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Issue Brief: New CMS Flexibilities

Issue Brief

April 10, 2020


The Centers for Medicare & Medicaid Services (CMS) has announced a number of new flexibilities for hospitals and other providers during COVID-19 response. These flexibilities touch on all areas of practice, so we encourage members to review the list in its entirety. Below, we have pulled out some of the flexibilities that are most directly applicable to hospital pharmacy practice.

New Waivers for COVID-19 Response

  • Verbal Orders: CMS is waiving many of the requirements around verbal orders, where read back is required, but authentication can take place within 48 hours. Under the waiver, verbal orders may be used for drugs and biologics. Orders no longer need to be dated, timed, or promptly authenticated. Pre-printed and electronic standing orders, order sets, and protocols can be used as needed. Finally, CMS is allowing medications to be administered without the supervision of a physician, registered nurse, or physician assistant in Critical Access Hospitals (CAHs). They are also allowing verbal order for CAHs, provided that the responsible practitioner authenticate the order in writing as soon as possible after it is given.
  • Sterile Compounding: To allow for conservation of scarce face masks, CMS is “waiving requirements (also outlined in USP <797> at 42 CFR §482.25(b)(1) and §485.635(a)(3) in order to allow used face masks to be removed and retained in the compounding area to be re-donned and reused during the same work shift in the compounding area only.” CMS notes that it will not review storage and use of face masks. However, this requirement conflicts with USP <797> requirements, so ASHP is seeking clarification from USP as to how to resolve the conflict between the USP and CMS requirements.
  • Physician Supervision: CMS is waiving the requirement that every hospital patient must be under the care of a physician. This is meant to allow hospitals more flexibility in deploying clinicians to care for patients. CMS notes that the waiver may “be implemented so long as it is not inconsistent with a state’s emergency preparedness or pandemic plan.” Theoretically, this means pharmacists could provide patient care services, however, there is no means provided to bill federal payers directly for those services.

Some states are also instituting looser supervision requirements for services during the emergency period. For example, Ohio recently announced that pharmacist services provided in pursuant to a pharmacist consult agreement can now be managed by a certified nurse practitioner, clinical nurse specialist, certified nurse midwife or physician assistant. This change is applicable on the hospital (inpatient and ambulatory) setting.

  • Claims Submission under Blanket Waivers: CMS also includes instructions for submitting claims under one of the blanket waivers that CMS has allowed during the declared emergency. Per CMS, “When submitting claims covered by the blanket waivers, the “DR” (disaster-related) condition code should be used for institutional billing (i.e., claims submitted using the ASC X12 837 institutional claims format or paper Form CMS-1450). The “CR” (catastrophe/disaster-related) modifier should be used for Part B billing, both institutional and non-institutional (i.e., claims submitted using the ASC X12 837 professional claim format or paper Form CMS-1500 or, for pharmacies, in the NCPDP format). This requirement does not apply for purposes of compliance with waivers (blanket or individual) of sanctions under the physician self-referral law.”

Applicability and Timing

It is important to note that these waivers are effective nationwide and are retroactive to March 1, 2020. Although we know the waivers are time-limited to allow effective COVID-19 response, CMS has not indicated how they will retract waivers once the patient surge slows down. Additionally, CMS has noted that its Inspector General and enforcement section will continue to review compliance throughout the emergency period.