On December 13th, President Obama signed into law the 21st Century Cures Act.  The legislation authorizes $4.8 billion for the National Institutes of Health to fund new initiatives in precision medicine, cancer, neuroscience, and regenerative medicine.  The bill also provides $500 million over ten years for the Food and Drug Administration for the development of new drugs and devices and enhancing clinical trials.

The legislation includes certain provisions that will affect hospitals.  One significant provision is Section 16001, which exempts from the site-neutral payment provisions in the Bipartisan Budget Act of 2015, Section 603, hospital off-campus outpatient departments that were under development as of November 2, 2015.

Specifically, a hospital off-campus outpatient department will continue to receive Medicare outpatient prospective payment system (OPPS) payments if all of the following conditions are met:

  1. before November 2, 2015, the hospital had a binding written agreement with an outside unrelated party for the actual construction of the off-campus outpatient department;
  2. the Secretary of Health and Human Services receives from the hospital an attestation not later than 60 days after the date of enactment (February 11, 2017) that the outpatient department complies with the provider-based status requirements;
  3. the Secretary receives not later than 60 days after the date of enactment a written certification from the hospital’s chief executive officer or chief operating officer that the outpatient department met the mid-build requirement of the first condition;
  4. the hospital includes the off-campus outpatient department as part of the hospital on its enrollment form in accordance with the enrollment process; and
  5. not later than December 31, 2018, the Secretary will audit the hospital’s compliance with the mid-build requirement of the first condition.  If the Secretary finds as a result of the audit that the mid-build requirement was not met, the off-campus outpatient department will not be eligible for payment under the OPPS.  Note that if a hospital off-campus outpatient department is determined to satisfy the mid-build requirement, services furnished in such facility will be paid under the Medicare Physician Fee Schedule in 2017 and thereafter under the OPPS.

The enrolled bill as signed by the President is available at https://www.congress.gov/bill/114th-congress/house-bill/34/text.