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CMS Announces New Provider Rules to Aid the COVID-19 Response
The Centers for Medicare & Medicaid Services (CMS) announced April 30 a second set of wide-reaching regulatory changes in response to the COVID-19 pandemic. These changes feature several augmentations of previously instituted reforms as well as brand new policies in response to continued stakeholder feedback. Below is a summary analysis of several provisions that may be relevant to SHEA members’ institutions or scope of practice.
Update to the Hospital Value-Based Purchasing (VBP) Program Extraordinary Circumstance Exception (ECE) Policy 
CMS details that in 2014, the agency finalized an ECE policy for the Hospital VBP Program to mitigate any adverse impact on quality performance as a direct result of unforeseen circumstances outside of the hospital’s control and the resulting impact on their value-based incentive payment amounts. Due to the overwhelming and widespread nature of the COVID-19 PHE, CMS is updating the ECE policy to include the ability to grant exceptions to hospitals located in entire regions without a request, rather than individual hospitals submitting requests. CMS notes that the agency will communicate the decision to hospitals when the determination to grant an exception to all hospitals in a region has been made.
Requirement for Facilities to Report Nursing Home Residents and Staff Infections, Potential Infections, and Deaths Related to COVID-19
CMS establishes explicit reporting requirements for confirmed or suspected cases of COVID-19 in long term care facilities to support surveillance efforts. The report, that is to be submitted to the Centers for Disease Control and Prevention (CDC), should include the following information: 
  • Suspected and confirmed COVID-19 infections among residents and staff; including residents previously treated for COVID-19; 
  • Total deaths and COVID-19 deaths among residents and staff; 
  • Personal protective equipment and hygiene supplies in the facility; 
  • Ventilator capacity and supplies available in the facility; 
  • Resident beds and census; 
  • Access to COVID-19 testing while the resident is in the facility; 
  • Staffing shortages; and 
  •  Other information specified by the HHS Secretary.
CMS notes that facilities will be required to provide the information at a frequency specified by the HHS Secretary, but no less than weekly. Additionally, the agency notes that the information will be shared CMS and the information will be publicly reported. 
 
CMS will also require facilities to inform residents, their representatives, and families of those residing the in facilities of confirmed or suspected COVID-19 cases in the facility among residents and staffs. CMS explains that this requirement ensures that all residents are informed participants in the care that they receive.
Modified Requirements for Ordering COVID-19 Diagnostic Laboratory Tests
The interim final rule temporarily eliminates the requirement that the treating physician or NPP order a covered diagnostic laboratory test for COVID-19 or for influenza virus or a similar respiratory condition. During the PHE, any healthcare professional authorized under state law to do so can order such tests, and they will be covered by Medicare. CMS will publish a list of covered diagnostic laboratory tests for which ordering requirements are modified.
COVID-19 Serology Testing 
CMS finalizes, on an interim basis, that FDA-authorized COVID-19 serology tests fall under the Medicare benefit category of diagnostic laboratory test and are eligible to be covered by the Medicare program. CMS explains that serology tests may potentially aid in identifying patients who have had an immune response to COVID-19 infection and are therefore immune and do not pose a risk to the community.
Payment for COVID-19 Specimen Collection to Physicians, Nonphysician Practitioners and Hospitals
In the March 31st IFC, CMS established a nominal specimen collection fee and associated travel allowance for independent laboratories that collect specimens for COVID-19 clinical diagnostic laboratory testing. CMS did so for homebound and non-hospital inpatients. 
 
These services are described by CPT code 88211. In the IFC, CMS further establishes that, for the duration of the COVID-19 public health emergency, providers may furnish such services for both new and established patients. This amends the current billing rules that require providers to have an established relationship with a patient before clinical staff can furnish such services. 
In addition, CMS is also creating a new E/M code to support COVID-19 testing for hospital outpatient departments (HOPDs) during the public health emergency. The new code is: HCPCS code C9803 (Hospital outpatient clinic visit specimen collection for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) (coronavirus disease [covid-19]) any specimen source.) 

