The Centers for Medicare and Medicaid Services (CMS) has provided preliminary guidance regarding two sections of the 21st Century Cures Act.

Section 16001 focuses on continuing Medicare payment under HOPD prospective payment system for services furnished by mid-build off-campus outpatient departments of providers. The provision provides for an exception to Section 603 of the Bipartisan Budget Act of 2015 for certain off-campus provider-based outpatient departments that were “mid-build” prior to Nov. 2, 2015 to continue to bill under the hospital outpatient prospective payment system (OPPS) rather than the physician fee schedule. “Mid-build” is defined as a provider that had a binding written agreement with an outside unrelated party for the actual construction of the department.

  • For 2017: If the Secretary received from a provider prior to Dec. 2, 2015, an attestation that a department was a department of a provider in accordance with the regulations at 42 CFR 413.65(b)(3), such department will be deemed to be “excepted” from payment under section 1833(t)(21)(C) of the Act. Accordingly, such departments will be paid for covered outpatient services under the OPPS and should not use modifier ‘PN’ which would trigger payment under the Medicare Physician Fee Schedule (MPFS). Such departments shall continue to report the ‘PO” modifier as appropriate.
  • For calendar year 2017, all other applicable off-campus departments of a provider that did not meet the attestation requirement to be deemed excepted for 2017, shall use modifier ‘PN’ as described in the CY 2017 OPPS final rule with comment period and interim final rule with comment period, including those that anticipate meeting the exception requirements for 2018 and subsequent years.
  • For 2018: An off-campus department of a provider that meets the specified requirements may continue to bill under the OPPS, rather than the physician fee schedule, for services furnished on or after January 1, 2018. Hospitals must submit specified materials to their Medicare Administrative Contractor no later than February 13, 2017.

The other guidance pertains to Section 16002: Treatment of cancer hospitals in off-campus outpatient department of a provider policy. The provision allows certain off-campus provider-based departments of cancer hospitals to continue to bill under the OPPS during 2017 or a subsequent year if the department met the requirements of 42 CFR 413.65 after Nov. 1, 2015 and before Dec. 13, 2016, and the Secretary receives an attestation that such requirements were met no later than Feb. 13, 2017. Alternatively, for certain off-campus provider-based departments of cancer hospitals that meet the requirements of 42 CFR 413.65 after Dec. 13, 2016, applicable items and services furnished by such department will be excepted and such department may continue to bill under the OPPS if the Secretary receives from the provider an attestation that such requirements were met no later than 60 days after the date such requirements are first met by such department.

More information is available here, and additional guidance on these sections may be forthcoming at a later date.