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The focus of the 21st Century Cures Act (the Act) is on pharmaceutical and medical device research, development, and regulatory oversight and approval.  But there are also several key provisions that will greatly benefit hospitals and physicians in the near term.

Mid-Build Off-Campus Provider-Based Departments: Very good news for hospitals: The Act provides relief to hospitals with off-campus provider-based departments (PBDs) that were under development but were not billing for services as of November 2, 2015 when the moratorium on new PBDs became effective. For 2017, a hospital may bill for services provided in a PBD under the Outpatient Prospective Payment System (OPPS) if the hospital was providing services in that PBD prior to November 2, 2015 and if it submitted prior to December 2, 2015 a provider-based attestation (under 42 C.F.R. 413.65(b)(3)) attesting that the PBD met the requirements to bill as a department of the hospital (found at 42 C.F.R. 413.65). Beginning in 2018 and continuing thereafter, a hospital may bill for services provided in a PBD under the OPPS if the hospital meets the following requirements: 1. The hospital submits to the Centers for Medicare & Medicaid Services (CMS) a provider-based attestation no later than sixty days following passage of the Act; 2. The hospital includes the PBD as part of the provider on its Medicare enrollment form; 3. Prior to November 2, 2015, the hospital had entered into a binding written agreement with an outside unrelated third-party for the construction of the PBD (known as the Mid-Build Requirement); and 4. Within sixty days of the passage of the Act, the hospital’s CEO or COO provides to CMS (and CMS receives) a written certification that the PBD met the Mid-Build Requirement. While the Act effectively mandates attestations for hospitals with mid-build PBDs, the good news is that it provides this narrow exception and timing window allowing hospitals to bill for services provided in these PBDs under OPPS. Time is the of the essence; hospitals should move quickly to prepare the attestation and pull together the necessary supporting documentation.  Guidance on the attestation format and process is available online through CMS and Medicare Administration Contractors.

Changes to Electronic Health Records Requirements: The Act looks to address two recurring issues with electronic health records systems (EHR). The first is continuing concerns regarding the regulatory requirements governing the documentation that must be included in the EHR, which slow the pace at which practitioners can complete medical record documentation following a patient encounter.  The Act requires the Department of Health and Human Services (HHS) to work with providers, payors, and the health information technology industry to establish a goal to reduce regulatory requirements relating to use of EHR.  HHS will have one year to put together a strategy to meet that goal. This provision of the Act will require a far-reaching evaluation by federal health care regulators, which will take some time, but the ultimate goal is to better balance documentation needs with patient care work flow. The second issue relates to concerns about data-blocking -- the purposeful blocking of permissible EHR data sharing among providers or with patients. This is an issue that the Office of the National Coordinator for Health IT encouraged Congress to act on last year. The Act provides HHS’ Office of the  Inspector General with the authority to investigate allegations of data-blocking and impose civil penalties in the event of it finds instances of data-blocking.

EHR Incentive Program Exception for Ambulatory Surgery Center Physicians:  Finally, physicians who provide substantially all of their professional services to Medicare beneficiaries in an ambulatory surgical center will be exempt from Merit-Based Incentive Payment System EHR Incentives Program (and the accompanying penalties for not adopting a certified EHR). This protection from being penalized was previously available to hospital-based physicians and has been extended to physicians practicing in surgery centers.  The exception will expire three years after HHS approves a certified EHR for ambulatory surgery centers.

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For additional information and discussion on this topic, please get in touch with your regular Calfee contact or the attorney listed below: Michael G. VanBuren 216-622-8343

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