot, as well as for regenerative medicine. The measure would also provide $500 million to the Food and Drug Administration over 10 years and $1 billion over two years for states responding to the opioid crisis.
The Bipartisan Budget Act of 2015 directs CMS to pay lower doctor-office rates to physician practices that hospitals buy and turn into outpatient departments. The policy applies to off-campus outpatient facilities that were not billing Medicare as of Nov. 2, 2015, and the pay cuts take effect the beginning of next year. The compromise 21st Century Cures bill includes language specifying that hospital outpatient departments that were in development when the site-neutral law took effect Nov. 2 of last year are exempt from Medicare site-neutral pay cuts.
The American Hospital Association (AHA) has praised the Cures Compromise but has indicated it will still lobby Congress and the Administration to make it easier to secure exemptions to the site-neutral policy. AHA may find Congress willing to grant more exceptions as Republicans have indicated their intention to use the Congressional Review Act to undo many regulatory changes that CMS has made.
SNMMI is currently preparing comments on the final rule that would implement the current CMS proposals for site neutral. SNMMI commends CMS for reevaluating and amending its original proposal. However, the society has concerns with the way CMS has chosen to pay for most services.
Sunshine ACT Provisions Remain in Cures
Responding to a threat from Sen. Charles Grassley (R-IA) to block a Senate vote on compromise 21st Century Cures legislation, the bill's two Sunshine Act exemptions have been removed from the bicameral deal. The exemptions would have excluded any education-related payments from reporting as part of the Open Payments Program, which the 2010 Sunshine Act, co-authored by Grassley, set up to track how drug and device manufacturers pay doctors.
In a November 29th statement, Senator Grassley noted “This is good news for transparency and the public. The Sunshine Act works as is. Billions of dollars in drug and device company payments to doctors have been disclosed for public benefit. With drug prices through the roof, the way drug and device makers spend money is of more public interest than ever. Given this change, I no longer plan to object to the Cures Act.”