CMS clarifies that it expects to retire the new code once the public health emergency concludes.
Scope of Practice
The interim final rule makes several policy changes intended to expand the number of healthcare professionals able to furnish COVID-19 related tests and services. 
  • Diagnostic Tests – The interim final rule allows a nurse practitioner, clinical nurse specialist, physician assistant, or a certified nurse-midwife to order, furnish directly, and supervise the performance of COVID-19 related diagnostic tests, subject to applicable scope of practice state laws, during the PHE. In addition, the interim final rule requires the physician or qualified NPP order the diagnostic test to document medical necessity in the beneficiary’s medical record. 
  • Therapy – The interim final rule allows an occupational therapy assistant (OTA) or physical therapy assistant (OTA) to furnish “maintenance therapy” services during the PHE. 
  • Student Documentation – The interim final rule allows qualified clinicians to review and verify, rather than re-document, notes in the medical record made by physicians, residents, nurses, and students (including students in therapy or other clinical disciplines), or other members of the medical team during the PHE. 
  • Pharmacists – The interim final rule allows pharmacists to work with a physician or other qualified non-physician practitioner (NPP) to provide assessment and special collection services, under the supervision of the billing physician or NPP, if the service is not reimbursed under the Medicare Part D benefit during the PHE.
CMS is seeking public feedback on the number of states where these changes would be implemented.
Medical Education
For the purposes of calculating the indirect medical education (IME) adjustment, the interim final rule allows a hospital’s available bed count to be the same as it was on the day before the PHE was declared. Similarly, the teaching status adjustment payment for inpatient rehabilitation facilities and inpatient psychiatric facilities will remain the same as it was on the day before the PHE was declared. In addition, the interim final rule allows a hospital that sends its residents to train at another hospital to claim those FTE residents on its Medicare cost report if it meets certain conditions.
Additional Flexibility under the Teaching Physician Regulations
CMS expands on flexibilities that were offered to teaching physicians and residents in the March 31, 2020 IFC, to allow that, on an interim basis for the duration of the PHE for the COVID-19 pandemic, a teaching physician may not only direct the care furnished by residents remotely, but also review the services provided with the resident, during or immediately after the visit, remotely through virtual means via audio/video real time communications technology. Additionally, the rule adds additional services to the primary care exception so that Medicare may make PFS payment to the teaching physician for such services when furnished by a resident.
Treatment of Certain Relocating Provider-Based Departments During the COVID-19 PHE 
The interim final rule temporarily expands the “extraordinary circumstances relocation policy” to include on-campus provider-based departments that relocate off-campus during the PHE in order to address the COVID-19 pandemic. Specifically, on-campus departments that relocate on or after March 1, 2020 through then end of the PHE may bill at the OPPS rate, provided the relocation is consistent with the state’s emergency preparedness or pandemic plan.
Furnishing Hospital Outpatient Services in Temporary Expansion Locations of a Hospital or a Community Mental Health Center (including the Patient’s Home) 
The interim final rule clarifies the following: 
  • Hospital and Community Mental Health Center (CMHC) staff can furnish certain outpatient therapy, counseling, and educational services to a beneficiary in their home or other temporary expansion location using telecommunications technology if the beneficiary is registered as a hospital outpatient; 
  • Hospitals can furnish clinical services (e.g., drug administration) in the patient’s home and bill and be paid for these services if the patient is registered as an outpatient; 
  • A hospital may bill the originating site facility fee for the delivery of a professional service via telehealth to a patient registered as an outpatient.
Payment for Audio-Only Telephone Evaluation and Management Services
In the March 31 IFC, CMS established separate payment for audio-only telephone evaluation and management (E/M) services (CPT Codes 99441, 99442, 99443). Since that time, CMS says it has learned that use of audio-only services is more prevalent than it had previously considered and is serving as a substitute for office/outpatient Medicare telehealth visits for beneficiaries not using video-enabled telecommunications technology. Therefore, in this new IFC, CMS establishes new relative value units (RVUs) (i.e. higher reimbursement rates) for the telephone E/M services based on crosswalks to the most analogous office/outpatient E/M codes.
Updating the Medicare Telehealth List 
CMS states that, for the duration of the public health emergency, it will now use a subregulatory process to modify the services included on the Medicare telehealth list. CMS states it is doing so to expedite the addition of approved services, as the current mechanism for adding new services currently employs the standard notice and comment rulemaking process. Though CMS does not codify the exact subregulatory process it will use to update the telehealth list, it states it may notify providers when it has added new services by posting such information to the web listing of telehealth services. CMS clarifies these services would remain on the list only during the COVID-19 public health emergency. See the discussion beginning at the bottom of p. 182. 
 
This summary analysis is provided to SHEA members for informational purposes only. Questions and comments should be sent to Lynne Batshon at lbatshon@shea-online.org.
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